Edoxaban for 12 vs. 3 months in cancer-associated isolated distal deep vein thrombosis according to different doses: insights from the ONCO DVT study.

IF 5.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

European Heart Journal - Cardiovascular Pharmacotherapy Pub Date : 2024-08-14 DOI:10.1093/ehjcvp/pvae028

Ryuki Chatani, Yugo Yamashita, Takeshi Morimoto, Nao Muraoka, Michihisa Umetsu, Yuji Nishimoto, Takuma Takada, Yoshito Ogihara, Tatsuya Nishikawa, Nobutaka Ikeda, Kazunori Otsui, Daisuke Sueta, Yukari Tsubata, Masaaki Shoji, Ayumi Shikama, Yutaka Hosoi, Yasuhiro Tanabe, Kengo Tsukahara, Naohiko Nakanishi, Kitae Kim, Satoshi Ikeda, Kazunori Mushiake, Kazushige Kadota, Koh Ono, Takeshi Kimura

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引用次数: 0

Abstract

Background: The ONCO DVT study revealed the superiority of 12-month relative to 3-month edoxaban treatment for cancer-associated isolated distal deep vein thrombosis (DVT) regarding the thrombotic risk.

Methods and results: In this pre-specified subgroup analysis of the ONCO DVT study, we stratified the patients into those with a standard edoxaban dose (60 mg/day; N = 151) and those with a reduced edoxaban dose (30 mg/day; N = 450) and evaluated the clinical outcomes for the 12- and 3-month treatments. The cumulative 12-month incidence of symptomatic recurrent venous thromboembolism was lower in the 12-month than 3-month group for both the 60 mg (1.3% vs. 11.6%, P = 0.02; odds ratio [OR], 0.12; 95% confidence interval [CI], 0.01-0.97) and 30 mg (1.1% vs. 7.6%, P = 0.002; OR, 0.14; 95% CI, 0.03-0.60) edoxaban subgroups, which was consistent across the edoxaban doses without a significant interaction (P = 0.90). The 12-month cumulative incidence of major bleeding was higher in the 12-month group than in the 3-month group for the 60 mg edoxaban subgroup (14.3% vs. 4.4%, P = 0.046; OR, 3.61; 95% CI, 0.97-13.52), whereas it did not significantly differ between the two groups for the 30 mg edoxaban subgroup (8.7% vs. 8.6%, P = 0.89; OR, 0.97; 95% CI, 0.49-1.91), signalling there was a potential interaction (P = 0.07).

Conclusions: A 12-month edoxaban regimen for cancer-associated isolated distal DVT was consistently superior to a 3-month regimen, across the edoxaban doses for the thrombotic risk. However, caution was suggested for the standard dose of edoxaban due to the potential for an increased risk of bleeding with prolonged anticoagulation therapy.

Trial registration number: NCT03895502 (ONCO DVT Trial): https://classic.clinicaltrials.gov/ct2/show/NCT03895502.

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不同剂量的埃多沙班治疗癌症相关孤立远端深静脉血栓 12 个月与 3 个月：ONCO深静脉血栓研究的启示。

背景：ONCO DVT研究显示，在血栓形成风险方面，对癌症相关孤立远端深静脉血栓形成（DVT）患者进行为期12个月的依多沙班治疗优于为期3个月的依多沙班治疗：在ONCO深静脉血栓研究的这一预先指定的亚组分析中，我们将患者分为服用标准埃多沙班剂量（60毫克/天；N=151）的患者和服用减量埃多沙班剂量（30毫克/天；N=450）的患者，并评估了12个月和3个月治疗的临床结果：60毫克组12个月的症状性复发性静脉血栓栓塞症累积发生率低于3个月组（1.3% vs. 11.6%，P=0.02；几率比[OR]，0.12；95% CI，0.01-0.97）和30 mg（1.1% vs. 7.6%，P=0.002；OR，0.14；95% CI，0.03-0.60）埃多沙班亚组，这在不同埃多沙班剂量之间是一致的，没有显著的交互作用（P =0.90）。在 60 毫克埃多沙班亚组中，12 个月组的大出血累积发生率高于 3 个月组（14.3% 对 4.4%，P=0.046；OR，3.61；95% CI，0.97-13.52）。52），而在30毫克埃多沙班亚组中，两组之间没有显著差异（8.7% vs. 8.6%，P=0.89；OR，0.97；95% CI，0.49-1.91），表明存在潜在的相互作用（P=0.07）：就血栓风险而言，12个月的依多沙班方案治疗癌症相关孤立远端深静脉血栓一直优于3个月的方案。然而，由于长期抗凝治疗可能会增加出血风险，因此建议谨慎使用标准剂量的依多沙班。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Heart Journal - Cardiovascular Pharmacotherapy Medicine-Cardiology and Cardiovascular Medicine

CiteScore

10.10

自引率

14.10%

发文量

期刊介绍： The European Heart Journal - Cardiovascular Pharmacotherapy (EHJ-CVP) is an international, peer-reviewed journal published in English, specifically dedicated to clinical cardiovascular pharmacology. EHJ-CVP publishes original articles focusing on clinical research involving both new and established drugs and methods, along with meta-analyses and topical reviews. The journal's primary aim is to enhance the pharmacological treatment of patients with cardiovascular disease by interpreting and integrating new scientific developments in this field. While the emphasis is on clinical topics, EHJ-CVP also considers basic research articles from fields such as physiology and molecular biology that contribute to the understanding of cardiovascular drug therapy. These may include articles related to new drug development and evaluation, the physiological and pharmacological basis of drug action, metabolism, drug interactions, and side effects.