Natalia C Berry1,2,3, Dean J Kereiakes4, Robert W Yeh2,3,5, P Gabriel Steg6,7, Donald E Cutlip2,3,8, Alice K Jacobs9, J Dawn Abbott10, Wen-Hua Hsieh3, Joseph M Massaro3,11, Laura Mauri1,2,3. 1. Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (N.C.B., L.M.). 2. Harvard Medical School, Boston, MA (N.C.B., L.M., D.E.C., R.W.Y.). 3. Baim Institute for Clinical Research, Boston, MA (N.C.B., L.M., D.E.C., R.W.Y., W.-H.H., J.M.M.). 4. The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K). 5. The Smith Center for Outcomes Research in Cardiology (R.W.Y.), Beth Israel Deaconess Medical Center, Boston, MA. 6. Université Paris-Diderot, Sorbonne Paris Cité, INSERM Unité-1148, Département Hospitalo-Universitaire Fibrosis Inflammation Remodeling, and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, France (P.G.S.). 7. National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, United Kingdom (P.G.S.). 8. Division of Cardiology, Department of Medicine (D.E.C.). 9. Boston University School of Medicine, Boston, MA (A.K.J.). 10. Rhode Island Hospital, Brown University School of Medicine (J.D.A.). 11. Boston University School of Public Health, MA (J.M.M.).
Abstract
BACKGROUND:Women may derive differential benefit from prolonged DAPT (dual antiplatelet therapy) after coronary stenting than men. We assessed whether the risks/benefits of prolonged DAPT differ between women and men. METHODS AND RESULTS: The DAPT study was a randomized double-blind, placebo-controlled trial comparing continued thienopyridine versus placebo beyond 12 months after coronary stenting. We compared rates of myocardial infarction, stent thrombosis, major adverse cardiovascular and cerebrovascular events, and bleeding by sex and randomized treatment. Of 11 648 patients, women (N=2925) were older, with higher prevalence of diabetes mellitus and lower rates of acute coronary syndrome than men. At 12 to 30 months, women had similar adjusted ischemic and bleeding events as men. The effects of continued thienopyridine therapy did not differ significantly by sex for stent thrombosis (women: hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.22-1.36; men: HR, 0.26; 95% CI, 0.15-0.44; interaction P=0.17), myocardial infarction (women: HR, 0.75; 95% CI, 0.50-1.14; men: HR, 0.46; 95% CI, 0.36-0.60; interaction P=0.052), major adverse cardiovascular and cerebrovascular events (women: HR, 0.87; 95% CI, 0.62-1.22; men: HR, 0.70; 95% CI, 0.58-0.85; interaction P=0.26), and bleeding (women: HR, 1.45; 95% CI, 0.88-2.40; men: HR, 1.78; 95% CI, 1.28-2.49; interaction P=0.50). CONCLUSIONS:Women had similar late risks of ischemia and bleeding as men after coronary stent procedures. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00977938.
RCT Entities:
BACKGROUND:Women may derive differential benefit from prolonged DAPT (dual antiplatelet therapy) after coronary stenting than men. We assessed whether the risks/benefits of prolonged DAPT differ between women and men. METHODS AND RESULTS: The DAPT study was a randomized double-blind, placebo-controlled trial comparing continued thienopyridine versus placebo beyond 12 months after coronary stenting. We compared rates of myocardial infarction, stent thrombosis, major adverse cardiovascular and cerebrovascular events, and bleeding by sex and randomized treatment. Of 11 648 patients, women (N=2925) were older, with higher prevalence of diabetes mellitus and lower rates of acute coronary syndrome than men. At 12 to 30 months, women had similar adjusted ischemic and bleeding events as men. The effects of continued thienopyridine therapy did not differ significantly by sex for stent thrombosis (women: hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.22-1.36; men: HR, 0.26; 95% CI, 0.15-0.44; interaction P=0.17), myocardial infarction (women: HR, 0.75; 95% CI, 0.50-1.14; men: HR, 0.46; 95% CI, 0.36-0.60; interaction P=0.052), major adverse cardiovascular and cerebrovascular events (women: HR, 0.87; 95% CI, 0.62-1.22; men: HR, 0.70; 95% CI, 0.58-0.85; interaction P=0.26), and bleeding (women: HR, 1.45; 95% CI, 0.88-2.40; men: HR, 1.78; 95% CI, 1.28-2.49; interaction P=0.50). CONCLUSIONS:Women had similar late risks of ischemia and bleeding as men after coronary stent procedures. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00977938.
Authors: Mina Madan; J Dawn Abbott; Ryan Lennon; Derek Y F So; Andrea M MacDougall; Mary Ann McLaughlin; Vishakantha Murthy; Jacqueline Saw; Charanjit Rihal; Michael E Farkouh; Naveen L Pereira; Shaun G Goodman Journal: J Am Heart Assoc Date: 2022-06-14 Impact factor: 6.106