Pradaxa safe, effective for recurrent VTE prevention
Warfarin and Pradaxa were both safe and effective at preventing recurrent venous thrombotic events in patients with cerebral venous thrombosis, according to findings from a randomized clinical trial published in JAMA Neurology.
“Non-vitamin K oral anticoagulants have not been evaluated in randomized controlled trials in [cerebral venous thrombosis],” José M. Ferro, MD, PhD, of the medicine faculty at the Universidade de Lisboa in Portugal, and colleagues wrote.
Researchers randomly assigned 120 patients with acute cerebral venous thrombosis (mean age, 45.2 years; 55% women) in a 1:1 ratio to receive either dose-adjusted warfarin or a 150 mg dose of Pradaxa (dabigatran etexilate, Boehringer Ingelheim) twice daily for 24 weeks.
There were no recurrent VTEs. Two major (intercranial) bleeding events (3.3%; 95% CI, 0.4-11.5) and one clinically relevant nonmajor bleeding event (1.7%; 95% CI, 0-8.9) occurred in the warfarin cohort. One major (intestinal) bleeding event (1.7%; 95% CI, 0-8.9) was recorded in the dabigatran group. Recanalization occurred in 35 patients in the warfarin cohort (67.3%; 95% CI, 52.9-79.7) and 33 patients in the dabigatran group (60%; 95% CI, 45.9-73).
“These results are in line with evidence that dabigatran is at least noninferior in efficacy compared with warfarin in indications other than cerebral venous thrombosis, presenting fewer bleeding events, specifically intracranial hemorrhages,” Ferro and colleagues wrote. “Because of the limited sample size, we could not demonstrate the noninferiority or superiority of either treatment,” they added. – by Janel Miller
Disclosures : Ferro reports receiving personal fees from Boehringer Ingelheim during the conduct of the study; personal fees from Bayer and Bristol-Myers Squibb outside the submitted work; and a grant for José Ferro Lab at Instituto de Medicina Molecular from Bayer. Please see the study for all other authors relevant financial disclosures.