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Need for prophylactic application of verapamil in transradial coronary procedures: a randomized trial. The VITRIOL (is Verapamil In TransRadial Interventions OmittabLe?) trial.
- Source :
-
Journal of the American Heart Association [J Am Heart Assoc] 2014 Apr 14; Vol. 3 (2), pp. e000588. Date of Electronic Publication: 2014 Apr 14. - Publication Year :
- 2014
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Abstract
- Background: Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings.<br />Methods and Results: During an investigator-initiated, randomized, double-blind trial, we evaluated the need for preventive verapamil administration. After vascular access was established, patients received either 5 mg verapamil (n=297) or placebo (n=294). We compared the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain were investigated as secondary end points. The rate of access site conversions was not different in the 2 arms (placebo 1.7% versus verapamil 0.7%, P=0.28, difference 1.0%, 95% CI for the difference -1.1% to 3.3%). Proportion of code breaks was similar in the 2 groups (3.4% versus 1.3%, P=0.11), whereas overall verapamil use was markedly lower in the placebo arm (2.0% versus 100%, P<0.0001). Procedural time (median [IQR] 16.0 minutes [9.0 to 30.0 minutes] versus 17.0 minutes [10.0 to 31.0 minutes], P=0.37), fluoroscopic time (4.4 minutes [2.1 to 9.6 minutes] versus 4.8 minutes [2.4 to 10.7 minutes], P=0.28), contrast volume (72.5 mL [48.0 to 146.0 mL] versus 75.5 mL [47.0 to 156.5 mL], P=0.74), and pain score (P for trend=0.12) were comparable in the 2 groups.<br />Conclusions: The preventive use of verapamil may be unnecessary for transradial procedures. The omission of prophylactic verapamil may not only reduce the rate of potential complications related to the drug but also allow the safe extension of the transradial method to those with contraindications to verapamil.<br />Clinical Trial Registration Url: http://www.clinicaltrials.gov. Unique identifier: NCT01402427.
- Subjects :
- Aged
Arterial Occlusive Diseases diagnosis
Arterial Occlusive Diseases etiology
Arterial Occlusive Diseases physiopathology
Calcium Channel Blockers adverse effects
Coronary Artery Disease diagnosis
Double-Blind Method
Drug Administration Schedule
Female
Humans
Hungary
Male
Middle Aged
Percutaneous Coronary Intervention adverse effects
Radial Artery diagnostic imaging
Radial Artery physiopathology
Radiography
Time Factors
Treatment Outcome
Unnecessary Procedures
Vasodilator Agents adverse effects
Verapamil adverse effects
Arterial Occlusive Diseases prevention & control
Calcium Channel Blockers administration & dosage
Coronary Artery Disease therapy
Percutaneous Coronary Intervention methods
Radial Artery drug effects
Vasoconstriction drug effects
Vasodilator Agents administration & dosage
Verapamil administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 2047-9980
- Volume :
- 3
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Journal of the American Heart Association
- Publication Type :
- Academic Journal
- Accession number :
- 24732918
- Full Text :
- https://doi.org/10.1161/JAHA.113.000588