Dataset Information

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.

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

http://clinicaltrials.gov/ - NCT04870047.

SUBMITTER: Pierot L

PROVIDER: S-EPMC10314041 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Publications

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.

Pierot Laurent L Lamin Saleh S Barreau Xavier X Berlis Ansgar A Ciceri Elisa E Cohen José E JE Costalat Vincent V Eker Omer F OF Henkes Hans H Holtmannspötter Markus M Januel Anne-Christine AC Keston Peter P Klisch Joachim J Psychogios Marios-Nikos MN Valvassori Luca L Cognard Christophe C Spelle Laurent L

Journal of neurointerventional surgery 20220524 7

<h4>Background</h4>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 th ...[more]

PMID: 35609974

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Project description:BackgroundDelayed aneurysm rupture after flow diverters (FDs) is a serious complication which mechanism remains unclear. The hemodynamics of FDs with proximal or distal densification implantation strategies have rarely been reported. In this study, we investigated not only the hemodynamic factors involved in postoperative rupture, but also the hemodynamic effects of different FDs implantation strategies on avoiding this complication.MethodsWe selected 2 internal carotid artery (ICA) aneurysms with similar morphological characteristics, both of which were treated with FDs but had opposite therapeutic outcomes (Case 1, ruptured after FD treatment; Case 2, recovered). The FDs strategies we designed were strategy A [with homogeneous 30% metal coverage ratio (MCR)], strategy B (with distal densification of 40% and proximal 30% MCR) and strategy C (with proximal densification of 40% and distal 30% MCR). Virtually FDs deployment and computational fluid dynamics (CFD) method were performed to simulate FDs implantation strategies and analyze the hemodynamics associated with postoperative rupture.ResultsAfter FDs implantation, the velocity of blood entering the aneurysm decreased (Case 1, 25.4%; Case 2, 30.6%), but the inflow jet impingement still existed in Case 1. The overall WSS decreased similarly in both cases, but the high WSS region hardly diminished in Case 1. For overall wall pressure, Case 2 decreased slightly but increased in Case 1. Of the three FDs implantation strategies, strategy C had the best hemodynamic effects, including the maximum blood velocity reduction and a tendency to form a more stable flow pattern, the maximum reduction rate of overall WSS and the effective diminish of high WSS area as well as the overall decrease of wall pressure.ConclusionsNot significant decrease of blood flow velocity entering the aneurysm adding persistent impact of inflow jet impingement, high WSS area that did not diminish and abnormal increase of pressure on the aneurysm wall may be causative of postoperative rupture and bleeding of ICA aneurysms. In addition, the hemodynamic effects were favorable when the FD was improved to proximal densification, which may reduce the risk of delayed aneurysm rupture following FDs treatment.KeywordsDelayed rupture; flow diverter (FD); computational fluid dynamics (CFD); intracranial aneurysm (IAs); internal carotid artery (ICA).

Project description:Background and objectivesRegarding the anti-inflammatory effect, methylprednisolone is a candidate to prevent patients with unruptured intracranial aneurysms (UIAs) from postoperative bleeding (PB) after flow diverter (FD) treatment. This study aimed to investigate whether methylprednisolone is related to a lower incidence of PB after FD treatment for UIAs.MethodsThis study retrospectively reviewed UIA patients receiving FD treatment between October 2015 and July 2021. All patients were observed until 72 h after FD treatment. The patients receiving methylprednisolone (80 mg, bid, for at least 24 h) were considered as standard methylprednisolone treatment (SMT) users, otherwise as non-SMT users. The primary endpoint indicated the occurrence of PB, including subarachnoid hemorrhage, intracerebral hemorrhage, and ventricular bleeding, within 72 h after FD treatment. This study compared the incidence of PB between SMT users and non-SMT users and investigated the protective effect of SMT on PB after FD treatment using the Cox regression model. Finally, after controlling the potential factors related to PB, we performed subgroup analysis to further confirm the protective effect of SMT on PB.ResultsThis study finally included 262 UIA patients receiving FD treatment. PB occurred in 11 patients (4.2%), and 116 patients (44.3%) received SMT postoperatively. The median time from the end of surgery to PB was 12.3 h (range: 0.5-48.0 h). SMT users had a lower incidence of PB comparing with non-SMT users (1/116, 0.9% vs. 10/146, 6.8%, respectively; p = 0.017). The multivariate Cox analysis demonstrated that SMT users (HR, 0.12 [95%CI, 0.02-0.94], p = 0.044) had a lower risk of PB postoperatively. After controlling the potential factors related to PB (i.e., gender, irregular shape, surgical methods [FD and FD + coil] and UIA sizes), the patients receiving SMT still had a lower cumulative incidence of PB, comparing with patients receiving non-SMT (all p < 0.05).ConclusionSMT was correlated with the lower incidence of PB for patients receiving FD treatment and may be a potential method to prevent PB after the FD treatment.

Project description:Background and purposeThe biologic mechanisms leading to aneurysm healing or rare complications such as delayed aneurysm ruptures after flow-diverter placement remain poorly understood. We used RNA sequencing following implantation of coils or flow diverters in elastase aneurysms in rabbits to identify genes and pathways of potential interest.Materials and methodsAneurysms were treated with coils (n = 5) or flow diverters (n = 4) or were left untreated for controls (n = 6). Messenger RNA was isolated from the aneurysms at 4 weeks following treatment. RNA samples were processed by using RNA-sequencing technology and were analyzed by using the Ingenuity Pathway Analysis tool.ResultsWith RNA sequencing for coiled versus untreated aneurysms, 464/9990 genes (4.6%) were differentially expressed (58 down-regulated, 406 up-regulated). When we compared flow-diverter versus untreated aneurysms, 177/10,041 (1.8%) genes were differentially expressed (8 down-regulated, 169 up-regulated). When we compared flow-diverter versus coiled aneurysms, 13/9982 (0.13%) genes were differentially expressed (8 down-regulated, 5 up-regulated). Keratin 8 was overexpressed in flow diverters versus coils. This molecule may potentially play a critical role in delayed ruptures due to plasmin production. We identified overregulation of apelin in flow diverters, supporting the preponderance of endothelialization, whereas we found overexpression of molecules implicated in wound healing (dectin 1 and hedgehog interacting protein) for coiled aneurysms. Furthermore, we identified metallopeptidases 1, 12, and 13 as overexpressed in coiled versus untreated aneurysms.ConclusionsWe observed different physiopathologic responses after endovascular treatment with various devices. Flow diverters promote endothelialization but express molecules that could potentially explain the rare delayed ruptures. Coils promote wound healing and express genes potentially implicated in the recurrence of coiled aneurysms.

Dataset Information

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.

Background

Methods

Results

Conclusions

Trial registration number

Publications

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.

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