Abstract：
OBJECTIVE: Oral anticoagulants (OACs) reduce the risk of ischemic stroke but may increase the risk of major bleeding in patients with non-valvular atrial fibrillation (NVAF). Various risk scores, such as HAS-BLED, ATRIA, ORBIT, and DOAC, have been proposed to assess the risk of major bleeding in patients with NVAF receiving OACs. However, limited data are available regarding bleeding risk stratification in Japanese patients with NVAF.
METHODS: Of the 16,098 NVAF patients from the J-RISK AF study, the combined data of the five major AF registries in Japan (J-RHYTHM Registry, Fushimi AF Registry, Shinken Database, Keio interhospital Cardiovascular Studies, and Hokuriku-Plus AF Registry), we analyzed 11,539 patients receiving OACs (median age, 71 years old; women, 29.6%; median CHA2DS2-VASc score, 3).
RESULTS: During the 2-year follow-up period, major bleeding occurred in 274 patients (1.3% per patient-year). In a multivariate Cox proportional hazards analysis, an advanced age, hypertension (systolic blood pressure ≥ 150 mmHg), bleeding history, anemia, thrombocytopenia, and concomitant antiplatelet agents were significantly associated with a higher incidence of major bleeding. We developed a novel risk stratification system, HED-[EPA]2-B3 score, which had a better predictive performance for major bleeding (C-statistics 0.67, [95% confidence interval, 0.63-0.70]) than the HAS-BLED (0.64, [0.60-0.67], P for difference 0.02) and ATRIA (0.63, [0.60-0.66], P for difference ＜0.01) scores. Furthermore, it was non-significantly higher than the ORBIT (0.65, [0.62-0.68], P for difference 0.07) and DOAC (0.65, [0.62-0.68], P for difference 0.17) scores.
CONCLUSIONS: Our novel risk stratification system, the HED-[EPA]2-B3 score, may be useful for identifying Japanese patients receiving OACs at a risk of major bleeding.
METHODS: Of the 16,098 NVAF patients from the J-RISK AF study, the combined data of the five major AF registries in Japan (J-RHYTHM Registry, Fushimi AF Registry, Shinken Database, Keio interhospital Cardiovascular Studies, and Hokuriku-Plus AF Registry), we analyzed 11,539 patients receiving OACs (median age, 71 years old; women, 29.6%; median CHA2DS2-VASc score, 3).
RESULTS: During the 2-year follow-up period, major bleeding occurred in 274 patients (1.3% per patient-year). In a multivariate Cox proportional hazards analysis, an advanced age, hypertension (systolic blood pressure ≥ 150 mmHg), bleeding history, anemia, thrombocytopenia, and concomitant antiplatelet agents were significantly associated with a higher incidence of major bleeding. We developed a novel risk stratification system, HED-[EPA]2-B3 score, which had a better predictive performance for major bleeding (C-statistics 0.67, [95% confidence interval, 0.63-0.70]) than the HAS-BLED (0.64, [0.60-0.67], P for difference 0.02) and ATRIA (0.63, [0.60-0.66], P for difference ＜0.01) scores. Furthermore, it was non-significantly higher than the ORBIT (0.65, [0.62-0.68], P for difference 0.07) and DOAC (0.65, [0.62-0.68], P for difference 0.17) scores.
CONCLUSIONS: Our novel risk stratification system, the HED-[EPA]2-B3 score, may be useful for identifying Japanese patients receiving OACs at a risk of major bleeding.
摘要：
目的：非瓣膜性心房颤动（NVAF）患者口服抗凝药（OAC）可降低缺血性卒中风险，但可增加大出血风险。各种风险评分，如BLED，ATRIA,轨道,DOAC,已被提议评估接受OAC的NVAF患者的大出血风险。然而,关于日本NVAF患者出血风险分层的数据有限.
方法：在来自J-RISKAF研究的16,098名NVAF患者中，日本五个主要AF登记处的综合数据(J-RHYTHM登记处，FushimiAF注册表，Shinken数据库,Keio医院间心血管研究，和北陆加AF注册表)，我们分析了11,539例接受OAC的患者(中位年龄，71岁；女性，29.6%；CHA2DS2-VASc评分中位数，3).
结果：在2年的随访期间，274例患者发生大出血(1.3%/患者-年).在多变量Cox比例风险分析中，高龄,高血压（收缩压≥150mmHg），出血史,贫血,血小板减少症,同时使用的抗血小板药物与大出血的发生率显著相关.我们开发了一个新的风险分层系统，HED-[EPA]2-B3得分,对大出血有更好的预测性能(C-统计0.67，[95%置信区间，0.63-0.70]）比HAS-BLED（0.64，[0.60-0.67]，P为差异0.02)和ATRIA(0.63，[0.60-0.66]，P为差值＜0.01)评分。此外，它不显著高于ORBIT（0.65，[0.62-0.68]，P代表差异0.07)和DOAC(0.65，[0.62-0.68]，P为差异0.17）分数。
结论：我们新颖的风险分层系统，HED-[EPA]2-B3得分,可能有助于确定接受OAC的日本患者有严重出血的风险.
方法：在来自J-RISKAF研究的16,098名NVAF患者中，日本五个主要AF登记处的综合数据(J-RHYTHM登记处，FushimiAF注册表，Shinken数据库,Keio医院间心血管研究，和北陆加AF注册表)，我们分析了11,539例接受OAC的患者(中位年龄，71岁；女性，29.6%；CHA2DS2-VASc评分中位数，3).
结果：在2年的随访期间，274例患者发生大出血(1.3%/患者-年).在多变量Cox比例风险分析中，高龄,高血压（收缩压≥150mmHg），出血史,贫血,血小板减少症,同时使用的抗血小板药物与大出血的发生率显著相关.我们开发了一个新的风险分层系统，HED-[EPA]2-B3得分,对大出血有更好的预测性能(C-统计0.67，[95%置信区间，0.63-0.70]）比HAS-BLED（0.64，[0.60-0.67]，P为差异0.02)和ATRIA(0.63，[0.60-0.66]，P为差值＜0.01)评分。此外，它不显著高于ORBIT（0.65，[0.62-0.68]，P代表差异0.07)和DOAC(0.65，[0.62-0.68]，P为差异0.17）分数。
结论：我们新颖的风险分层系统，HED-[EPA]2-B3得分,可能有助于确定接受OAC的日本患者有严重出血的风险.
