Author + information
- Holger Nef1,
- Karl Eugen Hauptmann2,
- Azeem Latib3,
- Lynn Morrison4,
- Sara Toyloy5,
- Lynn Vandertie6 and
- Antonio Colombo3
- 1Universitaetsklinikum Giessen, Giessen, Germany
- 2Trier, Germany
- 3Interventional Cardiology Institute San Raffaele Hospital, Milan, Italy
- 4Elixir Medical, sunnyvale, California, United States
- 5Elixir Medical Corporation, Sunnyvale, California, United States
- 6Medical Devices Consultancy, Christchurch, New Zealand
A post marketing clinical follow-up study was conducted evaluating the continued safety and effectiveness of the CE-mark approved DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System (NEBCSS) (Elixir Medical, Sunnyvale, CA). DESolve is a drug-eluting, fully bioresorbable scaffold combining a PLLA-based scaffold backbone with a coating of polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor. The drug dose is 5 μg per mm of scaffold length.
A total of 100 patients were treated with the DESolve NEBCSS in de novo, native coronary artery lesions with a reference vessel diameter between 2.25 and 3.5 mm and treatable with a single scaffold. Available diameters were 2.5, 3.0, 3.25 and 3.5 and lengths were 14, 18 and 28 mm. Patient data for the clinical endpoints of major adverse cardiac events (MACE) defined as: cardiac death, target vessel MI, clinically-indicated target lesion revascularization (TLR); target vessel revascularization and stent thrombosis are to be analyzed at 1, 6, 12 months and annually through 5 years. The study was approved by the local Ethics Committees and all patients provided informed consent.
Patients were enrolled over a one year period at 10 sites in Germany, and Italy. After the index procedure, patients were contacted at 1, 6 and 12 months either via an office visit or telephonically. The mean age of patients was 62 years; 25.5% were diabetics, 76.5% presented with hypercholesterolemia, 86.3% with hypertension and 15% had unstable angina. Baseline lesion characteristics revealed 50.5% of lesions were type C; the mean reference vessel diameter was 3.0 ± 0.4 mm and lesion length of 17.3 ± 8.7 mm. Clinically, the DESolve NEBCSS demonstrated excellent safety with only two clinical events reported through 6 months (2.0% MACE) with continued low MACE rates through the 12-month follow-up period. Full demographic, lesion and clinical data through 12 months will be presented.
The DESolve NEBCSS continues to demonstrate excellent clinical safety similar to the clinical safety results seen in the pivotal DESolve Nx Study. Demographic, lesion and clinical results through 12 months will be presented.
CORONARY: Bioresorbable Vascular Scaffolds