Distal Transradial Access for Primary PCI in STEMI Patients to Prevent RAO

Study Overview
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Brief Summary
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Randomized-controlled trial to comparison of early radial artery occlusion via distal vs proximal radial artery among ST segment elevation myocardial infarction patients for primary percutaneous coronary intervention.

Detailed Description
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Proximal radial artery (PRA) is recommend as the default approach for patients undergoing percutaneous coronary intervention (PCI) according 2018 ESC guidelines. However, radial artery occlusion(RAO) remains the frequent complication, precluding the future use of radial artery as access point for repeat coronary recanalization or as a conduit for coronary artery bypass surgery. More than 50% of patients with ST segment elevation myocardial infarction(STEMI) presents multiple vascular lesions, of which 50% require reprocessing non-culprit vessels. Therefore, the patency of radial artery is crucial for STEMI patients. Distal radial artery(DRA), located in anatomical snuffbox or the dorsum of the hand, was introduced as a promising alternative. Three recent RCTs have shown significant reductions of RAO after DRA compared with PRA. Nevertheless, all of them excluded the patients presenting with STEMI. Therefore, we conduct a prospective, single-center, open-label randomized clinical trial to assess the superiority of preventing RAO at 24h via DRA when compared PRA among STEMI patients for primary PCI.

Official Title
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Distal TransRAdial Access for Primary Percutaneous Coronary Intervention in STEMI Patients to Prevent Acute Radial Artery Occlusion

Conditions
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ST Segment Elevation Myocardial Infarction

Intervention / Treatment
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* Procedure: distal radial artery
* Procedure: proximal radial aretry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years ST-segment elevation myocardial infarction for primary percuteous coronary intervention Palpable pulses on both access sites of the radial artery Informed consent Exclusion Criteria: Thrombolysis before primary percutaneous coronary intervention Previous CABG or radio-cephalic fistula using radial artery Cardiogenic shock Severe arrhythmias Severe liver and kidney dysfunction Pregnancy Enrolment in another study within 1 month Inability to obtain written informed consent

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center, open-label, parallel randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: distal radial artery<br>Distal radial aretry for primary percutaneous coronary intervention in STEMI patients | Procedure: distal radial artery<br>* primary percutaneous coronary intervention via distal radial aretry<br>|
| Active Comparator: proximal radial artery<br>Proximal radial aretry for primary percutaneous coronary intervention in STEMI patients | Procedure: proximal radial aretry<br>* primary percutaneous coronary intervention via proximal radial aretry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radial artery occlusion | The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound. | at 24 hours after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of successful puncture | Successful puncture occurs when an introducer sheath can be properly placed through the punctured artery. | Immediately post-procedurally | 
| puncture time | The puncture time was defined as the time interval between local anesthesia induction and successful sheath insertion. | Immediately post-procedurally | 
| first medical contact to device (FMC2D) time | FMC2D time was defined as the time interval between the patient's initial contact with the first physician who made the diagnosis and the first angioplasty balloon inflation. | Immediately post-procedurally | 
| procedural time | Procedural time defined as the time interval between local anesthesia to sheath removal. | Immediately post-procedurally | 
| hemostasis time | Hemostasis time was defined as the time between sheath removal to complete hemostasis. | at 24 hours after procedure | 
| access-related complications | Access-related complications include AV fistula formation, pseudoaneurysm, and local haematoma. | at 24 hours after procedure | 
| hand function | Hand function was evaluated by QuickDASH questionnaire. | 1 week after procedure | 
| radial artery occlusion | The radial artery occlusion will be evaluated 1 month after procedure by ultrasound. | 30days after procedure | 
| radial aretry injury | Radial aretry injury including intimal tears, dissections, perforation and thrombosis was detected by optical coherence tomography. | Immediately post-procedurally | 
| major adverse cardiovascular events(MACE) | MACE was defined as all-cause death, any myocardial infarction, stroke and major bleeding. | 30 days after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal radial artey, radial artery occlusion, proximal radial artery, primary percutaneous coronary intervention