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
BackgroundDue 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...
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Published in | Journal of neurointerventional surgery Vol. 15; no. 7; pp. 684 - 688 |
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Main Authors | , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
BMA House, Tavistock Square, London, WC1H 9JR
BMJ Publishing Group Ltd
01.07.2023
BMJ Publishing Group LTD BMJ Journals BMJ Publishing Group |
Series | Original research |
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Online Access | Get full text |
ISSN | 1759-8478 1759-8486 1759-8486 |
DOI | 10.1136/neurintsurg-2022-018969 |
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Abstract | BackgroundDue 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.MethodsPatients 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.ResultsThe 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.ConclusionsThis 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 http://clinicaltrials.gov/ - NCT04870047. |
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AbstractList | BackgroundDue 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.MethodsPatients 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.ResultsThe 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.ConclusionsThis 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 numberhttp://clinicaltrials.gov/ - NCT04870047. 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 clinicaltrials.gov/ - NCT04870047 . 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. 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.BACKGROUNDDue 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.METHODSPatients 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.RESULTSThe 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.CONCLUSIONSThis 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.TRIAL REGISTRATION NUMBERhttp://clinicaltrials.gov/ - NCT04870047. BackgroundDue 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.MethodsPatients 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.ResultsThe 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.ConclusionsThis 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 http://clinicaltrials.gov/ - NCT04870047. |
Author | Januel, Anne-Christine Cohen, José E Holtmannspötter, Markus Henkes, Hans Ciceri, Elisa Pierot, Laurent Barreau, Xavier Cognard, Christophe Berlis, Ansgar Costalat, Vincent Keston, Peter Klisch, Joachim Valvassori, Luca Lamin, Saleh Spelle, Laurent Psychogios, Marios-Nikos Eker, Omer F |
AuthorAffiliation | 16 NEURI Interventional Neuroradiology , APHP , Paris , Île-de-France , France 10 Department of Neuroradiology , Nuremberg Hospital, South Campus, Paracelsus Medical University , Nuremberg , Bayern , Germany 2 Department of Interventional Neuroradiology , University Hospitals Birmingham NHS Foundation Trust , Birmingham , Birmingham , UK 11 Department of Neuroradiology , CHU Toulouse , Toulouse , Occitanie , France 3 Department of Neuroradiology , CHU Bordeaux GH Pellegrin , Bordeaux , Aquitaine , France 9 Neuroradiological Clinic , Klinikum Stuttgart , Stuttgart , Baden-Württemberg , Germany 7 Department of Neuroradiology , CHU Montpellier, Hôpital Gui de Chauliac , Montpellier , France 1 Department of Neuroradiology , Hôpital Maison Blanche, CHU Reims, Université Reims Champagne Ardenne , Reims , France 13 Department of Neuroradiology , HELIOS Klinikum Erfurt , Erfurt , Thüringen , Germany 6 Department of Neurosurgery and Radiology , Hadassah Hebrew University, University Medcal Centers , Jer |
AuthorAffiliation_xml | – name: 8 Department of Neuroradiology , CHU Lyon , Lyon , Auvergne-Rhône-Alpes , France – name: 11 Department of Neuroradiology , CHU Toulouse , Toulouse , Occitanie , France – name: 9 Neuroradiological Clinic , Klinikum Stuttgart , Stuttgart , Baden-Württemberg , Germany – name: 10 Department of Neuroradiology , Nuremberg Hospital, South Campus, Paracelsus Medical University , Nuremberg , Bayern , Germany – name: 14 Department of Neuroradiology , University Hospital Basel , Basel , BS , Switzerland – name: 13 Department of Neuroradiology , HELIOS Klinikum Erfurt , Erfurt , Thüringen , Germany – name: 3 Department of Neuroradiology , CHU Bordeaux GH Pellegrin , Bordeaux , Aquitaine , France – name: 5 Department of Neuroradiology , Fondazione IRCSS Instituto Neurologico Carlo Besta , Milano , Lombardia , Italy – name: 1 Department of Neuroradiology , Hôpital Maison Blanche, CHU Reims, Université Reims Champagne Ardenne , Reims , France – name: 17 Paris-Saclay University Faculty of Medicine , Le Kremlin-Bicetre , France – name: 4 Department of Diagnostic and Interventional Neuroradiology , Klinikum Augsburg , Augsburg , Bayern , Germany – name: 6 Department of Neurosurgery and Radiology , Hadassah Hebrew University, University Medcal Centers , Jerusalem , Jerusalem , Israel – name: 16 NEURI Interventional Neuroradiology , APHP , Paris , Île-de-France , France – name: 2 Department of Interventional Neuroradiology , University Hospitals Birmingham NHS Foundation Trust , Birmingham , Birmingham , UK – name: 7 Department of Neuroradiology , CHU Montpellier, Hôpital Gui de Chauliac , Montpellier , France – name: 15 Department of Neuroradiology , San Carlo Borromeo Hospital , Milano , Lombardia , Italy – name: 12 Department of Neuroradiology , Royal Infirmary of Edinburgh , Edinburgh , Edinburgh , UK |
Author_xml | – sequence: 1 givenname: Laurent orcidid: 0000-0002-2523-4909 surname: Pierot fullname: Pierot, Laurent email: lpierot@gmail.com organization: Department of Neuroradiology, Hôpital Maison Blanche, CHU Reims, Université Reims Champagne Ardenne, Reims, France – sequence: 2 givenname: Saleh surname: Lamin fullname: Lamin, Saleh organization: Department of Interventional Neuroradiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, Birmingham, UK – sequence: 3 givenname: Xavier surname: Barreau fullname: Barreau, Xavier organization: Department of Neuroradiology, CHU Bordeaux GH Pellegrin, Bordeaux, Aquitaine, France – sequence: 4 givenname: Ansgar surname: Berlis fullname: Berlis, Ansgar organization: Department of Diagnostic and Interventional Neuroradiology, Klinikum Augsburg, Augsburg, Bayern, Germany – sequence: 5 givenname: Elisa surname: Ciceri fullname: Ciceri, Elisa organization: Department of Neuroradiology, Fondazione IRCSS Instituto Neurologico Carlo Besta, Milano, Lombardia, Italy – sequence: 6 givenname: José E surname: Cohen fullname: Cohen, José E organization: Department of Neurosurgery and Radiology, Hadassah Hebrew University, University Medcal Centers, Jerusalem, Jerusalem, Israel – sequence: 7 givenname: Vincent surname: Costalat fullname: Costalat, Vincent organization: Department of Neuroradiology, CHU Montpellier, Hôpital Gui de Chauliac, Montpellier, France – sequence: 8 givenname: Omer F surname: Eker fullname: Eker, Omer F organization: Department of Neuroradiology, CHU Lyon, Lyon, Auvergne-Rhône-Alpes, France – sequence: 9 givenname: Hans surname: Henkes fullname: Henkes, Hans organization: Neuroradiological Clinic, Klinikum Stuttgart, Stuttgart, Baden-Württemberg, Germany – sequence: 10 givenname: Markus surname: Holtmannspötter fullname: Holtmannspötter, Markus organization: Department of Neuroradiology, Nuremberg Hospital, South Campus, Paracelsus Medical University, Nuremberg, Bayern, Germany – sequence: 11 givenname: Anne-Christine surname: Januel fullname: Januel, Anne-Christine organization: Department of Neuroradiology, CHU Toulouse, Toulouse, Occitanie, France – sequence: 12 givenname: Peter surname: Keston fullname: Keston, Peter organization: Department of Neuroradiology, Royal Infirmary of Edinburgh, Edinburgh, Edinburgh, UK – sequence: 13 givenname: Joachim surname: Klisch fullname: Klisch, Joachim organization: Department of Neuroradiology, HELIOS Klinikum Erfurt, Erfurt, Thüringen, Germany – sequence: 14 givenname: Marios-Nikos surname: Psychogios fullname: Psychogios, Marios-Nikos organization: Department of Neuroradiology, University Hospital Basel, Basel, BS, Switzerland – sequence: 15 givenname: Luca surname: Valvassori fullname: Valvassori, Luca organization: Department of Neuroradiology, San Carlo Borromeo Hospital, Milano, Lombardia, Italy – sequence: 16 givenname: Christophe surname: Cognard fullname: Cognard, Christophe organization: Department of Neuroradiology, CHU Toulouse, Toulouse, Occitanie, France – sequence: 17 givenname: Laurent orcidid: 0000-0002-6748-8528 surname: Spelle fullname: Spelle, Laurent organization: Paris-Saclay University Faculty of Medicine, Le Kremlin-Bicetre, France |
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Keywords | Flow Diverter Aneurysm |
Language | English |
License | This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. 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. Attribution - NonCommercial: http://creativecommons.org/licenses/by-nc |
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year: 2018 ident: R16 article-title: Evaluation of ischemic lesion prevalence after endovascular treatment of intracranial aneurysms, as documented by 3-T diffusion-weighted imaging: a 2-year, single-center cohort study publication-title: J Neurosurg doi: 10.3171/2016.11.JNS161020 – volume: 41 start-page: 1779 year: 2018 ident: R10 article-title: Hydrophilic stent coating inhibits platelet adhesion on stent surfaces: initial results in vitro publication-title: Cardiovasc Intervent Radiol doi: 10.1007/s00270-018-2036-7 – volume: 5 start-page: 47 year: 2019 ident: R11 article-title: Prospective study to assess the tissue response to HPC-coated p48 flow diverter stents compared to uncoated devices in the rabbit carotid artery model publication-title: Eur Radiol Exp doi: 10.1186/s41747-019-0128-z – volume: 27 start-page: 42 year: 2021 ident: R12 article-title: Initial experience with the novel p64MW HPC flow diverter from a cohort study in unruptured anterior circulation aneurysms under dual antiplatelet medication publication-title: Interv Neuroradiol doi: 10.1177/1591019920939845 – volume: 17 year: 2019 ident: R14 article-title: A brief review on resistance to P2Y 12 receptor antagonism in coronary artery disease publication-title: Thromb J doi: 10.1186/s12959-019-0197-5 – volume: 38 start-page: 40 year: 2011 ident: R1 article-title: Flow diverter stents in the treatment of intracranial aneurysms: where are we? publication-title: J Neuroradiol doi: 10.1016/j.neurad.2010.12.002 – volume: 10 start-page: 765 year: 2018 ident: R6 article-title: Feasibility, complications, morbidity, and mortality results at 6 months for aneurysm treatment with the flow re-direction endoluminal device: report of safe study publication-title: J Neurointerv Surg doi: 10.1136/neurintsurg-2017-013559 – volume: 12 start-page: 1107 year: 2020 ident: R9 article-title: Periprocedural to 1-year safety and efficacy outcomes with the Pipeline embolization device with Shield technology for 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Initial experience with the novel p64MW HPC flow diverter from a cohort study in unruptured anterior circulation aneurysms under dual antiplatelet medication publication-title: Interv Neuroradiol doi: 10.1177/1591019920939845 – volume: 128 start-page: 982 year: 2018 ident: 2024052309531805000_15.7.684.16 article-title: Evaluation of ischemic lesion prevalence after endovascular treatment of intracranial aneurysms, as documented by 3-T diffusion-weighted imaging: a 2-year, single-center cohort study publication-title: J Neurosurg doi: 10.3171/2016.11.JNS161020 – volume: 296 start-page: E130 year: 2020 ident: 2024052309531805000_15.7.684.15 article-title: Intraoperative complications of endovascular treatment of intracranial aneurysms with coiling or Balloon-assisted coiling in a prospective multicenter cohort of 1088 participants: Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm (ARETA) study publication-title: Radiology doi: 10.1148/radiol.2020204013 – 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Snippet | BackgroundDue to its high efficacy, flow diversion is increasingly used in the management of unruptured and recanalized aneurysms. Because of the need for... Due to its high efficacy, flow diversion is increasingly used in the management of unruptured and recanalized aneurysms. Because of the need for perioperative... Background Due to its high efficacy, flow diversion is increasingly used in the management of unruptured and recanalized aneurysms. Because of the need for... |
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SubjectTerms | Aneurysm Aneurysms Blood platelets Clinical trials Computer Science Embolization Endovascular Procedures Endovascular Procedures - methods Flow Diverter Human health and pathology Humans Hypotheses Intracranial Aneurysm Intracranial Aneurysm - diagnostic imaging Intracranial Aneurysm - surgery Life Sciences Medical Imaging Morbidity Mortality Neurons and Cognition New Devices and Techniques Platelet Aggregation Inhibitors Platelet Aggregation Inhibitors - therapeutic use Polymers Prospective Studies Retrospective Studies Stents Stroke Surgery Thromboembolism Thrombosis Transplants & implants Treatment Outcome Wire |
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