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.

中文翻译：

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桡动脉与股动脉通路在诊断性脑血管造影术程序上的成功

背景和目的

由于已证明对患者安全和舒适的好处，桡动脉通路已成为经皮冠状动脉手术的护理标准；然而，从业者对获得手术成功的能力的担忧限制了径向通路用于诊断性脑血管造影的应用。我们旨在提供随机临床试验证据，证明径向通路在取得手术成功方面的非劣效性。

材料与方法

具有非劣效性设计和盲法主要结果评估的单中心开放标签随机对照试验。在几小时内转诊进行诊断性脑血管造影的成年患者符合条件。参与者通过意向治疗分析接受了桡动脉或股动脉通路的置换区组随机化。主要结果是手术成功，定义为对预定的主动脉上血管进行选择性插管和/或诊断性血管造影。非劣效性限值为 10.0%。次要结果包括术后并发症、透视和手术时间、辐射剂量、造影剂体积和椎动脉插管率。

结果

共招募了 80 名参与者（女性 42 名，男性 38 名，平均年龄 47.0 岁，桡动脉组n  = 43，股骨n  = 37）。由于超声检查桡动脉内径不足，桡骨组中的一名患者在入组后被排除在外。桡骨组 42 名参与者中的 41 名 (97.6%) 和股骨组 37 名参与者中的 36 名 (97.3%) 获得了手术成功。组间差异为 -0.3%（单侧 95% 置信区间，CI 6.7%），拒绝原假设。

结论

对于脑血管造影术的手术成功而言，桡动脉通路并不劣于股动脉通路。下一步建议进行大型多中心试验。