First‐in‐man study of a thinner‐strut sirolimus‐eluting bioresorbable scaffold (FUTURE‐I): Three‐year clinical and imaging outcomes

Abstract Objectives The FUTURE‐I study aimed to assess preliminary safety and effectiveness with the long‐term clinical and imaging follow‐up for the Firesorb (MicroPort, Shanghai, China), a thinner‐strut sirolimus‐eluting bioresorbable scaffold (BRS). Background First‐generation BRS has been associated with unexpected device‐related adverse outcomes at long‐term follow‐up. Methods In this prospective, open‐label, first‐in‐man study, patients with single de novo lesions in native coronary arteries were randomized 2:1 into two cohorts after successful Firesorb implantation: cohort 1 ( n = 30) underwent multimodality imaging assessment at 6 and 24 months; and cohort 2 ( n = 15) at 12 and 36 months. All patients underwent clinical follow‐up at 1, 6, and 12 months and annually up to 5 years. Results Between January and March 2016, 45 patients were enrolled. At 3‐year follow‐up, one patient had experienced target lesion failure and none scaffold thrombosis. In‐scaffold minimal lumen diameter decreased significantly from 6‐month to 2‐year (2.53 ± 0.24 mm vs. 2.27 ± 0.37 mm, p = .0003), and only numerically from 1‐year to 3‐year follow‐up (2.48 ± 0.28 mm vs. 2.22 ± 0.13 mm, p = .08). By optical coherence tomography, neointimal strut coverage at 3‐year follow‐up was 99.8%, and very low rate of late scaffold discontinuity was observed, only in one patient on two cross sections with three malapposed struts. Conclusions At 3‐year follow‐up of the FUTURE‐I study, implantation of the thinner‐strut Firesorb BRS appeared preliminary feasible and effective in the treatment of patients with noncomplex coronary lesions.