TLF at 1-year, Non-inferiority Against the Control
One-sided p-value by using Farrington-Manning non-inferiority test will be used with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.
Angina at 1-year, Non-inferiority Against the Control
Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC).
This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first.
Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis)
Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.
Number of Participants With Acute Success- Procedural Success (Subject Level Analysis)
Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).
Number of Death (Cardiac, Vascular, Non-cardiovascular)
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.
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.
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
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.
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
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.
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
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.
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
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.
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
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.
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
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.
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
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.
Number of Participants With Myocardial Infarction (MI)
Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Number of Participants With Myocardial Infarction (MI)
Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Number of Participants With Myocardial Infarction (MI)
Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Number of Participants With Myocardial Infarction (MI)
Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Number of Participants With Myocardial Infarction (MI)
Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Number of Participants With Myocardial Infarction (MI)
Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Number of Participants With Myocardial Infarction (MI)
Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Number of Participants With Myocardial Infarction (MI)
Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Number of Participants With Myocardial Infarction (MI)
Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Number of Participants With Myocardial Infarction (MI)
Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Number of Participants withTarget Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Number of Participants With Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Number of Participants With Ischemia Driven TLR (ID-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography
Number of Participants With Target Vessel Revascularization (TVR)
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With Target Vessel Revascularization (TVR)
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With Target Vessel Revascularization (TVR)
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With Target Vessel Revascularization (TVR)
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. classified as: Ischemic driven TVR and Non-ischemic driven TVR.
-TVR includes all TVR, excluding TLR
Number of Participants With Target Vessel Revascularization (TVR)
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With Target Vessel Revascularization (TVR)
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With Target Vessel Revascularization (TVR)
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With Target Vessel Revascularization (TVR)
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With Target Vessel Revascularization (TVR)
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With Target Vessel Revascularization (TVR)
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With ID-TVR Excluding TLR
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With ID-TVR Excluding TLR
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With ID-TVR Excluding TLR
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With ID-TVR Excluding TLR
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With ID-TVR Excluding TLR
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With ID-TVR Excluding TLR
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With ID-TVR Excluding TLR
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With ID-TVR Excluding TLR
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With ID-TVR Excluding TLR
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With ID-TVR Excluding TLR
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.
TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
TVR includes all TVR, excluding TLR
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Number of Participants With All Coronary Revascularization
Revascularization includes TLR, TVR excluding TLR, and non TVR.
Number of Participants Experienced All Death/All MI
All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Participants Experienced All Death/All MI
All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Participants Experienced All Death/All MI
All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Participants Experienced All Death/All MI
All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Participants Experienced All Death/All MI
All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Participants Experienced All Death/All MI
All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Participants Experienced All Death/All MI
All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Participants Experienced All Death/All MI
All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Participants Experienced All Death/All MI
All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Participants Experienced All Death/All MI
All deaths includes
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants Experienced Cardiac Death/All MI
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition)
Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained
Number of Participants With Rehospitalization
Coronary artery disease (CAD) related
Cardiovascular, non-CAD related
Non-cardiovascular related
Number of Participants With Rehospitalization
CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Number of Participants With Rehospitalization
CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Number of Participants With Rehospitalization
CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Number of Participants With Rehospitalization
CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Number of Participants With Rehospitalization
CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Number of Participants With Rehospitalization
CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Number of Participants With Rehospitalization
CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Number of Participants With Rehospitalization
CAD related
Cardiovascular, non-CAD related
Non-cardiovascular related
Number of Participants With Repeat Coronary Arteriography
Number of Participants With Repeat Coronary Arteriography
Number of Participants With Repeat Coronary Arteriography
Number of Participants With Repeat Coronary Arteriography
Number of Participants With Repeat Coronary Arteriography
Number of Participants With Repeat Coronary Arteriography
Number of Participants With Repeat Coronary Arteriography
Number of Participants With Repeat Coronary Arteriography
Number of Participants With Repeat Coronary Arteriography
Number of Participants With Repeat Coronary Arteriography
Landmark Analysis on MACE and TVF and Their Components
Landmark Analysis on MACE and TVF and Their Components
Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Number of Participants With Target Lesion Failure (TLF)
The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)