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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Distal transradial approach | Experimental | Distal transradial approach as the default strategy |
|
| Conventional transradial approach | Active Comparator | Conventional transradial approach as the default strategy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| distal radial artery acess side | Other | coronary procedure (coronary angiography and/or coronary angioplasty) by the distal radial artery in the anatomical snuffbox area |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Łukasz Koziński, MD | Indywidualna Praltyka Lekarska Lekarz Łukasz Koziński | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szpital Specjalistyczny | Chojnice | Pomeranian | 89-600 | Poland |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Prospective, single-center, randomized trial
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|
| conventional radial artery acess side | Other | coronary procedure (coronary angiography and/or coronary angioplasty) by the forearm radial artery in the anatomical snuffbox area |
|
|
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 |
| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |