Abstract 17513: Edoxaban for the Prevention of Thromboembolism in Patients With Bioprosthetic Valves in ENGAGE AF-TIMI 48
Background: Randomized data with NOACs in patients (pts) with atrial fibrillation (AF) and bioprosthetic valves (BPV) are scarce. We compared outcomes in pts with BPV and in pts with valvular heart disease (VHD) but no BPV in ENGAGE AF-TIMI 48, which randomized pts to edoxaban (E) vs warfarin (W).
Methods: Pts with mechanical valves or mod-severe mitral stenosis were excluded from the trial. VHD was defined as aortic or mitral valve surgery, mod-severe aortic stenosis/regurgitation, or mod-severe mitral regurgitation. Outcomes included stroke or systemic embolism (SSE), ischemic stroke or systemic embolism (ISSE), major bleeding (MB), and a net clinical outcome (NCO = SSE, MB, CV death). Hazard ratios (HRs) comparing BPV vs no BPV were adjusted for baseline differences. HRs comparing higher-dose E (HDE) vs W stratified by BPV status were derived using Cox proportional hazards modeling. An interaction term was used to test for effect modification.
Results: Of 191 pts with BPV (31% aortic, 69% mitral), the mean age was 73.3 ± 8.6 yrs, 63.4% were male, and median CHA2DS2-VASc score was 5. Pts with BPV had higher adjusted risks of SSE (HRadj 1.84, p=0.027) and ISSE (HRadj 1.88, p=0.033), but not of MB or the NCO compared to other pts with VHD (n=2633). No effect modification (p-int >0.05) by BPV presence or absence was evident for SSE, ISSE, or MB with HDE vs W (Figure). Among pts with BPV, the risk of SSE (HR 0.37; [0.10-1.40]) and ISSE (HR 0.48; [0.12-1.96]) was no different between HDE (n=63) and W (n=70). For the NCO, the benefit of HDE vs W in pts with BPV (HR 0.45; [0.23-0.90]) was greater than in other pts with VHD (HR 1.01; [0.84-1.22]); p-int=0.03.
Conclusions: Although pts with BPV are at higher adjusted risk of SSE and ISSE than other pts with VHD, pts with BPV had no greater risk of SSE or ISSE when treated with HDE compared to W. Patients with BPV had better net outcomes with HDE than with W and the relative benefit may be even greater in pts with BPV than in those without BPV.
Author Disclosures: A. Carnicelli: None. R. De Caterina: Research Grant; Significant; Boehringer Ingelheim, Daiichi Sankyo. Honoraria; Modest; Bristol-Myers Squibb, Pfizer, Bayer, Merck, Novartis, Boehringer Ingelheim, Daiichi Sankyo. Consultant/Advisory Board; Modest; Bayer, Merck, Novartis, Boehringer-Ingelheim, Daiichi Sankyo. J. Halperin: Consultant/Advisory Board; Modest; Bayer AG HealthCare, Boehringer Ingelheim, Daiichi Sankyo, Johnson & Johnson, Ortho-McNeil-Janssen Pharmaceuticals, Pfizer, Sanofi Aventis, AstraZeneca, Biotronik, Boston Scientific, Janssen, Medtronic, Pfizer. G. Renda: Speakers Bureau; Modest; Boehringer Ingelheim Pharmaceuticals, Inc., Bayer HealthCare, Daichi Sankyo, Inc.. Consultant/Advisory Board; Modest; Boehringer Ingelheim Pharmaceuticals, Inc. C. Ruff: Research Grant; Significant; Daiichi Sankyo. Honoraria; Significant; Boehringer Ingelheim, Daiichi Sankyo, Bayer, Portola. Consultant/Advisory Board; Significant; Boehringer Ingelheim, Daiichi Sankyo. M. Trevisan: Research Grant; Significant; Daiichi Sankyo. F. Nordio: Research Grant; Significant; Daiichi Sankyo. M. Mercuri: Employment; Significant; Daiichi Sankyo Inc. E. Antman: Research Grant; Significant; Daiichi Sankyo. R. Giugliano: Research Grant; Significant; Daiichi Sankyo. Honoraria; Significant; Honoraria for CME programs: Daiichi-Sankyo, American College of Cardiology. Consultant/Advisory Board; Modest; Honoraria for Consultant: Boehering Ingelheim, Bristol Myers Squibb, Merck, Portola, Pfizer. Consultant/Advisory Board; Significant; Honoraria for consultant: Daiichi Sankyo.
- © 2016 by American Heart Association, Inc.