Clinical trial NCT02454491: Verapamil vs Heparin in Transradial Procedures
Official title: Comparison of VERapamil vs. Heparin Therapy on Procedural sUccess During Transradial Coronary Procedures (VERMUT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Disease, Ischemic
Keywords: percutaneous coronary interventions
radial artery access
access site complications
verapamil
heparin
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: number of participants with radial artery-related complications
timeFrame: 24 hours
Secondary outcomes:
measure: number of participants with each radial artery-related complication
timeFrame: 24 hours
measure: late radial artery occlusion
timeFrame: 30 days
measure: reopening early RAO
timeFrame: 30 days
measure: patient's satisfaction
timeFrame: 24 hours
measure: long term patient's satisfaction
timeFrame: 30 days
Other outcomes:
Locations:
city: Cona
country: Italy
facility: University Hospital of Ferrara
state: Ferrara
Study officials:
References: