Prospective, multi-center evaluation of the desolve NX novolimus-eluting bioresorbable coronary scaffold: principal clinical and imaging endpoints

Background and aims: Bioresorbable vascular scaffolds represent an exciting advance in percutaneous coronary intervention (PCI), providing an initial coronary scaffold which are eventually resorbed by the body. The DESolve Nx BCSS is a novel drug eluting bioresorbable vascular scaffold that combines a PLLA-based scaffold coated with a biodegradable polylactide-based polymer and the drug Novolimus, a macrocyclic lactone mTOR inhibitor which has demonstrated potent anti-proliferative properties in previous clinical trials using Elixir's metallic Novolimus-eluting coronary stents. The drug dose is 5 mcg per mm of scaffold length and is available in three diameters (3.0, 3.25 and 3.5) and two lengths (14 and 18 mm). The DESolve NX study is a prospective, multicenter evaluation of the safety and efficacy of the DESolve™ Nx Novolimus-Eluting Bioresorbable Coronary Scaffold (BCSS) in patients with single de novo native coronary artery lesions through clinical endpoints and multiple imaging modalities. Methods and results: 126 patients with single, de novo coronary artery lesions were enrolled in this prospective, multi-center, single-arm study. Those patients receiving the study device are being analysed for multiple clinical endpoints including: Device and Procedure Success; Major Adverse Cardiac Events (MACE), a composite endpoint of cardiac death, target vessel MI, or clinically-indicated target lesion revascularization (CI-TLR); Clinically-indicated Target Lesion and Target Vessel Revascularization, (CI-TVR) and Stent Thrombosis assessed at 1, 6 and 12 months and annually to 5 years. All patients underwent angiographic assessment at 6 months and a subset of patients underwent IVUS and OCT assessment at 6 months. Additional imaging analyses will be conducted in the subset of patients at 12 months using MSCT and at 24 months using Angiography, IVUS and OCT to assess the long-term scaffold, lesion and vessel characteristics. Device Success and Procedure Success were 95.2% and 100% respectively demonstrating the feasibility and initial safety of this novel device. Conclusion: The DESolve™ Nx Novolimus-Eluting BCSS demonstrated initial safety and efficacy in this study. A first report of the principal clinical and imaging outcomes through 6 months will be presented.