Author + information
- Stefan Verheye1,
- Joachim Schofer2,
- Michael Maeng3,
- Carsten Skurk4,
- Roberto Botelho5,
- J. Ribamar Costa Jr.6,
- Daniel Chamie7,
- Juliana Castro8,
- Andrea Abizaid7,
- John Yan9,
- Lynn Morrison10,
- Vinayak Bhat9,
- Sara Toyloy9 and
- Alexandre Abizaid7
- 1Cardiovascular Center ZNA Middelheim, Antwerp, Belgium
- 2Medical Care Center Prof. Mathey, Prof. Schofer and Albertinen Heart Center, Hamburg, Hamburg, Germany
- 3Aarhus University Hospital, Aarhus, Denmark
- 4Department of Cardiology, Charite medical University, Campus Benjamin Franklin, Berlin, Berlin, Germany
- 5Triangulo Heart Institute, Uberlândia, Minas Gerais, Brazil
- 6Instituto Dante Pazzanese, Sao Paulo, São Paulo, Brazil
- 7Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil
- 8CRC, São Paulo, São Paulo, Brazil
- 9Elixir Medical Corporation, Milpitas, California, United States
- 10Elixir Medical, sunnyvale, California, United States
The DESolve Nx study is a multi-center evaluation of the safety and efficacy of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System (NEBCSS) in patients with single, de novo, native coronary artery lesions.
The DESolve® NEBCSS is a novel drug-eluting bioresorbable scaffold (BRS) combining a PLLA-based scaffold coated with Novolimus, a macrocyclic lactone mTOR inhibitor and differentiates itself from other BRS with a shorter bioresorption time [>90% reduction in molecular weight within 6 months with near complete bioresorption by 1 year (∼70% mass loss) in preclinical studies], while offering high expansion capacity without strut fracture. The drug dose is 5 μg per mm of scaffold length and was available in multiple diameters (2.5 – 3.5 mm) and lengths (14, 18 and 28 mm). A total of 126 patients were enrolled in this prospective registry. Patients receiving the study device were 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), the individual components of MACE and stent thrombosis at 1, 6 months and annually to 5 years. All patients were to undergo angiographic assessment at 6 months; a subset of patients also underwent IVUS and OCT assessment at 6 months and multislice computed tomography (MSCT) imaging 12 months. Additionally, at two separate single centers, multi-modality imaging was completed at 18 months and 3 years.
Six-month QCA demonstrated low mean in-scaffold late lumen loss (0.20 mm), 18 %DS and an MLD of 2.44 mm. Serial IVUS at baseline and 6 months demonstrated a significant increase in mean lumen (Δ 9.8%, p = < 0.001) and scaffold areas (Δ 15.7%, p = < 0.001). Serial OCT demonstrated a significant increase in scaffold area (Δ 16.1 %, p = < 0.001) with 98.8% neointimal coverage of the scaffold at 6 months. Twelve-month MSCT demonstrated lumen maintenance from 6 to 12 months. QCA at 18 months shows minimal lumen change and 3 year OCT imaging reveals the “golden tube” indicating complete resorption of the scaffold. Clinical events remained low (MACE = 5.7%, 7.4%, 8.2% and 9.0% at 12, 24, 36, 48 months respectively) with no reports of definite scaffold thrombosis.
DESolve demonstrated safety and efficacy with low late lumen loss. Serial imaging indicated early vessel restoration at 6 months. Through 48 months, the clinical event rates remain low. Full imaging data from 6, 18 and 36 months as well as final 5-year clinical results will be presented.
CORONARY: Bioresorbable Vascular Scaffolds