First-in-Man trial of a drug-free bioresorbable stent designed to minimize the duration of coronary artery scaffolding - Université Paris Cité
Article Dans Une Revue Journal of Biomaterials Science, Polymer Edition Année : 2021

First-in-Man trial of a drug-free bioresorbable stent designed to minimize the duration of coronary artery scaffolding

Résumé

For the last two decades, various degradable stents have been proposed to treat coronary artery diseases and replace metallic stents to avoid residual foreign material after healing. To date, the right balance between suitable scaffolding and loss of radial strength soon after endothelium restoration is still an unmet need. The present article reports on the First-in-Man trial of a drug-free bioresorbable stent based on a lactic acid stereocopolymer composed of 98% l-lactyl units selected to release stress shielding earlier than in the case of homopoly(l-lactic acid). Thirty patients with single de novo coronary lesions were included in the trial. The fate of scaffolds was monitored by clinical and imaging follow-ups to assess rate of adverse events, acute recoil, late luminal loss, and late lumen recovery. There was no death, no myocardial infarction, and no stent thrombosis observed over the 36 months trial. Dismantling occurred about 3 months after implantation. Bioresorption was almost completed at 2 years. The late lumen loss observed at the end of the first year was partly compensated one year later by enlarging remodeling. At one year, a neointimal hyperplasia slightly greater than for drug-eluting metallic and bioresorbable stents was shown using optical coherence tomography. The excess of hyperplasia was discussed relative to struts thickness, absence of anti-proliferative drug, and release of degradation by-products.
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Dates et versions

hal-03239618 , version 1 (27-05-2021)

Identifiants

Citer

Jean Fajadet, Marco Mennuni, Didier Carrié, Paul Barragan, Pierre Coste, et al.. First-in-Man trial of a drug-free bioresorbable stent designed to minimize the duration of coronary artery scaffolding. Journal of Biomaterials Science, Polymer Edition, 2021, pp.1-16. ⟨10.1080/09205063.2021.1910919⟩. ⟨hal-03239618⟩
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