Division of Neuroradiology, Toronto Western Hospital, 399 Bathurst St., M5T 2S8, Toronto, Ontario, Canada.
Department of Medical Imaging, Sydney Children's Hospital Network, Cnr Hainsworth St and Hawkesbury Rd and Hawkesbury Rd, 2145, Westmead, NSW, Australia.
Clin Neuroradiol. 2021 Dec;31(4):1083-1091. doi: 10.1007/s00062-020-00984-1. Epub 2020 Dec 29.
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.
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.
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.
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.
由于桡动脉入路在经皮冠状动脉介入治疗中具有显著的患者安全性和舒适性优势,现已成为该治疗的标准入路;但由于术者担心桡动脉入路无法实现手术成功,其在诊断性脑血管造影中的应用仍受到限制。我们旨在提供随机临床试验证据,证明桡动脉入路在实现手术成功方面不劣于股动脉入路。
这是一项单中心、开放标签、非劣效性设计、盲法主要结局评估的随机对照试验。在工作时间内因诊断性脑血管造影而就诊的成年患者符合入组条件。参与者采用区组随机化方法分组接受桡动脉或股动脉入路,采用意向治疗分析。主要结局为手术成功,定义为选择性插管和/或预定的主动脉弓上感兴趣血管的诊断性血管造影。非劣效性界值为 10.0%。次要结局包括术后并发症、透视和手术时间、辐射剂量、造影剂体积和椎动脉插管率。
共纳入 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,股动脉组 n=37)。桡动脉组有 1 名患者在入组后因超声桡动脉内径不足而被排除。桡动脉组 42 名参与者中有 41 名(97.6%)、股动脉组 37 名参与者中有 36 名(97.3%)达到手术成功。两组之间的差异为-0.3%(单侧 95%置信区间,CI 为 6.7%),且零假设被拒绝。
桡动脉入路在诊断性脑血管造影中的手术成功率不劣于股动脉入路。建议下一步开展一项多中心大样本试验。