背景:远端放射状入路(DRA)作为替代入路缺乏证据,尽管最近的声誉。
目的:本研究的目的是在日常实践的基础上评估DRA的安全性和可行性。
方法:KODRA(评估远端放射状方法的安全性和有效性的韩国前瞻性注册)试验是一项前瞻性多中心注册,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(PCI)的成功率。次要终点包括成功的桡动脉远端穿刺,访问站点交叉,通路部位相关并发症,出血事件,和穿刺失败的预测因子。
结果:在排除735名患者后,共招募了5,712名筛查患者中的4,977名。主要终点,通过DRA进行CAG和PCI的成功率,分别为100%和98.8%,分别,成功穿刺桡动脉远端(94.4%)。333例患者(6.7%)发生了通路交叉。1个月随访时,远端桡动脉闭塞和触诊桡动脉闭塞的发生率分别为0.8%(4,340中的36)和0.8%(4,340中的33)。在3.3%的患者中观察到DRA相关出血事件,无严重血肿.多水平逻辑回归分析确定了弱脉搏(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。
结论:在这个大规模的前瞻性多中心注册中,DRA显示CAG和PCI的成功率较高,穿刺成功率较高,但桡动脉远端闭塞率较低。桡动脉闭塞,出血事件,和手术相关的并发症。脉搏弱和DRA经验<100例是穿刺失败的预测因素。(评估远端放射状入路的安全性和有效性的韩国前瞻性注册[KODRA];NCT04080700)。
BACKGROUND: Distal radial access (DRA) as an alternative access route lacks evidence, despite its recent reputation.
OBJECTIVE: The aim of this
study was to evaluate the safety and feasibility of DRA on the basis of daily practice.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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).