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Published at www.nejm.org February 18, 2009 (10.1056/NEJMoa0804626)

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Editor's note: Watch video of a roundtable discussion, participate in a poll, and contribute your comments in our Clinical Directions feature — CABG vs. Stenting: Clinical Implications of the SYNTAX Trial. Commenting closes March 4, 2009.

Background Percutaneous coronary intervention (PCI) involving drug-eluting stents is increasingly used to treat complex coronary artery disease, although coronary-artery bypass grafting (CABG) has been the treatment of choice historically. Our trial compared PCI and CABG for treating patients with previously untreated three-vessel or left main coronary artery disease (or both).

Methods We randomly assigned 1800 patients with three-vessel or left main coronary artery disease to undergo CABG or PCI (in a 1:1 ratio). 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.

Results Most of the preoperative characteristics were similar in the two groups. Rates of major adverse cardiac or 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); as a result, the criterion for noninferiority was not met. 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).

Conclusions CABG remains the standard of care for patients with three-vessel or left main coronary artery disease, since the use of CABG, as compared with PCI, resulted in lower rates of the combined end point of major adverse cardiac or cerebrovascular events 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. It will appear in the March 5 issue of the Journal.

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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