Gore Viabahn Studied for Treatment of Complex Femoropopliteal Lesions in a Japanese Population

October 31, 2023—Five-year outcomes were presented from a study to assess safety and effectiveness of the Viabahn endoprosthesis (Gore & Associates) for the treatment of symptomatic lower extremity arterial disease (LEAD) in complex femoropopliteal (FP) lesions in a Japanese population.

The prospective, multicenter, postmarket surveillance study was conducted in symptomatic LEAD patients with FP lesions ≥ 10 cm and reference vessel diameters ranging from 4 to 7.5 mm.

Osamu Iida, MD, revealed the findings during a late-breaking clinical trial session at VIVA23, the Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on October 30 to November 2 in Las Vegas, Nevada.

The study’s efficacy endpoints evaluated at 5 years were primary patency (PP), primary assisted patency (PAP), secondary patency (SP), and freedom from target lesion revascularization (fTLR).

Safety endpoints were occurrence of device- or procedure-related serious adverse events (SAEs) and stent fractures.

As summarized in the VIVA press release, a total of 321 patients were enrolled at 64 Japanese sites from 2016 to 2017.

The patients’ mean age was 73.9 ± 8.7 years. The frequency of dialysis and chronic limb-threatening ischemia were 23.1% and 26.5%, respectively. Mean lesion length was 23.6 ± 6.6 cm. Frequency of TASC II C/D lesions and chronic total occlusion were 86.6% and 70.4%, respectively.

A total of 562 devices were implanted in 324 limbs. Kaplan-Meier–estimated PP, PAP, SP, and fTLR were 69.8%, 82.6%, 88.9%, and 81.1% at 3 years, respectively, and 62.4%, 74.1%, 82.3%, and 75.9% at 5 years, respectively.

Through 5 years, cumulative device- or procedure-related SAEs were 19.9%, with 9.3% of those occurring after the first 12 months. Patients were 100% free from stent fractures and acute limb ischemia, and 97.4% were free from major adverse limb events.

This study showed that safety and effectiveness of the Viabahn endoprosthesis were clinically acceptable for treating complex FP lesions in Japanese patients with LEAD through 5 years.

Patients with LEAD and complex FP lesions treated with the Viabahn endoprosthesis have long-term acceptable safety and efficacy, making this an alternative to surgical bypass therapy, concluded Dr. Iida in the VIVA press release.