Vedovati Maria Cristina, Mancuso Alessandra, Pierpaoli Lucia, Paliani Ugo, Conti Serenella, Ascani Alessandra, Galeotti Giulia, Di Filippo Francesco, Caponi Carla, Agnelli Giancarlo, Becattini Cecilia
Internal, Vascular and Emergency Medicine - Stroke Unit, University of Perugia, Perugia, Italy.
Internal, Vascular and Emergency Medicine - Stroke Unit, University of Perugia, Perugia, Italy.
Int J Cardiol. 2020 Feb 15;301:167-172. doi: 10.1016/j.ijcard.2019.11.105. Epub 2019 Nov 17.
In the direct oral anticoagulants (DOACs) era, extended anticoagulation is an attractive strategy after venous thromboembolism (VTE). The role of currently available bleeding risk scores for VTE patients treated with DOACs in clinical practice is undefined.
Consecutive patients with VTE were included in a prospective multicenter cohort at the initiation of treatment with DOACs. The role of ATRIA, HAS-BLED, Kuijer, ORBIT, RIETE and VTE-BLEED scores in predicting major bleeding (ISTH definition) while on DOAC treatment was assessed.
Overall, 1034 patients were included and followed for one year or until the end of treatment or the occurrence of major bleeding. During study period, 26 major bleedings occurred in 25 patients (2.8% patient-year). Anemia, bleeding history and creatinine clearance <60 ml/min were significant predictors of major bleedings. The predictive value of bleeding risk scores was modest. In the 12-month study period, ORBIT (HR intermediate-high vs. low risk patients 3.62, 95% CI 1.65-7.94 and c-statistics 0.645, 95% CI 0.523-0.767) and VTE-BLEED (HR high vs. low 16.11, 95% CI 2.18-119.09 and c-statistics 0.674, 95% CI 0.593-0.755) score significantly predicted major bleeding. The lowest incidence of major bleeding (0.3%) was observed in the low-risk category of VTE-BLEED, while the highest (7.1%) in the high-risk category of ORBIT.
In a real-life cohort of patients with VTE treated with DOACs, the predictive value of currently available bleeding risk scores was modest and not statistically different. Whether these scores can be used for decision making on anticoagulation should be assessed in management studies.
在直接口服抗凝剂（DOACs）时代，延长抗凝治疗是静脉血栓栓塞症（VTE）后的一种有吸引力的策略。目前可用的出血风险评分在接受DOACs治疗的VTE患者临床实践中的作用尚不明确。
连续的VTE患者在开始接受DOACs治疗时被纳入一项前瞻性多中心队列研究。评估了ATRIA、HAS - BLED、Kuijer、ORBIT、RIETE和VTE - BLEED评分在预测DOAC治疗期间严重出血（按照国际血栓与止血学会的定义）方面的作用。
总体而言，共纳入1034例患者，随访1年或直至治疗结束或发生严重出血。在研究期间，25例患者发生了26次严重出血（每年2.8%）。贫血、出血史和肌酐清除率<60 ml/min是严重出血的显著预测因素。出血风险评分的预测价值一般。在12个月的研究期内，ORBIT评分（中高风险与低风险患者相比，HR为3.62，95%CI为1.65 - 7.94，c统计量为0.645，95%CI为0.523 - 0.767）和VTE - BLEED评分（高风险与低风险相比，HR为16.11，95%CI为2.18 - 119.09，c统计量为0.674，95%CI为0.593 - 0.755）能显著预测严重出血。在VTE - BLEED的低风险类别中观察到严重出血的发生率最低（0.3%），而在ORBIT的高风险类别中最高（7.1%）。
在接受DOACs治疗的VTE患者的真实队列中，目前可用的出血风险评分的预测价值一般，且无统计学差异。这些评分是否可用于抗凝决策应在管理研究中进行评估。
