The study might have been underpowered to detect meaningful clinical differences between the groups.
Bottom line: Intensive blood sugar control cannot be recommended in acute stroke patients.
Citation: Rosso C, Corvol JC, Pires C, et al. Intensive versus subcutaneous insulin in patients with hyperacute stroke: results from the randomized INSULINFARCT trial. Stroke. 2012;43(9):2343-2349.
Peri-Procedural Bleeding with Dabigatran Versus Warfarin
Clinical question: Is dabigatran more likely to result in periprocedural bleeding when compared to warfarin?
Background: In a randomized clinical trial (RE-LY), dabigatran had a lower risk of major bleeding compared with warfarin. However, given that the anticoagulant effect of dabigatran is difficult to measure and there is not an effective antidote, it is unknown if dabigatran is associated with higher periprocedural rates of bleeding compared with warfarin.
Study design: Post-hoc analysis of the RE-LY trial.
Setting: Multicenter randomized controlled trial.
Synopsis: Patients enrolled in the RE-LY trial all had urgent or elective-invasive procedures recorded. The protocol recommended cessation of warfarin based on local practice, and cessation of dabigatran 24 hours before the procedure; the protocol was amended in 2008 to recommend cessation of dabigatran 24 hours before low-bleeding risk procedures, but two to five hours before high-bleeding-risk procedures (depending on renal function). Periprocedural bleeding was defined as seven days prior and 30 days after the procedure. Dabigatran was interrupted a mean of 49 hours before the procedures, and warfarin for 114 hours. There was no significant difference in major bleeding rates between dabigatran (150-mg dose) and warfarin, which occurred in 5.1% versus 4.6% patients, respectively.
Bottom line: Warfarin and dabigatran have about the same rate of periprocedural bleeding rates, but interruption duration is shorter for dabigatran.
Citation: Healey JS, Eikelboom J, Douketis J, et al. Peri-procedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the randomized evaluation of long-term anticoagulation therapy (RE-LY) randomized trial. Circulation. 2012;126(3):343-348.