Abstract

Background: There are limited data for non-vitamin K antagonist oral anticoagulants (NOACs) impact on outcomes for patients with atrial fibrillation (AF) and valvular heart diseases (VHDs). Methods: We identified patients with AF and associated Evaluated Heartvalves, Rheumatic or Artificial (EHRA) type 2 VHDs, and who had been naïve from the oral anticoagulants in the Korean National Health Insurance Service database between 2014 and 2016 (warfarin: n = 2671; NOAC: n = 3058). For analyzing the effect of NOAC on primary prevention, we excluded those with a previous history of ischemic stroke, intracranial hemorrhage (ICH), and gastrointestinal (GI) bleeding events. To balance covariates, we used the propensity score weighting method. Ischemic stroke, ICH, GI bleeding, major bleeding, all-cause death, and their composite outcome and fatal clinical events were evaluated. Results: During a follow-up with a mean duration of 1.4 years, NOACs were associated with lower risks of ischemic stroke (hazard ratio (HR): 0.71, 95% confidence interval (CI): 0.53–0.96), GI bleeding (HR: 0.50, 95% CI: 0.35–0.72), fatal ICH (HR: 0.28, 95% CI: 0.07–0.83), and major bleeding (HR: 0.61, 95% CI: 0.45–0.80) compared with warfarin. Overall, NOACs were associated with a lower risk of the composite outcome (HR: 0.68, 95% CI: 0.58–0.80). Conclusions: In this nationwide Asian AF population with EHRA type 2 VHDs, NOAC use was associated with lower risks of ischemic stroke, major bleeding, all-cause death, and the composite outcome compared to warfarin use.

Highlights

  • Atrial fibrillation (AF) often co-exists with many types of valvular heart diseases (VHDs); for example, atrial fibrillation (AF) patients with mitral stenosis or mechanical heart valves have a significantly higher risk of thromboembolic events than those with non-valvular AF [1]

  • The main findings of our study are as follows: (i) non-vitamin K antagonist oral anticoagulants (NOACs) were associated with lower risks of ischemic stroke and all-cause death compared to warfarin; (ii) for safety outcomes, NOACs significantly reduced the risk of hospitalization for GI bleeding and major bleeding and showed a comparable outcome in intracranial hemorrhage (ICH) but a significant reduction in fatal ICH; (iii) overall, NOAC showed a better composite outcome than warfarin in patients with AF and EHRA type 2 VHDs; and (iv) NOAC showed comparable outcomes of 6 clinical outcomes in patients with EHRA type 1 VHDs

  • Within EHRA type 2 VHD patients, pooled standard-dose NOAC was associated with a lower risk of thromboembolic events (HR: 0.70, 95% confidence interval (CI): 0.58–0.86) and ICH (HR: 0.47, 95% CI: 0.24–0.93) than warfarin, whereas NOAC showed a comparable risk of major bleeding (HR: 0.93, 95% CI: 0.68–1.27)

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Summary

Introduction

Atrial fibrillation (AF) often co-exists with many types of valvular heart diseases (VHDs); for example, AF patients with mitral stenosis or mechanical heart valves have a significantly higher risk of thromboembolic events than those with non-valvular AF [1]. Pivotal randomized clinical trials (RCTs) for the evaluation of efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) in AF exclude these with mechanical heart valves and moderate to severe mitral stenosis [2,3,4,5]. In these pivotal RCTs, the effectiveness and safety of NOACs for stroke prevention was demonstrated, and NOACs are widely used for stroke prevention in the AF population without Evaluated Heartvalves, Rheumatic or Artificial (EHRA) type 1 VHDs [6,7,8,9]. Conclusions: In this nationwide Asian AF population with EHRA type 2 VHDs, NOAC use was associated with lower risks of ischemic stroke, major bleeding, all-cause death, and the composite outcome compared to warfarin use

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