López-Núñez Juan J, Pérez-Andrés Ricard, Di Micco Pierpaolo, Schellong Sebastian, Gómez-Cuervo Covadonga, Sahuquillo Joan Carles, Ciammaichella Maurizio, Morales Maria Del Valle, Bosevski Marijan, Monreal Manuel
Department of Internal Medicine, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain.
Department of Radiology, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain.
TH Open. 2019 Mar 20;3(1):e67-e76. doi: 10.1055/s-0039-1683970. eCollection 2019 Jan.
The efficacy and safety of the direct oral anticoagulants (DOACs) in fragile patients (age ≥ 75 years and/or creatinine clearance levels ≤ 50 mL/min and/or body weight ≤ 50kg) with venous thromboembolism (VTE) has not been evaluated. We used the RIETE database to compare the rates of the composite of VTE recurrences or major bleeding during anticoagulation in fragile patients with VTE, according to the use of DOACs or standard anticoagulant therapy. From January 2013 to April 2018, 24,701 patients were recruited. Of these, 10,054 (41%) were fragile. Initially, 473 fragile patients (4.7%) received DOACs and 8,577 (85%) low-molecular-weight heparin (LMWH). For long-term therapy, 1,298 patients (13%) received DOACs and 5,038 (50%) vitamin K antagonists (VKAs). Overall, 95 patients developed VTE recurrences and 262 had major bleeding. Patients initially receiving DOACs had a lower rate of the composite outcome (hazard ratio [HR]: 0.32; 95% confidence interval [CI]: 0.08-0.88) than those on LMWH. Patients receiving DOACs for long-term therapy had a nonsignificantly lower rate of the composite outcome (HR: 0.70; 95% CI: 0.46-1.03) than those on VKAs. On multivariable analysis, patients initially receiving DOACs had a nonsignificantly lower risk for the composite outcome (HR: 0.36; 95% CI: 0.11-1.15) than those on LMWH, while those receiving DOACs for long-term therapy had a significantly lower risk (HR: 0.61; 95% CI: 0.41-0.92) than those on VKAs. Our data suggest that the use of DOACs may be more effective and safe than standard therapy in fragile patients with VTE, a subgroup of patients where the risk for bleeding is particularly high.
直接口服抗凝剂（DOACs）在患有静脉血栓栓塞症（VTE）的脆弱患者（年龄≥75岁和/或肌酐清除率水平≤50 mL/分钟和/或体重≤50kg）中的疗效和安全性尚未得到评估。我们使用RIETE数据库，根据DOACs或标准抗凝治疗的使用情况，比较VTE脆弱患者在抗凝期间VTE复发或大出血复合事件的发生率。2013年1月至2018年4月，招募了24,701名患者。其中，10,054名（41%）为脆弱患者。最初，473名脆弱患者（4.7%）接受了DOACs治疗，8,577名（85%）接受了低分子量肝素（LMWH）治疗。对于长期治疗，1,298名患者（13%）接受了DOACs治疗，5,038名（50%）接受了维生素K拮抗剂（VKAs）治疗。总体而言，95名患者发生了VTE复发，262名患者发生了大出血。最初接受DOACs治疗的患者复合事件发生率低于接受LMWH治疗的患者（风险比[HR]：0.32；95%置信区间[CI]：0.08 - 0.88）。接受DOACs长期治疗的患者复合事件发生率低于接受VKAs治疗的患者，但差异无统计学意义（HR：0.70；95% CI：0.46 - 1.03）。在多变量分析中，最初接受DOACs治疗的患者复合事件风险低于接受LMWH治疗的患者，但差异无统计学意义（HR：0.36；95% CI：0.11 - 1.15），而接受DOACs长期治疗的患者风险显著低于接受VKAs治疗的患者（HR：0.61；95% CI：0.41 - 0.92）。我们的数据表明，在VTE脆弱患者（这是一个出血风险特别高的患者亚组）中，使用DOACs可能比标准治疗更有效和安全。
