title: Short- versus long-term duration of dual antiplatelet therapy in patients treated for in-stent restenosis: a PRODIGY trial substudy (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia).
abstract: OBJECTIVE
  This study sought to investigate the clinical outcome of patients treated with percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) randomized to short (6 months) versus long (24 months) dual antiplatelet therapy (DAPT) regimen.
  
  
  BACKGROUND
  It is still unclear if patients treated for ISR may benefit from a long DAPT regimen.
  
  
  METHODS
  For the present purpose, we selected 224 patients undergoing the PCI procedure for ISR enrolled in the PRODIGY (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) trial and randomized to short (6 months) versus long (24 months) DAPT regimen. The primary objective was the cumulative incidence of death, nonfatal myocardial infarction (MI), or cerebrovascular accident at 24 months. Safety endpoints were moderate and major bleeding complications.
  
  
  RESULTS
  Overall, 114 patients were allocated to short DAPT regimen, whereas 110 patients were allocated to long DAPT regimen. Twenty-seven patients reached the primary endpoint (19 in short DAPT regimen vs. 8 in long DAPT regimen; p = 0.02). The cumulative incidence of the primary endpoint at 24 months was 16.7% in the short DAPT regimen group compared with 7.3% in the long DAPT regimen group (p = 0.034). This is principally due to a lower occurrence of death and MI in the long DAPT regimen group as compared to the short DAPT regimen group (6.5% vs. 15.5%; p = 0.03). There was no difference in the occurrence of bleeding complications between long and short DAPT regimen.
  
  
  CONCLUSIONS
  Our study offers preliminary evidence that patients receiving a new PCI procedure for ISR may benefit from long-term administration of aspirin plus clopidogrel. (Synergy Between Stent and Drugs to Avoid Ischemic Recurrences After Percutaneous Coronary Intervention [PRODIGY]; NCT00611286).
authors.affiliation: Cardiovascular Institute, Azienda Ospedaliero-Universitaria Sant'Anna, Ferrara, Italy; Laboratorio per le Tecnologie delle Terapie Avanzate Center, Ferrara, Italy. Electronic address: cmpglc@unife.it.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Campo
authors.affiliation: Cardiovascular Institute, Azienda Ospedaliero-Universitaria Sant'Anna, Ferrara, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Tebaldi
authors.affiliation: Virga Jesse Ziekenhuis, Hasselt, Belgium.
authors.forename: Pascal
authors.initials: P
authors.lastname: Vranckx
authors.affiliation: Cardiovascular Institute, Azienda Ospedaliero-Universitaria Sant'Anna, Ferrara, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Biscaglia
authors.affiliation: Cardiovascular Institute, Azienda Ospedaliero-Universitaria Sant'Anna, Ferrara, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Tumscitz
authors.affiliation: Cardiovascular Institute, Azienda Ospedaliero-Universitaria Sant'Anna, Ferrara, Italy; Cardiovascular Research Centre, Salvatore Maugeri Foundation, IRCCS, Lumezzane, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Ferrari
authors.affiliation: Cardiovascular Institute, Azienda Ospedaliero-Universitaria Sant'Anna, Ferrara, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000008:administration & dosage*; D000077144:Clopidogrel; D023903:Coronary Restenosis / Q000150:complications / Q000401:mortality / Q000628:therapy*; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D020521:Stroke / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin
keywords: aspirin; clopidogrel; drug eluting stent(s); dual antiplatelet therapy; in-stent restenosis; percutaneous coronary intervention