Circ Cardiovasc Interv. 2026 Jan 29:e016191. doi: 10.1161/CIRCINTERVENTIONS.125.016191. Online ahead of print.
ABSTRACT
BACKGROUND: The DynamX bioadaptor, a novel coronary implant, is designed to restore vessel function when the thin polymer coating covering the helical strands resorbs 6 months post-percutaneous coronary intervention. We aimed to evaluate vessel conformability 1 year after percutaneous coronary intervention with the bioadaptor, compared with conventional drug-eluting stents (DESs).
METHODS: Vessel segments were 1:1 randomized to a novolimus-eluting bioadaptor or a durable polymer novolimus-eluting second-generation DES. Coronary computed tomography angiography was performed at 1 and 12 months post-implantation, and the 3-dimensional geometry of the treated segments in coronary computed tomography angiography was analyzed. The primary outcome was the change in dynamic vessel geometry, including curvature flexibility (bending motion), torsion flexibility (twisting motion), and path flexibility (3-dimensional motion) of the treated segment during the cardiac cycle.
RESULTS: A total of 48 vessel segments in 48 patients were randomized, with 24 receiving bioadaptor and 24 receiving DES. In within-group paired analyses, the bioadaptor group showed a significant improvement in torsion flexibility from 1 to 12 months, whereas no significant change was observed in the DES group. Although curvature and path flexibility increased numerically in the bioadaptor group, these within-group differences were not statistically significant. However, when comparing the magnitude of change between groups, the increase in path flexibility was significantly greater with the bioadaptor than with DES, indicating a superior restoration of 3-dimensional vessel motion.
CONCLUSIONS: The novel bioadaptor technology demonstrated favorable restoration of 3-dimensional dynamic geometry of the treated vessel segment 12 months after implantation, in comparison with traditional DES. These initial mechanistic findings suggest a potential explanation for the favorable clinical outcomes observed in prior trials, and our analytical approach may offer new insights to guide future vascular implant designs and evaluations.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04936191.
PMID:41608781 | DOI:10.1161/CIRCINTERVENTIONS.125.016191
