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慢性血栓栓塞性肺动脉高压患者直接抗凝剂使用、出血风险和静脉血栓栓塞复发的真实世界数据:一项观察性回顾性研究。

Real-life data of direct anticoagulant use, bleeding risk and venous thromboembolism recurrence in chronic thromboembolic pulmonary hypertension patients: an observational retrospective study.

作者信息

Sena Sert, Bulent Mutlu, Derya Kocakaya, Deniz Kaptan, Halil Ataş, Okan Erdogan, Bedrettin Yıldızeli

机构信息

Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.

Department of Cardiology, Faculty of Medicine, Marmara University, İstanbul, Turkey.

出版信息

Pulm Circ. 2020 Feb 19;10(1):2045894019873545. doi: 10.1177/2045894019873545. eCollection 2020 Jan-Mar.

DOI:10.1177/2045894019873545
PMID:32128155
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7031796/
Abstract

INTRODUCTION

Lifelong anticoagulation is the cornerstone of the chronic thromboembolic pulmonary hypertension (CTEPH) treatment regardless of the additional pulmonary endarterectomy, balloon pulmonary angioplasty, or medical treatment alone. Aim of this study was to evaluate the rate of oral anticoagulant preferences and document direct oral anticoagulants' (DOACs') safety, efficacy in the CTEPH population.

METHODS

Patients' demographic data obtained from database between September 2011 and April 2018. In-hospital events, death, venous thromboembolism (VTE) recurrence, bleeding events and anticoagulant therapy transition were recorded.

RESULTS

We reviewed 501 CTEPH patients who observed 9.0 ± 8.5 years. All-cause death, all bleeding, recurrent VTE was observed in 15.6%, 31% and 12%. Forty-one patients (8.2%) were diagnosed as inoperable. Of all, 15.2% of operable patients remained as residual. All-cause mortality rates were 13.8% (57 pts.) in the warfarin group as compared with 9.7% (13 pts.) in rivaroxaban group (HR: 1.61, 95% CI, 0.89-2.99; : 0.11). Higher bleeding events occurred with warfarin group (27.1%) as compared with rivaroxaban (24.6%; HR: 1.28, 95% CI, 0.86-1.88; : 0.22). Major bleeding was significantly higher with warfarin group (HR: 1.94, 95% CI, 1.05-3.62; : 0.03). Subgroup analysis of all-cause death revealed that this significance dominated by the rate of death according to bleeding events; warfarin versus those seen with rivaroxaban (4.85% vs. 2.2%; HR: 4.75, 95% CI: 1.12-20.16;  = 0.03). The rate of recurrent VTE was found 8.9% in the rivaroxaban group, 10.9% in warfarin group (HR: 1.21, 95% CI, 0.64-2.23; : 0.55).

CONCLUSION

DOACs could be a safe and effective alternative for lifelong anticoagulant therapy in CTEPH patients. Rivaroxaban produced similar rates of thromboembolism and non-relevant bleeding compared to those associated with warfarin. The main difference was found with major bleeding that it was mainly associated with the death rate according to major bleeding. Using DOACs might be a more reasonable way to prevent bleeding events without increasing thromboembolic risk.

摘要

引言

无论是否进行额外的肺动脉内膜剥脱术、球囊肺动脉成形术或单纯药物治疗,终身抗凝都是慢性血栓栓塞性肺动脉高压(CTEPH)治疗的基石。本研究的目的是评估口服抗凝剂的使用偏好率,并记录直接口服抗凝剂(DOACs)在CTEPH患者中的安全性和有效性。

方法

从2011年9月至2018年4月的数据库中获取患者的人口统计学数据。记录住院事件、死亡、静脉血栓栓塞(VTE)复发、出血事件和抗凝治疗转换情况。

结果

我们回顾了501例CTEPH患者,观察时间为9.0±8.5年。全因死亡、所有出血、VTE复发的发生率分别为15.6%、31%和12%。41例患者(8.2%)被诊断为无法手术。其中,15.2%的可手术患者仍有残留病变。华法林组的全因死亡率为13.8%(57例),而利伐沙班组为9.7%(13例)(HR:1.61,95%CI,0.89 - 2.99;P = 0.11)。华法林组的出血事件发生率(27.1%)高于利伐沙班组(24.6%;HR:1.28,95%CI,0.86 - 1.88;P = 0.22)。华法林组的大出血发生率显著更高(HR:1.94,95%CI,1.05 - 3.62;P = 0.03)。全因死亡的亚组分析显示,这种差异主要由出血事件导致的死亡率主导;华法林组与利伐沙班组相比(4.85%对2.2%;HR:4.75,95%CI:1.12 - 20.16;P = 0.03)。利伐沙班组的VTE复发率为8.9%,华法林组为10.9%(HR:1.21,95%CI,0.64 - 2.23;P = 0.55)。

结论

DOACs可能是CTEPH患者终身抗凝治疗的一种安全有效的替代方案。与华法林相比,利伐沙班产生的血栓栓塞和非相关性出血发生率相似。主要差异在于大出血,大出血主要与大出血导致的死亡率相关。使用DOACs可能是预防出血事件而不增加血栓栓塞风险的更合理方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6e2/7031796/fba50beb0a45/10.1177_2045894019873545-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6e2/7031796/6bdf5a87f0fa/10.1177_2045894019873545-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6e2/7031796/047aff6c0f5a/10.1177_2045894019873545-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6e2/7031796/fb505f7eaff8/10.1177_2045894019873545-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6e2/7031796/fba50beb0a45/10.1177_2045894019873545-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6e2/7031796/6bdf5a87f0fa/10.1177_2045894019873545-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6e2/7031796/047aff6c0f5a/10.1177_2045894019873545-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6e2/7031796/fb505f7eaff8/10.1177_2045894019873545-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6e2/7031796/fba50beb0a45/10.1177_2045894019873545-fig4.jpg

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