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W. Douglas Weaver, MD; Harvey D. White, MB; Robert G. Wilcox, MD; Philip E. Aylward, MD; Douglas Morris, MD; Alan Guerci, MD; E. Magnus Ohman, MD; Gabriel I. Barbash, MD; Amadeo Betriu, MD; Zygmunt Sadowski, MD; Eric J. Topol, MD; Robert M. Califf, MD; GUSTO-I Investigators

JAMA. 1996;275(10):777-782.

Abstract
Objective.
—To compare baseline characteristics, complications, and treatment-specific outcomes of women and men with acute myocardial infarction treated with thrombolytic therapy.

Design.
—Randomized controlled trial.

Patients and Setting.
—A total of 10315 women and 30706 men with acute myocardial infarction treated in 1081 hospitals in 15 countries as part of the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO-I).

Intervention.
—One of four thrombolytic regimens: (1) streptokinase with subcutaneous heparin; (2) streptokinase with intravenous heparin; (3) streptokinase plus alteplase (tissue-type plasminogen activator) with intravenous heparin; or (4) accelerated alteplase with intravenous heparin.

Main Outcome Measures.
—Mortality, stroke, and nonfatal complications during 30-day follow-up.

Results.
—Women were on average 7 years older than men and delayed 18 minutes (median) longer after symptom onset before presenting to the hospital. After adjustment for age, women more often had a history of diabetes, hypertension, and smoking than men. Time to treatment was significantly longer in women (1.2 vs 1.0 hours; P<.001). Women had more nonfatal complications after treatment, including shock (9% vs 5%; P<.001), congestive heart failure (22% vs 14%; P<.001), serious bleeding (15% vs 7%; P<.001), and reinfarction (5.1% vs 3.6%; P<.001). Women had twice as many total strokes as men (2.1% vs 1.2%; P<.001), secondary to their older age at presentation. The unadjusted mortality rate was twice as high in women as men (11.3% vs 5.5%; P<.001); the relative risk (RR) of death was greater among women than men after adjustment for differences in baseline characteristics (RR=1.15; 95% confidence interval, 1.0 to 1.31). Although women and men underwent angiography at similar rates, there were small but significant differences in their rates of revascularization procedures (angioplasty: 35% of women and 32% of men; bypass surgery: 7% of women and 9% of men; P<.001 for both). The higher rate of stroke in women after treatment with alteplase (2.0% vs 1.9% with streptokinase and intravenous heparin) was offset by a greater relative reduction in mortality (10.3% vs 11.1%).

Conclusion.
—Women who received thrombolytic therapy for treatment of acute myocardial infarction were at greater risk for both fatal and nonfatal complications than men.

(JAMA. 1996;275:777-782)

Author Affiliations
From the Division of Cardiology, University of Washington, Seattle (Dr Weaver); Cardiology Department, Green Lane Hospital, Auckland, New Zealand (Dr White); Department of Medicine, Queen's Medical Centre, Nottingham, England (Dr Wilcox); Department of Cardiovascular Medicine, Flinders Cardiovascular Centre, Adelaide, Australia (Dr Aylward); Emory Clinic, Emory University, Atlanta, Ga (Dr Morris); Department of Medicine, St Francis Hospital, Roslyn, NY (Dr Guerci); Division of Cardiology, Duke University Medical Center, Durham, NC (Drs Ohman and Califf); Department of Medicine, Tel-Aviv (Israel) Sourasky University Medical Center (Dr Barbash); Hospital Clinic I, Barcelona, Spain (Dr Betriu); Ischemic Heart Disease Department, Instytut Kardiologii, Warsaw, Poland (Dr Sadowski); and Department of Cardiology, Cleveland (Ohio) Clinic Foundation (Dr Topol).

Footnotes
For a complete list of the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO-I) investigators, see N Engl J Med. 1993;329:673-682.

Reprint requests to MITI Coordinating Center, Division of Cardiology RG-22, University of Washington, 1910 Fairview Ave E, Suite 205, Seattle, WA 98102 (Dr Weaver).

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