Coating (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) study. The first randomized controlled trial evaluating a coated flow diverter (p64 MW HPC): study design

Laurent Pierot, Saleh Lamin, Xavier Barreau, Ansgar Berlis, Elisa Ciceri, José E Cohen, Vincent Costalat, Omer F Eker, Hans Henkes, Markus Holtmannspötter, Anne-Christine Januel, Peter Keston, Joachim Klisch, Marios-Nikos Psychogios, Luca Valvassori, Christophe Cognard, Laurent Spelle, Laurent Pierot, Saleh Lamin, Xavier Barreau, Ansgar Berlis, Elisa Ciceri, José E Cohen, Vincent Costalat, Omer F Eker, Hans Henkes, Markus Holtmannspötter, Anne-Christine Januel, Peter Keston, Joachim Klisch, Marios-Nikos Psychogios, Luca Valvassori, Christophe Cognard, Laurent Spelle

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration number: https://ichgcp.net/clinical-trials-registry/NCT04870047" title="See in ClinicalTrials.gov">NCT04870047.

Keywords: Aneurysm; Flow Diverter.

Conflict of interest statement

Competing interests: LP consults for Balt, MicroVention, Perflow, phenox, Vesalio. XB receives payment from MicroVention and Stryker for presentations and educational events. VC consults for MicroVention and Balt and receives educational grants from Medtronic and Stryker. HH is co-founder and previous shareholder of phenox GmbH and femtos GmbH. PK consults for Medtronic, MicroVention, phenox, Stryker. JK consults for MicroVention/Sequent. LS consults for Stryker, MicroVention, Medtronic, and Balt. Other authors report no conflict of interest.

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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