Five-year data on GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis “raise the bar” in aortoiliac occlusive disease therapy

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Andrew Holden

At this year’s Charing Cross (CX) International Symposium (25–27 April, London, UK), Andrew Holden (Auckland City Hospital, Auckland, New Zealand), presented results from the longest follow-up study to date evaluating the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft; Gore) in aortoiliac occlusive disease (AIOD). Here, he details how these new data “raise the bar” for durable, robust AIOD treatments.

AIOD is an “increasingly common problem”, Holden asserts, with around a third of all peripheral arterial disease (PAD) cases involving the iliac arteries. Discussing the backdrop to the VBX FLEX Clinical Study, he notes that—with endovascular treatments growing in prevalence over the past 15 years—balloon-expandable covered stents represent a “very appealing” option for this indication, theoretically providing lower rates of serious complications as well as improvements in long-term patency outcomes.

Results from the original VBX FLEX Study appeared to bear out these benefits, with the VBX Stent Graft demonstrating high one-year rates of primary (94.5%), primary-assisted (99%) and secondary (99.5%) patency, in addition to a 98.1% rate of freedom from clinically driven target lesion revascularisation (fCD-TLR) at three years. However, in an attempt to further elucidate the durability of these positive findings, Holden led a physician-initiated follow-up in a subset of these patients out to five years.

“The concept of durable patency in aortoiliac disease is really important,” he says. “The vast majority of these patients are ‘claudicants’ [who] have a much longer life expectancy than patients with critical limb ischaemia—often living for 10 years or longer—so durability of treatment is something that has come into focus. But, until recently, we really had very little useful information on how durable these covered stents are, in particular in the iliac arteries.”

The five-year follow-up with the VBX Stent Graft saw 59 patients enrolled from the original study’s three highest-participating centres—Holden’s own centre in Auckland, as well as Prisma Health (Greenville, USA) and Wellmont Holston Valley Medical Center (Kingsport, USA). A total of 28 patients completed the five-year follow-up and could be assessed as per the study’s primary durability endpoint of long-term primary patency. An important detail Holden highlights here is that this patient cohort was representative of the full spectrum of disease seen in AIOD patients, with about one third of patients having more complex lesions (Trans-Atlantic Inter- Society Consensus [TASC] C or D).

Arriving at the crux of the study’s findings, he reports sustained long-term durability with the VBX Stent Graft, indicated by an “excellent” 84.4% primary patency rate per subject, and an 89.5% primary patency rate per lesion (n=94)—an “incredible, unrivalled performance”—at five years.

“To put that into context, there had only been one other publication reporting five-year patency—74.7% with the iCAST/Advanta V12 [Getinge] in COBEST,” Holden states, “so to really raise the bar and report a patency of 89.5% was extremely pleasing.”

He goes on to note that the per-subject primary-assisted and secondary patency rates were the same (93.3%) at five years, as was the per-lesion rate (96.1%) for both. Additionally, there was a five-year, per-subject fTLR rate of 89.1%—also a “very high figure”, according to Holden—and 12 deaths (20.3%), none of which were found to have been device-related. Finally, he outlines sustained improvements in Rutherford classification scores and walking impairment, as well as on quality-of-life questionnaires.

“For these patients, we hope to provide a durable treatment, and it is very difficult to imagine any treatment for aortoiliac disease that could achieve superior patencies to this—particularly a minimally invasive therapy like an endovascular covered stent,” Holden concludes. “To be able to tell patients they are going to get a durable patency, and the vast majority will never need to have another intervention related to this treatment; those are the most compelling outcomes for me.”

The CX Symposium also saw Holden announce a “very exciting” next step in evaluating the VBX Stent Graft: a multicentre randomised controlled trial, with long-term follow-up, comparing the device to bare metal stenting in complex iliac occlusive disease.


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