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 (IA) are pathologic bulging of the arterial walls that could rupture and cause SAH. Recently, stents with modified surfaces have been used as treatment for IA. 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 IA in 546 patients. At 12 months, overall adequate O'Kelly-Marotta grading scale (OKM = C-D) angiographic results were 83%. For the PEDV stent it was 97% and for the PED-Shield stent it was 80% (P ≤ .001). Mortality was 0.9% (P = .34) and overall morbidity was 0.5% (PEDV 0.3% and PED-Shield 0.2%). Overall complication events were 3.1%, thromboembolic events were 2.1% in the PED-Shield stent, and 6.7% in the PEDV stent (P = .008). Overall bleeding complications were 1.7%, in the PED-Shield stent (0.9%) and 2 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.