1. One-year outcomes of a novel venous stent for symptomatic iliofemoral venous obstruction: prospective cohort study.
- Author
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Sheng, Chang, Lu, Xin-Wu, Shi, Hong-Tao, Zhang, Lei, Wan, Sheng-Yun, Li, Hong-Pu, Li, Ke, Shi, Sen, Liu, Zhen-Jie, Luo, Yu-Xian, Chen, Guo-Dong, Liu, Mao-Rong, Kang, You-Gen, Ye, Bo, Yao, Kai, Yang, Pu, and Wang, Wei
- Subjects
QUALITY of life ,CONFIDENCE intervals ,LONGITUDINAL method ,CHRONIC diseases ,COHORT analysis - Abstract
Background: A stent with characteristics of a hybrid design may have advantages in improving the patency of symptomatic iliofemoral vein obstruction. This study assessed the safety and effectiveness of the V-Mixtent Venous Stent in treating symptomatic iliofemoral outflow obstruction. Methods: Eligible patients had a Clinical-Etiologic-Anatomic-Physiologic (CEAP) C classification of ≥ 3 or a Venous Clinical Severity Score (VCSS) pain score of ≥ 2. The primary safety endpoint was the rate of major adverse events within 30 days. The primary effectiveness endpoint was the 12-month primary patency rate. Secondary endpoints included changes in VCSS from baseline to 6 and 12 months, alterations in CEAP C classification, Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-14) scores at 12 months, and stent durability measures. Results: Between December 2020 and November 2021, 171 patients were enrolled across 15 institutions. A total of 185 endovenous stents were placed, with 91.81% of subjects receiving one stent and 8.19% receiving 2 stents. Within 30 days, only two major adverse events occurred (1.17%; 95% confidence interval [CI], 0.14–4.16%), below the literature-defined performance goal of 11% (P <.001). The 12-month primary patency rate (91.36%; 95% CI, 85.93–95.19%; P <.001) exceeded the literature-defined performance goal. VCSS changes from baseline demonstrated clinical improvement at 6 months (− 4.30 ± 3.66) and 12 months (− 4.98 ± 3.67) (P <.001). Significant reduction in symptoms, as measured by CEAP C classification and CIVIQ-14, was observed from pre-procedure to 12 months (P <.001). Conclusions: The 12-month outcomes confirm the safety and effectiveness of the V-Mixtent Venous Stent in managing symptomatic iliofemoral venous outflow obstruction, including clinical symptom improvement compared to before treatment. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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