Thrombolytic therapy for women with myocardial infarction: is there a gender gap? Thrombolysis and Angioplasty in Myocardial Infarction Study Group.
(Clinical Trial;Journal Article;Multicenter Study)
OBJECTIVES: The goal of this study was to investigate whether female gender portends an adverse prognosis independent of the severity of the underlying disease after acute myocardial infarction treated by thrombolysis. A total of 348 women were compared with 1,271 men enrolled in the Thrombolysis and Angioplasty in Myocardial Infarction (TAMI) trials. BACKGROUND: The reasons for gender differences in the management and prognosis of acute coronary artery syndromes remain poorly defined. The extent to which gender itself explains observed differences in outcome and use of diagnostic procedures remains unclear because confounding factors have not been specified. METHODS: Patients < 76 years of age presenting within 6 h of onset of ischemic symptoms with electrocardiographic ST segment elevation and without contraindications to thrombolysis, previous infarction in the same distribution or cardiogenic shock were prospectively enrolled in Phases 1 to 3, 5 and 7 of the TAMI trials. All patients received recombinant tissue-type plasminogen activator, urokinase or a combination of both agents. Protocol-mandated cardiac catheterization was performed during the hospital period. Rescue coronary angioplasty was carried out for reperfusion failure at angiography 90 min after initiation of thrombolytic therapy. Coronary artery bypass grafting or coronary angioplasty was performed for clinical indications. RESULTS: Women were older than men (61.0 +/- 9.7 vs. 55.8 +/- 10.1 years, mean +/- SD) and had a higher incidence of many risk factors for adverse outcome after myocardial infarction. There were no differences in baseline hemodynamic variables or time to thrombolytic treatment. Rates of acute and predischarge infarct-related artery patency and global and regional left ventricular function were similar in the two groups. Rates of in-hospital coronary angioplasty (52.6% and 54.1%) and bypass graft surgery (20.4% and 22.0%) were comparable in women and men, respectively. Women had higher unadjusted rates of mortality (9.2% vs. 5.4%, p = 0.014), reinfarction (6.4% vs. 2.6%, p = 0.005) and hemorrhagic stroke (2.0% vs. 0.55%, p = 0.017) than did men during the hospital period. When adjusted for clinical and angiographic variables, differences in mortality and hemorrhagic stroke did not reach statistical significance, and the risk of reinfarction was only marginally associated with gender. CONCLUSIONS: In selected patients undergoing thrombolytic therapy and cardiac catheterization for acute myocardial infarction, adjusted mortality rates and utilization of postlysis revascularization are similar in women and men. However, women may be at increased risk for reinfarction.
Lincoff, AM; Califf, RM; Ellis, SG; Sigmon, KN; Lee, KL; Leimberger, JD; Topol, EJ
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