title: Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial.
abstract: OBJECTIVE
  This open-label, randomized, and multicentre trial tested the hypothesis that, on a background of aspirin, continuing clopidogrel would be superior to stopping clopidogrel at 12 months following drug-eluting stent (DES) implantation.
  
  
  RESULTS
  Patients (N = 1799) who had undergone placement of ≥1 DES for stable coronary artery disease or acute coronary syndrome were included in 58 French sites (January 2009-January 2013). Patients (N = 1385) free of major cardiovascular/cerebrovascular events or major bleeding and on aspirin and clopidogrel 12 months after stenting were eligible for randomization (1:1) between continuing clopidogrel 75 mg daily (extended-dual antiplatelet therapy, DAPT, group) or discontinuing clopidogrel (aspirin group). The primary outcome was net adverse clinical events defined as the composite of death, myocardial infarction, stroke, or major bleeding. Follow-up was planned from a minimum of 6 to a maximum of 36 months after randomization. Owing to slow recruitment, the study was stopped after enrolment of 1385 of a planned 1966 patients. Median follow-up after stenting was 33.4 months. The primary outcome occurred in 40 patients (5.8%) in the extended-DAPT group and 52 in the aspirin group (7.5%; hazard ratio 0.75, 95% confidence interval 0.50-1.28; P = 0.17). Rates of death were 2.3% in the extended-DAPT group and 3.5% in the aspirin group (HR 0.65, 95% CI 0.34-1.22; P = 0.18). Rates of major bleeding were identical (2.0%, P = 0.95).
  
  
  CONCLUSIONS
  Extended DAPT did not achieve superiority in reducing net adverse clinical events compared to 12 months of DAPT after DES placement. The power of the OPTIDUAL trial was however low and reduced by premature termination of enrolment.
  NCT00822536.
authors.affiliation: Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie, boulevard de l'Hôpital, 75013 Paris, France IHU, Institute of Cardiometabolism and Nutrition, Hôpital Pitié-Salpétrière, Paris, France gerard.helft@aphp.fr.
authors.forename: Gérard
authors.initials: G
authors.lastname: Helft
authors.affiliation: DHU FIRE, Université Paris-Diderot, Sorbonne-Paris-Cité, Paris, France Hôpital Bichat, Assistance Publique Hôpitaux de Paris, INSERM-U1148, Paris, France NHLI, Royal Brompton Hospital, Imperial College, London, UK.
authors.forename: Philippe Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie, boulevard de l'Hôpital, 75013 Paris, France.
authors.forename: Claude
authors.initials: C
authors.lastname: Le Feuvre
authors.affiliation: Centre Hospitalier Versailles, Le Chesnay, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Georges
authors.affiliation: Centre Hospitalier Universitaire Rangueil, Toulouse, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Carrie
authors.affiliation: Espace Médical Mounier, Grenoble, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Dreyfus
authors.affiliation: Centre Hospitalier Universitaire, Angers, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Furber
authors.affiliation: Centre Hospitalier Universitaire, Montpellier, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Leclercq
authors.affiliation: Centre Hospitalier Universitaire, Rouen, France INSERM U 1096, Rouen, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Eltchaninoff
authors.affiliation: Polyclinique de Bergerac, Bergerac, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Falquier
authors.affiliation: Hôpital Lariboisière, Assistance Publique Hôpitaux de Paris, Paris 7, Paris, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Henry
authors.affiliation: Centre Hospitalier Intercommunal Le Raincy-Montfermeil, Montfermeil, France.
authors.forename: Simon
authors.initials: S
authors.lastname: Cattan
authors.affiliation: Hôpital Privé de l'Ouest Parisien, Trappes, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Sebagh
authors.affiliation: Hôpital Tenon, Assistance Publique Hôpitaux de Paris, Paris 6, France.
authors.forename: Pierre-Louis
authors.initials: PL
authors.lastname: Michel
authors.affiliation: Hôpital Cherbourg, Cherbourg, France.
authors.forename: Albert
authors.initials: A
authors.lastname: Tuambilangana
authors.affiliation: Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie, boulevard de l'Hôpital, 75013 Paris, France IHU, Institute of Cardiometabolism and Nutrition, Hôpital Pitié-Salpétrière, Paris, France.
authors.forename: Nadjib
authors.initials: N
authors.lastname: Hammoudi
authors.affiliation: Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris, Paris Pierre et Marie Curie, Paris, France INSERM UMR_S 938, Paris, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Boccara
authors.affiliation: Centre Hospitalier Universitaire Nîmes, Université de Montpellier, Nîmes, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Cayla
authors.affiliation: Centre Hospitalier Universitaire, Bordeaux, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Douard
authors.affiliation: Unité de Recherche Clinique Lariboisière St Louis Hôpital Fernand Widal, Assistance Publique Hôpitaux de Paris, Université Paris-Diderot, Paris, France.
authors.forename: Abdourahmane
authors.initials: A
authors.lastname: Diallo
authors.affiliation: Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie, boulevard de l'Hôpital, 75013 Paris, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Berman
authors.affiliation: Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie, boulevard de l'Hôpital, 75013 Paris, France IHU, Institute of Cardiometabolism and Nutrition, Hôpital Pitié-Salpétrière, Paris, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Komajda
authors.affiliation: Institut de Cardiologie, Hôpital Pitié-Salpétrière, Assistance Publique Hôpitaux de Paris, Université Pierre et Marie Curie, boulevard de l'Hôpital, 75013 Paris, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Metzger
authors.affiliation: Unité de Recherche Clinique Lariboisière St Louis Hôpital Fernand Widal, Assistance Publique Hôpitaux de Paris, Université Paris-Diderot, Paris, France PARTNERS/F-CRIN, Paris, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Vicaut
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000359:Aftercare; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000401:mortality; D004334:Drug Administration Schedule; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine
keywords: Bleeding; Clopidogrel; Drug-eluting stent; Dual antiplatelet therapy; Myocardial infarction; Randomized trial