Verapamil vs Heparin in Transradial Procedures

Study Overview
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Brief Summary
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Transradial approach (TRA) for cardiac catheterization and percutaneous coronary interventions (PCI) is increasingly being used worldwide. At the present is unknown the cocktail of agents necessary to minimize local access site complications. The investigators planned a prospective randomized clinical trial to test the superiority of verapamil vs. heparin in the reduction of access site related complications.

Detailed Description
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Transradial approach (TRA) for cardiac catheterization and percutaneous coronary interventions (PCI) is increasingly being used worldwide in both elective and emergency procedures because it reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality, when compared to transfemoral approach. However, radial artery occlusion (RAO) after the procedure (the incidence of which varies from 1% to 10%) remains one of the major limitations of TRA. The aim of the study is to assess the superiority of verapamil versus heparin in the access success during transradial percutaneous coronary interventions (PCI). METHODS Patients referred to the cath-lab of the Cardiovascular Institute of the University Hospital of Ferrara, Italy, for coronary angiography were randomized in 2 groups with a computer-generated random sequence. The study is double-blind. In the first group, patients received intravenous heparin (5000 UI) immediately after a 6 F sheath insertion. In the second group, patients received Verapamil (5 mg) immediately after a 6 F sheath insertion. If after the start of the procedure a radial artery spasm (RAS) occurs, the operators can choose to use bail-out a local vasodilator therapy. After sheath removal, hemostasis was obtained using a TR band (Terumo corporation, Tokyo, Japan) with a plethysmography-guided patent hemostasis technique. Radial artery patency was evaluated at 24 hours (early RAO) and 30 days after the procedure (late RAO) by ultrasound. The aim of the study is to demonstrate that verapamil administration is superior to heparin administration in the reduction of the combined endpoint (occurrence of radial artery occlusion (early RAO), access site complication, radial artery spasm (RAS) requiring local bailout use of vasodilatator) RAO will be assessed by ultrasonography by independent expert reviewer blinded to randomization The investigators defined access site complication the following items: local haematoma superficial <5 cm from access site; haematoma with moderate muscle infiltration <10 cm; forearm haematoma and muscular infiltration below the elbow; haematoma and muscular infiltration above the elbow; ischemic threat (compartmental syndrome); radial artery dissection during the procedure; The investigators defined radial artery spasm any spasm occurring during the procedure requiring the administration of local vasodilatators to allow the procedure

Official Title
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Comparison of VERapamil vs. Heparin Therapy on Procedural sUccess During Transradial Coronary Procedures (VERMUT Study)

Conditions
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Heart Disease, Ischemic

Intervention / Treatment
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* Drug: Heparin
* Drug: Verapamil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to hospital with diagnosis of acute coronary syndrome and stable coronary artery disease according current European guidelines and with clinical indication to coronary artery angiography. all patients receiving percutaneous coronary intervention by radial artery access as first attempt procedures with 6F catheter Exclusion Criteria: warfarin therapy previous ipsilateral TRA lack of consent scleroderma thrombocytopenia or other contraindications to heparin

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard of care<br>intraradial heparin (5000 UI) immediately after a 6 F sheath insertion | Drug: Heparin<br>* intraradial administration of heparin 5000 ui<br>|
| Experimental: experimental therapy<br>intraradial verapamil (5 mg) immediately after a 6 F sheath insertion | Drug: Verapamil<br>* intraradial administration of verapamil 5 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with radial artery-related complications | occurrence of early radial artery occlusion, access site complication, radial artery spasm (RAS) that requires the bailout use of vasodilatator | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with each radial artery-related complication | occurrence of each singular component of primary endpoint | 24 hours | 
| late radial artery occlusion | occurrence of radial artery occlusion (late RAO) | 30 days | 
| reopening early RAO | reopening of the closed radial at 24 hours. | 30 days | 
| patient's satisfaction | assessment with questionnaires of the pain and satisfaction of patients | 24 hours | 
| long term patient's satisfaction | assessment with questionnaires of the pain and satisfaction of patients | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous coronary interventions, radial artery access, access site complications, verapamil, heparin