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Distal versus conventional radial large-bore access for percutaneous coronary intervention of complex coronary
Juan F Iglesias1, Gregor Leibundgut2, Dik Heg3
1Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.
Insights
Distal radial access (DRA) is being studied against conventional transradial access (TRA) for complex percutaneous coronary intervention (PCI) using large-bore catheters. This trial investigates if DRA reduces forearm radial artery occlusion (RAO) compared to TRA.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Vascular Access Techniques
Background:
- Distal radial access (DRA) offers a potential alternative to traditional transradial access (TRA) for coronary procedures.
- Existing evidence for DRA largely focuses on low-risk patients and less complex interventions using smaller catheters (≤6 Fr).
- The efficacy and safety of DRA with large-bore catheters (≥7 Fr) in patients with complex coronary lesions remain unclear.
Purpose of the Study:
- To compare the incidence of forearm radial artery occlusion (RAO) between large-bore DRA and conventional TRA in patients undergoing complex PCI.
- To assess the impact of large-bore DRA versus TRA on hand function using the DASH questionnaire over 12 months.
- To determine the superiority of large-bore DRA in reducing RAO rates in complex PCI scenarios.
Main Methods:
- The DISCO COMPLEX trial is a prospective, multicenter, international, randomized controlled trial with blinded outcome assessment.
- It enrolls 708 patients undergoing PCI for complex coronary lesions (e.g., chronic total occlusions, left main disease) using 7-Fr guide catheters.
- Participants are randomized 1:1 to either large-bore DRA or conventional TRA, with RAO assessed by Doppler ultrasound at discharge.
Main Results:
- The primary endpoint is the incidence of forearm radial artery occlusion (RAO) at hospital discharge.
- A secondary noninferiority analysis evaluates changes in the Disabilities of the Arm, Shoulder and Hand (DASH) score at 12 months.
- Enrollment is ongoing, with 385 of 708 patients included as of August 20, 2025.
Conclusions:
- DISCO COMPLEX is the first randomized clinical trial specifically designed to evaluate large-bore DRA versus TRA for complex PCI.
- The study aims to provide crucial evidence on the safety and efficacy of DRA in a challenging patient population.
- Findings will inform clinical practice regarding the optimal vascular access strategy for complex coronary interventions.
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.
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