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经远端桡动脉行冠状动脉造影时 Glidesheath Slender 与传统 5Fr 动脉鞘的随机对照比较。

Randomized comparison of Glidesheath Slender with conventional 5Fr arterial sheaths for coronary angiography through the distal radial artery.

机构信息

Department of Cardiology, Patras University Hospital, Patras, Greece -

Department of Cardiology, Patras University Hospital, Patras, Greece.

出版信息

Minerva Cardiol Angiol. 2023 Dec;71(6):692-701. doi: 10.23736/S2724-5683.23.06337-8. Epub 2023 Jul 17.

Abstract

BACKGROUND

The potential benefits of the thin-walled 5F Glidesheath Slender sheath in the distal transradial access (dTRA) have not been investigated. This study aimed to compare the Glidesheath Slender versus conventional 5Fr arterial sheaths in patients undergoing diagnostic coronary angiography (CAG) through the dTRA.

METHODS

A total of 352 consecutive patients with an indication for CAG were randomized (1:1) to Glidesheath Slender 5Fr versus a conventional 5Fr arterial sheath for dTRA. The primary endpoint was the rate of successful hemostasis at 30 minutes after sheath removal. Follow-up ultrasound of the right radial and distal radial artery was performed 7-10 days after the procedure.

RESULTS

After exclusion of patients where a 6Fr sheath or crossover of access site was required, 108 patients in the Glidesheath Slender and 105 patients in the conventional 5Fr arterial sheath group were included in the analysis. The crossover rate to conventional radial access and the rate of successful hemostasis at 30 minutes after sheath removal were similar between the two groups (18.9% in the Glidesheath slender vs. 22% in the control group; P=0.460, and 62% vs. 51.4%; P=0.118, respectively). The level of pain associated with the procedure was significantly lower in the Glidesheath Slender group (2.69 vs. 3.29 in the control group; P=0.02). No significant difference was recorded between the two groups in the rate of access-related complications.

CONCLUSIONS

Use of Glidesheath Slender for dTRA did not increase the rate of early hemostasis compared with conventional arterial sheath.

摘要

背景

薄壁 5F Glidesheath Slender 护套在远端经桡动脉入路(dTRA)中的潜在优势尚未得到研究。本研究旨在比较 Glidesheath Slender 与传统 5Fr 动脉护套在通过 dTRA 进行诊断性冠状动脉造影(CAG)的患者中的应用。

方法

共 352 例有 CAG 适应证的患者被随机(1:1)分为 Glidesheath Slender 5Fr 组和传统 5Fr 动脉护套组进行 dTRA。主要终点是移除护套后 30 分钟止血的成功率。术后 7-10 天对右桡动脉和远端桡动脉进行超声随访。

结果

排除需要使用 6Fr 护套或改变入路的患者后,Glidesheath Slender 组有 108 例,传统 5Fr 动脉护套组有 105 例患者纳入分析。两组之间交叉到传统桡动脉入路的比率和移除护套后 30 分钟止血的成功率相似(Glidesheath Slender 组为 18.9%,对照组为 22%;P=0.460,和 62% vs. 51.4%;P=0.118)。Glidesheath Slender 组与手术相关的疼痛程度明显低于对照组(2.69 对 3.29;P=0.02)。两组在与入路相关的并发症发生率方面无显著差异。

结论

与传统动脉护套相比,使用 Glidesheath Slender 进行 dTRA 并不会增加早期止血的比率。

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