Abstract 15537: Dabigatran Versus Warfarin in Very Elderly Patients with Atrial Fibrillation: Results from the RE-LY Trial
BACKGROUND The RE-LY trial compared 2 doses of Dabigatran Etexilate (DE) with warfarin in 18,113 patients with atrial fibrillation (AF). Results showed that the 150 mg bid dose (DE 150) was superior and the 110 mg bid dose (DE 110) was non-inferior compared with warfarin in preventing stroke and systemic embolism (SSE). As the prevalence of AF increases with age, we determined the efficacy and safety of DE versus warfarin in very elderly patients.
METHODS This post-hoc analysis compared outcomes of patients aged ≥ 80 years with patients < 80 years. The relative efficacy and safety of each dose of dabigatran versus warfarin was evaluated using an interaction p-value.
RESULTS Of the 18,113 patients in RE-LY, 3,016 (17%) patients were aged ≥80 years, 720 (4%) patients were ≥85 years and 79 patients (0.4%) were ≥90 years of age. Elderly patients had higher risks of thromboembolic and bleeding outcomes compared with younger patients (Table). The effects of both DE doses compared with warfarin on the primary efficacy outcome of SSE were consistent in those aged <80 and those ≥80. Both DE doses provided large relative risk reductions in intracranial hemorrhage (ICH) compared with warfarin in all patients, including those over the age of 80. For major bleeding there was a significant interaction between age and treatment group due to relatively more major bleeding in patients aged ≥80 than in those < 80 years of age. The results were similar when patients ≥ 85 years of age were compared to those aged <85 years (data not shown in the table).
CONCLUSIONS The benefits in prevention of stroke and ICH with DE versus warfarin are preserved in those in the 9th decade compared to those younger except for major bleeding where, compared with warfarin, there is no difference with DE 110 and an increased bleeding rate with DE 150. Therefore a dose reduction should be considered in the very old patient population.
- © 2012 by American Heart Association, Inc.