One-year outcomes of a novel venous stent for symptomatic iliofemoral venous obstruction: prospective cohort study

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.

Keywords: Clinical improvement; Iliofemoral venous outflow obstruction; Multicenter study; Patency; Venous stenting.

Fig. 1

V-Mixtent Venous Stent design

Fig. 2

Preprocedural and postprocedural venography of a patient, with the lesion primarily located in the common iliac vein (CIV). The black arrows indicate the stent. A Preprocedural venography shows significant collateral circulation. B The patient received one stent implantation, and venography shows disappearance of vascular stenosis and collateral circulation

Fig. 3

Sankey diagram displayed the population flow in this study. The numbers on the colored ribbons in the figure indicate the included population. The different lines represent various scenarios of traffic diversion. PT, post-thrombotic; NT, non-thrombotic; PPS, per-protocol set; DUS, doppler ultrasound

Fig. 4

Change in Clinical, Etiological, Anatomical, Pathophysiological (CEAP) C classification from baseline through 12 months