National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037, China.
Peking University Health Science Center, Beijing, 100191, China.
Respir Med. 2024 Sep;231:107722. doi: 10.1016/j.rmed.2024.107722. Epub 2024 Jun 25.
Direct oral anticoagulants (DOACs) are increasingly prescribed for life-long anticoagulation in chronic thromboembolic pulmonary hypertension (CTEPH) patients, despite not being recommended in the guidelines. This study aims to evaluate the efficacy and safety of DOACs in CTEPH patients.
From May 2013 to December 2022, patients who were first diagnosed with CTEPH in Fuwai Hospital and started long-term anticoagulation treatment with warfarin or DOACs were retrospectively included and followed up until (1) death, (2) transition to other kinds of anticoagulants, or (3) discontinuation of anticoagulation. Propensity score matching was used to balance confounding bias of baseline characteristics. All-cause death, major bleeding, clinically relevant nonmajor bleeding and venous thromboembolism (VTE) recurrence were obtained and analysed.
After propensity score matching, 115 patients taking warfarin and 206 patients taking DOACs were included in our study and followed up for 5.5 [3.4, 7.1] years. There was no significant difference of survival between the warfarin and the DOAC group (p = 0.77). The exposure adjusted event rate of major bleeding (0.3 %/person-year vs 0.4 %/person-year, p = 0.705) and clinically relevant nonmajor bleeding (3.1 %/person-year vs 3.2 %/person-year, p > 0.999) was similar between two groups. The exposure adjusted rate of VTE recurrence was significantly higher in the DOAC group (1.5 %/person-year vs 0.3 %/person-year, p = 0.030).
In anticoagulation of CTEPH patients, DOACs have similar survival rate, similar risk of bleeding but higher risk of VTE recurrence than warfarin.
尽管指南中不推荐，但直接口服抗凝剂（DOAC）在慢性血栓栓塞性肺动脉高压（CTEPH）患者中越来越多地被用于长期抗凝治疗。本研究旨在评估 DOAC 在 CTEPH 患者中的疗效和安全性。
从 2013 年 5 月至 2022 年 12 月，我们回顾性纳入了在阜外医院首次诊断为 CTEPH 并开始使用华法林或 DOAC 进行长期抗凝治疗的患者，并进行随访，直至（1）死亡，（2）转为其他类型的抗凝药物，或（3）停止抗凝治疗。采用倾向评分匹配法平衡基线特征的混杂偏倚。我们获得并分析了全因死亡、大出血、临床相关非大出血和静脉血栓栓塞（VTE）复发的情况。
经倾向评分匹配后，共有 115 例服用华法林和 206 例服用 DOAC 的患者纳入本研究，随访时间为 5.5[3.4，7.1]年。华法林组和 DOAC 组的生存率无显著差异（p=0.77）。大出血（0.3%/人年比 0.4%/人年，p=0.705）和临床相关非大出血（3.1%/人年比 3.2%/人年，p＞0.999）的暴露调整事件率相似。DOAC 组的 VTE 复发率明显更高（1.5%/人年比 0.3%/人年，p=0.030）。
在 CTEPH 患者的抗凝治疗中，DOAC 的生存率与华法林相似，出血风险相似，但 VTE 复发风险高于华法林。
