Bolus Versus Infusion in Rescupase (Saruplase) Development - BIRD
Bolus vs. continuous saruplase for 30-day mortality in acute MI.
To test the equivalence of clinical efficacy and safety of two methods of administering saruplase, a thrombolytic agent.
Patients Screened: Not given
Patients Enrolled: 2,410
Acute MI within 6 hours
No contraindication for thrombolysis
ST segment elevation of at least 0.1 mV in 2 frontal plane leads or at least 0.2 mV in 2 precordial leads
Mortality within 30 days
Inadequate outcome, including stroke and severe bleeding
Saruplase, 20mg bolus, followed by 60mg infusion over one hour vs. Saruplase, 80mg bolus.
The death rate was 5.9% for the bolus group and 6.0% for the standard group.
The reinfarction rate was 6.5% for the bolus group and 5.0% for the standard group.
Recurrent angina was experienced by 24.7% of the bolus group and 25.9% of the standard group.
The hemorrhagic stroke rate was 0.8% for the bolus group and 0.7% for the standard group, and the thromboembolic stroke rate was 0.7% for the bolus group and 0.9% for the standard group.
Severe bleeding was experienced by 2.8% of the bolus group and 2.4% of the standard group.
In previous studies, saruplase was administered as a bolus of 20mg followed by an infusion of 60mg in one hour. As a result of a pilot study, investigators determined that the BIRD study would test a single bolus of 80mg, which might be more practical in some cases, against this standard regimen. The 30 day results suggest that the two dosing strategies are equivalent.
Presented at the XXth Congress of the European Society of Cardiology, Vienna, 1998
Keywords: Thrombolytic Therapy, Myocardial Infarction, Stroke, Urokinase-Type Plasminogen Activator, Recombinant Proteins, Fibrinolytic Agents
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