Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases

Journal：International Journal of Cardiology

Publication type: Research Article

IF(IF): 3.5

PMID: 37257512 Link To Pubmed Full text Download

Atrial fibrillation (AF), a well-established risk factor for ischemic stroke, increases stroke risk by a fold of 4 to 5, and accounts for 10% to 15% of all ischemic strokes. Anticoagulation therapy with warfarin or novel oral anticoagulants (NOACs) was highly recommended in the prevention of acute ischemic stroke in patients with AF. Previous studies have reported that prior anticoagulation therapy could reduce stroke severity at stroke onset and intravenous thrombolysis (IVT) is safe in selected patients with prior anticoagulation therapy. However, in the context that anticoagulation therapy was underused in AF patients in China, studies regarding to the associations of prior anticoagulation therapy with IVT and in-hospital outcomes in patients with AF and AIS in Chinese population remain scarce. Objectives: 1. We aimed to assess the rate of pre-hospital anticoagulation (warfarin or NOACs) in patients with AF and acute ischemic stroke (AIS) in a national registry database in China and its associations with stroke severity at admission and the usage of intravenous thrombolysis (IVT). 2. Furthermore, in a subgroup of patients with AF, AIS and IVT, we aimed to explore the associations of prior anticoagulation therapy with in-hospital mortality, symptomatic intracerebral hemorrhage (sICH) and functional outcomes at discharge.

Data source: the China Stroke Center Alliances (CSCA) registry database Population: Inclusion: Ischemic stroke patients with AF (AF diagnosed either before or after stroke onset) aged 18 years and older in the CSCA database. Exclusion: 1. patients with missing data on prior anticoagulation therapy 2. patients with other types of prior anticoagulants except for warfarin or NOACs 3. patients transferred from another hospital Statistical analyses: Baseline characteristics of the participants will be presented as frequencies (percentage) for categorical variables and mean (standard deviation, SD) and median (interquartile range, IQR) for continuous variables when appropriate. We compared the baseline characteristics across the prior anticoagulation therapy groups using absolute standardized differences (ASDs), with an ASD≥10 considered to be clinically significant. Univariate and multivariate-adjusted logistic regression models were used to investigate the associations of prior anticoagulation therapy with stroke severity at admission and in-hospital outcomes (in-hospital mortality and sICH). Prior anticoagulation was included as an independent variable, with controls (patients with AF without anticoagulation) as the reference group, and prior warfarin and NOACs as the other categorical groups. Given the large data set, traditional model building approaches that identify independent predictors based on statistical significance were not used. Instead, candidate risk factors list will be confirmed based on univariate analysis, literature review and clinical experiences. To account for within-hospital clustering, generalized estimating equations (GEE) were used to generate both unadjusted and adjusted models. All statistical analyses will be performed using SAS software. A two-sided P-value <0.05 was considered statistically significant.