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

BackgroundClinical 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.MethodsThis 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.ResultsThere 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.ConclusionThe incidence rate of SSE, major bleeding, and death remains high reflecting the unmet needs in AF management

Influence of gender on the clinical outcomes of Asian non-valvular atrial fibrillation patients: insights from the prospective multicentre COOL-AF registry

Objective To determine the effect of gender on clinical outcomes of Asian non-valvular atrial fibrillation patients.Design This is a cohort study.Setting 27 university and regional hospitals in Thailand.Participants Patients with non-valvular atrial fibrillation.Primary and secondary outcomes measures The clinical outcomes were ischaemic stroke/transient ischaemic attack (TIA), major bleeding, intracerebral haemorrhage (ICH), heart failure and death. Follow-up data were recorded every 6 months until 3 years. Differences in clinical outcomes between males and females were determined. Multivariate analysis was performed to assess the effect of gender on clinical outcomes. Survival analysis and log-rank test were performed to determine the time-dependent effect of clinical outcomes, and the difference between males and females. Effect of oral anticoagulant (OAC) on outcomes and net clinical benefit of OAC was assessed. The analysis was performed both for the whole dataset and propensity score matching with multiple imputation.Results A total of 3402 patients (mean age: 67.4±11.3 years; 58.2% male) were included. Average follow-up duration 25.7±10.6 months (7192.6 persons-year). Rate of ischaemic stroke/TIA, major bleeding, ICH, heart failure and death were 1.43 (1.17–1.74), 2.11 (1.79–2.48), 0.70 (0.52–0.92), 3.03 (2.64–3.46) and 3.77 (3.33–4.25) per 100 person-years. Females had increased risk for ischaemic stroke/TIA and heart failure and males had increased risk for major bleeding and ICH. Ischaemic stroke/TIA risk in females and major bleeding and ICH risk in males remained even after correction for age, comorbid conditions and anticoagulation treatment. OAC reduced the risk of ischaemic stroke/TIA in males and females, and markedly increased the risk of major bleeding and ICH in males.Conclusions Females had a higher risk of ischaemic stroke/TIA and heart failure, and a lower risk of major bleeding and ICH compared with males. OAC reduced risk of ischaemic stroke/TIA in females, and markedly increased risk of major bleeding and ICH in males