A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction

Background: Among physicians who treat patients with acute myocardial infarction, there is controversy about the magnitude of the clinical benefit of primary (i.e., immediate) coronary angioplasty as compared with thrombolytic therapy. Methods: As part of the Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes (GUSTO IIb) trial, we randomly assigned 1138 patients from 57 hospitals who presented within 12 hours of acute myocardial infarction (with ST-segment elevation on the electrocardiogram) to primary angioplasty or accelerated thrombolytic therapy with recombinant tissue plasminogen activator (t-PA). We also randomly assigned 1012 patients to heparin or hirudin treatment in a factorial design. The primary study end point was a composite outcome of death, nonfatal reinfarction, and nonfatal disabling stroke at 30 days. Results: The incidence of the primary end point in the angioplasty end t-PA groups was 9.6 percent and 13.7 percent, respectively (odds ratio, 0.67; 95 percent confidence interval, 0.47 to 0.97; P = 0.033). Death occurred in 5.7 percent of the patients assigned to angioplasty and 7.0 percent of those assigned to t-PA (P=0.37), reinfarction in 4.5 percent and 6.5 percent (P=0.13), and disabling stroke in 0.2 percent and 0.9 percent (P = 0.11). At six months, there was no significant difference in the incidence of the composite outcome (14.1 percent vs. 16.1 percent, P not significant). The primary end point was observed in 10.6 percent of the patients in the angioplasty group assigned to heparin and 8.2 percent of those assigned to hirudin (P=0.37). Conclusions: This trial suggests that angioplasty provides a small-to-moderate, short-term clinical advantage over thrombolytic therapy with t-PA. Primary angioplasty, when it can be accomplished promptly at experienced centers, should be considered an excellent alternative method for myocardial reperfusion.