Randomized Controlled Trial of Radial versus Femoral Access in Cerebral Angiography

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Abstract

Radial versus femoral artery access for procedural success in diagnostic cerebral angiography: a randomized clinical trial

Background: Radial artery access has become the standard of care in percutaneous coronary angiography 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 compared with the more established femoral approach.

Methods: We hypothesized that radial access is non-inferior to femoral access for procedural success in diagnostic cerebral angiography, defined as selective cannulation and/or diagnostic angiography of pre-determined supra-aortic vessels of interest. A monocentric open-label randomized controlled trial (ISRCTN11214237) with a non-inferiority design was undertaken for the primary outcome of procedural success with blinded primary outcome analysis. Adult patients referred for cerebral angiography were eligible. Consenting participants underwent permuted block randomization to either radial or femoral access with an intention-to-treat analysis. The primary outcome non-inferiority limit was 10.0%. Secondary outcomes included post-procedural complications, fluoroscopy and procedural times, radiation dose, contrast volume and rates of vertebral artery cannulation.

Findings: Eighty participants were enrolled (female 42, male 38, mean age 47 years, radial access group n=43, femoral n=37). One patient in the radial group was excluded after enrolment due to insufficient sonographic radial artery internal diameter (<2.0mm). Procedural success was achieved in 97.6% patients in the radial group (41/42) and in 97.3% in the femoral group (36/37). The difference between groups was -0.3% (+7.0%: one-sided 95% confidence interval). Because the one-sided 95% confidence interval limit (6.7%) was less than the non-inferiority limit (10.0%) the null hypothesis was rejected. Fluoroscopy time was significantly higher in the radial group (p=0.001), however there were no significant differences in procedural complications, contrast volume used, radiation dosage, procedural time or access-site pain.

Interpretation: Radial artery access is non-inferior to femoral artery access for procedural success in cerebral angiography.

Funding: No external funding was received for this study.

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