Feasibility and Safety of the Routine Distal Transradial Approach

Study Overview
=================
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.

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

Conditions
-----------------
Vascular Access Complication, Radial Artery, Coronary Artery Disease, Puncture, Coronary Angiography

Intervention / Treatment
-----------------
* Other: distal radial artery acess side
* Other: conventional radial artery acess side


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, single-center, randomized trial
Masking: None (Open Label)


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radial artery, distal transradial approach, access complication, anatomical snuffbox