title: An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin K antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention (PIONEER AF-PCI).
abstract: BACKGROUND
  Guidelines recommendations regarding anticoagulant therapy after percutaneous coronary intervention (PCI) among patients with atrial fibrillation (AF) rely on retrospective, nonrandomized observational data. Currently, patients are treated with triple-therapy (dual antiplatelet therapy [DAPT] + oral anticoagulation therapy), but neither the duration of DAPT nor the level of anticoagulation has been studied in a randomized fashion. Recent studies also suggest dual pathway therapy with clopidogrel plus oral anticoagulation therapy may be superior, and other studies suggest that novel oral anticoagulants such as rivaroxaban may further improve patient outcomes.
  
  
  METHODS
  PIONEER AF-PCI (ClinicalTrials.gov NCT01830543) is an exploratory, open-label, randomized, multicenter clinical study assessing the safety of 2 rivaroxaban treatment strategies and 1 vitamin K antagonist (VKA) treatment strategy in subjects who have paroxysmal, persistent, or permanent nonvalvular AF and have undergone PCI with stent placement. Approximately 2,100 subjects will be randomized in a 1:1:1 ratio to receive either rivaroxaban 15 mg once daily plus clopidogrel 75 mg daily for 12 months (a WOEST trial-like strategy), or rivaroxaban 2.5 mg twice daily (with stratification to a prespecified duration of DAPT 1, 6, or 12 months, an ATLAS trial-like strategy), or dose-adjusted VKA once daily (with stratification to a prespecified duration of DAPT 1, 6, or 12 months, traditional triple therapy). All patients will be followed up for 12 months for the primary composite end point of Thrombolysis in Myocardial Infarction major bleeding, bleeding requiring medical attention, and minor bleeding (collectively, clinically significant bleeding).
  
  
  CONCLUSIONS
  The PIONEER AF-PCI study is the first randomized comparison of VKA vs novel oral anticoagulant therapy in patients with NVAF receiving antiplatelet therapy after PCI to assess the relative risks of bleeding complications.
authors.affiliation: Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA. Electronic address: mgibson@perfuse.org.
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.affiliation: Department of Cardiology, Mount Sinai Medical Center, Mount Sinai Medical School, New York, NY.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: Heart Center, Department for Cardiology and Angiology I, University of Freiburg, Freiburg, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Bode
authors.affiliation: Department of Cardiology, Mount Sinai Medical Center, Mount Sinai Medical School, New York, NY.
authors.forename: Johnathan
authors.initials: J
authors.lastname: Halperin
authors.affiliation: Radboud University Medical Center, Nijmegen, the Netherlands.
authors.forename: Freek
authors.initials: F
authors.lastname: Verheugt
authors.affiliation: Jansen Pharmaceuticals, Inc, Titusville, NJ.
authors.forename: Peter
authors.initials: P
authors.lastname: Wildgoose
authors.affiliation: Bayer Pharmaceuticals, Inc, Berlin, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: van Eickels
authors.affiliation: University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom.
authors.forename: Gregory Y H
authors.initials: GY
authors.lastname: Lip
authors.affiliation: Division of Cardiology, Newark Beth Israel Medical Center, Newark, NJ.
authors.forename: Marc
authors.initials: M
authors.lastname: Cohen
authors.affiliation: Aarhus University Hospital, Medical Department, Hospital Unit West, Herning, Denmark.
authors.forename: Steen
authors.initials: S
authors.lastname: Husted
authors.affiliation: Duke Clinical Research Institute, Durham, NC.
authors.forename: Eric
authors.initials: E
authors.lastname: Peterson
authors.affiliation: Centre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.
authors.forename: Keith
authors.initials: K
authors.lastname: Fox
mesh_terms: D000284:Administration, Oral; D000368:Aged; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy*; D000077144:Clopidogrel; D017023:Coronary Angiography; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D004562:Electrocardiography; D065427:Factor Xa Inhibitors / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage*; D017202:Myocardial Ischemia / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D012189:Retrospective Studies; D000069552:Rivaroxaban; D013876:Thiophenes / Q000008:administration & dosage*; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome; D014812:Vitamin K / Q000037:antagonists & inhibitors*
chemical_list: D065427:Factor Xa Inhibitors; D009025:Morpholines; D010975:Platelet Aggregation Inhibitors; D013876:Thiophenes; D014812:Vitamin K; D000069552:Rivaroxaban; D000077144:Clopidogrel; D013988:Ticlopidine