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.
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.