Abstract 18819: Multi-Center, First-In-Man Evaluation of the Myolimus-Eluting Bioresorbable Coronary Scaffold: 6-Month Clinical and Imaging Results
Aims: To evaluate the clinical safety and effectiveness of the DESolve™ Myolimus-Eluting Bioresorbable Coronary Scaffold (DESolve) in patients with single de novo native coronary artery lesions through clinical endpoints and multiple imaging modalities.
Methods and Results: Background: The DESolve Bioresorbable Scaffold is a novel drug eluting device that combines 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 Myolimus-eluting coronary stents. The drug dose is 3 mcg per mm of scaffold length; the same dose as used as in the FIM studies. Sixteen patients with single, de novo coronary artery lesions were enrolled in this prospective, multi-center, single-arm FIM study. One patient did not receive a study stent and was deregistered. The 15 remaining patients are being analysed for multiple clinical endpoints: Device and Procedure Success; Major Adverse Cardiac Events (MACE), a composite endpoint of cardiac death, target vessel MI, and 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. Multiple assessments by angiographic, IVUS and OCT at 6 months were completed. An additional analysis using multislice computed tomography (MSCT) will be completed at 12 and 24 months. At 6 months, the in-scaffold late lumen loss was 0.19 ± 0.19 by QCA, the % volume obstruction was 7.18 ± 3.37 by IVUS, and by OCT 98.68 ± 2.44% of struts were demonstrated as covered. There was one MACE, event, a TLR, during the follow-up period. Detailed clinical and imaging results through 6 months will be presented.
Conclusion: The DESolve™ Myolimus-Eluting Bioresorbable Coronary Scaffold demonstrated both excellent safety and effectiveness in this FIM study, thus warranting further clinical evaluation of the novel technology in larger clinical studies. Detailed clinical and imaging results through 6 months will be presented.
- © 2012 by American Heart Association, Inc.