Higher-dose NOACs reduced stroke or systemic embolic events compared with warfarin in AF patients with valvular heart disease (RR 0.70; 95% CI 0.58-0.86).
Meta-Analysis (n=71,683)
Do higher-dose NOACs reduce stroke/systemic embolic events compared to warfarin in patients with atrial fibrillation and valvular heart disease?
High-dose NOACs are as safe and effective as warfarin in patients with atrial fibrillation and valvular heart disease (excluding moderate/severe mitral stenosis and mechanical valves).
Effect estimate: RR 0.70 (95% CI 0.58-0.86)
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.
Renda et al. (Wed,) conducted a meta-analysis in Atrial fibrillation and valvular heart disease (n=71,683). Non-vitamin K antagonist oral anticoagulants (NOACs) vs. warfarin was evaluated on stroke/systemic embolic events (SSEE) (RR 0.70, 95% CI 0.58-0.86). Higher-dose NOACs reduced stroke or systemic embolic events compared with warfarin in AF patients with valvular heart disease (RR 0.70; 95% CI 0.58-0.86).