Author + information
- Received September 5, 2017
- Revision received September 19, 2017
- Accepted September 26, 2017
- Published online February 5, 2018.
- Yaling Han, MD, PhDa,∗ (, )
- Bo Xu, MBBSb,
- Guosheng Fu, MDc,
- Xiaozeng Wang, MDa,
- Kai Xu, MDa,
- Chongying Jin, MDc,
- Ling Tao, MDd,
- Lang Li, MDe,
- Yuqing Hou, MDf,
- Xi Su, MDg,
- Quan Fang, MDh,
- Lianglong Chen, MDi,
- Huiliang Liu, MDj,
- Bin Wang, MDk,
- Zuyi Yuan, MDl,
- Chuanyu Gao, MDm,
- Shenghua Zhou, MDn,
- Zhongwei Sun, MScb,
- Yanyan Zhao, BSb,
- Changdong Guan, MScb,
- Gregg W. Stone, MDo,p,
- on behalf of the NeoVas Randomized Controlled Trial Investigators
- aDepartment of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China
- bCatheter Lab, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
- cDepartment of Cardiology, Sir Run Run Shaw Hospital, Hangzhou, China
- dDepartment of Cardiology, Xijing Hospital, The Fourth Military Medical University, Xi’an, China
- eDepartment of Cardiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China
- fDepartment of Cardiology, Nanfang Hospital, Guangzhou, China
- gDepartment of Cardiology, Wuhan Asia Heart Hospital, Wuhan, China
- hDepartment of Cardiology, Peking Union Medical College Hospital, Beijing, China
- iDepartment of Cardiology, Fujian Medical University Union Hospital, Fuzhou, China
- jDepartment of Cardiology, General Hospital of Chinese People's Armed Police Forces, Beijing, China
- kDepartment of Cardiology, Aero Space Center Hospital, Beijing, China
- lDepartment of Cardiology, The First Affiliated Hospital of Xi’an Jiongtong University, Xi’an, China
- mDepartment of Cardiology, Henan Provincial People’s Hospital, Zhengzhou, China
- nDepartment of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, China
- oCenter for Interventional Vascular Therapy, Division of Cardiology, Presbyterian Hospital and Columbia University, New York, New York
- pCardiovascular Research Foundation, New York, New York
- ↵∗Address for correspondence:
Dr. Yaling Han, Department of Cardiology, General Hospital of Shenyang Military Region, 83, Wenhua Road, Shenhe District, Shenyang 110016, China.
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)
The NeoVas randomized controlled trial was sponsored by Lepu Medical, Beijing, China. Dr. Stone is the global chairman of the Absorb clinical trial program (uncompensated); and a consultant for Reva Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Han, Xu, and Fu contributed equally to this work.
- Received September 5, 2017.
- Revision received September 19, 2017.
- Accepted September 26, 2017.
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