Department of Neuroradiology, Hôpital Maison Blanche, CHU Reims, Université Reims Champagne Ardenne, Reims, France
Department of Interventional Neuroradiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, Birmingham, UK.
J Neurointerv Surg. 2023 Jul;15(7):684-688. doi: 10.1136/neurintsurg-2022-018969. Epub 2022 May 24.
Due to its high efficacy, flow diversion is increasingly used in the management of unruptured and recanalized aneurysms. Because of the need for perioperative dual antiplatelet treatment (DAPT), flow diversion is not indicated for the treatment of ruptured aneurysms. To overcome this major limitation, surface modification-'coating'-of flow diverters has been developed to reduce platelet aggregation on the implanted device, reduce thromboembolic complications, and facilitate the use of coated flow diverter treatment in patients with single antiplatelet treatment (SAPT). COATING (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) is a prospective, randomized, multicenter trial that aims to determine whether the use of the coated flow diverter p64 MW HPC under SAPT is non-inferior (or even superior) to the use of the bare flow diverter p64 MW under DAPT in relation to thromboembolic and hemorrhagic complications.
Patients with unruptured or recanalized aneurysms for which endovascular treatment with a flow diverter is indicated will be enrolled and randomly assigned on a 1:1 ratio to one of two treatment groups: p64 MW HPC with SAPT or p64 MW with DAPT.
The primary endpoint is the number of diffusion-weighted imaging lesions visualized via MRI assessed within 48 hours (±24 hours) of the index procedure. Secondary primary endpoints are comparing safety and efficacy in both arms.
This randomized controlled trial is the first to directly compare safety and efficacy of coated flow diverters under SAPT with bare flow diverters under DAPT.
http://clinicaltrials.gov/ - NCT04870047.
由于其高效性，血流导向装置越来越多地用于未破裂和再通的动脉瘤的治疗。由于需要围手术期双联抗血小板治疗（DAPT），血流导向装置不适合破裂的动脉瘤的治疗。为了克服这一主要局限性，已经开发了血流导向装置的表面改性-“涂层”-以减少植入装置上的血小板聚集，减少血栓栓塞并发症，并促进使用涂层血流导向装置治疗接受单一抗血小板治疗（SAPT）的患者。COATING（用于优化新一代血流导向装置的动脉瘤治疗）是一项前瞻性、随机、多中心试验，旨在确定在 SAPT 下使用涂层血流导向装置 p64 MW HPC 是否不劣于（甚至优于）在 DAPT 下使用裸血流导向装置 p64 MW 与血栓栓塞和出血并发症相关。
将招募有未破裂或再通的动脉瘤且需要血管内治疗的患者，并按照 1:1 的比例随机分为两组：p64 MW HPC 接受 SAPT 或 p64 MW 接受 DAPT。
主要终点是通过 MRI 在索引手术后 48 小时（±24 小时）内评估的弥散加权成像病变数量。次要主要终点是比较两个臂的安全性和疗效。
这项随机对照试验是首次直接比较 SAPT 下涂层血流导向装置与 DAPT 下裸血流导向装置的安全性和疗效。
http://clinicaltrials.gov/- NCT04870047。
