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.

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.

Pierot L ，Lamin S ，Barreau X ，Berlis A ，Ciceri E ，Cohen JE ，Costalat V ，Eker OF ，Henkes H ，Holtmannspötter M ，Januel AC ，Keston P ，Klisch J ，Psychogios MN ，Valvassori L ，Cognard C ，Spelle L ... -  《-》

Use of a p64 MW Flow Diverter with Hydrophilic Polymer Coating (HPC) and Prasugrel Single Antiplatelet Therapy for the Treatment of Unruptured Anterior Circulation Aneurysms: Safety Data and Short-term Occlusion Rates.

To assess the safety and short-term occlusion rates in procedures using the p64 MW hydrophilic polymer-coated (HPC) flow diverter (FD) with prasugrel single antiplatelet therapy (SAPT) for the treatment of anterior circulation saccular aneurysms. We retrospectively identified patients who underwent treatment of one or more intracranial anterior circulation saccular aneurysms between March 2020 and December 2021 with a p64 MW HPC FD and prasugrel SAPT with verified P2Y12 platelet receptor inhibition. Patients diagnosed with fusiform, dissecting, or recently ruptured aneurysms were excluded. Periprocedural and postprocedural complications, clinical outcomes, and angiographic follow-up results were evaluated. One hundred and two patients with 132 intracranial aneurysms met the inclusion criteria. Previous or concomitant treatments (e.g., coil occlusion) had been performed on 18 of these aneurysms. The technical success rate (i.e., implantation of the intended FD) was 100% with an average of 1.1 devices implanted per patient. Periprocedural and postprocedural complications occurred in 13.6% and 6.8% of these patients, respectively. No mortality or permanent clinical deterioration (i.e., modified Rankin scale score ≥ 3) were reported. Early follow-up digital subtraction angiography revealed aneurysmal occlusion rates of 72.6% and 83.8% at four and nine months, respectively. The implantation of a p64 MW HPC FD with prasugrel SAPT is safe and results in rapid, reliable and effective aneurysmal occlusion.

Hellstern V ，Aguilar Pérez M ，Henkes E ，Donauer E ，Wendl C ，Bäzner H ，Ganslandt O ，Henkes H ... -  《-》

Early clinical experience with the p48MW HPC and p64MW HPC flow diverters in the anterior circulation aneurysm using single anti-platelet treatment.

Bhogal P ，Petrov A ，Rentsenkhu G ，Nota B ，Ganzorig E ，Regzengombo B ，Jagusch S ，Henkes E ，Henkes H ... -  《-》

Flow diverter stents with hydrophilic polymer coating for the treatment of acutely ruptured aneurysms using single antiplatelet therapy: Preliminary experience.

Guzzardi G ，Galbiati A ，Stanca C ，Del Sette B ，Paladini A ，Cossandi C ，Carriero A ... -  《-》

Surface-modified flow diverter p48-MW-HPC: Preliminary clinical experience in 28 patients treated in two centers.

Flow diversion is increasingly used for endovascular treatment of distal intracranial aneurysms and has led to the development of small diameter flow diverters such as p48-MW (phenox, Bochum, Germany). Use of flow diverters is limited, however, as patients require dual antiplatelet treatment to avoid thromboembolic complications. Hydrophilic Polymer Coating was developed to reduce platelet aggregation on the p48-MW (p48-MW-HPC). This study reports preliminary experience with p48-MW-HPC in aneurysm treatment in two centers. Patients with ruptured, unruptured, and recanalized aneurysms treated with p48-MW-HPC were prospectively included and retrospectively analyzed for safety and efficacy. Safety was evaluated by analyzing intra- and postoperative complications as well as thromboembolic events depicted by DWI in the 72 h post-procedure. Efficacy was evaluated at 6 months based on aneurysm occlusion. From April 2019 to May 2020, 28 patients aged 25-82 years with 29 aneurysms were treated. Two thromboembolic events (7.1%) were reported with good clinical outcome. Final morbidity and mortality were both 0.0%. Post-operative DWI-MRI was depicting lesions in 70.0% of patients. Short-term (6 months) anatomical results were complete aneurysm occlusion in 87.0% of aneurysms, neck remnant in 8.7%, and aneurysm remnant in 4.3%. This preliminary clinical evaluation conducted in a relatively small sample size shows high feasibility (100.0%) of p48-MW-HPC aneurysm treatment, without morbidity or mortality, and high efficacy (complete occlusion in 90.0%). Additional larger comparative studies are needed to confirm these results and optimize perioperative antiplatelet treatment.

Pierot L ，Soize S ，Cappucci M ，Manceau PF ，Riva R ，Eker OF ... -  《-》