Postmarket Study Published on Elixir Medical's DESolve Bioresorbable Scaffold
November 27, 2018—Twelve-month results from the multicenter postmarket clinical follow-up study of the DESolve novolimus‐eluting bioresorbable coronary scaffold system (Elixir Medical Corporation) were published by Holger Nef, MD, et al in Catheterization and Cardiovascular Interventions (2018;92:1021–1027). The investigators concluded that the DESolve bioresorbable scaffold (BRS) is a safe and effective treatment for coronary lesions in patients with stable coronary artery disease.
According to the investigators, the DESolve BRS combines a poly‐L‐lactide–based backbone with a biodegradable polylactide‐based polymer and novolimus, a macrocyclic lactone mTOR inhibitor.
The study enrolled 102 patients (mean age, 62 years; 77.5% men) at 10 European sites. Investigators performed a comparison of baseline and postprocedural angiographic assessments. Additionally, they examined a device‐oriented composite endpoint (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months.
As reported in Catheterization and Cardiovascular Interventions, the device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with the DESolve BRS. Postprocedural angiographic assessment indicated an in‐scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in percent diameter stenosis from 61.00% ± 11.29% to 12.69% ± 0.44%.
At 12 months, the device‐oriented composite endpoint had occurred in 3% (3/100) of patients, with 1% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3% (3/100) undergoing target lesion revascularization. There were no cardiac deaths.
Larger long‐term prospective studies are needed, advised the investigators in Catheterization and Cardiovascular Interventions.