One-year clinical outcomes and multislice computed
tomography angiographic results following implantation of the
NeoVas bioresorbable sirolimus-eluting scaffold in patients with
single de novo coronary artery lesions
Xiao-Zeng Wang, MD
Yao-Jun Zhang, PhD, FESC
Guo-Sheng Fu, MD
Quan-Min Jing, MD
Bo Xu, MBBS
Ya-Ling Han, MD, FACC
The General Hospital of Shenyang Military,
Xuzhou Third People’s Hospital, Jiangsu
University, Zhenjiang, China
Sir Run Shaw Hospital, School of Medicine,
Zhejiang University, Hangzhou, China
Fu Wai Hospital, National Center for
Cardiovascular Diseases, Chinese Academy
of Medical Sciences, Beijing, China
Ya-Ling Han, MD, FESC, The General
Hospital of Shenyang Military Region, 83
Wenhua Road, Shenyang, Liaoning 110840,
Lepu Medical; National Key Technology
R&D Program in the 12th Five-Year Plan of
China, Beijing, China; Grant/Award
Number: 2011BAI11B07; Key Project of
the National 12th Five-Year Research
Program of China, Beijing, China,
Grant/Award Number: 2012ZX093016-002
Background: Tremendous efforts have been made to establish the concept of vascular restoration
therapy with a fully bioresorbable scaffold for coronary artery disease. With an improved scaffold
design and technologies, the novel NeoVas scaffold has shown promising clinical performance at
6 months follow-up.
Objective: The aim of this study was to investigate the 1 year clinical outcomes and multislice
computed tomography (MSCT) angiographic results after implantation of the NeoVas scaffold in
patients with single de novo coronary artery lesions.
Methods: The NeoVas first-in-man study was a prospective, two-center, single-arm study enrolling
31 patients who were eligible for the treatment. The composite endpoint of target lesion failure
(TLF)—defined as cardiac death, target vessel myocardial infarction, and clinically indicated target
lesion revascularization (TLR)—was assessed. Of the 31 patients scheduled for 1 year clinical
follow-up, 29 patients received MSCT examinations.
Results: At 1 year follow-up, there was only 1 (3.2%) TLF, attributed to 1 patient who suffered
ischemia-driven TLR at 181 days postprocedure. No cardiac deaths or scaffold thrombosis were
observed. MSCT analysis demonstrated excellent vessel patency, with a median in-scaffold lumen
area of 10.6 mm
(interquartile range [IQR]: 8.2–11.7 mm
) and a minimal lumen diameter of
2.7 mm (IQR: 2.4–3.0 mm).
Conclusions: This study demonstrated the safety and efficacy of the NeoVas scaffold for patients
with single de novo coronary artery lesions at 1 year of follow-up. Noninvasive MSCT data con-
firmed vessel patency and the maintenance of vessel dimensions following implantation of the
NeoVas bioresorbable sirolimus-eluting scaffold.
bioresorbable sirolimus-eluting scaffold, clinical outcomes, multislice computed tomography,
Xiao-Zeng Wang and Yao-Jun Zhang contributed equally to this article.
Catheter Cardiovasc Interv. 2018;91:617–622. wileyonlinelibrary.com/journal/ccd
2018 Wiley Periodicals, Inc.
Received: 19 December 2017
Accepted: 27 December 2017