Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico acuto-1 - GISSI-1

Description:

Streptokinase vs. placebo for mortality in acute myocardial infarction.

Hypothesis:

To evaluate the efficacy of streptokinase for acute myocardial infarction.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 11,712
Mean Follow Up: 1 year

Patient Populations:

Acute myocardial infarction

Primary Endpoints:

Death

Drug/Procedures Used:

Streptokinase, 1.5 million units IV over 1 hour, or placebo

Concomitant Medications:

Heparin, nitrates, calcium channel blockade, antiplatelet agents, beta blockade at investigators discretion.

Principal Findings:

There was an 18% relative reduction in 21-day mortality for patients receiving streptokinase (10.7%) compared to placebo (13%), which was highly significant (p=0.0002). At 12 months, total mortality was significantly lower for the streptokinase group (17.2% compared to 19% for the placebo group, p=0.0008).

There was a larger relative reduction in mortality for patients receiving thrombolytic therapy within 3 hours after onset of symptoms.

Interpretation:

The GISSI study was one of the initial landmark studies that documented the large mortality benefits possible with thrombolytic therapy, and signaled the dawn of a new era for treatment of myocardial infarction.

References:

1. Lancet 1986;I:397-402. Final results
2. Lancet 1987;II:871-4. Long-term follow-up

Keywords: Thrombolytic Therapy, Myocardial Infarction, Streptokinase


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