Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention (PCI)

Study Overview
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Brief Summary
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Percutaneous coronary interventions (PCIs) from the femoral approach have more bleeding complications related to access site in comparison to the radial approach in patients with acute coronary syndrome (ACS). Major bleeding and access site complications have an important role in results of PCI for ACS and lead to higher morbidity and mortality. Primary PCIs in ST elevation myocardial infarction (STEMI) are associated with more aggressive antithrombotic treatment than in elective or semi-urgent interventions. Currently, both radial and femoral approaches are routinely used for primary PCI in STEMI. However, only non-randomized studies and registries or small randomized single center studies comparing both approaches in primary PCI have been published until now. The aim of STEMI-RADIAL trial is to evaluate potential reduction of bleeding complications in the radial approach primary PCI compared to femoral approach in randomized, multicenter study.

Official Title
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ST Elevation Myocardial Infarction Treated by RADIAL or Femoral Approach - Randomized Multicenter Study Comparing Radial Versus Femoral Approach in Primary PCI. The STEMI-RADIAL Trial.

Conditions
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ST Elevation Myocardial Infarction

Intervention / Treatment
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* Procedure: Access site in primary PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years Admission for STEMI less than 12 hours after onset of symptoms Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation ≥ 2 mm in two continuous precordial leads or ST elevations ≥ 1 mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI. Patients are planned to be treated with primary PCI Ability to sign written informed consent Exclusion Criteria: Killip IV class or unconsciousness Patient disagreement Prior aortobifemoral bypass Absence of both radial or femoral artery pulsation Participation in another clinical trial randomizing ACS patients using antithrombotic drug. Negative Allen's test or Barbeau test type D Treatment with oral anticoagulants

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radial approach<br>Primary percutaneous coronary intervention from the radial approach | Procedure: Access site in primary PCI<br> <br> |
| Active Comparator: Femoral approach<br>Primary percutaneous coronary intervention from the femoral approach | Procedure: Access site in primary PCI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of bleeding or entry site complications |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of major adverse cardiovascular events |  |  | 
| Primary access site failure - conversion to another access |  |  | 
| Angiographical procedural success |  |  | 
| Contrast media consumption |  |  | 
| Procedural and fluoroscopic times |  |  | 
| Duration of hospital / ICU stay |  |  | 
| TVR/TLR + any new hospitalization |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Primary percutaneous coronary intervention, Radial, Bleeding