title: Impact of clinical presentation on ischaemic and bleeding outcomes in patients receiving 6- or 24-month duration of dual-antiplatelet therapy after stent implantation: a pre-specified analysis from the PRODIGY (Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) trial.
abstract: OBJECTIVE
  We investigated if acute coronary syndrome (ACS) rather than stable coronary artery disease (SCAD) presentation is an outcome modifier with respect to the duration of dual-antiplatelet therapy (DAPT) in patients undergoing coronary stenting.
  
  
  RESULTS
  In the Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia (PRODIGY) trial, a total of 1465 (74.3%) patients presented ACS whereas 505 (25.7%) had SCAD and were randomized to 6- or 24-month DAPT. At 24 months, the composite of death, myocardial infarction (MI), or cerebrovascular accident (CVA) did not differ between the long- and short-term DAPT arms in both ACS (11.1 vs. 11.7%; P = 0.67) and SCAD (7.5 vs. 4.8%; P = 0.21) patients, respectively. Long-term DAPT was associated with a 75% increase of Bleeding Academic Research Consortium (BARC)-class 2, 3, or 5 bleeding in ACS [7.1 vs. 4.1%; hazard ratio (HR) 1.75, 95% confidence interval (CI) 1.11-2.74, P = 0.015; number needed to treat for harm (NNTH): 33.3] and a five-fold increase in SCAD (8.2 vs. 1.6%; HR 5.37, 95% CI 1.84-15.74, P = 0.002; NNTH: 15.1) patients, with a borderline quantitative interaction (PINT = 0.056). As a result, net adverse cardiovascular events (death, MI, CVA, BARC class 2, 3, or 5 bleeding) were more than doubled in SCAD patients receiving 24-month DAPT, whereas they did not differ in ACS patients (PINT = 0.024).
  
  
  CONCLUSIONS
  This analysis suggests that clinical presentation may be a treatment modifier with respect to DAPT duration after stenting consistent with the hypothesis that SCAD-but not ACS-patients are exposed to a significant increase in bleeding and net adverse clinical events when treated with 24-month compared with 6-month therapy.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00611286. http://clinicaltrials.gov/ct2/show/NCT00611286?term=prodigy&rank=2.
authors.affiliation: Thoraxcenter, Erasmus Medical Center, 3015 CE Rotterdam, The Netherlands Department of Clinical and Experimental Medicine, Policlinico 'G. Martino', University of Messina, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Costa
authors.affiliation: Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.
authors.forename: Pascal
authors.initials: P
authors.lastname: Vranckx
authors.affiliation: Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Leonardi
authors.affiliation: Division of Cardiology, Department of Cardiothoracic Sciences, Second University of Naples, Naples, Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Moscarella
authors.affiliation: Department of Clinical and Experimental Medicine, Policlinico 'G. Martino', University of Messina, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ando
authors.affiliation: Division of Cardiology, Department of Cardiothoracic Sciences, Second University of Naples, Naples, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Calabro
authors.affiliation: Department of Clinical and Experimental Medicine, Policlinico 'G. Martino', University of Messina, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Oreto
authors.affiliation: Thoraxcenter, Erasmus Medical Center, 3015 CE Rotterdam, The Netherlands.
authors.forename: Felix
authors.initials: F
authors.lastname: Zijlstra
authors.affiliation: Thoraxcenter, Erasmus Medical Center, 3015 CE Rotterdam, The Netherlands m.valgimigli@erasmusmc.nl vlgmrc@unife.it.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
mesh_terms: D054058:Acute Coronary Syndrome / Q000401:mortality / Q000628:therapy*; D000368:Aged; D001241:Aspirin / Q000008:administration & dosage*; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D006965:Hyperplasia / Q000209:etiology; D008297:Male; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D062645:Percutaneous Coronary Intervention / Q000379:methods / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011379:Prognosis; D015607:Stents; D020521:Stroke / Q000209:etiology / Q000401:mortality; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D017539:Tunica Intima / Q000473:pathology
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin
keywords: Bleeding; Clopidogrel; Drug-eluting stents; Dual-antiplatelet therapy