Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
BACKGROUND: NCT05501925.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
BACKGROUND: NCT05501925.
摘要：
背景：缺乏随机临床试验研究6-FrGlidesheathSlender（GSS）在接受冠状动脉造影（CAG）和/或通过远端经桡动脉途径（dTRA）的经皮冠状动脉介入（PCI）的患者中，远端桡动脉闭塞（dRAO）的早期发生率是否优于6-Fr常规桡动脉鞘管（CS）。
方法：这是一个前瞻性的，单中心试验纳入随机接受6-FrGSS或6-FrCS的CAG和/或PCI的患者.主要终点是术后24小时dRAO的发生率，通过多普勒超声评估。
结果：总共620名患者被纳入研究。两组患者的基线和手术特征相似。对于主端点，根据意向治疗(ITT)分析,术后24hdRAO发生率GSS组为1.0%(3/314),CS组为3.6%(11/306)(RR=0.266,95%CI=0.075~0.943,P=0.027).对于次要端点，GSS组的近端RAO发生率为0.3%(1/314),CS组为2.3%(7/306)(P=0.029).其他次要终点，包括穿刺成功率,程序性结果，其他穿刺相关结果和通路相关并发症,两组之间无显著差异。
结论：在通过dTRA接受CAG和/或PCI的患者中，使用薄壁且亲水的涂层护套可以降低早期dRAO的发生率。
方法：这是一个前瞻性的，单中心试验纳入随机接受6-FrGSS或6-FrCS的CAG和/或PCI的患者.主要终点是术后24小时dRAO的发生率，通过多普勒超声评估。
结果：总共620名患者被纳入研究。两组患者的基线和手术特征相似。对于主端点，根据意向治疗(ITT)分析,术后24hdRAO发生率GSS组为1.0%(3/314),CS组为3.6%(11/306)(RR=0.266,95%CI=0.075~0.943,P=0.027).对于次要端点，GSS组的近端RAO发生率为0.3%(1/314),CS组为2.3%(7/306)(P=0.029).其他次要终点，包括穿刺成功率,程序性结果，其他穿刺相关结果和通路相关并发症,两组之间无显著差异。
结论：在通过dTRA接受CAG和/或PCI的患者中，使用薄壁且亲水的涂层护套可以降低早期dRAO的发生率。
