DEFIANCE 研究的原理和设计:机械血栓切除术与单纯抗凝治疗髂股深静脉血栓的随机对照试验。

IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Steven D Abramowitz, Xhorlina Marko, Donna D'Souza, Sonya Noor, Keith Pereira, Mitchell J Silver, Stuart P Rosenberg, Craig D Markovitz, Thomas Tu, Ido Weinberg, Stephen Black
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引用次数: 0

摘要

背景:深静脉血栓形成(DVT)是一种常见的内科疾病,与包括血栓后综合征(PTS)在内的重大临床后遗症有关。对于许多髂股深层静脉血栓患者来说,仅靠抗凝治疗仍然是指南推荐的治疗方法。最近的技术进步使机械性血栓切除术在深静脉血栓形成治疗中的应用越来越多,但基于机械性血栓切除术的治疗方法尚未在随机研究中与标准抗凝疗法进行比较:DEFIANCE研究(ClinicalTrials.gov:NCT05701917)是一项国际性研究,目前正在进行下肢深静脉血栓形成的随机对照试验(RCT),评估包括使用ClotTriever系统(Inari Medical,Irvine,CA)进行机械血栓切除术与单纯抗凝治疗的干预策略。约 300 名单侧髂股深静脉血栓且症状持续时间不超过 12 周的患者将按 1:1 随机分配。研究方法包括:由独立的核心实验室进行双相超声评估,由独立的医疗监督员进行安全性判定,并采用最佳临床实践的 Villalta 量表评估 PTS 的严重程度。主要终点是综合结果,其结构为 1)医疗监控人员判定的治疗失败或治疗升级(失败定义为目标腿截肢或坏疽或静脉血栓栓塞相关死亡率)的分层胜率,以及 2)6 个月随访时的 PTS 严重程度评估。除了作为主要终点的一个组成部分外,6 个月时的 PTS 严重程度也作为一个独立的次要终点进行评估。另外一个次要终点是 10 天随访时的综合结果,其结构为 1)双相超声显示的血管可压缩性;2)患者报告的疼痛;3)水肿改善程度的分层胜率。安全性终点是需要进行血管内或外科修复的入路部位并发症,以及 30 天就诊期间的死亡率、大出血或新的无症状肺栓塞发生率:结论:DEFIANCE将是首个评估基于机械血栓切除术的介入疗法与单纯抗凝疗法治疗深静脉血栓的RCT。研究结果将为髂股深层静脉血栓患者的治疗和预防与 PTS 相关的发病率提供参考:试验注册:DEFIANCE:ClotTriever 系统与抗凝治疗深静脉血栓形成的 RCT(DEFIANCE),ClinicalTrials.gov:NCT05701917,网址:https://clinicaltrials.gov/study/NCT05701917?cond=Deep%20Vein%20Thrombosis&term=defiance&rank=1。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Rationale and Design of the DEFIANCE Study: A Randomized Controlled Trial of Mechanical Thrombectomy Versus Anticoagulation Alone for Iliofemoral Deep Vein Thrombosis.

Background: Deep vein thrombosis (DVT) is a common medical condition that is associated with clinically significant sequelae, including postthrombotic syndrome (PTS). Anticoagulation alone remains the guideline-recommended treatment for many patients with iliofemoral DVT. Recent technological advances have led to an increase in the use of mechanical thrombectomy for DVT, but mechanical thrombectomy-based procedures have not yet been compared with standard-of-care anticoagulation therapy in randomized studies.

Methods: The DEFIANCE study (ClinicalTrials.gov: NCT05701917) is an international and actively enrolling randomized controlled trial (RCT) in lower extremity DVT assessing an interventional strategy that includes mechanical thrombectomy with the ClotTriever System (Inari Medical, Irvine, CA) versus anticoagulation alone. Approximately 300 patients with unilateral iliofemoral DVT and symptom duration ≤12 weeks will be randomized 1:1. Study conduct includes an independent core laboratory for duplex ultrasound assessment, an independent medical monitor for safety adjudication, and evaluation of PTS severity on the Villalta scale using best clinical practices. The primary endpoint is a composite outcome structured as a hierarchal win ratio of 1) the occurrence of treatment failure or therapy escalation as adjudicated by the medical monitor, with failure defined as amputation or gangrene of the target leg or venous thromboembolism-related mortality, and 2) the assessment of PTS severity at the 6-month follow-up visit. In addition to being a component of the primary endpoint, the severity of PTS at 6 months is also evaluated as a stand-alone secondary endpoint. An additional secondary endpoint is a composite of outcomes at the 10-day visit and is structured as a hierarchal win ratio of 1) vessel compressibility on duplex ultrasound, 2) patient-reported pain, and 3) improvement of edema. The safety endpoints are access site complications requiring endovascular or surgical repair and the occurrence through the 30-day visit of mortality, major bleeding, or new symptomatic pulmonary embolism.

Conclusions: DEFIANCE will be the first RCT to evaluate a mechanical thrombectomy-based interventional approach versus anticoagulation therapy alone for DVT. The results will inform the treatment of patients with iliofemoral DVT and the prevention of PTS-associated morbidity.

Trial registration: DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis (DEFIANCE), ClinicalTrials.gov: NCT05701917, URL: https://clinicaltrials.gov/study/NCT05701917?cond=Deep%20Vein%20Thrombosis&term=defiance&rank=1.

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来源期刊
American heart journal
American heart journal 医学-心血管系统
CiteScore
8.20
自引率
2.10%
发文量
214
审稿时长
38 days
期刊介绍: The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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