A COMPARISON OF RETEPLASE WITH ALTEPLASE FOR ACUTE MYOCARDIAL-INFARCTION

Background Reteplase (recombinant plasminogen activator), a mutant of alteplase tissue plasminogen activator, has a longer half-life than it s parent molecule and produced superior angiographic results in pilot studies of acute myocardial infarction. In this large clinical trial, we compared the efficacy and safety of these two thrombolytic agents. Methods A total of 15,059 patients from 807 hospitals in 20 countries who presented within 6 hours after the onset of symptoms with ST-segme nt elevation or bundle-branch block were randomly assigned in a 2:1 ra tio to receive reteplase, in two bolus doses of 10 MU each given 30 mi nutes apart, or an accelerated infusion of alteplase, up to 100 mg inf used over a period of 90 minutes. The primary hypothesis was that mort ality at 30 days would be significantly lower with reteplase. Results The mortality rate at 30 days was 7.47 percent for reteplase and 7.24 percent for alteplase (adjusted P=0.54; odds ratio, 1.03; 95 percent c onfidence interval, 0.91 to 1.18). The 95 percent confidence interval for the absolute difference in mortality rates was -1.1 to 0.66 percen t. Stroke occurred in 1.64 percent of patients treated with reteplase and in 1.79 percent of those treated with alteplase (P=0.50). The resp ective rates of the combined end point of death or nonfatal, disabling stroke were 7.89 percent and 7.91 percent (P=0.97; odds ratio, 1.0; 9 5 percent confidence interval, 0.88 to 1.13). Conclusions As compared with an accelerated infusion of alteplase, reteplase, although easier to administer, did not provide any additional survival benefit in the treatment of acute myocardial infarction. Other results, particularly for the combined end point of death or nonfatal, disabling stroke, wer e remarkably similar for the two plasminogen activators. (C) 1997, Mas sachusetts Medical Society.