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Previous Volume 355:2395-2407 December 7, 2006 Number 23 Next

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ABSTRACT

Background It is unclear whether stable, high-risk patients with persistent total occlusion of the infarct-related coronary artery identified after the currently accepted period for myocardial salvage has passed should undergo percutaneous coronary intervention (PCI) in addition to receiving optimal medical therapy to reduce the risk of subsequent events.

Methods We conducted a randomized study involving 2166 stable patients who had total occlusion of the infarct-related artery 3 to 28 days after myocardial infarction and who met a high-risk criterion (an ejection fraction of <50% or proximal occlusion). Of these patients, 1082 were assigned to routine PCI and stenting with optimal medical therapy, and 1084 were assigned to optimal medical therapy alone. The primary end point was a composite of death, myocardial reinfarction, or New York Heart Association (NYHA) class IV heart failure.

Results The 4-year cumulative primary event rate was 17.2% in the PCI group and 15.6% in the medical therapy group (hazard ratio for death, reinfarction, or heart failure in the PCI group as compared with the medical therapy group, 1.16; 95% confidence interval [CI], 0.92 to 1.45; P=0.20). Rates of myocardial reinfarction (fatal and nonfatal) were 7.0% and 5.3% in the two groups, respectively (hazard ratio, 1.36; 95% CI, 0.92 to 2.00; P=0.13). Rates of nonfatal reinfarction were 6.9% and 5.0%, respectively (hazard ratio, 1.44; 95% CI, 0.96 to 2.16; P=0.08); only six reinfarctions (0.6%) were related to assigned PCI procedures. Rates of NYHA class IV heart failure (4.4% vs. 4.5%) and death (9.1% vs. 9.4%) were similar. There was no interaction between treatment effect and any subgroup variable (age, sex, race or ethnic group, infarct-related artery, ejection fraction, diabetes, Killip class, and the time from myocardial infarction to randomization).

Conclusions PCI did not reduce the occurrence of death, reinfarction, or heart failure, and there was a trend toward excess reinfarction during 4 years of follow-up in stable patients with occlusion of the infarct-related artery 3 to 28 days after myocardial infarction. (ClinicalTrials.gov number, NCT00004562 [ClinicalTrials.gov] .)

Source Information

From the Cardiovascular Clinical Research Center, New York University School of Medicine, New York (J.S.H., H.R.R., S.J.A.); Mount Sinai Medical Center, Miami Beach, FL (G.A.L.); Vancouver General Hospital, Vancouver, BC, Canada (C.E.B.); University Health Network, Toronto General Hospital, Toronto (V.D.); Maryland Medical Research Institute, Baltimore (S.F., G.L.K.); National Institute of Cardiology, Warsaw, Poland (W.R., Z.S.); Italian Association of Hospital Cardiologists Research Center, Florence (A.P.M.); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.W.); Hospital São Paulo, São Paulo (A.C.C.); Royal Perth Hospital, Perth, Australia (J.M.R.); Cliniques Universitaires St. Luc, Brussels (J.P.R.); Hôpital Bichat, Paris (P.G.S.); National Heart, Lung, and Blood Institute, Bethesda, MD (A.M.M., G.S.); University Hospital, Basel, Switzerland (M.E.P.); Sheba Medical Center, Tel Hashomer, Israel (J.L.); Slovak Institute of Cardiovascular Disease, Bratislava (V.F.); and Duke Clinical Research Institute, Durham, NC (D.B.M.).

This article was published at www.nejm.org on November 14, 2006.

Address reprint requests to Dr. Hochman at the Cardiovascular Clinical Research Center, Leon Charney Division of Cardiology, New York University School of Medicine, 530 First Ave., HCC 1173, New York, NY 10016.

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