Gorman E W, Perkel D, Dennis D, Yates J, Heidel R E, Wortham D
University of Tennessee Medical Center, Knoxville, TN.
J Atr Fibrillation. 2016 Aug 31;9(2):1461. doi: 10.4022/jafib.1461. eCollection 2016 Aug-Sep.
Atrial fibrillation (Afib) patients are at an increased risk of stroke. Patients at moderate to high risk of stroke typically receive antithrombotics, placing them at an increased risk of bleeding. The HAS-BLED tool has been validated in Afib patients receiving warfarin for prediction of major bleeding events. Although HAS-BLED has been researched in patients receiving warfarin, this tool has not been validated with the novel anticoagulant rivaroxaban. The trial design was retrospective case-control approved by the Institutional Review Board at University of Tennessee Medical Center. Patients who were identified as having a bleeding event were cross-referenced with a list of patients receiving rivaroxaban. Inclusion criteria were adult patients with atrial fibrillation who were taking rivaroxaban for at least six months, with a CHADS-VASc score greater than or equal to 2 OR CHADS score greater than or equal to 1. The primary endpoint is the predictive ability of HAS-BLED as measured through the c-statistic. Secondary endpoints include correlation of HAS-BLED and bleeding risk. After reviewing 9621 medical records, 15 patients met the inclusion criteria for major bleeding. Ninety patients were randomly selected for inclusion as the matched control group. The predictive ability of HAS-BLED was not statistically significant (c statistic = 0.68; p = 0.07), but did show some diagnostic ability to predict major bleeding events. Patients with major bleeding were more likely to have a history of bleeding and use concomitant antiplatelet agents. There were significantly more patients with a HAS-BLED score greater than or equal to 3 in the patients that experienced a major bleeding event. HAS-BLED demonstrated some diagnostic ability to predict major bleeding events in patients receiving rivaroxaban but this was not statistically significant due to limited sample size.
心房颤动（房颤）患者中风风险增加。中风中度至高度风险的患者通常接受抗血栓药物治疗，这使他们出血风险增加。HAS - BLED工具已在接受华法林治疗的房颤患者中得到验证，用于预测重大出血事件。尽管HAS - BLED已在接受华法林治疗的患者中进行了研究，但该工具尚未在新型抗凝药利伐沙班中得到验证。试验设计为回顾性病例对照研究，经田纳西大学医学中心机构审查委员会批准。被确定有出血事件的患者与接受利伐沙班治疗的患者名单进行交叉对照。纳入标准为患有房颤且服用利伐沙班至少六个月、CHADS - VASc评分大于或等于2或CHADS评分大于或等于1 的成年患者。主要终点是通过c统计量衡量的HAS - BLED的预测能力。次要终点包括HAS - BLED与出血风险的相关性。在查阅9621份病历后，15名患者符合重大出血的纳入标准。随机选择90名患者作为匹配对照组纳入。HAS - BLED的预测能力无统计学意义（c统计量 = 0.68；p = 0.07），但确实显示出一定的预测重大出血事件的诊断能力。发生重大出血的患者更可能有出血史并使用抗血小板药物。发生重大出血事件的患者中，HAS - BLED评分大于或等于3的患者明显更多。HAS - BLED在接受利伐沙班治疗的患者中显示出一定的预测重大出血事件的诊断能力，但由于样本量有限，这一结果无统计学意义。
