DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention (DISCO COMPLEX)

DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention (DISCO COMPLEX)

The use of the distal radial artery has recently emerged as a promising alternative access route to further reduce the risk of radial artery occlusion (RAO) and has been endorsed by recent International Consensus documents. The feasibility of a distal radial access (DRA) for coronary angiography and/or PCI has been demonstrated in several observational clinical registries and small-sized randomized clinical trials. In the recent prospective, multicenter, open label, randomized, controlled DIStal vs Conventional RADIAL access (DISCO RADIAL) trial, DRA was associated with low and similar rates of RAO at discharge when compared to conventional TRA among patients undergoing coronary angiography and/or PCI. There is however limited evidence on the feasibility and safety of 7F DRA for PCI.

In a prospective, multicenter, observational study including 41 patients undergoing CTO PCI using a left DRA with a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan), technical success was achieved in 90.3% of patients and procedural success was achieved in 78.1% of patients. No post-procedural DRA RAO were detected by clinical assessment and Doppler ultrasound examination, and no radial artery occlusions at the site of the forearm were found. Doppler ultrasound imaging of the DRA at one month was available in 67.6% of patients, with only one case (4.3%) of DRA RAO. This proof-of-concept study demonstrates that DRA using a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan) for CTO PCI is feasible and associated with a high procedural success rate and low vascular access-site complication rates.

No randomized clinical trial to date has however compared the feasibility and safety of a 7F DRA versus 7F TRA for PCI of complex coronary lesions, such as chronic total occlusions (CTO), left main coronary artery disease, heavily calcified lesions, complex bifurcations, or other complex coronary lesions for whom the operator anticipates that a 7F guiding catheter is indicated.

Study Overview

• Status: Recruiting
• Conditions: Vascular Access Site Occlusion
• Intervention / Treatment: Procedure: Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)

Detailed Description

The radial artery has become the standard vascular access site for most percutaneous coronary interventions (PCI) and is recommended by the most recent 2018 European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines on myocardial revascularization, irrespective of clinical presentation. Patients undergoing PCI of complex coronary lesions, such as a chronic total occlusion (CTO), left main (LM) coronary artery disease, complex bifurcation lesions, or heavily calcified lesions, have however been either absent or under-represented in most trials supporting these guidelines.

The small size of the radial artery remains an important limitation for the use of large bore guiding catheters (>6 F), restricting thereby the treatment of highly complex lesions through the transradial approach. The 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan) is a dedicated radial sheath with a thinner wall and hydrophilic coating. It combines an inner diameter compatible with any 7F guiding catheter and an outer diameter smaller than current 7F sheaths.

A prospective, multicenter, observational study including 60 patients demonstrates that a transradial access (TRA) using the 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan) for complex coronary interventions is feasible and associated with a high rate of procedural success and a low rate of vascular complications.

In the Complex Large-Bore Radial Percutaneous Coronary Intervention (COLOR) randomized trial, 388 patients with planned PCI for complex coronary lesions were randomly allocated to a 7F TRA or 7F transfemoral access (TFA). Conventional TRA was associated with a significant reduction in clinically relevant access- site bleeding or vascular complications without affecting procedural success when compared to TFA among patients undergoing complex PCI with a 7F large bore access.

The use of the distal radial artery has recently emerged as a promising alternative access route to further reduce the risk of radial artery occlusion (RAO) and has been endorsed by recent International Consensus documents. The feasibility of a distal radial access (DRA) for coronary angiography and/or PCI has been demonstrated in several observational clinical registries and small-sized randomized clinical trials. In the recent prospective, multicenter, open label, randomized, controlled DIStal vs Conventional RADIAL access (DISCO RADIAL) trial, DRA was associated with low and similar rates of RAO at discharge when compared to conventional TRA among patients undergoing coronary angiography and/or PCI. There is however limited evidence on the feasibility and safety of 7F DRA for PCI. The potential advantages of DRA when compared to TRA are contrasted by a slightly smaller size of the distal radial artery potentially impacting on device selection and procedural planning and by its less predictable course, due to the pronounced tortuosity and angulation of the vessel, leading to an overall higher number of puncture attempts, a longer time to achieve arterial access and a higher rate of access failure. These limitations may preclude the use of DRA for PCI of complex coronary lesions when a large bore guiding catheter is needed. There is however limited evidence on the feasibility and safety of 7F DRA for PCI.

In a prospective, multicenter, observational study including 41 patients undergoing CTO PCI using a left DRA with a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan), technical success was achieved in 90.3% of patients and procedural success was achieved in 78.1% of patients. No post-procedural DRA RAO were detected by clinical assessment and Doppler ultrasound examination, and no radial artery occlusions at the site of the forearm were found. Doppler ultrasound imaging of the DRA at one month was available in 67.6% of patients, with only one case (4.3%) of DRA RAO. This proof-of-concept study demonstrates that DRA using a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan) for CTO PCI is feasible and associated with a high procedural success rate and low vascular access-site complication rates.

No randomized clinical trial to date has however compared the feasibility and safety of a 7F DRA versus 7F TRA for PCI of complex coronary lesions, such as chronic total occlusions (CTO), left main coronary artery disease, heavily calcified lesions, complex bifurcations, or other complex coronary lesions for whom the operator anticipates that a 7F guiding catheter is indicated.

• Study Type: Interventional
• Enrollment (Estimated): 708
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maëlle Achard, RN; Phone Number: +41795533553; Email: maelle.achard@hcuge.ch

Study Locations

• Belgium
  • Arlon, Belgium
    • Recruiting
    • Clinique St. Joseph Arlon - Groupe Vivalia
    • Principal Investigator: Giuseppe Colletti, MD
• Greece
  • Patras, Greece
    • Recruiting
    • Patras University Hospital
    • Principal Investigator: Grigorios Tsigkas, MD
• Italy
  • Milan, Italy
    • Recruiting
    • Humanitas Research Hospital
    • Principal Investigator: Gabriele L Gasparini, MD
• Switzerland
  • Basel, Switzerland
    • Recruiting
    • Basel university hospital
    • Principal Investigator: Gregor Leibundgut, MD
  • Geneva, Switzerland, 1205
    • Recruiting
    • Geneva University Hospitals
    • Principal Investigator: Sophie Degrauwe, MD
    • Contact: Maëlle Achard, RN; Phone Number: +41795533553; Email: maelle.achard@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years.
• Patients presenting with CCS or ACS, including unstable angina or NSTEMI.
• Patients planned for PCI of complex coronary lesions, such as CTO, left main coronary artery disease, heavily calcified lesions, complex bifurcations, or other complex coronary lesions in whom the operator anticipates that a 7F guiding catheter is indicated.
• Patients able to provide written informed consent.

Exclusion Criteria:

• Patients with acute ST-segment elevation myocardial infarction.
• Patients with cardiogenic shock.
• Patients on chronic hemodialysis.
• Patients with contraindications to TRA, such as occlusive upper arm peripheral artery disease, or known anatomic variants prohibiting TRA on both sides.
• Patients with medical conditions that may cause non-compliance with the study protocol and/or may confound the data interpretation.
• Patients unable to provide written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distal radial access; Distal radial access using 7Fr Glidesheath Slender sheath (Terumo Corp., Japan)	Procedure: Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan); Large-bore radial access for complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)
Active Comparator: Conventional radial access; Conventional radial access using 7Fr Glidesheath Slender sheath (Terumo Corp., Japan)	Procedure: Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan); Large-bore radial access for complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of forearm radial artery occlusion	US Doppler	At hospital discharge (assessed up to day 5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of vascular access site-related bleeding	EASY criteria and BARC criteria	At hospital discharge (assessed up to day 5)
Incidence of vascular access site-related complication	Clinical assessment	At hospital discharge (assessed up to day 5)
Incidence of radial artery spasm	Angiographic assessment	During intervention (up to day 1)
Incidence of distal radial artery occlusion	US Doppler	At hospital discharge (assessed up to day 5)
Total hemostasis time	Clinical assessment	At hospital discharge (assessed up to day 5)
Incidence of vascular access site-related pain	Visual Analogue Scale (VAS, 0-10, lower scores represent less pain)	At hospital discharge (assessed up to day 5)
Incidence of hand dysfunction	Michigan Hand Outcomes Questionnaire (MHQ: 0-100, lower pain scores denote less pain, other high scores denote better hand performance) and QuickDASH Outcome Measure Questionnaire (0-100, lower scores indicate lower level of disability)	At hospital discharge (assessed up to day 5) and at 1 year
Rate of target lesion failure	Composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization.	At 1 year

Collaborators and Investigators

• Sponsor: IGLESIAS Juan Fernando
• Collaborators: University of Bern
• Investigators: Principal Investigator: Juan F. Iglesias, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Radial artery access; Distal radial artery; Complex PCI
• Other Study ID Numbers: 2022-0729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be shared upon reasonable request to the principal investigator after publication of the study primary and secondary endpoints.
• IPD Sharing Time Frame: After publication of the study primary and secondary endpoints.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No