不同抗血栓疗法对经导管主动脉瓣亚临床瓣叶增厚及其时间动态影响的前瞻性研究--NOTION-4 试验：抗血栓疗法和TAV-HALT。

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2024-10-05 DOI:10.1016/j.ahj.2024.10.002

Jani Thuraiaiyah , Troels Højsgaard Jørgensen , Jesper Møller Jensen , Andreas Fuchs , Yannick Willemen , Christian Juhl Terkelsen , Klaus Fuglsang Kofoed , Lars Søndergaard , Bjarne Linde Nørgaard , Ole De Backer

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引用次数: 0

摘要

背景：经导管主动脉瓣置换术（TAVR）已成为大多数严重无症状主动脉瓣狭窄患者的标准治疗方法。经导管主动脉瓣置换术（TAVR）已成为大多数重度无症状主动脉瓣狭窄患者的标准治疗方法，但术后抗血栓治疗管理仍是一个争论不休的话题，它可能会影响 HALT 的发生率，而 HALT 可通过四维计算机断层扫描（4DCT）进行评估：NOTION-4试验是一项随机对照试验，包括无口服抗凝剂（OAC）治疗指征的TAVR患者，比较终生单一抗血小板治疗（标准组）与早期3个月直接口服抗凝剂（DOAC）治疗后单一抗血小板治疗（实验组）。将在随机分组后的 3 个月、1 年和 5 年对两组的 HALT 发生率和临床终点进行评估。主要终点是通过心脏 4DCT 成像评估 1 年后至少有一片生物人工主动脉瓣叶出现 HALT 的患者人数。该试验已通过优效性测试，并于2021年开始招募患者。总共将纳入 324 名患者。最后一名患者预计将于2024年底入组，主要终点将于2026年公布：NOTION-4 试验旨在研究 TAVR 术后早期 3 个月 DOAC 治疗能否持续降低经导管主动脉瓣的 HALT 发生率。该试验有可能为是否应将早期OAC治疗纳入未来TAVR术后抗血栓治疗指南提供有价值的见解：NOTION-4，ClinicalTrials.gov ID NCT06449469，https://clinicaltrials.gov/study/NCT06449469。

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Prospective study on the impact of different antithrombotic therapies on subclinical leaflet thickening and its temporal dynamics in transcatheter aortic valves—The NOTION-4 trial

Background

Transcatheter aortic valve replacement (TAVR) has become the standard-of-care treatment for a majority of patients with severe, symptomatic aortic stenosis. The postprocedural antithrombotic therapeutic management is still a topic of debate and could affect the incidence of HALT, a phenomenon which can be assessed by 4-dimensional computed tomography (4DCT).

Trial design

The NOTION-4 trial is a randomized controlled trial comprising TAVR patients with no indication for oral anticoagulant (OAC) therapy, comparing lifelong single antiplatelet therapy (standard arm) versus early 3-month direct oral anticoagulant (DOAC) therapy followed by single antiplateletet therapy (experimental arm). The incidence of HALT and clinical endpoints will be evaluated in both groups at 3 months, 1 year and 5 years after randomization. The primary endpoint is the number of patients with at least 1 bioprosthetic aortic valve leaflet with HALT as assessed by cardiac 4DCT imaging at 1 year. The trial is powered for superiority testing and started enrollment in 2021. In total, 324 patients will be included. The last patient is expected to be enrolled by the end of 2024 and the primary endpoint is to be presented in 2026.

Conclusion and perspective

The NOTION-4 trial aims to study whether an early 3-month DOAC therapy after TAVR can result in a sustained lower incidence of HALT in transcatheter aortic valves. This trial holds the potential to give valuable insights into whether early OAC therapy should be integrated in future guidelines for post-TAVR antithrombotic therapeutic management.

Trial registration

NOTION-4, ClinicalTrials.gov ID NCT06449469, https://clinicaltrials.gov/study/NCT06449469

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来源期刊

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.