Background
Dabigatran reduces
ischemic stroke in comparison with
warfarin ; however, given the lack of
antidote , there is concern that it might increase
bleeding when
surgery or invasive
procedures are required.
Methods and ResultsThe current
analysis was undertaken to compare the periprocedural
bleeding risk of
patients in the Randomized Evaluation of Long-Term Anticoagulation
Therapy (RE-LY) trial treated with
dabigatran and
warfarin .
Bleeding rates were evaluated from 7 days before until 30 days after invasive
procedures , considering only the first
procedure for each
patient . A total of 4591
patients underwent at least 1 invasive
procedure 24.7% of
patients received
dabigatran 110 mg, 25.4% received
dabigatran 150 mg, and 25.9% received
warfarin , P 0.34.
Procedures included pacemaker/
defibrillator insertion (10.3%), dental
procedures (10.0%), diagnostic
procedures (10.0%),
cataract removal (9.3%),
colonoscopy (8.6%), and
joint replacement (6.2%). Among
patients assigned to either
dabigatran dose , the last
dose of study
drug was given 49 (35 85) hours before the
procedure on comparison with 114 (87144) hours in
patients receiving
warfarin , P 0.001. There was no significant difference in the rates of periprocedural major
bleeding between
patients receiving
dabigatran 110 mg (3.8%) or
dabigatran 150 mg (5.1%) or
warfarin (4.6%);
dabigatran 110 mg versus
warfarin relative risk , 0.83; 95% CI, 0.59 to 1.17; P 0.28;
dabigatran 150 mg versus
warfarin relative risk , 1.09; 95% CI, 0.80 to 1.49; P 0.58. Among
patients having urgent
surgery , major
bleeding occurred in 17.8% with
dabigatran 110 mg, 17.7% with
dabigatran 150 mg, and 21.6% with
warfarin dabigatran 110 mg;
relative risk , 0.82; 95% CI, 0.48 to1.41; P 0.47;
dabigatran 150 mg
relative risk , 0.82; 95% CI, 0.50 to 1.35; P 0.44.Conclusions ...