Long-Term Arterial Remodeling After Bioresorbable Scaffold Implantation 4-Year Follow-up of Quantitative Coronary Angiography, Histology and Optical Coherence Tomography.


Journal

Cardiovascular engineering and technology
ISSN: 1869-4098
Titre abrégé: Cardiovasc Eng Technol
Pays: United States
ID NLM: 101531846

Informations de publication

Date de publication:
12 2020
Historique:
received: 14 07 2020
accepted: 10 10 2020
pubmed: 28 10 2020
medline: 25 8 2021
entrez: 27 10 2020
Statut: ppublish

Résumé

Our previous studies have confirmed the safety and efficacy of the novel fully bioresorbable PLLA scaffold (PowerScaffold®) at 12 months implantation. In the present study, the scaffold absorption and coronary vessel remodeling at 4 years were evaluated. After PowerScaffold® were implanted into 13 coronary arteries of 6 miniature pigs, quantitative coronary angiography (QCA) was performed at 15 days and 4 years follow-up to measure the mean lumen diameter (MLD), late lumen loss (LLL), and % stenosis of the coronary arteries. Optical coherence tomography (OCT) was performed to obtain the strut footprints at 4 years before euthanization for histological analysis. In addition, 2 PowerScaffold® were implanted into 2 miniature pigs for 2 years as supplementary data. All stented arteries were dissected and stained with HE, Masson, EVG, and Alcian blue to observe struts, cells, fibrinoid, elastin, and proteoglycans, respectively. There were no significant differences in MLD, LLL and % stenosis in stented coronary arteries between 15 days and 4 years by QCA. At 4 years, most strut sites were indiscernible and replaced by extracellular matrix and connective tissue by histology. Both strut/vessel wall interaction and strut coverage were shown 100% by OCT. At 4 years, the scaffold struts were completely embedded into vessel wall and mostly replaced by regenerated tissue. There was no sign of in-stent stenosis in all stented arteries.

Identifiants

pubmed: 33108646
doi: 10.1007/s13239-020-00495-7
pii: 10.1007/s13239-020-00495-7
doi:

Substances chimiques

Polyesters 0
poly(lactide) 459TN2L5F5

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

636-645

Références

Byrne, R., G. Stefanini, D. Capodanno, et al. Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary. EuroIntervention 13(13):1574–1586, 2018.
doi: 10.4244/EIJ20170912-01
Chen, D., Z. Su, L. Weng, et al. Effect of inflammation on endothelial cells induced by poly-L-lactic acid degradation in vitro and in vivo. J. Biomater. Sci. Polym. Ed. 29(15):1909–1919, 2018.
doi: 10.1080/09205063.2018.1517858
Chen, D., L. Weng, C. Chen, et al. Inflammation and dysfunction in human aortic endothelial cells associated with poly-L-lactic acid degradation in vitro are alleviated by curcumin. J. Biomed. Mater. Res. A 107(12):2756–2763, 2019.
doi: 10.1002/jbm.a.36778
Farooq, V., P. W. Serruys, J. H. Heo, et al. Intracoronary optical coherence tomography and histology of overlapping everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model. JACC Cardiovasc. Interv. 6(5):523–532, 2013.
doi: 10.1016/j.jcin.2012.12.131
Feng, G., J. Xiao, Y. Bi, et al. 12-Month coronary angiography, intravascular ultrasound and histology evaluation of a novel fully bioabsorbable poly-L-lactic acid/amorphous calcium phosphate scaffolds in porcine coronary arteries. J. Biomed. Nanotechnol. 12(4):743–752, 2016.
doi: 10.1166/jbn.2016.2241
Frangieh, A. H., M. Jaguszewski, Y. Imori, et al. Impact of post-dilatation on strut apposition of second-generation bioresorbable vascular scaffolds: key role for scaffold thrombosis and prognosis? Cardiol. J. 25(1):148–150, 2018.
doi: 10.5603/CJ.2018.0013
Garcia-Garcia, H. M., P. W. Serruys, C. M. Campos, et al. Assessing bioresorbable coronary devices: methods and parameters. JACC Cardiovasc. Imaging 7(11):1130–1148, 2014.
doi: 10.1016/j.jcmg.2014.06.018
Gu, D., G. Feng, G. Kang, et al. Improved biocompatibility of novel biodegradable scaffold composed of poly-L-lactic acid and amorphous calcium phosphate nanoparticles in porcine coronary artery. J. Nanomater. 2016:1–8, 2016.
doi: 10.1155/2016/2710858
Kraak, R. P., H. H. de Boer, J. Elias, et al. Coronary artery vessel healing pattern, short and long term, after implantation of the everolimus-eluting bioresorbable vascular scaffold. J. Am. Heart Assoc. 2015. https://doi.org/10.1161/jaha.115.002551 .
doi: 10.1161/jaha.115.002551
Lan, Z., Y. Lyu, J. Xiao, et al. Novel biodegradable drug-eluting stent composed of poly-L-lactic acid and amorphous calcium phosphate nanoparticles demonstrates improved structural and functional performance for coronary artery disease. J. Biomed. Nanotechnol. 10(7):1194–1204, 2014.
doi: 10.1166/jbn.2014.1868
Nakatani, S., Y. Sotomi, Y. Ishibashi, et al. Comparative analysis method of permanent metallic stents (XIENCE) and bioresorbable poly-L-lactic (PLLA) scaffolds (absorb) on optical coherence tomography at baseline and follow-up. EuroIntervention 12(12):1498–1509, 2016.
doi: 10.4244/EIJY15M10_03
Nishio, S., K. Kosuga, K. Igaki, et al. Long-term (> 10 years) clinical outcomes of first-in-human biodegradable poly-L-lactic acid coronary stents. Circulation 125(19):2343–2353, 2012.
doi: 10.1161/CIRCULATIONAHA.110.000901
Onuma, Y., P. W. Serruys, T. Muramatsu, et al. Incidence and imaging outcomes of acute scaffold disruption and late structural discontinuity after implantation of the absorb everolimus-eluting fully bioresorbable vascular scaffold: optical coherence tomography assessment in the ABSORB cohort B Trial (A clinical evaluation of the bioabsorbable everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions). JACC Cardiovasc. Interv. 7(12):1400–1411, 2014.
doi: 10.1016/j.jcin.2014.06.016
Onuma, Y., P. W. Serruys, L. E. L. Perkins, et al. Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model. Circulation 122(22):2288–2300, 2010.
doi: 10.1161/CIRCULATIONAHA.109.921528
Ramot, Y., M. Haim-Zada, A. J. Domb, et al. Biocompatibility and safety of PLA and its copolymers. Adv. Drug Deliv. Rev. 107:153–162, 2016.
doi: 10.1016/j.addr.2016.03.012
Serruys, P. W., Y. Katagiri, Y. Sotomi, et al. Arterial remodeling after bioresorbable scaffolds and metallic stents. J. Am. Coll. Cardiol. 70(1):60–74, 2017.
doi: 10.1016/j.jacc.2017.05.028
Serruys, P. W., J. A. Ormiston, Y. Onuma, et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. The Lancet 373(9667):897–910, 2009.
doi: 10.1016/S0140-6736(09)60325-1
Serruys, P. W., J. Ormiston, R. van Geuns, et al. A polylactide bioresorbable scaffold eluting everolimus for treatment of coronary stenosis: 5-year follow-up. J. Am. Coll. Cardiol. 67(7):766–776, 2016.
doi: 10.1016/j.jacc.2015.11.060
Tanaka, A. M., N. D. Ruparelia, H. M. Kawamoto, et al. Positive vessel remodeling and appearance of pulsatile wall motion at long-term follow-up after bioresorbable scaffold implantation in a chronic total occlusion. JACC Cardiovasc. Interv. 8(12):1635–1637, 2015.
doi: 10.1016/j.jcin.2015.06.022
Teramoto, T., F. Ikeno, H. Otake, et al. Intriguing peri-strut low-intensity area detected by optical coherence tomography after coronary stent deployment. Circ. J. 74(6):1257–1259, 2010.
doi: 10.1253/circj.CJ-10-0189
Wiebe, J., M. Baquet, O. Dorr, et al. Long-term follow-up and predictors of target lesion failure after implantation of everolimus-eluting bioresorbable scaffolds in real-world practice. Int. J. Cardiol. 2020. https://doi.org/10.1016/j.ijcard.2020.02.062 .
doi: 10.1016/j.ijcard.2020.02.062
Wiebe, J., H. M. Nef, and C. W. Hamm. Current status of bioresorbable scaffolds in the treatment of coronary artery disease. J. Am. Coll. Cardiol. 64(23):2541–2551, 2014.
doi: 10.1016/j.jacc.2014.09.041
Xiao, J., G. Feng, G. Kang, et al. 6-Month follow-up of a novel biodegradable drug-eluting stent composed of poly-L-lactic acid and amorphous calcium phosphate nanoparticles in porcine coronary artery. J. Biomed. Nanotechnol. 11(10):1819–1825, 2015.
doi: 10.1166/jbn.2015.2102
Zhou, J., W. Hu, and L. Tang. Non-invasive characterization of immune responses to biomedical implants. Ann. Biomed. Eng. 44(3):693–704, 2016.
doi: 10.1007/s10439-015-1470-9

Auteurs

Dongping Chen (D)

Central Laboratory, The Dongguan Affiliated Hospital of Jinan University, Binhaiwan Central Hospital of Dongguan, Dongguan, China.

Zhihui Dong (Z)

Central Laboratory, The Dongguan Affiliated Hospital of Jinan University, Binhaiwan Central Hospital of Dongguan, Dongguan, China.

Yangbo Xi (Y)

Department of Cardiology, The Dongguan Affiliated Hospital of Jinan University, Binhaiwan Central Hospital of Dongguan, Dongguan, China.

Can Chen (C)

Department of Pathology, The Dongguan Affiliated Hospital of Jinan University, Binhaiwan Central Hospital of Dongguan, Dongguan, China.

Suzhen Zhang (S)

Central Laboratory, The Dongguan Affiliated Hospital of Jinan University, Binhaiwan Central Hospital of Dongguan, Dongguan, China.

Sufen Zeng (S)

Central Laboratory, The Dongguan Affiliated Hospital of Jinan University, Binhaiwan Central Hospital of Dongguan, Dongguan, China.

Yuying Bi (Y)

Dongguan TT Medical, Inc., Dongguan, China.
Vaso Tech, Inc., Lowell, MA, USA.

Tim Wu (T)

Dongguan TT Medical, Inc., Dongguan, China. tiangenwu@yahoo.com.
Vaso Tech, Inc., Lowell, MA, USA. tiangenwu@yahoo.com.

Jianmin Xiao (J)

Department of Cardiology, The Dongguan Affiliated Hospital of Jinan University, Binhaiwan Central Hospital of Dongguan, Dongguan, China. xiaojianmin0219@163.com.

Articles similaires

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male
Humans Meals Time Factors Female Adult

Classifications MeSH