Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularizatio

Completed

Conditions: unprotected left main coronary artery disease
10011082

Registration Number: NL-OMON39299

Lead Sponsor: Abbott Vascular International BVBA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 160

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 <70% (visually estimated) requiring revascularization as assessed by both a participating interventional cardiologist and cardiac surgeon (local Heart Team), with one or more of the following present:
- Non-invasive evidence of ischemia referable to a hemodynamically significant left main
lesion (large area of ischemia in both the LAD and LCX territories, or in either the LAD or
LCX territory in the absence of other obstructive coronary artery disease to explain the LAD
or LCX defect), or stress-induced hypotension, or stress-induced fall in LVEF, or stress-
induced transient ischemic dilatation of the left ventricle, or stress-induced
thallium/technetium lung uptake, and/or
- IVUS MLA <=6.0 mm2, and/or
- FFR <=0.80
OR
Left Main Equivalent Disease: Left main Medina classification 0,1,1 bifurcation disease (diameter stenosis of both the true ostial LAD and LCX [within 5mm of the left main distal bifurcation]) >= 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 <70% stenotic by visual estimation, then this lesion(s) is demonstrated to be significant either by
a) non-invasive evidence of ischemia in its myocardial distribution; and/or
b) FFR <=0.80; and/or
c) IVUS MLA <=4.0 mm2 (FFR is preferred).
Note: if both the ostial LAD and ostial LCX stenoses are >=50% and <70% stenotic by visual estimation, then both lesions must be significant by these criteria for the patient to be eligible for enrollment.;• Clinical and anatomic eligibility for both PCI and CABG as agreed to by the local Heart Team
- Interventionalist determines PCI appropriateness and eligibility
- Surgeon determines surgical appropriateness and eligibility;• Silent ischemia, stable angina, unstable angina or recent MI
- If recent MI, CK-MB must have returned to normal prior to randomization;• Ability to sign informed consent and comply with all study procedures including follow-up for at least three years;• The subject must be >= 18 years of age

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 <50% (visually assessed);• SYNTAX score >=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 <2.25 mm or >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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint:<br /><br>Composite measure of all-cause mortality, myocardial infarction or stroke<br /><br>(modified Rankin Scale >=1 and increase by >=1 from baseline) estimated via<br /><br>Kaplan-Meier at all randomized subjects having reached the anticipated median<br /><br>follow-up duration of three years (with all<br /><br>randomized subjects having reached a minimum of two years follow-up).</p><br>

Secondary Outcome Measures