Three-year outcomes of patients with non-valvular atrial fibrillation: the COOL-AF registry.

Abstract

Clinical outcomes of patients with non-valvular atrial fibrillation (AF) in Asian populations may be different from non-Asians. In this study, we aimed to determine the incidence of ischemic stroke/systemic embolism (SSE), major bleeding, and death, and the predictors for clinical outcomes in a contemporary Asian cohort of newly diagnosed AF patients. This is a prospective multicenter nationwide registry of patients with AF from 27 hospitals in Thailand. Baseline data and follow-up data were collected every 6 months until 3 years. Data collections included demographic, medical history, laboratory, and medication details. Clinical outcomes were SSE, major bleeding, and all-cause mortality. Incidence rates for each clinical outcome were calculated and presented as rate per 100 person-years. Univariate and multivariate analysis was performed to determine the independent predictors for clinical outcomes. There was a total of 3405 patients: mean age was 67.8 ± 11.3 years, 1981 (58.2%) were male. During 30.8 ± 9.7 months follow-up, there was a total of 132 SSE (3.9%), 191 major bleeding (5.6%), and 357 all-cause deaths (10.5%). The incidence rates of SSE, major bleeding, and death were 1.56 (1.30-1.84), 2.26 (1.96-2.61), and 4.17 (3.33-4.25), per 100 person-years respectively. Independent predictors for clinical outcomes were age, type of AF, and the presence of comorbid conditions. The incidence rate of SSE, major bleeding, and death remains high reflecting the unmet needs in AF management.