Five-Year Outcomes of the PRESERVE II Zenith Iliac Branch Pivotal Clinical Trial

Document Type

Conference Proceeding

Publication Date

6-2024

Publication Title

Journal of Vascular Surgery

Abstract

Objective: The PRESERVE II study evaluated the safety and effectiveness of the investigational Zenith Iliac Branch Graft (ZBIS) with the iCast covered stent to maintain perfusion of the internal iliac artery during endovascular aneurysm repair (EVAR) in patients with insufficient distal landing zone within the common iliac artery. This study was initiated after device integrity issues were observed using an investigational bridging stent in the PRESERVE I study. Methods: This study was a prospective, multicenter, nonrandomized study conducted among 18 U.S. sites. Patients were enrolled between 2014 and 2015, with follow-up to 5 years. The primary end point was 6- month freedom from patency-related interventions (performance goal of 55%). Secondary end points were 30-day freedom from morbidity (performance goal of 46%) and 6-month branch vessel patency. Events underwent independent core lab and clinical event committee adjudication. Results: Forty patients (38 males and 2 females, mean age 67.8 years) were treated; devices were implanted as intended in 100% of patients. Imaging follow-up availability was 100% (37/37) at 1 year. Six-month freedom from patency-related intervention was 100% (39/39), 30-day freedom from morbidity was 85% (34/40), and 6-month branch vessel patency was 100% (37/37). Major adverse events at 12 months included six patients with stroke (1), ileus (1), type Ib endoleak (1), leg ischemia (1), and impotence (2). There was one case of 7 mm ipsilateral iliac aneurysm growth at 4 years that was associated with a type Ib endoleak but left untreated. In addition, there was one case of bilateral buttock claudication at 2 years. Five-year follow-up was available in 75% (30/40) patients with complete imaging in 65% (26/40). Freedom from all-cause mortality at 5 years was 88.9%. There was no aneurysm-related mortality. There were four late occlusions related to the ZBIS: two in the EIA segment, both treated with thrombectomy and stent placement, and two in the iliac branch segment, both of which were symptomatic but managed expectantly. Five-year freedom from patency-related intervention was 100%. In total, nine patients required 15 secondary interventions, with six ipsilateral to the ZBIS. The treated iliac aneurysm size was decreased in 27% (7/26) of patients and unchanged in 73% (19/26). There were no ruptures, type III endoleaks, migrations, or device integrity issues. Conclusions: The early results of the PRESERVE II study exceeded its primary and secondary end points with their respective performance goals. The 5-year outcomes support the sustained safety and effectiveness of the ZIBS in combination with the Atrium iCast covered stent to preserve internal iliac artery perfusion during EVAR.

Volume

79

Issue

6

First Page

E119

Comments

Society for Vascular Surgery 2024 Vascular Annual Meeting, June 19-22, 2024, Chicago, IL

DOI

10.1016/j.jvs.2024.03.146

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