Department of Cardiovascular Medicine, Sendai Kousei Hospital, Sendai, Miyagi, Japan.
EuroIntervention. 2018 Apr 20;13(17):2018-2025. doi: 10.4244/EIJ-D-17-00239.
The aim of this study was to compare incidences of radial artery occlusion (RAO) and spasm (RAS) associated with transradial coronary intervention (TRI) using a 6.5 Fr SheathLess hydrophilic-coated guide catheter (SH-GC) vs. a 6.0 Fr Glidesheath Slender (GSS).
We conducted an open-label, single-centre, randomised study to compare radial complications in 600 consecutive patients undergoing elective TRI using 6.5 Fr SH-GC (n=300) or 6.0 Fr GSS (n=300) between 2015 and 2016. The primary endpoint was a composite of RAO evaluated by sonography and symptomatic RAS. The mean diameter of radial arteries was 2.20 mm in both groups; however, the sheath/radial artery diameter (S/RA) ratio was significantly smaller in the SH-GC group (1.03 vs. 1.17, p<0.001). SH-GC was associated with a higher rate of system crossover (1.7% vs. 0.7%, p=0.450) and coronary ostial dissection (1.0% vs. 0.3%, p=0.624), although there were no statistically significant differences. The incidence of major adverse cardiac events was comparable. A lower incidence of RAO and access-site crossover owing to RAS was significantly associated with SH-GC (0.0% vs. 2.0%, p=0.031). Multivariate analysis revealed that a larger S/RA ratio predicted RAO and RAS independently (p=0.007).
The 6.5 Fr SH-GC offers a promising alternative to conventional TRI and is associated with fewer radial complications than the 6.0 Fr GSS.
本研究旨在比较使用 6.5Fr SheathLess 亲水涂层导引导管(SH-GC)与 6.0Fr Glidesheath Slender(GSS)进行经桡动脉冠状动脉介入治疗(TRI)时桡动脉闭塞(RAO)和痉挛(RAS)的发生率。
我们进行了一项开放标签、单中心、随机研究,比较了 2015 年至 2016 年期间 600 例连续接受选择性 TRI 的患者使用 6.5Fr SH-GC(n=300)或 6.0Fr GSS(n=300)的桡动脉并发症。主要终点是超声评估的 RAO 和症状性 RAS 的复合事件。两组桡动脉平均直径为 2.20mm;然而,SH-GC 组的鞘/桡动脉直径(S/RA)比值显著较小(1.03 比 1.17,p<0.001)。SH-GC 与更高的系统交叉率(1.7%比 0.7%,p=0.450)和冠状动脉口部夹层(1.0%比 0.3%,p=0.624)相关,尽管无统计学差异。主要不良心脏事件的发生率相当。由于 RAS 导致的 RAO 和入路交叉的发生率较低,与 SH-GC 显著相关(0.0%比 2.0%,p=0.031)。多变量分析显示,较大的 S/RA 比值独立预测 RAO 和 RAS(p=0.007)。
6.5Fr SH-GC 为常规 TRI 提供了一种有前途的替代方法,与 6.0Fr GSS 相比,桡动脉并发症较少。