SYNTAX TRIAL |
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|---|---|
| Problem | 3VD and/or LMS |
| Format | Multi-center RCT |
| Treatment | CABG or PCI |
| Control | Nil |
| Population | 1800 patients |
| Inclusion criteria | Inclusion criteria included de novo (previously untreated) lesions, ≥50% target vessel stenosis with stable/unstable angina or atypical chest pain. If asymptomatic, positive evidence of myocardial ischemia was required. |
| Exclusion criteria | Key exclusion criteria included previous PCI or CABG, acute myocardial infarction (MI), or the need for concomitant cardiac surgery. |
| Follow-up | 12 months |
| Primary endpoint | Composite of death from any cause, stroke, myocardial infarction, or repeat vascularization by 12 months. |
| Secondary endpoint(s) | Primary endpoints, independently |
| Details | For all these patients, the local cardiac surgeon and interventional cardiologist determined that equivalent anatomical revascularization could be achieved with either treatment. A noninferiority comparison of the two groups was performed for the primary end point--a major adverse cardiac or cerebrovascular event (i.e., death from any cause, stroke, myocardial infarction, or repeat revascularization) during the 12-month period after randomization. Patients for whom only one of the two treatment options would be beneficial, because of anatomical features or clinical conditions, were entered into a parallel, nested CABG or PCI registry. |
| Brief summary: | In LMS/3VD PCI (1st gen DES) by 1 year had higher revasc. and CV death |
| PAPER: Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. | |
|---|---|
| Date | 5 Mar 2009 |
| Journal | N Engl J Med. 2009 Mar 5;360(10):961-72. |
| Information | Non inferiority trial for PCI (vs CABG) for 3VD and/or LMS disease All lesions deemed amenable to either therapy MACE or stroke @ 12 months significantly higher for PCI (RR 1.44; p=0.002) -Largely due to increased rate of repeat revascularization (RR 2.29; p<0.001) Death from cardiac causes higher for PCI (RR 1.75; p=0.05) Reduced rate of stroke for PCI (RR 0.25; p=0.003) Similar rates of death and MI Imp: CABG to remain standard |