Adaptive Coronary Artery Rotational Motion Through Uncaging of a Drug-Eluting Bioadaptor Aiming to Reduce Stress on the Coronary Artery.

Background: Caged drug-eluting stents impede natural coronary rotational motion and increase vessel stress, which can contribute towards adverse events. The DynamX™ Drug-Eluting Bioadaptor is a cobalt‑chromium platform with a novel mechanism that uncages the vessel after the bioresorbable coating resorbs over six months. This study aimed to analyze the effects of the rotational uncaging in a finite element analysis (FEA) model, validating its effect on coronary artery rotational motion through in-vivo stationary intravascular ultrasound (IVUS).

Methods: Maximum Von Mises stresses were measured in an FEA model and compared for caged and uncaged bioadaptors. Stationary IVUS images from 20 patients enrolled in a single center were acquired post implantation and at 9-12-month follow-up to evaluate coronary artery rotational motion.

Results: The FEA model showed that rotational uncaging of the bioadaptor reduces peak stress by 70%. In-vivo, the in-bioadaptor segment was significantly distorted post-implant compared to the native distal and proximal vessel, measured by IVUS: The sum of clockwise and counterclockwise rotational motion (net-effect rotational motion) was -2.7 ± 4.3° versus 0.5 ± 5.0° (proximal vessel), p = 0.036, and versus 0.2 ± 3.8° (distal vessel), p = 0.042. At follow up, when the bioadaptor had uncaged, the vessel returned towards its equilibrium (net-effect rotational motion -0.2 ± 5.6°), with no significant difference between the vessel segments.

Conclusions: In concurrence with the FEA observation, the in-vivo IVUS-analysis demonstrates that uncaging of the bioadaptor affects coronary artery rotational motion. The effect of these findings on reducing clinical events warrants further investigation.