Thrombolysis with saruplase versus streptokinase in acute myocardial infarction: Five-year results of the PRIMI Trial

Background Short-term safety and efficacy of thrombolysis with saruplase in acute myocardial infarction have been shown in several trials. To assess l ong-term outcome of patients treated with saruplase or streptokinase for my ocardial infarction, a 5-year follow-up of patients included in the Pro-Uro kinase in Myocardial Infarction Trial was performed. Methods and Results Follow-vp data are available from 8 centers on 255 (92. 4%) of 276 included patients. The 5-year mortality rate was comparable with 20.8% of patients in the saruplase group and 16.9% in the streptokinase gr oup (odds ratio 1.29, 95% confidence interval 0.69 to 2.42). In both groups , a considerable number of fatal cardiovascular events occurred more than 1 year after study inclusion. Rates of percutaneous transluminal coronary an gioplasty and coronary artery bypass grafting were comparable in both group s. Reinfarction within 5 years occurred in 19.0% of patients in the sarupla se group and tended to be less frequent at 10.8% after streptokinase treatm ent (odds ratio 1.94, 95% confidence interval 0.98 to 3.84). In both groups , the majority of reinfarctions took place more than 3 months after study i nclusion. The 5-year stroke rate was 3.6% and 7.2% in the saruplase and str eptokinase groups, respectively (odds ratio 0.49, 95% confidence interval 0 .16 to 1.47). Subjective symptoms of heart failure and angina pectoris were comparable in both groups. Conclusions Our data are consistent with a similar long-term outcome for pa tients treated with saruplase or streptokinase. Despite the low-risk profil e of the patient cohort, there were considerable adverse event rates over a 5-year period.