Verapamil vs Heparin in Transradial Procedures (VERMUT)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Disease, Ischemic
• Intervention / Treatment: Drug: Heparin; Drug: Verapamil

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 418
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • University Hospital of Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Estimate): October 4, 2016
• Last Update Submitted That Met QC Criteria: October 1, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: heparin; percutaneous coronary interventions; radial artery access; access site complications; verapamil
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Heart Diseases; Myocardial Ischemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Anticoagulants; Calcium Channel Blockers; Heparin; Verapamil
• Other Study ID Numbers: 58