Bioabsorbable scaffold benefits high-risk patients with infrapopliteal disease
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In a pooled analysis of three single-center studies, a bioresorbable scaffold was associated with high rates of patency and low rates of adverse events at 2 years in high-risk patients with infrapopliteal artery lesions.
The 121 patients (mean age, 73 years; 57% with diabetes), all of whom were treated with the bioresorbable vascular scaffold (BVS; Absorb, Abbott Vascular), were Rutherford class 3 or higher (84% with chronic limb-threatening ischemia (CLTI); 75% with tissue loss) and had infrapopliteal artery stenosis 50% or greater or total occlusion, Steven Kum, MD, director of vascular surgery in the department of surgery, Changi General Hospital, Singapore, said during a presentation at VIVA 20.
The patients had 161 lesions in 125 limbs treated with 189 BVS. Kum said 63% of the lesions were calcified, 22% were occluded and the median stenosis was 80%. He noted all patients were prescribed dual antiplatelet therapy for 6 months after revascularization.
At 2 years, primary patency was achieved in 86.6% of patients while 96.6% were free from clinically driven target lesion revascularization and the rate of major amputation was just 1.6%, Kum said, noting the results were similar to a 1-year pooled analysis of a similar population from five centers.
The 2-year rate of overall survival was 85%, he said.
“This is the largest pooled analysis of patients with infrapopliteal vessels treated with BVS, showing results and 24 months,” Kum said during the presentation. “In CLTI, which is often plagued with low primary patency and high mortality, a BVS with drug delivery may have a role to play.”
The BVS was approved in the United States to treat CAD but was withdrawn by the manufacturer due to low sales driven by concern over stent thrombosis. A new generation of the product is in development.
“There’s less concern here with the thickness of the struts that may have been a concern in the coronaries,” Misti Malone, PhD, chief of the peripheral interventional devices branch of the FDA’s Center for Devices and Radiological Health, said during a discussion after the presentation. “So, we look at what are the benefits patients may expect vs. the risk. In the CTLI patient population, there is a very high amputation rate and often high mortality. This may offer support for them to continue walking. We think about how the device will act in that particular anatomy, in a different circulation with different lesion characteristics.”
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Kum S, et al. Late-breaking clinical trials. Presented at: VIVA 20; Nov. 6-8, 2020 (virtual meeting).
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