The first large-scale thrombolytic trial was the GISSI-1 (Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico), which evaluated the efficacy of a thrombolytic treatment with streptokinase on in-hospital mortality of patients with acute myocardial infarction (AMI). The GISSI demonstrated that overall in-hospital mortality was reduced in those who received streptokinase (10.7%) compared to controls (13%). The degree of benefit, which was sustained up to 1 year after the AMI episode, was related to the time between onset of symptoms and streptokinase treatment; the sooner thrombolytics were administered the greater the reduction in mortality. When thrombolytics were administered more than 6 h after AMI no difference was appreciated.53

Similar benefits were noted in the ISIS-2 trial (Second International Study of Infarct Survival), in which patients presenting to hospitals within 24h (mean of 5h) of onset of suspected AMI were randomly assigned to either: (1) 1 h i.v. infusion of streptokinase; (2) 1 month of 160 mgday_ 1 of enteric coated aspirin (with the first tablet crushed for a rapid antiplatelet effect); (3) both treatments; or (4) neither treatment Streptokinase alone and aspirin alone each produced a significant reduction in 5-week vascular mortality. A combination of streptokinase and aspirin was significantly better than either agent alone and displayed a synergistic effect in the reduction of mortality from 13.2% (placebo) to 8.0% (streptokinase + aspirin).54 As in the GISSI trial, the ISIS-2 demonstrated that early therapy (within 6-24 h) is essential if mortality benefit and long-term benefit is to be achieved.55

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