In the field of coronary intervention, every innovation in interventional technology will promote rapid progress in interventional therapy, but it will also bring some challenges.
Not long ago, the innovative product "Bioresorbable Coronary Rapamycin Elution Stent System" developed by Lepu (Beijing) Medical Device Co., Ltd. has been approved for listing.
On January 7, the results of the 3-year clinical and imaging follow-up study of FUTURE‐I published by Academician Gao Runlin and Professor Xu Bo of Fuwai Hospital showed that the treatment of uncomplicated coronary artery diseases was feasible, safe and effective for the treatment of uncomplicated coronary artery diseases, and the bioresorceptible rapamycin (sirolimus) targeted eluting coronary stent Firesorb (Fire ibis, Shanghai Minimally Invasive Medical) independently developed by China was feasible, safe and effective.
According to the researchers, this is firesorb's first prospective, open-label study in humans.
This domestic stent is the second generation of bioresorbable stent, the stent wall is only 100 ~ 125 μm thick, far lower than the first generation of bioresorbable stent, which is conducive to rapid endometrification after stent insertion, thereby reducing the postoperative thrombosis risk and accelerating the absorption cycle in the later stage, reducing the risk of late biology.
Previously, the first generation of bioresorbable stents developed by Abbott in the United States Absorb BVS was quickly withdrawn from the market after listing, and it is estimated that the stent wall is too thick (> 150 μm), which is almost 2 times that of the metal stent, which will cause stent prominence, unstable blood flow, delayed vascular reenothelialization, and poor decomposition during absorption.
The domestic bracket Firesorb first has good physical properties, the instrument placement can achieve 100% success, anti-fracture, acute elastic retraction rate is low, there is no late elastic retraction, and the geometry is maintained well.
Secondly, the study showed that Firesorb had a good long-term safety profile, especially in the bioabsorbable phase, with no stent thrombosis during the 3-year follow-up period, while the vascular endothelium healed well, the stent trabeculum was completely covered, and the incidence of discontinuity of advanced stents was low.
In addition, the study confirmed the long-term effectiveness of Firesorb, with a revascularization rate of only 2.2% for target lesions due to myocardial ischemia at 3 years of follow-up, and the minimum luminal diameter and late occlusal loss were also satisfactory.
The study included a total of 45 patients with single-onset coronary lesions from January to March 2016, who were randomly divided into two cohorts in a 2:1 ratio after successful placement of Firesorb: Cohort 1 (30 patients) underwent a variety of imaging tests at 6 and 24 months postoperatively, including quantitative coronary angiography (QCA), intravascular ultrasound (IVUS), and optical coherence tomography (OCT), and cohort 2 (15 patients) received these imaging tests at 12 and 36 months postoperatively.
All patients were followed up clinically at 1, 6, and 12 months postoperatively, and thereafter once a year, up to a maximum of 5 years.
The results showed that at 3 years of follow-up, 1 patient had a failure of target lesions (including cardiogenic death, target vascular myocardial infarction, ischemia-driven revascularization of target lesions), but no stent thrombosis.
The minimum intra-stent lumen diameter in Cohort 1 decreased significantly from 6 months postoperatively to 2 years postoperatively (2.53 ± 0.24 mm vs 2.27 ± 0.37 mm), and the minimum intra-stent luminal diameter in Cohort 2 decreased from postoperative year 1 to year 3, but did not differ significantly (2.48 ± 0.28 mm vs 2.22 ± 0.13 mm).
The results of OCT examination showed that at 3 years of follow-up, the coverage rate of new endometrium of stents reached 99.8%, the incidence of discontinuity of advanced stents was extremely low, and only 1 patient had 3 poor stent adhesion in two cross-sections.
来源：Song L, et al. First-in-man study of a thinner-strut sirolimus-eluting bioresorbable scaffold (FUTURE-I): Three-year clinical and imaging outcomes. Catheter Cardiovasc Interv. 2020 Jan 7.
Reprint: Please indicate "China Circulation Magazine"
<h1 toutiao-origin="h2" > welcome to purchase the 2019 supplement to the China Cycle Magazine Guide! </h1>
The special edition of the "China Cycle Journal" guide invites senior experts from various related fields in China to interpret in detail nearly 30 important guidelines in the past year, hoping to bring new knowledge, new ideas and new thinking to the majority of cardiovascular doctors. Click View content
![The improvement of medical quality in county-level hospitals has not been taken seriously! Academician Gao Runlin and Wu Yangfeng and other CPACS-3 research[fig]](data:image/gif;base64,R0lGODlhAQABAIAAAP///wAAACwAAAAAAQABAAACAkQBADs=)