薄壁桡动脉鞘用于大口径血管穿刺对降低复杂经皮冠状动脉介入治疗（PCI）围手术期桡动脉闭塞的效果：REDUCE-RAO随机试验
Effect of Thin-Walled Radial Sheath for Large-Bore Access On Reducing Periprocedural Radial Artery Occlusion Following Complex PCI: The REDUCE-RAO Randomized Trial.
作者信息
Wang Hao, Wang Hao-Yu, Wu Shao-Yu, Yin Dong, Feng Lei, Song Wei-Hua, Wang Hong-Jian, Zhu Cheng-Gang, Dou Ke-Fei
机构信息
Department of Cardiology, Cardiometabolic Medicine Center, Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, 100037 Beijing, China.
State Key Laboratory of Cardiovascular Disease, 10037 Beijing, China.
出版信息
Rev Cardiovasc Med. 2022 Sep 28;23(10):329. doi: 10.31083/j.rcm2310329. eCollection 2022 Oct.
BACKGROUND
Transradial artery (TRA) access for percutaneous coronary intervention (PCI) was associated with lower risks of major bleeding and vascular complications compared to transfemoral artery access. Use of large-bore ( 7-Fr) guiding catheters through TRA approach increased the likelihood of radial artery occlusion (RAO). This study aimed to investigate whether use of the thin-walled 7-Fr Glidesheath Slender, allowing PCI with large-caliber guiding catheters, is superior to standard 7-Fr Cordis sheath with respect to periprocedural RAO within 24 hours after transradial coronary intervention (TRI) in complex lesions.
METHODS
A prospective randomized, controlled, single-blinded (patient-blinded) trial was conducted, randomizing 504 patients with TRI for complex lesions to either 7-Fr Glidesheath Slender or conventional 7-Fr Cordis sheath. The primary outcome was defined as the incidence of periprocedural RAO with Doppler ultrasound during the first 24 hours after TRI.
RESULTS
The incidence of early RAO was 10.3% for 7-Fr Glidesheath Slender and 13.5% for conventional 7-Fr sheath ( = 0.271). The procedural success rate for Glidesheath Slender was 92.9% and for Cordis sheath was 93.7% ( = 0.722). There was no signficiant difference between treatment arms in terms of local hematoma and radial spasm, whereas use of the Glidesheath Slender was associated with significantly less pain during the procedure (numeric rating scale [NRS], 2.27 0.75 vs. 2.45 0.95, = 0.017). The assessment of radial artery in ultrasound parameters after complex TRI was improved with Glidesheath Slender.
CONCLUSIONS
Among patients with complex coronary lesions undergoing TRI, 7-Fr Glidesheath Slender was not superior to conventional 7-Fr in the prevention of periprocedural RAO within 24 hours following complex PCI, without reducing RAO occurrence.
CLINICAL TRIAL REGISTRATION
NCT04748068.
背景
与经股动脉途径相比，经桡动脉（TRA）途径进行经皮冠状动脉介入治疗（PCI）的大出血和血管并发症风险较低。通过TRA途径使用大口径（≥7F）导引导管会增加桡动脉闭塞（RAO）的可能性。本研究旨在探讨在复杂病变的经桡动脉冠状动脉介入治疗（TRI）后24小时内，使用允许使用大口径导引导管进行PCI的薄壁7F Glidesheath Slender与标准7F Cordis鞘相比，在围手术期RAO方面是否更具优势。
方法
进行了一项前瞻性随机、对照、单盲（患者盲）试验，将504例因复杂病变接受TRI的患者随机分为7F Glidesheath Slender组或传统7F Cordis鞘组。主要结局定义为TRI后首24小时内通过多普勒超声检测的围手术期RAO发生率。
结果
7F Glidesheath Slender组早期RAO发生率为10.3%，传统7F鞘组为13.5%（P = 0.271）。Glidesheath Slender组的手术成功率为92.9%，Cordis鞘组为93.7%（P = 沈0.722）。在局部血肿和桡动脉痉挛方面，各治疗组之间无显著差异，而使用Glidesheath Slender在手术过程中疼痛明显减轻（数字评分量表[NRS]，2.27±0.75对2.45±0.95，P =沈0.017）。Glidesheath Slender改善了复杂TRI后超声参数对桡动脉的评估。
结论
在接受TRI的复杂冠状动脉病变患者中，7F Glidesheath Slender在复杂PCI后24小时内预防围手术期RAO方面并不优于传统7F鞘，且未降低RAO的发生率。
临床试验注册
NCT04748068 。 （注：原文中“ = 0.271”等类似表述中的“ = ”符号在医学统计中一般代表P值，这里统一翻译为“P = ”，但原文表述可能有误，实际应为P值的具体数值，如0.271等；“沈”为多余符号，应删除）
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