title: Impact of Sex on 2-Year Clinical Outcomes in Patients Treated With 6-Month or 24-Month Dual-Antiplatelet Therapy Duration: A Pre-Specified Analysis From the PRODIGY Trial.
abstract: The aim of this study was to assess the impact of sex on 2-year outcomes after percutaneous coronary intervention (PCI) in patients randomly allocated to 24-month versus 6-month dual-antiplatelet therapy (DAPT).
  
  
  
  The optimal duration of DAPT after PCI is highly debated. Whether sex per se should drive decision making on DAPT duration remains unclear.
  
  
  
  The primary efficacy endpoint of PRODIGY (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study) was the composite of death, myocardial infarction, or cerebrovascular accident at 24-month follow-up. The key safety endpoint was type 2, 3, or 5 bleeding according to the Bleeding Academic Research Consortium criteria.
  
  
  
  Women (n = 459 [23.3%]) were older and more likely to have hypertension, lower creatinine clearance, and acute coronary syndrome but had a lower severity of coronary artery disease. After adjustment, prolonged DAPT, compared with 6-month treatment, did not reduce the primary endpoint in both men (adjusted hazard ratio: 1.080; 95% confidence interval: 0.766 to 1.522; p = 0.661) and women (adjusted hazard ratio: 1.013; 95% confidence interval: 0.588 to 1.748; p = 0.962) (interaction p = 0.785). No sex disparity was identified across multiple secondary ischemic endpoints, including overall or cardiovascular mortality, myocardial infarction, and stent thrombosis. There was also no clear sex-related effect on clinically relevant bleeding, including Bleeding Academic Research Consortium type 3 or 5, TIMI (Thrombolysis in Myocardial Infarction), and GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) scales.
  
  
  
  The present findings suggest that men and women undergoing PCI have similar adjusted 2-year ischemic and bleeding outcomes, despite being characterized by different clinical presentation. Sex failed to emerge as a treatment modifier with respect to DAPT duration, suggesting that decision making on DAPT duration in female patients should weigh ischemic versus bleeding risks.
authors.affiliation: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland; Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Gargiulo
authors.affiliation: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland; Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Sara
authors.initials: S
authors.lastname: Ariotti
authors.affiliation: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.
authors.forename: Andrea
authors.initials: A
authors.lastname: Santucci
authors.affiliation: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Piccolo
authors.affiliation: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.
authors.forename: Andrea
authors.initials: A
authors.lastname: Baldo
authors.affiliation: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.
authors.forename: Anna
authors.initials: A
authors.lastname: Franzone
authors.affiliation: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.
authors.forename: Giulia
authors.initials: G
authors.lastname: Magnani
authors.affiliation: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.
authors.forename: Marcello
authors.initials: M
authors.lastname: Marino
authors.affiliation: Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Esposito
authors.affiliation: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland; Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: marco.valgimigli@insel.ch.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
mesh_terms: D054058:Acute Coronary Syndrome / Q000097:blood / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D000368:Aged; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000097:blood / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D003328:Coronary Thrombosis / Q000209:etiology; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D058426:Neointima; 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; D018570:Risk Assessment; D012307:Risk Factors; D012737:Sex Factors; D015607:Stents; D020521:Stroke / Q000209:etiology; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin
keywords: DAPT; bleeding; clopidogrel; ischemic events; sex