ABSORB-III: ABSORB III Randomized Controlled Trial (RCT)

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT01751906
Collaborator
(none)
2,008
192
2
94
10.5
0.1

Study Details

Study Description

Brief Summary

The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).

The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.

Condition or Disease Intervention/Treatment Phase
  • Device: Absorb BVS
  • Device: XIENCE
N/A

Detailed Description

ABSORB III RCT:
  1. Primary Objective: The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.
B. Powered Secondary Objectives:
  1. Lead-In Phase Objective: To evaluate the applicability and transferability of the didactic Absorb BVS physician training plan to US clinical practice.

The lead-in phase is a non-randomized, single-arm, open label group of up to 50 subjects treated with Absorb BVS at up to 35 US sites. The Lead-In phase will enroll/register subjects prior to the randomization phase of ABSORB III.

The Lead-In Phase allows the treatment of up to two de novo native coronary artery lesions in different epicardial vessels with reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 3.25 mm and lesion lengths ≥ 8 to ≤ 14 mm.

  1. Imaging Cohort Objective: To evaluate long-term vascular function and patency of the Absorb BVS treated segments compared to XIENCE treated segments in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

The imaging cohort-phase is a prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-center trial, registering approximately 200 subjects. This includes 150 subjects for the angiographic/intravascular ultrasound (IVUS) endpoints analysis and approximately 50 subjects for optical coherence tomography (OCT) endpoints analysis. The 200 subjects are separate from the 2000 subjects included in the primary analysis. Data from two powered secondary endpoints from this cohort will support label claims of superiority of Absorb BVS as compared to XIENCE specific to vasomotion and late lumen enlargement.

All other subjects in ABSORB III unless specified will receive treatment of up to two de novo native coronary artery lesions in different epicardial vessels with RVD ≥ 2.5 mm to ≤ 3.75 mm and lesion lengths ≤ 24 mm.

Study Design

Study Type:
Interventional
Actual Enrollment :
2008 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions.
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Absorb BVS

Subjects receiving Absorb BVS

Device: Absorb BVS
Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

Active Comparator: XIENCE

Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition

Device: XIENCE
Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

Outcome Measures

Primary Outcome Measures

  1. Number of Cardiac Death/TV-MI/ID-TLR (TLF) [1 year]

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Secondary Outcome Measures

  1. Number of Participants With Powered Secondary Endpoint: Angina [1 year]

    Angina is defined as the first adverse event resulting in the site diagnosis of angina.

  2. Number of Participants With Powered Secondary Endpoint: All Revascularization [1 year]

    This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.

  3. Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR) [1 year]

    This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.

  4. Acute Success- Device Success (Lesion Level Analysis) [On day 0 (the day of procedure)]

    Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.

  5. Acute Success: Procedural Success (Subject Level Analysis) [On day 0 (the day of procedure)]

    Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).

  6. Number of Death (Cardiac, Vascular, Non-cardiovascular) [0 to 5 years]

    DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

  7. Number of Participants With All Myocardial Infarction (MI) [0 to 5 years]

    Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)

  8. Number of Participants With All Target Lesion Revascularization (TLR) [0 to 5 years]

    TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.

  9. Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR) [0 to 5 years]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  10. Number of Participants With All Revascularization [0 to 5 years]

    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  11. Number of Death/All MI [0 to 5 years]

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

  12. Number of Cardiac Death/All MI [0 to 5 years]

    All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI

  13. Number of Cardiac Death/TV-MI/ID-TLR (TLF) [0 to 5 years]

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  14. Number of Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) [0 to 5 years]

    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  15. Number of Participants With Target Vessel Failure (TVF) [0 to 5 years]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  16. Number of Death/All MI/All Revascularization (DMR) [0 to 5 years]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  17. Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition) [≤ 1 Day]

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  18. Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition) [0 to 30 Days]

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  19. Number of Participants With Subacute Stent/Scaffold Thrombosis [>1 to 30 Days]

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  20. Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition) [31 to 365 Days]

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  21. Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition) [366 to 393 Days]

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  22. Number of Participants With Cumulative Stent/Scaffold Thrombosis [0 to 1853 Days]

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  23. Pre-Procedure Minimum Lumen Diameter (MLD) [< or = 1 day]

    Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.

  24. Pre-Procedure Percent Diameter Stenosis (%DS) [< or = 1 day]

    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

  25. Post-Procedure In-Segment Minimum Lumen Diameter (MLD) [≤ 7 days post index procedure]

    Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.

  26. Post-Procedure In-Segment Percent Diameter Stenosis (%DS) [≤ 7 days post index procedure]

    Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.

  27. Post-Procedure In-Device Minimum Lumen Diameter (MLD) [≤ 7 days post index procedure]

    Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold

  28. Post-Procedure In-Device Percent Diameter Stenosis (%DS) [≤ 7 days post index procedure]

    Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

  29. Post-Procedure In-Device Acute Gain [≤ 7 days post index procedure]

    The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).

  30. Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS) [From Post procedure to 3 Years]

    Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects. Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.

  31. Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA) [3 Years]

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

  32. Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal [3 Years]

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

  33. Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area [3 Years]

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

  34. Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area [3 Years]

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

  35. Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts [3 Years]

    All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

Other Outcome Measures

  1. Patient Reported Outcomes (PRO): Overall Health Status [Baseline]

    Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1

  2. Patient Reported Outcomes (PRO): Overall Health Status [1 month]

    Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1

  3. Patient Reported Outcomes (PRO): Overall Health Status [12 months]

    Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1

  4. Patient Reported Outcomes (PRO): Anxiety [Baseline]

    Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales

  5. Patient Reported Outcomes (PRO): Anxiety [1 month]

    Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales

  6. Patient Reported Outcomes (PRO): Anxiety [12 months]

    Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales

  7. Patient Reported Outcomes (PRO): Disease-Specific Quality of Life [Baseline]

    Disease-Specific quality of life assessed using the Seattle Angina Questionnaire (SAQ) Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).

  8. Patient Reported Outcomes (PRO): Disease-Specific Quality of Life [1 month]

    Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ). Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).

  9. Patient Reported Outcomes (PRO): Disease-Specific Quality of Life [12 months]

    Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ). Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).

  10. Patient Reported Outcomes (PRO): Dyspnea Severity [Baseline]

    Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales

  11. Patient Reported Outcomes (PRO): Dyspnea Severity [1 month]

    Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales

  12. Patient Reported Outcomes (PRO): Dyspnea Severity [12 months]

    Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales

  13. Landmark Analysis on TLF and Components [3-4 years]

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  14. Landmark Analysis on TLF and Components [3-5 years]

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  15. Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [3-4 years]

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  16. Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [3-5 years]

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
General Inclusion Criteria:
  1. Subject must be at least 18 years of age.

  2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.

  3. Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objectives sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG). In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.

  4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.

  5. Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.

  6. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.

  7. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.

Angiographic Inclusion Criteria:
  1. One or two de novo target lesions:

  2. If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.

  3. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.

  4. The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.

  5. Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥ 50% and < 100% with a TIMI flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve, stress test), unstable angina or post-infarct angina.

  6. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.

  7. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.

  8. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesions (s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.75 mm and ≤ 3.25 mm. The lesion length by visual estimation is ≥ 8 mm and ≤ 14 mm.

General Exclusion Criteria:
  1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.

  2. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.

  3. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.

  4. Subject had an acute myocardial infarction (AMI; STEMI or NSTEMI) within 72 hours of the index procedure and both CK and CK-MB have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.

  5. Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.

  6. Subject has a cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met:

  7. Subject requires coumadin or any other agent for chronic oral anticoagulation.

  8. Subject is likely to become hemodynamically unstable due to their arrhythmia.

  9. Subject has poor survival prognosis due to their arrhythmia.

  10. Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method, including but not limited to echocardiography, MRI, Multiple-Gated Acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with ACS, LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility.

  11. Subject has undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.

  12. Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions < 30 days after the index procedure

  13. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.

  14. At the time of screening, the subject has a malignancy that is not in remission.

  15. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.

  16. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.

  17. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).

  18. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.

  19. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.

  20. Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min/1.73m2 or dialysis at the time of screening.

  21. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months.

  22. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g. aneurysm, arteriovenous malformation, etc.).

  23. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.

  24. Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause.

  25. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Patient Reported Outcome instruments.

  26. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

  27. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

All exclusion criteria apply to the target lesion(s) or target vessel(s).

  1. Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:

  2. Residual %DS is a maximum < 40% (per visual estimation), ≤ 20% is strongly recommended.

  3. TIMI Grade-3 flow (per visual estimation).

  4. No angiographic complications (e.g. distal embolization, side branch closure).

  5. No dissections NHLBI grade D-F.

  6. No chest pain lasting > 5 minutes.

  7. No ST depression or elevation lasting > 5 minutes.

  8. Lesion is located in left main.

  9. Aorto-ostial RCA lesion (within 3 mm of the ostium).

  10. Lesion located within 3 mm of the origin of the LAD or LCX.

  11. Lesion involving a bifurcation with a:

  12. side branch ≥ 2 mm in diameter, or

  13. side branch with either an ostial or non-ostial lesion with diameter stenosis > 50%, or

  14. side branch requiring dilatation

  15. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or

XIENCE stent:
  1. Extreme angulation (≥ 90°) proximal to or within the target lesion.

  2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.

  3. Moderate or heavy calcification proximal to or within the target lesion. If IVUS used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.

  4. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.

  5. Lesion or vessel involves a myocardial bridge.

  6. Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE would need to cross the stent to reach the target lesion.

  7. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.

  8. Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baptist Medical Center Princeton Birmingham Alabama United States 35211
2 University of Alabama Hospital Birmingham Alabama United States 35233
3 Thomas Hospital Fairhope Alabama United States 36532
4 Baptist Medical Center South Montgomery Alabama United States 36117
5 Chandler Regional Medical Center Gilbert Arizona United States 85297
6 Banner Heart Hospital Mesa Arizona United States 85206
7 Banner Good Samaritan Medical Center Phoenix Arizona United States 85006
8 Scottsdale Healthcare Scottsdale Arizona United States 85260
9 Arkansas Heart Hospital Little Rock Arkansas United States 72211
10 John Muir Medical Center - Concord Campus Concord California United States 94520
11 Washington Hospital Fremont California United States 94538
12 Scripps Green Hospital La Jolla California United States 92037
13 Scripps Memorial Hospital La Jolla California United States 92037
14 Good Samaritan Hospital Los Angeles California United States 90017
15 Cedars-Sinai Medical Center Los Angeles California United States 90043
16 Sutter Central Valley Hospitals dba Memorial Medical Center Modesto California United States 95355
17 Mercy General Hospital Sacramento California United States 95816
18 UC Davis Medical Center Sacramento California United States 95817
19 Sutter Medical Center Sacramento California United States 95819
20 Sharp Memorial Hospital San Diego California United States 92123
21 Santa Barbara Cottage Hospital Santa Barbara California United States 93105
22 Stanford Hospital and Clinics Stanford California United States 94305
23 Little Company Of Mary Hospital Torrance California United States 90503
24 Torrance Memorial Medical Center Torrance California United States 90505
25 UCH-Memorial Health Systems Colorado Springs Colorado United States 80909
26 Medical Center of the Rockies Fort Collins Colorado United States 80538
27 Yale-New Haven Hospital New Haven Connecticut United States 06520
28 St. Vincent's Medical Center Stamford Connecticut United States 06905
29 Christiana Care Health Services Newark Delaware United States 19718
30 Brandon Regional Hospital Brandon Florida United States 33511
31 Morton Plant Hospital Clearwater Florida United States 33756
32 Holy Cross Hospital Fort Lauderdale Florida United States 33308
33 Memorial Regional Hospital Hollywood Florida United States 33021
34 St. Vincent's Medical Center Jacksonville Florida United States 32204
35 Baptist Medical Center - Downtown Jacksonville Florida United States 32207
36 University of Florida UF Health Jacksonville Florida United States 32209
37 University of Miami Hospital Miami Florida United States 33136
38 Baptist Hospital of Miami Miami Florida United States 33176
39 MediQuest Research Group Inc at Munroe Regional Medical Center Ocala Florida United States 34471
40 Florida Hospital Orlando Florida United States 32803
41 Palm Beach Gardens Medical Center Palm Beach Gardens Florida United States 33410
42 Bay County Health Systems Panama City Florida United States 32401
43 Baptist Hospital Pensacola Florida United States 32501
44 Tallahassee Memorial Hospital Tallahassee Florida United States 32308
45 Tampa General Hospital Tampa Florida United States 33609
46 Florida Hospital Pepin Heart Institute Tampa Florida United States 33613
47 Piedmont Hospital Atlanta Georgia United States 30309
48 Emory University Hospital Atlanta Georgia United States 30322
49 Saint Joseph's Hospital of Atlanta Atlanta Georgia United States 30342
50 University Hospital Augusta Georgia United States 30901
51 Northeast Georgia Medical Center Gainesville Georgia United States 30501
52 Wellstar Kennestone Hospital Marietta Georgia United States 30060
53 Northwestern Memorial Hospital Chicago Illinois United States 60611
54 Advocate Christ Medical Center Oak Lawn Illinois United States 60453
55 Saint Francis Medical Center Peoria Illinois United States 61614
56 St. John's Hospital Springfield Illinois United States 62701
57 Elkhart General Healthcare Elkhart Indiana United States 46514
58 Indiana University Health Methodist Hospital Indianapolis Indiana United States 46202
59 Franciscan St. Francis Health Indianapolis Indiana United States 46237
60 St. Vincent Heart Center of Indiana Indianapolis Indiana United States 46290
61 Genesis Medical Center Davenport Iowa United States 52803
62 Mercy Medical West Des Moines Iowa United States 50266
63 The University of Kansas Hospital and Medical Center Kansas City Kansas United States 66106
64 Baptist Health Lexington Lexington Kentucky United States 40503
65 University of Kentucky Medical Center Lexington Kentucky United States 40536
66 Jewish Hospital Louisville Kentucky United States 40202
67 Eastern Maine Medical Center Bangor Maine United States 04401
68 Maine Medical Center Portland Maine United States 04102
69 MedStar Washington Hospital Center Hyattsville Maryland United States 20782
70 Union Memorial Hospital Hyattsville Maryland United States 20782
71 Peninsula Regional Medical Center Salisbury Maryland United States 21804
72 Washington Adventist Hospital Takoma Park Maryland United States 20912
73 Brigham and Women's Hospital Boston Massachusetts United States 02115
74 Boston University Medical Center Boston Massachusetts United States 02118
75 St. Elizabeth's Medical Center of Boston Brighton Massachusetts United States 02135
76 UMass Memorial Medical Center Worcester Massachusetts United States 01655
77 Bay Regional Medical Center Bay City Michigan United States 48708
78 Oakwood Hospital and Medical Center Dearborn Michigan United States 48124
79 Harper University Hospital Detroit Michigan United States 48201
80 Henry Ford Hospital Detroit Michigan United States 48202
81 St. John Hospital & Medical Center Detroit Michigan United States 48236
82 Borgess Medical Center Kalamazoo Michigan United States 49048
83 Sparrow Hospital Lansing Michigan United States 48910
84 Northern Michigan Hospital Petoskey Michigan United States 49770
85 William Beaumont Hospital Royal Oak Michigan United States 48703
86 Munson Medical Center Traverse City Michigan United States 49684
87 St. Joseph Mercy Hospital Ypsilanti Michigan United States 48197
88 Abbott Northwestern Hospital Minneapolis Minnesota United States 55407
89 North Memorial Medical Center Robbinsdale Minnesota United States 55422
90 North Mississippi Medical Center Cardiology Associates Research, LLC Tupelo Mississippi United States 38801
91 Boone Hospital Center Columbia Missouri United States 65201
92 Barnes Jewish Hospital Saint Louis Missouri United States 63110
93 St. Anthony's Medical Center Saint Louis Missouri United States 63129
94 Mercy Hospital Springfield Springfield Missouri United States 65807
95 St. Patrick Hospital Missoula Montana United States 59802
96 Nebraska Heart Hospital Lincoln Nebraska United States 68526
97 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756
98 Englewood Hospital and Medical Center Englewood New Jersey United States 07631
99 Cooper University Hospital Haddon Heights New Jersey United States 08035
100 Our Lady of Lourdes Medical Center Haddon Heights New Jersey United States 08035
101 Morristown Medical Center Morristown New Jersey United States 07962
102 Jersey Shore University Medical Center Neptune New Jersey United States 07753
103 St. Joseph's Regional Medical Center Paterson New Jersey United States 07503
104 The Valley Hospital Ridgewood New Jersey United States 07450
105 Presbyterian Hospital Albuquerque New Mexico United States 87106
106 Montefiore Medical Center Bronx New York United States 10461
107 St. Joseph's Hospital Health Center Liverpool New York United States 13088
108 Long Island Jewish Medical Center Manhasset New York United States 11030
109 Winthrop University Hospital Mineola New York United States 11501
110 Mount Sinai Medical Center New York New York United States 10029
111 Columbia University Medical Center New York New York United States 10032
112 New York Presbyterian Hospital-Cornell University New York New York United States 10065
113 Lennox Hill Hospital, New York New York United States 10075
114 Rochester General Hospital Rochester New York United States 14621
115 Strong Memorial Hospital Rochester New York United States 14627
116 Stony Brook University Medical Center Stony Brook New York United States 11794
117 Carolinas Medical Center Charlotte North Carolina United States 28203
118 Presbyterian Hospital Charlotte North Carolina United States 28204
119 Duke University Medical Center Durham North Carolina United States 27110
120 Rex Hospital Raleigh North Carolina United States 27607
121 WakeMed Raleigh North Carolina United States 27610
122 Novant Health Forsyth Medical Center Winston-Salem North Carolina United States 27103
123 Wake Forest University Baptist Medical Center Winston-Salem North Carolina United States 27157
124 Aultman Hospital Canton Ohio United States 44710
125 University Hospital Cincinnati Ohio United States 45206
126 The Christ Hospital Cincinnati Ohio United States 45219
127 Tri-Health Good Samaritan Hospital Cincinnati Ohio United States 45220
128 Bethesda North Hospital Cincinnati Ohio United States 45242
129 University Hospitals of Cleveland Cleveland Ohio United States 44106
130 Cleveland Clinic Cleveland Ohio United States 44195
131 Ohio State University Medical Center Columbus Ohio United States 43210
132 Riverside Methodist Hospital Columbus Ohio United States 43214
133 EMH Healthcare Elyria Ohio United States 44035
134 Cleveland Cln Fairview Hospital Fairview Park Ohio United States 44126
135 Kettering Medical Center Kettering Ohio United States 45429
136 The Toledo Hospital Toledo Ohio United States 43606
137 Mercy St. Vincent's Medical Center Toledo Ohio United States 43608
138 Genesis-Good Samaritan Hospital Zanesville Ohio United States 43701
139 Integris Baptist Medical Center Oklahoma City Oklahoma United States 73112
140 Oklahoma Heart Hospital Oklahoma City Oklahoma United States 73120
141 Hillcrest Medical Center Tulsa Oklahoma United States 74104
142 Providence St. Vincent Medical Center Portland Oregon United States 97225
143 PeaceHealth Sacred Heart Medical Center Springfield Oregon United States 97477
144 Abington Memorial Hospital Abington Pennsylvania United States 19001
145 Holy Spirit Hospital Camp Hill Pennsylvania United States 17011
146 Geisinger Medical Center Danville Pennsylvania United States 17822
147 Doylestown Hospital Doylestown Pennsylvania United States 18901
148 UPMC Hamot Erie Pennsylvania United States 16550
149 St. Mary Medical Center Langhorne Pennsylvania United States 19047
150 Penn Presbyterian Medical Center Philadelphia Pennsylvania United States 19104
151 Pennsylvania Hospital Philadelphia Pennsylvania United States 19107
152 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
153 UPMC Presbyterian Pittsburgh Pennsylvania United States 15213
154 UPMC Shadyside Hospital Pittsburgh Pennsylvania United States 15219
155 Pinnacle Health at Harrisburg Hospital Wormleysburg Pennsylvania United States 17043
156 St. Joseph Medical Center Wyomissing Pennsylvania United States 19610
157 York Hospital York Pennsylvania United States 17405
158 Rhode Island Hospital Providence Rhode Island United States 02903
159 The Miriam Hospital Providence Rhode Island United States 02906
160 AnMed Health Anderson South Carolina United States 29621
161 Medical University of South Carolina Charleston South Carolina United States 29425
162 Sisters of Charity Providence Hospital Columbia South Carolina United States 29204
163 Greenville Memorial Hospital of the Greenville Health System Greenville South Carolina United States 29605
164 St. Francis Health System Greenville South Carolina United States 29607
165 Sanford USD Medical Center Sioux Falls South Dakota United States 57104
166 Memorial Hospital Chattanooga Tennessee United States 37404
167 Wellmont Holston Valley Medical Center Kingsport Tennessee United States 37660
168 Turkey Creek Medical Center Knoxville Tennessee United States 37934
169 Vanderbilt University Medical Center Nashville Tennessee United States 37232
170 Northwest Texas Healthcare System Amarillo Texas United States 79106
171 Seton Medical Center Austin Austin Texas United States 78705
172 Baylor Jack and Jane Hamilton Heart and Vascular Hospital Dallas Texas United States 75204
173 St. Luke's Episcopal Hospital Houston Texas United States 77030
174 The Methodist Hospital Research Institute Houston Texas United States 77030
175 The Heart Hospital Baylor Plano Plano Texas United States 75093
176 Methodist Texsan Hospital San Antonio Texas United States 78201
177 East Texas Medical Center Tyler Texas United States 75701
178 Trinity Mother Frances Hospital Regional Healthcare Center Tyler Texas United States 75701
179 InterMountain Medical Center Murray Utah United States 84107
180 Fletcher Allen Health Care Burlington Vermont United States 05401
181 Inova Fairfax Hospital Falls Church Virginia United States 22042
182 Mary Washington Hospital Fredericksburg Virginia United States 22401
183 Sentara Norfolk General Hospital Norfolk Virginia United States 23507
184 Carilion Roanoke Memorial Hospital Roanoke Virginia United States 24014
185 Winchester Medical Center Winchester Virginia United States 22601
186 St. Joseph Hospital Bellingham Washington United States 98225
187 Providence Regional Medical Center Everett Everett Washington United States 98201
188 Swedish Medical Center Seattle Washington United States 98122
189 St. Mary's Medical Center Huntington West Virginia United States 25701
190 Aurora St. Luke's Medical Center Milwaukee Wisconsin United States 53215
191 Royal Brisbane and Women's Hospital Herston Queensland Australia 4029
192 St. Vincent's Hospital Melbourne Fitzroy Victoria Australia 3065

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

  • Principal Investigator: Stephen G Ellis, MD, Cleveland Clinic, Cleveland OH
  • Principal Investigator: Dean J Kereiakes, MD, The Christ Hospital, Cincinnati, OH
  • Study Chair: Gregg W Stone, MD, Columbia University Medical Center, New York, NY
  • Study Director: Jennifer McMeans Jones, Abbott Medical Devices

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT01751906
Other Study ID Numbers:
  • 10-392
First Posted:
Dec 18, 2012
Last Update Posted:
May 19, 2022
Last Verified:
Jan 1, 2021

Study Results

Participant Flow

Recruitment Details The first Lead-In subject (Lead-In Group ) was registered on Dec 28, 2012. A total of 2008 patients (Primary Analysis Group) were randomized into Absorb BVS arm (n = 1322) and Xience arm (n = 686) at 193 study sites between March 22, 2013 & April 3,2014 and the last 5 year follow-up visit was on May 31, 2019.
Pre-assignment Detail Of total 13,789 eligible population,11,781 patients were excluded due to, Not meeting general eligibility criteria only (n=567); Not meeting angiographic eligibility criteria only (n=10,690); Not meeting both 1 and 2 (n=64); Other reasons (n=460).
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Period Title: Overall Study
STARTED 1322 686
COMPLETED 1059 555
NOT COMPLETED 263 131

Baseline Characteristics

Arm/Group Title Absorb BVS XIENCE Total
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Total of all reporting groups
Overall Participants 1322 686 2008
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
63.5
(10.6)
63.6
(10.3)
63.5
(10.5)
Sex: Female, Male (Count of Participants)
Female
388
29.3%
205
29.9%
593
29.5%
Male
934
70.7%
481
70.1%
1415
70.5%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino
50
3.8%
23
3.4%
73
3.6%
Not Hispanic or Latino
1250
94.6%
652
95%
1902
94.7%
Unknown or not reported
22
1.7%
11
1.6%
33
1.6%
American Indian or Alaska Native
8
0.6%
2
0.3%
10
0.5%
Asian
20
1.5%
13
1.9%
33
1.6%
Native Hawaiian or Other Pacific Islander
8
0.6%
1
0.1%
9
0.4%
Black or African American
70
5.3%
34
5%
104
5.2%
White
1152
87.1%
606
88.3%
1758
87.5%
Region of Enrollment (Count of Participants)
United States
1318
99.7%
683
99.6%
2001
99.7%
Australia
4
0.3%
3
0.4%
7
0.3%
Hypertension Requiring Medication (Count of Participants)
Count of Participants [Participants]
1071
81%
553
80.6%
1624
80.9%
Dyslipidemia Requiring Medication (Count of Participants)
Count of Participants [Participants]
1009
76.3%
533
77.7%
1542
76.8%
Prior Coronary Intervention (Count of Participants)
Count of Participants [Participants]
512
38.7%
260
37.9%
772
38.4%
Stable Angina (Count of Participants)
Count of Participants [Participants]
757
57.3%
417
60.8%
1174
58.5%

Outcome Measures

1. Primary Outcome
Title Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Description TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1313 677
Count of Participants [Participants]
102
7.7%
41
6%
2. Secondary Outcome
Title Number of Participants With Powered Secondary Endpoint: Angina
Description Angina is defined as the first adverse event resulting in the site diagnosis of angina.
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
The analysis will exclude angina following the index procedure through discharge, not to exceed a period of 7 days. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1303 678
Count of Participants [Participants]
238
18%
125
18.2%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Absorb BVS, XIENCE
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.9256
Comments
Method Chi-squared
Comments
3. Secondary Outcome
Title Number of Participants With Powered Secondary Endpoint: All Revascularization
Description This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through 1 year without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1313 677
Count of Participants [Participants]
120
9.1%
55
8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Absorb BVS, XIENCE
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.5040
Comments
Method Fisher Exact
Comments
4. Secondary Outcome
Title Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
For ID-TVR, Fisher's exact test is used for superiority testing based on the ITT population. This analysis will include ~2000 subjects. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1313 677
Count of Participants [Participants]
66
5%
25
3.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Absorb BVS, XIENCE
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.2126
Comments
Method Fisher Exact
Comments
5. Secondary Outcome
Title Acute Success- Device Success (Lesion Level Analysis)
Description Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.
Time Frame On day 0 (the day of procedure)

Outcome Measure Data

Analysis Population Description
Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1311 678
Measure Target Lesions 1355 704
Number [Percentage of lesions]
94.3
99.3
6. Secondary Outcome
Title Acute Success: Procedural Success (Subject Level Analysis)
Description Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).
Time Frame On day 0 (the day of procedure)

Outcome Measure Data

Analysis Population Description
Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1311 678
Count of Participants [Participants]
1240
93.8%
652
95%
7. Secondary Outcome
Title Number of Death (Cardiac, Vascular, Non-cardiovascular)
Description DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame 0 to 5 years

Outcome Measure Data

Analysis Population Description
ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1187 612
Count of Participants [Participants]
85
6.4%
44
6.4%
8. Secondary Outcome
Title Number of Participants With All Myocardial Infarction (MI)
Description Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
Time Frame 0 to 5 years

Outcome Measure Data

Analysis Population Description
ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1187 612
Count of Participants [Participants]
159
12%
69
10.1%
9. Secondary Outcome
Title Number of Participants With All Target Lesion Revascularization (TLR)
Description TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Time Frame 0 to 5 years

Outcome Measure Data

Analysis Population Description
ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1187 612
Count of Participants [Participants]
118
8.9%
51
7.4%
10. Secondary Outcome
Title Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)
Description TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame 0 to 5 years

Outcome Measure Data

Analysis Population Description
ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1187 612
Count of Participants [Participants]
108
8.2%
40
5.8%
11. Secondary Outcome
Title Number of Participants With All Revascularization
Description All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
Time Frame 0 to 5 years

Outcome Measure Data

Analysis Population Description
ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1187 612
Count of Participants [Participants]
255
19.3%
114
16.6%
12. Secondary Outcome
Title Number of Death/All MI
Description All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame 0 to 5 years

Outcome Measure Data

Analysis Population Description
ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1187 612
Count of Participants [Participants]
230
17.4%
101
14.7%
13. Secondary Outcome
Title Number of Cardiac Death/All MI
Description All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame 0 to 5 years

Outcome Measure Data

Analysis Population Description
ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1187 612
Count of Participants [Participants]
185
14%
81
11.8%
14. Secondary Outcome
Title Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Description Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 0 to 5 years

Outcome Measure Data

Analysis Population Description
ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1187 612
Count of Participants [Participants]
220
16.6%
98
14.3%
15. Secondary Outcome
Title Number of Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Description Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame 0 to 5 years

Outcome Measure Data

Analysis Population Description
ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1187 612
Count of Participants [Participants]
245
18.5%
113
16.5%
16. Secondary Outcome
Title Number of Participants With Target Vessel Failure (TVF)
Description Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame 0 to 5 years

Outcome Measure Data

Analysis Population Description
ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1187 612
Count of Participants [Participants]
290
21.9%
128
18.7%
17. Secondary Outcome
Title Number of Death/All MI/All Revascularization (DMR)
Description DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame 0 to 5 years

Outcome Measure Data

Analysis Population Description
ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1187 612
Count of Participants [Participants]
378
28.6%
168
24.5%
18. Secondary Outcome
Title Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)
Description Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame ≤ 1 Day

Outcome Measure Data

Analysis Population Description
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1319 686
Definite/Probable
3
0.2%
4
0.6%
Definite
3
0.2%
4
0.6%
Probable
0
0%
0
0%
19. Secondary Outcome
Title Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition)
Description Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame 0 to 30 Days

Outcome Measure Data

Analysis Population Description
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1314 686
Definite/Probable
14
1.1%
5
0.7%
Definite
12
0.9%
5
0.7%
Probable
2
0.2%
0
0%
20. Secondary Outcome
Title Number of Participants With Subacute Stent/Scaffold Thrombosis
Description Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame >1 to 30 Days

Outcome Measure Data

Analysis Population Description
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1314 686
Definite/Probable
12
0.9%
1
0.1%
Definite
10
0.8%
1
0.1%
Probable
2
0.2%
0
0%
21. Secondary Outcome
Title Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)
Description Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame 31 to 365 Days

Outcome Measure Data

Analysis Population Description
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1289 672
Definite/Probable
6
0.5%
0
0%
Definite
6
0.5%
0
0%
Probable
0
0%
0
0%
22. Secondary Outcome
Title Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition)
Description Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame 366 to 393 Days

Outcome Measure Data

Analysis Population Description
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1289 672
Definite/Probable
0
0%
0
0%
Definite
0
0%
0
0%
Probable
0
0%
0
0%
23. Secondary Outcome
Title Number of Participants With Cumulative Stent/Scaffold Thrombosis
Description Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame 0 to 1853 Days

Outcome Measure Data

Analysis Population Description
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1072 558
Definite/Probable
32
2.4%
7
1%
Definite
30
2.3%
7
1%
Probable
2
0.2%
0
0%
24. Secondary Outcome
Title Pre-Procedure Minimum Lumen Diameter (MLD)
Description Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.
Time Frame < or = 1 day

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1322 686
Measure Target Lesions 1380 708
Mean (Standard Deviation) [Millimeter]
0.92
(0.37)
0.90
(0.34)
25. Secondary Outcome
Title Pre-Procedure Percent Diameter Stenosis (%DS)
Description Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time Frame < or = 1 day

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1322 686
Measure Target Lesions 1380 708
Mean (Standard Deviation) [Percent Diameter stenosis]
65.25
(12.48)
65.90
(11.66)
26. Secondary Outcome
Title Post-Procedure In-Segment Minimum Lumen Diameter (MLD)
Description Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Time Frame ≤ 7 days post index procedure

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1322 686
Measure Target Lesions 1374 706
Mean (Standard Deviation) [Millimeter]
2.15
(0.41)
2.14
(0.43)
27. Secondary Outcome
Title Post-Procedure In-Segment Percent Diameter Stenosis (%DS)
Description Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Time Frame ≤ 7 days post index procedure

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1322 686
Measure Target Lesions 1374 706
Mean (Standard Deviation) [Percent Diameter stenosis]
20.04
(7.94)
19.82
(8.20)
28. Secondary Outcome
Title Post-Procedure In-Device Minimum Lumen Diameter (MLD)
Description Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold
Time Frame ≤ 7 days post index procedure

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1322 686
Measure Target Lesions 1373 706
Mean (Standard Deviation) [Millimeter]
2.37
(0.40)
2.49
(0.40)
29. Secondary Outcome
Title Post-Procedure In-Device Percent Diameter Stenosis (%DS)
Description Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time Frame ≤ 7 days post index procedure

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1322 686
Measure Target Lesions 1369 702
Mean (Standard Deviation) [Percent Diameter stenosis]
11.62
(8.77)
6.41
(8.91)
30. Secondary Outcome
Title Post-Procedure In-Device Acute Gain
Description The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
Time Frame ≤ 7 days post index procedure

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1322 686
Measure Target Lesions 1372 706
Mean (Standard Deviation) [mm]
1.45
(0.45)
1.59
(0.44)
31. Secondary Outcome
Title Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS)
Description Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects. Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.
Time Frame From Post procedure to 3 Years

Outcome Measure Data

Analysis Population Description
The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 188 93
Measure Lesions 119 65
Mean (Standard Deviation) [mm^2]
-0.30
(1.32)
-0.60
(0.91)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Absorb BVS, XIENCE
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.0665
Comments
Method Chi-squared
Comments
32. Secondary Outcome
Title Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA)
Description All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Time Frame 3 Years

Outcome Measure Data

Analysis Population Description
The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 33 16
Measure Leisions 21 10
Mean (Standard Deviation) [mm^2]
1.12
(0.48)
1.19
(0.61)
33. Secondary Outcome
Title Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal
Description All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Time Frame 3 Years

Outcome Measure Data

Analysis Population Description
The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 33 16
Measure Leisions 33 16
Post-procedure
6.89
(1.98)
7.25
(1.51)
3 Years
7.70
(2.54)
7.24
(1.90)
34. Secondary Outcome
Title Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area
Description All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Time Frame 3 Years

Outcome Measure Data

Analysis Population Description
The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 33 16
Measure Leisions 33 16
Post-procedure
7.99
(2.12)
7.50
(1.46)
3 Years
6.67
(2.36)
6.06
(1.73)
35. Secondary Outcome
Title Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area
Description All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Time Frame 3 Years

Outcome Measure Data

Analysis Population Description
The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 33 16
Measure Leisions 33 16
Post-procedure
6.47
(1.82)
6.07
(1.46)
3 Years
4.95
(1.78)
4.54
(1.40)
36. Secondary Outcome
Title Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts
Description All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Time Frame 3 Years

Outcome Measure Data

Analysis Population Description
The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 33 16
Measure Leisions 33 16
Post-procedure
7.42
(5.49)
7.64
(6.26)
3 Years
0.32
(0.99)
0.07
(0.22)
37. Other Pre-specified Outcome
Title Patient Reported Outcomes (PRO): Overall Health Status
Description Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1249 651
Mean (Standard Deviation) [score on a scale]
0.77
(0.2)
0.77
(0.20)
38. Other Pre-specified Outcome
Title Patient Reported Outcomes (PRO): Overall Health Status
Description Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1
Time Frame 1 month

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1231 647
Mean (Standard Deviation) [score on a scale]
0.85
(0.18)
0.85
(0.18)
39. Other Pre-specified Outcome
Title Patient Reported Outcomes (PRO): Overall Health Status
Description Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1
Time Frame 12 months

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1087 567
Mean (Standard Deviation) [score on a scale]
0.83
(0.20)
0.83
(0.19)
40. Other Pre-specified Outcome
Title Patient Reported Outcomes (PRO): Anxiety
Description Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1009 530
Mean (Standard Deviation) [score on a scale]
5.92
(5.86)
6.34
(6.07)
41. Other Pre-specified Outcome
Title Patient Reported Outcomes (PRO): Anxiety
Description Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales
Time Frame 1 month

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1067 556
Mean (Standard Deviation) [score on a scale]
3.39
(4.64)
3.33
(4.61)
42. Other Pre-specified Outcome
Title Patient Reported Outcomes (PRO): Anxiety
Description Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales
Time Frame 12 months

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 911 482
Mean (Standard Deviation) [score on a scale]
3.92
(4.99)
4.04
(5.08)
43. Other Pre-specified Outcome
Title Patient Reported Outcomes (PRO): Disease-Specific Quality of Life
Description Disease-Specific quality of life assessed using the Seattle Angina Questionnaire (SAQ) Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1195 617
Mean (Standard Deviation) [score on a scale]
67.67
(20.20)
67.11
(19.17)
44. Other Pre-specified Outcome
Title Patient Reported Outcomes (PRO): Disease-Specific Quality of Life
Description Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ). Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Time Frame 1 month

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1131 589
Mean (Standard Deviation) [score on a scale]
87.10
(14.27)
86.98
(14.16)
45. Other Pre-specified Outcome
Title Patient Reported Outcomes (PRO): Disease-Specific Quality of Life
Description Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ). Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Time Frame 12 months

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1014 514
Mean (Standard Deviation) [score on a scale]
87.05
(13.91)
86.42
(14.45)
46. Other Pre-specified Outcome
Title Patient Reported Outcomes (PRO): Dyspnea Severity
Description Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1242 651
Mean (Standard Deviation) [score on a scale]
1.66
(1.48)
1.65
(1.46)
47. Other Pre-specified Outcome
Title Patient Reported Outcomes (PRO): Dyspnea Severity
Description Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales
Time Frame 1 month

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1220 636
Mean (Standard Deviation) [score on a scale]
0.81
(1.24)
0.88
(1.29)
48. Other Pre-specified Outcome
Title Patient Reported Outcomes (PRO): Dyspnea Severity
Description Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales
Time Frame 12 months

Outcome Measure Data

Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1080 568
Mean (Standard Deviation) [score on a scale]
0.94
(1.26)
0.99
(1.30)
49. Other Pre-specified Outcome
Title Landmark Analysis on TLF and Components
Description TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 3-4 years

Outcome Measure Data

Analysis Population Description
ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1202 610
Count of Participants [Participants]
38
2.9%
16
2.3%
50. Other Pre-specified Outcome
Title Landmark Analysis on TLF and Components
Description TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame 3-5 years

Outcome Measure Data

Analysis Population Description
ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1108 580
Count of Participants [Participants]
60
4.5%
38
5.5%
51. Other Pre-specified Outcome
Title Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Description Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame 3-4 years

Outcome Measure Data

Analysis Population Description
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1180 607
Definite/Probable
1
0.1%
1
0.1%
Definite
1
0.1%
1
0.1%
Probable
0
0%
0
0%
52. Other Pre-specified Outcome
Title Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Description Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame 3-5 years

Outcome Measure Data

Analysis Population Description
Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Measure Participants 1059 556
Definite/Probable
1
0.1%
2
0.3%
Definite
1
0.1%
2
0.3%
Probable
0
0%
0
0%

Adverse Events

Time Frame 5 years
Adverse Event Reporting Description
Arm/Group Title Absorb BVS XIENCE
Arm/Group Description Subjects receiving Absorb BVS Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm. Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
All Cause Mortality
Absorb BVS XIENCE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 85/1322 (6.4%) 44/686 (6.4%)
Serious Adverse Events
Absorb BVS XIENCE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 801/1322 (60.6%) 398/686 (58%)
Blood and lymphatic system disorders
ANAEMIA 7/1322 (0.5%) 7/686 (1%)
ANAEMIA OF CHRONIC DISEASE 0/1322 (0%) 1/686 (0.1%)
COAGULOPATHY 0/1322 (0%) 2/686 (0.3%)
FEBRILE NEUTROPENIA 1/1322 (0.1%) 0/686 (0%)
HAEMORRHAGIC ANAEMIA 2/1322 (0.2%) 3/686 (0.4%)
HEPARIN-INDUCED THROMBOCYTOPENIA 1/1322 (0.1%) 0/686 (0%)
IRON DEFICIENCY ANEMIA 1/1322 (0.1%) 1/686 (0.1%)
LEUKOCYTOSIS 2/1322 (0.2%) 1/686 (0.1%)
LYMPHADENOPATHY 2/1322 (0.2%) 0/686 (0%)
MICROCYTIC ANAEMIA 1/1322 (0.1%) 0/686 (0%)
NORMOCHROMIC NORMOCYTIC ANAEMIA 1/1322 (0.1%) 0/686 (0%)
THROMBOCYTOPENIA 1/1322 (0.1%) 1/686 (0.1%)
Cardiac disorders
ACUTE CORONARY SYNDROME 6/1322 (0.5%) 5/686 (0.7%)
ACUTE LEFT VENTRICULAR FAILURE 0/1322 (0%) 1/686 (0.1%)
ACUTE MYOCARDIAL INFARCTION 49/1322 (3.7%) 21/686 (3.1%)
ANGINA PECTORIS 161/1322 (12.2%) 87/686 (12.7%)
ANGINA UNSTABLE 68/1322 (5.1%) 28/686 (4.1%)
AORTIC VALVE DISEASE 2/1322 (0.2%) 0/686 (0%)
AORTIC VALVE STENOSIS 6/1322 (0.5%) 2/686 (0.3%)
ARRHYTHMIA 1/1322 (0.1%) 2/686 (0.3%)
ARTERIOSCLEROSIS CORONARY ARTERY 2/1322 (0.2%) 0/686 (0%)
ARTERIOSPASM CORONARY 1/1322 (0.1%) 0/686 (0%)
ATRIAL FIBRILLATION 52/1322 (3.9%) 21/686 (3.1%)
ATRIAL FLUTTER 6/1322 (0.5%) 2/686 (0.3%)
ATRIAL TACHYCARDIA 0/1322 (0%) 1/686 (0.1%)
ATRIOVENTRICULAR BLOCK 3/1322 (0.2%) 0/686 (0%)
ATRIOVENTRICULAR BLOCK COMPLETE 1/1322 (0.1%) 1/686 (0.1%)
ATRIOVENTRICULAR BLOCK SECOND DEGREE 4/1322 (0.3%) 0/686 (0%)
BRADYCARDIA 9/1322 (0.7%) 2/686 (0.3%)
BUNDLE BRANCH BLOCK 0/1322 (0%) 1/686 (0.1%)
CARDIAC ARREST 10/1322 (0.8%) 6/686 (0.9%)
CARDIAC FAILURE 8/1322 (0.6%) 4/686 (0.6%)
CARDIAC FAILURE ACUTE 5/1322 (0.4%) 1/686 (0.1%)
CARDIAC FAILURE CHRONIC 2/1322 (0.2%) 3/686 (0.4%)
CARDIAC FAILURE CONGESTIVE 32/1322 (2.4%) 25/686 (3.6%)
CARDIAC TAMPONADE 1/1322 (0.1%) 0/686 (0%)
CARDIAC VALVE DISEASE 2/1322 (0.2%) 0/686 (0%)
CARDIO-RESPIRATORY ARREST 2/1322 (0.2%) 1/686 (0.1%)
CARDIOGENIC SHOCK 1/1322 (0.1%) 3/686 (0.4%)
CARDIOMYOPATHY 1/1322 (0.1%) 1/686 (0.1%)
CARDIORENAL SYNDROME 1/1322 (0.1%) 0/686 (0%)
CHRONIC LEFT VENTRICULAR FAILURE 1/1322 (0.1%) 0/686 (0%)
CONDUCTION DISORDER 0/1322 (0%) 1/686 (0.1%)
CONGESTIVE CARDIOMYOPATHY 1/1322 (0.1%) 0/686 (0%)
CORONARY ARTERY DISEASE 38/1322 (2.9%) 24/686 (3.5%)
CORONARY ARTERY DISSECTION 22/1322 (1.7%) 12/686 (1.7%)
CORONARY ARTERY EMBOLISM 2/1322 (0.2%) 2/686 (0.3%)
CORONARY ARTERY OCCLUSION 4/1322 (0.3%) 2/686 (0.3%)
CORONARY ARTERY PERFORATION 5/1322 (0.4%) 3/686 (0.4%)
CORONARY ARTERY STENOSIS 20/1322 (1.5%) 13/686 (1.9%)
CORONARY OSTIAL STENOSIS 1/1322 (0.1%) 0/686 (0%)
DRESSLER'S SYNDROME 0/1322 (0%) 2/686 (0.3%)
IN-STENT CORONARY ARTERY RESTENOSIS 4/1322 (0.3%) 5/686 (0.7%)
INTRACARDIAC THROMBUS 1/1322 (0.1%) 0/686 (0%)
ISCHAEMIC CARDIOMYOPATHY 3/1322 (0.2%) 1/686 (0.1%)
LEFT VENTRICULAR DYSFUNCTION 1/1322 (0.1%) 1/686 (0.1%)
MITRAL VALVE INCOMPETENCE 5/1322 (0.4%) 1/686 (0.1%)
MYOCARDIAL INFARCTION 52/1322 (3.9%) 23/686 (3.4%)
MYOCARDIAL ISCHAEMIA 3/1322 (0.2%) 0/686 (0%)
PALPITATIONS 1/1322 (0.1%) 0/686 (0%)
PERICARDIAL EFFUSION 5/1322 (0.4%) 1/686 (0.1%)
PERICARDITIS 1/1322 (0.1%) 1/686 (0.1%)
PRINZMETAL ANGINA 2/1322 (0.2%) 0/686 (0%)
SICK SINUS SYNDROME 6/1322 (0.5%) 3/686 (0.4%)
SINUS ARRHYTHMIA 0/1322 (0%) 1/686 (0.1%)
SINUS BRADYCARDIA 1/1322 (0.1%) 0/686 (0%)
SUPRAVENTRICULAR TACHYCARDIA 5/1322 (0.4%) 2/686 (0.3%)
TACHYCARDIA 1/1322 (0.1%) 1/686 (0.1%)
TORSADE DE POINTES 1/1322 (0.1%) 0/686 (0%)
VENTRICULAR ARRHYTHMIA 0/1322 (0%) 1/686 (0.1%)
VENTRICULAR EXTRASYSTOLES 3/1322 (0.2%) 0/686 (0%)
VENTRICULAR FIBRILLATION 5/1322 (0.4%) 0/686 (0%)
VENTRICULAR TACHYCARDIA 8/1322 (0.6%) 3/686 (0.4%)
Congenital, familial and genetic disorders
CYSTIC LYMPHANGIOMA 1/1322 (0.1%) 0/686 (0%)
PULMONARY ARTERIOVENOUS FISTULA 0/1322 (0%) 1/686 (0.1%)
Ear and labyrinth disorders
VERTIGO 5/1322 (0.4%) 1/686 (0.1%)
Eye disorders
AMAUROSIS FUGAX 1/1322 (0.1%) 0/686 (0%)
CATARACT 0/1322 (0%) 3/686 (0.4%)
CATARACT NUCLEAR 1/1322 (0.1%) 0/686 (0%)
DIPLOPIA 1/1322 (0.1%) 0/686 (0%)
GLAUCOMA 2/1322 (0.2%) 0/686 (0%)
MACULAR OEDEMA 1/1322 (0.1%) 0/686 (0%)
PAPILLOEDEMA 1/1322 (0.1%) 0/686 (0%)
POSTERIOR CAPSULE OPACIFICATION 1/1322 (0.1%) 0/686 (0%)
RETINAL DETACHMENT 1/1322 (0.1%) 1/686 (0.1%)
RETINAL HAEMORRHAGE 0/1322 (0%) 1/686 (0.1%)
VISION BLURRED 1/1322 (0.1%) 0/686 (0%)
Gastrointestinal disorders
ABDOMINAL HERNIA 3/1322 (0.2%) 3/686 (0.4%)
ABDOMINAL HERNIA OBSTRUCTIVE 1/1322 (0.1%) 0/686 (0%)
ABDOMINAL PAIN 3/1322 (0.2%) 3/686 (0.4%)
ABDOMINAL PAIN UPPER 2/1322 (0.2%) 3/686 (0.4%)
ABDOMINAL WALL HAEMATOMA 1/1322 (0.1%) 0/686 (0%)
ALCOHOLIC PANCREATITIS 0/1322 (0%) 1/686 (0.1%)
COELIAC ARTERY STENOSIS 1/1322 (0.1%) 0/686 (0%)
COLITIS 2/1322 (0.2%) 1/686 (0.1%)
COLITIS ISCHAEMIC 1/1322 (0.1%) 1/686 (0.1%)
CONSTIPATION 2/1322 (0.2%) 0/686 (0%)
CROHN'S DISEASE 2/1322 (0.2%) 0/686 (0%)
DENTAL CARIES 1/1322 (0.1%) 0/686 (0%)
DIABETIC GASTROPARESIS 1/1322 (0.1%) 0/686 (0%)
DIARRHOEA 3/1322 (0.2%) 2/686 (0.3%)
DIVERTICULUM 0/1322 (0%) 1/686 (0.1%)
DIVERTICULUM INTESTINAL HAEMORRHAGIC 2/1322 (0.2%) 1/686 (0.1%)
DUODENAL ULCER 1/1322 (0.1%) 0/686 (0%)
DUODENAL ULCER HAEMORRHAGE 1/1322 (0.1%) 0/686 (0%)
DYSPHAGIA 5/1322 (0.4%) 1/686 (0.1%)
ENTEROVESICAL FISTULA 1/1322 (0.1%) 0/686 (0%)
FAECALOMA 1/1322 (0.1%) 0/686 (0%)
GASTRIC HAEMORRHAGE 1/1322 (0.1%) 0/686 (0%)
GASTRIC ULCER 2/1322 (0.2%) 2/686 (0.3%)
GASTRIC ULCER HAEMORRHAGE 2/1322 (0.2%) 0/686 (0%)
GASTRITIS 2/1322 (0.2%) 0/686 (0%)
GASTROINTESTINAL ANGIODYSPLASIA 1/1322 (0.1%) 0/686 (0%)
GASTROINTESTINAL HAEMORRHAGE 13/1322 (1%) 13/686 (1.9%)
GASTROINTESTINAL ULCER HAEMORRHAGE 1/1322 (0.1%) 1/686 (0.1%)
GASTROOESOPHAGEAL REFLUX DISEASE 5/1322 (0.4%) 0/686 (0%)
HAEMATEMESIS 1/1322 (0.1%) 1/686 (0.1%)
HAEMATOCHEZIA 1/1322 (0.1%) 0/686 (0%)
HAEMORRHOIDAL HAEMORRHAGE 2/1322 (0.2%) 0/686 (0%)
HIATUS HERNIA 1/1322 (0.1%) 1/686 (0.1%)
ILEUS 1/1322 (0.1%) 2/686 (0.3%)
IMPAIRED GASTRIC EMPTYING 3/1322 (0.2%) 1/686 (0.1%)
INGUINAL HERNIA 2/1322 (0.2%) 3/686 (0.4%)
INTESTINAL MASS 2/1322 (0.2%) 1/686 (0.1%)
INTESTINAL OBSTRUCTION 0/1322 (0%) 2/686 (0.3%)
IRRITABLE BOWEL SYNDROME 1/1322 (0.1%) 0/686 (0%)
LARGE INTESTINE PERFORATION 0/1322 (0%) 1/686 (0.1%)
LOWER GASTROINTESTINAL HAEMORRHAGE 2/1322 (0.2%) 2/686 (0.3%)
MALLORY-WEISS SYNDROME 1/1322 (0.1%) 0/686 (0%)
MELAENA 1/1322 (0.1%) 1/686 (0.1%)
MOUTH HAEMORRHAGE 1/1322 (0.1%) 0/686 (0%)
OESOPHAGEAL ACHALASIA 0/1322 (0%) 1/686 (0.1%)
OESOPHAGITIS 1/1322 (0.1%) 0/686 (0%)
PANCREATIC CYST 0/1322 (0%) 1/686 (0.1%)
PANCREATITIS 1/1322 (0.1%) 2/686 (0.3%)
PANCREATITIS ACUTE 2/1322 (0.2%) 1/686 (0.1%)
RECTAL HAEMORRHAGE 2/1322 (0.2%) 2/686 (0.3%)
RETROPERITONEAL HAEMORRHAGE 3/1322 (0.2%) 0/686 (0%)
SMALL INTESTINAL OBSTRUCTION 3/1322 (0.2%) 6/686 (0.9%)
SMALL INTESTINAL PERFORATION 0/1322 (0%) 1/686 (0.1%)
UMBILICAL HERNIA 2/1322 (0.2%) 0/686 (0%)
UMBILICAL HERNIA, OBSTRUCTIVE 1/1322 (0.1%) 0/686 (0%)
UPPER GASTROINTESTINAL HAEMORRHAGE 3/1322 (0.2%) 4/686 (0.6%)
General disorders
ABASIA 0/1322 (0%) 1/686 (0.1%)
ADVERSE DRUG REACTION 3/1322 (0.2%) 1/686 (0.1%)
ASTHENIA 5/1322 (0.4%) 0/686 (0%)
CARDIAC DEATH 1/1322 (0.1%) 0/686 (0%)
CATHETER SITE HAEMATOMA 1/1322 (0.1%) 1/686 (0.1%)
CATHETER SITE HAEMORRHAGE 1/1322 (0.1%) 2/686 (0.3%)
CATHETER SITE PAIN 0/1322 (0%) 2/686 (0.3%)
CHEST DISCOMFORT 10/1322 (0.8%) 8/686 (1.2%)
CHEST PAIN 40/1322 (3%) 18/686 (2.6%)
DEATH 10/1322 (0.8%) 6/686 (0.9%)
DEVICE ELECTRICAL FINDING 0/1322 (0%) 1/686 (0.1%)
DEVICE FAILURE 1/1322 (0.1%) 1/686 (0.1%)
DEVICE MALFUNCTION 1/1322 (0.1%) 0/686 (0%)
DEVICE OCCLUSION 1/1322 (0.1%) 0/686 (0%)
DROWNING 1/1322 (0.1%) 0/686 (0%)
DRUG INTOLERANCE 1/1322 (0.1%) 0/686 (0%)
DRUG WITHDRAWAL SYNDROME 1/1322 (0.1%) 0/686 (0%)
HERNIA 0/1322 (0%) 1/686 (0.1%)
HERNIA OBSTRUCTIVE 1/1322 (0.1%) 0/686 (0%)
IMPAIRED HEALING 0/1322 (0%) 1/686 (0.1%)
MEDICAL DEVICE SITE REACTION 1/1322 (0.1%) 0/686 (0%)
MULTI-ORGAN FAILURE 1/1322 (0.1%) 2/686 (0.3%)
NON-CARDIAC CHEST PAIN 84/1322 (6.4%) 51/686 (7.4%)
OEDEMA PERIPHERAL 1/1322 (0.1%) 0/686 (0%)
PAIN 1/1322 (0.1%) 0/686 (0%)
PELVIC MASS 0/1322 (0%) 2/686 (0.3%)
PYREXIA 6/1322 (0.5%) 3/686 (0.4%)
SUDDEN CARDIAC DEATH 0/1322 (0%) 1/686 (0.1%)
SURGICAL FAILURE 1/1322 (0.1%) 0/686 (0%)
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME 3/1322 (0.2%) 1/686 (0.1%)
THROMBOSIS IN DEVICE 9/1322 (0.7%) 6/686 (0.9%)
Hepatobiliary disorders
BILE DUCT STONE 2/1322 (0.2%) 0/686 (0%)
CHOLANGITIS 1/1322 (0.1%) 0/686 (0%)
CHOLECYSTITIS 3/1322 (0.2%) 2/686 (0.3%)
CHOLECYSTITIS ACUTE 2/1322 (0.2%) 4/686 (0.6%)
CHOLECYSTITIS CHRONIC 1/1322 (0.1%) 0/686 (0%)
CHOLELITHIASIS 7/1322 (0.5%) 3/686 (0.4%)
GALLBLADDER DISORDER 1/1322 (0.1%) 0/686 (0%)
HEPATIC LESION 2/1322 (0.2%) 1/686 (0.1%)
PORTAL VEIN THROMBOSIS 1/1322 (0.1%) 0/686 (0%)
Immune system disorders
ALLERGY TO ARTHROPOD STING 1/1322 (0.1%) 1/686 (0.1%)
Infections and infestations
ABDOMINAL ABSCESS 0/1322 (0%) 1/686 (0.1%)
ABSCESS NECK 1/1322 (0.1%) 0/686 (0%)
APPENDICITIS 4/1322 (0.3%) 2/686 (0.3%)
APPENDICITIS PERFORATED 1/1322 (0.1%) 0/686 (0%)
ARTHRITIS BACTERIAL 1/1322 (0.1%) 0/686 (0%)
ARTHRITIS INFECTIVE 1/1322 (0.1%) 0/686 (0%)
BACTERAEMIA 4/1322 (0.3%) 0/686 (0%)
BACTERIAL INFECTION 0/1322 (0%) 1/686 (0.1%)
BACTERIAL SEPSIS 0/1322 (0%) 2/686 (0.3%)
BREAST CELLULITIS 1/1322 (0.1%) 0/686 (0%)
BRONCHITIS 10/1322 (0.8%) 6/686 (0.9%)
BRONCHITIS VIRAL 1/1322 (0.1%) 0/686 (0%)
CATHETER SITE ABSCESS 2/1322 (0.2%) 0/686 (0%)
CATHETER SITE CELLULITIS 1/1322 (0.1%) 0/686 (0%)
CATHETER SITE INFECTION 1/1322 (0.1%) 0/686 (0%)
CELLULITIS 11/1322 (0.8%) 11/686 (1.6%)
CHOLECYSTITIS INFECTIVE 0/1322 (0%) 2/686 (0.3%)
CLOSTRIDIAL INFECTION 1/1322 (0.1%) 1/686 (0.1%)
CLOSTRIDIUM DIFFICILE COLITIS 2/1322 (0.2%) 2/686 (0.3%)
CYSTITIS 1/1322 (0.1%) 0/686 (0%)
DIABETIC FOOT INFECTION 1/1322 (0.1%) 0/686 (0%)
DIVERTICULITIS 5/1322 (0.4%) 3/686 (0.4%)
ENDOCARDITIS 1/1322 (0.1%) 0/686 (0%)
ENTEROCOCCAL SEPSIS 0/1322 (0%) 1/686 (0.1%)
ESCHERICHIA BACTERAEMIA 1/1322 (0.1%) 0/686 (0%)
FUNGAL INFECTION 0/1322 (0%) 1/686 (0.1%)
GANGRENE 1/1322 (0.1%) 1/686 (0.1%)
GASTROENTERITIS 6/1322 (0.5%) 3/686 (0.4%)
GASTROENTERITIS VIRAL 1/1322 (0.1%) 2/686 (0.3%)
GENITAL INFECTION FEMALE 1/1322 (0.1%) 0/686 (0%)
HERPES ZOSTER 1/1322 (0.1%) 1/686 (0.1%)
HIV INFECTION 1/1322 (0.1%) 0/686 (0%)
IMPLANT SITE INFECTION 1/1322 (0.1%) 0/686 (0%)
INFECTED DERMAL CYST 1/1322 (0.1%) 0/686 (0%)
INFECTED SKIN ULCER 0/1322 (0%) 1/686 (0.1%)
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE 1/1322 (0.1%) 0/686 (0%)
INFLUENZA 3/1322 (0.2%) 3/686 (0.4%)
KIDNEY INFECTION 3/1322 (0.2%) 0/686 (0%)
LOBAR PNEUMONIA 1/1322 (0.1%) 1/686 (0.1%)
LOCALISED INFECTION 0/1322 (0%) 3/686 (0.4%)
LUNG ABSCESS 0/1322 (0%) 1/686 (0.1%)
MENINGITIS ASEPTIC 1/1322 (0.1%) 0/686 (0%)
METAPNEUMOVIRUS INFECTION 1/1322 (0.1%) 0/686 (0%)
MYCOBACTERIUM ABSCESSUS INFECTION 1/1322 (0.1%) 0/686 (0%)
ORAL FUNGAL INFECTION 1/1322 (0.1%) 0/686 (0%)
ORCHITIS 1/1322 (0.1%) 0/686 (0%)
OSTEOMYELITIS 3/1322 (0.2%) 4/686 (0.6%)
PERITONITIS 0/1322 (0%) 1/686 (0.1%)
PERITONSILLAR ABSCESS 1/1322 (0.1%) 0/686 (0%)
PNEUMONIA 25/1322 (1.9%) 19/686 (2.8%)
PNEUMONIA ADENOVIRAL 1/1322 (0.1%) 0/686 (0%)
PNEUMONIA BACTERIAL 2/1322 (0.2%) 0/686 (0%)
PNEUMONIA NECROTISING 1/1322 (0.1%) 0/686 (0%)
PNEUMONIA PRIMARY ATYPICAL 1/1322 (0.1%) 0/686 (0%)
PNEUMONIA STAPHYLOCOCCAL 1/1322 (0.1%) 0/686 (0%)
POST PROCEDURAL CELLULITIS 1/1322 (0.1%) 0/686 (0%)
POST PROCEDURAL INFECTION 1/1322 (0.1%) 0/686 (0%)
POST PROCEDURAL PNEUMONIA 1/1322 (0.1%) 0/686 (0%)
POSTOPERATIVE WOUND INFECTION 1/1322 (0.1%) 1/686 (0.1%)
RESPIRATORY SYNCYTIAL VIRUS INFECTION 1/1322 (0.1%) 0/686 (0%)
SEPSIS 14/1322 (1.1%) 10/686 (1.5%)
SEPSIS SYNDROME 2/1322 (0.2%) 0/686 (0%)
SEPTIC ENCEPHALOPATHY 0/1322 (0%) 1/686 (0.1%)
SEPTIC SHOCK 2/1322 (0.2%) 1/686 (0.1%)
SPINAL CORD INFECTION 1/1322 (0.1%) 0/686 (0%)
STAPHYLOCOCCAL BACTERAEMIA 0/1322 (0%) 2/686 (0.3%)
STAPHYLOCOCCAL INFECTION 1/1322 (0.1%) 0/686 (0%)
UPPER RESPIRATORY TRACT INFECTION 2/1322 (0.2%) 0/686 (0%)
URINARY TRACT INFECTION 9/1322 (0.7%) 7/686 (1%)
URINARY TRACT INFECTION BACTERIAL 1/1322 (0.1%) 1/686 (0.1%)
UROSEPSIS 3/1322 (0.2%) 4/686 (0.6%)
VIRAL INFECTION 2/1322 (0.2%) 0/686 (0%)
VIRAL LABYRINTHITIS 0/1322 (0%) 1/686 (0.1%)
WOUND INFECTION 1/1322 (0.1%) 2/686 (0.3%)
WOUND INFECTION BACTERIAL 0/1322 (0%) 1/686 (0.1%)
WOUND INFECTION STAPHYLOCOCCAL 0/1322 (0%) 1/686 (0.1%)
Injury, poisoning and procedural complications
ACETABULUM FRACTURE 0/1322 (0%) 1/686 (0.1%)
ALCOHOL POISONING 2/1322 (0.2%) 2/686 (0.3%)
ANAEMIA POSTOPERATIVE 3/1322 (0.2%) 2/686 (0.3%)
ANKLE FRACTURE 1/1322 (0.1%) 3/686 (0.4%)
BURNS THIRD DEGREE 0/1322 (0%) 1/686 (0.1%)
CARDIAC PROCEDURE COMPLICATION 1/1322 (0.1%) 1/686 (0.1%)
CEREBRAL HAEMORRHAGE TRAUMATIC 2/1322 (0.2%) 0/686 (0%)
CLAVICLE FRACTURE 0/1322 (0%) 1/686 (0.1%)
COLON INJURY 1/1322 (0.1%) 0/686 (0%)
CONCUSSION 1/1322 (0.1%) 0/686 (0%)
CONTRAST MEDIA ALLERGY 0/1322 (0%) 1/686 (0.1%)
CONTUSION 2/1322 (0.2%) 0/686 (0%)
CORONARY ARTERY RESTENOSIS 51/1322 (3.9%) 15/686 (2.2%)
CRANIOCEREBRAL INJURY 3/1322 (0.2%) 0/686 (0%)
CYSTITIS RADIATION 1/1322 (0.1%) 0/686 (0%)
DEEP VEIN THROMBOSIS POSTOPERATIVE 2/1322 (0.2%) 0/686 (0%)
EXPOSURE TO TOXIC AGENT 1/1322 (0.1%) 0/686 (0%)
FALL 9/1322 (0.7%) 7/686 (1%)
FEMORAL NECK FRACTURE 0/1322 (0%) 2/686 (0.3%)
FEMUR FRACTURE 3/1322 (0.2%) 0/686 (0%)
FOOT FRACTURE 1/1322 (0.1%) 0/686 (0%)
GASTROINTESTINAL ANASTOMOTIC LEAK 0/1322 (0%) 1/686 (0.1%)
HAND FRACTURE 0/1322 (0%) 1/686 (0.1%)
HEAD INJURY 0/1322 (0%) 1/686 (0.1%)
HIP FRACTURE 4/1322 (0.3%) 2/686 (0.3%)
HUMERUS FRACTURE 0/1322 (0%) 2/686 (0.3%)
ILIOTIBIAL BAND SYNDROME 0/1322 (0%) 1/686 (0.1%)
IN-STENT ARTERIAL RESTENOSIS 0/1322 (0%) 1/686 (0.1%)
IN-STENT CORONARY ARTERY RESTENOSIS 7/1322 (0.5%) 5/686 (0.7%)
INCISIONAL HERNIA 3/1322 (0.2%) 0/686 (0%)
INJURY 1/1322 (0.1%) 0/686 (0%)
JOINT DISLOCATION 1/1322 (0.1%) 1/686 (0.1%)
LACERATION 1/1322 (0.1%) 0/686 (0%)
LIGAMENT RUPTURE 1/1322 (0.1%) 0/686 (0%)
LIMB INJURY 1/1322 (0.1%) 1/686 (0.1%)
LIMB TRAUMATIC AMPUTATION 1/1322 (0.1%) 0/686 (0%)
MENISCUS LESION 4/1322 (0.3%) 1/686 (0.1%)
MULTIPLE FRACTURES 2/1322 (0.2%) 0/686 (0%)
MULTIPLE INJURIES 1/1322 (0.1%) 0/686 (0%)
MUSCLE RUPTURE 0/1322 (0%) 1/686 (0.1%)
PELVIC FRACTURE 1/1322 (0.1%) 0/686 (0%)
PLAQUE SHIFT 1/1322 (0.1%) 3/686 (0.4%)
POST CONCUSSION SYNDROME 1/1322 (0.1%) 0/686 (0%)
POST PROCEDURAL HAEMATOMA 1/1322 (0.1%) 2/686 (0.3%)
POST PROCEDURAL HAEMORRHAGE 1/1322 (0.1%) 2/686 (0.3%)
POST PROCEDURAL MYOCARDIAL INFARCTION 7/1322 (0.5%) 5/686 (0.7%)
POST PROCEDURAL STROKE 1/1322 (0.1%) 0/686 (0%)
POST-TRAUMATIC PAIN 2/1322 (0.2%) 0/686 (0%)
POSTOPERATIVE ADHESION 1/1322 (0.1%) 0/686 (0%)
PROCEDURAL COMPLICATION 1/1322 (0.1%) 0/686 (0%)
PROCEDURAL DIZZINESS 1/1322 (0.1%) 0/686 (0%)
PROCEDURAL HEADACHE 1/1322 (0.1%) 0/686 (0%)
PROCEDURAL HYPOTENSION 0/1322 (0%) 1/686 (0.1%)
PROCEDURAL VOMITING 1/1322 (0.1%) 0/686 (0%)
RADIUS FRACTURE 0/1322 (0%) 1/686 (0.1%)
RESPIRATORY FUME INHALATION DISORDER 1/1322 (0.1%) 0/686 (0%)
RIB FRACTURE 2/1322 (0.2%) 2/686 (0.3%)
ROAD TRAFFIC ACCIDENT 4/1322 (0.3%) 0/686 (0%)
SEROMA 1/1322 (0.1%) 0/686 (0%)
SKULL FRACTURE 1/1322 (0.1%) 0/686 (0%)
SNAKE BITE 1/1322 (0.1%) 0/686 (0%)
SPINAL COMPRESSION FRACTURE 4/1322 (0.3%) 2/686 (0.3%)
SPINAL FRACTURE 2/1322 (0.2%) 0/686 (0%)
SPLENIC RUPTURE 1/1322 (0.1%) 0/686 (0%)
STERNAL FRACTURE 0/1322 (0%) 1/686 (0.1%)
SUBDURAL HAEMATOMA 6/1322 (0.5%) 3/686 (0.4%)
TENDON INJURY 0/1322 (0%) 1/686 (0.1%)
TENDON RUPTURE 1/1322 (0.1%) 0/686 (0%)
THERMAL BURN 1/1322 (0.1%) 0/686 (0%)
THORACIC VERTEBRAL FRACTURE 1/1322 (0.1%) 0/686 (0%)
TIBIA FRACTURE 0/1322 (0%) 2/686 (0.3%)
TRAUMATIC HAEMATOMA 1/1322 (0.1%) 0/686 (0%)
TRAUMATIC HAEMORRHAGE 0/1322 (0%) 1/686 (0.1%)
ULNA FRACTURE 0/1322 (0%) 1/686 (0.1%)
UPPER LIMB FRACTURE 2/1322 (0.2%) 0/686 (0%)
URINARY RETENTION POSTOPERATIVE 3/1322 (0.2%) 0/686 (0%)
VASCULAR GRAFT OCCLUSION 2/1322 (0.2%) 1/686 (0.1%)
VASCULAR PSEUDOANEURYSM 7/1322 (0.5%) 3/686 (0.4%)
WOUND 1/1322 (0.1%) 0/686 (0%)
WOUND EVISCERATION 1/1322 (0.1%) 0/686 (0%)
WOUND HAEMORRHAGE 1/1322 (0.1%) 0/686 (0%)
WRIST FRACTURE 2/1322 (0.2%) 1/686 (0.1%)
Investigations
BIOPSY LUNG 0/1322 (0%) 1/686 (0.1%)
BLOOD CREATINE INCREASED 1/1322 (0.1%) 0/686 (0%)
BLOOD CREATINE PHOSPHOKINASE MB INCREASED 2/1322 (0.2%) 0/686 (0%)
BLOOD CREATININE INCREASED 3/1322 (0.2%) 0/686 (0%)
BLOOD PRESSURE INCREASED 1/1322 (0.1%) 1/686 (0.1%)
BLOOD PRESSURE SYSTOLIC INCREASED 1/1322 (0.1%) 0/686 (0%)
CARDIAC ENZYMES INCREASED 4/1322 (0.3%) 1/686 (0.1%)
CARDIAC STRESS TEST ABNORMAL 1/1322 (0.1%) 2/686 (0.3%)
COMPUTERISED TOMOGRAM ABNORMAL 1/1322 (0.1%) 0/686 (0%)
COMPUTERISED TOMOGRAM THORAX ABNORMAL 1/1322 (0.1%) 0/686 (0%)
EJECTION FRACTION DECREASED 1/1322 (0.1%) 0/686 (0%)
ELECTROCARDIOGRAM ST SEGMENT ELEVATION 1/1322 (0.1%) 0/686 (0%)
HAEMOGLOBIN DECREASED 1/1322 (0.1%) 0/686 (0%)
HEART RATE INCREASED 1/1322 (0.1%) 0/686 (0%)
OXYGEN CONSUMPTION INCREASED 0/1322 (0%) 1/686 (0.1%)
TROPONIN INCREASED 2/1322 (0.2%) 0/686 (0%)
WHITE BLOOD CELL COUNT INCREASED 1/1322 (0.1%) 0/686 (0%)
Metabolism and nutrition disorders
DEHYDRATION 7/1322 (0.5%) 5/686 (0.7%)
DIABETES MELLITUS 0/1322 (0%) 1/686 (0.1%)
DIABETIC KETOACIDOSIS 5/1322 (0.4%) 1/686 (0.1%)
FAILURE TO THRIVE 1/1322 (0.1%) 0/686 (0%)
FLUID OVERLOAD 0/1322 (0%) 1/686 (0.1%)
HYPERGLYCAEMIA 6/1322 (0.5%) 2/686 (0.3%)
HYPERKALAEMIA 0/1322 (0%) 2/686 (0.3%)
HYPOGLYCAEMIA 4/1322 (0.3%) 0/686 (0%)
HYPOKALAEMIA 3/1322 (0.2%) 1/686 (0.1%)
HYPOMAGNESAEMIA 0/1322 (0%) 1/686 (0.1%)
HYPONATRAEMIA 3/1322 (0.2%) 2/686 (0.3%)
HYPOVOLAEMIA 0/1322 (0%) 1/686 (0.1%)
LACTIC ACIDOSIS 1/1322 (0.1%) 0/686 (0%)
METABOLIC ACIDOSIS 1/1322 (0.1%) 1/686 (0.1%)
OBESITY 6/1322 (0.5%) 3/686 (0.4%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA 5/1322 (0.4%) 3/686 (0.4%)
ARTHRITIS 4/1322 (0.3%) 2/686 (0.3%)
BACK PAIN 3/1322 (0.2%) 4/686 (0.6%)
BURSITIS 1/1322 (0.1%) 1/686 (0.1%)
CHONDROCALCINOSIS PYROPHOSPHATE 1/1322 (0.1%) 0/686 (0%)
COSTOCHONDRITIS 2/1322 (0.2%) 0/686 (0%)
DUPUYTREN'S CONTRACTURE 1/1322 (0.1%) 1/686 (0.1%)
EXOSTOSIS 0/1322 (0%) 1/686 (0.1%)
FLANK PAIN 1/1322 (0.1%) 0/686 (0%)
FRACTURE NONUNION 1/1322 (0.1%) 0/686 (0%)
INTERVERTEBRAL DISC PROTRUSION 9/1322 (0.7%) 2/686 (0.3%)
JOINT EFFUSION 1/1322 (0.1%) 0/686 (0%)
LUMBAR SPINAL STENOSIS 7/1322 (0.5%) 2/686 (0.3%)
MUSCULAR WEAKNESS 2/1322 (0.2%) 1/686 (0.1%)
MUSCULOSKELETAL CHEST PAIN 4/1322 (0.3%) 0/686 (0%)
MUSCULOSKELETAL DISORDER 1/1322 (0.1%) 0/686 (0%)
MUSCULOSKELETAL PAIN 1/1322 (0.1%) 3/686 (0.4%)
NECK PAIN 1/1322 (0.1%) 0/686 (0%)
OSTEOARTHRITIS 26/1322 (2%) 14/686 (2%)
OSTEOPENIA 1/1322 (0.1%) 0/686 (0%)
OSTEOPOROSIS 1/1322 (0.1%) 0/686 (0%)
PAIN IN EXTREMITY 4/1322 (0.3%) 2/686 (0.3%)
PAIN IN JAW 1/1322 (0.1%) 0/686 (0%)
RHABDOMYOLYSIS 0/1322 (0%) 1/686 (0.1%)
RHEUMATOID ARTHRITIS 1/1322 (0.1%) 0/686 (0%)
ROTATOR CUFF SYNDROME 1/1322 (0.1%) 0/686 (0%)
SACROILIITIS 0/1322 (0%) 1/686 (0.1%)
SPINAL OSTEOARTHRITIS 3/1322 (0.2%) 2/686 (0.3%)
SPONDYLITIS 1/1322 (0.1%) 0/686 (0%)
SPONDYLOLISTHESIS 3/1322 (0.2%) 2/686 (0.3%)
TENDINOUS CONTRACTURE 1/1322 (0.1%) 0/686 (0%)
VERTEBRAL FORAMINAL STENOSIS 0/1322 (0%) 1/686 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA 1/1322 (0.1%) 0/686 (0%)
ACUTE MYELOID LEUKAEMIA RECURRENT 1/1322 (0.1%) 0/686 (0%)
ADENOCARCINOMA 2/1322 (0.2%) 1/686 (0.1%)
ADENOCARCINOMA PANCREAS 1/1322 (0.1%) 0/686 (0%)
B-CELL LYMPHOMA 1/1322 (0.1%) 0/686 (0%)
B-CELL LYMPHOMA STAGE IV 1/1322 (0.1%) 0/686 (0%)
BASAL CELL CARCINOMA 1/1322 (0.1%) 2/686 (0.3%)
BENIGN OVARIAN TUMOUR 1/1322 (0.1%) 0/686 (0%)
BILE DUCT CANCER 1/1322 (0.1%) 0/686 (0%)
BLADDER CANCER 3/1322 (0.2%) 1/686 (0.1%)
BLADDER CANCER RECURRENT 1/1322 (0.1%) 1/686 (0.1%)
BLADDER CANCER STAGE IV 1/1322 (0.1%) 0/686 (0%)
BLADDER NEOPLASM 1/1322 (0.1%) 1/686 (0.1%)
BRAIN NEOPLASM 0/1322 (0%) 1/686 (0.1%)
BREAST CANCER 5/1322 (0.4%) 0/686 (0%)
BREAST CANCER STAGE III 1/1322 (0.1%) 0/686 (0%)
CERVIX CARCINOMA 0/1322 (0%) 1/686 (0.1%)
CHRONIC LYMPHOCYTIC LEUKAEMIA 0/1322 (0%) 1/686 (0.1%)
COLON ADENOMA 2/1322 (0.2%) 2/686 (0.3%)
COLON CANCER 2/1322 (0.2%) 2/686 (0.3%)
DIFFUSE LARGE B-CELL LYMPHOMA 2/1322 (0.2%) 0/686 (0%)
GASTRIC CANCER 1/1322 (0.1%) 0/686 (0%)
GLIOBLASTOMA 0/1322 (0%) 2/686 (0.3%)
HEAD AND NECK CANCER 1/1322 (0.1%) 0/686 (0%)
HEAD AND NECK CANCER METASTATIC 1/1322 (0.1%) 0/686 (0%)
HEPATIC CANCER METASTATIC 0/1322 (0%) 1/686 (0.1%)
HEPATIC NEOPLASM MALIGNANT 1/1322 (0.1%) 0/686 (0%)
HYPOPHARYNGEAL CANCER 1/1322 (0.1%) 0/686 (0%)
LEUKAEMIA 1/1322 (0.1%) 0/686 (0%)
LEUKAEMIA RECURRENT 1/1322 (0.1%) 0/686 (0%)
LIP AND/OR ORAL CAVITY CANCER 0/1322 (0%) 1/686 (0.1%)
LUNG ADENOCARCINOMA 3/1322 (0.2%) 0/686 (0%)
LUNG CANCER METASTATIC 1/1322 (0.1%) 1/686 (0.1%)
LUNG NEOPLASM 2/1322 (0.2%) 0/686 (0%)
LUNG NEOPLASM MALIGNANT 6/1322 (0.5%) 0/686 (0%)
LUNG SQUAMOUS CELL CARCINOMA STAGE III 1/1322 (0.1%) 0/686 (0%)
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED 2/1322 (0.2%) 0/686 (0%)
LYMPHOMA 4/1322 (0.3%) 0/686 (0%)
MALIGNANT MELANOMA 1/1322 (0.1%) 0/686 (0%)
MENINGIOMA 1/1322 (0.1%) 0/686 (0%)
METASTASES TO LIVER 1/1322 (0.1%) 0/686 (0%)
METASTASES TO LUNG 1/1322 (0.1%) 0/686 (0%)
METASTASES TO LYMPH NODES 1/1322 (0.1%) 0/686 (0%)
METASTASES TO SPINE 1/1322 (0.1%) 0/686 (0%)
METASTATIC MALIGNANT MELANOMA 3/1322 (0.2%) 0/686 (0%)
METASTATIC NEOPLASM 1/1322 (0.1%) 1/686 (0.1%)
MULTIPLE MYELOMA 1/1322 (0.1%) 0/686 (0%)
NEOPLASM MALIGNANT 2/1322 (0.2%) 0/686 (0%)
NON-HODGKIN'S LYMPHOMA 0/1322 (0%) 1/686 (0.1%)
NON-SMALL CELL LUNG CANCER 1/1322 (0.1%) 1/686 (0.1%)
OESOPHAGEAL CARCINOMA 1/1322 (0.1%) 0/686 (0%)
ORAL NEOPLASM 0/1322 (0%) 1/686 (0.1%)
OROPHARYNGEAL CANCER STAGE UNSPECIFIED 0/1322 (0%) 1/686 (0.1%)
OVARIAN CANCER METASTATIC 1/1322 (0.1%) 0/686 (0%)
OVARIAN EPITHELIAL CANCER 1/1322 (0.1%) 0/686 (0%)
PANCREATIC CARCINOMA 1/1322 (0.1%) 1/686 (0.1%)
PERICARDIAL EFFUSION MALIGNANT 1/1322 (0.1%) 0/686 (0%)
PROSTATE CANCER 11/1322 (0.8%) 3/686 (0.4%)
RECTAL CANCER 1/1322 (0.1%) 0/686 (0%)
RENAL CANCER 0/1322 (0%) 1/686 (0.1%)
RENAL CELL CARCINOMA 1/1322 (0.1%) 0/686 (0%)
RENAL NEOPLASM 1/1322 (0.1%) 0/686 (0%)
SINONASAL PAPILLOMA 1/1322 (0.1%) 0/686 (0%)
SKIN CANCER 2/1322 (0.2%) 0/686 (0%)
SMALL CELL LUNG CANCER LIMITED STAGE 0/1322 (0%) 1/686 (0.1%)
SMALL CELL LUNG CANCER STAGE UNSPECIFIED 1/1322 (0.1%) 0/686 (0%)
SQUAMOUS CELL CARCINOMA 3/1322 (0.2%) 2/686 (0.3%)
SQUAMOUS CELL CARCINOMA OF SKIN 0/1322 (0%) 1/686 (0.1%)
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED 1/1322 (0.1%) 0/686 (0%)
TRANSITIONAL CELL CARCINOMA 1/1322 (0.1%) 0/686 (0%)
URETERIC CANCER 1/1322 (0.1%) 0/686 (0%)
UTERINE CANCER 1/1322 (0.1%) 0/686 (0%)
VULVAL CANCER STAGE 0 1/1322 (0.1%) 0/686 (0%)
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS 1/1322 (0.1%) 0/686 (0%)
APHASIA 0/1322 (0%) 1/686 (0.1%)
ARACHNOIDITIS 0/1322 (0%) 1/686 (0.1%)
AUTONOMIC NERVOUS SYSTEM IMBALANCE 1/1322 (0.1%) 0/686 (0%)
CAROTID ARTERY DISEASE 2/1322 (0.2%) 0/686 (0%)
CAROTID ARTERY STENOSIS 11/1322 (0.8%) 7/686 (1%)
CARPAL TUNNEL SYNDROME 1/1322 (0.1%) 0/686 (0%)
CENTRAL NERVOUS SYSTEM LESION 1/1322 (0.1%) 0/686 (0%)
CEREBELLAR INFARCTION 1/1322 (0.1%) 0/686 (0%)
CEREBRAL HAEMORRHAGE 0/1322 (0%) 1/686 (0.1%)
CEREBRAL INFARCTION 1/1322 (0.1%) 1/686 (0.1%)
CEREBROVASCULAR ACCIDENT 19/1322 (1.4%) 15/686 (2.2%)
CEREBROVASCULAR DISORDER 1/1322 (0.1%) 1/686 (0.1%)
CERVICOBRACHIAL SYNDROME 1/1322 (0.1%) 0/686 (0%)
COMPLICATED MIGRAINE 2/1322 (0.2%) 0/686 (0%)
CONVULSION 3/1322 (0.2%) 1/686 (0.1%)
DIABETIC NEUROPATHY 0/1322 (0%) 1/686 (0.1%)
DIZZINESS 6/1322 (0.5%) 1/686 (0.1%)
DYSARTHRIA 2/1322 (0.2%) 0/686 (0%)
EMBOLIC STROKE 1/1322 (0.1%) 0/686 (0%)
ENCEPHALOPATHY 2/1322 (0.2%) 2/686 (0.3%)
GUILLAIN-BARRE SYNDROME 2/1322 (0.2%) 0/686 (0%)
HAEMORRHAGE INTRACRANIAL 1/1322 (0.1%) 1/686 (0.1%)
HAEMORRHAGIC STROKE 1/1322 (0.1%) 0/686 (0%)
HEADACHE 2/1322 (0.2%) 3/686 (0.4%)
HEMIPARESIS 1/1322 (0.1%) 1/686 (0.1%)
HEMIPLEGIC MIGRAINE 1/1322 (0.1%) 0/686 (0%)
HEPATIC ENCEPHALOPATHY 1/1322 (0.1%) 0/686 (0%)
HYPOAESTHESIA 1/1322 (0.1%) 3/686 (0.4%)
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY 2/1322 (0.2%) 0/686 (0%)
ISCHAEMIC STROKE 5/1322 (0.4%) 3/686 (0.4%)
LATERAL MEDULLARY SYNDROME 1/1322 (0.1%) 0/686 (0%)
LOSS OF CONSCIOUSNESS 1/1322 (0.1%) 0/686 (0%)
LUMBAR RADICULOPATHY 2/1322 (0.2%) 1/686 (0.1%)
METABOLIC ENCEPHALOPATHY 2/1322 (0.2%) 0/686 (0%)
MIGRAINE 2/1322 (0.2%) 1/686 (0.1%)
MYELOMALACIA 1/1322 (0.1%) 0/686 (0%)
NEUROLOGICAL SYMPTOM 1/1322 (0.1%) 0/686 (0%)
NYSTAGMUS 1/1322 (0.1%) 0/686 (0%)
PARAESTHESIA 4/1322 (0.3%) 1/686 (0.1%)
POLYNEUROPATHY ALCOHOLIC 1/1322 (0.1%) 0/686 (0%)
POST-TRAUMATIC HEADACHE 0/1322 (0%) 1/686 (0.1%)
PRESYNCOPE 5/1322 (0.4%) 1/686 (0.1%)
RADICULITIS 0/1322 (0%) 1/686 (0.1%)
RADICULITIS CERVICAL 1/1322 (0.1%) 0/686 (0%)
SPONDYLITIC MYELOPATHY 1/1322 (0.1%) 0/686 (0%)
SUBARACHNOID HAEMORRHAGE 1/1322 (0.1%) 1/686 (0.1%)
SUBDURAL HYGROMA 2/1322 (0.2%) 0/686 (0%)
SYNCOPE 24/1322 (1.8%) 13/686 (1.9%)
THALAMIC INFARCTION 3/1322 (0.2%) 0/686 (0%)
THROMBOTIC STROKE 0/1322 (0%) 1/686 (0.1%)
TRANSIENT ISCHAEMIC ATTACK 11/1322 (0.8%) 6/686 (0.9%)
UNRESPONSIVE TO STIMULI 1/1322 (0.1%) 0/686 (0%)
URAEMIC ENCEPHALOPATHY 0/1322 (0%) 1/686 (0.1%)
VERTEBRAL ARTERY OCCLUSION 0/1322 (0%) 1/686 (0.1%)
VITH NERVE PARALYSIS 2/1322 (0.2%) 1/686 (0.1%)
Psychiatric disorders
ACUTE STRESS DISORDER 0/1322 (0%) 1/686 (0.1%)
ADJUSTMENT DISORDER WITH MIXED DISTURBANCE OF EMOTION AND CONDUCT 0/1322 (0%) 1/686 (0.1%)
ALCOHOL ABUSE 1/1322 (0.1%) 0/686 (0%)
ALCOHOL WITHDRAWAL SYNDROME 0/1322 (0%) 1/686 (0.1%)
ANXIETY 2/1322 (0.2%) 1/686 (0.1%)
BIPOLAR DISORDER 0/1322 (0%) 1/686 (0.1%)
COMPLETED SUICIDE 0/1322 (0%) 1/686 (0.1%)
CONFUSIONAL STATE 1/1322 (0.1%) 1/686 (0.1%)
DELIRIUM 0/1322 (0%) 1/686 (0.1%)
DELIRIUM TREMENS 0/1322 (0%) 1/686 (0.1%)
DEPRESSION SUICIDAL 1/1322 (0.1%) 0/686 (0%)
HALLUCINATION, VISUAL 0/1322 (0%) 1/686 (0.1%)
INTENTIONAL SELF-INJURY 1/1322 (0.1%) 0/686 (0%)
MAJOR DEPRESSION 2/1322 (0.2%) 1/686 (0.1%)
MENTAL STATUS CHANGES 5/1322 (0.4%) 2/686 (0.3%)
PANIC ATTACK 1/1322 (0.1%) 1/686 (0.1%)
SUICIDAL IDEATION 0/1322 (0%) 2/686 (0.3%)
Renal and urinary disorders
CALCULUS URETERIC 1/1322 (0.1%) 3/686 (0.4%)
HAEMATURIA 3/1322 (0.2%) 2/686 (0.3%)
HYDRONEPHROSIS 1/1322 (0.1%) 1/686 (0.1%)
NEPHROLITHIASIS 7/1322 (0.5%) 7/686 (1%)
RENAL ARTERY STENOSIS 1/1322 (0.1%) 2/686 (0.3%)
RENAL DISORDER 1/1322 (0.1%) 0/686 (0%)
RENAL FAILURE 5/1322 (0.4%) 4/686 (0.6%)
RENAL FAILURE ACUTE 12/1322 (0.9%) 12/686 (1.7%)
RENAL FAILURE CHRONIC 2/1322 (0.2%) 3/686 (0.4%)
RENAL IMPAIRMENT 0/1322 (0%) 1/686 (0.1%)
RENAL TUBULAR NECROSIS 1/1322 (0.1%) 0/686 (0%)
STRESS URINARY INCONTINENCE 1/1322 (0.1%) 0/686 (0%)
URINARY RETENTION 4/1322 (0.3%) 1/686 (0.1%)
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA 3/1322 (0.2%) 3/686 (0.4%)
FALLOPIAN TUBE CYST 1/1322 (0.1%) 0/686 (0%)
PELVIC HAEMATOMA 1/1322 (0.1%) 0/686 (0%)
UTERINE POLYP 1/1322 (0.1%) 0/686 (0%)
VAGINAL HAEMORRHAGE 1/1322 (0.1%) 1/686 (0.1%)
VULVA CYST 1/1322 (0.1%) 0/686 (0%)
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA 0/1322 (0%) 4/686 (0.6%)
ACUTE RESPIRATORY FAILURE 16/1322 (1.2%) 7/686 (1%)
ASPIRATION 1/1322 (0.1%) 0/686 (0%)
ASTHMA 2/1322 (0.2%) 0/686 (0%)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 28/1322 (2.1%) 10/686 (1.5%)
DYSPHONIA 1/1322 (0.1%) 0/686 (0%)
DYSPNOEA 33/1322 (2.5%) 13/686 (1.9%)
DYSPNOEA EXERTIONAL 5/1322 (0.4%) 3/686 (0.4%)
EPISTAXIS 2/1322 (0.2%) 0/686 (0%)
HAEMOPTYSIS 1/1322 (0.1%) 2/686 (0.3%)
HYPERVENTILATION 0/1322 (0%) 1/686 (0.1%)
HYPOXIA 2/1322 (0.2%) 2/686 (0.3%)
INTERSTITIAL LUNG DISEASE 1/1322 (0.1%) 0/686 (0%)
MEDIASTINAL MASS 0/1322 (0%) 1/686 (0.1%)
NASAL POLYPS 0/1322 (0%) 1/686 (0.1%)
NON-CARDIOGENIC PULMONARY OEDEMA 1/1322 (0.1%) 0/686 (0%)
ORGANISING PNEUMONIA 0/1322 (0%) 1/686 (0.1%)
PLEURAL EFFUSION 4/1322 (0.3%) 3/686 (0.4%)
PLEURITIC PAIN 1/1322 (0.1%) 1/686 (0.1%)
PNEUMONIA ASPIRATION 0/1322 (0%) 4/686 (0.6%)
PNEUMONITIS 1/1322 (0.1%) 0/686 (0%)
PNEUMOTHORAX 2/1322 (0.2%) 5/686 (0.7%)
PULMONARY EMBOLISM 9/1322 (0.7%) 7/686 (1%)
PULMONARY OEDEMA 3/1322 (0.2%) 1/686 (0.1%)
RESPIRATORY ARREST 2/1322 (0.2%) 0/686 (0%)
RESPIRATORY FAILURE 13/1322 (1%) 8/686 (1.2%)
TRACHEAL STENOSIS 1/1322 (0.1%) 0/686 (0%)
Skin and subcutaneous tissue disorders
DIABETIC FOOT 2/1322 (0.2%) 0/686 (0%)
RASH 1/1322 (0.1%) 0/686 (0%)
SKIN ULCER 4/1322 (0.3%) 1/686 (0.1%)
Surgical and medical procedures
AORTIC ANEURYSM REPAIR 1/1322 (0.1%) 0/686 (0%)
CHOLECYSTECTOMY 1/1322 (0.1%) 1/686 (0.1%)
COLOSTOMY 0/1322 (0%) 1/686 (0.1%)
CORONARY ARTERY BYPASS 1/1322 (0.1%) 0/686 (0%)
HIP ARTHROPLASTY 3/1322 (0.2%) 0/686 (0%)
INGUINAL HERNIA REPAIR 0/1322 (0%) 1/686 (0.1%)
KNEE ARTHROPLASTY 1/1322 (0.1%) 0/686 (0%)
LEG AMPUTATION 0/1322 (0%) 1/686 (0.1%)
MEDICAL DEVICE REMOVAL 0/1322 (0%) 1/686 (0.1%)
NEPHRECTOMY 1/1322 (0.1%) 0/686 (0%)
SPINAL FUSION SURGERY 1/1322 (0.1%) 0/686 (0%)
TENDON OPERATION 0/1322 (0%) 1/686 (0.1%)
TRANSURETHRAL PROSTATECTOMY 0/1322 (0%) 1/686 (0.1%)
Vascular disorders
ACCELERATED HYPERTENSION 3/1322 (0.2%) 1/686 (0.1%)
AORTIC ANEURYSM 6/1322 (0.5%) 2/686 (0.3%)
AORTIC DISSECTION 0/1322 (0%) 1/686 (0.1%)
AORTIC INTRAMURAL HAEMATOMA 1/1322 (0.1%) 1/686 (0.1%)
AORTIC STENOSIS 4/1322 (0.3%) 5/686 (0.7%)
ARTERIAL SPASM 1/1322 (0.1%) 0/686 (0%)
ARTERIOSCLEROSIS 0/1322 (0%) 1/686 (0.1%)
BLOOD PRESSURE INADEQUATELY CONTROLLED 1/1322 (0.1%) 0/686 (0%)
CIRCULATORY COLLAPSE 0/1322 (0%) 1/686 (0.1%)
DEEP VEIN THROMBOSIS 11/1322 (0.8%) 4/686 (0.6%)
FEMORAL ARTERIAL STENOSIS 1/1322 (0.1%) 1/686 (0.1%)
HAEMATOMA 1/1322 (0.1%) 0/686 (0%)
HYPERTENSION 8/1322 (0.6%) 2/686 (0.3%)
HYPERTENSIVE CRISIS 3/1322 (0.2%) 5/686 (0.7%)
HYPOTENSION 5/1322 (0.4%) 4/686 (0.6%)
ILIAC ARTERY STENOSIS 1/1322 (0.1%) 1/686 (0.1%)
INTERMITTENT CLAUDICATION 8/1322 (0.6%) 7/686 (1%)
MALIGNANT HYPERTENSION 1/1322 (0.1%) 0/686 (0%)
ORTHOSTATIC HYPOTENSION 2/1322 (0.2%) 1/686 (0.1%)
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE 3/1322 (0.2%) 8/686 (1.2%)
PERIPHERAL ISCHAEMIA 1/1322 (0.1%) 1/686 (0.1%)
PERIPHERAL VASCULAR DISORDER 7/1322 (0.5%) 6/686 (0.9%)
SUBCLAVIAN ARTERY OCCLUSION 1/1322 (0.1%) 0/686 (0%)
SUBCLAVIAN ARTERY STENOSIS 1/1322 (0.1%) 0/686 (0%)
SUBCLAVIAN STEAL SYNDROME 1/1322 (0.1%) 0/686 (0%)
THROMBOSIS 2/1322 (0.2%) 0/686 (0%)
VASOSPAM 1/1322 (0.1%) 0/686 (0%)
VENOUS INSUFFICIENCY 1/1322 (0.1%) 0/686 (0%)
Other (Not Including Serious) Adverse Events
Absorb BVS XIENCE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1174/1322 (88.8%) 601/686 (87.6%)
Blood and lymphatic system disorders
ANAEMIA 21/1322 (1.6%) 16/686 (2.3%)
ANAEMIA OF CHRONIC DISEASE 1/1322 (0.1%) 1/686 (0.1%)
COAGULOPATHY 0/1322 (0%) 2/686 (0.3%)
FEBRILE NEUTROPENIA 1/1322 (0.1%) 0/686 (0%)
HAEMORRHAGIC ANAEMIA 2/1322 (0.2%) 4/686 (0.6%)
HAEMORRHAGIC DIATHESIS 2/1322 (0.2%) 1/686 (0.1%)
HEPARIN-INDUCED THROMBOCYTOPENIA 1/1322 (0.1%) 0/686 (0%)
IRON DEFICIENCY ANAEMIA 3/1322 (0.2%) 1/686 (0.1%)
LEUKOCYTOSIS 5/1322 (0.4%) 2/686 (0.3%)
LYMPHADENITIS 1/1322 (0.1%) 0/686 (0%)
LYMPHADENOPATHY 2/1322 (0.2%) 0/686 (0%)
MICROCYTIC ANAEMIA 2/1322 (0.2%) 0/686 (0%)
NORMOCHROMIC NORMOCYTIC ANAEMIA 1/1322 (0.1%) 0/686 (0%)
SPLENIC INFARCTION 1/1322 (0.1%) 0/686 (0%)
THROMBOCYTOPENIA 2/1322 (0.2%) 2/686 (0.3%)
Cardiac disorders
ACUTE CORONARY SYNDROME 6/1322 (0.5%) 5/686 (0.7%)
ACUTE LEFT VENTRICULAR FAILURE 0/1322 (0%) 1/686 (0.1%)
ACUTE MYOCARDIAL INFARCTION 49/1322 (3.7%) 22/686 (3.2%)
ANGINA PECTORIS 381/1322 (28.8%) 202/686 (29.4%)
ANGINA UNSTABLE 77/1322 (5.8%) 29/686 (4.2%)
AORTIC VALVE DISEASE 2/1322 (0.2%) 0/686 (0%)
AORTIC VALVE INCOMPETENCE 2/1322 (0.2%) 0/686 (0%)
AORTIC VALVE STENOSIS 8/1322 (0.6%) 2/686 (0.3%)
ARRHYTHMIA 1/1322 (0.1%) 3/686 (0.4%)
ARTERIOSCLEROSIS CORONARY ARTERY 4/1322 (0.3%) 0/686 (0%)
ARTERIOSPASM CORONARY 4/1322 (0.3%) 4/686 (0.6%)
ATRIAL FIBRILLATION 95/1322 (7.2%) 42/686 (6.1%)
ATRIAL FLUTTER 11/1322 (0.8%) 3/686 (0.4%)
ATRIAL HYPERTROPHY 0/1322 (0%) 1/686 (0.1%)
ATRIAL TACHYCARDIA 0/1322 (0%) 1/686 (0.1%)
ATRIAL THROMBOSIS 1/1322 (0.1%) 0/686 (0%)
ATRIOVENTRICULAR BLOCK 6/1322 (0.5%) 0/686 (0%)
ATRIOVENTRICULAR BLOCK COMPLETE 1/1322 (0.1%) 1/686 (0.1%)
ATRIOVENTRICULAR BLOCK SECOND DEGREE 5/1322 (0.4%) 1/686 (0.1%)
BRADYCARDIA 31/1322 (2.3%) 13/686 (1.9%)
BUNDLE BRANCH BLOCK 0/1322 (0%) 1/686 (0.1%)
BUNDLE BRANCH BLOCK LEFT 0/1322 (0%) 1/686 (0.1%)
BUNDLE BRANCH BLOCK RIGHT 1/1322 (0.1%) 1/686 (0.1%)
CARDIAC ARREST 10/1322 (0.8%) 6/686 (0.9%)
CARDIAC FAILURE 8/1322 (0.6%) 4/686 (0.6%)
CARDIAC FAILURE ACUTE 5/1322 (0.4%) 1/686 (0.1%)
CARDIAC FAILURE CHRONIC 2/1322 (0.2%) 3/686 (0.4%)
CARDIAC FAILURE CONGESTIVE 39/1322 (3%) 30/686 (4.4%)
CARDIAC FLUTTER 2/1322 (0.2%) 1/686 (0.1%)
CARDIAC TAMPONADE 1/1322 (0.1%) 0/686 (0%)
CARDIAC VALVE DISEASE 2/1322 (0.2%) 0/686 (0%)
CARDIO-RESPIRATORY ARREST 2/1322 (0.2%) 1/686 (0.1%)
CARDIOGENIC SHOCK 1/1322 (0.1%) 3/686 (0.4%)
CARDIOMEGALY 1/1322 (0.1%) 0/686 (0%)
CARDIOMYOPATHY 1/1322 (0.1%) 2/686 (0.3%)
CARDIORENAL SYNDROME 1/1322 (0.1%) 0/686 (0%)
CHRONIC LEFT VENTRICULAR FAILURE 1/1322 (0.1%) 0/686 (0%)
CONDUCTION DISORDER 0/1322 (0%) 1/686 (0.1%)
CONGESTIVE CARDIOMYOPATHY 1/1322 (0.1%) 0/686 (0%)
CORONARY ARTERY DISEASE 44/1322 (3.3%) 28/686 (4.1%)
CORONARY ARTERY DISSECTION 85/1322 (6.4%) 56/686 (8.2%)
CORONARY ARTERY EMBOLISM 3/1322 (0.2%) 4/686 (0.6%)
CORONARY ARTERY OCCLUSION 5/1322 (0.4%) 2/686 (0.3%)
CORONARY ARTERY PERFORATION 7/1322 (0.5%) 3/686 (0.4%)
CORONARY ARTERY STENOSIS 23/1322 (1.7%) 14/686 (2%)
CORONARY NO-REFLOW PHENOMENON 1/1322 (0.1%) 1/686 (0.1%)
CORONARY OSTIAL STENOSIS 1/1322 (0.1%) 0/686 (0%)
CYANOSIS 0/1322 (0%) 1/686 (0.1%)
DIASTOLIC DYSFUNCTION 1/1322 (0.1%) 0/686 (0%)
DRESSLER'S SYNDROME 0/1322 (0%) 3/686 (0.4%)
EXTRASYSTOLES 1/1322 (0.1%) 1/686 (0.1%)
HEART VALVE INCOMPETENCE 1/1322 (0.1%) 0/686 (0%)
HYPERTROPHIC CARDIOMYOPATHY 1/1322 (0.1%) 0/686 (0%)
IN-STENT CORONARY ARTERY RESTENOSIS 4/1322 (0.3%) 5/686 (0.7%)
INTRACARDIAC THROMBUS 1/1322 (0.1%) 1/686 (0.1%)
ISCHAEMIC CARDIOMYOPATHY 4/1322 (0.3%) 2/686 (0.3%)
LEFT VENTRICULAR DYSFUNCTION 1/1322 (0.1%) 1/686 (0.1%)
LEFT VENTRICULAR HYPERTROPHY 1/1322 (0.1%) 0/686 (0%)
MITRAL VALVE INCOMPETENCE 8/1322 (0.6%) 1/686 (0.1%)
MYOCARDIAL INFARCTION 54/1322 (4.1%) 24/686 (3.5%)
MYOCARDIAL ISCHAEMIA 6/1322 (0.5%) 1/686 (0.1%)
NODAL ARRHYTHMIA 0/1322 (0%) 1/686 (0.1%)
NODAL RHYTHM 1/1322 (0.1%) 0/686 (0%)
PALPITATIONS 32/1322 (2.4%) 17/686 (2.5%)
PERICARDIAL EFFUSION 6/1322 (0.5%) 3/686 (0.4%)
PERICARDITIS 1/1322 (0.1%) 1/686 (0.1%)
PRINZMETAL ANGINA 2/1322 (0.2%) 0/686 (0%)
SICK SINUS SYNDROME 6/1322 (0.5%) 4/686 (0.6%)
SINUS ARREST 1/1322 (0.1%) 0/686 (0%)
SINUS ARRHYTHMIA 0/1322 (0%) 1/686 (0.1%)
SINUS BRADYCARDIA 3/1322 (0.2%) 3/686 (0.4%)
SINUS TACHYCARDIA 2/1322 (0.2%) 0/686 (0%)
SUPRAVENTRICULAR EXTRASYSTOLES 1/1322 (0.1%) 1/686 (0.1%)
SUPRAVENTRICULAR TACHYCARDIA 12/1322 (0.9%) 5/686 (0.7%)
TACHYCARDIA 12/1322 (0.9%) 6/686 (0.9%)
TORSADE DE POINTES 1/1322 (0.1%) 0/686 (0%)
TRICUSPID VALVE INCOMPETENCE 2/1322 (0.2%) 0/686 (0%)
VENTRICULAR ARRHYTHMIA 0/1322 (0%) 1/686 (0.1%)
VENTRICULAR EXTRASYSTOLES 6/1322 (0.5%) 0/686 (0%)
VENTRICULAR FIBRILLATION 6/1322 (0.5%) 0/686 (0%)
VENTRICULAR TACHYCARDIA 14/1322 (1.1%) 6/686 (0.9%)
Congenital, familial and genetic disorders
ARTERIOVENOUS MALFORMATION 1/1322 (0.1%) 1/686 (0.1%)
CYSTIC LYMPHANGIOMA 1/1322 (0.1%) 0/686 (0%)
MYOTONIC DYSTROPHY 1/1322 (0.1%) 0/686 (0%)
PULMONARY ARTERIOVENOUS FISTULA 0/1322 (0%) 1/686 (0.1%)
Ear and labyrinth disorders
DEAFNESS 1/1322 (0.1%) 1/686 (0.1%)
EAR PAIN 0/1322 (0%) 2/686 (0.3%)
EUSTACHIAN TUBE OBSTRUCTION 1/1322 (0.1%) 0/686 (0%)
MIXED DEAFNESS 1/1322 (0.1%) 0/686 (0%)
TINNITUS 1/1322 (0.1%) 2/686 (0.3%)
TYMPANIC MEMBRANE PERFORATION 1/1322 (0.1%) 0/686 (0%)
VERTIGO 13/1322 (1%) 7/686 (1%)
Endocrine disorders
ADRENAL MASS 1/1322 (0.1%) 0/686 (0%)
GOITRE 1/1322 (0.1%) 0/686 (0%)
HYPERTHYROIDISM 0/1322 (0%) 1/686 (0.1%)
HYPOGONADISM 0/1322 (0%) 1/686 (0.1%)
HYPOTHYROIDISM 6/1322 (0.5%) 1/686 (0.1%)
THYROID CYST 1/1322 (0.1%) 0/686 (0%)
Eye disorders
AGE-RELATED MACULAR DEGENERATION 1/1322 (0.1%) 0/686 (0%)
AMAUROSIS FUGAX 1/1322 (0.1%) 0/686 (0%)
CATARACT 7/1322 (0.5%) 8/686 (1.2%)
CATARACT NUCLEAR 1/1322 (0.1%) 0/686 (0%)
CONJUNCTIVAL HAEMORRHAGE 2/1322 (0.2%) 0/686 (0%)
CONJUNCTIVITIS 2/1322 (0.2%) 2/686 (0.3%)
DIABETIC RETINOPATHY 1/1322 (0.1%) 0/686 (0%)
DIPLOPIA 1/1322 (0.1%) 0/686 (0%)
EYE PRURITUS 1/1322 (0.1%) 0/686 (0%)
EYE SWELLING 0/1322 (0%) 1/686 (0.1%)
GAZE PALSY 1/1322 (0.1%) 0/686 (0%)
GLAUCOMA 4/1322 (0.3%) 0/686 (0%)
MACULAR FIBROSIS 1/1322 (0.1%) 0/686 (0%)
MACULAR OEDEMA 1/1322 (0.1%) 0/686 (0%)
PAPILLOEDEMA 1/1322 (0.1%) 0/686 (0%)
POSTERIOR CAPSULE OPACIFICATION 1/1322 (0.1%) 0/686 (0%)
RETINAL DETACHMENT 2/1322 (0.2%) 1/686 (0.1%)
RETINAL HAEMORRHAGE 1/1322 (0.1%) 1/686 (0.1%)
SCLERAL DISCOLOURATION 1/1322 (0.1%) 0/686 (0%)
SCLERAL HAEMORRHAGE 1/1322 (0.1%) 0/686 (0%)
VISION BLURRED 5/1322 (0.4%) 1/686 (0.1%)
VISUAL IMPAIRMENT 2/1322 (0.2%) 0/686 (0%)
Gastrointestinal disorders
ABDOMINAL DISCOMFORT 5/1322 (0.4%) 4/686 (0.6%)
ABDOMINAL DISTENSION 1/1322 (0.1%) 1/686 (0.1%)
ABDOMINAL HERNIA 3/1322 (0.2%) 3/686 (0.4%)
ABDOMINAL HERNIA OBSTRUCTIVE 1/1322 (0.1%) 0/686 (0%)
ABDOMINAL MASS 0/1322 (0%) 1/686 (0.1%)
ABDOMINAL PAIN 13/1322 (1%) 13/686 (1.9%)
ABDOMINAL PAIN LOWER 1/1322 (0.1%) 0/686 (0%)
ABDOMINAL PAIN UPPER 8/1322 (0.6%) 7/686 (1%)
ABDOMINAL WALL HAEMATOMA 1/1322 (0.1%) 0/686 (0%)
ALCOHOLIC PANCREATITIS 0/1322 (0%) 1/686 (0.1%)
BARRETT'S OESOPHAGUS 3/1322 (0.2%) 0/686 (0%)
COELIAC ARTERY STENOSIS 1/1322 (0.1%) 0/686 (0%)
COELIAC DISEASE 0/1322 (0%) 1/686 (0.1%)
COLITIS 4/1322 (0.3%) 3/686 (0.4%)
COLITIS ISCHAEMIC 1/1322 (0.1%) 1/686 (0.1%)
COLONIC POLYP 3/1322 (0.2%) 1/686 (0.1%)
CONSTIPATION 11/1322 (0.8%) 2/686 (0.3%)
CROHN'S DISEASE 2/1322 (0.2%) 1/686 (0.1%)
DENTAL CARIES 1/1322 (0.1%) 0/686 (0%)
DIABETIC GASTROPARESIS 1/1322 (0.1%) 0/686 (0%)
DIARRHOEA 18/1322 (1.4%) 7/686 (1%)
DIVERTICULUM 3/1322 (0.2%) 1/686 (0.1%)
DIVERTICULUM INTESTINAL 1/1322 (0.1%) 1/686 (0.1%)
DIVERTICULUM INTESTINAL HAEMORRHAGIC 2/1322 (0.2%) 1/686 (0.1%)
DRY MOUTH 1/1322 (0.1%) 0/686 (0%)
DUODENAL ULCER 1/1322 (0.1%) 0/686 (0%)
DUODENAL ULCER HAEMORRHAGE 1/1322 (0.1%) 0/686 (0%)
DUODENITIS 2/1322 (0.2%) 0/686 (0%)
DYSPEPSIA 15/1322 (1.1%) 4/686 (0.6%)
DYSPHAGIA 10/1322 (0.8%) 2/686 (0.3%)
ENTEROVESICAL FISTULA 1/1322 (0.1%) 0/686 (0%)
EROSIVE OESOPHAGITIS 1/1322 (0.1%) 0/686 (0%)
ERUCTATION 0/1322 (0%) 1/686 (0.1%)
FAECAL INCONTINENCE 1/1322 (0.1%) 0/686 (0%)
FAECALOMA 1/1322 (0.1%) 0/686 (0%)
FAECES DISCOLOURED 1/1322 (0.1%) 1/686 (0.1%)
FLATULENCE 2/1322 (0.2%) 0/686 (0%)
FOOD POISONING 1/1322 (0.1%) 0/686 (0%)
FUNCTIONAL GASTROINTESTINAL DISORDER 1/1322 (0.1%) 0/686 (0%)
GASTRIC HAEMORRHAGE 1/1322 (0.1%) 0/686 (0%)
GASTRIC ULCER 2/1322 (0.2%) 4/686 (0.6%)
GASTRIC ULCER HAEMORRHAGE 2/1322 (0.2%) 0/686 (0%)
GASTRITIS 6/1322 (0.5%) 3/686 (0.4%)
GASTRITIS EROSIVE 3/1322 (0.2%) 0/686 (0%)
GASTROINTESTINAL ANGIODYSPLASIA 1/1322 (0.1%) 0/686 (0%)
GASTROINTESTINAL DISORDER 2/1322 (0.2%) 0/686 (0%)
GASTROINTESTINAL HAEMORRHAGE 16/1322 (1.2%) 15/686 (2.2%)
GASTROINTESTINAL PAIN 0/1322 (0%) 1/686 (0.1%)
GASTROINTESTINAL ULCER HAEMORRHAGE 1/1322 (0.1%) 1/686 (0.1%)
GASTROOESOPHAGEAL REFLUX DISEASE 23/1322 (1.7%) 8/686 (1.2%)
HAEMATEMESIS 2/1322 (0.2%) 2/686 (0.3%)
HAEMATOCHEZIA 4/1322 (0.3%) 0/686 (0%)
HAEMORRHOIDAL HAEMORRHAGE 4/1322 (0.3%) 1/686 (0.1%)
HAEMORRHOIDS 1/1322 (0.1%) 0/686 (0%)
HIATUS HERNIA 9/1322 (0.7%) 4/686 (0.6%)
HYPOAESTHESIA ORAL 1/1322 (0.1%) 0/686 (0%)
ILEUS 1/1322 (0.1%) 2/686 (0.3%)
IMPAIRED GASTRIC EMPTYING 3/1322 (0.2%) 1/686 (0.1%)
INFREQUENT BOWEL MOVEMENTS 1/1322 (0.1%) 0/686 (0%)
INGUINAL HERNIA 4/1322 (0.3%) 6/686 (0.9%)
INTESTINAL MASS 2/1322 (0.2%) 1/686 (0.1%)
INTESTINAL OBSTRUCTION 0/1322 (0%) 2/686 (0.3%)
IRRITABLE BOWEL SYNDROME 2/1322 (0.2%) 0/686 (0%)
LARGE INTESTINE PERFORATION 0/1322 (0%) 1/686 (0.1%)
LOWER GASTROINTESTINAL HAEMORRHAGE 3/1322 (0.2%) 2/686 (0.3%)
MALLORY-WEISS SYNDROME 1/1322 (0.1%) 0/686 (0%)
MELAENA 2/1322 (0.2%) 1/686 (0.1%)
MOUTH HAEMORRHAGE 2/1322 (0.2%) 0/686 (0%)
MOUTH ULCERATION 1/1322 (0.1%) 0/686 (0%)
NAUSEA 19/1322 (1.4%) 13/686 (1.9%)
OESOPHAGEAL ACHALASIA 0/1322 (0%) 1/686 (0.1%)
OESOPHAGEAL FOOD IMPACTION 1/1322 (0.1%) 0/686 (0%)
OESOPHAGEAL PAIN 1/1322 (0.1%) 0/686 (0%)
OESOPHAGEAL SPASM 1/1322 (0.1%) 1/686 (0.1%)
OESOPHAGEAL ULCER 1/1322 (0.1%) 0/686 (0%)
OESOPHAGITIS 2/1322 (0.2%) 0/686 (0%)
PANCREATIC CYST 1/1322 (0.1%) 3/686 (0.4%)
PANCREATITIS 1/1322 (0.1%) 3/686 (0.4%)
PANCREATITIS ACUTE 2/1322 (0.2%) 1/686 (0.1%)
PANCREATITIS CHRONIC 1/1322 (0.1%) 0/686 (0%)
PEPTIC ULCER 1/1322 (0.1%) 0/686 (0%)
PROCTALGIA 1/1322 (0.1%) 0/686 (0%)
RECTAL HAEMORRHAGE 8/1322 (0.6%) 8/686 (1.2%)
RECTAL PROLAPSE 0/1322 (0%) 1/686 (0.1%)
RETROPERITONEAL HAEMATOMA 2/1322 (0.2%) 0/686 (0%)
RETROPERITONEAL HAEMORRHAGE 2/1322 (0.2%) 0/686 (0%)
SMALL INTESTINAL OBSTRUCTION 3/1322 (0.2%) 6/686 (0.9%)
SMALL INTESTINAL PERFORATION 0/1322 (0%) 1/686 (0.1%)
STOMATITIS 1/1322 (0.1%) 0/686 (0%)
TONGUE CYST 1/1322 (0.1%) 0/686 (0%)
TONGUE HAEMORRHAGE 1/1322 (0.1%) 0/686 (0%)
TOOTH SOCKET HAEMORRHAGE 0/1322 (0%) 1/686 (0.1%)
UMBILICAL HERNIA 4/1322 (0.3%) 2/686 (0.3%)
UMBILICAL HERNIA, OBSTRUCTIVE 2/1322 (0.2%) 0/686 (0%)
UPPER GASTROINTESTINAL HAEMORRHAGE 3/1322 (0.2%) 4/686 (0.6%)
VOMITING 13/1322 (1%) 10/686 (1.5%)
General disorders
ABASIA 0/1322 (0%) 1/686 (0.1%)
ADVERSE DRUG REACTION 74/1322 (5.6%) 42/686 (6.1%)
ASTHENIA 12/1322 (0.9%) 4/686 (0.6%)
BREAST COMPLICATION ASSOCIATED WITH DEVICE 0/1322 (0%) 1/686 (0.1%)
CARDIAC DEATH 1/1322 (0.1%) 0/686 (0%)
CATHETER SITE HAEMATOMA 30/1322 (2.3%) 14/686 (2%)
CATHETER SITE HAEMORRHAGE 22/1322 (1.7%) 14/686 (2%)
CATHETER SITE PAIN 29/1322 (2.2%) 15/686 (2.2%)
CATHETER SITE RASH 0/1322 (0%) 1/686 (0.1%)
CATHETER SITE RELATED REACTION 9/1322 (0.7%) 4/686 (0.6%)
CATHETER SITE SWELLING 5/1322 (0.4%) 2/686 (0.3%)
CHEST DISCOMFORT 87/1322 (6.6%) 34/686 (5%)
CHEST PAIN 79/1322 (6%) 49/686 (7.1%)
CHILLS 0/1322 (0%) 1/686 (0.1%)
CYST 1/1322 (0.1%) 1/686 (0.1%)
DEATH 10/1322 (0.8%) 6/686 (0.9%)
DEVICE ELECTRICAL FINDING 0/1322 (0%) 1/686 (0.1%)
DEVICE FAILURE 1/1322 (0.1%) 1/686 (0.1%)
DEVICE MALFUNCTION 1/1322 (0.1%) 0/686 (0%)
DEVICE OCCLUSION 1/1322 (0.1%) 0/686 (0%)
DISCOMFORT 1/1322 (0.1%) 1/686 (0.1%)
DROWNING 1/1322 (0.1%) 0/686 (0%)
DRUG INTOLERANCE 2/1322 (0.2%) 0/686 (0%)
DRUG WITHDRAWAL SYNDROME 1/1322 (0.1%) 0/686 (0%)
FACE OEDEMA 0/1322 (0%) 1/686 (0.1%)
FATIGUE 50/1322 (3.8%) 20/686 (2.9%)
FEELING COLD 0/1322 (0%) 1/686 (0.1%)
GAIT DISTURBANCE 1/1322 (0.1%) 1/686 (0.1%)
GENERALISED OEDEMA 1/1322 (0.1%) 0/686 (0%)
HERNIA 0/1322 (0%) 1/686 (0.1%)
HERNIA OBSTRUCTIVE 1/1322 (0.1%) 0/686 (0%)
HERNIA PAIN 0/1322 (0%) 1/686 (0.1%)
IMPAIRED HEALING 0/1322 (0%) 2/686 (0.3%)
IMPLANT SITE HAEMORRHAGE 1/1322 (0.1%) 0/686 (0%)
IMPLANT SITE PAIN 1/1322 (0.1%) 0/686 (0%)
INFLUENZA LIKE ILLNESS 2/1322 (0.2%) 1/686 (0.1%)
LOCAL SWELLING 2/1322 (0.2%) 0/686 (0%)
MALAISE 3/1322 (0.2%) 1/686 (0.1%)
MASS 1/1322 (0.1%) 1/686 (0.1%)
MEDICAL DEVICE SITE REACTION 1/1322 (0.1%) 0/686 (0%)
MULTI-ORGAN FAILURE 1/1322 (0.1%) 2/686 (0.3%)
NON-CARDIAC CHEST PAIN 271/1322 (20.5%) 122/686 (17.8%)
OEDEMA 2/1322 (0.2%) 0/686 (0%)
OEDEMA PERIPHERAL 25/1322 (1.9%) 10/686 (1.5%)
PAIN 9/1322 (0.7%) 6/686 (0.9%)
PELVIC MASS 0/1322 (0%) 2/686 (0.3%)
PYREXIA 9/1322 (0.7%) 3/686 (0.4%)
SPINAL PAIN 1/1322 (0.1%) 0/686 (0%)
SUDDEN CARDIAC DEATH 0/1322 (0%) 1/686 (0.1%)
SURGICAL FAILURE 1/1322 (0.1%) 0/686 (0%)
SWELLING 1/1322 (0.1%) 0/686 (0%)
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME 3/1322 (0.2%) 1/686 (0.1%)
THROMBOSIS IN DEVICE 14/1322 (1.1%) 6/686 (0.9%)
Hepatobiliary disorders
BILE DUCT STONE 2/1322 (0.2%) 0/686 (0%)
BILIARY COLIC 0/1322 (0%) 1/686 (0.1%)
CHOLANGITIS 1/1322 (0.1%) 0/686 (0%)
CHOLECYSTITIS 4/1322 (0.3%) 2/686 (0.3%)
CHOLECYSTITIS ACUTE 2/1322 (0.2%) 4/686 (0.6%)
CHOLECYSTITIS CHRONIC 1/1322 (0.1%) 0/686 (0%)
CHOLELITHIASIS 12/1322 (0.9%) 6/686 (0.9%)
GALLBLADDER DISORDER 1/1322 (0.1%) 0/686 (0%)
HEPATIC LESION 2/1322 (0.2%) 1/686 (0.1%)
HEPATIC STEATOSIS 1/1322 (0.1%) 0/686 (0%)
HEPATOMEGALY 0/1322 (0%) 1/686 (0.1%)
ISCHAEMIC HEPATITIS 1/1322 (0.1%) 0/686 (0%)
PORTAL VEIN THROMBOSIS 1/1322 (0.1%) 0/686 (0%)
Immune system disorders
ALLERGY TO ARTHROPOD STING 1/1322 (0.1%) 1/686 (0.1%)
ANAPHYLACTIC REACTION 1/1322 (0.1%) 0/686 (0%)
CONTRAST MEDIA ALLERGY 2/1322 (0.2%) 2/686 (0.3%)
DRUG HYPERSENSITIVITY 5/1322 (0.4%) 4/686 (0.6%)
FOOD ALLERGY 2/1322 (0.2%) 0/686 (0%)
HYPERSENSITIVITY 0/1322 (0%) 2/686 (0.3%)
SEASONAL ALLERGY 1/1322 (0.1%) 1/686 (0.1%)
Infections and infestations
ABDOMINAL ABSCESS 0/1322 (0%) 1/686 (0.1%)
ABDOMINAL INFECTION 1/1322 (0.1%) 0/686 (0%)
ABSCESS NECK 1/1322 (0.1%) 0/686 (0%)
ACUTE SINUSITIS 3/1322 (0.2%) 1/686 (0.1%)
ACUTE TONSILLITIS 1/1322 (0.1%) 0/686 (0%)
APPENDICITIS 4/1322 (0.3%) 2/686 (0.3%)
APPENDICITIS PERFORATED 1/1322 (0.1%) 0/686 (0%)
ARTERIOVENOUS GRAFT SITE INFECTION 0/1322 (0%) 1/686 (0.1%)
ARTHRITIS BACTERIAL 1/1322 (0.1%) 0/686 (0%)
ARTHRITIS INFECTIVE 1/1322 (0.1%) 0/686 (0%)
BACTERAEMIA 4/1322 (0.3%) 0/686 (0%)
BACTERIAL DISEASE CARRIER 0/1322 (0%) 1/686 (0.1%)
BACTERIAL INFECTION 0/1322 (0%) 1/686 (0.1%)
BACTERIAL SEPSIS 0/1322 (0%) 2/686 (0.3%)
BREAST ABSCESS 0/1322 (0%) 1/686 (0.1%)
BREAST CELLULITIS 1/1322 (0.1%) 0/686 (0%)
BRONCHITIS 34/1322 (2.6%) 21/686 (3.1%)
BRONCHITIS VIRAL 1/1322 (0.1%) 0/686 (0%)
BRONCHOPNEUMONIA 1/1322 (0.1%) 1/686 (0.1%)
CARBUNCLE 0/1322 (0%) 1/686 (0.1%)
CATHETER SITE ABSCESS 2/1322 (0.2%) 0/686 (0%)
CATHETER SITE CELLULITIS 3/1322 (0.2%) 0/686 (0%)
CATHETER SITE INFECTION 1/1322 (0.1%) 1/686 (0.1%)
CELLULITIS 15/1322 (1.1%) 14/686 (2%)
CHOLECYSTITIS INFECTIVE 0/1322 (0%) 2/686 (0.3%)
CLOSTRIDIAL INFECTION 4/1322 (0.3%) 1/686 (0.1%)
CLOSTRIDIUM DIFFICILE COLITIS 3/1322 (0.2%) 3/686 (0.4%)
CYSTITIS 2/1322 (0.2%) 1/686 (0.1%)
DIABETIC FOOT INFECTION 1/1322 (0.1%) 0/686 (0%)
DIVERTICULITIS 5/1322 (0.4%) 3/686 (0.4%)
EAR INFECTION 3/1322 (0.2%) 0/686 (0%)
ENDOCARDITIS 1/1322 (0.1%) 0/686 (0%)
ENTEROCOCCAL SEPSIS 0/1322 (0%) 1/686 (0.1%)
ESCHERICHIA BACTERAEMIA 1/1322 (0.1%) 0/686 (0%)
ESCHERICHIA URINARY TRACT INFECTION 1/1322 (0.1%) 0/686 (0%)
EYELID INFECTION 1/1322 (0.1%) 0/686 (0%)
FOLLICULITIS 1/1322 (0.1%) 0/686 (0%)
FUNGAL INFECTION 0/1322 (0%) 1/686 (0.1%)
FURUNCLE 1/1322 (0.1%) 0/686 (0%)
GANGRENE 1/1322 (0.1%) 1/686 (0.1%)
GASTROENTERITIS 10/1322 (0.8%) 3/686 (0.4%)
GASTROENTERITIS VIRAL 4/1322 (0.3%) 3/686 (0.4%)
GENITAL INFECTION FEMALE 1/1322 (0.1%) 0/686 (0%)
GROIN ABSCESS 1/1322 (0.1%) 0/686 (0%)
HELICOBACTER INFECTION 2/1322 (0.2%) 0/686 (0%)
HEPATITIS C 2/1322 (0.2%) 0/686 (0%)
HERPES ZOSTER 7/1322 (0.5%) 3/686 (0.4%)
HERPES ZOSTER OPHTHALMIC 1/1322 (0.1%) 0/686 (0%)
HIV INFECTION 1/1322 (0.1%) 0/686 (0%)
IMPLANT SITE INFECTION 1/1322 (0.1%) 0/686 (0%)
INFECTED DERMAL CYST 1/1322 (0.1%) 0/686 (0%)
INFECTED SKIN ULCER 0/1322 (0%) 1/686 (0.1%)
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE 1/1322 (0.1%) 0/686 (0%)
INFLUENZA 8/1322 (0.6%) 8/686 (1.2%)
KIDNEY INFECTION 4/1322 (0.3%) 0/686 (0%)
LARYNGITIS 2/1322 (0.2%) 1/686 (0.1%)
LOBAR PNEUMONIA 3/1322 (0.2%) 1/686 (0.1%)
LOCALISED INFECTION 0/1322 (0%) 3/686 (0.4%)
LUNG ABSCESS 0/1322 (0%) 1/686 (0.1%)
MENINGITIS ASEPTIC 1/1322 (0.1%) 0/686 (0%)
METAPNEUMOVIRUS INFECTION 1/1322 (0.1%) 0/686 (0%)
MYCOBACTERIUM ABSCESSUS INFECTION 1/1322 (0.1%) 0/686 (0%)
NASOPHARYNGITIS 6/1322 (0.5%) 5/686 (0.7%)
ONYCHOMYCOSIS 2/1322 (0.2%) 0/686 (0%)
ORAL FUNGAL INFECTION 1/1322 (0.1%) 0/686 (0%)
ORCHITIS 1/1322 (0.1%) 0/686 (0%)
OSTEOMYELITIS 3/1322 (0.2%) 4/686 (0.6%)
OTITIS EXTERNA 1/1322 (0.1%) 1/686 (0.1%)
OTITIS MEDIA 1/1322 (0.1%) 0/686 (0%)
OTITIS MEDIA ACUTE 1/1322 (0.1%) 0/686 (0%)
PARONYCHIA 2/1322 (0.2%) 0/686 (0%)
PERITONITIS 0/1322 (0%) 1/686 (0.1%)
PERITONSILLAR ABSCESS 1/1322 (0.1%) 0/686 (0%)
PHARYNGITIS 1/1322 (0.1%) 0/686 (0%)
PHARYNGITIS STREPTOCOCCAL 0/1322 (0%) 1/686 (0.1%)
PILONIDAL CYST 0/1322 (0%) 1/686 (0.1%)
PNEUMONIA 33/1322 (2.5%) 27/686 (3.9%)
PNEUMONIA ADENOVIRAL 1/1322 (0.1%) 0/686 (0%)
PNEUMONIA BACTERIAL 2/1322 (0.2%) 0/686 (0%)
PNEUMONIA NECROTISING 1/1322 (0.1%) 0/686 (0%)
PNEUMONIA PRIMARY ATYPICAL 1/1322 (0.1%) 0/686 (0%)
PNEUMONIA STAPHYLOCOCCAL 2/1322 (0.2%) 0/686 (0%)
POST PROCEDURAL CELLULITIS 1/1322 (0.1%) 0/686 (0%)
POST PROCEDURAL INFECTION 3/1322 (0.2%) 0/686 (0%)
POST PROCEDURAL PNEUMONIA 1/1322 (0.1%) 0/686 (0%)
POSTOPERATIVE WOUND INFECTION 1/1322 (0.1%) 1/686 (0.1%)
PROSTATE INFECTION 1/1322 (0.1%) 0/686 (0%)
PYELONEPHRITIS 1/1322 (0.1%) 0/686 (0%)
RESPIRATORY SYNCYTIAL VIRUS INFECTION 1/1322 (0.1%) 0/686 (0%)
RESPIRATORY TRACT INFECTION 1/1322 (0.1%) 1/686 (0.1%)
SEPSIS 15/1322 (1.1%) 10/686 (1.5%)
SEPSIS SYNDROME 2/1322 (0.2%) 0/686 (0%)
SEPTIC ENCEPHALOPATHY 0/1322 (0%) 1/686 (0.1%)
SEPTIC SHOCK 2/1322 (0.2%) 1/686 (0.1%)
SINUSITIS 11/1322 (0.8%) 10/686 (1.5%)
SPINAL CORD INFECTION 1/1322 (0.1%) 0/686 (0%)
STAPHYLOCOCCAL BACTERAEMIA 0/1322 (0%) 2/686 (0.3%)
STAPHYLOCOCCAL INFECTION 1/1322 (0.1%) 0/686 (0%)
SUBCUTANEOUS ABSCESS 1/1322 (0.1%) 0/686 (0%)
TINEA PEDIS 1/1322 (0.1%) 0/686 (0%)
TOOTH ABSCESS 2/1322 (0.2%) 2/686 (0.3%)
UPPER RESPIRATORY TRACT INFECTION 25/1322 (1.9%) 6/686 (0.9%)
URINARY TRACT INFECTION 32/1322 (2.4%) 23/686 (3.4%)
URINARY TRACT INFECTION BACTERIAL 1/1322 (0.1%) 1/686 (0.1%)
UROSEPSIS 3/1322 (0.2%) 4/686 (0.6%)
VIRAL INFECTION 4/1322 (0.3%) 3/686 (0.4%)
VIRAL LABYRINTHITIS 0/1322 (0%) 1/686 (0.1%)
VIRAL UPPER RESPIRATORY TRACT INFECTION 1/1322 (0.1%) 2/686 (0.3%)
WOUND INFECTION 2/1322 (0.2%) 3/686 (0.4%)
WOUND INFECTION BACTERIAL 0/1322 (0%) 1/686 (0.1%)
WOUND INFECTION STAPHYLOCOCCAL 1/1322 (0.1%) 2/686 (0.3%)
Injury, poisoning and procedural complications
ACCIDENT 0/1322 (0%) 1/686 (0.1%)
ACCIDENTAL OVERDOSE 2/1322 (0.2%) 0/686 (0%)
ACETABULUM FRACTURE 0/1322 (0%) 1/686 (0.1%)
ALCOHOL POISONING 3/1322 (0.2%) 2/686 (0.3%)
ANAEMIA POSTOPERATIVE 5/1322 (0.4%) 3/686 (0.4%)
ANIMAL BITE 2/1322 (0.2%) 1/686 (0.1%)
ANKLE FRACTURE 1/1322 (0.1%) 4/686 (0.6%)
ANXIETY POSTOPERATIVE 1/1322 (0.1%) 1/686 (0.1%)
ARTHROPOD BITE 2/1322 (0.2%) 0/686 (0%)
ARTHROPOD STING 1/1322 (0.1%) 1/686 (0.1%)
ASBESTOSIS 1/1322 (0.1%) 0/686 (0%)
AVULSION FRACTURE 1/1322 (0.1%) 0/686 (0%)
BURNS THIRD DEGREE 1/1322 (0.1%) 1/686 (0.1%)
CARDIAC FUNCTION DISTURBANCE POSTOPERATIVE 0/1322 (0%) 1/686 (0.1%)
CARDIAC PROCEDURE COMPLICATION 4/1322 (0.3%) 4/686 (0.6%)
CATHETER SITE HAEMATOMA 10/1322 (0.8%) 8/686 (1.2%)
CEREBRAL HAEMORRHAGE TRAUMATIC 2/1322 (0.2%) 0/686 (0%)
CLAVICLE FRACTURE 0/1322 (0%) 1/686 (0.1%)
COLON INJURY 1/1322 (0.1%) 0/686 (0%)
CONCUSSION 1/1322 (0.1%) 1/686 (0.1%)
CONTRAST MEDIA ALLERGY 0/1322 (0%) 1/686 (0.1%)
CONTUSION 25/1322 (1.9%) 6/686 (0.9%)
CORNEAL ABRASION 0/1322 (0%) 1/686 (0.1%)
CORONARY ARTERY RESTENOSIS 51/1322 (3.9%) 15/686 (2.2%)
CRANIOCEREBRAL INJURY 3/1322 (0.2%) 1/686 (0.1%)
CYSTITIS RADIATION 1/1322 (0.1%) 0/686 (0%)
DEEP VEIN THROMBOSIS POSTOPERATIVE 2/1322 (0.2%) 0/686 (0%)
DRUG ADMINISTRATION ERROR 1/1322 (0.1%) 0/686 (0%)
EXCORIATION 2/1322 (0.2%) 0/686 (0%)
EXPOSURE TO TOXIC AGENT 2/1322 (0.2%) 0/686 (0%)
FACIAL BONES FRACTURE 1/1322 (0.1%) 1/686 (0.1%)
FALL 28/1322 (2.1%) 20/686 (2.9%)
FEMORAL NECK FRACTURE 0/1322 (0%) 2/686 (0.3%)
FEMUR FRACTURE 3/1322 (0.2%) 0/686 (0%)
FOOT FRACTURE 4/1322 (0.3%) 1/686 (0.1%)
FOREIGN BODY 0/1322 (0%) 1/686 (0.1%)
GASTROINTESTINAL ANASTOMOTIC LEAK 0/1322 (0%) 1/686 (0.1%)
HAEMATURIA TRAUMATIC 1/1322 (0.1%) 0/686 (0%)
HAND FRACTURE 1/1322 (0.1%) 1/686 (0.1%)
HEAD INJURY 1/1322 (0.1%) 2/686 (0.3%)
HIP FRACTURE 4/1322 (0.3%) 2/686 (0.3%)
HUMERUS FRACTURE 3/1322 (0.2%) 2/686 (0.3%)
ILIOTIBIAL BAND SYNDROME 0/1322 (0%) 1/686 (0.1%)
IN-STENT ARTERIAL RESTENOSIS 0/1322 (0%) 1/686 (0.1%)
IN-STENT CORONARY ARTERY RESTENOSIS 8/1322 (0.6%) 6/686 (0.9%)
INCISION SITE PRURITUS 0/1322 (0%) 1/686 (0.1%)
INCISIONAL HERNIA 3/1322 (0.2%) 0/686 (0%)
INJURY 2/1322 (0.2%) 0/686 (0%)
JOINT DISLOCATION 1/1322 (0.1%) 1/686 (0.1%)
JOINT INJURY 2/1322 (0.2%) 0/686 (0%)
LACERATION 7/1322 (0.5%) 4/686 (0.6%)
LIGAMENT RUPTURE 1/1322 (0.1%) 0/686 (0%)
LIGAMENT SPRAIN 1/1322 (0.1%) 6/686 (0.9%)
LIMB INJURY 3/1322 (0.2%) 4/686 (0.6%)
LIMB TRAUMATIC AMPUTATION 1/1322 (0.1%) 0/686 (0%)
LOWER LIMB FRACTURE 1/1322 (0.1%) 0/686 (0%)
MENISCUS LESION 8/1322 (0.6%) 4/686 (0.6%)
MOUTH INJURY 0/1322 (0%) 1/686 (0.1%)
MULTIPLE FRACTURES 2/1322 (0.2%) 0/686 (0%)
MULTIPLE INJURIES 1/1322 (0.1%) 0/686 (0%)
MUSCLE RUPTURE 0/1322 (0%) 1/686 (0.1%)
MUSCLE STRAIN 2/1322 (0.2%) 1/686 (0.1%)
PELVIC FRACTURE 1/1322 (0.1%) 0/686 (0%)
PERIORBITAL HAEMATOMA 1/1322 (0.1%) 0/686 (0%)
PLAQUE SHIFT 4/1322 (0.3%) 6/686 (0.9%)
POST CONCUSSION SYNDROME 1/1322 (0.1%) 0/686 (0%)
POST PROCEDURAL CONSTIPATION 0/1322 (0%) 1/686 (0.1%)
POST PROCEDURAL DISCOMFORT 0/1322 (0%) 1/686 (0.1%)
POST PROCEDURAL HAEMATOMA 3/1322 (0.2%) 2/686 (0.3%)
POST PROCEDURAL HAEMORRHAGE 6/1322 (0.5%) 4/686 (0.6%)
POST PROCEDURAL MYOCARDIAL INFARCTION 12/1322 (0.9%) 7/686 (1%)
POST PROCEDURAL STROKE 1/1322 (0.1%) 0/686 (0%)
POST PROCEDURAL SWELLING 0/1322 (0%) 1/686 (0.1%)
POST-TRAUMATIC NECK SYNDROME 0/1322 (0%) 1/686 (0.1%)
POST-TRAUMATIC PAIN 4/1322 (0.3%) 1/686 (0.1%)
POSTOPERATIVE ADHESION 1/1322 (0.1%) 0/686 (0%)
POSTOPERATIVE FEVER 1/1322 (0.1%) 0/686 (0%)
PROCEDURAL COMPLICATION 2/1322 (0.2%) 0/686 (0%)
PROCEDURAL DIZZINESS 1/1322 (0.1%) 2/686 (0.3%)
PROCEDURAL HEADACHE 5/1322 (0.4%) 2/686 (0.3%)
PROCEDURAL HYPERTENSION 10/1322 (0.8%) 4/686 (0.6%)
PROCEDURAL HYPOTENSION 13/1322 (1%) 7/686 (1%)
PROCEDURAL NAUSEA 8/1322 (0.6%) 4/686 (0.6%)
PROCEDURAL PAIN 3/1322 (0.2%) 3/686 (0.4%)
PROCEDURAL VOMITING 3/1322 (0.2%) 0/686 (0%)
RADIUS FRACTURE 0/1322 (0%) 1/686 (0.1%)
RESPIRATORY FUME INHALATION DISORDER 1/1322 (0.1%) 0/686 (0%)
RIB FRACTURE 4/1322 (0.3%) 3/686 (0.4%)
ROAD TRAFFIC ACCIDENT 10/1322 (0.8%) 2/686 (0.3%)
SCAPULA FRACTURE 1/1322 (0.1%) 0/686 (0%)
SEROMA 1/1322 (0.1%) 0/686 (0%)
SKULL FRACTURE 1/1322 (0.1%) 0/686 (0%)
SNAKE BITE 1/1322 (0.1%) 0/686 (0%)
SOFT TISSUE INJURY 1/1322 (0.1%) 0/686 (0%)
SPINAL COMPRESSION FRACTURE 6/1322 (0.5%) 2/686 (0.3%)
SPINAL FRACTURE 2/1322 (0.2%) 1/686 (0.1%)
SPLENIC RUPTURE 1/1322 (0.1%) 0/686 (0%)
STERNAL FRACTURE 0/1322 (0%) 1/686 (0.1%)
SUBDURAL HAEMATOMA 6/1322 (0.5%) 4/686 (0.6%)
SUTURE RELATED COMPLICATION 0/1322 (0%) 1/686 (0.1%)
TENDON INJURY 0/1322 (0%) 2/686 (0.3%)
TENDON RUPTURE 1/1322 (0.1%) 2/686 (0.3%)
THERMAL BURN 1/1322 (0.1%) 0/686 (0%)
THORACIC VERTEBRAL FRACTURE 1/1322 (0.1%) 0/686 (0%)
TIBIA FRACTURE 0/1322 (0%) 4/686 (0.6%)
TOXICITY TO VARIOUS AGENTS 0/1322 (0%) 1/686 (0.1%)
TRAUMATIC HAEMATOMA 5/1322 (0.4%) 2/686 (0.3%)
TRAUMATIC HAEMORRHAGE 0/1322 (0%) 1/686 (0.1%)
ULNA FRACTURE 0/1322 (0%) 1/686 (0.1%)
UPPER LIMB FRACTURE 4/1322 (0.3%) 0/686 (0%)
URINARY RETENTION POSTOPERATIVE 5/1322 (0.4%) 1/686 (0.1%)
VASCULAR ACCESS COMPLICATION 1/1322 (0.1%) 0/686 (0%)
VASCULAR GRAFT OCCLUSION 2/1322 (0.2%) 1/686 (0.1%)
VASCULAR PSEUDOANEURYSM 10/1322 (0.8%) 6/686 (0.9%)
WOUND 1/1322 (0.1%) 0/686 (0%)
WOUND EVISCERATION 1/1322 (0.1%) 0/686 (0%)
WOUND HAEMORRHAGE 1/1322 (0.1%) 1/686 (0.1%)
WRIST FRACTURE 3/1322 (0.2%) 1/686 (0.1%)
Investigations
ALANINE AMINOTRANSFERASE INCREASED 1/1322 (0.1%) 0/686 (0%)
ANGIOGRAM 1/1322 (0.1%) 0/686 (0%)
ARTERIOGRAM CORONARY ABNORMAL 1/1322 (0.1%) 2/686 (0.3%)
BIOPSY LUNG 0/1322 (0%) 1/686 (0.1%)
BLOOD ALKALINE PHOSPHATASE INCREASED 3/1322 (0.2%) 0/686 (0%)
BLOOD CREATINE INCREASED 1/1322 (0.1%) 0/686 (0%)
BLOOD CREATINE PHOSPHOKINASE INCREASED 12/1322 (0.9%) 8/686 (1.2%)
BLOOD CREATINE PHOSPHOKINASE MB INCREASED 153/1322 (11.6%) 72/686 (10.5%)
BLOOD CREATININE INCREASED 5/1322 (0.4%) 2/686 (0.3%)
BLOOD GLUCOSE DECREASED 0/1322 (0%) 1/686 (0.1%)
BLOOD GLUCOSE INCREASED 4/1322 (0.3%) 1/686 (0.1%)
BLOOD HOMOCYSTEINE INCREASED 1/1322 (0.1%) 0/686 (0%)
BLOOD IRON DECREASED 0/1322 (0%) 1/686 (0.1%)
BLOOD MAGNESIUM DECREASED 0/1322 (0%) 1/686 (0.1%)
BLOOD POTASSIUM DECREASED 1/1322 (0.1%) 0/686 (0%)
BLOOD PRESSURE DECREASED 0/1322 (0%) 1/686 (0.1%)
BLOOD PRESSURE INCREASED 12/1322 (0.9%) 4/686 (0.6%)
BLOOD PRESSURE ORTHOSTATIC ABNORMAL 1/1322 (0.1%) 0/686 (0%)
BLOOD PRESSURE SYSTOLIC INCREASED 1/1322 (0.1%) 0/686 (0%)
BLOOD TESTOSTERONE DECREASED 0/1322 (0%) 1/686 (0.1%)
BLOOD THYROID STIMULATING HORMONE DECREASED 1/1322 (0.1%) 0/686 (0%)
BLOOD TRIGLYCERIDES INCREASED 3/1322 (0.2%) 0/686 (0%)
BLOOD URIC ACID INCREASED 0/1322 (0%) 1/686 (0.1%)
BLOOD URINE PRESENT 1/1322 (0.1%) 0/686 (0%)
BONE DENSITY ABNORMAL 0/1322 (0%) 1/686 (0.1%)
BREATH SOUNDS ABNORMAL 0/1322 (0%) 1/686 (0.1%)
CARDIAC ENZYMES INCREASED 104/1322 (7.9%) 45/686 (6.6%)
CARDIAC MURMUR 1/1322 (0.1%) 0/686 (0%)
CARDIAC STRESS TEST ABNORMAL 9/1322 (0.7%) 3/686 (0.4%)
CAROTID BRUIT 7/1322 (0.5%) 3/686 (0.4%)
CATHETERISATION CARDIAC 0/1322 (0%) 1/686 (0.1%)
CLOSTRIDIUM TEST POSITIVE 1/1322 (0.1%) 0/686 (0%)
COMPUTERISED TOMOGRAM ABNORMAL 1/1322 (0.1%) 0/686 (0%)
COMPUTERISED TOMOGRAM THORAX ABNORMAL 1/1322 (0.1%) 0/686 (0%)
ECHOCARDIOGRAM ABNORMAL 1/1322 (0.1%) 0/686 (0%)
EJECTION FRACTION ABNORMAL 1/1322 (0.1%) 0/686 (0%)
EJECTION FRACTION DECREASED 1/1322 (0.1%) 0/686 (0%)
ELECTROCARDIOGRAM ABNORMAL 0/1322 (0%) 1/686 (0.1%)
ELECTROCARDIOGRAM CHANGE 4/1322 (0.3%) 1/686 (0.1%)
ELECTROCARDIOGRAM QT PROLONGED 0/1322 (0%) 1/686 (0.1%)
ELECTROCARDIOGRAM ST SEGMENT ABNORMAL 0/1322 (0%) 1/686 (0.1%)
ELECTROCARDIOGRAM ST SEGMENT ELEVATION 8/1322 (0.6%) 0/686 (0%)
ELECTROCARDIOGRAM ST-T CHANGE 1/1322 (0.1%) 0/686 (0%)
FEMORAL BRUIT 0/1322 (0%) 1/686 (0.1%)
GLOMERULAR FILTRATION RATE DECREASED 1/1322 (0.1%) 0/686 (0%)
GLYCOSYLATED HAEMOGLOBIN INCREASED 1/1322 (0.1%) 1/686 (0.1%)
HAEMOGLOBIN DECREASED 3/1322 (0.2%) 0/686 (0%)
HEART RATE DECREASED 1/1322 (0.1%) 0/686 (0%)
HEART RATE INCREASED 4/1322 (0.3%) 0/686 (0%)
HEART RATE IRREGULAR 1/1322 (0.1%) 2/686 (0.3%)
HELICOBACTER TEST POSITIVE 0/1322 (0%) 1/686 (0.1%)
HEPATIC ENZYME INCREASED 4/1322 (0.3%) 1/686 (0.1%)
LIPIDS ABNORMAL 0/1322 (0%) 1/686 (0.1%)
LIVER FUNCTION TEST ABNORMAL 2/1322 (0.2%) 4/686 (0.6%)
METABOLIC FUNCTION TEST ABNORMAL 1/1322 (0.1%) 0/686 (0%)
OCCULT BLOOD POSITIVE 2/1322 (0.2%) 0/686 (0%)
OXYGEN CONSUMPTION INCREASED 0/1322 (0%) 1/686 (0.1%)
PROSTATIC SPECIFIC ANTIGEN INCREASED 2/1322 (0.2%) 0/686 (0%)
RED BLOOD CELL COUNT DECREASED 0/1322 (0%) 1/686 (0.1%)
RED BLOOD CELL SEDIMENTATION RATE INCREASED 0/1322 (0%) 1/686 (0.1%)
RENAL FUNCTION TEST ABNORMAL 2/1322 (0.2%) 0/686 (0%)
THYROID FUNCTION TEST ABNORMAL 1/1322 (0.1%) 0/686 (0%)
TROPONIN I INCREASED 24/1322 (1.8%) 10/686 (1.5%)
TROPONIN INCREASED 50/1322 (3.8%) 20/686 (2.9%)
TROPONIN T INCREASED 0/1322 (0%) 1/686 (0.1%)
URINE LEUKOCYTE ESTERASE POSITIVE 1/1322 (0.1%) 0/686 (0%)
VITAMIN B12 DECREASED 1/1322 (0.1%) 0/686 (0%)
VITAMIN D DECREASED 1/1322 (0.1%) 1/686 (0.1%)
WEIGHT DECREASED 3/1322 (0.2%) 1/686 (0.1%)
WEIGHT INCREASED 4/1322 (0.3%) 0/686 (0%)
WHITE BLOOD CELL COUNT INCREASED 2/1322 (0.2%) 0/686 (0%)
Metabolism and nutrition disorders
DECREASED APPETITE 1/1322 (0.1%) 0/686 (0%)
DEHYDRATION 11/1322 (0.8%) 11/686 (1.6%)
DIABETES MELLITUS 9/1322 (0.7%) 3/686 (0.4%)
DIABETES MELLITUS INADEQUATE CONTROL 1/1322 (0.1%) 0/686 (0%)
DIABETIC KETOACIDOSIS 5/1322 (0.4%) 1/686 (0.1%)
FAILURE TO THRIVE 1/1322 (0.1%) 0/686 (0%)
FLUID OVERLOAD 2/1322 (0.2%) 2/686 (0.3%)
FLUID RETENTION 1/1322 (0.1%) 0/686 (0%)
GOUT 5/1322 (0.4%) 2/686 (0.3%)
HYPERGLYCAEMIA 14/1322 (1.1%) 7/686 (1%)
HYPERKALAEMIA 4/1322 (0.3%) 5/686 (0.7%)
HYPERLIPIDAEMIA 1/1322 (0.1%) 1/686 (0.1%)
HYPERURICAEMIA 2/1322 (0.2%) 0/686 (0%)
HYPOALBUMINAEMIA 1/1322 (0.1%) 0/686 (0%)
HYPOCALCAEMIA 0/1322 (0%) 1/686 (0.1%)
HYPOGLYCAEMIA 10/1322 (0.8%) 3/686 (0.4%)
HYPOKALAEMIA 15/1322 (1.1%) 11/686 (1.6%)
HYPOMAGNESAEMIA 5/1322 (0.4%) 3/686 (0.4%)
HYPONATRAEMIA 8/1322 (0.6%) 5/686 (0.7%)
HYPOVOLAEMIA 1/1322 (0.1%) 1/686 (0.1%)
IMPAIRED FASTING GLUCOSE 1/1322 (0.1%) 0/686 (0%)
LACTIC ACIDOSIS 1/1322 (0.1%) 0/686 (0%)
METABOLIC ACIDOSIS 1/1322 (0.1%) 1/686 (0.1%)
OBESITY 6/1322 (0.5%) 3/686 (0.4%)
TYPE 2 DIABETES MELLITUS 5/1322 (0.4%) 4/686 (0.6%)
VITAMIN B COMPLEX DEFICIENCY 1/1322 (0.1%) 0/686 (0%)
VITAMIN D DEFICIENCY 0/1322 (0%) 2/686 (0.3%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA 27/1322 (2%) 16/686 (2.3%)
ARTHRITIS 8/1322 (0.6%) 5/686 (0.7%)
ARTHROFIBROSIS 1/1322 (0.1%) 0/686 (0%)
BACK PAIN 55/1322 (4.2%) 28/686 (4.1%)
BONE LESION 0/1322 (0%) 1/686 (0.1%)
BONE PAIN 1/1322 (0.1%) 0/686 (0%)
BURSITIS 4/1322 (0.3%) 4/686 (0.6%)
CERVICAL SPINAL STENOSIS 0/1322 (0%) 1/686 (0.1%)
CHONDROCALCINOSIS PYROPHOSPHATE 1/1322 (0.1%) 0/686 (0%)
COSTOCHONDRITIS 6/1322 (0.5%) 1/686 (0.1%)
DUPUYTREN'S CONTRACTURE 2/1322 (0.2%) 1/686 (0.1%)
EXOSTOSIS 0/1322 (0%) 2/686 (0.3%)
FLANK PAIN 1/1322 (0.1%) 3/686 (0.4%)
FOOT DEFORMITY 0/1322 (0%) 1/686 (0.1%)
FRACTURE NONUNION 1/1322 (0.1%) 0/686 (0%)
INTERVERTEBRAL DISC DEGENERATION 2/1322 (0.2%) 1/686 (0.1%)
INTERVERTEBRAL DISC PROTRUSION 9/1322 (0.7%) 2/686 (0.3%)
JOINT EFFUSION 1/1322 (0.1%) 0/686 (0%)
JOINT STIFFNESS 1/1322 (0.1%) 0/686 (0%)
JOINT SWELLING 4/1322 (0.3%) 1/686 (0.1%)
LIMB DISCOMFORT 3/1322 (0.2%) 2/686 (0.3%)
LUMBAR SPINAL STENOSIS 7/1322 (0.5%) 2/686 (0.3%)
MOBILITY DECREASED 1/1322 (0.1%) 0/686 (0%)
MUSCLE SPASMS 10/1322 (0.8%) 1/686 (0.1%)
MUSCULAR WEAKNESS 6/1322 (0.5%) 4/686 (0.6%)
MUSCULOSKELETAL CHEST PAIN 21/1322 (1.6%) 7/686 (1%)
MUSCULOSKELETAL DISCOMFORT 5/1322 (0.4%) 2/686 (0.3%)
MUSCULOSKELETAL DISORDER 1/1322 (0.1%) 0/686 (0%)
MUSCULOSKELETAL PAIN 18/1322 (1.4%) 16/686 (2.3%)
MYALGIA 12/1322 (0.9%) 8/686 (1.2%)
MYOSITIS 2/1322 (0.2%) 0/686 (0%)
NECK PAIN 7/1322 (0.5%) 5/686 (0.7%)
OSTEOARTHRITIS 30/1322 (2.3%) 18/686 (2.6%)
OSTEOPENIA 1/1322 (0.1%) 0/686 (0%)
OSTEOPOROSIS 1/1322 (0.1%) 0/686 (0%)
PAIN IN EXTREMITY 40/1322 (3%) 15/686 (2.2%)
PAIN IN JAW 7/1322 (0.5%) 1/686 (0.1%)
PERIARTHRITIS 1/1322 (0.1%) 0/686 (0%)
PLANTAR FASCIITIS 2/1322 (0.2%) 1/686 (0.1%)
POLYMYALGIA RHEUMATICA 0/1322 (0%) 2/686 (0.3%)
RHABDOMYOLYSIS 0/1322 (0%) 1/686 (0.1%)
RHEUMATOID ARTHRITIS 2/1322 (0.2%) 0/686 (0%)
ROTATOR CUFF SYNDROME 8/1322 (0.6%) 4/686 (0.6%)
SACROILIITIS 0/1322 (0%) 1/686 (0.1%)
SPINAL OSTEOARTHRITIS 6/1322 (0.5%) 4/686 (0.6%)
SPONDYLITIS 1/1322 (0.1%) 0/686 (0%)
SPONDYLOLISTHESIS 3/1322 (0.2%) 2/686 (0.3%)
SYNOVIAL CYST 1/1322 (0.1%) 1/686 (0.1%)
SYSTEMIC LUPUS ERYTHEMATOSUS 0/1322 (0%) 1/686 (0.1%)
TENDINOUS CONTRACTURE 1/1322 (0.1%) 0/686 (0%)
TENDONITIS 1/1322 (0.1%) 0/686 (0%)
TENOSYNOVITIS STENOSANS 0/1322 (0%) 1/686 (0.1%)
TRIGGER FINGER 1/1322 (0.1%) 0/686 (0%)
VERTEBRAL FORAMINAL STENOSIS 0/1322 (0%) 1/686 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACOUSTIC NEUROMA 1/1322 (0.1%) 0/686 (0%)
ACUTE MYELOID LEUKAEMIA 1/1322 (0.1%) 0/686 (0%)
ACUTE MYELOID LEUKAEMIA RECURRENT 1/1322 (0.1%) 0/686 (0%)
ADENOCARCINOMA 2/1322 (0.2%) 1/686 (0.1%)
ADENOCARCINOMA PANCREAS 1/1322 (0.1%) 0/686 (0%)
B-CELL LYMPHOMA 1/1322 (0.1%) 0/686 (0%)
B-CELL LYMPHOMA STAGE IV 1/1322 (0.1%) 0/686 (0%)
BASAL CELL CARCINOMA 6/1322 (0.5%) 7/686 (1%)
BENIGN BREAST NEOPLASM 0/1322 (0%) 1/686 (0.1%)
BENIGN OVARIAN TUMOUR 1/1322 (0.1%) 0/686 (0%)
BILE DUCT CANCER 1/1322 (0.1%) 0/686 (0%)
BLADDER CANCER 3/1322 (0.2%) 1/686 (0.1%)
BLADDER CANCER RECURRENT 1/1322 (0.1%) 1/686 (0.1%)
BLADDER CANCER STAGE IV 1/1322 (0.1%) 0/686 (0%)
BLADDER NEOPLASM 1/1322 (0.1%) 1/686 (0.1%)
BRAIN NEOPLASM 0/1322 (0%) 1/686 (0.1%)
BREAST CANCER 5/1322 (0.4%) 0/686 (0%)
BREAST CANCER STAGE III 1/1322 (0.1%) 0/686 (0%)
CERVIX CARCINOMA 0/1322 (0%) 1/686 (0.1%)
CHRONIC LYMPHOCYTIC LEUKAEMIA 0/1322 (0%) 1/686 (0.1%)
COLON ADENOMA 3/1322 (0.2%) 2/686 (0.3%)
COLON CANCER 3/1322 (0.2%) 2/686 (0.3%)
DIFFUSE LARGE B-CELL LYMPHOMA 2/1322 (0.2%) 0/686 (0%)
GASTRIC CANCER 1/1322 (0.1%) 0/686 (0%)
GLIOBLASTOMA 0/1322 (0%) 2/686 (0.3%)
HAEMANGIOMA OF SPLEEN 0/1322 (0%) 1/686 (0.1%)
HEAD AND NECK CANCER 1/1322 (0.1%) 0/686 (0%)
HEAD AND NECK CANCER METASTATIC 1/1322 (0.1%) 0/686 (0%)
HEPATIC CANCER METASTATIC 0/1322 (0%) 1/686 (0.1%)
HEPATIC NEOPLASM MALIGNANT 1/1322 (0.1%) 0/686 (0%)
HYPOPHARYNGEAL CANCER 1/1322 (0.1%) 0/686 (0%)
LARYNGEAL CANCER 0/1322 (0%) 1/686 (0.1%)
LEUKAEMIA 1/1322 (0.1%) 0/686 (0%)
LEUKAEMIA RECURRENT 1/1322 (0.1%) 0/686 (0%)
LIP AND/OR ORAL CAVITY CANCER 0/1322 (0%) 1/686 (0.1%)
LIPOMA 2/1322 (0.2%) 0/686 (0%)
LUNG ADENOCARCINOMA 3/1322 (0.2%) 0/686 (0%)
LUNG CANCER METASTATIC 1/1322 (0.1%) 2/686 (0.3%)
LUNG NEOPLASM 5/1322 (0.4%) 6/686 (0.9%)
LUNG NEOPLASM MALIGNANT 7/1322 (0.5%) 0/686 (0%)
LUNG SQUAMOUS CELL CARCINOMA STAGE III 1/1322 (0.1%) 0/686 (0%)
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED 2/1322 (0.2%) 0/686 (0%)
LYMPHOMA 4/1322 (0.3%) 0/686 (0%)
MALIGNANT MELANOMA 2/1322 (0.2%) 1/686 (0.1%)
MELANOCYTIC NAEVUS 1/1322 (0.1%) 1/686 (0.1%)
MENINGIOMA 1/1322 (0.1%) 0/686 (0%)
METASTASES TO LIVER 1/1322 (0.1%) 0/686 (0%)
METASTASES TO LUNG 1/1322 (0.1%) 0/686 (0%)
METASTASES TO LYMPH NODES 1/1322 (0.1%) 0/686 (0%)
METASTASES TO SPINE 1/1322 (0.1%) 0/686 (0%)
METASTATIC MALIGNANT MELANOMA 3/1322 (0.2%) 0/686 (0%)
METASTATIC NEOPLASM 1/1322 (0.1%) 1/686 (0.1%)
MULTIPLE MYELOMA 1/1322 (0.1%) 0/686 (0%)
NEOPLASM MALIGNANT 2/1322 (0.2%) 0/686 (0%)
NEURILEMMOMA MALIGNANT 1/1322 (0.1%) 0/686 (0%)
NON-HODGKIN'S LYMPHOMA 0/1322 (0%) 1/686 (0.1%)
NON-SMALL CELL LUNG CANCER 1/1322 (0.1%) 1/686 (0.1%)
OESOPHAGEAL CARCINOMA 1/1322 (0.1%) 0/686 (0%)
ORAL NEOPLASM 0/1322 (0%) 1/686 (0.1%)
OROPHARYNGEAL CANCER STAGE UNSPECIFIED 0/1322 (0%) 1/686 (0.1%)
OVARIAN CANCER METASTATIC 1/1322 (0.1%) 0/686 (0%)
OVARIAN EPITHELIAL CANCER 1/1322 (0.1%) 0/686 (0%)
PANCREATIC CARCINOMA 1/1322 (0.1%) 1/686 (0.1%)
PERICARDIAL EFFUSION MALIGNANT 1/1322 (0.1%) 0/686 (0%)
PROSTATE CANCER 11/1322 (0.8%) 4/686 (0.6%)
PROSTATE CANCER RECURRENT 1/1322 (0.1%) 0/686 (0%)
RECTAL CANCER 1/1322 (0.1%) 0/686 (0%)
RENAL CANCER 0/1322 (0%) 1/686 (0.1%)
RENAL CELL CARCINOMA 1/1322 (0.1%) 0/686 (0%)
RENAL HAEMANGIOMA 1/1322 (0.1%) 0/686 (0%)
RENAL NEOPLASM 1/1322 (0.1%) 0/686 (0%)
SEBORRHOEIC KERATOSIS 2/1322 (0.2%) 0/686 (0%)
SINONASAL PAPILLOMA 1/1322 (0.1%) 0/686 (0%)
SKIN CANCER 3/1322 (0.2%) 0/686 (0%)
SKIN PAPILLOMA 1/1322 (0.1%) 0/686 (0%)
SMALL CELL LUNG CANCER LIMITED STAGE 0/1322 (0%) 1/686 (0.1%)
SMALL CELL LUNG CANCER STAGE UNSPECIFIED 1/1322 (0.1%) 0/686 (0%)
SQUAMOUS CELL CARCINOMA 5/1322 (0.4%) 3/686 (0.4%)
SQUAMOUS CELL CARCINOMA OF SKIN 0/1322 (0%) 1/686 (0.1%)
THYROID NEOPLASM 1/1322 (0.1%) 2/686 (0.3%)
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED 1/1322 (0.1%) 0/686 (0%)
TRANSITIONAL CELL CARCINOMA 1/1322 (0.1%) 0/686 (0%)
URETERIC CANCER 1/1322 (0.1%) 0/686 (0%)
UTERINE CANCER 1/1322 (0.1%) 0/686 (0%)
UTERINE LEIOMYOMA 0/1322 (0%) 1/686 (0.1%)
VULVAL CANCER STAGE 0 1/1322 (0.1%) 0/686 (0%)
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS 1/1322 (0.1%) 0/686 (0%)
AMNESIA 4/1322 (0.3%) 2/686 (0.3%)
APHASIA 0/1322 (0%) 1/686 (0.1%)
ARACHNOIDITIS 0/1322 (0%) 1/686 (0.1%)
ATAXIA 1/1322 (0.1%) 0/686 (0%)
AUTONOMIC NERVOUS SYSTEM IMBALANCE 1/1322 (0.1%) 0/686 (0%)
BALANCE DISORDER 1/1322 (0.1%) 1/686 (0.1%)
BURNING SENSATION 1/1322 (0.1%) 0/686 (0%)
CAROTID ARTERY DISEASE 2/1322 (0.2%) 1/686 (0.1%)
CAROTID ARTERY STENOSIS 15/1322 (1.1%) 9/686 (1.3%)
CARPAL TUNNEL SYNDROME 4/1322 (0.3%) 2/686 (0.3%)
CAUDA EQUINA SYNDROME 1/1322 (0.1%) 0/686 (0%)
CENTRAL NERVOUS SYSTEM LESION 1/1322 (0.1%) 0/686 (0%)
CEREBELLAR INFARCTION 1/1322 (0.1%) 0/686 (0%)
CEREBRAL HAEMORRHAGE 0/1322 (0%) 1/686 (0.1%)
CEREBRAL INFARCTION 1/1322 (0.1%) 1/686 (0.1%)
CEREBROVASCULAR ACCIDENT 20/1322 (1.5%) 15/686 (2.2%)
CEREBROVASCULAR DISORDER 1/1322 (0.1%) 1/686 (0.1%)
CERVICOBRACHIAL SYNDROME 1/1322 (0.1%) 1/686 (0.1%)
COMPLICATED MIGRAINE 2/1322 (0.2%) 0/686 (0%)
CONVULSION 4/1322 (0.3%) 2/686 (0.3%)
CUBITAL TUNNEL SYNDROME 0/1322 (0%) 1/686 (0.1%)
DEMENTIA 0/1322 (0%) 1/686 (0.1%)
DIABETIC NEUROPATHY 1/1322 (0.1%) 1/686 (0.1%)
DIZZINESS 58/1322 (4.4%) 27/686 (3.9%)
DIZZINESS EXERTIONAL 2/1322 (0.2%) 0/686 (0%)
DIZZINESS POSTURAL 7/1322 (0.5%) 0/686 (0%)
DYSAESTHESIA 1/1322 (0.1%) 0/686 (0%)
DYSARTHRIA 4/1322 (0.3%) 0/686 (0%)
DYSGEUSIA 1/1322 (0.1%) 0/686 (0%)
EMBOLIC STROKE 1/1322 (0.1%) 0/686 (0%)
ENCEPHALOPATHY 1/1322 (0.1%) 1/686 (0.1%)
ESSENTIAL TREMOR 1/1322 (0.1%) 0/686 (0%)
GUILLAIN-BARRE SYNDROME 1/1322 (0.1%) 0/686 (0%)
HAEMORRHAGE INTRACRANIAL 1/1322 (0.1%) 1/686 (0.1%)
HAEMORRHAGIC STROKE 1/1322 (0.1%) 0/686 (0%)
HEAD DISCOMFORT 1/1322 (0.1%) 0/686 (0%)
HEAD TITUBATION 1/1322 (0.1%) 0/686 (0%)
HEADACHE 28/1322 (2.1%) 19/686 (2.8%)
HEMIPARESIS 1/1322 (0.1%) 1/686 (0.1%)
HEMIPLEGIC MIGRAINE 1/1322 (0.1%) 0/686 (0%)
HEPATIC ENCEPHALOPATHY 1/1322 (0.1%) 0/686 (0%)
HYPOAESTHESIA 13/1322 (1%) 8/686 (1.2%)
HYPOXIC-ISCHAEMIC ENCEPHALOPATHYv 2/1322 (0.2%) 0/686 (0%)
IIIRD NERVE PARALYSIS 1/1322 (0.1%) 0/686 (0%)
INTENTION TREMOR 0/1322 (0%) 1/686 (0.1%)
ISCHAEMIC STROKE 6/1322 (0.5%) 3/686 (0.4%)
LACUNAR INFARCTION 1/1322 (0.1%) 1/686 (0.1%)
LATERAL MEDULLARY SYNDROME 1/1322 (0.1%) 0/686 (0%)
LETHARGY 2/1322 (0.2%) 0/686 (0%)
LOSS OF CONSCIOUSNESS 2/1322 (0.2%) 0/686 (0%)
LUMBAR RADICULOPATHY 2/1322 (0.2%) 2/686 (0.3%)
MEMORY IMPAIRMENT 6/1322 (0.5%) 0/686 (0%)
MENTAL IMPAIRMENT 1/1322 (0.1%) 0/686 (0%)
METABOLIC ENCEPHALOPATHY 2/1322 (0.2%) 1/686 (0.1%)
MIGRAINE 3/1322 (0.2%) 1/686 (0.1%)
MYELOMALACIA 1/1322 (0.1%) 0/686 (0%)
NERVE COMPRESSION 1/1322 (0.1%) 2/686 (0.3%)
NEURALGIA 0/1322 (0%) 1/686 (0.1%)
NEUROLOGICAL SYMPTOM 1/1322 (0.1%) 2/686 (0.3%)
NEUROPATHY PERIPHERAL 1/1322 (0.1%) 0/686 (0%)
NYSTAGMUS 2/1322 (0.2%) 0/686 (0%)
PARAESTHESIA 8/1322 (0.6%) 4/686 (0.6%)
POLYNEUROPATHY ALCOHOLIC 1/1322 (0.1%) 0/686 (0%)
POST-TRAUMATIC HEADACHE 0/1322 (0%) 2/686 (0.3%)
PRESYNCOPE 26/1322 (2%) 8/686 (1.2%)
RADICULITIS 1/1322 (0.1%) 1/686 (0.1%)
RADICULITIS CERVICAL 1/1322 (0.1%) 0/686 (0%)
SCIATICA 4/1322 (0.3%) 2/686 (0.3%)
SENSORY DISTURBANCE 1/1322 (0.1%) 0/686 (0%)
SOMNOLENCE 3/1322 (0.2%) 0/686 (0%)
SPEECH DISORDER 0/1322 (0%) 1/686 (0.1%)
SPONDYLITIC MYELOPATHY 1/1322 (0.1%) 0/686 (0%)
SUBARACHNOID HAEMORRHAGE 1/1322 (0.1%) 1/686 (0.1%)
SUBDURAL HYGROMA 2/1322 (0.2%) 0/686 (0%)
SYNCOPE 40/1322 (3%) 22/686 (3.2%)
THALAMIC INFARCTION 3/1322 (0.2%) 0/686 (0%)
THROMBOTIC STROKE 0/1322 (0%) 1/686 (0.1%)
TRANSIENT GLOBAL AMNESIA 2/1322 (0.2%) 0/686 (0%)
TRANSIENT ISCHAEMIC ATTACK 17/1322 (1.3%) 8/686 (1.2%)
TREMOR 4/1322 (0.3%) 2/686 (0.3%)
UNRESPONSIVE TO STIMULI 1/1322 (0.1%) 0/686 (0%)
URAEMIC ENCEPHALOPATHY 0/1322 (0%) 1/686 (0.1%)
VERTEBRAL ARTERY OCCLUSION 0/1322 (0%) 1/686 (0.1%)
VITH NERVE PARALYSIS 2/1322 (0.2%) 1/686 (0.1%)
Psychiatric disorders
ACUTE STRESS DISORDER 0/1322 (0%) 1/686 (0.1%)
ADJUSTMENT DISORDER WITH MIXED DISTURBANCE OF EMOTION AND CONDUCT 0/1322 (0%) 1/686 (0.1%)
AFFECTIVE DISORDER 1/1322 (0.1%) 0/686 (0%)
ALCOHOL ABUSE 1/1322 (0.1%) 1/686 (0.1%)
ALCOHOL PROBLEM 1/1322 (0.1%) 0/686 (0%)
ALCOHOL WITHDRAWAL SYNDROME 0/1322 (0%) 1/686 (0.1%)
ANXIETY 20/1322 (1.5%) 7/686 (1%)
ANXIETY DISORDER 1/1322 (0.1%) 0/686 (0%)
BIPOLAR DISORDER 0/1322 (0%) 1/686 (0.1%)
BIPOLAR I DISORDER 1/1322 (0.1%) 0/686 (0%)
COMPLETED SUICIDE 0/1322 (0%) 1/686 (0.1%)
CONFUSIONAL STATE 4/1322 (0.3%) 2/686 (0.3%)
DELIRIUM 1/1322 (0.1%) 1/686 (0.1%)
DELIRIUM TREMENS 0/1322 (0%) 1/686 (0.1%)
DEPRESSED MOOD 1/1322 (0.1%) 0/686 (0%)
DEPRESSION 17/1322 (1.3%) 3/686 (0.4%)
DEPRESSION SUICIDAL 1/1322 (0.1%) 1/686 (0.1%)
HALLUCINATION 0/1322 (0%) 1/686 (0.1%)
HALLUCINATION, VISUAL 0/1322 (0%) 1/686 (0.1%)
INSOMNIA 4/1322 (0.3%) 3/686 (0.4%)
INTENTIONAL SELF-INJURY 1/1322 (0.1%) 0/686 (0%)
MAJOR DEPRESSION 2/1322 (0.2%) 1/686 (0.1%)
MENTAL STATUS CHANGES 6/1322 (0.5%) 2/686 (0.3%)
OBSESSIVE-COMPULSIVE DISORDER 0/1322 (0%) 1/686 (0.1%)
PANIC ATTACK 2/1322 (0.2%) 1/686 (0.1%)
STRESS 1/1322 (0.1%) 0/686 (0%)
SUICIDAL IDEATION 0/1322 (0%) 2/686 (0.3%)
Renal and urinary disorders
BLADDER DISORDER 0/1322 (0%) 1/686 (0.1%)
CALCULUS URETERIC 1/1322 (0.1%) 3/686 (0.4%)
CYSTITIS HAEMORRHAGIC 2/1322 (0.2%) 0/686 (0%)
CYSTITIS INTERSTITIAL 1/1322 (0.1%) 0/686 (0%)
DYSURIA 4/1322 (0.3%) 0/686 (0%)
HAEMATURIA 13/1322 (1%) 11/686 (1.6%)
HYDRONEPHROSIS 2/1322 (0.2%) 1/686 (0.1%)
HYPERTONIC BLADDER 1/1322 (0.1%) 0/686 (0%)
MICROALBUMINURIA 1/1322 (0.1%) 0/686 (0%)
NEPHROLITHIASIS 18/1322 (1.4%) 10/686 (1.5%)
NOCTURIA 1/1322 (0.1%) 0/686 (0%)
POLLAKIURIA 1/1322 (0.1%) 0/686 (0%)
RENAL ARTERY STENOSIS 1/1322 (0.1%) 3/686 (0.4%)
RENAL CYST 4/1322 (0.3%) 2/686 (0.3%)
RENAL DISORDER 1/1322 (0.1%) 0/686 (0%)
RENAL FAILURE 8/1322 (0.6%) 5/686 (0.7%)
RENAL FAILURE ACUTE 17/1322 (1.3%) 14/686 (2%)
RENAL FAILURE CHRONIC 3/1322 (0.2%) 5/686 (0.7%)
RENAL IMPAIRMENT 1/1322 (0.1%) 2/686 (0.3%)
RENAL TUBULAR NECROSIS 1/1322 (0.1%) 0/686 (0%)
STRESS URINARY INCONTINENCE 1/1322 (0.1%) 0/686 (0%)
URETHRAL STENOSIS 1/1322 (0.1%) 0/686 (0%)
URINARY HESITATION 1/1322 (0.1%) 0/686 (0%)
URINARY INCONTINENCE 2/1322 (0.2%) 0/686 (0%)
URINARY RETENTION 12/1322 (0.9%) 3/686 (0.4%)
URINE FLOW DECREASED 1/1322 (0.1%) 0/686 (0%)
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA 7/1322 (0.5%) 5/686 (0.7%)
BREAST CALCIFICATIONS 1/1322 (0.1%) 0/686 (0%)
BREAST MASS 2/1322 (0.2%) 0/686 (0%)
BREAST PAIN 1/1322 (0.1%) 0/686 (0%)
DYSFUNCTIONAL UTERINE BLEEDING 1/1322 (0.1%) 0/686 (0%)
EPIDIDYMAL CYST 0/1322 (0%) 1/686 (0.1%)
FALLOPIAN TUBE CYST 1/1322 (0.1%) 0/686 (0%)
FEMALE GENITAL TRACT FISTULA 1/1322 (0.1%) 0/686 (0%)
HAEMATOSPERMIA 3/1322 (0.2%) 0/686 (0%)
MENORRHAGIA 0/1322 (0%) 2/686 (0.3%)
PELVIC HAEMATOMA 1/1322 (0.1%) 0/686 (0%)
PENILE HAEMORRHAGE 2/1322 (0.2%) 0/686 (0%)
POLYCYSTIC OVARIES 1/1322 (0.1%) 0/686 (0%)
PROSTATITIS 2/1322 (0.2%) 0/686 (0%)
PROSTATOMEGALY 1/1322 (0.1%) 1/686 (0.1%)
SEXUAL DYSFUNCTION 1/1322 (0.1%) 0/686 (0%)
SPERMATOCELE 1/1322 (0.1%) 0/686 (0%)
TESTICULAR PAIN 1/1322 (0.1%) 0/686 (0%)
UTERINE POLYP 1/1322 (0.1%) 0/686 (0%)
VAGINAL HAEMORRHAGE 2/1322 (0.2%) 1/686 (0.1%)
VULVA CYST 1/1322 (0.1%) 0/686 (0%)
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA 0/1322 (0%) 4/686 (0.6%)
ACUTE RESPIRATORY FAILURE 18/1322 (1.4%) 7/686 (1%)
ALLERGIC GRANULOMATOUS ANGIITIS 1/1322 (0.1%) 0/686 (0%)
ASPIRATION 1/1322 (0.1%) 0/686 (0%)
ASTHMA 6/1322 (0.5%) 4/686 (0.6%)
ATELECTASIS 2/1322 (0.2%) 1/686 (0.1%)
BRONCHIAL HYPERREACTIVITY 0/1322 (0%) 1/686 (0.1%)
BRONCHITIS CHRONIC 1/1322 (0.1%) 0/686 (0%)
CHOKING 1/1322 (0.1%) 0/686 (0%)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 35/1322 (2.6%) 15/686 (2.2%)
COUGH 21/1322 (1.6%) 12/686 (1.7%)
DYSPHONIA 1/1322 (0.1%) 1/686 (0.1%)
DYSPNOEA 126/1322 (9.5%) 55/686 (8%)
DYSPNOEA EXERTIONAL 51/1322 (3.9%) 33/686 (4.8%)
DYSPNOEA PAROXYSMAL NOCTURNAL 0/1322 (0%) 1/686 (0.1%)
EMPHYSEMA 1/1322 (0.1%) 0/686 (0%)
EPISTAXIS 26/1322 (2%) 15/686 (2.2%)
HAEMOPTYSIS 2/1322 (0.2%) 5/686 (0.7%)
HYPERVENTILATION 0/1322 (0%) 1/686 (0.1%)
HYPOXIA 3/1322 (0.2%) 2/686 (0.3%)
INTERSTITIAL LUNG DISEASE 1/1322 (0.1%) 0/686 (0%)
MEDIASTINAL MASS 0/1322 (0%) 1/686 (0.1%)
NASAL POLYPS 1/1322 (0.1%) 1/686 (0.1%)
NASAL SEPTUM ULCERATION 0/1322 (0%) 1/686 (0.1%)
NON-CARDIOGENIC PULMONARY OEDEMA 1/1322 (0.1%) 0/686 (0%)
OBSTRUCTIVE AIRWAYS DISORDER 0/1322 (0%) 1/686 (0.1%)
ORGANISING PNEUMONIA 0/1322 (0%) 1/686 (0.1%)
OROPHARYNGEAL PAIN 4/1322 (0.3%) 3/686 (0.4%)
ORTHOPNOEA 3/1322 (0.2%) 0/686 (0%)
PHARYNGEAL OEDEMA 1/1322 (0.1%) 0/686 (0%)
PLEURAL EFFUSION 9/1322 (0.7%) 6/686 (0.9%)
PLEURITIC PAIN 4/1322 (0.3%) 2/686 (0.3%)
PNEUMONIA ASPIRATION 0/1322 (0%) 4/686 (0.6%)
PNEUMONITIS 1/1322 (0.1%) 0/686 (0%)
PNEUMOTHORAX 2/1322 (0.2%) 6/686 (0.9%)
PRODUCTIVE COUGH 0/1322 (0%) 1/686 (0.1%)
PULMONARY CONGESTION 0/1322 (0%) 1/686 (0.1%)
PULMONARY EMBOLISM 9/1322 (0.7%) 7/686 (1%)
PULMONARY FIBROSIS 0/1322 (0%) 2/686 (0.3%)
PULMONARY HYPERTENSION 1/1322 (0.1%) 0/686 (0%)
PULMONARY OEDEMA 3/1322 (0.2%) 2/686 (0.3%)
RESPIRATORY ALKALOSIS 0/1322 (0%) 1/686 (0.1%)
RESPIRATORY ARREST 2/1322 (0.2%) 0/686 (0%)
RESPIRATORY DISORDER 1/1322 (0.1%) 0/686 (0%)
RESPIRATORY FAILURE 14/1322 (1.1%) 8/686 (1.2%)
RHINITIS ALLERGIC 3/1322 (0.2%) 0/686 (0%)
RHINORRHOEA 1/1322 (0.1%) 0/686 (0%)
SINUS CONGESTION 2/1322 (0.2%) 1/686 (0.1%)
SLEEP APNOEA SYNDROME 8/1322 (0.6%) 6/686 (0.9%)
THROAT TIGHTNESS 2/1322 (0.2%) 0/686 (0%)
TRACHEAL STENOSIS 1/1322 (0.1%) 0/686 (0%)
UPPER RESPIRATORY TRACT CONGESTION 1/1322 (0.1%) 0/686 (0%)
UPPER-AIRWAY COUGH SYNDROME 0/1322 (0%) 1/686 (0.1%)
WHEEZING 2/1322 (0.2%) 0/686 (0%)
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS 2/1322 (0.2%) 1/686 (0.1%)
ANGIOEDEMA 2/1322 (0.2%) 1/686 (0.1%)
DECUBITUS ULCER 3/1322 (0.2%) 1/686 (0.1%)
DERMATITIS 0/1322 (0%) 1/686 (0.1%)
DERMATITIS ATOPIC 1/1322 (0.1%) 0/686 (0%)
DERMATITIS CONTACT 2/1322 (0.2%) 0/686 (0%)
DIABETIC FOOT 3/1322 (0.2%) 0/686 (0%)
DRUG ERUPTION 0/1322 (0%) 2/686 (0.3%)
ECCHYMOSIS 3/1322 (0.2%) 0/686 (0%)
ECZEMA 2/1322 (0.2%) 0/686 (0%)
ERYTHEMA 2/1322 (0.2%) 0/686 (0%)
HYPERHIDROSIS 5/1322 (0.4%) 1/686 (0.1%)
HYPERKERATOSIS 0/1322 (0%) 2/686 (0.3%)
INCREASED TENDENCY TO BRUISE 9/1322 (0.7%) 5/686 (0.7%)
INGROWING NAIL 0/1322 (0%) 1/686 (0.1%)
LICHENOID KERATOSIS 1/1322 (0.1%) 0/686 (0%)
LIVEDO RETICULARIS 1/1322 (0.1%) 0/686 (0%)
NIGHT SWEATS 1/1322 (0.1%) 1/686 (0.1%)
PRECANCEROUS SKIN LESION 1/1322 (0.1%) 0/686 (0%)
PRURITUS 4/1322 (0.3%) 2/686 (0.3%)
PRURITUS ALLERGIC 0/1322 (0%) 1/686 (0.1%)
PSORIASIS 1/1322 (0.1%) 0/686 (0%)
RASH 15/1322 (1.1%) 8/686 (1.2%)
RASH GENERALISED 2/1322 (0.2%) 1/686 (0.1%)
RASH PRURITIC 2/1322 (0.2%) 1/686 (0.1%)
SEBORRHOEIC DERMATITIS 1/1322 (0.1%) 0/686 (0%)
SKIN LESION 2/1322 (0.2%) 0/686 (0%)
SKIN ULCER 5/1322 (0.4%) 3/686 (0.4%)
SWELLING FACE 2/1322 (0.2%) 0/686 (0%)
URTICARIA 4/1322 (0.3%) 0/686 (0%)
Surgical and medical procedures
AORTIC ANEURYSM REPAIR 1/1322 (0.1%) 0/686 (0%)
CARDIAC ABLATION 0/1322 (0%) 1/686 (0.1%)
CARDIAC PACEMAKER BATTERY REPLACEMENT 0/1322 (0%) 1/686 (0.1%)
CARDIAC PACEMAKER REPLACEMENT 1/1322 (0.1%) 0/686 (0%)
CHOLECYSTECTOMY 1/1322 (0.1%) 1/686 (0.1%)
COLOSTOMY 0/1322 (0%) 1/686 (0.1%)
CORONARY ARTERY BYPASS 1/1322 (0.1%) 0/686 (0%)
DENTAL IMPLANTATION 1/1322 (0.1%) 0/686 (0%)
HERNIA HIATUS REPAIR 1/1322 (0.1%) 0/686 (0%)
HIP ARTHROPLASTY 3/1322 (0.2%) 0/686 (0%)
INGUINAL HERNIA REPAIR 0/1322 (0%) 1/686 (0.1%)
KNEE ARTHROPLASTY 1/1322 (0.1%) 0/686 (0%)
LEG AMPUTATION 0/1322 (0%) 1/686 (0.1%)
MEDICAL DEVICE REMOVAL 0/1322 (0%) 1/686 (0.1%)
NEPHRECTOMY 1/1322 (0.1%) 0/686 (0%)
SINUS OPERATION 1/1322 (0.1%) 0/686 (0%)
SPINAL FUSION SURGERY 1/1322 (0.1%) 0/686 (0%)
TENDON OPERATION 0/1322 (0%) 1/686 (0.1%)
THERAPY CESSATION 1/1322 (0.1%) 0/686 (0%)
TONSILLECTOMY 0/1322 (0%) 1/686 (0.1%)
TOOTH EXTRACTION 0/1322 (0%) 1/686 (0.1%)
TRANSURETHRAL PROSTATECTOMY 0/1322 (0%) 1/686 (0.1%)
Vascular disorders
ACCELERATED HYPERTENSION 4/1322 (0.3%) 1/686 (0.1%)
AORTIC ANEURYSM 8/1322 (0.6%) 3/686 (0.4%)
AORTIC DISSECTION 0/1322 (0%) 1/686 (0.1%)
AORTIC INTRAMURAL HAEMATOMA 1/1322 (0.1%) 1/686 (0.1%)
AORTIC STENOSIS 4/1322 (0.3%) 5/686 (0.7%)
ARTERIAL SPASM 1/1322 (0.1%) 0/686 (0%)
ARTERIOSCLEROSIS 0/1322 (0%) 1/686 (0.1%)
ARTERIOVENOUS FISTULA 1/1322 (0.1%) 0/686 (0%)
BLEEDING VARICOSE VEIN 1/1322 (0.1%) 0/686 (0%)
BLOOD PRESSURE FLUCTUATION 0/1322 (0%) 1/686 (0.1%)
BLOOD PRESSURE INADEQUATELY CONTROLLED 1/1322 (0.1%) 0/686 (0%)
CIRCULATORY COLLAPSE 0/1322 (0%) 1/686 (0.1%)
DEEP VEIN THROMBOSIS 12/1322 (0.9%) 8/686 (1.2%)
ESSENTIAL HYPERTENSION 1/1322 (0.1%) 1/686 (0.1%)
FEMORAL ARTERIAL STENOSIS 2/1322 (0.2%) 1/686 (0.1%)
FEMORAL ARTERY OCCLUSION 0/1322 (0%) 1/686 (0.1%)
FLUSHING 0/1322 (0%) 1/686 (0.1%)
HAEMATOMA 8/1322 (0.6%) 1/686 (0.1%)
HAEMORRHAGE 2/1322 (0.2%) 1/686 (0.1%)
HOT FLUSH 1/1322 (0.1%) 0/686 (0%)
HYPERTENSION 60/1322 (4.5%) 24/686 (3.5%)
HYPERTENSIVE CRISIS 7/1322 (0.5%) 7/686 (1%)
HYPOTENSION 38/1322 (2.9%) 13/686 (1.9%)
ILIAC ARTERY OCCLUSION 1/1322 (0.1%) 0/686 (0%)
ILIAC ARTERY STENOSIS 1/1322 (0.1%) 1/686 (0.1%)
INTERMITTENT CLAUDICATION 14/1322 (1.1%) 10/686 (1.5%)
LABILE HYPERTENSION 1/1322 (0.1%) 0/686 (0%)
MALIGNANT HYPERTENSION 1/1322 (0.1%) 0/686 (0%)
ORTHOSTATIC HYPERTENSION 1/1322 (0.1%) 0/686 (0%)
ORTHOSTATIC HYPOTENSION 8/1322 (0.6%) 3/686 (0.4%)
PALLOR 1/1322 (0.1%) 0/686 (0%)
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE 5/1322 (0.4%) 10/686 (1.5%)
PERIPHERAL COLDNESS 2/1322 (0.2%) 0/686 (0%)
PERIPHERAL ISCHAEMIA 1/1322 (0.1%) 1/686 (0.1%)
PERIPHERAL VASCULAR DISORDER 8/1322 (0.6%) 6/686 (0.9%)
POOR PERIPHERAL CIRCULATION 1/1322 (0.1%) 0/686 (0%)
RAYNAUD'S PHENOMENON 1/1322 (0.1%) 0/686 (0%)
REPERFUSION INJURY 5/1322 (0.4%) 2/686 (0.3%)
SUBCLAVIAN ARTERY OCCLUSION 1/1322 (0.1%) 0/686 (0%)
SUBCLAVIAN ARTERY STENOSIS 1/1322 (0.1%) 0/686 (0%)
SUBCLAVIAN STEAL SYNDROME 1/1322 (0.1%) 0/686 (0%)
THROMBOPHLEBITIS SUPERFICIAL 1/1322 (0.1%) 1/686 (0.1%)
THROMBOSIS 3/1322 (0.2%) 0/686 (0%)
VARICOSE VEIN 1/1322 (0.1%) 0/686 (0%)
VASOSPASM 1/1322 (0.1%) 0/686 (0%)
VENOUS INSUFFICIENCY 1/1322 (0.1%) 0/686 (0%)
WEGENER'S GRANULOMATOSIS 1/1322 (0.1%) 0/686 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title Latania Chura / Project Manager
Organization Abbott Vascular
Phone 503.935.3002
Email latania.chura@abbott.com
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT01751906
Other Study ID Numbers:
  • 10-392
First Posted:
Dec 18, 2012
Last Update Posted:
May 19, 2022
Last Verified:
Jan 1, 2021