Abstract
Background and Purpose
Radial artery access has become the standard of care in percutaneous coronary procedures due to demonstrated patient safety and comfort benefits; however, uptake of radial access for diagnostic cerebral angiography has been limited by practitioner concerns over the ability to achieve procedural success. We aimed to provide randomized clinical trial evidence for the non-inferiority of radial access to achieve procedural success.
Material and Methods
Monocentric open label randomized controlled trial with a non-inferiority design and blinded primary outcome assessment. Adult patients referred in-hours for diagnostic cerebral angiography were eligible. Participants underwent permuted block randomization to radial or femoral artery access with an intention-to-treat analysis. The primary outcome was procedural success, defined as selective cannulation and/or diagnostic angiography of predetermined supra-aortic vessels of interest. The non-inferiority limit was 10.0%. Secondary outcomes included postprocedural complications, fluoroscopy and procedural times, radiation dose, contrast volume and rates of vertebral artery cannulation.
Results
A total of 80 participants were enrolled (female 42, male 38, mean age 47.0 years, radial access group n = 43, femoral n = 37). One patient in the radial group was excluded after enrollment due to insufficient sonographic radial artery internal diameter. Procedural success was achieved in 41 of 42 participants in the radial group (97.6%) and 36 of 37 in the femoral group (97.3%). The difference between groups was −0.3% (one-sided 95% confidence interval, CI 6.7%) and the null hypothesis was rejected.
Conclusion
Radial artery access is non-inferior to femoral artery access for procedural success in cerebral angiography. A large multicenter trial is recommended as the next step.
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Funding
No funding was sought or received for this study. All procedures were undertaken under the standard of care in Ontario and funded accordingly. Administrative costs were borne by the Division of Neuroradiology, University Health Network, Toronto.
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Contributions
KB contributed to study design, data collection, data analysis, and writing. WG, HL, and JK contributed to data collection, data analysis, and recruitment. HK and EO contributed to study design and data interpretation. AQ contributed to data collection and recruitment. AK contributed to study design, randomization, and data collection. RA and RF contributed to supervision, data analysis, and data interpretation. IR contributed to supervision, administrative support, and data interpretation. PN undertook the blinded independent primary outcome analysis. TK contributed to supervision, administrative support, data analysis, and data interpretation. VMP contributed to study design, supervision, administrative support, data analysis, and data interpretation.
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Conflict of interest
V.M. Pereira is a consultant for Stryker, Medtronic, Philips Healthcare, Balt and Cerenovus. T. Krings is a consultant for Stryker, Medtronic and Penumbra, has royalties through Thieme and stock options in Marblehead. R. Farb owns stock options in Marblehead. K. Bhatia, W. Guest, H. Lee, J. Klostranec, H. Kortman, E. Orru, A. Qureshi, A. Kostynskyy, R. Agid, I. Radovanovic and P. Nicholson declare that they have no competing interests.
Ethical standards
Ethics approval for this study was granted by the University Health Network Research Ethics Board. Consent to participate: informed written consent for study involvement was obtained from all participants (or their approved next of kin as appropriate). Consent for publication: informed written consent for publication of de-identified results was obtained from all participants (or their approved next of kin as appropriate).
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Presentation at meeting
The results of this randomized clinical trial were presented by Dr Kartik Bhatia at the American Society of Neuroradiology (ASNR) virtual annual meeting from 30 May to 4 June 2020.
Availability of data and material
The study protocol is included with the Supplementary Material for this article. Individual participant data that underlie the results reported in this article, after de-identification, will be made available beginning 3 months and ending 5 years following article publication, to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose (where possible directly or in collaboration with the Research Ethics Board of the University Health Network, Toronto) for the purpose of individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication and should be directed to alex.kostynskyy@uhn.ca.
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Bhatia, K., Guest, W., Lee, H. et al. Radial vs. Femoral Artery Access for Procedural Success in Diagnostic Cerebral Angiography. Clin Neuroradiol 31, 1083–1091 (2021). https://doi.org/10.1007/s00062-020-00984-1
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DOI: https://doi.org/10.1007/s00062-020-00984-1