Dabigatran voordelen consistent voor patiënten met voorgaande stroke

Nieuws - 8 nov. 2010

Dabigatran benefits consistent for patients with previous stroke

09 November 2010

Dabigatran is comparable with warfarin in atrial fibrillation patients with a history of stroke or transient ischemic attack (TIA), shows further analysis of the RE-LY study.

In a prespecified subgroup analysis, Hans-Christoph Deiner (University Hospital Essen, Germany) and colleagues assessed outcomes in 1195 patients with previous stroke or TIA who were randomly assigned to receive dabigatran 110 mg, 1233 who received dabigatran 150 mg, and 1195 who were given dose-adjusted warfarin.

Patients with previous cerebrovascular events "are at high risk of recurrent stroke and are more susceptible to adverse events from anticoagulation, in particular cerebral hemorrhage," the team notes in The Lancet Neurology.

Rates of stroke or systemic embolism over the 2-year follow-up period were similar with all three treatments, at 2.78% per year among patients on warfarin, and 2.32% and 2.07% per year among those on dabigatran 110 mg and 150 mg, respectively.

The major bleeding rate was 4.15% per year among patients taking warfarin and among those taking dabigatran 150 mg, but was significantly lower in the dabigatran 110 mg group, at 2.74% per year.

When assessing data for the rest of the 18,113-strong RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial population, the researchers found no difference in the effect of dabigatran on outcomes between patients with and without previous stroke or TIA.

There was no evidence for an interaction between previous stroke/TIA and treatment allocation on any outcome except for vascular death, which was lower in the dabigatran 110 mg than in the warfarin group. However, there was no interaction for the outcome of all-cause mortality, leading the researchers to stress that "we cannot conclude that there is a true benefit on mortality."

In an accompanying commentary, Deirdre Lane and Gregory Lip (City Hospital, Birmingham, UK) said that the study is "important for several reasons," the major one being that there is currently very little evidence for the benefits and safety of oral anticoagulation in patients with previous stroke.

But they stressed that evidence is still needed for dabigatran use in patients with very recent stroke or TIA (within 2 weeks), as this subgroup was excluded from RE-LY.

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