HOLLYWOOD, Fla. — Approved by the FDA in late January, the first balloon-expandable stent graft with an indication for iliac occlusive disease performed well at 9 months in complex lesions; it is a valuable treatment in the management of that disease, a speaker said at the International Symposium on Endovascular Therapy.
In the week leading up to ISET 2017, W.L. Gore and Associates announced FDA approval of the Gore Viabahn BVX Balloon Expandable Bioprosthesis for treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation.
During a presentation here, Jean Bismuth, MD, associate professor of cardiovascular surgery, Houston Methodist Hospital, DeBakey Heart and Vascular Center, presented 9-month outcomes of the prospective, single-arm VBX FLEX Investigational Device Exemption clinical trial.
In total, investigators enrolled 134 patients at 27 centers, in whom 234 devices were implanted in 213 lesions in 201 limbs. Eligible patients were in Rutherford class 2-4, had unilateral or bilateral disease, total occlusions, severe lesion calcification, tortuous iliacs, kissing stent treatment or need for direct stenting without predilatation. One-third of patients presented with TransAtlantic Inter-Society Consesus (TASC) II type C/D lesions and 42% needed kissing stents at aortic bifurcation.
The primary endpoint was a composite of major adverse events including device- or procedure-related death within 30 days, MI within 30 days, target lesion revascularization within 9 months or amputation above the metatarsals. In 132 patients, the rate of major adverse events was 2.3% (P < .001).
Examined separately, there were no cases of death and MI within 30 days and no need for amputation within 9-month follow-up. TLR was reported in three patients (2.3%). In the kissing-stent group (n = 57), the rate of major adverse events was 3.5%.
Bismuth also presented results of additional analyses at 9 months at ISET 2017. The rate of primary patency in 157 lesions was 96.9% at 9 months, including 95.3% for patients with TASC II C/D lesions. Freedom from TLR was 97.4%. Almost 95% of patients experienced improvement in Rutherford class from preprocedure through 9 months. Quality of life also improved, with participants doubling their walking distance, walking speed and stair-climbing scores at 9 months compared with baseline.
The stent graft was linked to a 100% technical success rate (successful delivery and ≤ 30% residual stenosis) and a 97% acute procedural success rate. Four patients experienced procedure-related serious adverse events that were resolved. Moreover, there was no change in median length of the device upon deployment (mean change, –0.05 mm).
“[These data prove] efficacy and safety of the VBX stent graft for the treatment of iliac occlusive disease. Nine-month patency data, plus inclusion/exclusion criteria, plus unique product features make the VBX stent graft a valuable treatment in the management of iliac occlusive disease. The VBX stent graft performed well in disadvantaged and complex lesions, which supports trackability, radial strength, conformability and stent retention,” Bismuth said during the session.
Follow-up in the VBX FLEX study continues. Patients will be followed out to 3 years, according to Bismuth. – by Katie Kalvaitis
Bismuth J. Concurrent Session VI: Late-Breaking Trials and Hot Topics. Session Title. Presented at: International Symposium on Endovascular Therapy; Feb. 4-8, 2017; Hollywood, Fla.
Disclosure: Bismuth reports consulting and speaking for W.L. Gore and Associates.