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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,...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Blackwell Publishing Ltd
2014
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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 |
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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 |
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