Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI

Study Overview
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Brief Summary
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This clinical trial aims to compare conventional radial access versus distal radial access in patients with STEMI undergoing PCI. The main question it aims to answer is: • Mayor adverse cardiac events (MACE) at 30 days in STEMI patients treated by PCI are not inferior when comparing the distal radial approach versus the conventional radial approach ? Participants will: sign the informed consent to enroll in the clinical trial. will agree to be treated by PCI will be randomized 1:1 to perform PCI by conventional radial or distal radial approach. If there is a comparison group: Researchers will compare conventional radial access vs distal radial access to see if the distal approach is not inferior compared to the conventional radial access in order to offer less or equal MACE and a similar rate of a successful procedure.

Official Title
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Adverse Clinical Outcomes Associated With Conventional Versus Distal Radial Access in Patients With Acute Coronary Syndrome With ST-segment Elevation Treated by Percutaneous Coronary Intervention

Conditions
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STEMI - ST Elevation Myocardial Infarction, Myocardial Infarction, Acute Coronary Syndrome

Intervention / Treatment
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* Procedure: Radial Artery approach on percutaneous coronary intervention (PCI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: STEMI patients underwent PCI. Patent radial access (distal and conventional) Patients who agree to participate in the study and sign the informed consent form. Exclusion Criteria: Cardiogenic shock. Previous coronary artery bypass grafting (CABG). Absence of palpable radial pulse. Arteriovenous fistula for hemodialysis. Previous radial artery occlusion.

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: Distal radial approach<br>Clean and dry the puncture site. Simple lidocaine 2% is infiltrated. The artery is punctured in the radial distal zone, and a 6 Fr hydrophilic radial introducer is placed with the Seldinger technique. Verapamil 2.5 mg and Heparin 5000 IU are administered. PCI is performed. Finally, the introducer is withdrawn with the patent hemostasis technique, and a radial compression device is placed (prelude mostly or terumo). | Procedure: Radial Artery approach on percutaneous coronary intervention (PCI)<br>* Randomized patients with a right patent radial artery. The outcomes of the distal radial approach will be compared with those of the conventional radial approach. Technique and devices (introducer and compression devices) are the same in both approaches.<br>|
| Active Comparator: Conventional radial approach (proximal radial approach).<br>Clean and dry the puncture site. Simple lidocaine 2% is infiltrated. The artery is punctured in the radial proximal zone, and a 6 Fr hydrophilic radial introducer is placed with the Seldinger technique. Verapamil 2.5 mg and Heparin 5000 IU are administered. PCI is performed. Finally, the introducer is withdrawn with the patent hemostasis technique, and a radial compression device is placed (terumo). | Procedure: Radial Artery approach on percutaneous coronary intervention (PCI)<br>* Randomized patients with a right patent radial artery. The outcomes of the distal radial approach will be compared with those of the conventional radial approach. Technique and devices (introducer and compression devices) are the same in both approaches.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of adverse events of all-cause mortality, myocardial infarction, cerebral vascular event, BARC 3-5 (Bleeding Academic Research Consortium), myocardial infarction and cerebrovascular event, bleeding measure will be with BARC classification. | At 24 hours and 30 days after the procedure, patients will be evaluated by radial doppler ultrasonography, lab test, and interrogation of clinical adverse events during hospital stay or 30 days after PCI. | 24 hours and 30 days after PCI. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of myocardial infarction after the procedure | A new STEMI event is an event that meets the fourth definition of a myocardial infarction according to the current guidelines. | 24 hours to 30 days after PCI | 
| Incidence of cerebral vascular event (hemorrhagic or ischemic stroke) after the procedure | Diagnosed by a doctor based on clinical symptoms and imaging tests (CT scan). | 24 hours to 30 days after PCI. | 
| Urgent TVR (Revascularization of the treated vessel) | Diagnosed by coronary angiography or intracoronary imaging (IVUS/OCT) showing a complication related to the culprit vessel of the initial event. | If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI. | 
| Definite stent thrombosis | Diagnosed by coronary angiography or intracoronary imaging (IVUS/OCT) showing a complication related to the culprit vessel of the initial event. | If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI. | 
| Bleeding assessed by BARC 3-5 to 30 days of evolution in patients with STEMI who received interventional treatment via RD access versus RC access. | Evaluated by BARC scale will be used to classify the severity of bleeding into types 0-5 (3-5 are the most important criteria for the clinical trial will define the worse outcome ) Type 0 = no evidence of bleeding Type 1 = minimal bleeding Type 2 = clinically evident bleeding other than 3, 4 or 5 Type 3 = with haematocrit fall ≥ 3g% and/or hemodynamic compromise and/or requiring transfusion and/or intracranial or intraocular bleeding Type 4 = associated with Myocardial Revascularization Surgery Type 5 = fatal bleeding. | 24 hours to 30 days after PCI. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, distal radial access, conventional radial access, MACE