Gastrointestinal bleeding and cardiovascular events in patients with atrial fibrillation: results from the SAKURA AF registry and RAFFINE registry

Abstract Background Anticoagulants for patients with atrial fibrillation (AF) reduce cardiovascular events but increase gastrointestinal bleeding. However, the association between gastrointestinal bleeding and cardiovascular events is unclear. The present study aimed to evaluate the association between bleeding and major adverse cardiac and cerebrovascular events (MACCE) among patients with AF. Methods We analyzed the data of 2 Japanese multicenter registries (the SAKURA AF registry and RAFFINE registry). Primary endpoint was MACCE, which was defined as a composite of death, myocardial infarction and stroke. The association of gastrointestinal bleeding with subsequent MACCE risk was investigated using time-adjusted Cox multivariate analysis after adjusting for baseline characteristics and time from bleeding. Results Among 7,133 AF patients, 192 (2.7%) had gastrointestinal bleeding events during follow-up. Multivariate logistic regression analysis showed that age (Odds ratio (OR) 1.02, 95% CI 1.00-1.05, p=0.046), hypertension (OR 1.52, 95% CI 1.04-2.21, p=0.03), diabetes mellitus (OR 1.38, 95% CI 1.02-1.88, p=0.04) and lower hemoglobin level (OR 0.84, 95% CI 0.76-0.92, p=0.0002) were independent predictors of gastrointestinal bleeding. Incidence of MACCE was significantly higher in patients with gastrointestinal bleeding than those without (13.93% versus 3.54% per patient-year; p<0.0001, Figure). Even after adjusted for other risk factors, patients who experienced gastrointestinal bleeding had significantly higher risk of MACCE (hazard ratio, 3.09; 95% CI, 2.20-4.33; p<0.0001). Conclusions In patients with AF, gastrointestinal bleeding was strongly associated with incidence of MACCE. Thus, it is important to prevent gastrointestinal bleeding to avoid adverse cardiovascular events.Figure