18 and older, any sex, with Chronic Coronary Occlusion or Unprotected Left Main Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined StrokePrimary· 5 years
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.
Myocardial Infarction (MI):
* Q wave MI: Development of new, pathological Q wave on the ECG.
* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Group
Value
95% CI
Percutaneous Coronary Intervention (PCI)
203
Coronary Artery Bypass Graft (CABG)
176
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined StrokeSecondary· In-hospital (≤ 7 days of index-procedure)
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.
Myocardial Infarction (MI):
* Q wave MI: Development of new, pathological Q wave on the ECG.
* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Group
Value
95% CI
Percutaneous Coronary Intervention (PCI)
40
Coronary Artery Bypass Graft (CABG)
77
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined StrokeSecondary· 30 days
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.
Myocardial Infarction (MI):
* Q wave MI: Development of new, pathological Q wave on the ECG.
* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Group
Value
95% CI
Percutaneous Coronary Intervention (PCI)
46
Coronary Artery Bypass Graft (CABG)
75
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined StrokeSecondary· 0 to 6 months
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.
Myocardial Infarction (MI):
* Q wave MI: Development of new, pathological Q wave on the ECG.
* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Group
Value
95% CI
Percutaneous Coronary Intervention (PCI)
66
Coronary Artery Bypass Graft (CABG)
97
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined StrokeSecondary· 0 to 1 year
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.
Myocardial Infarction (MI):
* Q wave MI: Development of new, pathological Q wave on the ECG.
* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Group
Value
95% CI
Percutaneous Coronary Intervention (PCI)
80
Coronary Artery Bypass Graft (CABG)
106
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined StrokeSecondary· 0 to 2 years
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.
Myocardial Infarction (MI):
* Q wave MI: Development of new, pathological Q wave on the ECG.
* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Group
Value
95% CI
Percutaneous Coronary Intervention (PCI)
115
Coronary Artery Bypass Graft (CABG)
122
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined StrokeSecondary· 0 to 3 years
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.
Myocardial Infarction (MI):
* Q wave MI: Development of new, pathological Q wave on the ECG.
* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Group
Value
95% CI
Percutaneous Coronary Intervention (PCI)
137
Coronary Artery Bypass Graft (CABG)
135
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined StrokeSecondary· 0 to 4 years
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.
Myocardial Infarction (MI):
* Q wave MI: Development of new, pathological Q wave on the ECG.
* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Group
Value
95% CI
Percutaneous Coronary Intervention (PCI)
173
Coronary Artery Bypass Graft (CABG)
154
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined StrokeSecondary· 0 to 5 years
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.
Myocardial Infarction (MI):
* Q wave MI: Development of new, pathological Q wave on the ECG.
* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Group
Value
95% CI
Percutaneous Coronary Intervention (PCI)
203
Coronary Artery Bypass Graft (CABG)
176
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for IschemiaSecondary· In-hospital (≤ 7 days of index-procedure)
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.
Myocardial Infarction (MI):
* Q wave MI: Development of new, pathological Q wave on the ECG.
* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Group
Value
95% CI
Percutaneous Coronary Intervention (PCI)
40
Coronary Artery Bypass Graft (CABG)
82
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for IschemiaSecondary· 0 to 30 days
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.
Myocardial Infarction (MI):
* Q wave MI: Development of new, pathological Q wave on the ECG.
* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Group
Value
95% CI
Percutaneous Coronary Intervention (PCI)
46
Coronary Artery Bypass Graft (CABG)
80
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for IschemiaSecondary· 0 to 6 months
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.
Myocardial Infarction (MI):
* Q wave MI: Development of new, pathological Q wave on the ECG.
* Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Group
Value
95% CI
Percutaneous Coronary Intervention (PCI)
79
Coronary Artery Bypass Graft (CABG)
112
Adverse events — posted to ClinicalTrials.gov
Time frame: 5 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Percutaneous Coronary Intervention (PCI)
Serious: 535/948 (56%)
Deaths: 119/948
Coronary Artery Bypass Graft (CABG)
Serious: 550/957 (57%)
Deaths: 89/957
Serious adverse events (173 terms)
Reaction
System
Percutaneous Coronary Inte…
Coronary Artery Bypass Gra…
Angina pectoris (includes atypical angina and cardiac chest pain)
To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO \[for use outside the United States \[OUS\] only\]) in subjects with unprotected left main coronary artery disease by comparing to coronary artery bypass graft surgery.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Abbott Medical Devices
Last refreshed: 7 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01205776.