title: Strategy of continued vs interrupted novel oral anticoagulant at time of device surgery in patients with moderate to high risk of arterial thromboembolic events: The BRUISE CONTROL-2 trial.
abstract: BACKGROUND
  Patients who require perioperative anticoagulation during cardiac implantable electronic device surgery are at increased risk for bleeding complications. The BRUISE CONTROL trial demonstrated that continuing warfarin was safer than heparin bridging, reducing the incidence of clinically significant pocket hematoma. Novel oral anticoagulants are being increasingly prescribed in place of warfarin. The best perioperative management of these new anticoagulants is unknown.
  
  
  METHODS
  A randomized controlled trial to investigate whether a strategy of continued vs interrupted novel oral anticoagulant (dabigatran, rivaroxaban, or apixaban) at the time of device surgery, in patients with moderate to high risk of arterial thromboembolic events, reduces the incidence of clinically significant hematoma (defined as a hematoma requiring reoperation and/or resulting in prolongation of hospitalization, and/or requiring interruption of anticoagulation). The secondary outcomes include components of the primary outcome, composite of all other major perioperative bleeding events, thromboembolic events, all-cause mortality, cost-effectiveness, patient quality of life, perioperative pain, and satisfaction. Planned analyses include descriptive statistics of all baseline variables. For the primary outcome, interrupted vs continued novel oral anticoagulant arms will be compared using the χ(2) test. If any clinically significant differences are identified, a logistic regression analysis will be conducted. Quality of life will be assessed using EuroQol-5D, and perioperative pain using a visual analog scale.
  
  
  CONCLUSIONS
  BRUISE CONTROL-2 is a randomized trial evaluating the best strategy to manage novel oral anticoagulants at the time of device surgery. We hypothesize that device surgery can be performed safely without interruption of these medications.
authors.affiliation: McGill University Health Centre, Montreal, Quebec, Canada; Hôpital Sacré-Coeur de Montréal, Montreal, Quebec, Canada. Electronic address: vidal.essebag@mcgill.ca.
authors.forename: Vidal
authors.initials: V
authors.lastname: Essebag
authors.affiliation: Population Health Research Institute, Hamilton, Ontario, Canada.
authors.forename: Jeff S
authors.initials: JS
authors.lastname: Healey
authors.affiliation: Centre Hospitalier Université de Sherbrooke, Sherbrooke, Quebec, Canada.
authors.forename: Felix
authors.initials: F
authors.lastname: Ayala-Paredes
authors.affiliation: McGill University Health Centre, Montreal, Quebec, Canada; Galilee Medical Center, Nahariya, Israel.
authors.forename: Eli
authors.initials: E
authors.lastname: Kalfon
authors.affiliation: Centre Hospitalier Université de Montréal, Montreal, Quebec, Canada.
authors.forename: Benoit
authors.initials: B
authors.lastname: Coutu
authors.affiliation: University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
authors.forename: Pablo
authors.initials: P
authors.lastname: Nery
authors.affiliation: Southlake Regional Health Centre, Newmarket, Ontario, Canada.
authors.forename: Atul
authors.initials: A
authors.lastname: Verma
authors.affiliation: Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Sapp
authors.affiliation: Quebec Heart and Lung Institute, Sainte Foy, Quebec, Canada.
authors.forename: Francois
authors.initials: F
authors.lastname: Philippon
authors.affiliation: Division of Cardiology, Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada.
authors.forename: Roopinder K
authors.initials: RK
authors.lastname: Sandhu
authors.affiliation: University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Doug
authors.initials: D
authors.lastname: Coyle
authors.affiliation: Population Health Research Institute, Hamilton, Ontario, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Eikelboom
authors.affiliation: University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
authors.forename: George
authors.initials: G
authors.lastname: Wells
authors.affiliation: University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
authors.forename: David H
authors.initials: DH
authors.lastname: Birnie
mesh_terms: D000284:Administration, Oral; D000925:Anticoagulants / Q000008:administration & dosage*; D001145:Arrhythmias, Cardiac / Q000628:therapy; D002170:Canada / Q000453:epidemiology; D002423:Cause of Death / Q000639:trends; D000069604:Dabigatran / Q000008:administration & dosage; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology*; D006801:Humans; D015994:Incidence; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D017410:Practice Guidelines as Topic; D011300:Preoperative Care / Q000379:methods*; D011446:Prospective Studies; D011720:Pyrazoles / Q000008:administration & dosage; D011728:Pyridones / Q000008:administration & dosage; D000069552:Rivaroxaban / Q000008:administration & dosage; D015996:Survival Rate / Q000639:trends; D013923:Thromboembolism / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D014859:Warfarin / Q000008:administration & dosage
chemical_list: D000925:Anticoagulants; D011720:Pyrazoles; D011728:Pyridones; C522181:apixaban; D014859:Warfarin; D000069552:Rivaroxaban; D000069604:Dabigatran