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The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00823212
Collaborator
(none)
1,530
Enrollment
133
Locations
2
Arms
71
Duration (Months)
11.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions.

This clinical trial compares outcomes in patients treated with PROMUS Element to those in patients treated with a different everolimus-eluting coronary stent. The lesions are of average length in average-sized vessels ("workhorse"). A companion sub-trial evaluates outcomes in smaller vessels (SV) and another sub-trial evaluates outcomes in longer lesions (LL).

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The wide-spread use of DES has evolved as standard of care in de novo lesions. The proposed study will evaluate the safety and effectiveness of PROMUS Element for the treatment of de novo atherosclerotic lesions in native coronary arteries. The study design is consistent with the draft guidance for industry titled, "Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies" (March 2008).

During the trial, thienopyridines must be administered according to the 2007 American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines, which recommended that clopidogrel (75 mg daily) or ticlopidine (250 mg twice daily) be prescribed after stent implantation for at least 6 months in all patients, and for at least 12 months in patients who are not at high risk of bleeding. For sites in the United States, the use of prasugrel is not allowed as part of the PLATINUM Clinical Trial. For sites in other countries, prasugrel may be prescribed according to its approved dosing in countries in which it is available. For patients taking aspirin daily a loading dose is recommended; for patients who have not been taking aspirin daily, aspirin must be administered as a loading dose. Patients continue to take aspirin indefinitely to reduce the risk of thrombosis.

The main study is the PLATINUM Workhorse Randomized Controlled Trial, which is registered under NCT00823212. The clinical protocol includes two companion sub-trials with smaller vessels (PLATINUM SV) and longer lesions (PLATINUM LL) plus a Pharmacokinetics sub-trial (PLATINUM PK). The three sub-trials are registered under separate NCT numbers.

Study Design

Study Type:
Interventional
Actual Enrollment :
1530 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions
Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PROMUS

Patients who received the PROMUS (XIENCE V) Everolimus-Eluting Coronary Stent

Device: PROMUS Coronary Stent System
PROMUS is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
Other Names:
  • XIENCE V

    • Drug: Aspirin
    Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.

    Drug: Thienopyridine
    Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.
    Other Names:
  • A brand name for clopidogrel is PLAVIX.
  • A brand name for ticlopidine is TICLID.

    		•
    Experimental: PROMUS Element

    Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent

    Device: PROMUS Element Coronary Stent System
    PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating that is the same as on the PROMUS [XIENCE V] stent).

    Drug: Aspirin
    Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.

    Drug: Thienopyridine
    Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.
    Other Names:
  • A brand name for clopidogrel is PLAVIX.
  • A brand name for ticlopidine is TICLID.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Target Lesion Failure (TLF) [12-month post index procedure]

      Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.

    Secondary Outcome Measures

    1. Target Lesion Failure (TLF) [30 days]

      TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.

    2. Target Lesion Failure (TLF) [6 months]

      TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.

    3. Target Lesion Failure (TLF) [12 months]

      TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.

    4. Target Vessel Failure (TVF) [30 days]

      TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.

    5. Target Vessel Failure (TVF) [6 months]

      TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.

    6. Target Vessel Failure (TVF) [12 months]

      TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.

    7. Myocardial Infarction (MI) Related to the Target Vessel [30 days]

      Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal

    8. Myocardial Infarction (MI) Related to the Target Vessel [6 months]

      Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal

    9. Myocardial Infarction (MI) Related to the Target Vessel [12 months]

      Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal

    10. All Cause Mortality [30 days]

    11. All Cause Mortality [6 months]

    12. All Cause Mortality [12 months]

    13. Cardiac Death Related to the Target Vessel [30 days]

      Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded

    14. Cardiac Death Related to the Target Vessel [6 months]

      Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded

    15. Cardiac Death Related to the Target Vessel [12 months]

      Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded

    16. Non-cardiac Death [30 Days]

      Defined as a death not due to cardiac causes (see definition of cardiac death above)

    17. Non-cardiac Death [6 Months]

      Defined as a death not due to cardiac causes (see definition of cardiac death above)

    18. Non-cardiac Death [12 months]

      Defined as a death not due to cardiac causes (see definition of cardiac death above)

    19. Cardiac Death or Myocardial Infarction (MI) [30 days]

      Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above

    20. Cardiac Death or Myocardial Infarction (MI) [6 months]

      Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above

    21. Cardiac Death or Myocardial Infarction (MI) [12 months]

      Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above

    22. All Death or Myocardial Infarction (MI) [30 days]

      Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal

    23. All Death or Myocardial Infarction (MI) [6 months]

      Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal

    24. All Death or Myocardial Infarction (MI) [12 months]

      Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal

    25. Target Lesion Revascularization (TLR) [30 days]

      Target lesion revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.

    26. Target Lesion Revascularization (TLR) [6 months]

      TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.

    27. Target Lesion Revascularization (TLR) [12 months]

      TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.

    28. Target Vessel Revascularization (TVR) [30 days]

      Target vessel revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.

    29. Target Vessel Revascularization (TVR) [6 months]

      TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.

    30. Target Vessel Revascularization (TVR) [12 months]

      TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.

    31. Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition [24 hours]

      DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).

    32. Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition [>24 hr-30 days]

      DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).

    33. Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition [>30 days-1 year]

      DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).

    34. Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) [30 days]

      See above for definitions of MI and TVR

    35. Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) [6 months]

      See above for definitions of MI and TVR.

    36. Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) [12 months]

      See above for definitions of MI and TVR.

    37. Clinical Procedural Success [In hospital]

      Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or cardiac death

    38. Acute Technical Success [Acute-At time of index procedure]

      Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient must be at least 18 years of age

    • Patient (or legal guardian) understands study requirements and treatment procedures and provides written informed consent before any study-specific tests or procedures are performed

    • For patients less than 20 years of age enrolled at a Japanese site, patient and patient's legal representative must provide written informed consent before any study-specific tests or procedures are performed

    • Patient is eligible for percutaneous coronary intervention (PCI)

    • Patient has documented stable angina pectoris or documented silent ischemia; or unstable angina pectoris

    • Patient is an acceptable candidate for coronary artery bypass grafting (CABG)

    • Patient has a left ventricular ejection fraction (LVEF) >=30% as measured within 30 days prior to enrollment

    • Patient is willing to comply with all protocol-required follow-up evaluations

    Angiographic Inclusion Criteria (visual estimate):
    • Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) >=2.50 mm and <=4.25 mm. Target lesion length must measure (by visual estimate) <=24 mm. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >=50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow >1.
    Exclusion Criteria:

    • Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI)

    • Patient has had a known diagnosis of recent MI (ie, within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure as follows.

    • Patients are excluded if any of the following criteria are met at time of the index procedure.

    • If creatine kinase-myoglobin band (CK-MB) >2× upper limit of normal (ULN), the patient is excluded regardless of CK Total.

    • If CK-MB is 1-2× ULN, the patient is excluded if the CK Total is >2× ULN.

    • If CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at time of index procedure.

    • Troponin >1× ULN with at least one of the following.

    • Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg, >1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block [LBBB]);

    • Development of pathological Q waves in the ECG; or

    • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

    Note: For patients with unstable angina or patients who have had a recent MI, CK Total/CK MB (or Troponin if CK Total/CK MB are not used) must be documented prior to enrolling/randomizing the patient.

    • Patient has received an organ transplant or is on a waiting list for an organ transplant

    • Patient is receiving or scheduled to receive chemotherapy within 30 days before or after index procedure

    • Patient is receiving oral or intravenous immunosuppressive therapy (ie, inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (eg, human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)

    • Patient is receiving chronic (>=72 hours) anticoagulation therapy (eg, heparin, coumadin) for indications other than acute coronary syndrome

    • Patient has platelet count <100,000 cells/mm3 or >700,000 cells/mm3

    • Patient has white blood cell (WBC) count <3,000 cells/mm3

    • Patient has documented or suspected liver disease, including laboratory evidence of hepatitis

    • Patient is on dialysis or has known renal insufficiency (ie, estimated creatinine clearance <50 ml/min by the Cockcroft Gault formula, or [(140-age)*lean body weight (in kg)]/[plasma creatinine (mg/dl)*72])

    • Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions

    • Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol

    • Target vessel(s) or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to index procedure

    • Target vessel(s) has been treated within 10 mm proximal or distal to target lesion (by visual estimate) with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to index procedure

    • Non-target vessel or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to index procedure

    • Planned or actual target vessel(s) treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement

    • Planned PCI or CABG after index procedure

    • Patient previously treated at any time with coronary intravascular brachytherapy

    • Patient has a known allergy to the study stent system or protocol-required concomitant medications (eg, stainless steel, platinum, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated

    • Patient has active peptic ulcer or active gastrointestinal (GI) bleeding

    • Patient has one of the following.

    • Other serious medical illness (eg, cancer, congestive heart failure) that may reduce life expectancy to less than 24 months

    • Current problems with substance abuse (eg, alcohol, cocaine, heroin, etc.)

    • Planned procedure that may cause non-compliance with protocol or confound data interpretation

    • Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint

    • Patient intends to participate in another investigational drug or device clinical trial within 12 months after index procedure

    • Patient with known intention to procreate within 12 months after index procedure (Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.)

    • Patient is a woman who is pregnant or nursing (A pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)

    • Patient has more than 2 target lesions, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure

    Angiographic Exclusion Criteria (visual estimate):

    • Target lesion meets any of the following criteria:

    • Aorto-ostial location (ie, lesion located within 5 mm of ostium by visual estimate)

    • Left main location

    • Located within 5 mm of origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate

    • Located within a saphenous vein graft or arterial graft

    • Will be accessed via a saphenous vein graft or arterial graft

    • Involves a side branch >=2.0 mm in diameter by visual estimate

    • Involves a clinically significant side branch <2.0 mm in diameter by visual estimate that has a clinically significant stenosis at the ostium

    • TIMI flow 0 (total occlusion) or TIMI flow 1 prior to wire crossing

    • Excessive tortuosity proximal to or within the lesion

    • Extreme angulation proximal to or within the lesion

    • Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified by visual estimate

    • Restenotic from previous intervention

    • Thrombus, or possible thrombus, present in target vessel

    • Non-target lesion to be treated during the index procedure meets any of the following criteria:

    • Located within the target vessel

    • Located within a bypass graft (venous or arterial)

    • Left main location

    • Chronic total occlusion

    • Involves a complex bifurcation (eg, bifurcations requiring treatment with more than 1 stent)

    • Restenotic from previous intervention

    • Patient has unprotected left main coronary artery disease (>50% diameter stenosis)

    • Patient has protected left main coronary artery disease and a target lesion in the LAD or LCX

    • Patient has an additional clinically significant lesion(s) in target vessel for which an intervention within 12 months after the index procedure is likely to be required

    • Patient has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate) Note: Multiple focal stenoses will be considered as a single lesion if they can be completely covered with 1 stent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baptist Medical Center Princeton Birmingham Alabama United States 35211
    2 Banner Good Samaritan Regional Medical Center Phoenix Arizona United States 85006
    3 Arkansas Heart Hospital Little Rock Arkansas United States 72211
    4 Bakersfield Memorial Hospital Bakersfield California United States 93301
    5 Scripps Clinic La Jolla California United States 92037
    6 Good Samaritan Hospital Los Angeles California United States 90017
    7 University of California Davis Medical Center Sacramento California United States 95817
    8 Mercy General Hospital Sacramento California United States 95819
    9 University of California San Diego San Diego California United States 92103
    10 Alvarado Hospital San Diego California United States 92120
    11 South Denver Cardiology Associates, PC Littleton Colorado United States 80120
    12 Medical Center of the Rockies (Loveland) Loveland Colorado United States 80538
    13 Holy Cross Hospital Fort Lauderdale Florida United States 33308
    14 MediQuest Research Group Inc. at Munroe Regional Medical Center Ocala Florida United States 34471
    15 Florida Hospital Orlando Florida United States 32803
    16 Tallahassee Memorial Hospital Tallahassee Florida United States 32308
    17 Medical Center of Central Georgia Macon Georgia United States 31201
    18 Southern Illinois University Memorial Medical Center Springfield Illinois United States 62702
    19 St. John's Hospital Springfield Illinois United States 62769
    20 Krannert Institute of Cardiology Indianapolis Indiana United States 46202
    21 St. Vincent's Hospital Indianapolis Indiana United States 46260
    22 Mercy Hospital Medical Center Des Moines Iowa United States 50314
    23 Jewish Hospital and St. Mary's Healthcare Louisville Kentucky United States 40202
    24 Maine Medical Center Portland Maine United States 04102
    25 Union Memorial Hospital Baltimore Maryland United States 21218
    26 Washington Adventist Hospital Takoma Park Maryland United States 20912
    27 Tufts Medical Center Boston Massachusetts United States 02111
    28 Baystate Medical Center Springfield Massachusetts United States 01199
    29 Genesys Regional Medical Center Grand Blanc Michigan United States 48439
    30 Spectrum Health Hospitals Grand Rapids Michigan United States 49503
    31 Northern Michigan Hospital Petoskey Michigan United States 49770
    32 William Beaumont Hospital Royal Oak Michigan United States 48073
    33 St. Mary's Duluth Clinic Regional Heart Center Duluth Minnesota United States 55805
    34 Abbott Northwestern Hospital Minneapolis Minnesota United States 55407
    35 Mayo Clinic Foundation Rochester Minnesota United States 55905
    36 North Mississippi Medical Center Tupelo Mississippi United States 38801
    37 St. Luke's Hospital / Mid America Heart Institute Kansas City Missouri United States 64111
    38 Washington University School of Medicine Saint Louis Missouri United States 63110
    39 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    40 Nebraska Heart Institute Lincoln Nebraska United States 68526
    41 Cooper Hospital/University Medical Center Camden New Jersey United States 08103
    42 Our Lady of Lourdes Medical Center Camden New Jersey United States 08103
    43 Maimonides Medical Center Brooklyn New York United States 11219
    44 Kaleida Health Buffalo New York United States 14209
    45 Mount Sinai School Medical Center New York New York United States 10029
    46 Columbia University Medical Center New York New York United States 10032
    47 St. Francis Hospital Roslyn New York United States 11576
    48 Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation Greensboro North Carolina United States 27401
    49 Wake Medical Center Raleigh North Carolina United States 27610
    50 Wake Forest University School of Medicine Winston-Salem North Carolina United States 27157
    51 Lindner Center for Research and Education at The Christ Hospital Cincinnati Ohio United States 45219
    52 Good Samaritan Hospital Cincinnati Ohio United States 45220
    53 Ohio State University Medical Center Columbus Ohio United States 43210
    54 Ohio Health Research and Innovation Institute Columbus Ohio United States 43214
    55 Firelands Regional Medical Center Sandusky Ohio United States 44870
    56 Mercy St. Vincent Medical Center Toledo Ohio United States 43608
    57 Oklahoma Heart Hospital Oklahoma City Oklahoma United States 73120
    58 Providence St. Vincent Medical Center Portland Oregon United States 97225
    59 Lankenau Institute for Medical Research Bryn Mawr Pennsylvania United States 19010
    60 Pinnacle Health at Harrisburg Hospital Harrisburg Pennsylvania United States 17105
    61 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033
    62 Sisters of Charity Providence Hospital Columbia South Carolina United States 29204
    63 Jackson-Madison County General Hospital Jackson Tennessee United States 38301
    64 Baptist Memorial Hospital Memphis Tennessee United States 38120
    65 Heart Hospital of Austin Austin Texas United States 78756
    66 Baylor Heart & Vascular Hospital Dallas Texas United States 75226
    67 St. Luke's Episcopal Hospital Houston Texas United States 77030
    68 Methodist Texsan Hospital San Antonio Texas United States 78201
    69 Trinity Mother Frances Health System Tyler Texas United States 75701
    70 Lynchburg General Hospital Lynchburg Virginia United States 24501
    71 Sentara Norfolk General Hospital Norfolk Virginia United States 23507
    72 Swedish Medical Center Seattle Washington United States 98122
    73 Deaconess Medical Center Spokane Washington United States 99204
    74 Providence Health & Services - Washington Spokane Washington United States 99204
    75 Aspirus Heart and Vascular Institute - Research and Education Wausau Wisconsin United States 54401
    76 Monash Medical Centre Clayton Victoria Australia 3168
    77 St. Vincent's Hospital Fitzroy Victoria Australia 3065
    78 Royal Perth Hospital Perth Australia 6000
    79 The Prince Charles Hospital Queensland Australia 4032
    80 Allgemeines Krankenhauas AKH Vienna Austria A-1090
    81 Academisch Ziekenhuis Middelheim Antwerpen Belgium B-2020
    82 Ziekenhuis Oost Limburg Genk Belgium 3600
    83 Universitair Ziekenhuis Gent Gent Belgium B-9000
    84 UZ Gasthuisberg Leuven Belgium B-3000
    85 Skejby Sygehus Aarhus Denmark D-8200
    86 Rigshospitalet Copenhagen Copenhagen Denmark 2100
    87 Oulu University Hospital Oulu Finland 90029
    88 Tampere University Hospital Tampere Finland 33521
    89 Turku University Hospital Turku Finland 20521
    90 CHU de Besancon Besancon France 25030
    91 Clinique St. Augustin Bordeaux France 33000
    92 Institut Cardiovasculaire - Paris Sud / Institut Hospitalier Jacques Cartier Massy France 91300
    93 Clinique du Millenaire Montpellier France 34960
    94 Centre Hopital Universitaire Rangueil Toulouse France 31059
    95 Clinique Pasteur Toulouse France 31076
    96 Kerckhoff Klinik Bad Nauheim Germany 61231
    97 Herz-und Diabeteszentrum Nordrhein-Westfalen Bad Oeynhausen Germany 32545
    98 Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH Bad Segeberg Germany 23795
    99 Universitatsklinik Charite Berlin Berlin Germany 10117
    100 Universitat Heidelberg Heidelberg Germany 69120
    101 Herzzentrum Universitat Leipzig Leipzig Germany 04289
    102 Kokura Memorial Hospital Kitakyushu-shi Fukuoka Japan
    103 Japan Community Health Care Organization Hokkaido Hospital Sapporo-shi Hokkaido Japan
    104 Shonan Kamakura General Hospital Kamakura-shi Kanagawa Japan
    105 Saiseikai Yokohama-City Eastern Hospital Yokohama-shi Kanagawa Japan
    106 Sakakibara Heart Institute, Japan Research Promotion Society for Cardiovascular Diseases Fuchu-shi Tokyo Japan
    107 Teikyo University Hospital Itabashi-ku Tokyo Japan
    108 Toho University Ohashi Medical Center Meguro-ku Tokyo Japan
    109 The Cardiovascular Institute Hospital Minato-ku Tokyo Japan
    110 Tokyo Women's Medical University Hospital Shinjuku-ku Tokyo Japan
    111 Sakurabashi Watanabe Hospital Osaka Japan 530-0001
    112 P. Stradins University Hospital Riga Latvia
    113 Sarawak General Hospital Kota Samarahan Sarawak Malaysia 94300
    114 Institut Jantung Negara Kuala Lumpur Malaysia 50400
    115 Medisch Centrum Alkmaar Alkmaar Netherlands 1815 JD
    116 Amphia Ziekenhuis Breda Netherlands 4818CK
    117 Catherina Ziekenhuis Eindhoven Netherlands 5623 EJ
    118 St Antonius Ziekenhuis Nieuwegein Netherlands 3435 CM
    119 Middlemore Hospital Otahuhu Auckland New Zealand 1640
    120 Ascot Angiography Auckland New Zealand 1051
    121 Wellington Hospital Wellington New Zealand 6021
    122 Szpital Uniwersytecki Bydgoszcz Poland 85-094
    123 SPZOZ Szpital Uniwersytecki w Krakowie Krakow Poland 31-501
    124 National Institute of Cardiology Warsaw Poland 04-628
    125 Military Hospital Wroklaw Poland 50-891
    126 Hospital De Santa Cruz Carnaxide Portugal 2799-532
    127 National Heart Centre Singapore Singapore Singapore 168752
    128 Guys and St. Thomas NHS Foundation Trust St. Thomas Hospital London England United Kingdom SE1 7EH
    129 James Cook University Hospital Middlesbrough England United Kingdom TS4 3BW
    130 John Radcliffe Infirmary Oxford II Oxford England United Kingdom OX3 9DU
    131 Royal Victoria Hospital Belfast Ireland United Kingdom BT12 6BA
    132 Golden Jubilee National Hospital Clydebank United Kingdom G81 4HX
    133 Southampton University Hospital Southampton United Kingdom SO16 6YD

    Sponsors and Collaborators

    • Boston Scientific Corporation

    Investigators

    • Study Director: Peter M Maurer, MPH, Boston Scientific Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boston Scientific Corporation
    ClinicalTrials.gov Identifier:
    NCT00823212
    Other Study ID Numbers:
    • S2046
    • ACTRN12608000582358
    First Posted:
    Jan 15, 2009
    Last Update Posted:
    Mar 27, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Boston Scientific Corporation
    drug-eluting stents
    DES
    atherosclerotic
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Aspirin
    Ticlopidine
    Clopidogrel

    Study Results

    Participant Flow

    Recruitment Details Enrollment of 1,532 patients was planned; 1,530 patients (762 PROMUS and 768 PROMUS Element) were enrolled and randomized at 132 clinical sites from January 27, 2009 to September 4, 2009. Of these, 788 patients were from the USA, 562 from Europe, 124 from Japan, and 56 from the Asia-Pacific region excluding Japan.
    Pre-assignment Detail
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Period Title: Overall Study
    STARTED 762 768
    COMPLETED 727 735
    NOT COMPLETED 35 33

    Baseline Characteristics

    Arm/Group Title PROMUS PROMUS Element Total
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device) Total of all reporting groups
    Overall Participants 762 768 1530
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    413
    54.2%
    377
    49.1%
    790
    51.6%
    >=65 years
    349
    45.8%
    391
    50.9%
    740
    48.4%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    63.11
    (10.28)
    63.99
    (10.27)
    63.55
    (10.28)
    Sex: Female, Male (Count of Participants)
    Female
    220
    28.9%
    218
    28.4%
    438
    28.6%
    Male
    542
    71.1%
    550
    71.6%
    1092
    71.4%
    Race/Ethnicity, Customized (participant) [Number]
    Caucasian
    644
    650
    1294
    Hispanic or Latino
    15
    13
    28
    Asian
    68
    75
    143
    Black of African heritage
    21
    18
    39
    Native Hawaiian or other Pacific Islander
    4
    3
    7
    American Indian or Alaska Native
    4
    3
    7
    Other
    1
    4
    5
    Maori
    0
    1
    1
    Not Disclosed
    6
    5
    11
    Region of Enrollment (participants) [Number]
    United States
    396
    52%
    392
    51%
    788
    51.5%
    Japan
    61
    8%
    63
    8.2%
    124
    8.1%
    Europe
    276
    36.2%
    286
    37.2%
    562
    36.7%
    Pacifica
    29
    3.8%
    27
    3.5%
    56
    3.7%
    Cardiac History (Participant) [Number]
    Previous Percutaneous Coronary Intervention (PCI)
    247
    238
    485
    Previous Coronary Artery Bypass Graft (CABG)
    40
    45
    85
    Previous Myocardial Infarction (MI)
    160
    160
    320
    Congestive Heart Failure
    50
    57
    107
    Stable Angina
    463
    474
    937
    Unstable Angina
    188
    185
    373
    Silent Ischemia
    143
    128
    271
    Cardiac History-Ejection Fraction (Percent Ejection Fraction) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Percent Ejection Fraction]
    59.04
    (9.54)
    59.53
    (10.07)
    59.29
    (9.81)
    Cardiac Risk Factor (Participant) [Number]
    Smoking, Ever
    448
    493
    941
    Medically Treated Diabetes
    191
    169
    360
    Hyperlipidemia Requiring Medication
    579
    598
    1177
    Hypertension Requiring Medication
    558
    544
    1102
    Family History of Coronary Artery Disease
    401
    392
    793
    Comorbidities (Number) [Number]
    History of Peripheral Vascular Disease
    66
    8.7%
    70
    9.1%
    136
    8.9%
    History of Transient Ischemic Attack
    13
    1.7%
    31
    4%
    44
    2.9%
    History of Cerebrovascular Accident
    23
    3%
    27
    3.5%
    50
    3.3%
    History of Renal Disease
    23
    3%
    26
    3.4%
    49
    3.2%
    History of Gastrointestinal Bleeding
    8
    1%
    10
    1.3%
    18
    1.2%
    Lesion Characteristic: Target Lesion Vessel (Lesion) [Number]
    Left Anterior Descending Artery
    354
    357
    711
    Left Circumflex Artery
    219
    222
    441
    Right Coronary Artery
    268
    273
    541
    Lesion Characteristic: Lesion Location (Lesions) [Number]
    Ostial
    30
    33
    63
    Proximal
    338
    348
    686
    Mid
    401
    387
    788
    Distal
    72
    84
    156
    Lesion Characteristics (Millimeters) [Mean (Standard Deviation) ]
    Reference Vessel Diameter
    2.63
    (0.49)
    2.67
    (0.49)
    2.65
    (0.49)
    Minimum Lumen Diameter
    0.74
    (0.34)
    0.75
    (0.35)
    0.75
    (0.34)
    Lesion Length
    12.50
    (5.51)
    12.95
    (5.74)
    12.72
    (5.63)
    Lesion Characteristic-Percent Diameter Stenosis (Percent Diameter Stenosis) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Percent Diameter Stenosis]
    71.90
    (11.47)
    71.81
    (11.46)
    71.86
    (11.46)
    Lesion Characteristics (Lesions) [Number]
    Eccentric Lesion
    454
    477
    931
    > 45 Degree Bend
    142
    148
    290
    > 90 Degree Bend
    18
    13
    31
    Tortuosity, any
    62
    72
    134
    Calcification, any
    236
    238
    474
    Total Occlusion
    6
    5
    11
    Bifurcation
    62
    78
    140
    Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class (Lesions) [Number]
    Type A
    82
    72
    154
    Type B1
    225
    223
    448
    Type B2
    361
    378
    739
    Type C
    173
    179
    352
    Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow (Lesion) [Number]
    TIMI 0
    0
    0
    0
    TIMI 1
    6
    5
    11
    TIMI 2
    27
    29
    56
    TIMI 3
    808
    818
    1626

    Outcome Measures

    1. Primary Outcome
    Title Target Lesion Failure (TLF)
    Description Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
    Time Frame 12-month post index procedure

    Outcome Measure Data

    Analysis Population Description
    The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
    Measure Participants 714 731
    Number [percentage of participants]
    2.9
    0.4%
    3.4
    0.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection PROMUS, PROMUS Element
    Comments Study had 89% statistical power to demonstrate non-inferiority for target lesion failure (TLF, accounting for an expected 1-year attrition rate of 5%), assuming a 1-year TLF rate of 5.5% for both stents.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments A 2-group Farrington-Manning test was used to test the 1-sided hypothesis of non-inferiority in differences with a non-inferiority margin of 3.5%. A p value <0.05 would indicate non-inferiority and correspond to the upper limit of the 1-sided 95% confidence interval of the difference not exceeding 3.5%.
    Statistical Test of Hypothesis p-Value 0.001
    Comments
    Method Farrington-Manning test
    Comments
    Method of Estimation Estimation Parameter Difference in percent of participants
    Estimated Value 0.5
    Confidence Interval (1-Sided) 95%
    to 2.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments The standard error for the difference was estimated according to the Farrington-Manning test.
    2. Secondary Outcome
    Title Target Lesion Failure (TLF)
    Description TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 761 766
    Number [Percentage of participants]
    1.4
    0.2%
    0.9
    0.1%
    3. Secondary Outcome
    Title Target Lesion Failure (TLF)
    Description TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 756 763
    Number [percentage of participants]
    1.9
    0.2%
    1.7
    0.2%
    4. Secondary Outcome
    Title Target Lesion Failure (TLF)
    Description TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 727 742
    Number [percentage of participants]
    3.2
    0.4%
    3.5
    0.5%
    5. Secondary Outcome
    Title Target Vessel Failure (TVF)
    Description TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 761 766
    Number [percentage of participants]
    1.4
    0.2%
    0.9
    0.1%
    6. Secondary Outcome
    Title Target Vessel Failure (TVF)
    Description TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 756 763
    Number [percentage of participants]
    2.0
    0.3%
    1.8
    0.2%
    7. Secondary Outcome
    Title Target Vessel Failure (TVF)
    Description TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 727 742
    Number [percentage of participants]
    4.0
    0.5%
    4.2
    0.5%
    8. Secondary Outcome
    Title Myocardial Infarction (MI) Related to the Target Vessel
    Description Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 761 766
    Number [percentage of participants]
    1.3
    0.2%
    0.7
    0.1%
    9. Secondary Outcome
    Title Myocardial Infarction (MI) Related to the Target Vessel
    Description Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 759 765
    Number [percentage of participants]
    1.4
    0.2%
    0.7
    0.1%
    10. Secondary Outcome
    Title Myocardial Infarction (MI) Related to the Target Vessel
    Description Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 732 745
    Number [percentage of participants]
    1.4
    0.2%
    0.7
    0.1%
    11. Secondary Outcome
    Title All Cause Mortality
    Description
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 761 766
    Number [percentage of patients]
    0.1
    0.1
    12. Secondary Outcome
    Title All Cause Mortality
    Description
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 759 765
    Number [percentage of participants]
    0.5
    0.1%
    0.8
    0.1%
    13. Secondary Outcome
    Title All Cause Mortality
    Description
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 732 745
    Number [percentage of participants]
    1.2
    0.2%
    1.3
    0.2%
    14. Secondary Outcome
    Title Cardiac Death Related to the Target Vessel
    Description Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 761 766
    Number [percentage of participants]
    0.0
    0%
    0.1
    0%
    15. Secondary Outcome
    Title Cardiac Death Related to the Target Vessel
    Description Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 759 765
    Number [percentage of participants]
    0.1
    0%
    0.5
    0.1%
    16. Secondary Outcome
    Title Cardiac Death Related to the Target Vessel
    Description Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 732 745
    Number [percentage of participants]
    0.4
    0.1%
    0.8
    0.1%
    17. Secondary Outcome
    Title Non-cardiac Death
    Description Defined as a death not due to cardiac causes (see definition of cardiac death above)
    Time Frame 30 Days

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 761 766
    Number [percentage of participants]
    0.0
    0%
    0.0
    0%
    18. Secondary Outcome
    Title Non-cardiac Death
    Description Defined as a death not due to cardiac causes (see definition of cardiac death above)
    Time Frame 6 Months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 759 765
    Number [percentage of participants]
    0.1
    0%
    0.3
    0%
    19. Secondary Outcome
    Title Non-cardiac Death
    Description Defined as a death not due to cardiac causes (see definition of cardiac death above)
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 732 745
    Number [percentage of participants]
    0.5
    0.1%
    0.4
    0.1%
    20. Secondary Outcome
    Title Cardiac Death or Myocardial Infarction (MI)
    Description Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 761 766
    Number [percentage of participants]
    1.4
    0.2%
    0.8
    0.1%
    21. Secondary Outcome
    Title Cardiac Death or Myocardial Infarction (MI)
    Description Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 759 765
    Number [percentage of participants]
    1.8
    0.2%
    1.4
    0.2%
    22. Secondary Outcome
    Title Cardiac Death or Myocardial Infarction (MI)
    Description Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 732 745
    Number [percentage of participants]
    2.5
    0.3%
    2.0
    0.3%
    23. Secondary Outcome
    Title All Death or Myocardial Infarction (MI)
    Description Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 761 766
    Number [percentage of participants]
    1.4
    0.2%
    0.8
    0.1%
    24. Secondary Outcome
    Title All Death or Myocardial Infarction (MI)
    Description Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 759 765
    Number [percentage of participants]
    2.0
    0.3%
    1.7
    0.2%
    25. Secondary Outcome
    Title All Death or Myocardial Infarction (MI)
    Description Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 732 735
    Number [percentage of participants]
    3.0
    0.4%
    2.4
    0.3%
    26. Secondary Outcome
    Title Target Lesion Revascularization (TLR)
    Description Target lesion revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 761 766
    Number [percentage of participants]
    0.8
    0.1%
    0.1
    0%
    27. Secondary Outcome
    Title Target Lesion Revascularization (TLR)
    Description TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 759 765
    Number [percentage of participants]
    1.1
    0.1%
    0.5
    0.1%
    28. Secondary Outcome
    Title Target Lesion Revascularization (TLR)
    Description TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 732 745
    Number [percentage of participants]
    1.9
    0.2%
    1.9
    0.2%
    29. Secondary Outcome
    Title Target Vessel Revascularization (TVR)
    Description Target vessel revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 761 766
    Number [percentage of participants]
    0.8
    0.1%
    0.1
    0%
    30. Secondary Outcome
    Title Target Vessel Revascularization (TVR)
    Description TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 759 765
    Number [percentage of participants]
    1.2
    0.2%
    0.7
    0.1%
    31. Secondary Outcome
    Title Target Vessel Revascularization (TVR)
    Description TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 732 745
    Number [percentage of participants]
    2.9
    0.4%
    2.7
    0.4%
    32. Secondary Outcome
    Title Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
    Description DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
    Time Frame 24 hours

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 762 768
    Number [percentage of participants]
    0.1
    0%
    0.1
    0%
    33. Secondary Outcome
    Title Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
    Description DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
    Time Frame >24 hr-30 days

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 762 766
    Number [percentage of participants]
    0.3
    0%
    0.0
    0%
    34. Secondary Outcome
    Title Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
    Description DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
    Time Frame >30 days-1 year

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 760 764
    Number [percentage of participants]
    0.0
    0%
    0.3
    0%
    35. Secondary Outcome
    Title Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
    Description See above for definitions of MI and TVR
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 761 766
    Number [percentage of participants]
    1.6
    0.2%
    0.9
    0.1%
    36. Secondary Outcome
    Title Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
    Description See above for definitions of MI and TVR.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 759 765
    Number [percentage of participants]
    2.4
    0.3%
    2.4
    0.3%
    37. Secondary Outcome
    Title Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
    Description See above for definitions of MI and TVR.
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 732 745
    Number [percentage of participants]
    4.9
    0.6%
    5.0
    0.7%
    38. Secondary Outcome
    Title Clinical Procedural Success
    Description Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or cardiac death
    Time Frame In hospital

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat (all patients in study).
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 761 767
    Number [percentage of participants]
    98.2
    12.9%
    98.3
    12.8%
    39. Secondary Outcome
    Title Acute Technical Success
    Description Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent
    Time Frame Acute-At time of index procedure

    Outcome Measure Data

    Analysis Population Description
    Analysis was intention to treat (all patients in the study).
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    Measure Participants 762 768
    Measure Stents 894 887
    Number [percentage of stents]
    98.8
    99.4

    Adverse Events

    Time Frame Site reported other adverse events were collected through 365 days.
    Adverse Event Reporting Description
    Arm/Group Title PROMUS PROMUS Element
    Arm/Group Description Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
    All Cause Mortality
    PROMUS PROMUS Element
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    PROMUS PROMUS Element
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 237/762 (31.1%) 238/768 (31%)
    Blood and lymphatic system disorders
    Anaemia 5/762 (0.7%) 6 4/768 (0.5%) 5
    Haemorrhagic anaemia 0/762 (0%) 0 1/768 (0.1%) 1
    Hypercoagulation 1/762 (0.1%) 1 0/768 (0%) 0
    Iron deficiency anaemia 1/762 (0.1%) 1 0/768 (0%) 0
    Cardiac disorders
    Angina pectoris 35/762 (4.6%) 39 44/768 (5.7%) 48
    Angina unstable 9/762 (1.2%) 9 15/768 (2%) 17
    Coronary artery dissection 14/762 (1.8%) 15 8/768 (1%) 8
    Coronary artery disease 4/762 (0.5%) 5 7/768 (0.9%) 7
    Atrial fibrillation 6/762 (0.8%) 6 4/768 (0.5%) 5
    Myocardial ischemia 3/762 (0.4%) 3 5/768 (0.7%) 5
    Cardiac failure 0/762 (0%) 0 3/768 (0.4%) 5
    Bradycardia 4/762 (0.5%) 4 3/768 (0.4%) 3
    Cardiac failure congestive 2/762 (0.3%) 2 3/768 (0.4%) 3
    Coronary artery thrombosis 3/762 (0.4%) 3 2/768 (0.3%) 2
    Coronary artery stenosis 5/762 (0.7%) 6 1/768 (0.1%) 1
    Sick sinus syndrome 4/762 (0.5%) 5 1/768 (0.1%) 1
    Supraventricular tachycardia 2/762 (0.3%) 2 1/768 (0.1%) 1
    Ventricular extrasystoles 2/762 (0.3%) 2 1/768 (0.1%) 1
    Ventricular tachycardia 1/762 (0.1%) 2 1/768 (0.1%) 1
    Atrioventricular block complete 1/762 (0.1%) 1 1/768 (0.1%) 1
    Cardiac arrest 1/762 (0.1%) 1 1/768 (0.1%) 1
    Coronary artery perforation 1/762 (0.1%) 1 1/768 (0.1%) 1
    Acute coronary syndrome 0/762 (0%) 0 1/768 (0.1%) 1
    Atrial flutter 0/762 (0%) 0 1/768 (0.1%) 1
    Atrioventricular block second degree 0/762 (0%) 0 1/768 (0.1%) 1
    Cardiac valve disease 0/762 (0%) 0 1/768 (0.1%) 1
    Cardiomyopathy acute 0/762 (0%) 0 1/768 (0.1%) 1
    Congestive cardiomyopathy 0/762 (0%) 0 1/768 (0.1%) 1
    Coronary artery occlusion 0/762 (0%) 0 1/768 (0.1%) 1
    Dressler's syndrome 0/762 (0%) 0 1/768 (0.1%) 1
    Ischemic cardiomyopathy 0/762 (0%) 0 1/768 (0.1%) 1
    Pericardial effusion 0/762 (0%) 0 1/768 (0.1%) 1
    Sinus bradychardia 0/762 (0%) 0 1/768 (0.1%) 1
    Sinus tachycardia 0/762 (0%) 0 1/768 (0.1%) 1
    Ventricular arrhythmia 0/762 (0%) 0 1/768 (0.1%) 1
    Cardiac failure chronic 2/762 (0.3%) 2 0/768 (0%) 0
    Cardio-respiratory arrest 2/762 (0.3%) 2 0/768 (0%) 0
    Atrial thrombosis 1/762 (0.1%) 1 0/768 (0%) 0
    Hypertensive heart disease 1/762 (0.1%) 1 0/768 (0%) 0
    Prinzmetal angina 1/762 (0.1%) 1 0/768 (0%) 0
    Stress cardiomyopathy 1/762 (0.1%) 1 0/768 (0%) 0
    Ulcer 1/762 (0.1%) 1 0/768 (0%) 0
    Congenital, familial and genetic disorders
    Gastrointestinal arteriovenous malformation 0/762 (0%) 0 1/768 (0.1%) 1
    Atrial septal defect 1/762 (0.1%) 1 0/768 (0%) 0
    Ear and labyrinth disorders
    Vertigo 2/762 (0.3%) 2 0/768 (0%) 0
    Eye disorders
    Cataract 2/762 (0.3%) 3 1/768 (0.1%) 1
    Eye disorder 1/762 (0.1%) 1 0/768 (0%) 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage 5/762 (0.7%) 5 4/768 (0.5%) 5
    Rectal haemorrhage 2/762 (0.3%) 3 2/768 (0.3%) 2
    Upper gastrointestinal haemorrhage 2/762 (0.3%) 2 2/768 (0.3%) 2
    Inguinal haemorrhage 0/762 (0%) 0 2/768 (0.3%) 2
    Retroperitoneal haemorrhage 0/762 (0%) 0 2/768 (0.3%) 2
    Abdominal pain 1/762 (0.1%) 1 1/768 (0.1%) 1
    Duodenitis 1/762 (0.1%) 1 1/768 (0.1%) 1
    Gastritis 1/762 (0.1%) 1 1/768 (0.1%) 1
    Enterovesical fistula 0/762 (0%) 0 1/768 (0.1%) 1
    Haematemesis 0/762 (0%) 0 1/768 (0.1%) 1
    Intestinal obstruction 0/762 (0%) 0 1/768 (0.1%) 1
    Mesenteric artery stenosis 0/762 (0%) 0 1/768 (0.1%) 1
    Nausea 0/762 (0%) 0 1/768 (0.1%) 1
    Oesophagitis 0/762 (0%) 0 1/768 (0.1%) 1
    Retroperitoneal haematoma 0/762 (0%) 0 1/768 (0.1%) 1
    Vomiting 0/762 (0%) 0 1/768 (0.1%) 1
    Diarrhoea 2/762 (0.3%) 2 0/768 (0%) 0
    Abdominal pain lower 1/762 (0.1%) 1 0/768 (0%) 0
    Cholitis ischaemic 1/762 (0.1%) 1 0/768 (0%) 0
    Gastritis erosive 1/762 (0.1%) 1 0/768 (0%) 0
    Intestinal perforation 1/762 (0.1%) 1 0/768 (0%) 0
    Melaena 1/762 (0.1%) 1 0/768 (0%) 0
    Pancreatitis 1/762 (0.1%) 1 0/768 (0%) 0
    Rectal polyp 1/762 (0.1%) 1 0/768 (0%) 0
    General disorders
    Non-cardiac chest pain 32/762 (4.2%) 37 26/768 (3.4%) 28
    Chest pain 8/762 (1%) 8 7/768 (0.9%) 7
    Catheter site haematoma 1/762 (0.1%) 1 2/768 (0.3%) 2
    Adverse drug reaction 2/762 (0.3%) 2 1/768 (0.1%) 1
    Chest discomfort 2/762 (0.3%) 2 1/768 (0.1%) 1
    Asthenia 1/762 (0.1%) 1 1/768 (0.1%) 1
    Pyrexia 1/762 (0.1%) 1 1/768 (0.1%) 1
    Catheter site haemorrhage 0/762 (0%) 0 1/768 (0.1%) 1
    Catheter site pain 0/762 (0%) 0 1/768 (0.1%) 1
    Sudden death 0/762 (0%) 0 1/768 (0.1%) 1
    Abdominal pain upper 1/762 (0.1%) 1 1/768 (0.1%) 1
    Hepatobiliary disorders
    Cholecystitis acute 1/762 (0.1%) 1 1/768 (0.1%) 1
    Cholelithiasis 1/762 (0.1%) 1 0/768 (0%) 0
    Gallbladder disorder 1/762 (0.1%) 1 0/768 (0%) 0
    Immune system disorders
    Hypersensitivity 0/762 (0%) 0 1/768 (0.1%) 1
    Contrast media allergy 1/762 (0.1%) 1 0/768 (0%) 0
    Drug hypersensitivity 0/762 (0%) 0 1/768 (0.1%) 1
    Infections and infestations
    Urinary tract infection 2/762 (0.3%) 2 3/768 (0.4%) 3
    Cellulitis 2/762 (0.3%) 2 3/768 (0.4%) 3
    Gastroenteritis 1/762 (0.1%) 1 2/768 (0.3%) 2
    Sepsis 1/762 (0.1%) 1 2/768 (0.3%) 2
    Diverticulitis 3/762 (0.4%) 3 1/768 (0.1%) 1
    Bronchitis 2/762 (0.3%) 2 1/768 (0.1%) 1
    Upper respiratory tract infection 2/762 (0.3%) 2 1/768 (0.1%) 1
    Cystitis 1/762 (0.1%) 1 1/768 (0.1%) 1
    Lobar pneumonia 1/762 (0.1%) 1 1/768 (0.1%) 1
    Septic shock 1/762 (0.1%) 1 1/768 (0.1%) 1
    Catheter sepsis 0/762 (0%) 0 1/768 (0.1%) 1
    Catheter site infection 0/762 (0%) 0 1/768 (0.1%) 1
    Fungaemia 0/762 (0%) 0 1/768 (0.1%) 1
    Osteomyelitis 0/762 (0%) 0 1/768 (0.1%) 1
    Vestibular neuronitis 0/762 (0%) 0 1/768 (0.1%) 1
    Wound infection 0/762 (0%) 0 1/768 (0.1%) 1
    Infection 1/762 (0.1%) 2 0/768 (0%) 0
    Abscess intestinal 1/762 (0.1%) 1 0/768 (0%) 0
    Abscess limb 1/762 (0.1%) 1 0/768 (0%) 0
    Cholecystitis infective 1/762 (0.1%) 1 0/768 (0%) 0
    Endocarditis 1/762 (0.1%) 1 0/768 (0%) 0
    Infective exacerbation of chronic obstruction airways disease 1/762 (0.1%) 1 0/768 (0%) 0
    Pneomonia haemophilus 1/762 (0.1%) 1 0/768 (0%) 0
    Postoperative wound infection 1/762 (0.1%) 1 0/768 (0%) 0
    Renal abscess 1/762 (0.1%) 1 0/768 (0%) 0
    Sinusitis 1/762 (0.1%) 1 0/768 (0%) 0
    Pneumonia 5/762 (0.7%) 5 6/768 (0.8%) 7
    Injury, poisoning and procedural complications
    Vascular pseudoaneurysm 2/762 (0.3%) 2 7/768 (0.9%) 7
    Facial bones fracture 0/762 (0%) 0 2/768 (0.3%) 2
    Meniscus lesion 1/762 (0.1%) 1 1/768 (0.1%) 1
    Wound dehiscence 1/762 (0.1%) 1 1/768 (0.1%) 1
    Fall 0/762 (0%) 0 1/768 (0.1%) 1
    Gun shot wound 0/762 (0%) 0 1/768 (0.1%) 1
    Hip fracture 0/762 (0%) 0 1/768 (0.1%) 1
    Laceration 0/762 (0%) 0 1/768 (0.1%) 1
    Lower limb fracture 0/762 (0%) 0 1/768 (0.1%) 1
    Skin laceration 0/762 (0%) 0 1/768 (0.1%) 1
    Sternal fracture 0/762 (0%) 0 1/768 (0.1%) 1
    Subdural haematoma 0/762 (0%) 0 1/768 (0.1%) 1
    Tendon rupture 0/762 (0%) 0 1/768 (0.1%) 1
    Thermal burn 0/762 (0%) 0 1/768 (0.1%) 1
    Wrist fracture 0/762 (0%) 0 1/768 (0.1%) 1
    Acetabulum fracture 1/762 (0.1%) 1 0/768 (0%) 0
    Ankle fracture 1/762 (0.1%) 1 0/768 (0%) 0
    Clavicle fracture 1/762 (0.1%) 1 0/768 (0%) 0
    Contusion 1/762 (0.1%) 1 0/768 (0%) 0
    Face injury 1/762 (0.1%) 1 0/768 (0%) 0
    Multiple injuries 1/762 (0.1%) 1 0/768 (0%) 0
    Patella fracture 1/762 (0.1%) 1 0/768 (0%) 0
    Post procedural haematuria 1/762 (0.1%) 1 0/768 (0%) 0
    Rib fracture 1/762 (0.1%) 1 0/768 (0%) 0
    Spinal cord injury 1/762 (0.1%) 1 0/768 (0%) 0
    Spinal fracture 1/762 (0.1%) 1 0/768 (0%) 0
    Traumatic haemorrhage 1/762 (0.1%) 1 0/768 (0%) 0
    Investigations
    Cardiac enzymes increased 2/762 (0.3%) 2 3/768 (0.4%) 3
    Troponin increased 0/762 (0%) 0 1/768 (0.1%) 1
    Blood creatinine increased 1/762 (0.1%) 1 0/768 (0%) 0
    Cardiac stress test abnormal 1/762 (0.1%) 1 0/768 (0%) 0
    Electrocardiogram ST segment elevation 1/762 (0.1%) 1 0/768 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 0/762 (0%) 0 1/768 (0.1%) 1
    Diabetes mellitus inadequate control 0/762 (0%) 0 1/768 (0.1%) 1
    Hyperglycaemia 0/762 (0%) 0 1/768 (0.1%) 1
    Hyperkalaemia 0/762 (0%) 0 1/768 (0.1%) 1
    Hypoglycaemia 0/762 (0%) 0 1/768 (0.1%) 1
    Obesity 0/762 (0%) 0 1/768 (0.1%) 1
    Diabetes mellitus 2/762 (0.3%) 2 0/768 (0%) 0
    Anorexia 1/762 (0.1%) 1 0/768 (0%) 0
    Diabetes ketoacidosis 1/762 (0.1%) 1 0/768 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthritis 0/762 (0%) 0 2/768 (0.3%) 3
    Pain in extremity 0/762 (0%) 0 2/768 (0.3%) 3
    Back pain 1/762 (0.1%) 1 2/768 (0.3%) 2
    Musculoskeletal chest pain 0/762 (0%) 0 2/768 (0.3%) 2
    Rotator cuff syndrome 3/762 (0.4%) 4 1/768 (0.1%) 1
    Osteoarthritis 3/762 (0.4%) 3 1/768 (0.1%) 1
    Athralgia 0/762 (0%) 0 1/768 (0.1%) 1
    Costochondritis 0/762 (0%) 0 1/768 (0.1%) 1
    Lumbar spinal stenosis 2/762 (0.3%) 2 0/768 (0%) 0
    Monarthritis 1/762 (0.1%) 1 0/768 (0%) 0
    Muscular weakness 1/762 (0.1%) 1 0/768 (0%) 0
    Neck pain 1/762 (0.1%) 1 0/768 (0%) 0
    Pseudarthritis 1/762 (0.1%) 1 0/768 (0%) 0
    Spinal ligament ossification 1/762 (0.1%) 1 0/768 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer 1/762 (0.1%) 1 3/768 (0.4%) 3
    Non-Hodgkin's lymphoma 0/762 (0%) 0 2/768 (0.3%) 2
    Colon cancer 2/762 (0.3%) 2 1/768 (0.1%) 1
    Bladder cancer 1/762 (0.1%) 1 1/768 (0.1%) 1
    Pancreatic carcinoma 1/762 (0.1%) 1 1/768 (0.1%) 1
    Acute leukemia 0/762 (0%) 0 1/768 (0.1%) 1
    Benign neoplasm of thyroid gland 0/762 (0%) 0 1/768 (0.1%) 1
    Brain cancer metastatic 0/762 (0%) 0 1/768 (0.1%) 1
    Breast cancer 0/762 (0%) 0 1/768 (0.1%) 1
    Gastric cancer 0/762 (0%) 0 1/768 (0.1%) 1
    Gastrointestinal carcinoma 0/762 (0%) 0 1/768 (0.1%) 1
    gastrointestinal tract adenoma 0/762 (0%) 0 1/768 (0.1%) 1
    Hepatic neoplasm malignant 0/762 (0%) 0 1/768 (0.1%) 1
    Lung carcinoma cell type unspecified recurrent 0/762 (0%) 0 1/768 (0.1%) 1
    Lung neoplasm malignant 0/762 (0%) 0 1/768 (0.1%) 1
    Lymphoma 0/762 (0%) 0 1/768 (0.1%) 1
    Small cell lung cancer stage unspecified 0/762 (0%) 0 1/768 (0.1%) 1
    Angiomyolipoma 1/762 (0.1%) 1 0/768 (0%) 0
    Basal cell carcinoma 1/762 (0.1%) 1 0/768 (0%) 0
    Benign bone neoplasm 1/762 (0.1%) 1 0/768 (0%) 0
    Benign renal neoplasm 1/762 (0.1%) 1 0/768 (0%) 0
    Lung adenocarcinoma 1/762 (0.1%) 1 0/768 (0%) 0
    Lung adenocarcinoma metastatic 1/762 (0.1%) 1 0/768 (0%) 0
    Metastatic malignant melanoma 1/762 (0.1%) 1 0/768 (0%) 0
    Multiple myeloma 1/762 (0.1%) 1 0/768 (0%) 0
    Neoplasm malignant 1/762 (0.1%) 1 0/768 (0%) 0
    Ovarian cancer 1/762 (0.1%) 1 0/768 (0%) 0
    Rectal cancer metastatic 1/762 (0.1%) 1 0/768 (0%) 0
    Skin cancer 1/762 (0.1%) 1 0/768 (0%) 0
    Nervous system disorders
    Transient ischaemic attack 3/762 (0.4%) 3 3/768 (0.4%) 3
    Syncope 0/762 (0%) 0 3/768 (0.4%) 3
    Carotid artery stenosis 3/762 (0.4%) 3 2/768 (0.3%) 2
    Presyncope 2/762 (0.3%) 3 1/768 (0.1%) 1
    Cerebral haemorrhage 1/762 (0.1%) 1 1/768 (0.1%) 1
    Cerebral infarction 1/762 (0.1%) 1 1/768 (0.1%) 1
    Amnesia 0/762 (0%) 0 1/768 (0.1%) 1
    Coma 0/762 (0%) 0 1/768 (0.1%) 1
    Encephalopathy 0/762 (0%) 0 1/768 (0.1%) 1
    Nerve compression 0/762 (0%) 0 1/768 (0.1%) 1
    Epilepsy 1/762 (0.1%) 4 0/768 (0%) 0
    Cerebrovascular accident 2/762 (0.3%) 2 0/768 (0%) 0
    Embolic stroke 2/762 (0.3%) 2 0/768 (0%) 0
    Ischaemic stroke 1/762 (0.1%) 1 0/768 (0%) 0
    Lacunar infarction 1/762 (0.1%) 1 0/768 (0%) 0
    Lumbar radiculopathy 1/762 (0.1%) 1 0/768 (0%) 0
    Migraine 1/762 (0.1%) 1 0/768 (0%) 0
    Psychiatric disorders
    Mental status changes 0/762 (0%) 0 2/768 (0.3%) 2
    Suicide attempt 0/762 (0%) 0 1/768 (0.1%) 1
    Insomnia 1/762 (0.1%) 1 0/768 (0%) 0
    Suicidal ideation 1/762 (0.1%) 1 0/768 (0%) 0
    Renal and urinary disorders
    Renal failure acute 4/762 (0.5%) 4 3/768 (0.4%) 5
    Renal failure 1/762 (0.1%) 1 3/768 (0.4%) 3
    Haematuria 1/762 (0.1%) 1 2/768 (0.3%) 2
    Urinary retention 0/762 (0%) 0 2/768 (0.3%) 2
    Renal artery stenosis 1/762 (0.1%) 1 1/768 (0.1%) 1
    Calculus ureteric 0/762 (0%) 0 1/768 (0.1%) 1
    Hydronephrosis 0/762 (0%) 0 1/768 (0.1%) 1
    Urethral stenosis 0/762 (0%) 0 1/768 (0.1%) 1
    Bladder tamponade 1/762 (0.1%) 1 0/768 (0%) 0
    Incontinence 1/762 (0.1%) 1 0/768 (0%) 0
    Nephrolithiasis 1/762 (0.1%) 1 0/768 (0%) 0
    Urinary incontinence 1/762 (0.1%) 1 0/768 (0%) 0
    Reproductive system and breast disorders
    Prostatitis 0/762 (0%) 0 2/768 (0.3%) 2
    Benign prostatic hyperplasia 2/762 (0.3%) 2 1/768 (0.1%) 1
    Endometrial hyperplasia 0/762 (0%) 0 1/768 (0.1%) 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 5/762 (0.7%) 5 5/768 (0.7%) 5
    Chronic obstructive pulmonary disease 7/762 (0.9%) 8 4/768 (0.5%) 4
    Pleural effusion 0/762 (0%) 0 1/768 (0.1%) 3
    Pulmonary embolism 1/762 (0.1%) 1 2/768 (0.3%) 2
    Pulmonary oedema 1/762 (0.1%) 1 2/768 (0.3%) 2
    Organising pneumonia 0/762 (0%) 0 2/768 (0.3%) 2
    Respiratory failure 3/762 (0.4%) 4 1/768 (0.1%) 1
    Epistaxis 1/762 (0.1%) 1 1/768 (0.1%) 1
    Acute pulmonary oedema 0/762 (0%) 0 1/768 (0.1%) 1
    Diaphragmatic hernia 0/762 (0%) 0 1/768 (0.1%) 1
    Haemoptysis 0/762 (0%) 0 1/768 (0.1%) 1
    Hypoxia 0/762 (0%) 0 1/768 (0.1%) 1
    Interstitial lung disease 0/762 (0%) 0 1/768 (0.1%) 1
    Pleurisy 0/762 (0%) 0 1/768 (0.1%) 1
    Asthma 2/762 (0.3%) 2 0/768 (0%) 0
    Hyperventillation 1/762 (0.1%) 1 0/768 (0%) 0
    Idiopathic pulmonary fibrosis 1/762 (0.1%) 1 0/768 (0%) 0
    Nasal polyps 1/762 (0.1%) 1 0/768 (0%) 0
    Pneumonia aspiration 1/762 (0.1%) 1 0/768 (0%) 0
    Skin and subcutaneous tissue disorders
    Angioedema 0/762 (0%) 0 1/768 (0.1%) 1
    Surgical and medical procedures
    Tooth extraction 0/762 (0%) 0 1/768 (0.1%) 1
    Vascular disorders
    Intermittant claudication 1/762 (0.1%) 1 4/768 (0.5%) 4
    Peripheral vascular disorder 1/762 (0.1%) 1 2/768 (0.3%) 4
    Femoral arterial stenosis 3/762 (0.4%) 3 3/768 (0.4%) 3
    Hypertension 2/762 (0.3%) 2 3/768 (0.4%) 3
    Aortic aneurysm 1/762 (0.1%) 1 3/768 (0.4%) 3
    Iliac artery occlusion 0/762 (0%) 0 2/768 (0.3%) 2
    Orthostatic hypotension 0/762 (0%) 0 2/768 (0.3%) 2
    Deep vein thrombosis 2/762 (0.3%) 2 1/768 (0.1%) 1
    Aortic stenosis 1/762 (0.1%) 1 1/768 (0.1%) 1
    Femoral artery occlusion 1/762 (0.1%) 1 1/768 (0.1%) 1
    Hypotension 1/762 (0.1%) 1 1/768 (0.1%) 1
    Arterial disorder 0/762 (0%) 0 1/768 (0.1%) 1
    Arterial stenosis limb 0/762 (0%) 0 1/768 (0.1%) 1
    Embolism 0/762 (0%) 0 1/768 (0.1%) 1
    Haematoma 0/762 (0%) 0 1/768 (0.1%) 1
    Venous thrombosis 0/762 (0%) 0 1/768 (0.1%) 1
    Venous thrombosis limb 0/762 (0%) 0 1/768 (0.1%) 1
    Peripheral arterial occlusive disease 3/762 (0.4%) 3 0/768 (0%) 0
    Hypertensive emergency 1/762 (0.1%) 1 0/768 (0%) 0
    Hypovolaemic shock 1/762 (0.1%) 1 0/768 (0%) 0
    Other (Not Including Serious) Adverse Events
    PROMUS PROMUS Element
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 190/762 (24.9%) 197/768 (25.7%)
    Cardiac disorders
    Angina pectoris 79/762 (10.4%) 86 65/768 (8.5%) 73
    Myocardial infarction 28/762 (3.7%) 28 41/768 (5.3%) 41
    General disorders
    Adverse drug reaction 28/762 (3.7%) 28 40/768 (5.2%) 44
    Catheter site haematoma 41/762 (5.4%) 41 41/768 (5.3%) 42
    Non-cardiac chest pain 53/762 (7%) 59 49/768 (6.4%) 53

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    The Principal Investigator shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to Sponsor for review at least 45 days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.

    Results Point of Contact

    Name/Title Ruth Starzyk, PhD
    Organization Boston Scientific Corporation
    Phone 508-683-6577
    Email ruth.starzyk@bsci.com
    Responsible Party:
    Boston Scientific Corporation
    ClinicalTrials.gov Identifier:
    NCT00823212
    Other Study ID Numbers:
    • S2046
    • ACTRN12608000582358
    First Posted:
    Jan 15, 2009
    Last Update Posted:
    Mar 27, 2019
    Last Verified:
    Mar 1, 2019