Distal versus conventional radial large-bore access for percutaneous coronary intervention of complex coronary lesions: Rationale and design of the DISCO COMPLEX randomized superiority trial

IF 3.4 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2026-02-01 Epub Date: 2025-10-18 DOI:10.1016/j.ahj.2025.107291

Juan F. Iglesias MD , Gregor Leibundgut MD , Dik Heg PhD , Gabriele L. Gasparini MD , Grigorios Tsigkas MD, PhD , Claudiu Ungureanu MD , Giuseppe Colletti MD , Sophie Degrauwe MD , Panagiotis Xaplanteris MD, PhD , Karsten Schenke MD , Alexandru Achim MD , Maarten AH van Leeuwen MD, PhD , Maia Muresan MSc , Shigeru Saito MD , Gregory A. Sgueglia MD, PhD , Adel Aminian MD

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引用次数: 0

Abstract

Rationale

Distal radial access (DRA) has emerged as a promising alternative to conventional transradial access (TRA) for coronary angiography and percutaneous coronary intervention (PCI). However, existing randomized evidence on DRA primarily involves low-risk patients undergoing diagnostic angiography or noncomplex PCI using ≤6 French (Fr) introducer sheaths. The clinical benefits of DRA among patients undergoing PCI for complex coronary lesions using large-bore guide catheters remain therefore uncertain.

Design

DISCO COMPLEX is an investigator-initiated, prospective, multicenter, international, open-label, randomized, controlled trial with a blinded outcome assessment and superiority design. The trial will compare in a 1:1 ratio large-bore DRA versus conventional TRA using a 7-Fr introducer sheath in 708 patients undergoing PCI for complex coronary lesions (chronic total occlusions, left main disease, heavily calcified lesions, or complex bifurcations) with a 7-Fr guide catheter. The primary hypothesis is that large-bore DRA is superior to conventional TRA with respect to the incidence of forearm radial artery occlusion (RAO) assessed by Doppler ultrasound at hospital discharge. The prespecified DISCOPHILE COMPLEX hand function substudy is a noninferiority trial evaluating whether large-bore DRA is not inferior to conventional TRA with respect to change in full-Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire score from baseline to 12 months in participants of the DISCO COMPLEX trial.

Enrolment status

The trial aims to recruit a total of 708 patients from 10 to 15 participating centers across Europe. The first patient was enrolled on August 31, 2023. As of August 20, 2025, 385 patients have been included.

Conclusion

DISCO COMPLEX is the first randomized clinical trial designed to test the superiority of large-bore DRA over conventional TRA in reducing RAO rates among patients undergoing complex PCI with 7-Fr guide catheters.

Trial Registration

Clinicaltrials.gov: Identifier, NCT05490238.

查看原文本刊更多论文

复杂冠状动脉病变经皮冠状动脉介入治疗的远端与传统桡骨大口径通道：DISCO complex随机优势试验的基本原理和设计。

理由：桡动脉远端通路（DRA）已成为传统经桡动脉通路（TRA）的替代方案，用于冠状动脉造影和经皮冠状动脉介入治疗（PCI）。然而，现有的DRA随机证据主要涉及使用≤6个French （Fr）导管套进行诊断性血管造影或非复杂PCI的低风险患者。因此，DRA在使用大口径导管接受复杂冠状动脉病变PCI治疗的患者中的临床益处仍不确定。设计：DISCO COMPLEX是一项研究者发起的、前瞻性、多中心、国际、开放标签、随机对照试验，采用盲法结局评估和优势设计。该试验将对708例因复杂冠状动脉病变（慢性全闭塞、左主干疾病、严重钙化病变或复杂分叉）使用7-Fr导管接受PCI的患者进行大口径DRA与使用7-Fr导管的传统TRA的1:1比例的比较。主要假设是大口径DRA在出院时通过多普勒超声评估前臂桡动脉闭塞（RAO）的发生率方面优于常规TRA。预先指定的DISCOPHILE COMPLEX手功能亚研究是一项非劣效性试验，评估大孔径DRA在DISCO COMPLEX试验参与者从基线到12个月的手臂、肩膀和手的全面残疾（DASH）问卷评分的变化方面是否不劣于常规TRA。入组状况：该试验旨在从欧洲10至15个参与中心招募总共708名患者。第一位患者于2023年8月31日入组。截至2025年8月20日，共纳入385例患者。结论：DISCO COMPLEX是首个随机临床试验，旨在测试大口径DRA在降低采用7-Fr导管的复杂PCI患者的RAO率方面优于传统TRA。

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.