Verapamil vs Heparin in Transradial Procedures

Phase 4

Completed

• Conditions: Heart Disease, Ischemic
• Interventions: Drug: Verapamil; Drug: Heparin

• Registration Number: NCT02454491
• Lead Sponsor: University Hospital of Ferrara

Brief Summary

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

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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-13
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-27
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-01
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 418

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental therapy	Verapamil	intraradial verapamil (5 mg) immediately after a 6 F sheath insertion
standard of care	Heparin	intraradial heparin (5000 UI) immediately after a 6 F sheath insertion

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Ferrara; 🇮🇹 Cona, Ferrara, Italy