Patient with angina and/or evidence of myocardial ischemia or myocardial infarction cardiac catheterization multivessel left main disease Percutaneous Coronary Intervention Taxus and Cardiac Surgery (SYNTAX)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with angina and/or evidence of myocardial ischemia or myocardial infarction 2. Three vessel CAD, defined as equal or more than 70 percent diameter stenosis (visual estimation) in each of the three major epicardial vessels or major side branches or equal or more than 50 percent but less than 70 percemt with evidence of myocardial ischemia from non-invasive test or FFR equal or less than 0.80 or NHPR equal or less than 0.89 or angioFFR equal or less than 0.80. Patients with a non-dominant right coronary artery may be included if only the left anterior descending artery (LAD) and left circumflex have equal or more than 50 percent but less than 70 percent with evidence of myocardial ischemia from non-invasive test or FFR equal or less than 0.80 or NHPR equal or less than 0.89 or angioFFR equal or less than 0.80. 3. Unprotected left main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) equal or more than 70 percent (visually estimated) requiring revascularization or ULMCA disease with angiographic DS equal or more than 50 percent but less 70 percent (visually estimated) requiring revascularization with non-invasive evidence of ischemia referable to a hemodynamically significant left main lesion and/or FFR equal or less than 0.80 or NHPR equal or less than 0.89 or angio FFR equal or less than 0.80 4. Left Main Equivalent Disease: Left main Medina classification 0,1,1 bifurcation disease (diameter stenosis of both the true ostial LAD and LCX [within 5 mm of the left main distal bifurcation]) equal or more than 50 percent but less than 70 percent with evidence of myocardial ischemia from non-invasive test or FFR equal or less than 0.80 or NHPR equal or less than 0.89 or angioFFR equal or less than 0.80. 5. Willing and able to provide informed, written consent for the prospective phase
Exclusion criteria
Exclusion criteria: the subject is not eligible for randomization if any of the following are present: 1. previous Coronary Artery Bypass Grafting (CABG) surgery 2. ST-segment elevation myocardial infarction post percutaneous coronary intervention 3. Non ST-elevation Myocardial Infarction with cardiogenic shock 4. Any target lesion with in-stent drug-eluting stent restenosis 5. Life expectancy less than 1 year 6. Undergoing evaluation for organ transplantation 7. Requirement for any concomitant cardiac surgery other than CABG and non-cardiac surgical procedure (e.g carotid revascularization) 8. Pregnancy or intention to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoint of All-cause Mortality 1 year Time to first occurance,Endpoint of all spontaneous Myocardial Infarction 1 year Time to first occurance,Endpoint of stroke 1 year Time to first occurance,Endpoint of unplanned revascularization 1 year Time to first occurance | — |
Secondary
| Measure | Time frame |
|---|---|
| Residual SYNTAX score (rSS) is a method to quantify incomplete revascularisation in patients undergoing PCI for 3 vessel disease 1 year Score,Residual Jeopardy Score (rJS) is to quantifies the remaining burden of coronary artery disease after a revascularization procedure 1 year Score,Length of index hospital stay 1 year Number of Day,Bleeding complication 1 year Number of Event,Significant arrhythmia 1 year Number of Event,Development of acute renal failure Year Number of Event,Health Economics - Cardiovascular-specific resource 1 year Cost | — |
Countries
Thailand
Contacts
Faculty of Medicine, Chiang Mai University