Kartik Bhatia1,2, William Guest3, Hubert Lee3,4, Jesse Klostranec3, Hans Kortman3, Emanuele Orru3,5, Ayman Qureshi3, Alexander Kostynskyy3, Ronit Agid3, Richard Farb3, Ivan Radovanovic4, Patrick Nicholson3, Timo Krings3,4, Vitor Mendes Pereira3,4. 1. Division of Neuroradiology, Toronto Western Hospital, 399 Bathurst St., M5T 2S8, Toronto, Ontario, Canada. Kartik.bhatia@health.nsw.gov.au. 2. Department of Medical Imaging, Sydney Children's Hospital Network, Cnr Hainsworth St and Hawkesbury Rd and Hawkesbury Rd, 2145, Westmead, NSW, Australia. Kartik.bhatia@health.nsw.gov.au. 3. Division of Neuroradiology, Toronto Western Hospital, 399 Bathurst St., M5T 2S8, Toronto, Ontario, Canada. 4. Division of Neurosurgery, Toronto Western Hospital, 399 Bathurst St., M5T 2S8, Toronto, Ontario, Canada. 5. Division of Neurointerventional Radiology, Lahey Hospital and Medical Center, 41 Burlington Mall Rd, 01805, Burlington, MA, USA.
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.
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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