SYNTAX Trial: PCI vs CABG for Severe CAD
Posted by medliorator on September 16, 2009
Rationale: Several trials comparing PCI involving bare-metal stents with CABG in patients with multivessel disease [ARTS I Trial, MASS II Trial, ERACI-II Trial & AWESOME Trial] showed similar survival rates but higher revascularization rates among patients with bare-metal stents at 5 years. Others have shown a significant long-term survival advantage with surgery [SOS Trial]. Studies comparing PCI involving drug-eluting stents with CABG have generally been smaller and nonrandomized.
Funding: Boston Scientific (manufacturer of TAXUS Express Coronary Stent System). The sponsor’s biostatisticians performed the analyses; however, data analyses were verified independently by a statistician on a “data and safety monitoring committee”
Endpoints: major adverse cardiac and cerebrovascular events (i.e., death from any cause, stroke, myocardial infarction, or repeat revascularization) throughout the 12-month period after randomization
Methods: 1800 patients with three-vessel or left main coronary artery disease were randomized to undergo CABG or PCI.
Results: Rates of adverse cardiac/cerebrovascular events at 12 months were significantly higher in the PCI group (17.8%, vs. 12.4% for CABG; P = 0.002), in large part because of an increased rate of repeat revascularization (13.5% vs. 5.9%, P<0.001). At 12 months, the rates of death and myocardial infarction were similar between the two groups; stroke was significantly more likely to occur with CABG (2.2%, vs. 0.6% with PCI; P = 0.003).
Percutaneous Coronary Intervention versus Coronary-Artery Bypass Grafting for Severe Coronary Artery Disease [N Engl J Med. 2009 Mar 5;360(10):961-72]
