Division of Cardiology, Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, South Korea.
Division of Cardiology, Department of Internal Medicine, Yongin Severance Hospital and Cardiovascular Center, Yonsei University College of Medicine, Yongin, South Korea.
JACC Cardiovasc Interv. 2024 Feb 12;17(3):329-340. doi: 10.1016/j.jcin.2023.11.021.
Distal radial access (DRA) as an alternative access route lacks evidence, despite its recent reputation.
The aim of this study was to evaluate the safety and feasibility of DRA on the basis of daily practice.
The KODRA (Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach) trial was a prospective multicenter registry conducted at 14 hospitals between September 2019 and September 2021. The primary endpoints were the success rates of coronary angiography (CAG) and percutaneous coronary intervention (PCI). The secondary endpoints included successful distal radial artery puncture, access-site crossover, access site-related complications, bleeding events, and predictors of puncture failure.
A total of 4,977 among 5,712 screened patients were recruited after the exclusion of 735 patients. The primary endpoints, the success rates of CAG and PCI via DRA, were 100% and 98.8%, respectively, among successful punctures of the distal radial artery (94.4%). Access-site crossover occurred in 333 patients (6.7%). The rates of distal radial artery occlusion and radial artery occlusion by palpation were 0.8% (36 of 4,340) and 0.8% (33 of 4,340) at 1-month follow-up. DRA-related bleeding events were observed in 3.3% of patients, without serious hematoma. Multilevel logistic regression analysis identified weak pulse (OR: 9.994; 95% CI: 7.252-13.774) and DRA experience <100 cases (OR: 2.187; 95% CI: 1.383-3.456) as predictors of puncture failure.
In this large-scale prospective multicenter registry, DRA demonstrated high success rates of CAG and PCI, with a high rate of puncture success but low rates of distal radial artery occlusion, radial artery occlusion, bleeding events, and procedure-related complications. Weak pulse and DRA experience <100 cases were predictors of puncture failure. (Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach [KODRA]; NCT04080700).
尽管桡动脉远端入路(DRA)作为一种替代入路的声誉日益提高,但缺乏相关证据。
本研究旨在基于日常实践评估 DRA 的安全性和可行性。
KODRA(韩国经桡动脉远端入路评估安全性和疗效的前瞻性注册研究)是一项前瞻性多中心注册研究,于 2019 年 9 月至 2021 年 9 月在 14 家医院进行。主要终点是冠状动脉造影(CAG)和经皮冠状动脉介入治疗(PCI)的成功率。次要终点包括桡动脉远端穿刺成功、入路部位转换、与入路部位相关的并发症、出血事件以及穿刺失败的预测因素。
在排除 735 例患者后,对 5712 例筛查患者中的 4977 例进行了招募。桡动脉远端穿刺成功的主要终点(DRA),即 CAG 和 PCI 的成功率分别为 100%和 98.8%(94.4%)。入路部位转换发生在 333 例患者(6.7%)中。1 个月随访时,桡动脉远端闭塞和触诊桡动脉闭塞的发生率分别为 0.8%(36/4340)和 0.8%(33/4340)。3.3%的患者发生 DRA 相关出血事件,但无严重血肿。多水平逻辑回归分析发现,弱脉搏(OR:9.994;95%CI:7.252-13.774)和 DRA 经验<100 例(OR:2.187;95%CI:1.383-3.456)是穿刺失败的预测因素。
在这项大规模的前瞻性多中心注册研究中,DRA 显示出 CAG 和 PCI 的高成功率,穿刺成功率高,但桡动脉远端闭塞、桡动脉闭塞、出血事件和与操作相关的并发症发生率低。弱脉搏和 DRA 经验<100 例是穿刺失败的预测因素。(韩国经桡动脉远端入路评估安全性和疗效的前瞻性注册研究[KODRA];NCT04080700)。