title: Ischaemic and bleeding outcomes in elderly patients undergoing a prolonged versus shortened duration of dual antiplatelet therapy after percutaneous coronary intervention: insights from the PRODIGY randomised trial.
abstract: OBJECTIVE
  The aim of this study was to evaluate the efficacy and safety of 24-month vs. six-month dual antiplatelet therapy (DAPT) among elderly (≥75 years) and non-elderly patients (<75 years) undergoing percutaneous coronary intervention.
  
  
  RESULTS
  The primary efficacy endpoint of the PRODIGY trial 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 BARC criteria. Of 1,970 participants, 587 (29.8%) were elderly and had a higher risk of adverse events compared with younger patients. The risk of the primary endpoint was not significantly reduced with 24-month compared to six-month DAPT among both elderly (HR 0.80, 95% CI: 0.55-1.16, p=0.24) and non-elderly patients (HR 1.48, 95% CI: 0.95-2.30, p=0.08), although interaction testing was significant (p=0.036). A 24-month versus six-month DAPT significantly increased the risk of BARC type 2, 3 or 5 bleeding in both older (HR 1.90, 95% CI: 1.06-3.38, p=0.03) and younger patients (HR 2.54, 95% CI: 1.43-4.53, p=0.002, p-interaction=0.48). However, measures of absolute risk difference indicated a less favourable safety profile of prolonged DAPT for older rather than younger patients.
  
  
  CONCLUSIONS
  In the PRODIGY trial, prolonging clopidogrel-based DAPT beyond six months in elderly patients increased the risk of bleeding, without affording a significant prevention of ischaemic events.
authors.affiliation: Bern University Hospital, University of Bern, Bern, Switzerland.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Piccolo
authors.forename: Giulia
authors.initials: G
authors.lastname: Magnani
authors.forename: Sara
authors.initials: S
authors.lastname: Ariotti
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Gargiulo
authors.forename: Marcello
authors.initials: M
authors.lastname: Marino
authors.forename: Andrea
authors.initials: A
authors.lastname: Santucci
authors.forename: Anna
authors.initials: A
authors.lastname: Franzone
authors.forename: Matteo
authors.initials: M
authors.lastname: Tebaldi
authors.forename: Dik
authors.initials: D
authors.lastname: Heg
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D001241:Aspirin / Q000627:therapeutic use; D000077144:Clopidogrel; D004359:Drug Therapy, Combination; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011183:Postoperative Complications / Q000517:prevention & control*; D013927:Thrombosis / Q000517:prevention & control*; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin