Abstract 12422: Influence of Polypharmacy on the Efficacy And Safety Of Dabigatran Versus Warfarin for the Treatment of Acute Venous Thromboembolism: A Pooled Analysis of RE-COVER® and RE-COVER II™
Background: Polypharmacy in patients treated for acute venous thromboembolism (VTE) has been associated with increased bleeding risk during warfarin (W) treatment. Polypharmacy is common in patients with VTE, who are likely to carry a greater burden of comorbidity, and may itself indicate increased VTE risk. In RE-COVER® and RE-COVER II™, dabigatran etexilate (DE) showed similar efficacy and lower bleeding vs W.
Objective: To evaluate the impact of polypharmacy on the efficacy/safety of DE vs W, we conducted a pooled post-hoc analysis of RE-COVER®/RE-COVER II™ subgroups taking ≤3 or >3 concomitant medications (con-meds) at baseline.
Methods: Patients with acute VTE, initially on parenteral anticoagulation, were randomized to W (parallel initiation; target INR range 2.0–3.0) or DE 150 mg bid for 6 months. The efficacy endpoint was recurrent, symptomatic VTE/VTE-related death at the end of post-treatment follow-up (6 months + 30 days). Safety endpoints were centrally adjudicated major bleeding events (MBEs), composite of MBEs or clinically relevant non-major bleeding (MBEs/CRBEs), and any bleeds during the 6-month oral-only treatment period (DE or W alone, double-dummy).
Results: 2553 patients received DE and 2554 W; both groups had similar proportions taking con-meds: ≤3, 47.5% and 48.3%; >3, 52.5% and 51.7% for DE and W, respectively. VTE/VTE-related deaths occurred at low rates (Graph), with no statistically significant differences between treatments. Irrespective of number of con-meds, rates of MBEs, MBE/CRBEs, and any bleeds were lower with DE vs W, and statistically significant for MBE/CRBEs and any bleeds. With both treatments, more con-meds generally corresponded with greater risks of bleeds and a slightly greater risk of VTE/VTE-related deaths.
Conclusion: Polypharmacy was an indicator of increased bleeding risk with both anticoagulants; however, irrespective of number of con-meds, safety outcomes were better with DE and efficacy was similar to W.
Author Disclosures: S.Z. Goldhaber: None. H. Eriksson: None. A. Kakkar: None. S.M. Schellong: None. M. Feuring: None. M. Fraessdorf: None. J. Kreuzer: None. S. Schulman: None.
- © 2015 by American Heart Association, Inc.