Background Thrombin has a pivotal role in the pathogenesis ofacute coronary thrombosis. We compared the clinical efficacyof a potent, direct thrombin inhibitor, recombinant hirudin,with that of heparin (an indirect antithrombin agent) in patientswith unstable angina or acute myocardial infarction.
Methods At 373 hospitals in 13 countries, 12,142 patients withacute coronary syndromes were randomly assigned to 72 hoursof therapy with either intravenous heparin or hirudin. Patientswere stratified according to the presence of ST-segment elevationon the base-line electrocardiogram (4131 patients) or its absence(8011 patients), with the latter characteristic considered toindicate unstable angina or non–Q-wave myocardial infarction.
Results At 24 hours, the risk of death or myocardial infarctionwas significantly lower in the group assigned to hirudin therapythan in the group assigned to heparin (1.3 percent vs. 2.1 percent,P = 0.001). The primary end point of death or nonfatal myocardialinfarction or reinfarction at 30 days was reached in 9.8 percentof the heparin group as compared with 8.9 percent of the hirudingroup (odds ratio for the risk of the end point in the hirudingroup, 0.89; 95 percent confidence interval, 0.79 to 1.00; P= 0.06). The predominant effect of hirudin was on myocardialinfarction or reinfarction and was not influenced by ST-segmentstatus. There were no significant differences in the incidenceof serious or life-threatening bleeding complications, but hirudintherapy was associated with a higher incidence of moderate bleeding(8.8 percent vs. 7.7 percent, P = 0.03).
Conclusions For acute coronary syndromes, recombinant hirudinprovided a small advantage, as compared with heparin, principallyrelated to a reduction in the risk of nonfatal myocardial infarction.The relative therapeutic effect was more pronounced early (at24 hours) but dissipated over time. The small benefit was consistentacross the spectrum of acute coronary syndromes and was notassociated with a greater risk of major bleeding complications.
Source Information
Dr. Topol, as study chairman, is responsible for the content of the article.
Address reprint requests to Dr. Eric J. Topol at the Cleveland Clinic Foundation, Dept. of Cardiology F/25, 9500 Euclid Ave., Cleveland, OH 44195.
Coronary Artery Disease in Men and Women
Rosén M., Spetz C.-L., Hammar N., Greenland P., Goldbourt U., Cao L., Song W., Ornstein D. L., Zacharski L. R., Vaccarino V., Hochman J. S., Thompson T. D.
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N Engl J Med 1999;
341:1931-1935, Dec 16, 1999.
Correspondence
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