New data from the RE-LY trial show that dabigatran is associated with similar rates of bleeding and thrombotic complications to warfarin in patients who have to undergo invasive procedures and surgery.
The study, published in Circulation on June 14 (Circulation 2012; 126:343–8. http://dx.doi.org/10.1161/CIRCULATIONAHA.111.090464), reported bleeding rates in RE-LY from seven days before until 30 days following invasive procedures in a total of 4,591 patients. Procedures included pacemaker/defibrillator insertion, dental procedures, diagnostic procedures, cataract removal, colonoscopy, and joint replacement.
Among patients assigned to dabigatran, the last dose of study drug was given an average of 49 hours prior to the procedure, compared with 114 hours in patients receiving warfarin. Bridging anticoagulation with heparin was given in 28% of warfarin patients and 16% of dabigatran patients. Peri-procedural bleeding rates were similar in all three groups.
An accompanying editorial points out that invasive procedures were very common in the two years of this trial, underscoring the clinical importance of this issue. It also highlights the “very low risk of thromboembolic peri-procedural events” – just 0.5% – showing that the risk of briefly interrupting anticoagulation is low.
The editorial notes that these results “should serve as a reassurance to those who are concerned about the lack of a standard way to measure anticoagulant effect and of a specific antidote with dabigatran,” and “support the welcome hypothesis that novel shorter-acting oral anticoagulants will simplify the process of interrupting therapy for elective invasive procedures”.