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随机比较使用 6.5Fr SheathLess Eaucath 引导导管与 6.0Fr Glidesheath Slender 进行选择性经桡动脉冠状动脉介入治疗时,桡动脉闭塞和症状性桡动脉痉挛的发生率。

A randomised comparison of incidence of radial artery occlusion and symptomatic radial artery spasm associated with elective transradial coronary intervention using 6.5 Fr SheathLess Eaucath Guiding Catheter vs. 6.0 Fr Glidesheath Slender.

机构信息

Department of Cardiovascular Medicine, Sendai Kousei Hospital, Sendai, Miyagi, Japan.

出版信息

EuroIntervention. 2018 Apr 20;13(17):2018-2025. doi: 10.4244/EIJ-D-17-00239.

Abstract

AIMS

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).

METHODS AND RESULTS

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).

CONCLUSIONS

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.

摘要

目的

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。

方法和结果

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)。

结论

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。

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