title: Short-versus long-term Dual Antiplatelet therapy after drug-eluting stent implantation in women versus men: A sex-specific patient-level pooled-analysis of six randomized trials.
abstract: BACKGROUND
  Whether the efficacy and safety of dual antiplatelet therapy (DAPT) are uniform between sexes is unclear. We sought to compare clinical outcomes between short- (≤6 months) versus long-term (≥1 year) DAPT after drug-eluting stent (DES) placement in women and men.
  
  
  RESULTS
  We pooled individual patient data from 6 randomized trials of DAPT (EXCELLENT, OPTIMIZE, PRODIGY, RESET, SECURITY, ITALIC PLUS). The primary outcome was 1-year risk of major adverse cardiac events (MACE). The main secondary outcome was 1-year risk of any bleeding. Out of the 11,473 randomized patients included in the pooled dataset, 3,454 (30%) were females. At 1-year follow-up, women had higher risk of MACE (3.6% vs. 2.8%; P = 0.01) but similar risk of bleeding (1.9% vs. 1.6%; P = 0.16) as compared with men. Compared with long-term DAPT, short-term DAPT was associated with similar rates of MACE in both women (HR 0.88; 95% CI 0.62-1.25) and men (HR 1.25; 95% CI 0.95-1.6; P interaction = 0.08)]. At 1-year follow-up, short-term DAPT was associated with lower rates of bleeding as compared with long-term DAPT in both women (HR 0.84; 95% CI 0.51-1.37) and men (HR 0.58; 95% CI 0.40-0.84; P-interaction = 0.25). The presence of MVD was associated with higher MACE rates in the short-term DAPT group in women (HR: 1.16; CI 0.60-2.23) and men (HR: 2.29; CI 1.22-4.29; P interaction = 0.25).
  
  
  CONCLUSIONS
  Short-term DAPT is associated with similar rates of MACE but lower risk of bleeding when as compared with prolonged DAPT. There was no significant difference between sexes in the population studied. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris, Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Fadi J
authors.initials: FJ
authors.lastname: Sawaya
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris, Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris, Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Marco
authors.initials: M
authors.lastname: Spaziano
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, New York.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: Department of Cardiology, CHU de la Cavale Blanche, Brest, France.
authors.forename: Romain
authors.initials: R
authors.lastname: Didier
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris, Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Andrew
authors.initials: A
authors.lastname: Roy
authors.affiliation: Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.affiliation: Department of Cardiology, Seoul National University Main Hospital, Seoul, South Korea.
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
authors.affiliation: Department of Cardiology, Seoul National University Main Hospital, Seoul, South Korea.
authors.forename: Kyung
authors.initials: K
authors.lastname: Woo Park
authors.affiliation: Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Myeong-Ki
authors.initials: MK
authors.lastname: Hong
authors.affiliation: Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Byeong-Keuk
authors.initials: BK
authors.lastname: Kim
authors.affiliation: Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Yangsoo
authors.initials: Y
authors.lastname: Jang
authors.affiliation: Istituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil.
authors.forename: Fausto
authors.initials: F
authors.lastname: Feres
authors.affiliation: Istituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.affiliation: Istituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil.
authors.forename: Ricardo A
authors.initials: RA
authors.lastname: Costa
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Giustino
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.affiliation: VA Boston Healthcare System, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts.
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.affiliation: Dipartimento Cardio-Toraco-Vascolare, University of Bologna, Bologna, Italy.
authors.forename: Tullio
authors.initials: T
authors.lastname: Palmerini
authors.affiliation: Department of Cardiology, CHU de la Cavale Blanche, Brest, France.
authors.forename: Martine
authors.initials: M
authors.lastname: Gilard
mesh_terms: D000368:Aged; D003328:Coronary Thrombosis / Q000209:etiology; D004334:Drug Administration Schedule; D054855:Drug-Eluting Stents; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012307:Risk Factors; D012737:Sex Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors
keywords: drug-eluting stents; dual antiplatelet therapy duration; major adverse cardiac events; women