Aims: The study sought to investigate clinical and multimodality imaging assessment of a bioresorbable sirolimus-eluting scaffold (NeoVas, Lepu Medical, Beijing, China) for patients with single de novo coronary artery lesions.
Methods and results: The NeoVas first-in-man study was a prospective, open-label study which enrolled 31 patients with single de novo lesions treated with a bioresorbable sirolimus-eluting scaffold. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation (TLR). Angiography, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging were performed at baseline and six months. Procedural success and device success were 100% (31/31 patients). At six months, the rate of TLF was 3.2%, with only one patient having clinically indicated TLR. No scaffold thrombosis was observed. The angiographic six-month in-scaffold late loss was 0.26±0.32 mm. The minimal scaffold area decreased from 7.11±1.56 mm2 post procedure to 6.74±1.38 mm2 at six months, as measured by IVUS. The OCT results showed that the neointimal hyperplasia area was low (1.56±0.46 mm2), with a high proportion of scaffold strut coverage (95.7%).
Conclusions: This first-in-man study shows feasibility, promising clinical and multimodality imaging results up to six months for the NeoVas bioresorbable sirolimus-eluting scaffold in the treatment of patients with simple de novo lesions, with an acceptable in-scaffold late loss, low neointimal hyperplasia, and a high percentage of scaffold strut coverage.