Feasibility and Safety of the Routine Distal Transradial Approach (ANTARES)

distAl vs. coNventional Transradial Access for coRonary procEdures Study (ANTARES)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Vascular Access Complication; Coronary Angiography; Radial Artery; Puncture
• Intervention / Treatment: Other: distal radial artery acess side; Other: conventional radial artery acess side

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Pomeranian
    • Chojnice, Pomeranian, Poland, 89-600
      • Szpital Specjalistyczny

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distal transradial approach; Distal transradial approach as the default strategy	Other: distal radial artery acess side; coronary procedure (coronary angiography and/or coronary angioplasty) by the distal radial artery in the anatomical snuffbox area; Other Names: dTRA
Active Comparator: Conventional transradial approach; Conventional transradial approach as the default strategy	Other: conventional radial artery acess side; coronary procedure (coronary angiography and/or coronary angioplasty) by the forearm radial artery in the anatomical snuffbox area; Other Names: cTRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications.	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.	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy endpoint: rate of access crossover	Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.	during the procedure index
safety endpoint: patients' discomfort evaluated during access performance	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)	during the procedure
efficacy endpoint: duration of access performance	(measured from the time of skin puncture with local anesthetic to the successful sheath insertion confirmed by an outflow of arterial blood)	during the procedure index
safety endpoint: access-site vascular complications	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	after 24 hours post procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access-time	counted from local anesthesia to successful insertion of the sheath	during procedure
radial artery size	parameter measured by Doppler Ultrasound at the access point	before the procedure, 24 hours and 60 days after the procedure
radial artery velocity	parameter measured by Doppler Ultrasound at the access point	before the procedure, 24 hours and 60 days after the procedure

Collaborators and Investigators

• Sponsor: Łukasz Koziński
• Investigators: Study Chair: Łukasz Koziński, MD, Indywidualna Praltyka Lekarska Lekarz Łukasz Koziński

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: radial artery; anatomical snuffbox; distal transradial approach; access complication
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: AntaresStudy01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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