Peter Clemmensen1, Matthew T Roe2, Judith S Hochman3, Derek D Cyr4, Megan L Neely4, Darren K McGuire5, Jan H Cornel6, Kurt Huber7, Dmitry Zamoryakhin8, Harvey D White9, Paul W Armstrong10, Keith A A Fox11, Dorairaj Prabhakaran12, Erik Magnus Ohman13. 1. Department of Medicine, Division of Cardiology, Nykoebing F Hospital and Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark. 2. Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Durham, NC. Electronic address: matthew.roe@dm.duke.edu. 3. New York University Langone Medical Center, New York, NY. 4. Duke Clinical Research Institute, Durham, NC. 5. University of Texas-Southwestern Medical Center, Dallas, TX. 6. Medisch Centrum Alkmaar, Alkmaar, the Netherlands. 7. Department of Cardiology and Intensive Care Medicine, Wilhelminen Hospital, Vienna, Austria. 8. Daiichi Sankyo Development Ltd, London, United Kingdom. 9. Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. 10. Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada. 11. Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, Scotland, United Kingdom. 12. Centre for Chronic Disease Control and Public Health Foundation of India, New Delhi, India. 13. Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Durham, NC.
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 toprasugrel 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.
RCT Entities:
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.
Authors: Michael G Nanna; Alexandra M Hajduk; Harlan M Krumholz; Terrence E Murphy; Rachel P Dreyer; Karen P Alexander; Mary Geda; Sui Tsang; Francine K Welty; Basmah Safdar; Dharshan K Lakshminarayan; Sarwat I Chaudhry; John A Dodson Journal: Circ Cardiovasc Qual Outcomes Date: 2019-10-14
Authors: Babatunde A Yerokun; Judson B Williams; Jeffrey Gaca; Peter K Smith; Matthew T Roe Journal: Coron Artery Dis Date: 2016-06 Impact factor: 1.439