Author + information
- Received June 15, 2018
- Revision received September 30, 2018
- Accepted October 9, 2018
- Published online February 4, 2019.
- Jian-Feng Zheng, MSca,
- Hong Qiu, MDa,∗ (, )
- Yuan Tian, BSb,
- Xiao-Ying Hu, MDa,
- Tong Luo, MDa,
- Chao Wu, MDa,
- Yi Tian, MDc,
- Yue Tang, MDc,
- Lai-Feng Song, MDd,
- Li Li, MDd,
- Liang Xu, MDa,
- Bo Xu, MBBSa and
- Run-Lin Gao, MDa,∗ ()
- aDepartment of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
- bUrumqi Friendship Hospital, Urumqi, Xinjiang Uygur Autonomous Region, China
- cBeijing Key Laboratory of Preclinical Research and Evaluation for Cardiovascular Implant Materials, Animal Experimental Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
- dDepartment of Pathology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
- ↵∗Address for correspondence:
Dr. Run-Lin Gao OR Dr. Hong Qiu, Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, No. 167 North Lishi Road, Xicheng District, Beijing 100037, China.
Objectives The aim of this study was to investigate the operability, 6-month efficacy, and safety of the novel sirolimus-eluting iron bioresorbable coronary scaffold (IBS) system compared with a cobalt-chromium everolimus-eluting stent (EES) (XIENCE Prime stent) in porcine coronary arteries.
Background Bioresorbable scaffolds have been considered the fourth revolution in percutaneous coronary intervention. However, the first-generation bioresorbable scaffold showed suboptimal results.
Methods Forty-eight IBS and 48 EES were randomly implanted into nonatherosclerotic swine. The operability, efficacy, and safety of the IBS and EES were evaluated using coronary angiography, optical coherence tomography, micro–computed tomography, scanning electron microscopy, and histopathologic evaluation at 7, 14, 28, 90, and 180 days after implantation.
Results The operability of the ultrathin IBS (∼70 μm) was comparable with that of the EES, except for its visibility. There was no statistically significant difference in area stenosis between the IBS and EES from 28 to 180 days. The IBS maintained its integrity up to 90 days without corrosion, while corrosion was observed in a few struts in 2 of 10 IBS at 180 days. The percentage of endothelialization of IBS was higher than that of XIENCE Prime stents within 14 days after implantation. The fibrin score was higher in the IBS group at 28 days but comparable with the EES group at 90 and 180 days. No scaffold or stent thrombosis was seen in either group. No abnormal histopathologic changes in scaffolded or stented vessel segments and 5 main remote organs were observed in either group.
Conclusions Preclinical results suggest that the novel IBS has comparable operability, mid-term efficacy, and safety with the EES, and its corrosion profile in porcine coronary arteries is reasonable, which could support initial clinical study of the IBS.
Drs. Gao and Qiu have received research grants from Lifetech Scientific (Shenzhen). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 15, 2018.
- Revision received September 30, 2018.
- Accepted October 9, 2018.
- 2019 American College of Cardiology Foundation
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