NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Department of Cardiovascular Medicine, University of Oxford, Oxford, UK.
EuroIntervention. 2023 Apr 24;18(17):1428-1435. doi: 10.4244/EIJ-D-22-00713.
Transcatheter aortic valve implantation (TAVI) is an established treatment for aortic stenosis. Cerebral embolic protection (CEP) devices may impact periprocedural stroke by capturing debris destined for the brain. However, there is a lack of high-quality randomised trial evidence supporting the use of CEP during TAVI. The British Heart Foundation (BHF) PROTECT-TAVI trial will address whether the routine use of CEP reduces the incidence of stroke in patients undergoing TAVI. BHF PROTECT-TAVI is a prospective, open-label, outcome-adjudicated, multicentre randomised controlled trial. The trial is open to all adult patients scheduled for TAVI at participating specialist cardiac centres across the United Kingdom who are able to receive the CEP device. The trial will recruit 7,730 participants. Participants will be randomised in a 1:1 ratio to undergo TAVI with CEP or TAVI without CEP (standard of care). The primary outcome is the incidence of stroke at 72 hours post-TAVI. Key secondary outcomes include the incidence of stroke and all-cause mortality up to 12 months post-TAVI, disability and cognitive outcomes, stroke severity, access site complications and a health economics analysis. The sample size of 7,730 participants has 80% power to detect a 33% relative risk reduction from a 3% incidence of the primary outcome in the controls. Trial recruitment commenced in October 2020. As of October 2022, 3,068 patients have been enrolled. BHF PROTECT-TAVI is designed to provide definitive evidence on the clinical efficacy and cost-effectiveness of using routine CEP with the SENTINEL device to reduce stroke in TAVI.
经导管主动脉瓣植入术(TAVI)是治疗主动脉瓣狭窄的一种已确立的方法。脑保护装置(CEP)可通过捕获注定进入大脑的碎片来影响围手术期卒中。然而,缺乏支持 TAVI 期间常规使用 CEP 的高质量随机试验证据。英国心脏基金会(BHF)的 PROTECT-TAVI 试验将探讨在接受 TAVI 的患者中常规使用 CEP 是否会降低卒中的发生率。BHF PROTECT-TAVI 是一项前瞻性、开放标签、结局裁定、多中心随机对照试验。该试验面向所有在英国参与研究的专科心脏中心接受 TAVI 治疗的成年患者开放,这些患者能够接受 CEP 装置。该试验将招募 7730 名参与者。参与者将按照 1:1 的比例随机分为接受 CEP 辅助 TAVI 或不接受 CEP(标准护理)的 TAVI 治疗。主要结局是 TAVI 后 72 小时内的卒中发生率。关键次要结局包括 TAVI 后 12 个月内的卒中发生率和全因死亡率、残疾和认知结局、卒中严重程度、入路部位并发症和卫生经济学分析。7730 名参与者的样本量具有 80%的效能,可检测出对照组中主要结局发生率从 3%降低到 33%的相对风险降低。试验招募于 2020 年 10 月开始。截至 2022 年 10 月,已有 3068 名患者入组。BHF PROTECT-TAVI 旨在提供关于使用 SENTINEL 装置常规进行 CEP 以降低 TAVI 中卒中的临床疗效和成本效益的明确证据。
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