Background:In the Japanese clinical setting, the prevalence, potential cofounders of gastrointestinal (GI) bleeding from anticoagulant therapy, including direct oral anticoagulants (DOACs) and warfarin, and prognosis after GI bleeding are unclear.

Methods and Results:We examined about GI bleeding from anticoagulant therapy using data from the SAKURA AF Registry, a prospective multicenter registry in Japan. Among 3,237 enrollees, 48.8% (n=1,561) were warfarin users and 51.2% (n=1,676) DOAC users. GI bleeding was identified in 68 patients (2.1%). No incidental differences in GI bleeding were observed between the DOAC and warfarin users (32 [1.9%] patients [0.67 events per 100 person-years] vs. 36 [2.3%] patients [0.75 events per 100 person-years], respectively; P=0.43). Multivariate Cox proportional hazard model analysis revealed that creatinine (hazard ratio [HR] 1.379, 95% confidence interval [CI] 1.091–1.743 P=0.007) and hemoglobin (HR 0.814, 95% CI 0.705–0.941, P=0.005) remained independent determinants of GI bleeding. Patients experiencing GI bleeding events had a higher risk of all-cause death (18%) than those without GI bleeding (6%) (P=0.045).

Conclusions:GI bleeding was strongly associated with anemia and renal impairment. Patients experiencing GI bleeding had higher risk for all-cause death than those without GI bleeding.

背景：在日本的临床环境中，包括直接口服抗凝剂 (DOAC) 和华法林在内的抗凝治疗导致胃肠 (GI) 出血的患病率、潜在共同创始人以及 GI 出血后的预后尚不清楚。

方法和结果：我们使用日本前瞻性多中心登记处 SAKURA AF 登记处的数据检查了抗凝治疗引起的胃肠道出血。在 3,237 名登记者中，48.8% (n=1,561) 是华法林使用者和 51.2% (n=1,676) DOAC 使用者。68 名患者 (2.1%) 发现胃肠道出血。在 DOAC 和华法林使用者之间没有观察到胃肠道出血的偶然差异（分别为 32 [1.9%] 名患者 [0.67 次事件每 100 人年] 和 36 名 [2.3%] 患者 [0.75 次事件每 100 人年]； P=0.43）。多变量 Cox 比例风险模型分析显示肌酐（风险比 [HR] 1.379，95% 置信区间 [CI] 1.091–1.743 P=0.007）和血红蛋白（HR 0.814，95% CI 0.705–0.941，P=0.005）保持独立胃肠道出血的决定因素。

结论：胃肠道出血与贫血和肾功能损害密切相关。胃肠道出血患者的全因死亡风险高于没有胃肠道出血的患者。