MedElevator
Войти в исследования JAMA network open · 2026
Transradial vs Transfemoral Access for Cerebral Angiography: A Randomized Noninferiority Clinical Trial.
СтатьяРандомизированное исследованиеEquivalence TrialМногоцентровое исследованиеСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Ni Wei, Yang Heng, Su Jiabin, Peng Ya, Wang Dengliang, Lin Zhiqing, Sun Jun, Chen Xuelin, Wang Jiyue, Li Yi, Wang Jiaxiong, Wan Shu, Ye Xin, Zhang Qingrong, Wang Donghai, Gao Chao, Jiang Hanqiang, Gao Xinjie, Zhang Yingying, Han Bing, Cao Jie, Zhu Xucheng, Zhou Shengjun, Zeng Yiyong, Chen Fuxiang, Lin Yuanxiang, Ba Huajun, Chen Xiaoxiang, Liu Xianglu, Hao Jiheng, Sun Zhaoliang, Li Mei, Wang Ming, Xie Dajiang, Zhuang Zong, Shi Lin, Zhou Liang, Tang Hongyu, Chen Dan, Anderson Craig S, Kang Dezhi, Gu Yuxiang, TRACE Investigators
Аннотация
IMPORTANCE: 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.
OBJECTIVE: To compare the efficacy and safety of TRA with TFA for diagnostic cerebral angiography.
DESIGN, SETTING, AND PARTICIPANTS: 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.
INTERVENTIONS: Patients were randomly allocated to TRA (n = 431) or TFA (n = 430) for diagnostic cerebral angiography.
MAIN OUTCOMES AND MEASURES: 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.
RESULTS: 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.
CONCLUSIONS AND RELEVANCE: 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.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05401669.
OBJECTIVE: To compare the efficacy and safety of TRA with TFA for diagnostic cerebral angiography.
DESIGN, SETTING, AND PARTICIPANTS: 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.
INTERVENTIONS: Patients were randomly allocated to TRA (n = 431) or TFA (n = 430) for diagnostic cerebral angiography.
MAIN OUTCOMES AND MEASURES: 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.
RESULTS: 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.
CONCLUSIONS AND RELEVANCE: 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.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05401669.