BACKGROUND:Intravenous streptokinase and primary coronary angioplasty are both considered to be effective treatment strategies for patients with acute myocardial infarction. Although primary coronary angioplasty is associated with a high patency rate and a well-preserved left ventricular function, it is not known whether it results in a more favorable clinical outcome in randomized comparisons. METHODS: Clinical data were obtained after a mean follow-up of 18 months (range 6-36 months) after random allocation of 301 patients either to intravenous streptokinase (n = 149) or to primary angioplasty (n = 152). The primary endpoint includes death from cardiac causes and non-fatal reinfarction. The secondary endpoint is a weighted unsatisfactory outcome, one that includes death, stroke, heart failure, shock, ejection fraction lower than 30%, reinfarction, reocclusion and bleeding complications. The need for revascularization procedures was recorded. RESULTS: The relative risk of death from cardiac causes and non-fatal reinfarction in the streptokinase group was 6.1 (95% confidence interval 2.9-12.7) compared with the angioplasty group. There was a lower weighted unsatisfactory outcome score of 0.13 +/- 0.29 in patients randomly assigned to angioplasty compared with 0.34 +/- 0.33 in patients randomly assigned to streptokinase (P < 0.001). Coronary angioplasty or coronary artery bypass grafting, or both, were performed more often in the streptokinase group, with a relative risk of 2.1 compared with patients randomly assigned to angioplasty (95% confidence interval 1.5-3.2). CONCLUSION: Clinical outcome in patients with acute myocardial infarction after a mean follow-up of 18 months was more favorable in patients randomly assigned to primary angioplasty compared with those receiving intravenous streptokinase.
RCT Entities:
BACKGROUND: Intravenous streptokinase and primary coronary angioplasty are both considered to be effective treatment strategies for patients with acute myocardial infarction. Although primary coronary angioplasty is associated with a high patency rate and a well-preserved left ventricular function, it is not known whether it results in a more favorable clinical outcome in randomized comparisons. METHODS: Clinical data were obtained after a mean follow-up of 18 months (range 6-36 months) after random allocation of 301 patients either to intravenous streptokinase (n = 149) or to primary angioplasty (n = 152). The primary endpoint includes death from cardiac causes and non-fatal reinfarction. The secondary endpoint is a weighted unsatisfactory outcome, one that includes death, stroke, heart failure, shock, ejection fraction lower than 30%, reinfarction, reocclusion and bleeding complications. The need for revascularization procedures was recorded. RESULTS: The relative risk of death from cardiac causes and non-fatal reinfarction in the streptokinase group was 6.1 (95% confidence interval 2.9-12.7) compared with the angioplasty group. There was a lower weighted unsatisfactory outcome score of 0.13 +/- 0.29 in patients randomly assigned to angioplasty compared with 0.34 +/- 0.33 in patients randomly assigned to streptokinase (P < 0.001). Coronary angioplasty or coronary artery bypass grafting, or both, were performed more often in the streptokinase group, with a relative risk of 2.1 compared with patients randomly assigned to angioplasty (95% confidence interval 1.5-3.2). CONCLUSION: Clinical outcome in patients with acute myocardial infarction after a mean follow-up of 18 months was more favorable in patients randomly assigned to primary angioplasty compared with those receiving intravenous streptokinase.