Author + information
- 1University of Giessen, Giessen, Germany
- 2Interventional Cardiology Institute San Raffaele Hospital, Milan, Milan, Italy
- 3Elixir Medical, sunnyvale, California, United States
- 4Elixir Medical Corporation, Milpitas, California, United States
- 5Medical Devices Consultancy, Christchurch, New Zealand
- 6San Raffaele Scientific Institute, Milan, Italy
Bioresorbable scaffolds are an equivalent alternative to metallic drug-eluting stents for the treatment of coronary artery lesions, but experience with other than Everolimus-eluting PLLA-based scaffolds is limited. 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 (Elixir Medical, Sunnyvale, CA), a drug-eluting bioresorbable scaffold combining a PLLA-based backbone coated with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor.
A total of 100 patients with stable coronary artery disease were treated with a DESolve scaffold in de novo coronary artery lesions with a reference vessel diameter between 2.25 and 3.5 mm and treatable with a single scaffold between 14 and 28 mm in length. Patient data was analyzed for the occurrence of clinical endpoints including major adverse cardiac events (MACE) defined as cardiac death, target vessel MI, clinically-indicated target lesion revascularization, and stent thrombosis at 24 months.
A total of 102 DESolve scaffolds were analyzed. The mean age of the patients was 62.0±12.9 years, 77.5% were male. Hypertension was present in 86.3%, 25.5% were diabetics. The lesion morphology according to the AHA/ACC lesion class B2/C was present in 50.5%. Predilation was performed in 89.9%, and postdilation in 81.7%, respectively. The MACE rate at 24 months was 4.0%. Target lesion revascularization and definite/probable scaffold thrombosis occurred in 3% and 1.0%, respectively, with no reported late scaffold thrombosis.
The DESolve post-marketing clinical follow-up study shows efficacy of the DESolve scaffold after 24 months with a very low event rate. Thus, the DESolve scaffold can be considered as a reasonable alternative for an effective treatment of coronary artery lesions. However, this has to be confirmed by larger randomized trials and long-term data is needed.
CORONARY: Stents: Bioresorbable Vascular Scaffolds