A multicenter post‐marketing evaluation of the Elixir DESolve® Novolimus‐eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study

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Abstract
Objectives: To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post‐marketing clinical follow‐up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease.Background: The DESolve BRS combines a poly‐l‐lactide‐based backbone with a biodegradable polylactide‐based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor.Methods: One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post‐procedural angiographic assessment was performed, and a device‐oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined.Results: 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 a DESolve BRS. Post‐procedural angiographic assessment indicated an in‐scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device‐oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths.Conclusions: Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long‐term prospective studies are needed.

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