Duration of Anticoagulation for Venous Thromboembolism in Pediatric Patients: Kids-DOTT Trial Outcomes at Two Years.

IF 5.5 2区医学 Q1 HEMATOLOGY

Journal of Thrombosis and Haemostasis Pub Date : 2024-10-24 DOI:10.1016/j.jtha.2024.09.038

Neil A Goldenberg, Sam Schulman, John M Kittelson, Thomas C Abshire, James F Casella, Rita Dale, Jonathan L Halperin, Jade Hanson, Craig M Kessler, Marilyn J Manco-Johnson, Laurel McDevitt, Robert F Sidonio, Alex C Spyropoulos, P Gabriel Steg, Marc P Bonaca

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引用次数: 0

Abstract

Background: The Kids-DOTT multinational randomized clinical trial (RCT) revealed non-inferiority of a six-week versus three-month duration of anticoagulation for the treatment of provoked venous thromboembolism (VTE) in patients <21 years old, in regard to net clinical benefit at one year.

Objective: To evaluate non-inferiority at two years.

Patients/methods: Patients whose repeat imaging six weeks after VTE diagnosis did not show complete veno-occlusion were randomized to discontinue anticoagulation versus receive a total three-month course and followed for two years for the occurrence of symptomatic recurrent (SR-) VTE (efficacy outcome) and clinically-relevant bleeding (CRB, safety outcome). Outcomes were centrally adjudicated and net clinical benefit was compared between treatment arms via a pre-specified bivariate non-inferiority boundary, using 95% confidence intervals (CIs) in absolute risk differences (ARDs) between treatment arms.

Results: Kaplan-Meier estimates of two-year cumulative incidences in the six-week and three-months arms of the intention-to-treat (ITT) population (n=417) were 1.7% (95% CI: 0%, 3.7%) and 2.9% (95% CI: 0.3%, 5.4%) for SR-VTE and 1.1% (95% CI: 0%, 2.5%) and 3.2% (95% CI: 0.6%, 5.7%) for CRB. Bivariate analysis of the ARDs in the ITT population demonstrated that a six-week anticoagulation duration was non-inferior to a three-month course.

Conclusions: These findings support durability of the Kids-DOTT RCT findings of net clinical benefit at two years.

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儿科静脉血栓栓塞症患者抗凝治疗的持续时间：Kids-DOTT 试验两年后的结果。

背景：Kids-DOTT多国随机临床试验（RCT）显示，在治疗诱发静脉血栓栓塞症（VTE）患者时，抗凝时间为六周与三个月相比并无劣效：评估两年后的非劣效性：患者/方法： VTE 诊断六周后重复成像未显示完全静脉闭塞的患者被随机分为停止抗凝与接受为期三个月的疗程，并随访两年，以观察有症状复发 (SR-) VTE 的发生情况（疗效结果）和临床相关出血（CRB，安全性结果）。结果由中央裁定，并通过预先指定的双变量非劣效界值比较各治疗臂之间的净临床获益，采用各治疗臂之间绝对风险差异（ARD）的95%置信区间（CI）：在意向治疗（ITT）人群（n=417）中，六周组和三个月组的两年累积发病率卡普兰-梅耶估计值分别为：SR-VTE为1.7%（95% CI：0%，3.7%）和2.9%（95% CI：0.3%，5.4%）；CRB为1.1%（95% CI：0%，2.5%）和3.2%（95% CI：0.6%，5.7%）。对ITT人群的ARD进行的双变量分析表明，6周的抗凝疗程不劣于3个月的疗程：这些研究结果表明，Kids-DOTT RCT 研究发现的两年净临床获益具有持久性。

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

Journal of Thrombosis and Haemostasis 医学-外周血管病

CiteScore

24.30

自引率

3.80%

发文量

321

审稿时长

1 months

期刊介绍： The Journal of Thrombosis and Haemostasis (JTH) serves as the official journal of the International Society on Thrombosis and Haemostasis. It is dedicated to advancing science related to thrombosis, bleeding disorders, and vascular biology through the dissemination and exchange of information and ideas within the global research community. Types of Publications: The journal publishes a variety of content, including: Original research reports State-of-the-art reviews Brief reports Case reports Invited commentaries on publications in the Journal Forum articles Correspondence Announcements Scope of Contributions: Editors invite contributions from both fundamental and clinical domains. These include: Basic manuscripts on blood coagulation and fibrinolysis Studies on proteins and reactions related to thrombosis and haemostasis Research on blood platelets and their interactions with other biological systems, such as the vessel wall, blood cells, and invading organisms Clinical manuscripts covering various topics including venous thrombosis, arterial disease, hemophilia, bleeding disorders, and platelet diseases Clinical manuscripts may encompass etiology, diagnostics, prognosis, prevention, and treatment strategies.