首例薄壁生物可吸收支架(BIOMAGIC)治疗冠状动脉原位病变3年造影和临床结果3-Year angiographic and clinical results of the first case with coronary de novo lesion treated by BIOMAGIC bioresorbable scaffold
吴轶喆,钱菊英,殷嘉晟,沈雳,Robert Ndondolay,聂芳芳,唐乃杰,缪永生,霍勇,葛均波
摘要(Abstract):
生物可吸收支架被誉为冠状动脉介入治疗的第四次革命性进展。新一代薄壁生物可吸收支架克服了前一代支架梁较厚的劣势,同时能保持良好的径向支撑力,具有替代前一代的潜力。由上海脉全医疗器械有限公司研发的BIOMAGIC支架,厚度为130μm,置入冠状动脉后预期在3~5年内完全吸收。首例接受BIOMAGIC支架置入的患者为33岁女性,诊断为稳定型心绞痛。冠状动脉造影提示左前降支近段重度狭窄,置入一枚3.0 mm×15 mm BIOMAGIC支架。术后3年随访,患者无缺血相关症状,冠状动脉造影和光学相干断层成像显示左前降支支架置入部位仍保持通畅,支架表面内膜覆盖完整,支架梁已部分吸收。
关键词(KeyWords): 冠状动脉粥样硬化性心脏病;冠状动脉介入治疗;生物可吸收支架
基金项目(Foundation): 上海市放射与治疗(介入治疗)临床医学研究中心项目(19MC1910300)
作者(Author): 吴轶喆,钱菊英,殷嘉晟,沈雳,Robert Ndondolay,聂芳芳,唐乃杰,缪永生,霍勇,葛均波
参考文献(References):
- [1] Ormiston JA,Webster MW,Armstrong G. First-in-human implantation of a fully bioabsorbable drug-eluting stent:the BVS poly-L-lactic acid everolimus-eluting coronary stent[J].Catheter Cardiovasc Interv,2007,69(1):128-131.
- [2] Wu Y,Shen L,Ge L,et al. Six-month outcomes of the XINSORB bioresorbable sirolimus-eluting scaffold in treating single de novo lesions in human coronary artery[J]. Catheter Cardiovasc Interv,2016,87 Suppl 1:630-637.
- [3] Wu Y,Shen L,Yin J,et al. 5 years of serial intravascular imaging outcomes of XINSORB sirolimus-eluting bioresorbable vascular scaffold[J]. JACC Cardiovasc Interv,2019,12(6):602-603.
- [4] Wu Y,Shen L,Yin J,et al. Twelve-month angiographic and clinical outcomes of the XINSORB bioresorbable sirolimuseluting scaffold and a metallic stent in patients with coronary artery disease[J]. Int J Cardiol,2019,293:61-66.
- [5] Wu Y,Yin J,Chen J,et al. Final report of the 5-year clinical outcomes of the XINSORB bioresorbable sirolimus-eluting scaf fold in the treatment of single de novo coronary lesions in a first-inhuman study[J]. Ann Transl Med,2020,8(18):1162.
- [6] Wu Y,Yao Z,Yin J,et al. Three-year clinical outcomes of a sirolimus-eluting bioresorbable scaf fold(XINSORB)and a metallic stent to treat coronary artery stenosis[J]. Ann Transl Med,2020,8(22):1489.
- [7] Zhang YJ,Wang XZ,Fu G,et al. Clinical and multimodality imaging results at 6 months of a bioresorbable sirolimus-eluting scaf fold for patients with single de novo coronary artery lesions:the NeoVas fi rst-in-man trial[J]. EuroIntervention, 2016,12(10):1279-1287.
- [8] Han Y,Xu B,Fu G,et al. A randomized trial comparing the NeoVas sirolimus-eluting bioresorbable scaffold and metallic everolimus-eluting stents[J]. JACC Cardiovasc Interv,2018,11(3):260-272.
- [9]吴轶喆,殷嘉晟,葛雷,等. XINSORB生物可吸收西罗莫司洗脱支架治疗原位冠状动脉狭窄病变随机对照研究4年临床结果[J].中国介入心脏病学杂志,2020,28(9):493-499.
- [10] Song L,Xu B,Chen Y,et al. Thinner strut sirolimus-eluting BRS versus EES in patients with coronary artery disease:FUTURE-Ⅱtrial[J]. JACC Cardiovasc Interv, 2021,14(13):1450-1462.
- [11] Song L,Sun Z,Guan C,et al. First-in-man study of a thinnerstrut sirolimus-eluting bioresorbable scaf fold(FUTURE-Ⅰ):three-year clinical and imaging outcomes[J]. Catheter Cardiovasc Interv,2020,95 Suppl 1:648-657.
- [12] Stone GW,Ellis SG,Gori T,et al. Blinded outcomes and angina assessment of coronary bioresorbable scaf folds:30-day and 1-year results from the ABSORBⅣrandomised trial[J].Lancet,2018,392(10157):1530-1540.
- [13] Smits PC,Chang CC,Chevalier B,et al. Bioresorbable vascular scaf fold versus metallic drug-eluting stent in patients at high risk of restenosis:the COMPARE-ABSORB randomised clinical trial[J]. EuroIntervention,2020,16(8):645-653.