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BVS show promise in peripheral arteries, but challenges remain
HOLLYWOOD, Fla. — Recent data show that bioresorbable vascular scaffolds may be able to successfully treat lesions in peripheral arteries, but more research is needed and many hurdles remain, an expert said at the International Symposium on Endovascular Therapy.
“There are works in progress, but all remain unrealized potential benefits,” said Michael D. Dake, MD, Thelma and Henry Doelger Professor of Cardiovascular Surgery and medical director of the catheterization and angiography laboratories at Stanford Health Care.
Interest in BVS technology for treatment of superficial femoral artery (SFA) disease was heightened after the publication of the single-arm ESPRIT I trial, in which a BVS (Esprit BVS, Abbott Vascular) showed positive outcomes at 3 years (freedom from clinically driven target lesion revascularization = 91.1%), with no events occurring between 2 and 3 years, he said.
“Three-year results in a first-in-man clinical evaluation confirm earlier data demonstrating safety and feasibility of everolimus-eluting bioresorbable scaffold treatment of SFA and iliac lesions,” Dake said. “Low event rates are further reduced when the vessel diameter is appropriately sized for the scaffold.”
Research is also underway to test a BVS in below-the-knee lesions, he said, noting that in a study of 22 patients, the rate of procedural success was 100%, the rate of clinical improvement at 6 months was 88%, the rate of primary patency at 6 months was 94.4% and the rate of TLR at 6 months was 5.6%.
Encouraging factors include that the materials used in BVS are already used in medical platforms and are well-known to the FDA, and that “non-metallic stents are a better solution for a challenging vascular segment — the SFA,” he said. “They provide minimal resistance to arterial movement and natural vessel motion is not inhibited. They allow the vessel to relax to its native state. They permit tunable radial strength, flexibility, conformability and resistance to coil. They enable single or combination drug loading. And they do not preclude or complicate re-intervention options.”
However, he said, current materials used in BVS have suboptimal flexibility, radial force, conformability and accommodation to arterial motion.
“The ideal award-winning SFA stent recipe may be unobtainable with currently available ingredients because there is limited opportunity to manipulate radial force, flexibility and dissolution kinetics independently,” he said. “We end up shorting each variable to create an acceptable compromise: passable, but not super. There are also unresolved questions of acute fracture resistance and safety.” – by Erik Swain
Reference:
Dake MD. Biodegradable or absorbable devices: What is the future? Presented at: International Symposium on Endovascular Therapy; Feb. 4-8, 2017; Hollywood, Fla.
Disclosure: Dake reports consulting for Cook Medical and Novate Medical and serving on an advisory board for W.L. Gore & Associates.