Clinical trial NCT05982366: Feasibility and Safety of the Routine Distal Transradial Approach
Official title: distAl vs. coNventional Transradial Access for coRonary procEdures Study (ANTARES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Complication
Radial Artery
Coronary Artery Disease
Puncture
Coronary Angiography
Keywords: radial artery
distal transradial approach
access complication
anatomical snuffbox
Lead sponsor: Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-center, randomized trial
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications.
timeFrame: up to 24 hours
Secondary outcomes:
measure: efficacy endpoint: rate of access crossover
timeFrame: during the procedure index
measure: safety endpoint: patients' discomfort evaluated during access performance
timeFrame: during the procedure
measure: efficacy endpoint: duration of access performance
timeFrame: during the procedure index
measure: safety endpoint: access-site vascular complications
timeFrame: after 24 hours post procedure
Other outcomes:
measure: Access-time
timeFrame: during procedure
measure: radial artery size
timeFrame: before the procedure, 24 hours and 60 days after the procedure
measure: radial artery velocity
timeFrame: before the procedure, 24 hours and 60 days after the procedure
Locations:
city: Chojnice
country: Poland
facility: Szpital Specjalistyczny
state: Pomeranian
Study officials:
affiliation: Indywidualna Praltyka Lekarska Lekarz Łukasz Koziński
name: Łukasz Koziński, MD
role: STUDY_CHAIR
References: