Department of Pharmacy, Chi Mei Medical Center, Tainan, Taiwan.
Department of Public Health, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Medicine (Baltimore). 2022 Sep 16;101(37):e30412. doi: 10.1097/MD.0000000000030551.
Venous thromboembolism (VTE) is associated with a high risk of morbidity and mortality. However, data on the association between oral anticoagulants and the hazards of VTE complications in Taiwanese patients with VTE is limited. This study aimed to compare the hazards of recurrent VTE, bleeding, and mortality between patients with VTE receiving rivaroxaban, a non-vitamin K antagonist oral anticoagulant (NOAC), and those receiving heparin or low-molecular-weight heparin (LMWH) followed by warfarin. Patients with VTE treated with rivaroxaban, or heparin or LMWH followed by warfarin were enrolled from 2 million random samples from Taiwan's National Health Insurance database between 2013 and 2016. Hazards of recurrent VTE (deep vein thrombosis and pulmonary embolism), major bleeding, and mortality in rivaroxaban and warfarin users were investigated. Survival analyses were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). Users of rivaroxaban (183) and warfarin (456) were included in the study. Patients receiving rivaroxaban did not have significantly lower hazards of developing recurrent VTE (HR, 0.72 [CI, 0.37-1.37], P = .31) and mortality (HR, 0.86 [CI, 0.49-1.50], P = .59) than those receiving heparin or LMWH followed by warfarin. In addition, the hazard ratio of major bleeding was not significantly different between the 2 regimens (HR, 1.80 [CI, 0.39-8.29], P = .45). Rivaroxaban was not associated with lower risks of recurrent VTE and mortality and higher hazards of major bleeding than heparin or LMWH followed by warfarin in Taiwanese patients with VTE. Clinicians may tailor oral anticoagulants for VTE patients according to the patient's characteristics, cost-effectiveness and healthcare system policy.
静脉血栓栓塞症(VTE)与较高的发病率和死亡率相关。然而,关于口服抗凝剂与台湾 VTE 患者 VTE 并发症风险之间的关联的数据有限。本研究旨在比较 VTE 患者接受利伐沙班(一种非维生素 K 拮抗剂口服抗凝剂(NOAC))与接受肝素或低分子量肝素(LMWH)后再用华法林治疗的患者之间复发性 VTE、出血和死亡率的风险。从 2013 年至 2016 年,从台湾全民健康保险数据库的 200 万随机样本中招募了接受利伐沙班或肝素或 LMWH 后再用华法林治疗的 VTE 患者。研究了利伐沙班和华法林使用者的复发性 VTE(深静脉血栓形成和肺栓塞)、大出血和死亡率的风险。生存分析用于估计危险比(HR)和 95%置信区间(CI)。纳入了 183 名利伐沙班和 456 名华法林使用者。接受利伐沙班治疗的患者发生复发性 VTE(HR,0.72 [CI,0.37-1.37],P=0.31)和死亡率(HR,0.86 [CI,0.49-1.50],P=0.59)的风险无显著降低与接受肝素或 LMWH 后再用华法林的患者相比。此外,两种方案的大出血风险无显著差异(HR,1.80 [CI,0.39-8.29],P=0.45)。在台湾 VTE 患者中,与肝素或 LMWH 后再用华法林相比,利伐沙班与复发性 VTE 和死亡率的风险降低无关,而大出血的风险更高。临床医生可以根据患者的特征、成本效益和医疗保健系统政策,为 VTE 患者定制口服抗凝剂。