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Romanian Multicenter Study - Accelerated Streptokinase in Acute Myocardial Infarction - ROMAS
Description:
Accelerated vs. standard streptokinase for clinical reperfusion in acute MI.
Hypothesis:
Evaluation of accelerated streptokinase versus standard streptokinase treatment for patients with acute myocardial infarction.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 625
Mean Patient Age: 57
Patient Populations:
MI within 12 hours
Primary Endpoints:
Rate of clinical reperfusion, determined by resolution of chest pain, decrease of ST elevation by more than 50%, and rapid enzyme increases.
Secondary Endpoints:
Safety
30-day mortality
Drug/Procedures Used:
Accelerated streptokinase (1.5. million units over 20 minutes or 750,000 units over 10 minutes) vs. standard streptokinase (1.5 million units. over 60 minutes)
Principal Findings:
The standard regimen group consisted of 308 patients who received 1.5 M.U. of streptokinase over 60 minutes. The accelerated regimen group of 293 patients was further divided into two groups. One group received 1.5 M.U. of streptokinase over 20 minutes, and the other group received 0.75 M.U. over 10 minutes.
Reperfusion rates were 74.8% for accelerated streptokinase, compared to 59% for patients receiving group A, compared to 59.0% for group B (p < 0.001). The reperfusion rates for the two accelerated regimens were similar (74.6% vs 72.5%).
There were no differences in 30-day mortality between patients who received the accelerated regimens (7.4%) and those who received standard therapy (10.5%).
No major bleeding events were observed.
Symptomatic hypotension was observed more often with the accelerated regimens (36.5% vs 24.1%)
Interpretation:
Based on the study results, the investigators concluded that accelerated streptokinase is a thrombolytic regimen as safe as the standard regimen and is followed by a significantly higher rate of clinical reperfusion. However, the study is limited by sample size, the open-label design, and use of clinical rather than angiographic detection of reperfusion.
Several experiments with reteplase and saruplase have also explored accelerated dosing regimens. The cost-effectiveness of streptokinase may be enhanced if efficacy can be improved using accelerated dosing regimens.
References:
1. Eur Heart J 1998;19(Abstr Suppl):280. Preliminary results
Keywords: Myocardial Infarction, Streptokinase, Urokinase-Type Plasminogen Activator, Research Personnel, Recombinant Proteins, Coronary Disease, Hypotension, Fibrinolytic Agents, Tissue Plasminogen Activator
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