Placebo or Nonthrombolytic Controlled Mortality Studies of Intravenous Thrombolytics

During the late 1980s, a few key placebo or nonthrombolytic controlled studies were performed that firmly established the basis for a survival benefit of iv thrombolysis (49,98-100). These studies are summarized in Table 2 (100) and discussed below.

Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Myocardio (GISSI)

The Italian GISSI study was the first adequately powered and designed mortality study in the modern era of thrombolysis to establish a survival benefit for iv fibrinolytic therapy (101). GISSI enrolled 11,806 patients with presumed AMI within 12 h of symptom onset who had ST-segment deviation (elevation or depression) on electrocardiogram (ECG) and assigned them to receive 1.5 MU of iv SK over 1 h or standard therapy alone. Treatment was unblinded. The primary end point was 21-d mortality, which could be assessed in 11,712 patients. Aspirin was not routinely given, and heparin use was left to the physician's discretion. Most patients (about 90%) showed STE, and 94% were confirmed to have suffered AMI by discharge. Coronary angiography and coronary interventions were rarely used. Overall, a relative mortality risk reduction of 19% was observed (p = 0.0002). Survival benefit was time-dependent: relative risk reduction was not significant for treatment begun after 6 h, but it averaged 26% for therapy begun within 3 h (p = 0.0005) and, in an exploratory analysis, 51% (p < 0.0001) in a subgroup treated within 1 h of symptom onset. Other subgroup analyses demonstrated benefit specifically in patients with anterior infarction (relative risk [RR] = 0.75), with no

Table 2

Large Mortality Trials Comparing Standard Therapy with tPA or Streptokinase

Table 2

Large Mortality Trials Comparing Standard Therapy with tPA or Streptokinase

End points

GISSI (101)a

ISIS-2 (103)b

ASSET (107)c


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