Six-month intravascular ultrasound analysis of the DESolve FIM Trial with a novel PLLA-based fully biodegradable drug-eluting Scaffold

Abstract

Background: The DESolve Bioresorbable Coronary Scaffold is a novel drug-eluting device combining a PLLA-based scaffold coated with a bioresorbable polylactide-based polymer and the drug Myolimus. Myolimus, a macrocyclic lactone mTOR inhibitor, has demonstrated potent anti-proliferative properties in two First-in-Man (FIM) trials using Elixir's metallic coronary stents. The drug dose is 3 mcg per mm of scaffold length. We aimed to present the IVUS results of the first-in-man evaluation of this novel scaffold. Methods: The DESolve FIM trial enrolled 15 patients, treated with a single 3.0x14 mm DESolve at 3 centers. IVUS was performed at the end of the procedure and repeated at six-month invasive follow-up. Complete and adequate IVUS images at baseline and follow-up were obtained for 11 cases. Serial changes in vessel volume, scaffold area and the degree of NIH formation were assessed. All analyses were performed by an independent core laboratory. Results: From baseline to 6 months, IVUS showed a small increase in scaffold mean area (from 5.35±0.78mm2 to 5.61±0.81mm2). Additionally, there was no significant change in vessel volume (from 148.0±37.0 mm3 to 150.03±35.38 mm3) or area, demonstrating the absence of constrictive or expansive remodelling. There was very low neointimal volume (5.6±2.8 mm3) and % scaffold obstruction (7.18±3.37%) and no cases of incomplete strut apposition. Also no scaffold discontinuity (e.g.: fracture) was observed in this sample. Conclusions: The DESolve scaffold demonstrated a unique property of expansion and no chronic recoil from baseline to follow-up. Results at 6 months showed effective neointimal suppression and no late strut malapposition thus suggesting a very efficacious and novel bioresorbable scaffold.