Background Antithrombotic therapy improves the prognosis ofpatients with acute coronary syndromes, yet the syndromes remaina therapeutic challenge. We evaluated tirofiban, a specificinhibitor of the platelet glycoprotein IIb/IIIa receptor, inthe treatment of unstable angina and non–Q-wave myocardialinfarction.
Methods A total of 1915 patients were randomly assigned in adouble-blind manner to receive tirofiban, heparin, or tirofibanplus heparin. Patients received aspirin if its use was not contraindicated.The study drugs were infused for a mean (±SD) of 71.3±20hours, during which time coronary angiography and angioplastywere performed when indicated after 48 hours. The compositeprimary end point consisted of death, myocardial infarction,or refractory ischemia within seven days after randomization.
Results The study was stopped prematurely for the group receivingtirofiban alone because of excess mortality at seven days (4.6percent, as compared with 1.1 percent for the patients treatedwith heparin alone). The frequency of the composite primaryend point at seven days was lower among the patients who receivedtirofiban plus heparin than among those who received heparinalone (12.9 percent vs. 17.9 percent; risk ratio, 0.68; 95 percentconfidence interval, 0.53 to 0.88; P=0.004). The rates of thecomposite end point in the tirofiban-plus-heparin group werealso lower than those in the heparin-only group at 30 days (18.5percent vs. 22.3 percent, P=0.03) and at 6 months (27.7 percentvs. 32.1 percent, P=0.02). At seven days, the frequency of deathor myocardial infarction was 4.9 percent in the tirofiban-plus-heparingroup, as compared with 8.3 percent in the heparin-only group(P=0.006). The comparable figures at 30 days were 8.7 percentand 11.9 percent (P=0.03), respectively, and those at 6 monthswere 12.3 percent and 15.3 percent (P= 0.06). The benefit wasconsistent in the various subgroups of patients and in thosetreated medically as well as those treated with angioplasty.Major bleeding occurred in 3.0 percent of the patients receivingheparin alone and 4.0 percent of the patients receiving combinationtherapy (P=0.34).
Conclusions When administered with heparin and aspirin, theplatelet glycoprotein IIb/IIIa receptor inhibitor tirofibanwas associated with a lower incidence of ischemic events inpatients with acute coronary syndromes than in patients whoreceived only heparin and aspirin.
Source Information
Address reprint requests to Dr. Pierre Théroux at the Montreal Heart Institute, 5000 Belanger St. E., Montreal, QC H1T 1C8, Canada.
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A correction has been published: N Engl J Med 1998;339(6):415.
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