Vidal Essebag1, Jeff S Healey2, Felix Ayala-Paredes3, Eli Kalfon4, Benoit Coutu5, Pablo Nery6, Atul Verma7, John Sapp8, Francois Philippon9, Roopinder K Sandhu10, Doug Coyle11, John Eikelboom2, George Wells6, David H Birnie6. 1. McGill University Health Centre, Montreal, Quebec, Canada; Hôpital Sacré-Coeur de Montréal, Montreal, Quebec, Canada. Electronic address: vidal.essebag@mcgill.ca. 2. Population Health Research Institute, Hamilton, Ontario, Canada. 3. Centre Hospitalier Université de Sherbrooke, Sherbrooke, Quebec, Canada. 4. McGill University Health Centre, Montreal, Quebec, Canada; Galilee Medical Center, Nahariya, Israel. 5. Centre Hospitalier Université de Montréal, Montreal, Quebec, Canada. 6. University of Ottawa Heart Institute, Ottawa, Ontario, Canada. 7. Southlake Regional Health Centre, Newmarket, Ontario, Canada. 8. Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada. 9. Quebec Heart and Lung Institute, Sainte Foy, Quebec, Canada. 10. Division of Cardiology, Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada. 11. University of Ottawa, Ottawa, Ontario, Canada.
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/ DESIGN: 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. DISCUSSION: 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.
RCT Entities:
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/ DESIGN: 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. DISCUSSION: 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.
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