title: Bridge or continue Coumadin for device surgery: a randomized  controlled trial rationale and design.
abstract: OBJECTIVE
  Many patients requiring cardiac arrhythmia device surgery are on chronic oral anticoagulation therapy. The periprocedural management of their anticoagulation presents a dilemma to physicians, particularly in the subset of patients with moderate-to-high risk of arterial thromboembolic events. Physicians have responded by treating patients with bridging anticoagulation while oral anticoagulation is temporarily discontinued. However, there are a number of downsides to bridging anticoagulation around device surgery; there is a substantial risk of significant device pocket hematoma with important clinical sequelae; bridging anticoagulation may lead to more arterial thromboembolic events and bridging anticoagulation is expensive.
  
  
  RESULTS
  In response to these issues, a number of centers have explored the option of performing device surgery without cessation of oral anticoagulation. The observational data suggest a greatly reduced hematoma rate with this strategy. Despite these encouraging results, most physicians are reluctant to move to operating on continued Coumadin in the absence of confirmatory data from a randomized trial.
  
  
  CONCLUSIONS
  We have designed a prospective, single-blind, randomized, controlled trial to address this clinical question. In the conventional arm, patients will be bridged. In the experimental arm, patients will continue on oral anticoagulation and the primary outcome is clinically significant hematoma. Our study has clinical relevance to at least 70 000 patients per year in North America.
authors.affiliation: University of Ottawa Heart Institute, Ottawa, Canada. dbirnie@ottawaheart.ca
authors.forename: David
authors.initials: D
authors.lastname: Birnie
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Healey
authors.forename: Andrew
authors.initials: A
authors.lastname: Krahn
authors.forename: Vidal
authors.initials: V
authors.lastname: Essebag
authors.forename: Soori
authors.initials: S
authors.lastname: Sivakumaran
authors.forename: Anthony
authors.initials: A
authors.lastname: Tang
authors.forename: Christopher
authors.initials: C
authors.lastname: Simpson
mesh_terms: D000925:Anticoagulants / Q000008:administration & dosage*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects; D003362:Cost-Benefit Analysis; D006406:Hematoma / Q000209:etiology; D006801:Humans; D010138:Pacemaker, Artificial; D019990:Perioperative Care; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013923:Thromboembolism / Q000209:etiology / Q000517:prevention & control; D014859:Warfarin / Q000008:administration & dosage*
chemical_list: D000925:Anticoagulants; D014859:Warfarin