STUDY SUMMARY
When it comes to stroke/TIA, there’s no advantage to bridging
This double-blind, placebo-controlled trial compared bridging with dalteparin, a form of LMWH, to placebo among 1,884 patients with atrial fibrillation who were taking warfarin and whose anticoagulation therapy needed to be interrupted for an elective procedure. Patients were included if they were receiving warfarin to prevent stroke and had been taking it for at least 12 weeks, with a goal International Normalized Ratio (INR) of 2.0 to 3.0. Exclusion criteria included having a mechanical heart valve or having a stroke/transient ischemic attack (TIA; 12 weeks prior) or major bleeding (six weeks prior). Patients undergoing cardiac, intracranial, and intraspinal surgeries were also excluded from the study.
The mean CHADS2 score was 2.3; 38.3% of patients had a CHADS2 score ≥ 3, and 9.4% of patients had a history of stroke. Forty-four percent of patients underwent a gastrointestinal procedure, 17.2% underwent a cardiothoracic procedure, and 9.2% underwent an orthopedic procedure.
Patients stopped taking warfarin five days before their procedure and began subcutaneous dalteparin (100 IU/kg) or an identical placebo three days before the procedure. The dalteparin/placebo was stopped 24 hours before the procedure and restarted after the procedure, until the patient’s INR was in the therapeutic range. Warfarin was resumed on the evening of the procedure or the following day.
The primary efficacy outcome was ATE, including stroke, TIA, or systemic embolism. The primary safety endpoint was major bleeding (defined as bleeding at a critical anatomic site, symptomatic or clinically overt bleeding, or a decrease in hemoglobin > 2 g/dL). Secondary efficacy and safety outcomes included minor bleeding, acute myocardial infarction, deep vein thrombosis, pulmonary embolism, and death. Outcomes were assessed within 37 days of the procedure.
The incidence of ATE was 0.4% (four events) in the no-bridging group vs 0.3% (three events) in the bridging group. Major bleeding occurred in 1.3% of the no-bridging group (12 events) and in 3.2% of the bridging group (29 events), indicating that no bridging was superior in terms of the major bleeding outcome (number needed to harm [NNH], 53; relative risk [RR], 0.41).
The no-bridging group also had significantly fewer minor bleeds in comparison to the bridging group (NNH, 11; 12% vs 20.9%). There were no differences between groups in other secondary outcomes.
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