A Prospective, Multicentre Registry on Thirty Day and One Year Outcomes of the E-liac Stent Graft System in Patients with Unilateral or Bilateral Aorto-iliac or Iliac Aneurysms: The PLIANTII Study.

Abstract

Objective: The aim of this study was to prospectively evaluate the real world outcomes of the E-liac stent graft system used to electively treat common iliac artery aneurysms, either unilaterally or bilaterally.

Methods: PLIANTII is an observational, prospective, non-randomised, multicentre study. The E-liac stent graft system was implanted for the treatment of iliac artery aneurysms in 295 patients across 30 European centres between September 2018 and September 2023, with 236 patients also treated for a concomitant infrarenal abdominal aortic aneurysm. The endpoints, including clinical outcomes, are reported up to the twelve month follow up. The primary endpoint was a composite of freedom from endoleak type I or III plus patency of the external iliac artery (EIA) and internal iliac artery (IIA) on the E-liac implantation side(s) at the twelve month follow up. Technical success was defined as successful access and deployment of the stent graft without surgical conversion, death, type I or III endoleak, or graft limb occlusion, assessed at discharge or 30 days. Clinical success, evaluated at twelve months, also included the absence of stent graft infection and iliac aneurysm rupture.

Results: A total of 295 consecutive patients (95.6% male; mean age 72.7 years) were included. The primary endpoint was achieved in 91.8%. No death was recorded within 30 days after implantation, and seven deaths had occurred at twelve months. The Kaplan-Meier estimated survival rate until the twelve month follow up visit was 96.7 ± 1.2%. Technical success at discharge or 30 days was achieved in 93.1% of patients, while clinical success at twelve months was achieved in 91.2%. There were 5.4% re-interventions within 30 days and 12.9% within twelve months. The Kaplan-Meier estimated freedom from E-liac related re-intervention until the twelve month follow up visit was 91.3 ± 1.8%. The primary patency rate at discharge or 30 day visit was 97.6% (284/291) for the EIA and 96.2% (280/291) for the IIA, whereas Kaplan-Meier estimated freedom from occlusion up to twelve months was 94.5 ± 1.6% for the EIA and 94.7 ± 1.5% for the IIA.

Conclusion: The one year data from the PLIANTII study show that treatment with the E-liac stent graft system is safe and results in good technical and clinical success rates.