Novel bioabsorbable scaffold for tibial vessels safe in first-in-human study
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Key takeaways:
- A novel bioresorbable scaffold was safe at 6 months in a first-in-human study in patients with stenosis in the tibial vessels.
- The rate of restenosis was low and wound status improved.
A novel bioabsorbable scaffold for tibial vessels was safe and associated with a low rate of restenosis in patients with Rutherford class 3, 4 or 5 peripheral artery disease, according to the results of a first-in-human study.
Marianne Brodmann, MD, substitute head of the division of angiology, Medical University Graz, Austria, presented the 6-month results from the RESOLV first-in-human single-arm study of the sirolimus-eluting scaffold (Magnitude, R3 Vascular) at VIVA.23.
“We all know the challenges of below-the-knee lesions; we have a high restenosis rate and we do not have a fixed treatment algorithm so far,” Brodmann said during a presentation. “The ideal achievement would be a drug on this technology, if we have a scaffold that minimizes recoil and if there is a leave-nothing-behind strategy. Bioresorbable scaffolds will for sure be in the future, especially in the below-the-knee space, one of the most valuable tools we have to treat our patients in an ideal way.”
The cohort included 22 patients with Rutherford class 5 (mean age, 76 years; 86% men), three patients with Rutherford class 4 (mean age, 76 years; 67% men) and five patients with Rutherford class 3 (mean age, 79 years; 80% men).
Between baseline and 6 months, in the Rutherford class 5 group, mean lumen diameter improved from 0.7 mm to 2.2 mm and percent diameter stenosis improved from 78.4% to 28.8%; in the Rutherford 4 group, mean lumen diameter improved from 0.7 mm to 2.6 mm and percent diameter stenosis improved from 77.7% to 20.5%; and in the Rutherford 3 group, mean lumen diameter improved from 0.7 mm to 2.5 mm and percent diameter stenosis improved from 80.1% to 23%, Brodmann said.
At 6 months, 81% of the overall cohort achieved Rutherford class 0, and wound status in the Rutherford 5 cohort improved by 77%, she said.
The primary safety endpoint of freedom from perioperative death and major adverse limb events at 6 months was achieved in all patients, whereas the primary performance endpoint of freedom from binary restenosis by angiography or freedom from absence of flow by duplex ultrasound at 6 months was achieved in 90% of the Rutherford 5 cohort and all of the patients in the Rutherford 3 and 4 cohorts, Brodmann said.
“Drug-eluting bioresorbable scaffolds may provide all the advantages of metallic DES without a permanent implant,” she said during the presentation. “The R3 Vascular scaffold has significant biomechanical properties: High radial force with the flexibility of self-expandable stents and no fracture with overexpansion and no recoil. Our preliminary BTK territory data is promising, with a low rate of observed restenosis at 6 months.”
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Brodmann M, et al. Late-breaking clinical trials. Presented at: VIVA 23; Oct. 30-Nov. 2, 2023; Las Vegas (hybrid meeting).
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