distAl vs. coNventional Transradial Access for coRonary procEdures Study (ANTARES)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vascular Access Complication
- Sponsor
- Łukasz Koziński
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications.
- Status
- Completed
- Last Updated
- 2 years ago
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.
Investigators
Łukasz Koziński
Principal Investigator Łukasz Koziński, Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński
Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński
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
Outcomes
Primary Outcomes
The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications.
Time Frame: 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 Outcomes
- efficacy endpoint: duration of access performance(during the procedure index)
- efficacy endpoint: rate of access crossover(during the procedure index)
- safety endpoint: access-site vascular complications(after 24 hours post procedure)
- safety endpoint: patients' discomfort evaluated during access performance(during the procedure)