Primary coronary angioplasty compared with intravenous thrombolytic therapy for acute myocardial infarction: six-month follow up and analysis of individual patient data from randomized trials.

BACKGROUND Overviews of trials suggest that percutaneous transluminal coronary angioplasty (PTCA) may be more effective than thrombolysis. However, whether these effects are sustained beyond hospital discharge, and the extent to which the results are applicable to a broad cross section of patients and the wider community are unknown. We compared the effectiveness of primary PTCA and thrombolysis in acute myocardial infarction during a 6-month follow-up period. METHODS Detailed individual patient data were collected from randomized trials commenced from 1989 to 1996 that compared primary PTCA with thrombolysis. Data were combined to produce estimates of relative reduction in events at 30 days and 6 months for the group and for predefined clinical subgroups. Treatment effects were also assessed in relation to several study-related factors. RESULTS Eleven trials were identified. The mortality rate at 30 days was 4.3% for 1348 patients randomized to undergo PTCA, and 6.9% for 1377 patients assigned to thrombolytic therapy (relative risk [RR] 0.62, 95% CI 0.44-0.86, P =.004). At 6 months, the mortality rate was 6.2% for PTCA and 8.2% for thrombolysis (RR 0.73, 95% CI 0.55-0.98, P =.04). Combined death and reinfarction rates at 30 days were 7.0% for PTCA and 12.9% for thrombolysis, with a sustained effect at 6 months (RR 0.60, 95% CI 0.48-0.75, P <.0001). The risk of hemorrhagic stroke at 30 days was lower in the PTCA group (RR 0.06, 95% CI 0.0-0.50, P =.009). The relative treatment effect did not vary across clinically important subgroups, but the absolute benefit varied according to baseline risk. The relative treatment effect varied across the trials and according to the thrombolytic comparator used, the delay in performing PTCA, and the recruitment rate. CONCLUSION In the context of these trials, primary PTCA was more effective than thrombolytic therapy in reducing death, reinfarction, and stroke, with the greatest absolute benefit in patients who were at the highest risk. These benefits appear to be sustained for 6 months. The effect of treatment varied significantly across the trials, and this raises issues about how widely the results can be applied.