About Index

GUSTO

"Mortality and Morbidity with Thrombolytic Regimens in Myocardial Infarction: The GUSTO Trial". The New England Journal of Medicine. 1993.

Links to original sources: Wiki Journal Post Full Journal Article

Clinical Question


In patients with acute myocardial infarction undergoing thrombolytic therapy, which regimen improves survival: streptokinase with subcutaneous heparin, streptokinase with intravenous heparin, accelerated tissue plasminogen activator (t-PA) with intravenous heparin, or a combination of streptokinase plus t-PA with intravenous heparin?

Bottom Line


In patients with acute myocardial infarction, accelerated t-PA combined with intravenous heparin provided a survival benefit over standard thrombolytic regimens with streptokinase.

Major Points


The GUSTO trial compared four thrombolytic strategies in patients with evolving myocardial infarction and found that accelerated t-PA given with intravenous heparin reduces 30-day mortality more effectively than regimens using streptokinase.

Guidelines


Current guidelines for management of myocardial infarction may reflect the findings of the GUSTO trial, recommending the use of accelerated t-PA with intravenous heparin based on patient-specific factors and balancing the benefits and risks.

Design


- Multicenter, randomized, open-label trial - N=41,021 - Four treatment groups: 1. Streptokinase with subcutaneous heparin 2. Streptokinase with intravenous heparin 3. Accelerated t-PA with intravenous heparin 4. Combination streptokinase plus t-PA with intravenous heparin - Setting: 1081 hospitals in 15 countries - Enrollment: December 1990 to February 1993

Population


- Patients with symptoms of myocardial infarction of less than 6 hours' duration with ST-segment elevation

Interventions


- Streptokinase (1.5 million U) with either subcutaneous or intravenous heparin, or - Accelerated t-PA with intravenous heparin, or - Combined streptokinase plus t-PA with intravenous heparin

Outcomes


- Primary: 30-day mortality - Secondary: Combined endpoints of death and nonfatal stroke, death and nonfatal hemorrhagic stroke, and death and nonfatal disabling stroke - Tertiary: Stroke and bleeding complications

Criticisms


- Open-label design without a placebo group may introduce bias - The cost and complexity of administering t-PA may limit its widespread use

Funding


- Supported by a combined grant from Bayer, CIBA-Corning, Genentech, ICI Pharmaceuticals, and Sanofi Pharmaceuticals

Further Reading


The full article, as published in The New England Journal of Medicine, provides a detailed account of the study methods, populations, interventions, and outcomes.