XIENCE 28 Global Study

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03355742
• Collaborator: (none)
• Enrollment: 963
• Locations: 52
• Arm: 1
• Actual Duration (Months): 26.6
• Patients Per Site: 18.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System [EECSS], XIENCE Alpine EECSS, XIENCE PROX EECSS, XIENCE ProA EECSS or XIENCE Sierra EECSS of coronary drug-eluting stents

Condition or Disease	Intervention/Treatment	Phase
Bleeding Disorder; Stroke, Ischemic; Stroke Hemorrhagic; Hematological Disease; Thrombocytopenia; Coagulation Disorder; Anemia; Renal Insufficiency; Coronary Artery Disease	Device: XIENCE; Drug: DAPT	N/A

Detailed Description

The XIENCE 28 Global Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. A minimum of 800 to a maximum of 960 subjects will be registered from approximately 50 sites globally and subject registration is capped at 120 per site. Eligibility of P2Y12 receptor inhibitor discontinuation will be assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1 month (prior to 1-month visit but at least 28 days) after stenting and have been compliant with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days are considered as "1-month clear", and will discontinue P2Y12 receptor inhibitor as early as 28 days and continue with aspirin monotherapy through 12-month follow-up.

All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The data collected from the XIENCE 28 Global Study will be compared with the historical control of non-complex HBR subjects treated with standard DAPT up to 12 months from the XIENCE V USA Study .

Study Design

• Study Type: Interventional
• Actual Enrollment: 963 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: XIENCE 28 Global Study
• Actual Study Start Date: Feb 9, 2018
• Actual Primary Completion Date: Oct 24, 2019
• Actual Study Completion Date: Apr 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: XIENCE XIENCE + Short duration (1 month) of DAPT	Device: XIENCE; Subjects who received XIENCE family stent systems will be included.; Drug: DAPT; 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.; Other Names: Dual antiplatelet therapy

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles [From 1 to 6 months]

   Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)

Secondary Outcome Measures

1. Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE) [From 6 to 12 months]

   Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)

2. Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE) [From 1 to 12 months]

   Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)

3. Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite) [From 1 to 6 months]

   Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the first 30 days Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause

4. Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite) [From 6 to 12 months]

   Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the first 30 days Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause

5. Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite) [From 1 to 12 months]

   Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the first 30 days Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause

6. Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death [From 1 to 6 months]

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

7. Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death [From 6 to 12 months]

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

8. Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death [From 1 to 12 months]

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

9. Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC) [From 1 to 6 months]

   Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

10. Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC) [From 6 to 12 months]

    Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

11. Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC) [From 1 to 12 months]

    Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

12. Number of Participants With Composite of Cardiac Death or MI (Modified ARC) [From 1 to 6 months]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

13. Number of Participants With Composite of Cardiac Death or MI (Modified ARC) [From 6 to 12 months]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

14. Number of Participants With Composite of Cardiac Death or MI (Modified ARC) [From 1 to 12 months]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

15. Number of Participants With Composite of All Death or All MI (Modified ARC) [From 1 to 6 months]

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

16. Number of Participants With Composite of All Death or All MI (Modified ARC) [From 6 to 12 months]

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

17. Number of Participants With Composite of All Death or All MI (Modified ARC) [From 1 to 12 months]

    All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL

18. Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke [From 1 to 6 months]

    An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)

19. Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke [From 6 to 12 months]

    An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)

20. Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke [From 1 to 12 months]

    An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)

21. Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR) [From 1 to 6 months]

    TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

22. Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR) [From 6 to 12 months]

    TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

23. Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR) [From 1 to 12 months]

    TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

24. Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR) [From 1 to 6 months]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

25. Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR) [From 6 to 12 months]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

26. Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR) [From 1 to 12 months]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.

27. Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR) [From 1 to 6 months]

    TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

28. Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR) [From 6 to 12 months]

    TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

29. Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR) [From 1 to 12 months]

    TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.

30. Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR) [From 1 to 6 months]

    TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

31. Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR) [From 6 to 12 months]

    TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

32. Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR) [From 1 to 12 months]

    TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.

33. Number of Participants With Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 2-5 and Type 3-5 [From 1 to 6 months]

    Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.

34. Number of Participants With Bleeding Defined by the BARC, Type 2-5 and Type 3-5 [From 6 to 12 months]

    Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.

35. Number of Participants With Bleeding Defined by BARC, Type 2-5 and Type 3-5 [From 1 to 12 months]

    Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Subject is considered at HBR, defined as meeting one or more of the following criteria at the time of registration and in the opinion of the referring physician, the risk of major bleeding with > 1-month DAPT outweighs the benefit:

2. Subjects ≥ 75 years of age.

3. Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy.

4. History of major bleeding which required medical attention within 12 months of the index procedure.

5. History of stroke (ischemic or hemorrhagic).

6. Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).

7. Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count <100,000/mm^3, or any known coagulation disorder associated with increased bleeding risk).

8. Anemia with hemoglobin < 11g/dl.

9. Subject must be at least 18 years of age.

10. Subject must provide written informed consent as approved by the Ethics Committee (EC) of the respective clinical site prior to any trial related procedure.

11. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.

12. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.

Angiographic Inclusion Criteria

1. Up to three target lesions with a maximum of two target lesions per epicardial vessel.

Note:

1. The definition of epicardial vessels means left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX) and right coronary artery (RCA) and their branches. For example, the subject must not have >2 lesions requiring treatment within both the LAD and a diagonal branch in total.

2. If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion.

3. Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.

4. Exclusive use of XIENCE family of stent systems during the index procedure.

5. Target lesion has been treated successfully, which is defined as achievement of a final in-stent residual diameter stenosis of <20% with final thrombolysis in myocardial infarction (TIMI-3) flow assessed by online quantitative angiography or visual estimation, with no residual dissection National Heart, Lung, and Blood Institute (NHLBI) grade ≥ type B, and no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting

5 minutes, and no ST segment elevation > 0.5mm or depression lasting > 5 minutes.

Exclusion Criteria:

1. Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).

2. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.

3. Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.

4. Subject has a known left ventricular ejection fraction (LVEF) <30%.

5. Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.

6. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure.

7. Subject with a current medical condition with a life expectancy of less than 12 months.

8. Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure.

9. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Note: Female subjects of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release). It is accepted, in certain cases, to include subjects having a sterilised regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the trial design, product characteristics and/or trial population.

1. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

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

Angiographic Exclusion Criteria

1. Target lesion is in a left main location.

2. Target lesion is located within an arterial or saphenous vein graft.

3. Target lesion is restenotic from a previous stent implantation.

4. Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0 for at least 3 months).

5. Target lesion is implanted with overlapping stents, whether planned or for bailout.

Note: If there is more than one target lesion, all target lesions must satisfy the angiographic eligibility criteria. Non-target lesion (i.e., lesions that do not meet the angiographic criteria listed above) treatments are not allowed during the index procedure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kepler Universitätsklinikum GmbH	Linz	Upr Aus	Austria	4021
2	Onze-Lieve-Vrouwziekenhuis Campus Aalst	Aalst	Eflndrs	Belgium	9300
3	UZ Gent	Gent	Flemish	Belgium	42100
4	Ziekenhuis Oost-Limburg	Genk	Limburg	Belgium	3600
5	Jesse Ziekenhuis	Hasselt	Limburg	Belgium	3500
6	Beijing AnZhen Hospital	Beijing	Beijing	China	100029
7	The Second Hospital of Jilin University	Changchun	N China	China
8	Universitäts-Herzzentrum Freiburg - Bad Krozingen	Bad Krozingen	Bad-wur	Germany	79189
9	Elisabeth-Krankenhaus Essen GmbH	Essen	N. Rhin	Germany	45138
10	UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz	Mainz	Rhinela	Germany	55131
11	Herzzentrum Leipzig GmbH	Leipzig	Saxony	Germany	4289
12	Segeberger Kliniken GmbH	Bad Segeberg	Schlesw	Germany	23795
13	Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)	Berlin		Germany	12200
14	UKE Hamburg (Universitatsklinik Eppendorf)	Hamburg		Germany	20246
15	Prince of Wales Hospital	Hong Kong	Hong Ko	Hong Kong
16	Queen Elizabeth Hospital	Hong Kong	Hong Ko	Hong Kong
17	The University of Hong Kong (Queen Mary Hospital)	Hong Kong	Hong Ko	Hong Kong
18	Clinica Mediterranea	Napoli	Campani	Italy	80122
19	AOU Federico II - Università degli Studi di Napoli	Napoli	Campani	Italy	80138
20	Az.Osp. Universitaria di Ferrara	Cona	Emi-rom	Italy	44124
21	AOU di Parma	Parma	Emi-rom	Italy	43126
22	Policlinico Universitario A. Gemelli	Roma	Latium	Italy	00168
23	Azienda Ospedaliero Universitaria Policlinico Umberto I	Rome	Latium	Italy	00161
24	Centro Cardiologico Monzino	Milano	Lombard	Italy	20138
25	Istituto Clinico Humanitas	Rozzano	Lombard	Italy	20089
26	Scheperziekenhuis	Emmen	Drenthe	Netherlands	7824 AA
27	Medisch Centrum Leeuwarden	Leeuwarden	Friesld	Netherlands	8934 AD
28	Albert Schweitzer Ziekenhuis	Dordrecht	Zuid	Netherlands	3318 AT
29	Hospital de Santa Cruz	Carnaxide	Lisbon	Portugal	2799-523
30	Santa Maria Hospital	Lisboa	Lisbon	Portugal	1649-035
31	National Heart Centre Singapore	Singapore	Central	Singapore	169609
32	Tan Tock Seng Hospital	Singapore	Central	Singapore	308433
33	HCU Virgen de la Victoria	Malaga	Andalu	Spain	29010
34	Hospital Universitario Marqués de Valdecilla	Santander	Cantabr	Spain	39008
35	Hospital del Mar	Barcelona	Catalon	Spain	08003
36	Hospital Clinic I Provincial de Barcelona	Barcelona	Catalon	Spain	08036
37	Hospital Clinico Universitario de Valladolid	Valladolid	Cstleon	Spain	47005
38	Hospital Alvaro Cunqueiro Dept of Interventional Cardiology	Vigo	Pontev	Spain	36312
39	Hospital Universitario Doce de Octubre	Madrid		Spain	28041
40	Kantonsspital Aarau	Aarau	Basel	Switzerland	5001
41	Center Inselspital Bern	Bern		Switzerland	3010
42	Luzerner Kantonsspital	Luzern		Switzerland	6004
43	Chang Gung Memorial Hospital	LinKou	Ntaiwan	Taiwan	333
44	Taipei Veterans General Hospital (VGH)	Taipei City	Ntaiwan	Taiwan	11217
45	National Taiwan University Hospital	Taipei	Ntaiwan	Taiwan	10002
46	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung	Staiwan	Taiwan	83301
47	Freeman Hospital	Newcastle Upon Tyne	NE Engl	United Kingdom	NE7 7DN
48	Craigavon Area Hospital	Portadown	Nirelnd	United Kingdom	BT63 5QQ
49	Southampton University Hospital	Southampton	Soeast	United Kingdom	SO16 6YD
50	Royal Bournemouth Hospital	Bournemouth	Sowest	United Kingdom	BH7 7DW
51	Royal Devon and Exeter Hospital	Exeter	Sowest	United Kingdom	EX2 5DW
52	University Hospital of Wales	Cardiff	Wales	United Kingdom	CF14 4XW

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Marco Valgimigli, MD, Bern University Hospital

Study Documents (Full-Text)

• Study Protocol - Nov 13, 2018
• Statistical Analysis Plan - Jun 19, 2020

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03355742
• Other Study ID Numbers: ABT-CIP-10235
• First Posted: Nov 28, 2017
• Last Update Posted: Mar 4, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Abbott Medical Devices: XIENCE; High bleeding risk (HBR); Dual antiplatelet therapy (DAPT); Coronary Artery Disease; Drug eluting stent (DES)
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Hemorrhagic Stroke; Renal Insufficiency; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hemostatic Disorders; Thrombocytopenia; Blood Coagulation Disorders; Hematologic Diseases; Disease

Study Results

Participant Flow

Recruitment Details	A total of 963 subjects were enrolled across 52 sites globally, between 09 February, 2018 and 30 April, 2020. The last subject last visit was on 30 April, 2020 and the final data was extracted from the database on 01 July, 2020.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Period Title: Overall Study
STARTED	963
COMPLETED	864
NOT COMPLETED	99

Baseline Characteristics

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Overall Participants	963
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.84 (7.73)
Sex: Female, Male (Count of Participants)
Female	320 33.2%
Male	643 66.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	145 15.1%
Not Hispanic or Latino	360 37.4%
Unknown or Not Reported	458 47.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	124 12.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	381 39.6%
More than one race	0 0%
Unknown or Not Reported	458 47.6%
Region of Enrollment (participants) [Number]
Singapore	22 2.3%
Hong Kong	48 5%
United Kingdom	30 3.1%
Portugal	8 0.8%
Switzerland	37 3.8%
Spain	89 9.2%
Austria	3 0.3%
Netherlands	49 5.1%
Belgium	64 6.6%
China	7 0.7%
Taiwan	48 5%
Italy	231 24%
Germany	327 34%
Prior Percutaneous Coronary Intervention (PCI) (participants) [Number]
Number [participants]	276 28.7%
History of Major Bleeding (participants) [Number]
Number [participants]	26 2.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles
Description	Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	828
Q1	2 0.2%
Q2	5 0.5%
Q3	10 1%
Q4	15 1.6%
Q5	40 4.2%

2. Secondary Outcome

Title	Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
Description	Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	811
Count of Participants [Participants]	55 5.7%

3. Secondary Outcome

Title	Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
Description	Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	825
Count of Participants [Participants]	121 12.6%

4. Secondary Outcome

Title	Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Description	Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the first 30 days Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up, or withdrew consent, or died before time point analyzed, without any Stent Thrombosis event, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	816
Count of Participants [Participants]	4 0.4%

5. Secondary Outcome

Title	Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Description	Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the first 30 days Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up, or withdrew consent, or died before time point analyzed, without any Stent Thrombosis event, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	791
Count of Participants [Participants]	0 0%

6. Secondary Outcome

Title	Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Description	Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the first 30 days Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up, or withdrew consent, or died before time point analyzed, without any Stent Thrombosis event, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	793
Count of Participants [Participants]	4 0.4%

7. Secondary Outcome

Title	Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	828
Count of Participants [Participants]	13 1.3%

8. Secondary Outcome

Title	Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	811
Count of Participants [Participants]	30 3.1%

9. Secondary Outcome

Title	Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Description	All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	825
Count of Participants [Participants]	43 4.5%

10. Secondary Outcome

Title	Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Description	Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	828
Count of Participants [Participants]	16 1.7%

11. Secondary Outcome

Title	Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Description	Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	811
Count of Participants [Participants]	11 1.1%

12. Secondary Outcome

Title	Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Description	Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	825
Count of Participants [Participants]	27 2.8%

13. Secondary Outcome

Title	Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Description	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	828
Count of Participants [Participants]	22 2.3%

14. Secondary Outcome

Title	Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Description	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	811
Count of Participants [Participants]	23 2.4%

15. Secondary Outcome

Title	Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Description	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	825
Count of Participants [Participants]	45 4.7%

16. Secondary Outcome

Title	Number of Participants With Composite of All Death or All MI (Modified ARC)
Description	All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	828
Count of Participants [Participants]	29 3%

17. Secondary Outcome

Title	Number of Participants With Composite of All Death or All MI (Modified ARC)
Description	All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	811
Count of Participants [Participants]	41 4.3%

18. Secondary Outcome

Title	Number of Participants With Composite of All Death or All MI (Modified ARC)
Description	All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	825
Count of Participants [Participants]	70 7.3%

19. Secondary Outcome

Title	Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Description	An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	815
Count of Participants [Participants]	3 0.3%

20. Secondary Outcome

Title	Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Description	An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	784
Count of Participants [Participants]	3 0.3%

21. Secondary Outcome

Title	Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Description	An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	785
Count of Participants [Participants]	6 0.6%

22. Secondary Outcome

Title	Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Description	TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	828
Count of Participants [Participants]	7 0.7%

23. Secondary Outcome

Title	Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Description	TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	811
Count of Participants [Participants]	3 0.3%

24. Secondary Outcome

Title	Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Description	TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	825
Count of Participants [Participants]	10 1%

25. Secondary Outcome

Title	Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
Description	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	828
Count of Participants [Participants]	5 0.5%

26. Secondary Outcome

Title	Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
Description	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	811
Count of Participants [Participants]	4 0.4%

27. Secondary Outcome

Title	Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
Description	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	825
Count of Participants [Participants]	9 0.9%

28. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Description	TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	828
Count of Participants [Participants]	21 2.2%

29. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Description	TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	811
Count of Participants [Participants]	21 2.2%

30. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Description	TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	825
Count of Participants [Participants]	42 4.4%

31. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Description	TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	828
Count of Participants [Participants]	22 2.3%

32. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Description	TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	811
Count of Participants [Participants]	22 2.3%

33. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Description	TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	825
Count of Participants [Participants]	44 4.6%

34. Secondary Outcome

Title	Number of Participants With Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 2-5 and Type 3-5
Description	Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.
Time Frame	From 1 to 6 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	817
BARC Type 2-5	44 4.6%
BARC Type 3-5	20 2.1%

35. Secondary Outcome

Title	Number of Participants With Bleeding Defined by the BARC, Type 2-5 and Type 3-5
Description	Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.
Time Frame	From 6 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	789
BARC Type 2-5	19 2%
BARC Type 3-5	7 0.7%

36. Secondary Outcome

Title	Number of Participants With Bleeding Defined by BARC, Type 2-5 and Type 3-5
Description	Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.
Time Frame	From 1 to 12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator.

Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Measure Participants	792
BARC Type 2-5	61 6.3%
BARC Type 3-5	27 2.8%

Adverse Events

Time Frame	1 Year
Arm/Group Title	XIENCE
Arm/Group Description	XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
All Cause Mortality
	XIENCE
	Affected / at Risk (%)	# Events
Total	55/963 (5.7%)
Serious Adverse Events
	XIENCE
	Affected / at Risk (%)	# Events
Total	374/963 (38.8%)
Blood and lymphatic system disorders
Anaemia	11/963 (1.1%)
Bicytopenia	1/963 (0.1%)
Hypochromic Anaemia	1/963 (0.1%)
Nephrogenic Anaemia	1/963 (0.1%)
Normochromic Normocytic Anaemia	1/963 (0.1%)
Cardiac disorders
Angina Pectoris	55/963 (5.7%)
Angina Unstable	1/963 (0.1%)
Aortic Valve Incompetence	2/963 (0.2%)
Aortic Valve Stenosis	3/963 (0.3%)
Arrhythmia	2/963 (0.2%)
Atrial Fibrillation	27/963 (2.8%)
Atrial Flutter	3/963 (0.3%)
Atrial Tachycardia	1/963 (0.1%)
Atrioventricular Block	2/963 (0.2%)
Atrioventricular Block Complete	3/963 (0.3%)
Atrioventricular Block Second Degree	1/963 (0.1%)
Bifascicular Block	1/963 (0.1%)
Bradycardia	3/963 (0.3%)
Cardiac Failure	30/963 (3.1%)
Cardiac Failure Acute	6/963 (0.6%)
Cardiac Failure Congestive	4/963 (0.4%)
Cardiac Tamponade	1/963 (0.1%)
Cardiomyopathy	1/963 (0.1%)
Congestive Cardiomyopathy	1/963 (0.1%)
Coronary Artery Disease	7/963 (0.7%)
Dressler's Syndrome	1/963 (0.1%)
Mitral Valve Incompetence	5/963 (0.5%)
Myocardial Infarction	18/963 (1.9%)
Myocardial Ischaemia	1/963 (0.1%)
Myopericarditis	1/963 (0.1%)
Palpitations	1/963 (0.1%)
Pericarditis	1/963 (0.1%)
Pleuropericarditis	1/963 (0.1%)
Right Ventricular Failure	1/963 (0.1%)
Sick Sinus Syndrome	3/963 (0.3%)
Sinoatrial Block	1/963 (0.1%)
Sinus Bradycardia	2/963 (0.2%)
Supraventricular Tachycardia	2/963 (0.2%)
Tachyarrhythmia	4/963 (0.4%)
Tricuspid Valve Incompetence	2/963 (0.2%)
Ventricular Extrasystoles	3/963 (0.3%)
Ventricular Fibrillation	1/963 (0.1%)
Ventricular Tachycardia	5/963 (0.5%)
Ear and labyrinth disorders
Vertigo	3/963 (0.3%)
Vertigo Positional	2/963 (0.2%)
Endocrine disorders
Hypothyroidism	1/963 (0.1%)
Eye disorders
Retinal Artery Occlusion	1/963 (0.1%)
Gastrointestinal disorders
Abdominal Pain	4/963 (0.4%)
Abdominal Pain Upper	1/963 (0.1%)
Colonic Polyp	2/963 (0.2%)
Constipation	1/963 (0.1%)
Diarrhoea	1/963 (0.1%)
Duodenal Ulcer	1/963 (0.1%)
Enteritis	2/963 (0.2%)
Faeces Discoloured	1/963 (0.1%)
Gastric Ulcer	1/963 (0.1%)
Gastritis	1/963 (0.1%)
Gastritis Erosive	2/963 (0.2%)
Gastrointestinal Haemorrhage	1/963 (0.1%)
Inguinal Hernia	2/963 (0.2%)
Intestinal Ischaemia	1/963 (0.1%)
Nausea	1/963 (0.1%)
Peritoneal Haemorrhage	1/963 (0.1%)
Small Intestinal Obstruction	1/963 (0.1%)
Vomiting	1/963 (0.1%)
General disorders
Chest Pain	5/963 (0.5%)
Death	15/963 (1.6%)
General Physical Health Deterioration	1/963 (0.1%)
Hernia Obstructive	1/963 (0.1%)
Impaired Healing	1/963 (0.1%)
Multi-Organ Failure	2/963 (0.2%)
Pain	2/963 (0.2%)
Pyrexia	3/963 (0.3%)
Hepatobiliary disorders
Cholangitis	4/963 (0.4%)
Cholecystitis	2/963 (0.2%)
Hepatic Cirrhosis	1/963 (0.1%)
Jaundice Cholestatic	1/963 (0.1%)
Infections and infestations
Abscess Limb	2/963 (0.2%)
Arthritis Infective	1/963 (0.1%)
Bronchitis	4/963 (0.4%)
Bronchopneumonia	1/963 (0.1%)
Cellulitis	3/963 (0.3%)
Cholecystitis Infective	1/963 (0.1%)
Diverticulitis	1/963 (0.1%)
Endocarditis	1/963 (0.1%)
Erysipelas	2/963 (0.2%)
Gangrene	1/963 (0.1%)
Gastroenteritis	5/963 (0.5%)
Haematoma Infection	1/963 (0.1%)
Herpes Zoster	1/963 (0.1%)
Infection	4/963 (0.4%)
Infectious Pleural Effusion	1/963 (0.1%)
Influenza	1/963 (0.1%)
Lobar Pneumonia	1/963 (0.1%)
Localised Infection	1/963 (0.1%)
Lower Respiratory Tract Infection	1/963 (0.1%)
Lung Abscess	1/963 (0.1%)
Muscle Abscess	1/963 (0.1%)
Osteomyelitis	1/963 (0.1%)
Otitis Externa	1/963 (0.1%)
Peritonitis	1/963 (0.1%)
Pneumonia	22/963 (2.3%)
Pyelonephritis Acute	1/963 (0.1%)
Respiratory Tract Infection	6/963 (0.6%)
Sepsis	6/963 (0.6%)
Septic Shock	4/963 (0.4%)
Sinusitis	1/963 (0.1%)
Soft Tissue Infection	1/963 (0.1%)
Upper Respiratory Tract Infection	2/963 (0.2%)
Urinary Tract Infection	10/963 (1%)
Vulval Abscess	1/963 (0.1%)
Wound Infection	2/963 (0.2%)
Injury, poisoning and procedural complications
Clavicle Fracture	1/963 (0.1%)
Compression Fracture	1/963 (0.1%)
Cranial Nerve Injury	1/963 (0.1%)
Fall	5/963 (0.5%)
Femoral Neck Fracture	1/963 (0.1%)
Femur Fracture	5/963 (0.5%)
Hip Fracture	1/963 (0.1%)
Lumbar Vertebral Fracture	1/963 (0.1%)
Patella Fracture	2/963 (0.2%)
Pelvic Fracture	2/963 (0.2%)
Pubis Fracture	1/963 (0.1%)
Rib Fracture	1/963 (0.1%)
Subdural Haematoma	1/963 (0.1%)
Vascular Pseudoaneurysm	1/963 (0.1%)
Investigations
Arteriogram Coronary	1/963 (0.1%)
Blood Pressure Abnormal	1/963 (0.1%)
Ejection Fraction Decreased	1/963 (0.1%)
Electrocardiogram Abnormal	1/963 (0.1%)
Metabolism and nutrition disorders
Dehydration	1/963 (0.1%)
Diabetes Mellitus	3/963 (0.3%)
Diabetic Ketoacidosis	1/963 (0.1%)
Fluid Overload	4/963 (0.4%)
Hyperglycaemia	1/963 (0.1%)
Hyperkalaemia	2/963 (0.2%)
Hypoglycaemia	1/963 (0.1%)
Type 2 Diabetes Mellitus	1/963 (0.1%)
Musculoskeletal and connective tissue disorders
Arthritis	1/963 (0.1%)
Back Pain	2/963 (0.2%)
Fistula	1/963 (0.1%)
Intervertebral Disc Protrusion	1/963 (0.1%)
Joint Effusion	1/963 (0.1%)
Lumbar Spinal Stenosis	1/963 (0.1%)
Muscular Weakness	1/963 (0.1%)
Musculoskeletal Disorder	1/963 (0.1%)
Osteoarthritis	10/963 (1%)
Osteochondrosis	1/963 (0.1%)
Polyarthritis	1/963 (0.1%)
Spondylitis	1/963 (0.1%)
Systemic Lupus Erythematosus	1/963 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Lymphocytic Leukaemia Re	1/963 (0.1%)
Biliary Neoplasm	2/963 (0.2%)
Bladder Cancer	2/963 (0.2%)
Bladder Transitional Cell Carc	1/963 (0.1%)
Colon Cancer	1/963 (0.1%)
Endometrial Cancer	1/963 (0.1%)
Gastric Cancer	1/963 (0.1%)
Gastrointestinal Tract Adenoma	1/963 (0.1%)
Hepatic Neoplasm Malignant	1/963 (0.1%)
Lipoma	1/963 (0.1%)
Lung Cancer Metastatic	1/963 (0.1%)
Lung Neoplasm	2/963 (0.2%)
Lung Neoplasm Malignant	2/963 (0.2%)
Multiple Myeloma	1/963 (0.1%)
Myelodysplastic Syndrome	1/963 (0.1%)
Myelofibrosis	1/963 (0.1%)
Neoplasm Malignant	1/963 (0.1%)
Oesophageal Adenocarcinoma	1/963 (0.1%)
Pancreatic Carcinoma	1/963 (0.1%)
Pancreatic Neoplasm	1/963 (0.1%)
Pleural Mesothelioma	1/963 (0.1%)
Prostate Cancer	2/963 (0.2%)
Prostate Cancer Metastatic	1/963 (0.1%)
Renal Cancer	1/963 (0.1%)
Squamous Cell Carcinoma	2/963 (0.2%)
Transitional Cell Carcinoma	1/963 (0.1%)
Urethral Cancer	1/963 (0.1%)
Nervous system disorders
Carotid Artery Stenosis	1/963 (0.1%)
Cauda Equina Syndrome	1/963 (0.1%)
Cerebrovascular Accident	7/963 (0.7%)
Cognitive Disorder	1/963 (0.1%)
Complex Regional Pain Syndrome	1/963 (0.1%)
Dementia	2/963 (0.2%)
Dizziness Postural	1/963 (0.1%)
Epilepsy	1/963 (0.1%)
Headache	2/963 (0.2%)
Hepatic Encephalopathy	1/963 (0.1%)
Loss Of Consciousness	1/963 (0.1%)
Neurodegenerative Disorder	1/963 (0.1%)
Syncope	5/963 (0.5%)
Transient Ischaemic Attack	2/963 (0.2%)
Viith Nerve Paralysis	1/963 (0.1%)
Psychiatric disorders
Confusional State	1/963 (0.1%)
Delirium	1/963 (0.1%)
Mental Disorder	1/963 (0.1%)
Renal and urinary disorders
Diabetic Nephropathy	1/963 (0.1%)
Nephrolithiasis	1/963 (0.1%)
Prerenal Failure	1/963 (0.1%)
Renal Failure	6/963 (0.6%)
Renal Failure Acute	13/963 (1.3%)
Renal Failure Chronic	3/963 (0.3%)
Urinary Retention	2/963 (0.2%)
Reproductive system and breast disorders
Benign Prostatic Hyperplasia	2/963 (0.2%)
Prostatomegaly	1/963 (0.1%)
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema	2/963 (0.2%)
Acute Respiratory Failure	1/963 (0.1%)
Asthma	1/963 (0.1%)
Bronchial Hyperreactivity	1/963 (0.1%)
Chronic Obstructive Pulmonary Disease	9/963 (0.9%)
Cough	1/963 (0.1%)
Dyspnoea	10/963 (1%)
Haemoptysis	1/963 (0.1%)
Idiopathic Pulmonary Fibrosis	1/963 (0.1%)
Pleural Effusion	4/963 (0.4%)
Pneumonia Aspiration	3/963 (0.3%)
Pneumothorax	2/963 (0.2%)
Pulmonary Embolism	2/963 (0.2%)
Pulmonary Fibrosis	1/963 (0.1%)
Pulmonary Oedema	1/963 (0.1%)
Respiratory Failure	1/963 (0.1%)
Skin and subcutaneous tissue disorders
Diabetic Foot	2/963 (0.2%)
Skin Ulcer	2/963 (0.2%)
Subcutaneous Emphysema	1/963 (0.1%)
Telangiectasia	1/963 (0.1%)
Surgical and medical procedures
Arteriovenous Fistula Operation	1/963 (0.1%)
Cardiac Pacemaker Insertion	1/963 (0.1%)
Cataract Operation	1/963 (0.1%)
Colon Polypectomy	1/963 (0.1%)
Hip Arthroplasty	1/963 (0.1%)
Hospitalisation	1/963 (0.1%)
Limb Immobilisation	1/963 (0.1%)
Vascular disorders
Aortic Stenosis	6/963 (0.6%)
Arteriovenous Fistula	2/963 (0.2%)
Deep Vein Thrombosis	1/963 (0.1%)
Femoral Arterial Stenosis	1/963 (0.1%)
Haemorrhage	54/963 (5.6%)
Hypertension	2/963 (0.2%)
Hypertensive Crisis	6/963 (0.6%)
Hypotension	1/963 (0.1%)
Orthostatic Hypotension	1/963 (0.1%)
Peripheral Arterial Occlusive Disease	2/963 (0.2%)
Peripheral Ischaemia	2/963 (0.2%)
Thrombosis	1/963 (0.1%)
Vascular Stenosis	1/963 (0.1%)
Other (Not Including Serious) Adverse Events
	XIENCE
	Affected / at Risk (%)	# Events
Total	357/963 (37.1%)
Blood and lymphatic system disorders
Anaemia	6/963 (0.6%)
Hypochromic Anaemia	1/963 (0.1%)
Iron Deficiency Anaemia	2/963 (0.2%)
Microcytic Anaemia	1/963 (0.1%)
Normochromic Normocytic Anaemia	1/963 (0.1%)
Splenomegaly	1/963 (0.1%)
Spontaneous Haematoma	1/963 (0.1%)
Thrombocytopenia	1/963 (0.1%)
Cardiac disorders
Acute Coronary Syndrome	1/963 (0.1%)
Angina Pectoris	54/963 (5.6%)
Atrial Fibrillation	15/963 (1.6%)
Atrial Flutter	1/963 (0.1%)
Atrial Thrombosis	1/963 (0.1%)
Atrioventricular Block Complete	1/963 (0.1%)
Atrioventricular Block First Degree	3/963 (0.3%)
Atrioventricular Block Second Degree	1/963 (0.1%)
Bradyarrhythmia	1/963 (0.1%)
Bradycardia	4/963 (0.4%)
Bundle Branch Block Left	2/963 (0.2%)
Bundle Branch Block Right	1/963 (0.1%)
Cardiac Arrest	1/963 (0.1%)
Cardiac Failure	7/963 (0.7%)
Cardiac Failure Congestive	1/963 (0.1%)
Coronary Artery Dissection	1/963 (0.1%)
Myocardial Infarction	2/963 (0.2%)
Palpitations	8/963 (0.8%)
Pericardial Effusion	1/963 (0.1%)
Pericarditis	1/963 (0.1%)
Tachyarrhythmia	1/963 (0.1%)
Tachycardia	2/963 (0.2%)
Ventricular Tachycardia	1/963 (0.1%)
Congenital, familial and genetic disorders
Phimosis	1/963 (0.1%)
Ear and labyrinth disorders
Otorrhoea	1/963 (0.1%)
Vertigo	8/963 (0.8%)
Eye disorders
Cataract	1/963 (0.1%)
Conjunctivitis	1/963 (0.1%)
Visual Impairment	1/963 (0.1%)
Gastrointestinal disorders
Abdominal Discomfort	1/963 (0.1%)
Abdominal Pain	3/963 (0.3%)
Abdominal Pain Upper	4/963 (0.4%)
Aphthous Stomatitis	1/963 (0.1%)
Constipation	1/963 (0.1%)
Diarrhoea	6/963 (0.6%)
Diverticulum	2/963 (0.2%)
Dry Mouth	1/963 (0.1%)
Dyspepsia	2/963 (0.2%)
Epigastric Discomfort	1/963 (0.1%)
Gastric Disorder	1/963 (0.1%)
Gastric Ulcer	1/963 (0.1%)
Gastritis	8/963 (0.8%)
Gastritis Erosive	1/963 (0.1%)
Gingival Bleeding	1/963 (0.1%)
Haematochezia	1/963 (0.1%)
Hiatus Hernia	1/963 (0.1%)
Inguinal Hernia	1/963 (0.1%)
Nausea	1/963 (0.1%)
Peptic Ulcer	1/963 (0.1%)
Tooth Loss	1/963 (0.1%)
Toothache	2/963 (0.2%)
Upper Gastrointestinal Haemorrhage	1/963 (0.1%)
Vomiting	4/963 (0.4%)
General disorders
Chest Discomfort	4/963 (0.4%)
Chest Pain	5/963 (0.5%)
Fatigue	3/963 (0.3%)
Impaired Healing	1/963 (0.1%)
Nodule	1/963 (0.1%)
Non-Cardiac Chest Pain	4/963 (0.4%)
Oedema	3/963 (0.3%)
Oedema Peripheral	9/963 (0.9%)
Pacemaker Generated Arrhythmia	1/963 (0.1%)
Pain	2/963 (0.2%)
Pyrexia	2/963 (0.2%)
Spinal Pain	1/963 (0.1%)
Ulcer	2/963 (0.2%)
Hepatobiliary disorders
Biliary Colic	1/963 (0.1%)
Hepatic Cirrhosis	1/963 (0.1%)
Hepatic Steatosis	3/963 (0.3%)
Liver Disorder	1/963 (0.1%)
Infections and infestations
Asymptomatic Bacteriuria	1/963 (0.1%)
Bronchitis	2/963 (0.2%)
Bronchopneumonia	1/963 (0.1%)
Cellulitis	1/963 (0.1%)
Cystitis	2/963 (0.2%)
Enterobiasis	1/963 (0.1%)
Erysipelas	1/963 (0.1%)
Gastroenteritis	1/963 (0.1%)
Gastroenteritis Viral	1/963 (0.1%)
Herpes Zoster	1/963 (0.1%)
Influenza	2/963 (0.2%)
Lower Respiratory Tract Infection	1/963 (0.1%)
Lung Infection	1/963 (0.1%)
Nasopharyngitis	5/963 (0.5%)
Osteomyelitis	1/963 (0.1%)
Paronychia	1/963 (0.1%)
Pneumonia	7/963 (0.7%)
Respiratory Tract Infection	1/963 (0.1%)
Sinusitis	1/963 (0.1%)
Tinea Cruris	1/963 (0.1%)
Upper Respiratory Tract Infection	2/963 (0.2%)
Urethritis	2/963 (0.2%)
Urinary Tract Infection	15/963 (1.6%)
Vaginal Infection	1/963 (0.1%)
Viral Infection	1/963 (0.1%)
Injury, poisoning and procedural complications
Cardiac Procedure Complication	2/963 (0.2%)
Contusion	3/963 (0.3%)
Fall	6/963 (0.6%)
Joint Injury	1/963 (0.1%)
Lumbar Vertebral Fracture	1/963 (0.1%)
Rib Fracture	1/963 (0.1%)
Spinal Compression Fracture	1/963 (0.1%)
Vascular Pseudoaneurysm	4/963 (0.4%)
Wound	1/963 (0.1%)
Wound Complication	1/963 (0.1%)
Investigations
Blood Calcium Increased	1/963 (0.1%)
Blood Creatinine Increased	2/963 (0.2%)
Blood Glucose Abnormal	1/963 (0.1%)
Blood Thyroid Stimulating Hormone Increased	1/963 (0.1%)
Cardiac Enzymes Increased	1/963 (0.1%)
Ejection Fraction Decreased	2/963 (0.2%)
Glycosylated Haemoglobin Increased	1/963 (0.1%)
Haemoglobin Decreased	1/963 (0.1%)
Prostatic Specific Antigen Increased	1/963 (0.1%)
Troponin I Increased	1/963 (0.1%)
Metabolism and nutrition disorders
Decreased Appetite	1/963 (0.1%)
Dehydration	1/963 (0.1%)
Diabetes Mellitus	4/963 (0.4%)
Diabetes Mellitus Inadequate Control	1/963 (0.1%)
Gout	1/963 (0.1%)
Hypercholesterolaemia	1/963 (0.1%)
Hyperkalaemia	2/963 (0.2%)
Hyperlipidaemia	1/963 (0.1%)
Hypoglycaemia	1/963 (0.1%)
Hypokalaemia	4/963 (0.4%)
Hyponatraemia	3/963 (0.3%)
Hypoproteinaemia	1/963 (0.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/963 (0.3%)
Arthritis	1/963 (0.1%)
Back Pain	3/963 (0.3%)
Bursitis	1/963 (0.1%)
Exostosis	1/963 (0.1%)
Foot Deformity	1/963 (0.1%)
Intervertebral Disc Protrusion	1/963 (0.1%)
Joint Swelling	3/963 (0.3%)
Muscle Fatigue	1/963 (0.1%)
Muscle Spasms	1/963 (0.1%)
Musculoskeletal Chest Pain	1/963 (0.1%)
Musculoskeletal Pain	2/963 (0.2%)
Myalgia	5/963 (0.5%)
Neck Pain	2/963 (0.2%)
Osteoarthritis	2/963 (0.2%)
Pain In Extremity	6/963 (0.6%)
Spondylolisthesis	1/963 (0.1%)
Systemic Sclerosis	1/963 (0.1%)
Tendonitis	1/963 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm	1/963 (0.1%)
Lung Neoplasm Malignant	1/963 (0.1%)
Neoplasm Malignant	1/963 (0.1%)
Oesophageal Papilloma	1/963 (0.1%)
Prostate Cancer	1/963 (0.1%)
Nervous system disorders
Amnesia	1/963 (0.1%)
Balance Disorder	1/963 (0.1%)
Cerebrovascular Accident	3/963 (0.3%)
Cervicogenic Headache	1/963 (0.1%)
Dizziness	9/963 (0.9%)
Dizziness Postural	1/963 (0.1%)
Headache	4/963 (0.4%)
Paraesthesia	1/963 (0.1%)
Petit Mal Epilepsy	1/963 (0.1%)
Polyneuropathy	2/963 (0.2%)
Presyncope	2/963 (0.2%)
Restless Legs Syndrome	1/963 (0.1%)
Sciatica	1/963 (0.1%)
Syncope	4/963 (0.4%)
Transient Ischaemic Attack	2/963 (0.2%)
Tunnel Vision	1/963 (0.1%)
Psychiatric disorders
Delirium	1/963 (0.1%)
Depression	2/963 (0.2%)
Listless	1/963 (0.1%)
Sleep Disorder	1/963 (0.1%)
Renal and urinary disorders
Cystitis Haemorrhagic	1/963 (0.1%)
Dysuria	1/963 (0.1%)
Haematuria	3/963 (0.3%)
Nephrolithiasis	1/963 (0.1%)
Renal Failure	2/963 (0.2%)
Renal Failure Acute	6/963 (0.6%)
Renal Failure Chronic	3/963 (0.3%)
Renal Impairment	1/963 (0.1%)
Urinary Retention	2/963 (0.2%)
Reproductive system and breast disorders
Benign Prostatic Hyperplasia	1/963 (0.1%)
Vaginismus	1/963 (0.1%)
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease	3/963 (0.3%)
Cough	6/963 (0.6%)
Dyspnoea	29/963 (3%)
Dyspnoea Exertional	2/963 (0.2%)
Epistaxis	2/963 (0.2%)
Haemoptysis	1/963 (0.1%)
Oropharyngeal Pain	1/963 (0.1%)
Productive Cough	1/963 (0.1%)
Pulmonary Oedema	2/963 (0.2%)
Rhinitis Allergic	2/963 (0.2%)
Skin and subcutaneous tissue disorders
Alopecia	1/963 (0.1%)
Decubitus Ulcer	1/963 (0.1%)
Dermatitis	2/963 (0.2%)
Hyperhidrosis	3/963 (0.3%)
Pruritus	5/963 (0.5%)
Rash	5/963 (0.5%)
Rash Generalised	1/963 (0.1%)
Skin Ulcer	1/963 (0.1%)
Urticaria	2/963 (0.2%)
Surgical and medical procedures
Cardiac Ablation	1/963 (0.1%)
Vascular disorders
Aortic Aneurysm	2/963 (0.2%)
Arteriosclerosis	1/963 (0.1%)
Femoral Arterial Stenosis	1/963 (0.1%)
Haematoma	8/963 (0.8%)
Haemorrhage	100/963 (10.4%)
Hypertension	17/963 (1.8%)
Hypertensive Crisis	4/963 (0.4%)
Hypotension	5/963 (0.5%)
Intermittent Claudication	1/963 (0.1%)
Orthostatic Hypotension	1/963 (0.1%)
Peripheral Arterial Occlusive Disease	2/963 (0.2%)
Vascular Dissection	1/963 (0.1%)
Vascular Stenosis	1/963 (0.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.