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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.) (Fig 3).
Figure 3: Rates of major adverse cardiac or cerebrovascular events among the study patients, according to treatment group and SYNTAX score category. Kaplan–Meier curves are shown for the percutaneous coronary intervention (PCI) group and the coronary-artery bypass grafting (CABG) group for major adverse cardiac or cerebrovascular events at 12 months. The 12-month event rates were similar between the two treatment groups for patients with low SYNTAX scores (0 to 22) (Panel A) or intermediate SYNTAX scores (23 to 32) (Panel B). Among patients with high SYNTAX scores (≥33, indicating the most complex disease), those in the PCI group had a significantly higher event rate at 12 months than those in the CABG group. SYNTAX scores were calculated at the core laboratory. The I bars indicate 1.5 SE. P values were calculated with the use of the chi-square test. (Reprinted from Serruys PW, Morice MC, Kappetein AP, et al. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009;360:961-972. Copyright 2009 Massachusetts Medical Society. All rights reserved.)
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