Background Reteplase (recombinant plasminogen activator), amutant of alteplase tissue plasminogen activator, has a longerhalf-life than its parent molecule and produced superior angiographicresults in pilot studies of acute myocardial infarction. Inthis large clinical trial, we compared the efficacy and safetyof these two thrombolytic agents.
Methods A total of 15,059 patients from 807 hospitals in 20countries who presented within 6 hours after the onset of symptomswith ST-segment elevation or bundle-branch block were randomlyassigned in a 2:1 ratio to receive reteplase, in two bolus dosesof 10 MU each given 30 minutes apart, or an accelerated infusionof alteplase, up to 100 mg infused over a period of 90 minutes.The primary hypothesis was that mortality at 30 days would besignificantly lower with reteplase.
Results The mortality rate at 30 days was 7.47 percent for reteplaseand 7.24 percent for alteplase (adjusted P = 0.54; odds ratio,1.03; 95 percent confidence interval, 0.91 to 1.18). The 95percent confidence interval for the absolute difference in mortalityrates was -1.1 to 0.66 percent. Stroke occurred in 1.64 percentof patients treated with reteplase and in 1.79 percent of thosetreated with alteplase (P = 0.50). The respective rates of thecombined end point of death or nonfatal, disabling stroke were7.89 percent and 7.91 percent (P =0.97; odds ratio, 1.0; 95percent confidence interval, 0.88 to 1.13).
Conclusions As compared with an accelerated infusion of alteplase,reteplase, although easier to administer, did not provide anyadditional survival benefit in the treatment of acute myocardialinfarction. Other results, particularly for the combined endpoint of death or nonfatal, disabling stroke, were remarkablysimilar for the two plasminogen activators.
Source Information
Dr. Topol, as study chairman, assumes full responsibility for the overall content and integrity of the manuscript.
Address reprint requests to Dr. Eric J. Topol at the Cleveland Clinic Foundation, Dept. of Cardiology, F25, 9500 Euclid Ave., Cleveland, OH 44195.
Thrombolytic Therapy for Myocardial Infarction
Frei S., Brophy J., Andreotti F., Thron C. D., Topol E. J., Califf R. M., Wilcox R., The GUSTO III Steering Committee , Van de Werf F., The COBALT Investigators , Ware J. H., Antman E. M.
Extract |
Full Text
N Engl J Med 1998;
338:545-548, Feb 19, 1998.
Correspondence
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