Noamen Aymen, Ben Amara Ahmed, Ben Ayed Houssem, Jabloun Taha Yassine, Hajlaoui Nadhem, Fehri Wafa
Department of Cardiology, Military hospital of Tunis, Faculty of Medicine of Tunis, University of Tunis El Manar, Tunisia.
Tunis Med. 2023 Jun 5;101(6):574-579.
The conventional radial approach (CRA), the gold standard approach for percutaneous coronary interventions (PCI), is associated with the risk of radial artery occlusion (RAO). The distal radial approach (DRA) is an effective alternative with fewer complications.
To evaluate the efficacy in terms of puncture success and safety by RAO rate of the DRA in elective PCI in Tunisian patients.
It was a randomized controlled non-inferiority trial including patients hospitalized for elective PCI. The protocol was previously published (Tunis Med 2022; 100(3): 192-202). The primary endpoints were puncture success and RAO rate at 30 days.
Overall, 250 patients were included and the groups were comparable. The preprocedural examination of the radial pulse and the Barbeau test were similar. The majority of PCIs were coronary angiography (82%). In ITT, respectively in CRA versus DRA, puncture success rates were similar (97.6% versus 96.8%; p≤0.500). RAO rates were similar (2.4% versus 3.2%; p≤0.500). Crossovers were similar. PCI through DRA lasted longer but was not more irradiating, however it required more contrast. Overall bleeding and vascular complications were similar.
This study demonstrated the non-inferiority of DRA compared to CRA for elective PCIs in a Tunisian population regarding puncture success and RAO rate at 30 days. Multicenter trials including urgent PCI with systematic ultrasound screening for RAO are needed.
传统桡动脉入路(CRA)是经皮冠状动脉介入治疗(PCI)的金标准入路,但存在桡动脉闭塞(RAO)风险。桡动脉远端入路(DRA)是一种有效的替代方法,并发症较少。
评估突尼斯患者在择期PCI中采用DRA的穿刺成功率和安全性(以RAO发生率衡量)方面的疗效。
这是一项随机对照非劣效性试验,纳入因择期PCI住院的患者。该方案先前已发表(《突尼斯医学》2022年;100(3):192 - 202)。主要终点是30天时的穿刺成功率和RAO发生率。
总体而言,纳入了250例患者,两组具有可比性。桡动脉搏动的术前检查和巴博试验相似。大多数PCI为冠状动脉造影(82%)。在意向性分析中,CRA组与DRA组相比,穿刺成功率相似(97.6%对96.8%;p≤0.500)。RAO发生率相似(2.4%对3.2%;p≤0.500)。交叉情况相似。通过DRA进行的PCI持续时间更长,但辐射量并不更大,不过需要更多造影剂。总体出血和血管并发症相似。
本研究表明,在突尼斯人群中,对于择期PCI,DRA在30天时的穿刺成功率和RAO发生率方面与CRA相比具有非劣效性。需要开展包括紧急PCI并对RAO进行系统超声筛查的多中心试验。