VERNACULAR trial 12-month data show successful use of Venovo stent in obstructive lesions

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Michael Dake
Michael Dake

The 12-month results from the VERNACULAR trial have shown that the Venovo venous stent (BD Interventional) is successful when deployed in obstructive iliac and femoral lesions with a primary patency rate of 88.3%, a low reintervention rate of 7.4%, and no core-lab–assessed stent fractures.

VERNACULAR is a prospective multicentre single-arm clinical trial designed to assess the performance of the Venovo venous stent, a self-expanding stent for the treatment of iliac and femoral vein occlusive disease. A total of 170 patients were treated at 22 centres in the USA, Europe, and Australia. The 12-month data were presented by Michael Dake (Stanford, USA) at VIVA 2018 (5–8 November, Las Vegas, USA).

The primary efficacy measure was 12-month primary patency, defined as freedom from target vessel revascularisation and freedom from thrombotic occlusion and stenosis >50% (duplex ultrasound–derived). Secondary outcomes included the Venous Clinical Severity Score (VCSS) pain assessment and Chronic Venous Insufficiency Quality-of-Life Questionnaire (CIVIQ-20), both hypothesis-tested for improvement at 12 months compared to baseline values. One hundred fifty-six patients completed 12-month follow-up, including 84 patients with post-thrombotic syndrome (PTS) and 72 patients with non-thrombotic iliac vein lesions.

All stents (219) were deployed success­fully to the intended location. The 12-month primary patency rate was 88.3%, which was significantly better than a performance goal (74%) derived from the venous stent lit­erature (p<0.0001). The VCSS pain score at 12 months improved significantly from baseline, with a mean improvement in the pain score of –1.7 (p<0.0001). CIVIQ-20 scores also improved significantly at 12 months from baseline, with a mean improvement of –15.7 (p<0.0001). Additional observations included a 12-month freedom from target lesion revascularisation of 92.6% (95% CI, 87.5%, 96.1%). Radiographs were assessed by the Yale core lab for stent fractures, with no fractures reported at 12-month follow-up.

Dake concluded that one-year results from the VERNACULAR trial demonstrated that the Venovo venous stent could be deployed successfully in obstructive iliac and femoral vein lesions, including acute or chronic deep vein thrombosis, post-thrombotic syndrome, or venous compression syndrome (e.g., May Thurner), with a primary patency rate of 88.3%, a low reintervention rate of 7.4%, and no core-lab–assessed stent fractures.

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