Dabigatran plus antiplatelet therapy ‘safe, effective versus warfarin’
MedWire News: A subgroup analysis of the RE-LY trial shows that the oral anticoagulant dabigatran etexilate provides better protection against stroke than does well-controlled warfarin, at a relatively low risk for bleeding, whether used alone or concomitantly with antiplatelet therapy.
"In patients with atrial fibrillation, at least one risk factor for stroke, and indications for antiplatelet use, dabigatran is a safe and effective choice for oral anticoagulation," said RE-LY co-investigator Antonio Dans (Philippines College of Medicine, Manila).
"In [atrial fibrillation] patients who need oral anticoagulation but are at high risk for bleeding, one may choose to stop antiplatelets, use the lower dose of dabigatran, or do both. The choice will depend on careful assessment of the routine need for both drugs."
The RE-LY (Randomized Evaluation of Long-term anticoagulant therapY) trial showed that the oral anticoagulant dabigatran was statistically non-inferior to well-controlled warfarin (median time in therapeutic range of 67%) for the prevention of stroke or systemic embolic events in patients with atrial fibrillation.
The current study is a post hoc analysis of a subgroup of patients in RE-LY receiving dabigatran (either 110 or 150 mg bid) or warfarin plus an antiplatelet agent. Antiplatelet therapy was defined as the use of either aspirin or clopidogrel at any time during the study period.
Presenting the findings at the European Society of Cardiology annual congress, in Paris, France, Dans reported that the hazard ratio (HR) for the primary efficacy endpoint among patients on dabigatran 150 mg and an antiplatelet agent versus warfarin was 0.80. Rates of bleeding were similar between the groups (HR=0.93).
Dabigatran 110 mg bid was comparable in efficacy to warfarin among patients on antiplatelet therapy (HR=0.93). Patients on the lower dabigatran dose had a non-significant reduction in major bleeding versus warfarin (HR=0.82).
In all treatment arms, concomitant antiplatelet therapy increased major bleeding risk, at HRs of 1.5-1.7, but the risk increases did not differ among the treatment groups.
"Low-dose dabigatran seems to be a good candidate for patients with atrial fibrillation in need of antiplatelet therapy, for instance in use with stenting, but this has to be confirmed in a new randomized trial against warfarin," said invited discussant Freek Verheugt (Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands).
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By Neil Osterweil