Cargando…

Need for Prophylactic Application of Verapamil in Transradial Coronary Procedures: A Randomized Trial

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. METHODS AND RESULTS: During an investigator‐initiated, randomized, double‐blind trial,...

Descripción completa

Detalles Bibliográficos
Autores principales: Hizoh, Istvan, Majoros, Zsuzsanna, Major, Laszlo, Gulyas, Zalan, Szabo, Gabor, Kerecsen, Gabor, Korda, Andras, Molnar, Ferenc, Kiss, Robert Gabor
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4187515/
https://www.ncbi.nlm.nih.gov/pubmed/24732918
http://dx.doi.org/10.1161/JAHA.113.000588
_version_ 1782338187319836672
author Hizoh, Istvan
Majoros, Zsuzsanna
Major, Laszlo
Gulyas, Zalan
Szabo, Gabor
Kerecsen, Gabor
Korda, Andras
Molnar, Ferenc
Kiss, Robert Gabor
author_facet Hizoh, Istvan
Majoros, Zsuzsanna
Major, Laszlo
Gulyas, Zalan
Szabo, Gabor
Kerecsen, Gabor
Korda, Andras
Molnar, Ferenc
Kiss, Robert Gabor
author_sort Hizoh, Istvan
collection PubMed
description 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. 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. 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01402427.
format Online
Article
Text
id pubmed-4187515
institution National Center for Biotechnology Information
language English
publishDate 2014
publisher Blackwell Publishing Ltd
record_format MEDLINE/PubMed
spelling pubmed-41875152014-11-03 Need for Prophylactic Application of Verapamil in Transradial Coronary Procedures: A Randomized Trial Hizoh, Istvan Majoros, Zsuzsanna Major, Laszlo Gulyas, Zalan Szabo, Gabor Kerecsen, Gabor Korda, Andras Molnar, Ferenc Kiss, Robert Gabor J Am Heart Assoc Original Research 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. 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. 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01402427. Blackwell Publishing Ltd 2014-04-25 /pmc/articles/PMC4187515/ /pubmed/24732918 http://dx.doi.org/10.1161/JAHA.113.000588 Text en © 2014 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/3.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Research
Hizoh, Istvan
Majoros, Zsuzsanna
Major, Laszlo
Gulyas, Zalan
Szabo, Gabor
Kerecsen, Gabor
Korda, Andras
Molnar, Ferenc
Kiss, Robert Gabor
Need for Prophylactic Application of Verapamil in Transradial Coronary Procedures: A Randomized Trial
title Need for Prophylactic Application of Verapamil in Transradial Coronary Procedures: A Randomized Trial
title_full Need for Prophylactic Application of Verapamil in Transradial Coronary Procedures: A Randomized Trial
title_fullStr Need for Prophylactic Application of Verapamil in Transradial Coronary Procedures: A Randomized Trial
title_full_unstemmed Need for Prophylactic Application of Verapamil in Transradial Coronary Procedures: A Randomized Trial
title_short Need for Prophylactic Application of Verapamil in Transradial Coronary Procedures: A Randomized Trial
title_sort need for prophylactic application of verapamil in transradial coronary procedures: a randomized trial
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4187515/
https://www.ncbi.nlm.nih.gov/pubmed/24732918
http://dx.doi.org/10.1161/JAHA.113.000588
work_keys_str_mv AT hizohistvan needforprophylacticapplicationofverapamilintransradialcoronaryproceduresarandomizedtrial
AT majoroszsuzsanna needforprophylacticapplicationofverapamilintransradialcoronaryproceduresarandomizedtrial
AT majorlaszlo needforprophylacticapplicationofverapamilintransradialcoronaryproceduresarandomizedtrial
AT gulyaszalan needforprophylacticapplicationofverapamilintransradialcoronaryproceduresarandomizedtrial
AT szabogabor needforprophylacticapplicationofverapamilintransradialcoronaryproceduresarandomizedtrial
AT kerecsengabor needforprophylacticapplicationofverapamilintransradialcoronaryproceduresarandomizedtrial
AT kordaandras needforprophylacticapplicationofverapamilintransradialcoronaryproceduresarandomizedtrial
AT molnarferenc needforprophylacticapplicationofverapamilintransradialcoronaryproceduresarandomizedtrial
AT kissrobertgabor needforprophylacticapplicationofverapamilintransradialcoronaryproceduresarandomizedtrial