Background Surface-modified flow diverters are increasingly used in clinical settings. However, their safety profiles and additional benefits over non-coated devices still need to be explored. In this meta-analysis, we aimed to investigate and compare the clinical outcomes of the uncoated Phenox and coated Phenox HPC flow diverters.
Methods A systematic literature review was performed using PubMed, Scopus, Embase, and Web of Science databases. Collected data were pooled and corresponding 95% confidence intervals (CI) were calculated. Outcomes of interest included aneurysm occlusion (>6 months) and complication rates. Additionally, the safety outcomes of prophylactic single (SAPT) and dual antiplatelet treatment (DAPT) approaches were compared for patients treated with coated Phenox HPC flow diverters.
Results We included 17 studies with 1238 patients. The overall complete occlusion rates were 80% (95% CI 74.01% to 86.56%) for Phenox HPC and 71.3% (95% CI 59.71% to 85.20%) for non-coated Phenox flow diverters (p=0.24). Ischemic complication rates were 7.3% (95% CI 4.6% to 11.39%) with the Phenox HPC and 5.3% (95% CI 4.07% to 6.91%) with the Phenox (p=0.24). For patients treated with Phenox HPC, the SAPT (5.5%; 95% CI 2.83% to 10.85%) and DAPT (7.1%; 95% CI 1.23% to 41.45%) approaches resulted in comparable ischemic complication rates (p=0.79). The DAPT group (4.8%; 95% CI 1.46% to 16.24%) had higher hemorrhagic complication rates than the SAPT group (1.7%; 95% CI 0.52% to 6.09%), but the difference was not statistically significant for patients treated with Phenox HPC (p=0.25).
Conclusions Our findings indicate that Phenox HPC is equally as safe and effective as non-coated Phenox devices. Additionally, our results suggest that prasugrel monotherapy might effectively prevent ischemic complications in patients treated with Phenox HPC flow diverters.
- Flow Diverter
Data availability statement
Data are available upon reasonable request.
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Contributors All authors contributed to the conception and design of the work. CB, YCS, HK, AO, and AAO were responsible for data extraction, literature search, and risk of bias assessment. SG performed statistical analyses. All authors were involved in the drafting of the article, critical revision of the article, and final approval of the version to be published. CB is responsible for the overall content as guarantor.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests AAO is supported by American Heart Association Grant Number 23PRE1012781. RK received research support from Cerenovus Inc, Medtronic, Endovascular Engineering, Frontier Bio, Sensome Inc, Endomimetics, Ancure LLC, Neurogami Medical, MIVI Biosciences, Monarch Biosciences, Stryker, Conway Medical, Piraeus Medical, and Bionaut Labs. WB holds equity in Nested Knowledge, Superior Medical Experts, Piraeus Medical, Sonoris Medical, and MIVI Neurosciences; he receives royalties from Medtronic; he receives consulting fees from Medtronic, Stryker, Imperative Care, Microvention, MIVI Neurosciences, Cerenovus, Asahi, and Balt; he serves in a leadership or fiduciary role for MIVI Neurosciences, Marblehead Medical LLC, Interventional Neuroradiology (editor in chief), Piraeus Medical, and WFITN. DFK holds equity in Nested Knowledge, Superior Medical Experts, and Conway Medical, Marblehead Medical, and Piraeus Medical; he received grant support from Microvention, Medtronic, Neurogami, Cerenovus, Brainomix, MIVI Neurosciences, Stryker, Balt, and Insera Therapeutics; has served on the Data Safety Monitoring Board for Vesalio and NoNo Inc.; and received royalties from Medtronic. The remaining authors report no conflicts of interest concerning the materials or methods used in the manuscript.
Provenance and peer review Not commissioned; externally peer reviewed.
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