Abstract 15834: Evolution of Differences in Women and Men With Non-ST-Segment Elevation Acute Coronary Syndromes: Insights From Clinical Trials Over 15 Years
Background: Historically, women are less often enrolled in ACS trials and receive less evidence-based care than men. Whether these differences and outcomes have changed over time is unclear.
Methods: We characterized trends in inclusion of women vs men in non-ST-segment elevation ACS clinical trials and their treatment (discharge medications, angiography, revascularization) and outcomes (in-hospital bleeding and 30-d and 6-m death) using data from 58,790 patients enrolled in 9 phase III clinical trials of antithrombotic therapy over 15 years. Patient-level data were mapped to 3 prespecified enrollment periods (1994-98, 1999-2003, 2004-08) and stratified by sex.
Results: In total, 20,031 patients (34.1%) were women with little temporal change: 1994-98, 34.1%; 1999-2003, 35.1%; 2004-08, 31.6%. The Table shows baseline characteristics, discharge medication use, angiography, revascularization, and outcomes by sex and time period. Age, comorbidities, and acute risk (GRACE score >140 [>3% risk of in-hospital death]) increased over time in women and men. Increases in the use of evidence-based medication and angiography were dramatic for both women and men, with only small quantitative differences by sex over time. Despite similar use of angiography by sex by time period, revascularization remained lower among women. 30-d and 6-m mortality declined similarly over time among women and men. GUSTO severe bleeding was similar by sex and stable over time (1994-98, 1.3% vs 2004-08, 1.1%). Women were transfused more often than men in all time periods, and overall transfusion use increased by an absolute 3.7% from 1994-98 to 2004-08 with similar trajectory by sex.
Conclusions: Despite efforts to include more women in ACS trials, enrollment of women has not changed. Importantly, use of evidence-based care has increased and mortality has steadily declined for both sexes. Increasing use of transfusion despite stable bleeding rates deserves further study.
- © 2013 by American Heart Association, Inc.