Three-year data for Elixir Medical’s Desolve novolimus-eluting bioresorbable scaffold indicate that the device is associated with a low overall major adverse cardiac events rate and sustained lumen gain. The results were from the DESolve Nx international pivotal clinical trial for the CE Marked device and were presented at the 2015 Transcatheter Cardiovascular Therapeutics meeting (TCT; 11–15 October, San Francisco, USA).
At 36 months, DESolve continued to show a low overall MACE (rate (8.2%) with no definite stent thrombosis, no acute myocardial infarction after six months and no visible struts at 36 months. In terms of efficacy, the early lumen gain seen at six months was sustained through three years and quantitative coronary angiography (QCA) showed no additional significant late lumen loss. Neointimal suppression was also sustained at 18 and 36 months, with no significant late target lesion revascularisation.
Alexandre Abizaid (The Instituto Dante Pazzanese de Cardiologia, Brazil) and co-Principal Investigator of the DESolve Nx Trial, presented the results at TCT. He says: “The golden tube continuation from 18 through 36 months, with plaque regression and the restoration of the vessels to their normal physiologic condition, clearly reinforces the advantage of DESolve over other modes of treatment, and expands its potential for evaluation in new clinical indications.”
The Desolve Nx pivotal trial enrolled 126 patients at 13 centres in Europe, Brazil and New Zealand. At six months, the scaffold demonstrated excellent mean late lumen loss of 0.20±0.32mm as measured by QCA. Intravascular ultrasound imaging results demonstrated a statistically significant increase of 9% in the lumen area between post procedure and six-month follow-up with no late acquired incomplete scaffold apposition (ISA). Optical coherence tomography imaging results demonstrated an impressive 99% strut coverage with a thin and uniform 0.10mm neointimal layer and confirmed no late acquired ISA.