Results from a new sub-analysis of the RE-LY trial support consistent benefit of dabigatran (Pradaxa, Boehringer Ingelheim) over warfarin in difficult-to-treat patients with non-valvular atrial fibrillation and previous symptomatic heart failure. The results were published in the European Journal of Heart Failure.
The outcomes in heart failure patients were consistent with the results from the main RE-LY trial. Dabigatran 150mg twice daily reduced the risk of stroke including ischaemic stroke with similar rates of major bleeding compared to warfarin and dabigatran, 110mg twice daily showed similar rates of stroke but significantly reduced major bleeding compared to warfarin.
Importantly, both doses of dabigatran significantly reduced intracranial as well as total bleeding. The new results support that dabigatran can also be beneficial for patients with multiple co-morbidities and further reinforce the consistent efficacy and safety profile of dabigatran that was shown in the main trial and various previous RE-LY sub-analyses in several other patient subgroups, including patients with type 2 diabetes.
“Atrial fibrillation and heart failure frequently coexist and are known to worsen patient prognoses. Heart failure is a specific risk factor for stroke in atrial fibrillation patients, therefore these patients especially need anticoagulant treatment,” said Jorge Ferreira, cardiologist, Hospital Santa Cruz, Lisbon, Portugal. “However, anticoagulation with a vitamin-K-antagonist in these patients is often associated with poor INR control. This results in more challenging management and impacts the overall efficacy and safety of VKA treatment.”
From a total of 18,113 patients with non-valvular atrial fibrillation participating in the landmark RE-LY trial, 4,904 patients (27%) had previous symptomatic heart failure. In the sub-analysis comparing the main outcomes of stroke and systemic embolism as well as major bleeding between patients with and without previous symptomatic heart failure, the results were consistent with no statistically significant differences (p-values for interaction) between the two patient groups.
