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

Panneton JM, Bismuth J, Gray BH, Holden A. Three-year follow-up of patients with iliac occlusive disease treated with the Viabahn Balloon-Expandable Endoprosthesis. Journal of Endovascular Therapy. In press.

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.

 

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