Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI

Study Overview
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Brief Summary
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Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed for undertaking percutaneous coronary angiography and interventions. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.

Detailed Description
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Gaining vascular access is the first, mandatory step for undertaking percutaneous coronary angiography and interventions. The recent guidelines, published by European Society of Cardiology (ESC), American College of Cardiology (ACC), American Heart Association (AHA) and Society for Cardiovascular Angiography and Interventions (SCAI), propose TRA as the gold standard for acute coronary syndromes (ACS), chronic coronary syndrome (CCS) percutaneous coronary interventions (PCI). Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Mutual point of all the previous RCTs is that excluded patients suffering from ST-elevation Myocardial Infraction (STEMI). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.

Official Title
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Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With ST-elevation Myocardial Infraction (STEMI): The DR-STEMI Trial

Conditions
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Primary PCI, ST Elevation Myocardial Infarction, Coronary Artery Disease, Distal Transradial Artery, Transradial Artery, Coronary Catheterization, Percutaneous Coronary Intervention

Intervention / Treatment
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* Procedure: Coronary angiography +/- percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old Indication: ST-Elevation Myocardial Infraction Exclusion Criteria: Non-palpable radial artery Previous CABG Anatomical restrictions for forearm approach Hemodynamic instability Previous radial artery catheterization from the same arm during the last 30-days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distal transradial artery access<br>Vascular access after cannulation of distal transradial artery through anatomical snuffbox for coronary angiography and interventions | Procedure: Coronary angiography +/- percutaneous coronary intervention<br>* Coronary angiography +/- percutaneous coronary intervention<br>|
| Active Comparator: Conventional transradial artery access<br>Vascular access after puncturing on the conventional transradial artery for performing coronary angiography and interventions | Procedure: Coronary angiography +/- percutaneous coronary intervention<br>* Coronary angiography +/- percutaneous coronary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| needle-to-wire time | needle-to-wire time | Immediately post-procedurally | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial artery occlusion using Doppler examination prior to hospital discharge | Radial artery patency evaluation with Doppler ultrasound prior to hospital discharge for detecting possible occlusion after cannulation | The evaluation will be performed during hospitalization for STEMI and prior discharge, typically the 4th day after PCI | 
| Access site crossover rate | Crossover rate from distal transradial artery access to other access point | Immediately post-procedurally | 
| Sheath insertion time | Duration required from the beginning of puncture until sheath insertion | Immediately post-procedurally | 
| Total procedure time | Total duration of coronary angiography and angioplasty | Immediately post-procedurally | 
| The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI | The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI | Immediately post-procedurally | 
| Required time for coronary angiography completion, after sheath insertion | Required time for coronary angiography completion, after sheath insertion | Immediately post-procedurally | 
| Required time percutaneous coronary intervention completion | Required time percutaneous coronary intervention completion | Immediately post-procedurally | 
| Total fluoroscopy time | Total fluoroscopy time | Immediately post-procedurally | 
| Total Dose Area Product (DAP) | Total Dose Area Product (DAP) | Immediately post-procedurally | 
| Air Kerma | Air Kerma | Immediately post-procedurally | 
| Hemostasis time | Time required for achieving hemostasis | 3 hours | 
| Vascular complications | Vascular complications | 24 hours | 
| Hematomas classification (modified EASY classification) | Hematomas classification using modified EASY which is compatible with dTRA | 24 hours | 
| 30-days Clinical follow-up (on site or via telephone call) | 30-days Clinical follow-up (on site or via telephone call) | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST Elevation Myocardial Infarction, Coronary Artery Disease, distal transradial artery, transradial artery, coronary catheterization, percutaneous coronary intervention, primary PCI