Cardiology Department, Gosford Hospital, Central Coast Local Health District, Australia (A.C.B., W.M., P.M., E.C., E.R., N.H., A.P., S.L.S., A.K., T.K., A.H., R.S., K.S., A.M., M.P., M.I., M.W., P.J., T.J.F.).
School of Medicine and Public Health, The University of Newcastle, Australia (A.C.B., S.L.S., N.C., A.B., M.W., T.J.F.).
Circ Cardiovasc Interv. 2024 Oct;17(10):e014529. doi: 10.1161/CIRCINTERVENTIONS.124.014529. Epub 2024 Aug 31.
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).
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.
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/m). 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]; <0.001). Women assigned to the control wire experienced a higher failure rate compared with men (31% versus 8% in men; <0.001). Fluoroscopy time was significantly lower in the Baby J group (median, 344 versus 491 seconds; =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.
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.
URL: https://www.anzctr.org.au/; Unique identifier: ACTRN12622001557729.
1.5 毫米 Baby J 亲水型小 J 尖端导丝是标准 0.035"3 毫米 J 尖端外周导丝的改进型，旨在通过安全地将小口径桡动脉引导至主动脉，提高经桡动脉冠状动脉介入治疗的效率。目前，缺乏比较不同经桡动脉心脏介入治疗中使用的外周导丝的手术成功率和安全性的证据。我们比较了一种小 J 尖端亲水型 0.035"导丝（干预组，Radifocus Baby J 导丝；TERUMO Co，东京，日本）与标准的固定芯 0.035"J 导丝（对照组）的疗效和安全性。
这是一项由研究者发起的、盲法的、澳大利亚多中心随机临床试验，纳入了接受临床指征明确的冠状动脉造影或经皮冠状动脉介入治疗的患者。患者按 1:1 随机分配使用对照组导丝或干预组导丝。主要终点（技术成功率）定义为使用随机导丝获得主动脉根部入路。
2022 年 10 月至 2023 年 6 月期间共纳入 330 例患者（中位年龄 69 岁，36%为女性，体重指数 29 kg/m）。干预组更频繁地达到主要终点（96% vs. 84%；绝对风险降低 12%[95%CI，5.7-18.3]；<0.001）。与男性相比，分配至对照组导丝的女性失败率更高（31% vs. 8%男性；<0.001）。Baby J 组的透视时间显著更低（中位数 344 秒 vs. 491 秒；=0.024）。使用对照组导丝的主要失败机制是桡动脉痉挛（15/26；57%）和锁骨下动脉迂曲（5/26；19.2%）。两组的总手术时间、主要心血管不良事件或血管并发症均无差异。
与标准的 3 毫米 J 尖端非亲水导丝相比，小直径 1.5 毫米 J 尖端亲水导丝可提高技术成功率并减少透视时间。导丝安全，为经桡动脉入路提供了关键的增量获益，特别是对女性。
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