unprotected left main coronary artery disease
Conditions
Interventions
Group I: PCI using the XIENCE stents (N=1300)
Group II: Coronary artery bypass grafting (CABG) (N=1300)
Sponsors
Abbott Vascular International BVBA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Unprotected left main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) >=70% (visually estimated) requiring revascularization as assessed by both a participating interventional cardiologist and cardiac surgeon (local Heart Team), or;• ULMCA disease with angiographic DS >=50% but = 50%, in the absence of significant angiographic stenosis in the left main coronary artery, may also be enrolled if one of the following conditions are present: - Both the ostial LAD and ostial LCX stenoses are >= 70% stenotic by visual estimation, or - If one or both of the ostial LAD and ostial LCX stenoses are >=50% and =50% and = 18 years of age
Exclusion criteria
Exclusion criteria: • Prior PCI of the left main trunk at any time prior to randomization;• Prior PCI of any other (non-left main) coronary artery lesions within one year prior to randomization;• Prior CABG at any time prior to randomization;• Need for any concomitant cardiac surgery other than CABG (e.g. valve surgery, aortic repair, etc.), or intent that if the subject randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed;• CK-MB greater than the local laboratory upper limit of normal, or recent MI with CK-MB levels still elevated Note: Subject with a recent MI in whom the troponin levels are still elevated but falling and in whom the CK-MB is within normal range may be enrolled, with the CK-MB levels used to assess periprocedural MI.;• Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year;• Subjects requiring or who may require additional surgery (cardiac or non cardiac) within one year;• The presence of any clinical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present (i.e. the subject should not be treated by PCI, but rather should be managed with CABG or medical therapy (reasons will be documented in the Heart Team worksheet));• The presence of any clinical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present (i.e. the subject should not be treated by CABG, but rather should be managed with PCI or medical therapy (reasons will be documented in the Heart Team worksheet));• Pregnancy or intention to become pregnant (female subjects of child bearing potential must have a negative pregnancy test within 7 days of the index procedure);• Non cardiac co-morbidities with life expectancy less than 3 years;• Other investigational drug or device studies that have not reached their primary endpoint ;Angiographic exclusion criteria (the subject is not eligible for randomization if any of the following are present): • Left main diameter stenosis =33, as determined by the consensus of at least one participating interventional cardiologist and one surgeon of the local Heart Team;• Visually estimated left main reference vessel diameter 4.5 mm (post dilatation up to 4.5mm is allowed);• The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present (i.e. the subject should not be treated by PCI, but rather should be managed with CABG or medical therapy - reasons will be documented);• The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present (i.e. the subject should not be treated by CABG, but rather should be managed with PCI or medical therapy - reasons will be documented)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: Composite measure of all-cause mortality, myocardial infarction or stroke (modified Rankin Scale >=1 and increase by >=1 from baseline) estimated via Kaplan-Meier at all randomized subjects having reached the anticipated median follow-up duration of three years (with all randomized subjects having reached a minimum of two years follow-up). | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Secondary Endpoints: - Composite measure of all-cause mortality, myocardial infarction and stroke (mRS >=1 and increase by >=1 from baseline) at 30 days. - Stroke (mRS >=1 and increase by >=1 from baseline) at 30 days - Unplanned revascularization for ischemia at an anticipated median follow-up duration of three years (with all randomized subjects having reached a minimum of two years follow-up). Additional Powered Secondary Endpoint: A composite of all-cause mortality, MI, stroke (mRS>=1 and increase by >=1 from baseline), or unplanned revascularization for the anticipated median follow-up of three years and with a minimum follow-up in all subjects of two years. Other secondary endpoints: Time points for all other secondary endpoints, unless specified otherwise, are in-hospital, 30 days, 6 months, 1, 2, 3, 4, and 5 years post-procedure. The other secondary endpoints are: • All cause mortality * Cardiac death * Non-cardiac death • All MI (periprocedural, spontaneous, Q-wave and non Q-wave) including large and small MIs • Protocol-defined MI • MI adjudicated per Universal MI Definition • Stroke (all, ischemic, and hemorrhagic) • Disability following stroke event at 90 days± 2 weeks • Ischemia-driven revascularization o Ischemia-driven target lesion revascularization (TLR) o Ischemia-driven target vessel revascularization (TVR) o Ischemia-driven non target vessel revascularization (Non-TVR) • All revascularization (ischemia driven and non-ischemia driven) * All target lesion revascularization (TLR) * All target vessel revascularization (TVR) * All non target vessel revascularization (non TVR) • Complete revascularization at baseline procedure, anatomic and functional (see Section 19. Appendix D.) • Stent thrombosis (ARC definition) symptomatic or asymptomatic • Symptomatic graft stenosis or occlusion (since this requires angiographic documentation, this endpoint will be compared to symptomatic ARC definite stent thrombosis) | — |
Countries
Netherlands
Outcome results
None listed