远端桡动脉入路预防ST段抬高型心肌梗死患者桡动脉闭塞（RAPID III）：一项随机对照试验
Distal radial access to prevent radial artery occlusion for STEMI patients (RAPID III): a randomized controlled trial.
作者信息
Li Zixuan, Wang Yujie, Song Jiahui, Wang Senhu, Wang Yuntao, Wu Yongxia, Wang Haotian, Liu Zijing, Yan Rui, Zhai Guangyao, Guo Jincheng
机构信息
Division of Cardiology, Beijing Luhe Hospital, Capital Medical University, Beijing, 101149, China.
Department of Nephrology, Yan'an People's Hospital, Yan'an, 716000, China.
出版信息
BMC Med. 2025 Mar 24;23(1):173. doi: 10.1186/s12916-025-04005-1.
BACKGROUND
Compared with conventional transradial access (TRA), distal radial access (DRA) is rarely used for percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarction (STEMI) and may be beneficial to prevent radial artery occlusion (RAO). We aimed to evaluate the incidence of RAO between DRA and TRA 24 h after primary PCI in patients with STEMI.
METHODS
This is a single-center, open-label, prospective, randomized controlled trial conducted at Beijing Luhe Hospital, China, between January 2022 and July 2023. Five hundred and twenty patients (mean age: 61.3 ± 13.0 years; 81% male) with STEMI were randomly assigned to the DRA (n = 260) or TRA (n = 260) group. Primary PCI was performed using the radial artery access assigned study group. The primary endpoint was the rate of RAO assessed using Doppler ultrasound 24 h after primary PCI. Secondary outcomes included time taken for sheath insertion, access success rate, hemostasis time, fluoroscopy time, radiation dosage, and access-related complications.
RESULTS
The incidence of RAO was significantly lower in the DRA group than that in the TRA group (1.9% vs. 8.5%, P = 0.001). Access was successful in 94.6% of patients, and the crossover rate was 5.4% in both groups. The median time taken for sheath insertion was significantly longer (133 s vs. 114 s, P = 0.009), whereas the mean hemostasis time was shorter (209 ± 71 min vs. 372 ± 70 min, P < 0.001) in the DRA group. The incidence of modified Early Discharge After Transradial Stenting of Coronary Arteries (mEASY) ≥ II hematoma was lower in the DRA group (0.8% vs. 3.5%, P = 0.033). However, there was no significant difference in fluoroscopy time, radiation dosage, or access-related complications.
CONCLUSIONS
In patients with STEMI undergoing primary PCI, compared with TRA, DRA prevented RAO 24 h postoperatively and was associated with shorter hemostasis time and a lower incidence of mEASY ≥ II hematoma.
TRIAL REGISTRATION
Clinical Trials.gov Identifier: NCT05461781.
背景
与传统经桡动脉入路（TRA）相比，桡动脉远段入路（DRA）在ST段抬高型心肌梗死（STEMI）患者的经皮冠状动脉介入治疗（PCI）中很少使用，可能有助于预防桡动脉闭塞（RAO）。我们旨在评估STEMI患者在直接PCI术后24小时DRA与TRA之间RAO的发生率。
方法
这是一项于2022年1月至2023年7月在中国北京潞河医院进行的单中心、开放标签、前瞻性、随机对照试验。520例STEMI患者（平均年龄：61.3±13.0岁；81%为男性）被随机分配至DRA组（n = 260）或TRA组（n = 260）。使用分配至研究组的桡动脉入路进行直接PCI。主要终点是直接PCI术后24小时使用多普勒超声评估的RAO发生率。次要结局包括鞘管插入时间、入路成功率、止血时间、透视时间、辐射剂量和与入路相关的并发症。
结果
DRA组的RAO发生率显著低于TRA组（1.9%对8.5%，P = 0.001）。94.6%的患者入路成功，两组的交叉率均为5.4%。DRA组鞘管插入的中位时间显著更长（133秒对114秒，P = 0.009），而平均止血时间更短（209±71分钟对372±70分钟，P < 0.001）。DRA组改良的经桡动脉冠状动脉支架置入术后早期出院（mEASY）≥II级血肿的发生率更低（0.8%对3.5%，P = 0.033）。然而，透视时间、辐射剂量或与入路相关的并发症方面无显著差异。
结论
在接受直接PCI的STEMI患者中，与TRA相比，DRA可预防术后24小时的RAO，且止血时间更短，mEASY≥II级血肿的发生率更低。
试验注册
ClinicalTrials.gov标识符：NCT05461781。
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