Department of Cardiology, Wujin Hospital Affiliated with Jiangsu University, the Wujin Clinical College of Xuzhou Medical University, Changzhou, Jiangsu Province, China.
Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China; Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing, China.
Can J Cardiol. 2024 Nov;40(11):2292-2300. doi: 10.1016/j.cjca.2024.07.011. Epub 2024 Jul 19.
There is a lack of randomized clinical trials on whether the 6-French (Fr) Glidesheath Slender (GSS; Terumo, Tokyo, Japan) is superior to the 6-Fr conventional radial sheath (CS) with respect to the early-term incidence of distal radial artery occlusion (dRAO) in patients who have undergone coronary angiography (CAG) and/or percutaneous coronary intervention (PCI) via distal transradial access.
This was a prospective, single-centre trial of patients who were randomized to undergo CAG and/or PCI with either a 6-Fr GSS or a 6-Fr CS. The primary end point was the incidence of dRAO at 24 hours postoperatively, evaluated using Doppler ultrasound.
A total of 620 patients were included in the study. The baseline patient and procedural characteristics were similar among the 2 groups. For the primary end point, the incidence of dRAO at 24 hours after the procedure was 1.0% (3/314) in the GSS group and 3.6% (11/306) in the CS group (risk ratio, 0.266; 95% confidence interval, 0.075-0.943; P = 0.027) according to the intention to treat analysis. For the secondary end points, the incidence of proximal radial artery occlusion was 0.3% (1/314) in the GSS group and 2.3% (7/306) in the CS group (P = 0.029). Other secondary end points, including the puncture success rate, procedural outcomes, other puncture-related outcomes, and access-related complications were not significantly different in the 2 groups.
The use of a thin-walled and hydrophilic coating sheath can reduce the incidence of early-term dRAO in patients who undergo CAG and/or PCI via the distal transradial access.
NCT05501925.
目前缺乏随机临床试验来比较 6Fr Glidesheath Slender（GSS；日本东京 Terumo 公司）与 6Fr 常规桡动脉鞘（CS）在经远端桡动脉入路行冠状动脉造影（CAG）和/或经皮冠状动脉介入治疗（PCI）的患者中早期远端桡动脉闭塞（dRAO）发生率方面的优劣。
这是一项前瞻性、单中心试验，将接受 CAG 和/或 PCI 的患者随机分为使用 6Fr GSS 或 6Fr CS 组。主要终点是术后 24 小时使用多普勒超声评估 dRAO 的发生率。
共有 620 例患者纳入研究。两组患者的基线特征和手术特征相似。主要终点方面，GSS 组术后 24 小时 dRAO 发生率为 1.0%（3/314），CS 组为 3.6%（11/306）（风险比，0.266；95%置信区间，0.075-0.943；P=0.027），根据意向治疗分析。次要终点方面，GSS 组近端桡动脉闭塞发生率为 0.3%（1/314），CS 组为 2.3%（7/306）（P=0.029）。两组穿刺成功率、手术结果、其他穿刺相关结果和入路相关并发症等其他次要终点无显著差异。
在经远端桡动脉入路行 CAG 和/或 PCI 的患者中，使用薄壁亲水涂层鞘可降低早期 dRAO 的发生率。
NCT05501925。
