8.2 Bioresorbable Scaffolds for Vascular Interventions: Is it Time to Move Up or Stay BTK?

Problem Presenter: Lawrence Garcia

These proceedings summarize the educational activity of the 18th Biennial Meeting of the International Andreas Gruentzig Society held January 27 to 30, 2026, in Puerto Ayora, Santa Cruz, Ecuador.

Faculty Disclosures     Sponsors

2026 IAGS Summary Document

Statement of problem or issue

Standard endovascular treatment for above-the-knee common (CFA) and superficial (SFA) femoral artery disease has been self-expanding metallic nitinol stents.[1] The mechanical properties of nitinol in response to flexion, compression, and torsion within these arteries have made it the preferred stent material. Metal fracture, thrombosis, and restenosis have been the limiting issues with nitinol, but overall the problems have been acceptably few. A polymer-coated, drug-eluting (paclitaxel), self-expanding nitinol stent (Eluvia) was found to be remarkably effective in reducing restenosis in femoral artery lesions and maintaining primary patency over 3 years.[2]

Bioresorbable vascular scaffolds (BVS) have been available for many years to treat iliac and femoral artery lesions. However, results to date with these devices have been decidedly mixed.[3,4]

Gaps in current knowledge

Alternative stent materials to nitinol have many disadvantages, which are thought to be due to the superior ability of nitinol metal to absorb the flexion, compression, and torsion forces that exist in the iliofemoral arterial system. This is a huge knowledge gap area. In addition, long lesions, heavily calcified lesions, and in-stent restenosis are areas where the knowledge base is weak.

Possible solutions or future directions

In the arteries below the knee, an everolimus-eluting BVS was superior to balloon angioplasty alone in patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease [5]. Separately, a new polymeric, balloon-expandable, sirolimus-eluting BVS has been developed for the above the knee location and is presently undergoing clinical study.[6,7] Earlier this year (2026) the preliminary results in 20 patients with 3-year follow-up were presented at a symposium.[8] Primary patency was 100% with no stent fractures or thrombosis. The study (NCT04584632) is still ongoing and full results are awaited.

References

1. Bamdé CC, et al. Evaluation of balloon and self-expandable stents for common femoral artery stenosis. J Vasc Surg. 2025 Feb;81(2):397-407. doi: 10.1016/j.jvs.2024.09.017. Epub 2024 Sep 23. PMID: 39321897.
2. Gray WA, et al; IMPERIAL investigators. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet. 2018 Oct 27;392(10157):1541-1551. doi: 10.1016/S0140-6736(18)32262-1. Epub 2018 Sep 24. PMID: 30262332.
3. Bontinck J, et al. Treatment of the femoropopliteal artery with the bioresorbable REMEDY stent. J Vasc Surg. 2016 Nov;64(5):1311-1319. doi: 10.1016/j.jvs.2016.05.066. Epub 2016 Jul 25. PMID: 27462002.
4. Obara H, et al. Five-Year Outcomes of the Bioresorbable Peripheral Remedy Stent in the Treatment of Iliac Artery Disease. J Vasc Interv Radiol. 2023 Jun;34(6):1024-1035.e2. doi: 10.1016/j.jvir.2023.01.038. Epub 2023 Feb 16. PMID: 36806564.
5. Varcoe RL, et al; LIFE-BTK Investigators. Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease. N Engl J Med. 2024 Jan 4;390(1):9-19. doi: 10.1056/NEJMoa2305637. Epub 2023 Oct 25. PMID: 37888915.
6. Tannu M, et al. Femoropopliteal Endovascular Intervention: A Review of the Current Landscape. Circ Cardiovasc Interv. 2025 May;18(5):e014024. doi: 10.1161/CIRCINTERVENTIONS.124.014024. Epub 2025 Apr 25. PMID: 40276857.
7. El Khoury R, et al. The Efemoral Vascular Scaffold System (EVSS): A Novel, Resorbable, Sirolimus-eluting Device for Percutaneous Peripheral Intervention (PPI). J Vasc Surg 2024;80:e68-e69.
8. Available at: www.prnewswire.com/news-releases/efemoral-medical-reports-exceptional-long-term-efemoral-i-results-highlighting-durability-and-differentiated-performance-in-femoropopliteal-disease-302747762.html. Accessed May 5, 2026.