Comparison of Success Rate Between Distal Radial Approach and Radial Approach in STEMI

Study Overview
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Brief Summary
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ST-segment elevation myocardial infarction (STEMI) is an emergent disease to treat as soon as possible. 2017 ESC guidelines for the management of STEMI recommend using radial approach (RA) rather than femoral approach (FA) to reduce mortality and bleeding complications if the operators are expert for RA. Recently, Ferdinand Kiemeneij reported that distal radial approach (DRA) could be a feasible and safe route for coronary angiography (CAG) and percutaneous coronary intervention (PCI) in 70 patients. The right-handed patient could feel more comfortable in left DRA than right RA. Left DRA also could provide a better comfortable position for the operator compared to left RA. Distal radial artery is located around the anatomical snuffbox, which doesn't contain nerve and vein beside artery. Therefore, the possibility of procedure-related complications such as nerve injury or arteriovenous fistula is very low. Also, the superficial location of DRA could make easier hemostasis. There were no vascular-related complications from the report of Kiemeneij. But, the rate of puncture failure was 11%, which was higher than RA-based study (5.34% in STEMI patients of RIVAL trial, 6% in RIFLESTEACS trial and 5.8% in MATRIX trial). Nevertheless, this study was a pilot study with a small number of patients. There is no clinical study to compare the feasibility and safety for CAG and PCI between DRA and RA in patients with STEMI. Therefore, this study aimed to evaluate whether DRA is feasible and safe compared to RA in STEMI setting.

Official Title
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Comparison of Success Rate Between Distal Radial Approach and Radial Approach in ST-segment Elevation Myocardial Infarction

Conditions
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Distal Radial Artery Approach, ST Elevation Myocardial Infarction

Intervention / Treatment
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* Procedure: Distal radial artery
* Procedure: Radial artery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 20 years ST-segment elevation myocardial infarction Palpable unilateral distal radial and radial artery Exclusion Criteria: Cardiogenic shock Thrombolysis before primary percutaneous coronary intervention Inability to obtain written informed consent Patient with ipsilateral arteriovenous fistula Participation in another ongoing clinical trial Pregnancy Expected lifespan <12 months * Eligible operator criteria Qualified operator who had experienced ≥ 100 cases of distal radial artery puncture

Ages Eligible for Study
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Minimum Age: 20 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
Interventional Model Description: Patients will be randomized either distal radial approach or radial approach.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Distal radial artery<br>After subcutaneous injection of lidocaine, the distal radial artery around the bony surface area is punctured with a 20-gauge venipuncture catheter needle or steel needle according to the operator's discretion. After successful puncture, flexible, straight plastic 0.025 mini-guidewire is inserted through the hole of the puncture needle. Then, Radifocus® introducer sheath (Terumo, Tokyo, Japan) is inserted into the distal radial artery. | Procedure: Distal radial artery<br>* The distal radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.<br>|
| Placebo Comparator: Radial artery<br>After subcutaneous injection of lidocaine, the radial artery is punctured with a 20-gauge venipuncture catheter needle or steel needle according to the operator's discretion. After successful puncture, flexible, straight plastic 0.025 mini-guidewire is inserted through the hole of the puncture needle. Then, Radifocus® introducer sheath (Terumo, Tokyo, Japan) is inserted into the radial artery. | Procedure: Radial artery<br>* The radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puncture success rate (%) | The success rate (%) of arterial puncture will be compared between distal radial artery approach and radial artery approach group. | Through procedure completion, up to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of coronary angiography (%) | The success rate (%) of coronary angiography will be compared between distal radial artery approach and radial artery approach group. | Through procedure completion, up to 6 hours | 
| Success rate of percutaneous coronary intervention (%) | The success rate (%) of percutaneous coronary intervention will be compared between distal radial artery approach and radial artery approach group. | Through procedure completion, up to 6 hours | 
| Procedure success rate (%) | The success rate (%) of final procedure will be compared between distal radial artery approach and radial artery approach group. | Through procedure completion, up to 6 hours | 
| Bleeding complication rate (%) | The bleeding complication rate (%) will be compared between distal radial artery approach and radial artery approach group. | During hospitalization, up to 1 month | 
| Total procedure time (minutes) | Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups. | Through procedure completion, up to 6 hours | 
| Total fluoroscopic time (minute) | Scale range: 0 - 360 minutes Shorter time is associated with better outcome. An averaged time value will be compared and reported between two groups. | Through procedure completion, up to 6 hours | 
| Total fluoroscopic dose (Gray/cm2) | Scale range: 0 - 500 Gray/cm2 Lesser fluoroscopic dose is better. An averaged value will be compared and reported between two groups. | Through procedure completion, up to 6 hours | 
| MACCE (%) | Incidence rate (%) of composite endpoints defined as all-cause death, any myocardial infarction, stroke and major bleeding | 1 year | 
| Puncture time (minute) | Scale range: 0 - 60 minutes Shorter time is considered better result. An averaged time value will be compared and reported between two groups. | Through procedure completion, up to 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal radial approach, ST Elevation Myocardial Infarction