Yaling Han1, Bo Xu2, Guosheng Fu3, Xiaozeng Wang4, Kai Xu4, Chongying Jin3, Ling Tao5, Lang Li6, Yuqing Hou7, Xi Su8, Quan Fang9, Lianglong Chen10, Huiliang Liu11, Bin Wang12, Zuyi Yuan13, Chuanyu Gao14, Shenghua Zhou15, Zhongwei Sun2, Yanyan Zhao2, Changdong Guan2, Gregg W Stone16. 1. Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China. Electronic address: hanyalingnh@163.com. 2. Catheter Lab, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. 3. Department of Cardiology, Sir Run Run Shaw Hospital, Hangzhou, China. 4. Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China. 5. Department of Cardiology, Xijing Hospital, The Fourth Military Medical University, Xi'an, China. 6. Department of Cardiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. 7. Department of Cardiology, Nanfang Hospital, Guangzhou, China. 8. Department of Cardiology, Wuhan Asia Heart Hospital, Wuhan, China. 9. Department of Cardiology, Peking Union Medical College Hospital, Beijing, China. 10. Department of Cardiology, Fujian Medical University Union Hospital, Fuzhou, China. 11. Department of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing, China. 12. Department of Cardiology, Aero Space Center Hospital, Beijing, China. 13. Department of Cardiology, The First Affiliated Hospital of Xi'an Jiongtong University, Xi'an, China. 14. Department of Cardiology, Henan Provincial People's Hospital, Zhengzhou, China. 15. Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, China. 16. Center for Interventional Vascular Therapy, Division of Cardiology, Presbyterian Hospital and Columbia University, New York, New York; Cardiovascular Research Foundation, New York, New York.
Abstract
OBJECTIVES: The authors sought to evaluate the safety and effectiveness of the NeoVas bioresorbable scaffold (BRS) compared with metallic drug-eluting stents. BACKGROUND: BRS have the potential to improve very late outcomes compared with metallic drug-eluting stents, but some BRS 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. METHODS:Eligible patients with a single de novo native coronary artery lesion with a reference vessel diameter 2.5 to 3.75 mm and a lesion length≤20 mm were randomized 1:1 to NeoVas BRS versus cobalt-chromium everolimus-eluting stents (CoCr-EES). Angiographic follow-up was performed in all patients at 1 year. The primary endpoint was angiographic in-segment late loss (LL), and the major secondary endpoint was the rate of angina. Baseline and follow-up optical coherence tomography and fractional flow reserve were performed in a pre-specified subgroup of patients. RESULTS: The authors randomized 560 patients at 32 centers to treatment with NeoVas (n = 278) versus CoCr-EES (n = 282). One-year in-segment LL with NeoVas and CoCr-EES were 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; pnoninferiority < 0.0001; psuperiority = 0.36). Clinical outcomes at 1 year were similar in the 2 groups, as were the rates of recurrent angina (27.9% vs. 32.1%; p = 0.26). Optical coherence tomography at 1 year demonstrated a higher proportion of covered struts (98.7% vs. 96.2%; p < 0.001), less strut malapposition (0% vs. 0.6%; p <0.001), and a smaller minimal lumen area (4.71 ± 1.64 vs. 6.00 ± 2.15 mm2; p < 0.001) with NeoVas compared with CoCr-EES respectively, with nonsignificant differences in fractional flow reserve (0.89 ± 0.08 vs. 0.91 ± 0.06; p = 0.07). CONCLUSIONS: The NeoVas BRS was noninferior to CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL, and resulted in comparable 1-year clinical outcomes, including recurrent angina. (NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial; NCT02305485).
RCT Entities:
OBJECTIVES: The authors sought to evaluate the safety and effectiveness of the NeoVas bioresorbable scaffold (BRS) compared with metallic drug-eluting stents. BACKGROUND: BRS have the potential to improve very late outcomes compared with metallic drug-eluting stents, but some BRS 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. METHODS: Eligible patients with a single de novo native coronary artery lesion with a reference vessel diameter 2.5 to 3.75 mm and a lesion length ≤20 mm were randomized 1:1 to NeoVas BRS versus cobalt-chromium everolimus-eluting stents (CoCr-EES). Angiographic follow-up was performed in all patients at 1 year. The primary endpoint was angiographic in-segment late loss (LL), and the major secondary endpoint was the rate of angina. Baseline and follow-up optical coherence tomography and fractional flow reserve were performed in a pre-specified subgroup of patients. RESULTS: The authors randomized 560 patients at 32 centers to treatment with NeoVas (n = 278) versus CoCr-EES (n = 282). One-year in-segment LL with NeoVas and CoCr-EES were 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; pnoninferiority < 0.0001; psuperiority = 0.36). Clinical outcomes at 1 year were similar in the 2 groups, as were the rates of recurrent angina (27.9% vs. 32.1%; p = 0.26). Optical coherence tomography at 1 year demonstrated a higher proportion of covered struts (98.7% vs. 96.2%; p < 0.001), less strut malapposition (0% vs. 0.6%; p <0.001), and a smaller minimal lumen area (4.71 ± 1.64 vs. 6.00 ± 2.15 mm2; p < 0.001) with NeoVas compared with CoCr-EES respectively, with nonsignificant differences in fractional flow reserve (0.89 ± 0.08 vs. 0.91 ± 0.06; p = 0.07). CONCLUSIONS: The NeoVas BRS was noninferior to CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL, and resulted in comparable 1-year clinical outcomes, including recurrent angina. (NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial; NCT02305485).
Authors: Yaokun Liu; Bo Zheng; Bin Zhang; Robert Ndondo-Lay; Fangfang Nie; Naijie Tang; Yongsheng Miao; Jianping Li; Yong Huo Journal: Front Cardiovasc Med Date: 2022-07-22