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Impact of Female Sex on Death and Bleeding After Fibrinolytic Treatment of Myocardial Infarction in GUSTO V
Harmony R. Reynolds, MD;
Michael E. Farkouh, MSc, MD;
A. Michael Lincoff, MD;
Amy Hsu, MS;
Eva Swahn, MD;
Zygmunt P. Sadowski, MD;
Jennifer A. White, MS;
Eric J. Topol, MD;
Judith S. Hochman, MD; for the GUSTO V Investigators
Arch Intern Med. 2007;167(19):2054-2060.
Background Women with acute myocardial infarction are more likely than men to experience reinfarction, bleeding, or death. This difference has been hypothesized to be due to older age, treatment delay, and comorbidities in women. Use of diagnostic and therapeutic modalities may also differ. There is controversy regarding whether female sex is an independent risk factor for death and/or bleeding.
Methods The GUSTO (Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes) V Investigators studied standard-dose reteplase vs standard-dose abciximab plus half-dose reteplase in patients with myocardial infarction.
Results Women were older and more often had diabetes mellitus and hypertension. Angiography and percutaneous coronary intervention were less frequent in women. Death (9.8% vs 4.4% at 30 days; odds ratio [OR], 2.00; 95% confidence interval, 1.59-2.53; P < .001) and bleeding (6.4% vs 2.5%; OR, 1.31; 95% confidence interval, 1.18-1.45; P < .01) were more common in women. There was no association between treatment assignment and death in either sex; bleeding was more common in both sexes receiving combination therapy. Female sex was independently associated with mortality. After Killip class greater than 1 (OR, 4.7), female sex (OR, 2.0) was the strongest correlate of death. Female sex was independently associated with bleeding for both treatments.
Conclusions Female sex is independently associated with death and bleeding complications among fibrinolytic-treated patients with myocardial infarction. There remains a sex differential in the use of angiography and, therefore, percutaneous coronary intervention after fibrinolysis. Further research will determine what mediates excess risk in women.
Trial Registration clinicaltrials.gov Identifier: NCT00245648
Author Affiliations: Cardiovascular Clinical Research Center, New York University School of Medicine, New York (Drs Reynolds, Farkouh, and Hochman); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio (Drs Lincoff and Topol and Mss Hsu and White); Department of Cardiology, Heart Centre, University Hospital, Linkoping, Sweden (Dr Swahn); and National Institute of Cardiology, Warsaw, Poland (Dr Sadowski). Ms White is now with the Duke Clinical Research Institute, Durham, North Carolina.
Group Information: A list of the members of the GUSTO (Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes) V Investigators appears in Lancet (2001;357[9272]:1905-1914).
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