Three-Year Follow-up of Patients With Iliac Occlusive Disease Treated With the Viabahn Balloon- Expandable Endoprosthesis

Abstract

Purpose: To assess the midterm safety and effectiveness of the Gore Viabahn Balloon-Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of patients with de novo or restenotic aortoiliac lesions. Materials and Methods: The prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study ( ClinicalTrials.gov identifier: NCT02080871) evaluated 134 patients (mean age 66±9.5 years; 79 men) up to 3 years after treatment with the VBX Stent-Graft. A total of 213 lesions were treated with 234 stent-grafts. The primary safety endpoint was a composite of major adverse events (MAEs), which were evaluated through 30 days and 9 months. Secondary outcomes collected through 3 years included freedom from target lesion revascularization (TLR), target vessel revascularization (TVR), clinically-driven TLR (CD-TLR), and CD-TVR as well as Rutherford category, resting ankle-brachial index (ABI), and functional status. A univariate analysis determined any correlation between baseline variables and TLR. Results: The observed composite percentage of MAEs was 2.3%, well below the 17% performance goal (p<0.001). Of the 134 patients in the per protocol analysis, 107 (80%) completed the study. The 1-year Kaplan-Meier estimate of primary patency was 94.5% and assisted primary patency was 99.0%. The estimate of freedom from TLR per-lesion/vessel was 97.6% at 9 months and 91.2% at 3 years. The 9-month estimate of freedom from CD-TLR was 98.6% and the 3-year estimate was 98.1%. The 3-year mean resting ABI was 0.93±0.19, an improvement of 0.17±0.26 from baseline (p<0.001). At 3 years, 82 patients (92.1%) improved ≥1 Rutherford category from baseline, and 77 patients (86.5%) maintained or improved upon their baseline functional status. Conclusion: The VBX Stent-Graft is a robust and durable treatment option for aortoiliac occlusive disease as evidenced by the sustained 3-year safety and effectiveness outcomes.

Commentary: Excellent Midterm Results for the Viabahn Balloon-Expandable Endoprosthesis in Iliac Lesions

“…Device effectiveness at midterm was encouraging for the vast majority of lesions treated; in fact, the TLR rates at 3 years were similar between TASC A/B and C/D lesions. 1 Furthermore, these results are also confirmed by the significant clinical improvement reported for this cohort both in terms of ankle-brachial index (p<0.001) and Rutherford category (92.1% ≥1 at 3 years) improvement from baseline.…”

“…In the October 2020 issue of the JEVT , Panneton et al 1 present the midterm safety and effectiveness of the Viabahn Balloon-Expandable (VBX) Endoprosthesis (W.L. Gore & Associates, Flagstaff, AZ, USA) for the treatment of aortoiliac occlusive disease.…”

“…These investigators now report in the present study the 3-year results from the same patient population to assess safety and efficacy of the VBX Stent-Graft at midterm. 1…”

Clinical outcomes of endovascular procedure using VIABAHN® VBX covered stent in complex aortoiliac artery disease: Result from AVOCADO study

“…The estimate of freedom from TLR per-lesion/vessel was 91.2% at 3 years, and 98.1% of the patients did not require CD-TLR for 3 years. 18 The outcomes of the AVOCADO study compared favorably with other VBX studies. From our study, the high rate of IVUS usage (74%) and high rate of larger sized balloon usage post dilatation was reported (aorta 73%, iliac 80%), which reflects on the scope for improvement of the clinical outcomes.…”

“…This study showed long‐term durability of the stent up to 3 years. The estimate of freedom from TLR per‐lesion/vessel was 91.2% at 3 years, and 98.1% of the patients did not require CD‐TLR for 3 years 18 …”