Long-Term Arterial Remodeling After Bioresorbable Scaffold Implantation 4-Year Follow-up of Quantitative Coronary Angiog
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Cardiovascular Engineering and Technology ( 2020) https://doi.org/10.1007/s13239-020-00495-7
Original Article
Long-Term Arterial Remodeling After Bioresorbable Scaffold Implantation 4-Year Follow-up of Quantitative Coronary Angiography, Histology and Optical Coherence Tomography DONGPING CHEN
,1 ZHIHUI DONG,1 YANGBO XI,2 CAN CHEN,3 SUZHEN ZHANG,1 SUFEN ZENG,1 YUYING BI,4,5 TIM WU,4,5 and JIANMIN XIAO2
1 Central Laboratory, The Dongguan Affiliated Hospital of Jinan University, Binhaiwan Central Hospital of Dongguan, Dongguan, China; 2Department of Cardiology, The Dongguan Affiliated Hospital of Jinan University, Binhaiwan Central Hospital of Dongguan, Dongguan, China; 3Department of Pathology, The Dongguan Affiliated Hospital of Jinan University, Binhaiwan Central Hospital of Dongguan, Dongguan, China; 4Dongguan TT Medical, Inc., Dongguan, China; and 5Vaso Tech, Inc., Lowell, MA, USA
(Received 14 July 2020; accepted 10 October 2020) Associate Editor Craig Alexander Simmons oversaw the review of this article.
Abstract Purpose—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. Methods—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. Results—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. Conclusion—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.
Address correspondence to Tim Wu, Dongguan TT Medical, Inc., Dongguan, China; Jianmin Xiao Department of Cardiology, The Dongguan Affiliated Hospital of Jinan University, Binhaiwan Central Hospital of Dongguan, Dongguan, China. Electronic mail: [email protected], [email protected]
Keywords—Resorption, Arterial remodeling, Bioresorbable scaffold, QCA, OCT, Histology.
ABBREVIATIONS BRS DES QCA OCT MLD LLL RVD HE
Bioresorbable scaffold Drug-eluting stent Quantitative coronary angiography Optical coherence tomography Mean lumen diameter Late l
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