Percutaneous Coronary Intervention versus Coronary-Artery Bypass Grafting for Severe Coronary Artery Disease
Patrick W. Serruys, M.D., Ph.D., Marie-Claude Morice, M.D., A. Pieter Kappetein, M.D., Ph.D., Antonio Colombo, M.D., David R. Holmes, M.D., Michael J. Mack, M.D., Elisabeth Ståhle, M.D., Ted E. Feldman, M.D., Marcel van den Brand, M.D., Eric J. Bass, B.A., Nic Van Dyck, R.N., Katrin Leadley, M.D., Keith D. Dawkins, M.D., Friedrich W. Mohr, M.D., Ph.D., for the SYNTAX Investigators
Background Percutaneous coronary intervention (PCI) involvingdrug-eluting stents is increasingly used to treat complex coronaryartery disease, although coronary-artery bypass grafting (CABG)has been the treatment of choice historically. Our trial comparedPCI and CABG for treating patients with previously untreatedthree-vessel or left main coronary artery disease (or both).
Methods We randomly assigned 1800 patients with three-vesselor left main coronary artery disease to undergo CABG or PCI(in a 1:1 ratio). For all these patients, the local cardiacsurgeon and interventional cardiologist determined that equivalentanatomical revascularization could be achieved with either treatment.A noninferiority comparison of the two groups was performedfor the primary end point — a major adverse cardiac orcerebrovascular event (i.e., death from any cause, stroke, myocardialinfarction, or repeat revascularization) during the 12-monthperiod after randomization. Patients for whom only one of thetwo treatment options would be beneficial, because of anatomicalfeatures or clinical conditions, were entered into a parallel,nested CABG or PCI registry.
Results Most of the preoperative characteristics were similarin the two groups. Rates of major adverse cardiac or cerebrovascularevents at 12 months were significantly higher in the PCI group(17.8%, vs. 12.4% for CABG; P=0.002), in large part becauseof an increased rate of repeat revascularization (13.5% vs.5.9%, P<0.001); as a result, the criterion for noninferioritywas not met. At 12 months, the rates of death and myocardialinfarction were similar between the two groups; stroke was significantlymore likely to occur with CABG (2.2%, vs. 0.6% with PCI; P=0.003).
Conclusions CABG remains the standard of care for patients withthree-vessel or left main coronary artery disease, since theuse of CABG, as compared with PCI, resulted in lower rates ofthe combined end point of major adverse cardiac or cerebrovascularevents at 1 year. (ClinicalTrials.gov number, NCT00114972
[ClinicalTrials.gov]
.)
Source Information
From Erasmus University Medical Center Rotterdam, Rotterdam, the Netherlands (P.W.S., A.P.K., M.B.); Institut Cardiovasculaire Paris Sud, Massy, France (M.-C.M.); San Raffaele Scientific Institute, Milan (A.C.); Mayo Clinic, Rochester, MN (D.R.H.); Medical City Hospital, Dallas (M.J.M.); University Hospital Uppsala, Uppsala, Sweden (E.S.); Evanston Hospital, Evanston, IL (T.E.F.); Boston Scientific, Marlborough, MA (E.J.B., N.V.D., K.L., K.D.D.); and Herzzentrum Universität Leipzig, Leipzig, Germany (F.W.M.). This article (10.1056/NEJMoa0804626) was published at NEJM.org on February 18, 2009.
Address reprint requests to Dr. Serruys at the Erasmus University Medical Center, Rotterdam, Gravendijkwal 230, 3015 CE Rotterdam, the Netherlands, or at p.w.j.c.serruys{at}erasmusmc.nl.
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