Distal versus conventional radial access for coronary angiography and intervention: Design and rationale of DISCO RADIAL study?
Distal versus conventional radial access for coronary angiography and intervention: Design and rationale of DISCO RADIAL study?
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DOI：
10.1016/j.ahj.2021.10.180
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发表时间：
2022-02-01
影响因子：
4.8
通讯作者：
Saito, Shigeru
中科院分区：
文献类型：
--
作者：
Aminian, Adel;Sgueglia, Gregory A.;Saito, Shigeru
背景经放射状通路(TRA)已成为冠状动脉诊断和介入治疗的默认通路方法。与经股动脉入路相比，TRA已被证明是更安全、经济和对患者更友好的方法。放射状动脉闭塞(RAO)是TRA最常见的并发症，它妨碍了未来的经桡动脉冠状动脉手术，不能将其用作冠状动脉搭桥术的管道或血液透析患者的动静脉瘘。最近，远端放射状通路(DRA)已成为TRA的一种有前途的替代方法，有可能将RAO的风险降至最低。然而，关于DRA和传统TRA在RAO发生率方面的国际多中心随机比较仍然缺乏。试验设计DISCO RADIUS是一项前瞻性、多中心、开放标签、随机、对照、优势试验。总共1300名符合条件的患者将被随机分配，接受使用6Fr Glidesheath细长鞘导入器通过DRA或TRA进行冠状动脉造影术和/或经皮冠状动脉介入治疗(PCI)。运营商的资格和最佳循证最佳实践需要TRA和DRA方面的丰富经验，以系统地通过协议实施降低RAO。主要终点是出院时血管超声评估前臂RAO的发生率。几个重要的次要终点也将被评估，包括进入部位的交叉、止血时间和进入部位相关的并发症。DISCO放射状试验将提供第一个大规模多中心随机证据，比较DRA和TRA在接受冠状动脉造影术或经皮冠状动脉介入治疗的患者出院时RAO的发生率。(上午心脏J 2022；244：19-30。)
Background Transradial access (TRA) has become the default access method for coronary diagnostic and interven-tional procedures. As compared to transfemoral access, TRA has been shown to be safer, cost-effective and more patient-friendly. Radial artery occlusion (RAO) represents the most frequent complication of TRA, and precludes future coronary procedures through the radial artery, the use of the radial artery as a conduit for coronary artery bypass grafting or as ar-teriovenous fistula for patients on hemodialysis. Recently, distal radial access (DRA) has emerged as a promising alternative to TRA, yielding potential for minimizing the risk of RAO. However, an international multicenter randomized comparison between DRA, and conventional TRA with respect to the rate of RAO is still lacking.Trial Design DISCO RADIAL is a prospective, multicenter, open-label, randomized, controlled, superiority trial. A total of 1300 eligible patients will be randomly allocated to undergo coronary angiography and/or percutaneous coronary intervention (PCI) through DRA or TRA using the 6 Fr Glidesheath Slender sheath introducer. Extended experience with both TRA and DRA is required for operators' eligibility and optimal evidence-based best practice to reduce RAO systematically implemented by protocol. The primary endpoint is the incidence of forearm RAO assessed by vascular ultrasound at discharge. Several important secondary endpoints will also be assessed, including access-site cross-over, hemostasis time, and access-site related complications.Summary The DISCO RADIAL trial will provide the first large-scale multicenter randomized evidence comparing DRA to TRA in patients scheduled for coronary angiography or PCI with respect to the incidence of RAO at discharge. (Am Heart J 2022;244:19-30.)