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经导管主动脉瓣植入术中常规脑栓塞保护:随机英国心脏基金会 PROTECT-TAVI 试验的原理和设计。

Routine cerebral embolic protection in transcatheter aortic valve implantation: rationale and design of the randomised British Heart Foundation PROTECT-TAVI trial.

机构信息

NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.

Department of Cardiovascular Medicine, University of Oxford, Oxford, UK.

出版信息

EuroIntervention. 2023 Apr 24;18(17):1428-1435. doi: 10.4244/EIJ-D-22-00713.


DOI:10.4244/EIJ-D-22-00713
PMID:36706009
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10111121/
Abstract

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.

摘要

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。

相似文献

[1]
Routine cerebral embolic protection in transcatheter aortic valve implantation: rationale and design of the randomised British Heart Foundation PROTECT-TAVI trial.

EuroIntervention. 2023-4-24

[2]
Stroke events after transcatheter aortic valve implantation: Temporal relationships and affected brain regions.

Am Heart J. 2022-5

[3]
Cerebral embolic protection and severity of stroke following transcatheter aortic valve replacement.

Catheter Cardiovasc Interv. 2022-11

[4]
Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement.

N Engl J Med. 2022-10-6

[5]
Clinical impact of cerebral protection during transcatheter aortic valve implantation.

Eur J Clin Invest. 2024-5

[6]
Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: a patient-level propensity-matched analysis.

Eur Heart J. 2019-5-1

[7]
First-in-man use of a novel embolic protection device for patients undergoing transcatheter aortic valve implantation.

EuroIntervention. 2012-5-15

[8]
Stroke reduction by cerebral embolic protection devices in transcatheter aortic valve implantation: a systematic review and Bayesian meta-analysis.

Heart. 2024-5-10

[9]
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Acta Cardiol. 2022-5

[10]
A systematic review and meta-analysis of the cerebrovascular event incidence after transcatheter aortic valve implantation.

Clin Res Cardiol. 2022-8

引用本文的文献

[1]
Incidence, Risk Factors, and Stroke Prevention During Transcatheter Aortic Valve Implantation.

Rev Cardiovasc Med. 2025-4-22

[2]
[Advances in stroke after transcatheter aortic valve replacement].

Zhejiang Da Xue Xue Bao Yi Xue Ban. 2025-3-25

[3]
Cerebral Embolic Protection Devices in Transcatheter Aortic Valve Implantation: Meta-Analysis With Trial Sequential Analysis.

J Am Heart Assoc. 2025-4

[4]
Neuroprotection Devices in Cardiac Catheterization Laboratories: Does It Sufficiently Protect Our Patients?

Medicina (Kaunas). 2025-2-10

[5]
Management of Acute Ischemic Stroke Following Transcatheter Aortic Valve Implantation: A Systematic Review and Multidisciplinary Treatment Recommendations.

J Clin Med. 2024-12-6

[6]
2024 Update on Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement.

J Clin Med. 2024-11-28

[7]
TAVI with the ACURATE neo2 in severe bicuspid aortic valve stenosis: the Neo2 BAV Registry.

EuroIntervention. 2025-1-20

[8]
Cerebral Embolic Protection Devices: Are There Any Indications in Transcatheter Aortic Valve Replacement?

J Clin Med. 2024-9-14

[9]
Impact of Cerebral Embolic Protection Devices on Disabling Stroke After TAVR: Updated Results From the STS/ACC TVT Registry.

Circ Cardiovasc Interv. 2024-9

[10]
Anaesthesia for Minimally Invasive Cardiac Surgery.

J Cardiovasc Dev Dis. 2023-11-15

本文引用的文献

[1]
Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement.

N Engl J Med. 2022-10-6

[2]
Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.

N Engl J Med. 2019-3-16

[3]
Predictors, Incidence, and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation Complicated by Stroke.

Circ Cardiovasc Interv. 2019-3

[4]
Impact of Short-Term Complications on Mortality and Quality of Life After Transcatheter Aortic Valve Replacement.

JACC Cardiovasc Interv. 2019-2-25

[5]
Safety and efficacy of cerebral protection devices in transcatheter aortic valve replacement: A clinical end-points meta-analysis.

Cardiovasc Revasc Med. 2018-10

[6]
Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures.

JACC Cardiovasc Interv. 2017-9-13

[7]
Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke.

N Engl J Med. 2017-9-14

[8]
Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke.

N Engl J Med. 2017-9-14

[9]
Cerebral Embolic Protection Devices During Transcatheter Aortic Valve Implantation: Systematic Review and Meta-Analysis.

Stroke. 2017-5

[10]
Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

Eur Heart J. 2018-5-14

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