Long-term outcome of chronic thromboembolic pulmonary hypertension using direct oral anticoagulants and warfarin: a Japanese prospective cohort study
Long-term outcome of chronic thromboembolic pulmonary hypertension using direct oral anticoagulants and warfarin: a Japanese prospective cohort study
复制标题
DOI：
10.1016/j.jtha.2023.03.036
复制
发表时间：
2023-07-17
影响因子：
10.4
通讯作者：
Tsutsui, Hiroyuki
中科院分区：
文献类型：
--
作者：
Hosokawa, Kazuya;Abe, Kohtaro;Tsutsui, Hiroyuki
背景：慢性血栓栓塞性肺动脉高压（CTEPH）需要终身抗凝治疗。CTEPH根据目前的anticoagulants.Objectives的长期结果：CTEPH AC注册是一个前瞻性的，全国性的队列研究比较直接口服抗凝剂（DOACs）和华法林的安全性和有效性CTEPH.Patients/方法：CTEPH患者，治疗初治和治疗，有资格登记。入选标准为年龄> 20岁的患者和根据标准指南诊断为CTEPH的患者。未规定排除标准。主要疗效结局为复合发病率，死亡率结局包括全因死亡、补救再灌注治疗、启动肠外肺血管扩张剂、6分钟步行距离和WHO功能分级恶化。安全性结果是临床相关出血，包括大出血。结果：927例口服抗凝剂在基线进行了分析：481（52%）使用DOAC和446（48%）使用华法林。DOAC组和华法林组的1年、2年和3年复合发病率和死亡率结局相当（分别为2.6%、3.1%和4.2% vs 3.0%、4.8%和5.9%; P = 0.52）。DOAC组的1年、2年和3年临床相关出血发生率显著低于华法林组（分别为0.8%、2.4%和2.4% vs 2.5%、4.8%和6.4%; P = 0.036）。多变量考克斯比例风险回归模型显示，DOAC组的临床相关出血风险低于华法林组（风险比：0.35; 95% CI：0.13-0.91; P = 0.032）。该登记研究表明，在当前标准治疗下，无论使用何种抗凝剂，而使用DOAC时临床相关出血率低于华法林。
Background: Chronic thromboembolic pulmonary hypertension (CTEPH) requires lifelong anticoagulation. Long-term outcomes of CTEPH under current anticoagulants are unclear.Objectives: The CTEPH AC registry is a prospective, nationwide cohort study comparing the safety and effectiveness of direct oral anticoagulants (DOACs) and warfarin for CTEPH.Patients/Methods: Patients with CTEPH, both tre atment-naive and on treatment, were eligible for the registry. Inclusion criteria were patients aged & GE;20 years and those who were diagnosed with CTEPH according to standard guidelines. Exclusion criteria were not specified. The primary efficacy outcome was a composite morbidity, and mortality outcome comprised all-cause death, rescue reperfusion therapy, initiation of parenteral pulmonary vasodilators, and worsened 6-minute walk distance and WHO functional class. The safety outcome was clinically relevant bleeding, including major bleeding.Results: Nine hundred twenty-seven patients on oral anticoagulants at baseline were analyzed: 481 (52%) used DOACs and 446 (48%) used warfarin. The 1-, 2-, and 3-year rates of composite morbidity and mortality outcome were comparable between the DOAC and warfarin groups (2.6%, 3.1%, and 4.2% vs 3.0%, 4.8%, and 5.9%, respectively; P = .52). The 1-, 2-, and 3-year rates of clinically relevant bleeding were significantly lower in DOACs than in the warfarin group (0.8%, 2.4%, and 2.4% vs 2.5%, 4.8%, and 6.4%, respectively; P = 0.036). Multivariable Cox proportional-hazards regression models revealed lower risk of clinically relevant bleeding in the DOAC group than the warfarin group (hazard ratio: 0.35; 95% CI: 0.13-0.91; P = .032).Conclusion: This registry demonstrated that under current standard of care, morbidity and mortality events were effectively prevented regardless of anticoagulants, while the clinically relevant bleeding rate was lower when using DOACs compared with warfarin.