Editor's Choice - Clinical Efficacy of Venastent - A Novel Iliac Vein Stent for Non-Thrombotic Iliac Vein Lesions: A Multi-Centre Randomised Controlled Trial

Lei Hong; Xiaotian Wang; Zhengdong Fang; Xiaojie Sun; Xinbao Ge; Can Chen; Haiquan Feng; Hejie Hu

doi:10.1016/j.ejvs.2022.04.005

Editor's Choice - Clinical Efficacy of Venastent - A Novel Iliac Vein Stent for Non-Thrombotic Iliac Vein Lesions: A Multi-Centre Randomised Controlled Trial

Eur J Vasc Endovasc Surg. 2022 Jun;63(6):883-889. doi: 10.1016/j.ejvs.2022.04.005. Epub 2022 Apr 9.

Authors

Lei Hong¹, Xiaotian Wang¹, Zhengdong Fang¹, Xiaojie Sun¹, Xinbao Ge¹, Can Chen¹, Haiquan Feng², Hejie Hu³

Affiliations

¹ Department of Vascular Surgery, The First Affiliated Hospital of USTC, Anhui, China.
² Inner Mongolia University of Technology, Hohhot, China.
³ Department of Vascular Surgery, The First Affiliated Hospital of USTC, Anhui, China. Electronic address: hu.hejie@163.com.

PMID: 35717357
DOI: 10.1016/j.ejvs.2022.04.005

Abstract

Objective: To determine the efficacy of Venastent - a novel iliac vein stent for non-thrombotic iliac vein lesions (NIVLs).

Methods: From October 2018 to January 2021, 256 NIVL patients were recruited at 19 Chinese hospitals. A randomised controlled trial was conducted to compare the efficacy of the new iliac vein stent-Venastent (Tianhong China) with Zilver stent (Cook USA). All patients were allocated randomly to two groups: the experimental group patients used Venastent, while the control group received the Zilver stent. The trial was registered in Chinese Clinical Trial Registry (ChiCTR2200057851).

Results: A total of 123 patients in the experimental group and 122 patients in the control group had a full set of data collected (p = ns). The technical success rate was 100% (n = 245/245). The patency rate was 100% (n = 123/123) in the experimental group and 98.4% (n = 120/122) in control group one year after operation (p = ns). The lower extremity swelling remission rate was 79.1% (n = 87/110) in the experimental group and 78.4% (n = 91/116) in the control group (p = ns). The lower extremity pain relief rate was 68.8% (n = 50/80) in the experimental group and 77.2% (n = 71/92) in the control group (p = ns). The ulcer healing rate was 90% (n = 18/20) in the experimental group and 87% (n = 20/23) in the control group (p = ns). There was no difference in stent re-stenosis or clinical remission between the two groups.

Conclusion: The new iliac vein stent, Venastent, had a comparable high patency rate and safety profile as the Zilver stent (Cook) in NIVLs patients. Venastent significantly reduced symptoms of chronic venous disease.

Keywords: Non-thrombotic iliac vein lesions; Novel iliac vein stent; Randomised controlled trial.