Bridging Anticoagulation in Patients Who Require Temporary Interruption of Warfarin for Elective Surger or Procedure - the BRIDGE Trial: Design, Rationale and Clinical Implications
Authors: Spyropoulos Alex C , Douketis James , Kaatz Scott , Ortel Thomas L. 
Published: October 2019

Abstract 4327

Background:

Low-molecular-weight heparin (LMWH) bridging, usually in treatment doses, may be used in patients with atrial fibrillation (AF) on chronic warfarin who require interruption for an invasive procedure or surgery to minimize the period of sub-therapeutic anticoagulation with the aim of reducing perioperative thromboembolism, as warfarin interruption and surgery may confer a prothrombotic state. However, the efficacy and safety of LMWH bridging therapy has not been tested in a rigorous and large randomized trial. We describe the design of the BRIDGE Trial, explain the rationale for the study population and bridging dose regimen, and discuss its implications for clinical practice.

Hypothesis:

No bridging is non-inferior to LMWH bridging for the prevention of arterial thromboembolism and is superior to bridging for perioperative bleeding.

Design:

BRIDGE is a NHLBI-funded randomized, multi-center, placebo-controlled trial assessing a standardized bridging protocol (NCT00786474).

Population:

3,626 adults with AF from at least 45 centers in the United States and Canada with ≥1 additional stroke risk factor who require interruption of warfarin for surgery/invasive procedure and do not have a prior stroke (within 12 weeks), major bleeding (within 6 weeks), severe renal insufficiency (CrCl <30 mL/min), thrombocytopenia (<100,000 × 109/L) or contraindication to perioperative LMWH.

Intervention:

Dalteparin, 100 IU/kg SC twice-daily, before and after surgery compared to SC placebo injections.

Outcomes:

1) primary outcomes: arterial thromboembolism (ischemic stroke, transient ischemic attack or systemic embolism) and major bleeding from perioperative Day −5 to Day +30; 2) secondary outcomes: acute coronary syndrome, venous thrombosis, minor bleeding.

Analysis:

Comparison of prespecified outcomes in LMWH and placebo groups.

BRIDGE is an ongoing trial designed to definitively assess the efficacy and safety of LMWH bridging in patients with AF who require interruption of warfarin for an invasive procedure or surgery and aims to establish a standard-of-care for patients who require perioperative interruption of anticoagulants.

Disclosures:

Spyropoulos: sanofi: Consultancy, Membership on an entity’s Board of Directors or advisory committees; Eisai: Consultancy; Pfizer: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau. Off Label Use: Low molecular weight heparin dalteparin for bridging therapy. Douketis:sanofi: Membership on an entity’s Board of Directors or advisory committees, Speakers Bureau, event adjudication; bristol meyer squibb: event adjudication; Pfizer: Speakers Bureau; boehringer-ingelheim: Membership on an entity’s Board of Directors or advisory committees. Kaatz:Boehringer-Ingelheim: Consultancy, Research Funding, Speakers Bureau; Bristol Myer Squibb: Consultancy, Research Funding; Bayer: Research Funding; National Institute of Health: Research Funding; Canadian Institute of Health Research: Research Funding; Pfizer: Consultancy; Johnson and Johnson: Consultancy; Ortho-McNeil: Consultancy; GlaxoSmithKline: Speakers Bureau; AC Forum: Membership on an entity’s Board of Directors or advisory committees; National Certification Board of Anticoagulation Providers: Membership on an entity’s Board of Directors or advisory committees; National Blood Clot Alliance: Membership on an entity’s Board of Directors or advisory committees. Ortel:Eisai: Research Funding; Instrumentation Laboratory: Consultancy; GSK: Research Funding.