Thrombolysis with saruplase versus streptokinase in acute myocardial infarction: five-year results of the PRIMI trial.

Abstract

BACKGROUND:

Short-term safety and efficacy of thrombolysis with saruplase in acute myocardial infarction have been shown in several trials. To assess long-term outcome of patients treated with saruplase or streptokinase for myocardial infarction, a 5-year follow-up of patients included in the Pro-Urokinase in Myocardial Infarction Trial was performed.

METHODS AND RESULTS:

Follow-up 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 group (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 angioplasty and coronary artery bypass grafting were comparable in both groups. Reinfarction within 5 years occurred in 19.0% of patients in the saruplase group and tended to be less frequent at 10.8% after streptokinase treatment (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 inclusion. The 5-year stroke rate was 3.6% and 7.2% in the saruplase and streptokinase 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 patients treated with saruplase or streptokinase. Despite the low-risk profile of the patient cohort, there were considerable adverse event rates over a 5-year period.

• Authors: M Spiecker, J Windeler, F Vermeer, R Michels, R Seabra-Gomes, J vom Dahl, S Kerber, F W Verheugt, P W Westerhof, F W Bär, U Nixdorff, H Barth, G R Hopkins, M J von Fisenne, J Meyer
• Journal: American heart journal (Am Heart J) Vol. 138 Issue 3 Pt 1 Pg. 518-24 (Sep 1999) ISSN: 0002-8703 [Print] United States
• PMID: 10467203 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Fibrinolytic Agents
• Recombinant Proteins
• Streptokinase
• Urokinase-Type Plasminogen Activator
• saruplase

Topics

• Aged
• Angioplasty, Balloon, Coronary (statistics & numerical data)
• Cerebrovascular Disorders (epidemiology)
• Cohort Studies
• Coronary Artery Bypass (statistics & numerical data)
• Female
• Fibrinolytic Agents (adverse effects, therapeutic use)
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Myocardial Infarction (drug therapy)
• Recombinant Proteins (adverse effects, therapeutic use)
• Recurrence
• Streptokinase (adverse effects, therapeutic use)
• Survival Analysis
• Thrombolytic Therapy
• Urokinase-Type Plasminogen Activator (adverse effects, therapeutic use)