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尺动脉介入治疗不劣于桡动脉途径:阿杰梅尔尺动脉(AJULAR)介入治疗工作组研究结果

Ulnar Artery Interventions Non-Inferior to Radial Approach: AJmer Ulnar ARtery (AJULAR) Intervention Working Group Study Results.

作者信息

Gokhroo Rajendra, Kishor Kamal, Ranwa Bhanwar, Bisht Devendra, Gupta Sajal, Padmanabhan Deepak, Avinash A

机构信息

Department of Cardiology, JLN MC, Ajmer, Rajasthan, India.

出版信息

J Invasive Cardiol. 2016 Jan;28(1):1-8.

Abstract

BACKGROUND

Percutaneous coronary procedures are undergoing a paradigm shift from femoral to forearm approach due to obvious advantages in terms of patient safety and comfort, and faster time to ambulation. Transradial access (TRA) has been established as a primary forearm access site. We have tried to use ulnar artery access as an alternative to radial route and found that transulnar access (TUA) is an excellent alternative and non-inferior to TRA if performed by an experienced operator.

METHODS

This was a prospective, single-center study involving 2532 patients who were randomized in a 1:1 manner to either TUA (n = 1270) or TRA (n = 1262). All cannulations were performed by operators who were experienced in radial artery (RA) cannulation and had performed a minimum of 50 ulnar artery (UA) cannulations. The primary endpoint was a composite of major adverse cardiac events during hospital stay, crossover to another arterial access route, major vascular events during hospital stay (large hematoma with hemoglobin drop of ≥3 g%) or vessel occlusion rate. To prove non-inferiority of TUA, a margin of 1.93 was derived by fixed-margin method (preserving 50% of difference of procedural failure rate [4.87%] between radial and femoral access from meta-analysis).

RESULTS

The composite primary endpoint occurred in 14.6% of TUA and 14.4% of TRA patients (risk ratio, 1.01; 95% confidence interval, 0.83-1.2; P=.92 at α=0.05). All assessed parameters (except large hematoma, for which non-inferiority could not be proved conclusively) were non-inferior in TUA when compared with TRA.

CONCLUSIONS

TUA is non-inferior to TRA when performed by an experienced operator. The utilization of TUA as an access site option increases the chance of success with forearm access and reduces the need for crossover to femoral route.

摘要

背景

由于在患者安全性和舒适度方面具有明显优势,且能更快实现下床活动,经皮冠状动脉介入手术正经历从股动脉入路向前臂入路的模式转变。经桡动脉入路(TRA)已成为主要的前臂入路部位。我们尝试使用尺动脉入路作为桡动脉入路的替代方法,发现如果由经验丰富的操作者进行,经尺动脉入路(TUA)是一种极佳的替代方法,且不劣于TRA。

方法

这是一项前瞻性单中心研究,纳入2532例患者,这些患者以1:1的比例随机分为TUA组(n = 1270)和TRA组(n = 1262)。所有插管操作均由有桡动脉(RA)插管经验且至少进行过50次尺动脉(UA)插管的操作者进行。主要终点是住院期间主要不良心脏事件、交叉至另一种动脉入路途径、住院期间主要血管事件(血红蛋白下降≥3 g%的大血肿)或血管闭塞率的复合指标。为证明TUA不劣于TRA,采用固定界值法得出界值为1.93(保留荟萃分析中桡动脉和股动脉入路之间手术失败率差异[4.87%]的50%)。

结果

TUA组和TRA组患者中复合主要终点的发生率分别为14.6%和14.4%(风险比,1.01;95%置信区间,0.83 - 1.2;α = 0.05时P = 0.92)。与TRA相比,TUA组所有评估参数(除大血肿外,其不劣性无法确凿证明)均不劣于TRA。

结论

由经验丰富的操作者进行时,TUA不劣于TRA。将TUA作为一种入路部位选择可增加前臂入路的成功机会,并减少交叉至股动脉入路的需求。

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