February 12, 2018
Lepu Medical's NeoVas Bioresorbable Scaffold Shown to Be Noninferior to Metallic Drug-Eluting Stents
February 12, 2018—Findings from a randomized controlled trial show that the NeoVas bioresorbable scaffold (BRS; Lepu Medical Technology (Beijing) Co., Ltd.) is noninferior to a cobalt-chromium everolimus-eluting stents (CoCr-EES) at the primary endpoint of 1-year angiographic in-segment late loss (LL). The data were published by Yaling Han et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2018;11:260–272).
According to researchers, the study objective was to evaluate the safety and efficacy of the NeoVas BRS because BRSs have the potential to improve very late outcomes compared with metallic drug-eluting stents. However, some BRSs have been associated with increased rates of device thrombosis before complete bioresorption. NeoVas is a new poly-L-lactic acid BRS that elutes sirolimus from a poly-D, L-lactide coating.
The study design included 560 patients with a single de novo native coronary artery lesion with a reference vessel diameter between 2.5 to 3.75 mm and a lesion length ≤ 20 mm randomized 1:1 at 32 centers to treatment with NeoVas (n = 278) versus CoCr-EES (n = 282). The primary endpoint was angiographic in-segment LL at 1 year; the major secondary endpoint was the rate of angina. Baseline and 1-year follow-up optical coherence tomography and fractional flow reserve were performed in a prespecified subgroup of patients.
In JACC: Cardiovascular Interventions, investigators reported 1-year in-segment LL was 0.14 ± 0.36 mm versus 0.11 ± 0.34 mm (difference, 0.03 mm; upper 1-sided 97.5% confidence interval, 0.09 mm; P noninferiority < .0001; P superiority = .36) in NeoVas and CoCr-EES, respectively. In both groups, clinical outcomes at 1 year and the rates of recurrent angina were similar (27.9% vs. 32.1%; P = .26). Optical coherence tomography at 1 year demonstrated a higher proportion of covered struts (98.7% vs 96.2%; P < .001), less strut malapposition (0% vs 0.6%; P < .001), and a smaller minimal lumen area (4.71 ± 1.64 mm2 vs 6 ± 2.15 mm2; P < .001) in NeoVas compared with CoCr-EES, respectively. Nonsignificant differences in fractional flow reserve (0.89 ± 0.08 vs 0.91 ± 0.06; P = .07) were also reported.