Net clinical benefit of NOAC in Korean atrial fibrillation patients with low to intermediate stroke risk

Abstract

Abstract Background The balance of stroke risk reduction and potential hemorrhagic risk associated with anti-thrombotic treatment (ATT) remain unclear in Korean atrial fibrillation (AF) patients with low to intermediate stroke risk, defined as non-gender CHA2DS2-VASc score 0–1. Purpose The net clinical benefit (NCB) analysis of ATT may be helpful to guide stroke prevention strategy in AF patients with non-gender CHA2DS2-VASc score 0–1. Methods This Korean multi-center cohort study retrospectively evaluated the clinical outcomes with single antiplatelet (SAPT), vitamin K antagonist (VKA), and non-vitamin K antagonist oral anticoagulant (NOAC) in non-gender CHA2DS2-VASc score 0–1 and further stratified by biomarker-based ABCD score (Age [≥60 years], B-type natriuretic peptide [BNP] or N-terminal pro-BNP [≥300 pg/ml], Creatinine clearance [<50 ml/min/1.73 m2], and Dimension of the left atrium [≥45 mm]). The primary outcome was the NCB of ATT including thromboembolic and major bleeding events. Results We included 2465 patients (56.2±9.5 years; female, 665 [27.0%]) followed-up for 4.0±2.8 years, of whom 661 (26.8%) were treated with SAPT; 423 (17.2%) with VKA; and 1040 (42.2%) with NOAC. In comparison with no treatment, only NOAC demonstrated a positive tendency for stroke prevention (NOAC, NCB 0.47, 95% confidence interval [CI] −0.40 to 2.10; SAPT, NCB −0.31, 95% CI −1.48 to 1.40; and VKA, NCB −1.26, 95% CI −2.97 to 0.67). With detailed risk stratification with ABCD score, NOAC showed a significant NCB for stroke prevention compared with SAPT and VKA (SAPT vs. NOAC, NCB 1.6, 95% CI 0.26–3.50; VKA vs. NOAC, NCB 1.96, 95% CI 0.47–4.16) in patients with ABCD score ≥1. ATT failed to show NCB in patients with truly low stroke risk defined as ABCD score=0. Conclusion Korean AF cohort with low to intermediate stroke risk indicates that, in comparison with no ATT, only ATT with NOAC showed marginal NCB. With further risk stratification by ABCD score, NOAC showed significant advantages over other ATTs (VKA or SAPT) in patients with ABCD ≥1. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Korean Disease Control and Prevention Agency