急性基底动脉闭塞血管内治疗的多中心随机对照试验（ATTENTION）。
Endovascular treatment for acute basilar artery occlusion: A multicenter randomized controlled trial (ATTENTION).
机构信息
Stroke Center and Department of Neurology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.
Lehigh Valley Health Network, Allentown, PA, USA.
出版信息
Int J Stroke. 2022 Aug;17(7):815-819. doi: 10.1177/17474930221077164. Epub 2022 Feb 22.
BACKGROUND AND HYPOTHESIS
Recently, two multicenter randomized controlled trials (RCT) failed to show a significantly beneficial effect of endovascular treatment (EVT) in patients with acute basilar artery occlusion (BAO). However, both trials suffered from equipoise issues which may have hindered the validity of the trial results. Therefore, additional RCT studies are needed to explore the potential benefit of EVT in patients presenting with BAO.
STUDY DESIGN
ATTENTION is an investigator-initiated, multicenter, prospective, randomized, controlled clinical trial with open-label treatment and blinded outcome assessment (PROBE) of EVT versus best medical management (BMM). The primary effect parameter is a modified Rankin Score of 0-3 at day 90.
DISCUSSION
ATTENTION will provide evidence for the efficacy and safety of EVT in stroke patients within 12 h after BAO.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04751708.
背景与假设
最近，两项多中心随机对照试验（RCT）未能显示血管内治疗（EVT）对急性基底动脉闭塞（BAO）患者有显著的益处。然而，这两项试验都存在均衡问题，这可能影响了试验结果的有效性。因此，需要进行更多的 RCT 研究来探索 EVT 在 BAO 患者中的潜在益处。
研究设计
ATTENTION 是一项由研究者发起的、多中心、前瞻性、随机、对照的临床试验，采用开放标签治疗和盲法结局评估（PROBE），比较 EVT 与最佳药物治疗（BMM）。主要的疗效参数是 90 天时改良 Rankin 评分 0-3 分。
讨论
ATTENTION 将为 BAO 后 12 小时内的卒中患者 EVT 的疗效和安全性提供证据。
试验注册
ClinicalTrials.gov NCT04751708。
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