Ban Seung Pil, Kwon O-Ki, Kim Young Deok, Kim Bum-Tae, Oh Jae Sang, Kim Kang Min, Kim Chang Hyeun, Kim Chang-Hyun, Choi Jai Ho, Kim Young Woo, Lim Yong Cheol, Byoun Hyoung Soo, Park Sukh Que, Chung Joonho, Park Keun Young, Park Jung Cheol, Kwon Hyon-Jo
Department of Neurosurgery, Seoul National University Bundang Hospital, Seongnam, Korea.
Department of Neurosurgery, Seoul National University College of Medicine, Seoul, Korea.
J Korean Neurosurg Soc. 2022 Nov;65(6):765-771. doi: 10.3340/jkns.2022.0082. Epub 2022 Jun 16.
Stent-assisted coil embolization (SAC) has been increasingly used to treat various types of intracranial aneurysms. Delayed thromboembolic complications are major concerns regarding this procedure, so dual antiplatelet therapy with aspirin and clopidogrel is needed. However, clinicians vary the duration of dual antiplatelet therapy after SAC, and no randomized study has been performed. This study aims to compare the safety and efficacy of long-term (12 months) dual antiplatelet therapy and shortterm dual antiplatelet therapy (6 months) after SAC for patients with unruptured intracranial aneurysms (UIAs).
This is a prospective, randomized and multicenter trial to investigate the optimal duration of dual antiplatelet therapy after SAC in patients with UIAs. Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (longterm group) after SAC. The primary endpoint is the assessment of thromboembolic complications between 1 and 18 months after SAC. We will enroll 528 subjects (264 subjects in each group) and perform 1 : 1 randomization. This study will involve 14 topperforming, high-volume Korean institutions specializing in coil embolization.
The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up.
This article describes that the aim of this prospective randomized multicenter trial is to compare the effect of short-term (6 months) and long-term (12 months) dual antiplatelet therapy on UIAs in patients undergoing SAC, and to find the optimal duration.
支架辅助弹簧圈栓塞术(SAC)已越来越多地用于治疗各种类型的颅内动脉瘤。延迟性血栓栓塞并发症是该手术的主要关注点,因此需要阿司匹林和氯吡格雷联合抗血小板治疗。然而,临床医生对SAC术后联合抗血小板治疗的持续时间各不相同,且尚未进行随机研究。本研究旨在比较未破裂颅内动脉瘤(UIA)患者SAC术后长期(12个月)和短期联合抗血小板治疗(6个月)的安全性和有效性。
这是一项前瞻性、随机、多中心试验,旨在研究UIA患者SAC术后联合抗血小板治疗的最佳持续时间。受试者将在SAC术后接受6个月(短期组)或12个月(长期组)的联合抗血小板治疗。主要终点是评估SAC术后1至18个月内的血栓栓塞并发症。我们将招募528名受试者(每组264名受试者)并进行1:1随机分组。本研究将涉及14家韩国顶尖的、高容量的专门从事弹簧圈栓塞术的机构。
该试验将于2022年开始招募,招募和随访后将获得临床数据。
本文描述了这项前瞻性随机多中心试验的目的是比较短期(6个月)和长期(12个月)联合抗血小板治疗对接受SAC的UIA患者的影响,并找到最佳持续时间。