Abstract
Background Women with acute coronary syndromes (ACS) are less likely to undergo invasive revascularization than men, but sex-specific differences in long-term outcomes and platelet reactivity among medically managed ACS patients remain uncertain. We examined sex-specific differences in long-term ischemic and bleeding outcomes and platelet reactivity for medically managed ACS patients randomized to prasugrel versus clopidogrel plus aspirin. Methods Data from 9,326 patients enrolled in TRILOGY ACS were analyzed to determine differences in long-term ischemic and bleeding outcomes between women (n = 3,650 [39%]) and men (n = 5,676 [61%]) randomized to prasugrel 10 mg/d (5 mg/d for patients ≥75 years and/or <60 kg) versus clopidogrel 75 mg/d. Sex-specific differences in 30-day platelet reactivity were analyzed in 2,564 (27%) patients participating in a platelet function substudy. Results Compared with men, women were older, weighed less, were less likely to have prior myocardial infarction or revascularization, and had lower baseline creatinine clearance and hemoglobin level values. Rates of the composite of cardiovascular death/myocardial infarction/stroke (20.2% vs 19.1%; P =.56), all-cause mortality (12.2% vs 11.7%; P =.88), and Global Use of Strategies to Open Occluded Arteries severe/life-threatening/moderate bleeding (3.8% vs 2.8%; P =.74) through 30 months were similar in women versus men. After adjustment, women had significantly lower risk for ischemic outcomes and all-cause mortality. There were no sex-specific, treatment-related differences in 30-day platelet reactivity. Conclusions Long-term ischemic and bleeding outcomes in medically managed ACS patients were similar for women versus men, as was treatment-related platelet reactivity. Women had a higher baseline risk profile and, after adjustment, significantly lower risk of the primary composite end point and all-cause death through 30 months.
| Original language | English |
|---|---|
| Pages (from-to) | 695-705.e5 |
| Journal | American heart journal |
| Volume | 170 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - 1 Oct 2015 |
Funding
Dr Clemmensen reports receiving research grants from Eli Lilly and Daiichi Sankyo; speakers bureau payments from Bristol-Myers Squibb, Lilly, Daiichi Sankyo, and AstraZeneca; and consulting/other payments from AstraZeneca, Boehringer Ingelheim, Pfizer, Bristol-Myers Squibb, Lilly, Daiichi Sankyo, Bayer, and WebMD. Dr Roe receives research grants from Eli Lilly, Daiichi Sankyo, Ferring Pharmaceuticals, Janssen Pharmaceuticals, KAI Pharmaceuticals, the Familial Hypercholesterolemia Foundation, and Sanofi-Aventis. He also receives consulting payments or honoraria from AstraZeneca, Eli Lilly, Merck, Janssen, Elsevier Publishers, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, PriMed, and Regeneron. All conflicts of interest are listed at https://www.dcri.org/about-us/conflict-of-interest . Dr Hochman reports receiving consulting fees from Eli Lilly and GlaxoSmithKline. Dr Cyr and Dr Neely have no conflicts of interest to report. Dr McGuire reports receiving research grants from Daiichi Sankyo, Lilly, AstraZeneca, and Bristol-Myers Squibb and consulting fees from Sanofi-Aventis. Dr Cornel reports receiving consulting fees from Lilly, Merck Sharp & Dohme, AstraZeneca, and Merck. Dr Huber reports receiving speakers bureau payments from Eli Lilly, Daiichi Sankyo, and AstraZeneca. Dr Zamoryakhin is an employee of Daiichi Sankyo Pharma Development (London). Dr White reports receiving grant support from Sanofi-Aventis, Eli Lilly, The Medicines Company, National Institutes of Health, Pfizer, Roche, Johnson & Johnson, Schering-Plough, Merck Sharp & Dohme, AstraZeneca, GlaxoSmithKline, Daiichi Sankyo Pharma Development, and Bristol-Myers Squibb; he also participates in advisory boards for Merck Sharp & Dohme, Roche, and Regado Biosciences. Dr Armstrong reports receiving consulting fees from Eli Lilly, Hoffmann-La Roche, Merck, Axio Research, and Orexigen; grant support from Boehringer Ingelheim, Hoffmann-La Roche, Sanofi-Aventis, Scios, Ortho Biotech, Johnson & Johnson, Janssen Pharmaceuticals, GlaxoSmithKline, Amylin Pharmaceuticals, and Merck; and payment for developing educational presentations from AstraZeneca and Eli Lilly and Company. Dr Fox reports receiving research grants from Lilly, Bayer, Johnson & Johnson, and AstraZeneca; speakers bureau payments from Bayer, Johnson & Johnson, AstraZeneca, and Sanofi-Aventis; and consulting/other payments from Lilly, Bayer, Johnson & Johnson, AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, and Eli Lilly. Dr Prabhakaran reports receiving research grants from Eli Lilly and the Medtronic Foundation and honoraria from Eli Lilly. Dr Ohman reports receiving grant support and travel expenses from Daiichi Sankyo and Eli Lilly; consulting fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen Pharmaceuticals, Liposcience, Merck, Pozen, Hoffmann-La Roche, Sanofi-Aventis, The Medicines Company, and Web MD; grant support from Gilead Sciences; and lecture fees from Gilead Sciences, Boehringer Ingelheim, and The Medicines Company.
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