Clinical studies: GISSI-1
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Objective: evaluation of the efficacy of a thrombolytic treatment with streptokinase (SK) on hospital mortality of patients with acute myocardial infarction (AMI).

Study design: open controlled clinical trial with central randomisation to SK or control of AMI patients admitted within 12 hours from first symptoms.

Population randomised: 11,712 patients in 17 months, from February 1984 to June 1985.

Results:

- thrombolytic treatment significantly reduces mortality among patients treated with SK compared to controls, receiving conventional treatments: 10.7% SK vs 13% controls, for an 18% reduction (p=.0002, relative risk (RR) 0.81, 95%CI: 0.72-0.90);

- the benefit, in terms of mortality, is present in the hospital phase and remains unaltered for at least one year after the AMI episode. One year mortality is hence reduced as follows: 17.2% SK vs 19.0% controls (p=.008, RR 0.90, 95%CI: 0.84-0.97);

- the sooner thrombolytic treatment is administered, the greater is the reduction in mortality: 9.2% SK vs 12% controls (p=0.0005, RR 0.74, 95%CI 0.63-0.87) among patients treated within 3 hours of first symptoms.

Ten years follow up results:

-The difference in survival produced by streptokinase and sustained up to one year was still significant at 10 years (log-rank test: p=0.02) with the absolute benefit of 19 (95%CI: 1 to 37) lives saved per 1000 patients treated.

-In the overall population, most of the benefit was obtained before hospital discharge (RR 0.81, 95%CI 0.72-0.90), since no difference in survival between thrombolyzed and control patients discharged alive was found at 10 years (RR 0.98, 95%CI 0.90-1.06).

-A slight albeit non significant divergence of the survival curves of patients randomized within the first hour was observed [90 (95%CI: 34 to 146) lives saved per 1000 at 10 years versus 72 (95%CI: 37 to 107) lives saved at hospital discharge].

References:

Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI) . Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Lancet 1986; i: 397-402.
Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI) . Long-term effects of intravenous thrombolysis in acute myocardial infarction: Final report of the GISSI study. Lancet 1987; ii: 871-874.
Farina ML, Franzosi MG, Mauri F, Pampallona S, Tognoni G. Fibrinolisi sistemica nell'infarto miocardico acuto. Casistica, metodo, risultati preliminari del GISSI. In: Rovelli F, ed. Cardiologia 1985, Milano: Librex, 1985: 290-297.
Franzosi MG, Santoro E, De Vita C, Geraci E, Lotto A, Maggioni AP, Mauri F, Rovelli F, Santoro L, Tavazzi L, Tognoni G, on behalf of GISSI Investigators. Ten-year follow-up of the first megatrial testing thrombolytic therapy in patients with acute myocardial infarction: results of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto-1 study. The GISSI Investigators. Circulation 1998; 98: 2659-2665.  


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GISSI Coordinating Centre
"Mario Negri" Institute for Pharmacological Research

Via Eritrea, 62 - 20157 Milano - Italy
Tel. +39-0239014482 Fax. +39-0233200049

 

Scientific Info:DepCardio
Technical Info:Enrico Nicolis