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比较利伐沙班与低分子肝素治疗癌症相关静脉血栓栓塞症:一项基于瑞典全国人群登记的研究。

Comparison of rivaroxaban and low molecular weight heparin in the treatment of cancer-associated venous thromboembolism: a Swedish national population-based register study.

机构信息

Department of Medicine Solna, Clinical Epidemiology/ Centre for Pharmacoepidemiology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.

Consultant for Bayer AG, Berlin, Germany.

出版信息

J Thromb Thrombolysis. 2024 Aug;57(6):973-983. doi: 10.1007/s11239-024-02992-1. Epub 2024 May 12.

Abstract

BACKGROUND

Treating cancer-associated venous thromboembolism (CAT) with anticoagulation prevents recurrent venous thromboembolism (rVTE), but increases bleeding risk.

OBJECTIVES

To compare incidence of rVTE, major bleeding, and all-cause mortality for rivaroxaban versus low molecular weight heparin (LMWH) in patients with CAT.

METHODS

We developed a cohort study using Swedish national registers 2013-2019. Patients with CAT (venous thromboembolism within 6 months of cancer diagnosis) were included. Those with other indications or with high bleeding risk cancers were excluded (according to guidelines). Follow-up was from index-CAT until outcome, death, emigration, or end of study. Incidence rates (IR) per 1000 person-years with 95% confidence interval (CI) and propensity score overlap-weighted hazard ratios (HRs) for rivaroxaban versus LMWH were estimated.

RESULTS

We included 283 patients on rivaroxaban and 5181 on LMWH. The IR for rVTE was 68.7 (95% CI 40.0-109.9) for rivaroxaban, compared with 91.6 (95% CI 81.9-102.0) for LMWH, with adjusted HR 0.77 (95% CI 0.43-1.35). The IR for major bleeding was 23.5 (95% CI 8.6-51.1) for rivaroxaban versus 49.2 (95% CI 42.3-56.9) for LMWH, with adjusted HR 0.62 (95% CI 0.26-1.49). The IR for all-cause mortality was 146.8 (95% CI 103.9-201.5) for rivaroxaban and 565.6 (95% CI 541.8-590.2) for LMWH with adjusted HR 0.48 (95% CI 0.34-0.67).

CONCLUSIONS

Rivaroxaban performed similarly to LMWH for patients with CAT for rVTE and major bleeding. An all-cause mortality benefit was observed for rivaroxaban which potentially may be attributed to residual confounding.

TRIAL REGISTRATION NUMBER

NCT05150938 (Registered 9 December 2021).

摘要

背景

使用抗凝剂治疗癌症相关静脉血栓栓塞症(CAT)可预防复发性静脉血栓栓塞症(rVTE),但会增加出血风险。

目的

比较利伐沙班与低分子肝素(LMWH)治疗 CAT 患者的 rVTE、大出血和全因死亡率。

方法

我们使用瑞典全国登记处 2013-2019 年的数据开展了一项队列研究。纳入 CAT 患者(癌症诊断后 6 个月内发生静脉血栓栓塞症)。排除有其他适应证或有高出血风险癌症的患者(根据指南)。随访从 CAT 索引期开始,直至结局、死亡、移民或研究结束。估计每 1000 人年的发生率(IR)及其 95%置信区间(CI)和倾向评分重叠加权的利伐沙班与 LMWH 比值比(HR)。

结果

我们纳入了 283 例利伐沙班组和 5181 例 LMWH 组患者。利伐沙班组 rVTE 的 IR 为 68.7(95%CI 40.0-109.9),而 LMWH 组为 91.6(95%CI 81.9-102.0),调整后的 HR 为 0.77(95%CI 0.43-1.35)。利伐沙班组大出血的 IR 为 23.5(95%CI 8.6-51.1),而 LMWH 组为 49.2(95%CI 42.3-56.9),调整后的 HR 为 0.62(95%CI 0.26-1.49)。利伐沙班组全因死亡率的 IR 为 146.8(95%CI 103.9-201.5),而 LMWH 组为 565.6(95%CI 541.8-590.2),调整后的 HR 为 0.48(95%CI 0.34-0.67)。

结论

利伐沙班在 rVTE 和大出血方面与 LMWH 对 CAT 患者的疗效相似。利伐沙班在全因死亡率方面有获益,这可能归因于残余混杂因素。

试验注册

NCT05150938(2021 年 12 月 9 日注册)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/652a/11315776/c956dbcc35be/11239_2024_2992_Fig1_HTML.jpg

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