Safety and efficacy of non-vitamin K antagonist oral anticoagulants compared to warfarin in patients with atrial fibrillation and end stage renal disease: a meta-analysis of randomized trials

Abstract

Abstract Background Stroke prevention in patients with atrial fibrillation (AF) and end stage renal disease (ESRD) is difficult because of the lacking of high-quality evidence. Although there were few randomized trials comparing NOACs and warfarin in AF patients with ESRD, the small patient size prohibits these studies from making a conclusion. We aimed to perform a meta-analysis to evaluate currently available randomized trials in this special population. Methods We searched the literature for randomized clinical trials comparing NOAC to warfarin in AF patients with ESRD undergoing hemodialysis. Results A total of 3 randomized trials were identified from the literature (one for rivaroxaban [Valkyrie study] and two for apixaban [AXADIA-AFNET 8 and RENAL-AF]). About the principal efficacy outcome, NOACs did not decrease the risk compared to warfarin (relative risk [RR] 0.79, 95%CI 0.45-1.37) while a significant heterogeneity was noted (p = 0.03). In Valkyrie study, rivaroxaban had better efficacy outcome than warfarin (RR 0.57, 95%CI 0.43-0.75). For the safety outcome, the risk was similar between NOACs and warfarin (RR 0.81, 95%CI 0.52-1.27) without significant heterogeneity (p = 0.11)(Figure 1). The pooled event rate of 3 trials disclosed a high risk of all-cause mortality (39.9% for NOACs, 34.6% for warfarin) and cardiovascular mortality (10.1% for NOACs, 8.5% for warfarin) for AF patients with ESRD even on OACs (Figure 2). Conclusions This meta-analysis suggested that NOACs (rivaroxaban or apixaban) was at least as safe and effective as warfarin in AF patients with ESRD. Even on OACs, these patients remain at high risk of cardiovascular events and all-cause mortality. Integrated care and holistic management were important for this high-risk population.