Feasibility and Safety of the Routine Distal Transradial Approach

Not Applicable

Completed

• Conditions: Radial Artery; Coronary Artery Disease; Vascular Access Complication; Puncture; Coronary Angiography
• Interventions: Other: distal radial artery acess side; Other: conventional radial artery acess side

• Registration Number: NCT05982366
• Lead Sponsor: Łukasz Koziński

Brief Summary

The distal transradial approach (dTRA) via the anatomical snuffbox is hypothesized to be more beneficial than the conventional transradial access (cTRA) in patients undergoing coronary procedures. This prospective single-center randomized trial was designed to investigate the safety, efficacy, and various ultrasound parameters of dTRA.

Detailed Description

Transradial approach (TRA) has emerged in most countries as a default strategy in urgent and elective coronary procedures. The advantages of TRA compared to the transfemoral access encompass a reduction of mortality, complications, and cost as well as improvement of patient's comfort. The aim of the present study (ANTARES, distAl vs coNventional Transradial Access for coRonary procEdures Study) was to assess the feasibility, safety and various ultrasound parameters of dTRA in the anatomical snuffbox as the first-line strategy, in comparison with cTRA, in patients undergoing coronary angiography (CAG) and percutaneous coronary intervention (PCI). The study is a non-inferiority, randomized controlled trial. There are two arms: distal transradial access and conventional transradial approach.

400 patients were enrolled.

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-05-31
• Study First Submitted: 2023-06-21
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-01
• Study First Posted: 2023-08-08
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• patients referred for CAG and/or PCI

Exclusion Criteria

• ST-elevation myocardial infarction
• sudden cardiac arrest
• hemody-namic instability
• chronic kidney disease (stages 4-5)
• forearm artery occlusion
• previous unsuccessful ipsilateral TRA
• unfavorable RA diameter
• ultrasound unavailability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distal transradial approach	distal radial artery acess side	Distal transradial approach as the default strategy
Conventional transradial approach	conventional radial artery acess side	Conventional transradial approach as the default strategy

Primary Outcome Measures

Name	Time	Method
The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications.	up to 24 hours	Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.; Access-related complications after the procedure measured with Doppler Ultrasound (included radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm).; MACE definied as myocardial infarction, stroke, urgent revascularization, all-cause death.

Secondary Outcome Measures

Name	Time	Method
efficacy endpoint: duration of access performance	during the procedure index	(measured from the time of skin puncture with local anesthetic to the successful sheath insertion confirmed by an outflow of arterial blood)
efficacy endpoint: rate of access crossover	during the procedure index	Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.
safety endpoint: access-site vascular complications	after 24 hours post procedure	it is composed by the rate of radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm; measured with Doppler Ultrasound
safety endpoint: patients' discomfort evaluated during access performance	during the procedure	physical discomfort at the time of vascular access performance was assessed using a numerical scale (0/1/2/3 - respectively no/mild/moderate/severe discomfort)

Trial Locations

Locations (1)

Szpital Specjalistyczny; 🇵🇱 Chojnice, Pomeranian, Poland