Giulia Renda1, Fabrizio Ricci1, Robert P Giugliano2, Raffaele De Caterina3. 1. Institute of Cardiology and Center of Excellence on Aging, "G. d'Annunzio" University, Chieti, Italy. 2. Division of Cardiovascular Medicine, Brigham and Women's Hospital, TIMI Study Group, Boston, Massachusetts. Electronic address: rgiugliano@partners.org. 3. Institute of Cardiology and Center of Excellence on Aging, "G. d'Annunzio" University, Chieti, Italy. Electronic address: rdecater@unich.it.
Abstract
BACKGROUND: Valvular heart disease (VHD) and atrial fibrillation (AF) often coexist. Phase III trials comparing non-vitamin K antagonist oral anticoagulants (NOACs) with warfarin excluded patients with moderate/severe mitral stenosis or mechanical heart valves, but variably included patients with other VHD and valve surgeries. OBJECTIVES: This study aimed to determine relative safety and efficacy of NOACs in patients with VHD. METHODS: We performed a meta-analysis of the 4 phase III AF trials of the currently available NOACs versus warfarin in patients with coexisting VHD to assess pooled estimates of relative risk (RR) and 95% confidence intervals (CIs) for stroke/systemic embolic events (SSEE), major bleeding, intracranial hemorrhage (ICH), and all-cause death. RESULTS: Compared with warfarin, the rate of SSEE in patients treated with higher-dose NOACs was lower and consistent among 13,585 patients with (RR: 0.70; 95% CI: 0.58 to 0.86) or 58,098 without VHD (RR: 0.84; 95% CI: 0.75 to 0.95; interaction p = 0.13). Major bleeding in patients on higher-dose NOACs versus warfarin was similar and consistent among patients with (RR: 0.93; 95% CI: 0.68 to 1.27) or without VHD (RR: 0.85; 95% CI: 0.70 to 1.02; interaction p = 0.63 for VHD/no-VHD difference). Intracranial hemorrhage was lower with higher-dose NOACs than with warfarin irrespective of VHD (RR: 0.47; 95% CI: 0.24 to 0.93, and 0.49; 95% CI: 0.41 to 059, respectively; interaction p = 0.91). No protective effect of higher-dose NOACs in preventing all-cause death seemed to be present in patients with VHD versus without VHD (RR:1.01; 95% CI: 0.90 to 1.14 vs. RR: 0.88; 95% CI: 0.82 to 0.94, respectively; interaction p = 0.03). CONCLUSIONS: High-dose NOACs provide overall efficacy and safety similar in AF patients with or without VHD.
BACKGROUND:Valvular heart disease (VHD) and atrial fibrillation (AF) often coexist. Phase III trials comparing non-vitamin K antagonist oral anticoagulants (NOACs) with warfarin excluded patients with moderate/severe mitral stenosis or mechanical heart valves, but variably included patients with other VHD and valve surgeries. OBJECTIVES: This study aimed to determine relative safety and efficacy of NOACs in patients with VHD. METHODS: We performed a meta-analysis of the 4 phase III AF trials of the currently available NOACs versus warfarin in patients with coexisting VHD to assess pooled estimates of relative risk (RR) and 95% confidence intervals (CIs) for stroke/systemic embolic events (SSEE), major bleeding, intracranial hemorrhage (ICH), and all-cause death. RESULTS: Compared with warfarin, the rate of SSEE in patients treated with higher-dose NOACs was lower and consistent among 13,585 patients with (RR: 0.70; 95% CI: 0.58 to 0.86) or 58,098 without VHD (RR: 0.84; 95% CI: 0.75 to 0.95; interaction p = 0.13). Major bleeding in patients on higher-dose NOACs versus warfarin was similar and consistent among patients with (RR: 0.93; 95% CI: 0.68 to 1.27) or without VHD (RR: 0.85; 95% CI: 0.70 to 1.02; interaction p = 0.63 for VHD/no-VHD difference). Intracranial hemorrhage was lower with higher-dose NOACs than with warfarin irrespective of VHD (RR: 0.47; 95% CI: 0.24 to 0.93, and 0.49; 95% CI: 0.41 to 059, respectively; interaction p = 0.91). No protective effect of higher-dose NOACs in preventing all-cause death seemed to be present in patients with VHD versus without VHD (RR:1.01; 95% CI: 0.90 to 1.14 vs. RR: 0.88; 95% CI: 0.82 to 0.94, respectively; interaction p = 0.03). CONCLUSIONS: High-dose NOACs provide overall efficacy and safety similar in AFpatients with or without VHD.
Authors: Gabriello Marchetti; Emanuele Bertaglia; Alberto Camerini; Giuseppe De Angelis; Lucia Filippucci; Antonio Maggi; Sebastiano Marra; Carlo Racani; Carlo Serrati Journal: J Atr Fibrillation Date: 2020-02-28
Authors: Kevin L Thomas; Larry R Jackson; Peter Shrader; Jack Ansell; Gregg C Fonarow; Bernard Gersh; Peter R Kowey; Kenneth W Mahaffey; Daniel E Singer; Laine Thomas; Jonathan P Piccini; Eric D Peterson Journal: J Am Heart Assoc Date: 2017-12-22 Impact factor: 5.501
Authors: Ashwin S Nathan; Lin Yang; Zhi Geng; Elias J Dayoub; Sameed Ahmed M Khatana; Paul N Fiorilli; Howard C Herrmann; Wilson Y Szeto; Pavan Atluri; Michael A Acker; Nimesh D Desai; David S Frankel; Francis E Marchlinski; Alexander C Fanaroff; Jay Giri; Peter W Groeneveld Journal: Am Heart J Date: 2020-10-24 Impact factor: 5.099