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

Abstract

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.

Keywords:

• PLA98
• lactic acid-based stereocopolymer
• bioresorbable stent
• bioresorbable scaffolding
• angioplasty
• in-human degradation

Acknowledgments

The authors are indebted to Machiel van der Leest, ARTs CEO, for financial support and supply of PLA98-based bioresorbable ART–BRS, and to the various hospitals and universities the authors are belonging to that allowed concretization of this First-in-Man trial.