经桡动脉与经股动脉进行脑血管造影：一项随机非劣效性临床试验

摘要(中文译文)

经桡动脉入路（TRA）已成为介入心脏手术中替代标准经股动脉入路（TFA）的一种有前景的选择，但其在脑循环检查中的应用尚未在临床试验中得到验证。旨在比较TRA与TFA用于诊断性脑血管造影的有效性和安全性。这项由研究者发起、多中心、开放标签、非劣效性随机临床试验采用盲法结局评估，在中国13个中心开展。符合脑血管造影条件的患者于2023年9月15日至2024年11月4日期间被随机分组，最终随访于2024年11月27日完成。主要分析在意向治疗人群中进行；次要分析在符合方案人群中进行。患者被随机分配至TRA组（n=431）或TFA组（n=430）接受诊断性脑血管造影。主要结局为诊断性脑血管造影的成功率。次要结局包括获得准确诊断的成功率、造影和透视持续时间、卧床时间，以及患者报告的术后24小时内11点视觉模拟量表疼痛评分（范围从0[无痛]至10[最严重疼痛]）满意度。非劣效性界值为造影诊断成功率和准确诊断成功率的绝对差异5%。共有858例患者（中位年龄58.4[IQR，52.0-67.0]岁；479例[55.8%]男性）完成了试验。TRA组诊断性脑血管造影成功率低于TFA组（392/431[91.0%] vs 409/427[95.8%]；差异为-4.8个百分点[pp][95%CI，-8.1至-1.5 pp]；相对危险度[RR]，0.95[95%CI，0.92-0.98]；非劣效性检验P=.46）。TRA组准确诊断成功率为78.9%，TFA组为91.1%（差异为-12.2 pp[95%CI，-16.9至-7.5 pp]；RR，0.87[95%CI，0.82-0.92]；非劣效性检验P=.99）。与TFA组相比，TRA组的中位造影时间更长（33.7[IQR，23.0-40.0] vs 38.7[IQR，26.0-47.0]分钟；P<.001），中位透视时间更长（10.6[IQR，5.6-12.9] vs 11.8[IQR，6.2-15.0]分钟；P=.02）；TRA组的中位卧床时间显著更短（188.4[IQR，3.0-180.0] vs 1079.0[IQR，842.0-1366.0]分钟；P<.001），中位疼痛评分更低（0.5[IQR，0.0-1.0] vs 0.7[IQR，0.0-1.0]；P<.001）。两组总体造影并发症相当（19/445[4.3%] vs 25/413[6.1%]；P=.28），但TRA组桡动脉穿刺失败次数多于TFA组。在这项针对接受诊断性脑血管造影患者的随机临床试验中，就诊断性脑血管造影成功率而言，TRA未显示出对TFA的非劣效性。需要进一步研究，包括优效性试验，以明确界定TRA与TFA的比较获益。ClinicalTrials.gov注册号：NCT05401669。

Abstract

Transradial access (TRA) has emerged as a promising alternative to standard transfemoral access (TFA) for interventional cardiac procedures, but its application for examination of the cerebral circulation has not been tested in a clinical trial. To compare the efficacy and safety of TRA with TFA for diagnostic cerebral angiography. This investigator-initiated, multicenter, open-label, noninferiority randomized clinical trial with a blinded outcome assessment was conducted at 13 sites in China. Patients eligible for cerebral angiography were randomized between September 15, 2023, and November 4, 2024, with final follow-up performed on November 27, 2024. The primary analysis was performed in the intention-to-treat population; secondary analyses were performed in the per-protocol population. Patients were randomly allocated to TRA (n = 431) or TFA (n = 430) for diagnostic cerebral angiography. The primary outcome was the success of diagnostic cerebral angiography. Secondary outcomes were success in achieving an accurate diagnosis, duration of angiography and fluoroscopy, time in bed, and patient-reported satisfaction on an 11-point visual analog scale for pain (ranging from 0 [none] to 10 [worst possible]) within 24 hours after the procedure. The noninferiority margin was an absolute difference of 5% in success of angiographic diagnosis and success of accurate diagnosis. A total of 858 patients (median age, 58.4 [IQR, 52.0-67.0] years; 479 [55.8%] male) completed the trial. Success of diagnostic cerebral angiography in the TRA group was lower than that in the TFA group (392 of 431 [91.0%] vs 409 of 427 [95.8%]; difference, -4.8 percentage points [pp] [95% CI, -8.1 to -1.5 pp]; relative risk [RR], 0.95 [95% CI, 0.92-0.98]; P = .46 for noninferiority test). The success rate of accurate diagnosis was 78.9% in the TRA group vs 91.1% in the TFA group (difference, -12.2 pp [95% CI, -16.9 to -7.5 pp]; RR, 0.87 [95% CI, 0.82-0.92]; P = .99 for noninferiority test). Compared with the TFA group, the TRA group had longer median times for angiography (33.7 [IQR, 23.0-40.0] vs 38.7 [IQR, 26.0-47.0] minutes; P < .001) and fluoroscopy (10.6 [IQR, 5.6-12.9] vs 11.8 [IQR, 6.2-15.0] minutes; P = .02); the TRA group had significantly shorter median time in bed (188.4 [IQR, 3.0-180.0] vs 1079.0 [IQR, 842.0-1366.0] minutes; P < .001) and lower median pain scores (0.5 [IQR, 0.0-1.0] vs 0.7 [IQR, 0.0-1.0]; P < .001). Overall angiography complications were comparable between the groups (19 of 445 [4.3%] vs 25 of 413 [6.1%]; P = .28), but TRA had more radial artery puncture failures than TFA. In this randomized clinical trial of patients undergoing diagnostic cerebral angiography, TRA was not shown to be noninferior to TFA with regard to the success rate of diagnostic cerebral angiography. Additional research, including superiority trials, is needed to clearly define the comparative benefits of TRA and TFA. ClinicalTrials.gov Identifier: NCT05401669.

如何引用

JAMA network open 的其他文献

• 非心脏手术中围手术期抗生素的指南依从性与手术部位感染
• 西维来司他与心血管手术后急性呼吸窘迫综合征的发病率：一项随机临床试验
• 外周静脉注射加压素使用不良事件的发生率：系统评价和荟萃分析
• III期炎症性和非炎症性乳腺癌症的生存和治疗模式
• 盆底锻炼预防初产妇压力性尿失禁：一项随机临床试验。
• 中老年人24小时休息活动节律和表观年龄加速
• 临床脓毒症表型的多中心验证
• 长期阻力训练与2型糖尿病风险
• 来曲唑与生精失败男性不育：一项随机临床试验
• 永久支持性住房中的无烟家庭干预：一项整群随机临床试验