Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb/IIIa inhibitor tirofiban.

Background: There is continued debate as to whether a routine, early invasi ve strategy is superior to a conservative strategy for the management of un stable angina and myocardial infarction without ST-segment elevation. Methods: We enrolled 2220 patients with unstable angina and myocardial infa rction without ST-segment elevation who had electrocardiographic evidence o f changes in the ST segment or T wave, elevated levels of cardiac markers, a history of coronary artery disease, or all three findings. All patients w ere treated with aspirin, heparin, and the glycoprotein IIb/IIIa inhibitor tirofiban. They were randomly assigned to an early invasive strategy, which included routine catheterization within 4 to 48 hours and revascularizatio n as appropriate, or to a more conservative (selectively invasive) strategy , in which catheterization was performed only if the patient had objective evidence of recurrent ischemia or an abnormal stress test. The primary end point was a composite of death, nonfatal myocardial infarction, and rehospi talization for an acute coronary syndrome at six months. Results: At six months, the rate of the primary end point was 15.9 percent with use of the early invasive strategy and 19.4 percent with use of the co nservative strategy (odds ratio, 0.78; 95 percent confidence interval, 0.62 to 0.97; P=0.025). The rate of death or nonfatal myocardial infarction at six months was similarly reduced (7.3 percent vs. 9.5 percent; odds ratio, 0.74; 95 percent confidence interval, 0.54 to 1.00; P<0.05). Conclusions: In patients with unstable angina and myocardial infarction wit hout ST-segment elevation who were treated with the glycoprotein IIb/IIIa i nhibitor tirofiban, the use of an early invasive strategy significantly red uced the incidence of major cardiac events. These data support a policy inv olving broader use of the early inhibition of glycoprotein IIb/IIIa in comb ination with an early invasive strategy in such patients. (N Engl J Med 200 1;344:1879-87.) Copyright (C) 2001 Massachusetts Medical Society.