Efficacy and safety in the use of Pipeline Vantage Shield stent versus Pipeline Flex Shield stent in the treatment of patients with unruptured intracranial aneurysms: a multicenter study.

Abstract

Background and purpose: Unruptured intracranial aneurysms are pathological bulging of the arterial walls that could rupture and cause subarachnoid hemorrhage. Recently, stents with modified surfaces have been used as treatment for intracranial aneurysms. Thus, comparing efficacy and security of the Pipeline Flex Embolization Device with Shield Technology (PED-Shield) and the Pipeline Vantage Embolization Device with Shield Technology (PEDV) contributes to the scientific literature. Aiming to determine the efficacy of these stents, we believe the PEDV is as effective and safe as the PED-Shield in management of patients with unruptured aneurysms.

Materials and methods: We analyzed data through an anonymized, multicentered cohort from multiple interventional radiology services in Colombia from January 2017 until June 2023.

Results: Our study included 574 unruptured intracranial aneurysms in 546 patients. At 12 months, overall adequate O'Kelly-Marotta grading scale (OKM=C-D) angiographic results was 83%. For the PEDV stent was 97% and for the PED-Shield stent 80% (p=<0.001). Mortality (0.9%, p=0.34) and overall morbidity 0.5% (PEDV 0.3% and 0.2% PED-Shield). Overall complications events were 3.1%, thromboembolic events were 2.1% in the PED-Shield stent, and 6.7% in the PEDV stent (p=0.008). (p=0.34) Overall bleeding complications were 1.7%, in the PED-Shield stent (0.9%) and two in the PEDV stent (1.4%).

Conclusions: The PEDV stent improved efficacy in comparison with PED-Shield stent at 12-months while the PED-Shield stent showed a slightly better safety profile.

Abbreviations: ICA= Internal carotid artery; AcomA= Anterior communicating artery; ACA= Anterior cerebral artery; PCA= Posterior cerebral artery; aSAH= Aneurysmal subarachnoid hemorrhage; FDS= flow-diverting stents; IA= Intracranial aneurysm; PEDV= Pipeline Vantage Embolization Device with Shield Technology; PED-Shield= Pipeline Flex Embolization Device with Shield Technology; DAPT= Dual antiplatelet therapy; PcomA= Posterior communicating artery.