经皮冠状动脉介入治疗与经导管主动脉瓣植入术治疗顺序的随机比较:TAVI PCI 试验的原理与设计。

IF 3.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS American heart journal Pub Date : 2024-08-08 DOI:10.1016/j.ahj.2024.07.019
Barbara E. Stähli MD, MPH, MBA , Axel Linke MD , Dirk Westermann MD , Nicolas M. Van Mieghem MD , David M. Leistner MD , Steffen Massberg MD , Hannes Alber MD , Andreas Mügge MD , Giuseppe Musumeci MD , Rahel Kesterke PhD , Steffen Schneider PhD , Adnan Kastrati MD , Ian Ford PhD , Frank Ruschitzka MD , Markus A. Kasel MD , TAVI PCI Investigators, Barbara E. Stähli , Markus Kasel , Frank Ruschitzka , Axel Linke , Aldo Maggioni
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引用次数: 0

摘要

背景:大约一半的重度主动脉瓣狭窄患者同时伴有冠状动脉疾病。对于严重主动脉瓣狭窄并伴有冠状动脉疾病的患者,经皮冠状动脉介入治疗(PCI)和经导管主动脉瓣植入术(TAVI)的最佳时机仍然未知:TAVI PCI 试验是一项前瞻性、国际性、多中心、随机、双臂、开放标签研究,计划共招募 986 名患者。该研究旨在探讨在重度主动脉瓣狭窄并伴有冠状动脉疾病的患者中,使用 Edwards SAPIEN 3 或 3 Ultra 经导管心脏瓣膜™进行 "TAVI 后(1-45 天内)血管造影引导下的完全血运重建 "策略是否优于 "TAVI 前(1-45 天内)血管造影引导下的完全血运重建 "策略。患者按 1:1 的比例随机选择两种治疗策略中的一种。主要终点是1年内全因死亡、非致死性心肌梗死、缺血导致的血管再通、再住院(瓣膜或手术相关,包括心衰)或危及生命/致残或大出血的复合终点:TAVI PCI试验验证了一个假设,即对于严重主动脉瓣狭窄并伴有冠状动脉疾病的患者,"TAVI术后PCI "策略并不优于 "TAVI术前PCI "策略。
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A randomized comparison of the treatment sequence of percutaneous coronary intervention and transcatheter aortic valve implantation: Rationale and design of the TAVI PCI trial

Background

About half of patients with severe aortic stenosis present with concomitant coronary artery disease. The optimal timing of percutaneous coronary intervention (PCI) and transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and concomitant coronary artery disease remains unknown.

Study design

The TAVI PCI trial is a prospective, international, multicenter, randomized, 2-arm, open-label study planning to enroll a total of 986 patients. It is designed to investigate whether the strategy “angiography-guided complete revascularization after (within 1-45 days) TAVI” is noninferior to the strategy “angiography-guided complete revascularization before (within 1-45 days) TAVI” using the Edwards SAPIEN 3 or 3 Ultra Transcatheter Heart Valve in patients with severe aortic stenosis and concomitant coronary artery disease. Patients are randomized in a 1:1 ratio to one of the 2 treatment strategies. The primary end point is a composite of all-cause death, nonfatal myocardial infarction, ischemia-driven revascularization, rehospitalization (valve- or procedure-related including heart failure), or life-threatening/disabling or major bleeding at 1 year.

Conclusions

The TAVI PCI trial tests the hypothesis that the strategy “PCI after TAVI” is noninferior to the strategy “PCI before TAVI” in patients with severe aortic stenosis and concomitant coronary artery disease.

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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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