利伐沙班与华法林在肺栓塞和右室功能障碍患者中的有效性和安全性：一项回顾性队列研究

IF 3.4 3区医学 Q2 HEMATOLOGY

Research and Practice in Thrombosis and Haemostasis Pub Date : 2025-07-01 DOI:10.1016/j.rpth.2025.102951

François Laliberté , Behnood Bikdeli , Veronica Ashton , Guillaume Germain , Julien Boudreau , Manasvi Sundar , Sean D. MacKnight , Brahim Bookhart , Dereck Wentworth , Shawn Murphy , Yichuan G. Hsieh , Gregory Piazza

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引用次数: 0

摘要

比较利伐沙班和华法林治疗右室功能障碍（RVD）患者的有效性和安全性的数据有限，RVD是一种常见的急性肺栓塞（PE）并发症。目的比较利伐沙班与华法林在PE和RVD患者中的有效性和安全性。方法从2013年1月至2023年5月期间，新开利伐沙班或华法林的pe相关住院且有RVD证据的成年患者中识别。结果包括首次复发静脉血栓栓塞（VTE）的时间和首次大出血的时间。描述了华法林治疗期间国际标准化比值（INR）测量值在治疗范围（INR: 2-3）内的比例。Kaplan-Meier分析描述了6个月至36个月的事件发生率，使用Cox比例风险模型的风险比、95% ci和P值进行比较。结果共纳入利伐沙班患者246例，华法林患者315例(平均年龄63岁；女:53%)。利伐沙班和华法林患者的中位治疗时间分别为270天和235天；华法林使用者中50.9%的INR测量值在治疗范围内。在所有时间点，利伐沙班的静脉血栓栓塞复发风险显著低于华法林，包括36个月时风险降低41% (20.4% vs 30.3%；风险比[95% CI]， 0.59[0.38, 0.92])。治疗36个月后，两组患者发生大出血的风险无显著差异（8.2% vs 13.6%）。结论利伐沙班与华法林相比，静脉血栓栓塞复发风险较低，大出血风险无显著差异。

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Effectiveness and safety of rivaroxaban vs warfarin in patients with pulmonary embolism and right ventricular dysfunction: a retrospective cohort study

Background

Limited data exist comparing the effectiveness and safety of rivaroxaban and warfarin in patients with right ventricular dysfunction (RVD), a common acute pulmonary embolism (PE) complication.

Objectives

To assess the effectiveness and safety of rivaroxaban compared with warfarin among patients with PE and RVD.

Methods

Adult patients newly prescribed rivaroxaban or warfarin during PE-related hospitalization with evidence of RVD were identified from Mass General Brigham’s Research Patient Data Registry database (January 2013-May 2023). Outcomes included time-to-first recurrent venous thromboembolism (VTE) and time-to-first major bleeding event. The proportion of international normalized ratio (INR) measurements within therapeutic range (INR: 2-3) while on warfarin was described. Kaplan–Meier analysis described event rates at 6-month intervals up to 36 months, which were compared using hazard ratios, 95% CIs, and P values from Cox proportional hazards models.

Results

Overall, 246 rivaroxaban and 315 warfarin users were included (mean age, 63 years; female: 53%). Median time of treatment was 270 and 235 days for rivaroxaban and warfarin users, respectively; 50.9% of INR measurements among warfarin users were within therapeutic range. Rivaroxaban was associated with significantly lower risk of VTE recurrence than warfarin at all-time points, including 41% lower risk at 36 months (20.4% vs 30.3%; hazard ratio [95% CI], 0.59 [0.38, 0.92]). There was no significant difference in risk of major bleeding between cohorts up to 36 months of treatment (8.2% vs 13.6%).