"Bridging Anticoagulation in Patients with Atrial Fibrillation".The New England Journal of Medicine. 2015. 373(9):823-833.
Links to original sources: Wiki Journal Post Full Journal Article
Contents
1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcomes 8.2 Secondary Outcomes 9 Criticisms 10 Funding 11 Further Reading
In patients with atrial fibrillation who require a temporary interruption of warfarin for an elective operation or other elective invasive procedure, is forgoing bridging anticoagulation with low-molecular-weight heparin noninferior to perioperative bridging for the prevention of arterial thromboembolism and does it decrease the risk of major bleeding?
For patients with atrial fibrillation who require a temporary interruption of warfarin for an elective procedure, a strategy of forgoing bridging anticoagulation was noninferior to perioperative bridging with low-molecular-weight heparin for preventing arterial thromboembolism and reduced the risk of major bleeding.
The question of using bridging anticoagulation during perioperative interruption of warfarin treatment in patients with atrial fibrillation was uncertain. The BRIDGE trial demonstrated that discontinuing warfarin without bridging anticoagulation was noninferior to bridging for the prevention of arterial thromboembolism and offered a superior safety profile with significantly fewer instances of major bleeding.
As of the last knowledge update, no guidelines have been published that reflect the results of this trial.
- Randomized, double-blind, placebo-controlled trial - N=1,884 - No-bridging group (placebo) (n=950) - Bridging group (dalteparin) (n=934) - Setting: 108 centers in the United States and Canada - Enrollment: 2009-2014 - Mean follow-up: 30 days after the procedure - Analysis: Intention-to-treat - Primary outcomes: Arterial thromboembolism and major bleeding within 30 days after the procedure
Inclusion Criteria
- Age ≥18 years - Chronic atrial fibrillation or flutter, confirmed by previous electrocardiography or pacemaker interrogation - Receiving warfarin therapy for ≥3 months with an INR therapeutic range of 2.0 to 3.0 - Undergoing an elective operation or other invasive procedure requiring warfarin interruption - At least one CHADS2 stroke risk factor
Exclusion Criteria
- Mechanical heart valve - Stroke, systemic embolism, or transient ischemic attack within the previous 12 weeks - Major bleeding within the previous 6 weeks - Creatinine clearance <30 ml/min - Platelet count <100×103/mm³ - Planned cardiac, intracranial, or intraspinal surgery
Baseline Characteristics
- Mean age: 71.7 years - Male: 73.4% - Mean body weight: 95.8 kg - Mean CHADS2 score: 2.3
- Discontinuation of warfarin 5 days before the procedure - Randomization to placebo (no-bridging) or bridging treatment with dalteparin (100 IU/kg subcutaneously twice daily) starting 3 days before the procedure until 24 hours before the procedure and then for 5 to 10 days after the procedure - Resumption of warfarin within 24 hours after the procedure
- Arterial thromboembolism: 0.4% in the no-bridging group vs. 0.3% in the bridging group (risk difference, 0.1 percentage points; 95% CI, −0.6 to 0.8; P=0.01 for noninferiority; P=0.73 for superiority) - Major bleeding: 1.3% in the no-bridging group vs. 3.2% in the bridging group (relative risk, 0.41; 95% CI, 0.20 to 0.78; P=0.005 for superiority)
- Acute myocardial infarction, deep-vein thrombosis, pulmonary embolism, or death: no significant difference between the two groups - Minor bleeding: significantly lower in no-bridging group (12.0% vs. 20.9%, P<0.001)
- The trial did not include patients with mechanical heart valves, and few patients had high CHADS2 scores. - The trial did not include procedures with high rates of arterial thromboembolism and bleeding, such as major surgery. - The observed rate of arterial thromboembolism was lower than expected, potentially affecting the power to detect a clear benefit of bridging. - The trial was conducted during the period where the use of warfarin is being overtaken by newer direct oral anticoagulants.
Supported by grants from the National Heart, Lung, and Blood Institute for the clinical coordinating center and for the data coordinating center. Dalteparin supplied by Eisai through an unrestricted investigator-initiated grant.
Please refer to the original publication for a complete list of references and further reading.