增强经桡动脉入路的导丝功效:EAGER 随机对照试验。

IF 6.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Adam C Bland, William Meere, Philopatir Mikhail, Eunice Chuah, Eleanor Redwood, David Ferreira, Nicklas Howden, Adam Perkovic, Samantha L Saunders, Amy Kelty, Tony Kull, Andrew Hill, Roberto Spina, Kiran Sarathy, Austin May, Michael Parkinson, Mark Ishak, Nicholas Collins, Andrew Boyle, Maged William, Prajith Jeyaprakash, Tom J Ford
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引用次数: 0

摘要

背景:1.5 毫米 "Baby J "亲水窄 J 端导引钢丝是对标准 0.035" 3 毫米 J 端外周导引钢丝的改进,旨在通过将小口径桡动脉安全引向主动脉来提高经桡动脉冠状动脉手术的效率。目前缺乏证据比较经桡动脉心脏手术中使用的不同外周导丝的手术成功率和安全性。我们比较了窄 J 端亲水 0.035 英寸导丝(干预 - Radifocus™ 'Baby J'导丝,TERUMO 公司,日本东京)与标准固定芯(FC)0.035 英寸 J 导丝(对照)的有效性和安全性。方法:由研究者发起、盲法、澳大利亚多中心随机试验,对象为接受临床冠状动脉造影术和/或 PCI 的患者。通过密封信封法以 1:1 随机分配使用对照组或介入导丝。主要终点(技术成功)定义为使用随机导丝获得主动脉根部通路。结果330 名患者在 2022 年 10 月至 2023 年 6 月期间接受了随机治疗(中位年龄 69 岁,36% 为女性,体重指数 29 kg/m²)。干预组达到主要终点的比例更高[96% 对 84%;平均差异 12% (95% CI 5.7-18.3); p结论:与标准的 3 毫米 J 端非亲水导丝相比,1.5 毫米 J 端窄亲水导丝的技术成功率更高,透视时间更短。这种导丝非常安全,并显示出经桡动脉入路的关键增量优势,尤其是对女性而言。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Enhancing Guidewire Efficacy for Transradial Access: The EAGER Randomized Controlled Trial.

Background: The 1.5 mm Baby J hydrophilic narrow J-tipped wire is a development of the standard 0.035" 3-mm J-tipped peripheral guidewire, designed to improve efficiency of transradial coronary procedures by safely navigating small caliber radial arteries to the aorta. There is currently a lack of evidence comparing the procedural success and safety of different peripheral guidewires used in transradial cardiac procedures. We compared the efficacy and safety of a narrow J-tipped hydrophilic 0.035" wire (intervention, Radifocus Baby J guidewire; TERUMO Co, Tokyo, Japan) versus a standard fixed-core 0.035" J wire (control).

Methods: Investigator-initiated, blinded, Australian, multicenter randomized trial in patients undergoing clinically indicated coronary angiography or percutaneous coronary intervention. Patients were randomized 1:1 to use either the control guidewire or the intervention guidewire. The primary end point (technical success) was defined as gaining aortic root access with the randomized guidewire.

Results: In all, 330 patients were randomized between October 2022 and June 2023 (median age was 69 years, 36% were female, and body mass index was 29 kg/m2). The primary end point was achieved more frequently in the intervention group (96% versus 84%; absolute risk reduction 12% [95% CI, 5.7-18.3]; P<0.001). Women assigned to the control wire experienced a higher failure rate compared with men (31% versus 8% in men; P<0.001). Fluoroscopy time was significantly lower in the Baby J group (median, 344 versus 491 seconds; P=0.024). The main mechanisms of failure using the control wire were radial artery spasm (15/26; 57%) and subclavian tortuosity (5/26; 19.2%). There were no differences in overall procedure times, major adverse cardiovascular events, or vascular complications between guidewires.

Conclusions: A narrow 1.5 mm J-tipped hydrophilic guidewire resulted in greater technical success and reduced fluoroscopy time compared with the standard 3-mm J-tipped nonhydrophilic guidewire. The guidewire is safe and demonstrated key incremental benefits for the transradial approach, particularly in women.

Registration: URL: https://www.anzctr.org.au/; Unique identifier: ACTRN12622001557729.

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来源期刊
Circulation: Cardiovascular Interventions
Circulation: Cardiovascular Interventions CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
10.30
自引率
1.80%
发文量
221
审稿时长
6-12 weeks
期刊介绍: Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.
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