Comparison of the Zylox Penguin Venous Stent System and Zilver Vena Stent for Non-thrombotic Iliac Vein Lesions: A Multicentre Randomised Controlled Trial.

Abstract

The aim of this study was to evaluate the safety, efficacy, and associated complications of the Zylox Penguin venous stent system vs. the Zilver Vena stent for treating non-thrombotic iliac vein lesions (NIVLs) through a multicentre randomised controlled trial (NCT04812444). Patients with NIVLs were assigned randomly to either the Zylox Penguin stent group or the Zilver Vena stent group to assess treatment efficacy. The primary outcome was 12 month primary patency. Secondary outcomes included minimum luminal diameter (MLD), degree of diameter stenosis, target vein revascularisation rate at 12 months, device placement success, procedural success, and improvement of Venous Clinical Severity Score (VCSS), Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification, and Chronic Venous Disease Quality of Life Questionnaire 14 (CIVIQ-14). The study recruited 161 patients from 14 Chinese hospitals. The 12 month primary patency rate was 98% for the Zylox Penguin stent and 90% for the Zilver Vena stent, with an absolute risk difference of 7.5% (95% confidence interval -0.1 - 16.6%). The Zylox Penguin met the non-inferiority endpoint (p = .069). No significant differences were observed in MLD, degree of iliac vein stenosis, or rates of target lesion revascularisation, device placement success, or procedural success. The Zylox Penguin stent group showed a significantly lower degree of iliac vein diameter stenosis (17.6 ± 10.0%) than the Zilver Vena stent group (23.2 ± 15.7%) at 12 months (p = .010). VCSS changes were -5 and -6 for the Zylox Penguin and Zilver Vena stent groups, respectively, while CIVIQ-14 changes were -7 for both groups at 12 months, showing statistically significant improvements compared with baseline (both p < .001). At 12 months post-procedure, oedema resolution occurred in 28% and 29% of all Zylox and Zilver patients, respectively (p = .92), with 85% and 82% of baseline C6 patients showing ulcer healing (p = .85). The Zylox Penguin venous stent system is safe and effective for treating NIVLs, significantly relieving clinical symptoms and improving quality of life.