Abstract
Introduction: Newer generation bioresorbable scaffolds (BRSs) with thinner struts and improved deliverability are expected to enhance safety and efficacy profiles. Bioheart (Bio-Heart, Shanghai, China) BRS is constructed from a PLLA (poly-l-lactic acid) backbone coated with a PDLLA (poly d-l-lactic acid) layer eluting sirolimus. We report 2-year serial intracoronary imaging findings. Methods: In this first-in-human study, 46 patients with single de novo lesions in native coronary vessels (vessel size 3.0–3.75 mm, lesion length ≤ 25 mm) were enrolled at a single institution. Baseline intravascular ultrasound (IVUS) and post-implantation IVUS and optical coherence tomography (OCT) examinations were mandatory. After successful implantations of BRS, the 46 patients were randomized to two different follow-up cohorts in a 2:1 ratio. Thirty patients in cohort 1 had to undergo angiography, IVUS, and OCT follow-ups at 6 and 24 months, respectively. The 16 patients in cohort 2 underwent the same types of imaging follow-ups at 12 and 36 months, respectively. Clinical follow-ups were scheduled uniformly in both cohorts at 1, 6, and 12 months and annually up to 5 years for all patients. Results: Between August and November 2016, a total of 54 patients were assessed. However, 8 patients could not meet all the inclusion criteria; thus, the remaining 46 patients (age 57.5 ± 8.7 years, 34.8% female, 50.0% with unstable angina, 26.1% diabetics) with 46 target lesions were enrolled in this study. All patients in both cohorts were required to complete clinical follow-up uniformly and regularly. In cohort 1, one patient had definite scaffold thrombosis within 6 months of follow-up; thus, after 6 months, cohort 1 had 96.7% patients. Imaging follow-up was available in 24 patients, and in-scaffold late loss was 0.44 ± 0.47 mm; intracoronary imaging confirmed the late loss was mainly due to to neointimal hyperplasia, but not scaffold recoil. Conclusions: Serial 2-year clinical and imaging follow-up results confirmed the preliminary safety and efficacy of Bioheart BRS for treatment of simple coronary lesions.
Original language | English |
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Pages (from-to) | 3749-3765 |
Number of pages | 17 |
Journal | Advances in Therapy |
Volume | 39 |
Issue number | 8 |
DOIs | |
Publication status | Published - Aug 2022 |
Bibliographical note
Funding Information:We thank the participants of the study. The study was sponsored by Bio-Heart, Shanghai, China, through an institutional research grant. The executive committee, as well as the sponsor, designed the study. The sponsor had no role in data analysis, data interpretation, writing the manuscript, or the decision to submit the manuscript or journal rapid service and Open Access fees for publication. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. Supervision and approval of the clinical trial by Bo Xu and Yongjian Wu. Data Analysis and interpretation by Changdong Guan, Zhongwei Sun, and Md Misbahul Ferdous. IVUS data evaluation by Md Misbahul Ferdous, Lijian Gao, Shubi Qiao, and Haibo Liu. OCT data evaluation by Md Misbahul Ferdous, Fenghuan Hu, Jie Qian, and Hong Qiu. Angiographic and stenting procedure by Md Misbahul Ferdous, Hongbin Yan, Tong Luo, Weixian Yang, and Yi Mao. Draft writing by Md Misbahul Ferdous, Jie Zhao, and Lakshme Kottu. Draft proofreading and supervision of manuscript by Mengyue Yu and Jingang Cui. MD Misbahul Ferdous, Zhao Jie, Lijian Gao, Shubin Qiao, Haibo Liu, Changdong Guan, Fenghuan Hu, Lakshme Kottu, Jie Qian, Hongbin Yan, Tong Luo, Weixian Yang, Hong Qiu, Yi Mao, Zhongwei Sun, Mengyue Yu, Jingang Cui, Bo Xu, and Yongjian Wu all have nothing to disclose. This study was approved by the ethics committee at Fuwai Hospital and is in accordance with the principles stated in the Declaration of Helsinki and in line with the International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines for good clinical practice. An institutional review board at site approved the study. All study participants provided written informed consent before study commencement. The study was registered at ClinicalTrials.gov, identifier NCT02844270. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Funding Information:
This study was approved by the ethics committee at Fuwai Hospital and is in accordance with the principles stated in the Declaration of Helsinki and in line with the International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines for good clinical practice. An institutional review board at site approved the study. All study participants provided written informed consent before study commencement. The study was sponsored by Bio-Heart Biological Technology Co., Ltd. (Shanghai, China), and registered at ClinicalTrials.gov, identifier NCT02844270.
Publisher Copyright:
© 2022, The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.