周登双,游琼,莫海亮,吴子君,林余标,陈陆军,范君宇,林永建,张瑞生,万佩姗,周卫国,吴铿

• 1:广东医科大学附属医院冠心病专科

摘要(Abstract)：

目的 探讨置入国产新型生物可吸收支架（BVS）治疗复杂冠状动脉病变患者的安全性及有效性。方法 本研究为回顾性、匹配对照的单中心观察性研究，连续入选2020年6月至2021年6月于广东医科大学附属医院冠心病专科进行BVS治疗冠心病患者45例（BVS组），同期按匹配研究要求选取置入药物洗脱支架（DES）冠心病患者45例（DES组）。比较两组患者的基线资料、手术资料和随访资料以评估安全性和有效性。安全性的主要指标为：手术耗时、术中不良事件等，有效性终点为靶病变失败（TLF），包括心原性死亡、靶血管心肌梗死、缺血驱动的靶病变血运重建。结果 本研究共入选90例患者，均接受了至少3年的临床随访。两组分叉病变和弥漫性长病变分别为20例和25例，90例患者中复查冠状动脉造影或冠状动脉CT血管造影50例；BVS组中稳定性冠心病、糖尿病史、高血压病史、吸烟史的占比，预扩张球囊压力、术后舒张压均高于DES组，家族史占比低于DES组，差异均有统计学意义（均P<0.05）；两组间心原性死亡、靶血管心肌梗死、缺血驱动的靶病变血运重建率比较，差异均无统计学意义（均P>0.05）。二元Logistic回归模型分析结果 显示靶病变直径狭窄比是支架内再狭窄的独立危险因素（OR2.786,95%CI 1.096～7.081,P=0.031）。结论 与传统DES相比，置入BVS治疗复杂冠状动脉病变在3年内具有一致的安全性和有效性。靶病变直径狭窄比是支架内再狭窄的独立危险因素。

关键词(KeyWords)： 生物可吸收支架;药物洗脱支架;经皮冠状动脉介入治疗;冠心病

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 周登双,游琼,莫海亮,吴子君,林余标,陈陆军,范君宇,林永建,张瑞生,万佩姗,周卫国,吴铿

参考文献(References)：

• [1]Kerkmeijer LSM,Renkens MPL,Tijssen RYG,et al.Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents:final five-year results of the AIDA randomised clinical trial[J].Euro Intervention,2022,17(16):1340-1347.DOI:10.4244/EIJ-D-21-00419.
• [2]Kozuma K,Tanabe K,Hamazaki Y,et al.Long-term outcomes of Absorb bioresorbable vascular scaffold vs.Everolimus-Eluting Metallic Stent-a randomized comparison through 5 years in Japan[J].Circ J,2020,84(5):733-741.DOI:10.1253/circj.CJ-19-1184.
• [3]中华医学会心血管病学分会.冠状动脉生物可吸收支架临床应用中国专家共识[J].中华心血管病杂志,2020,48(5):350-358.DOI:10.3760/cma.j.cn112148-20200317-00224.
• [4]Ellis SG,Vandormael MG,Cowley MJ,et al.Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease.Implications for patient selection.Multivessel Angioplasty Prognosis Study Group[J].Circulation,1990,82(4):1193-1202.DOI:10.1161/01.cjr.82.4.1193.
• [5]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.DOI:10.3969/j.issn.1004-8812.2020.09.004.
• [6]Regazzoli D,Latib A,Ezhumalai B,et al.Long-term follow-up of BVS from a prospective multicenter registry:impact of a dedicated implantation technique on clinical outcomes[J].Int J Cardiol,2018,270:113-117.DOI:10.1016/j.ijcard.2018,06.094.
• [7]Capranzano P,Longo G,Tamburino CI,et al.Oneyear outcome s after Absorb biore sorbable vascular scaffold implantation in routine clinical practice[J].EuroIntervention,2016,12(2):e152-e159.DOI:10.4244/EIJV12I2A28.
• [8]Pan M,Romero M,Ojeda S,et al.Fracture of bioresorbable vascular scaffold after side-branch balloon dilation in bifurcation coronary narrowings[J].Am J Cardiol,2015,116(7):1045-1049.DOI:10.1016/j.amjcard.2015.07.015.
• [9]Naganuma T,Colombo A,Lesiak M,et al.Bioresorbable vascular scaffold use for coronary bifurcation lesions:a substudy from GHOST EU registry[J].Catheter Cardiovasc Interv,2016,89(1):47-56.DOI:10.1002/ccd.26634.
• [10]Erglis A,Narbute I,Sondore D,et a1.Four-year outcomes of left main percutaneous coronary intervention with a bioresorbable scaffold in the circumflex ostium[J].J Interv Cardiol,2022,2022:7934868.DOI:10.1155/2022/7934868.
• [11]Durmaz E,Karadag B,Ikitimur B,et al,The impact of lesion complexity on no-reflow phenomenon and predictors of reversibility in patients treated with primary percutaneous intervention[J].Coron Artery Dis,2020,31(8):678-686.DOI:10.1097/MCA.0000000000000889.
• [12]Iakovou I,Schmidt T,Bonizzoni E,et al.Incidence,predictors,and outcome of thrombosis after successful implantation of drug-eluting stents[J].JAMA,2005,293(17):2126-2130.DOI:10.1001/jama.293.17.2126.
• [13]Seo J,Ahn JM,Hong SJ,et al.Bioresorbable vascular scaffolds versus drug-eluting stents for diffuse long coronary narrowings[J].Am J Cardiol,2020,125(11):1624-1630.DOI:10.1016/j.amjcard.2020.02.031.
• [14]Reichart C,W?hrle J,Markovic S,et al.Clinical results of bioresorbable drug-eluting scaffolds in short and long coronary artery lesions using the PSP technique[J].BMC Cardiovasc Disord,2019,19(1):22.DOI:10.1186/s12872-018-0994-y.
• [15]Zhao J,Wang X,Wang H,et al.Occurrence and predictive factors of restenosis in coronary heart disease patients underwent sirolimus-eluting stent implantation[J].Ir J Med Sci,2020,189(3):907-915.DOI:10.1007/s11845-020-02176-9.
• [16]Wei L,Leo HL,Chen Q,et al.Structural and hemodynamic analyses of different stent structures in curved and stenotic coronary artery[J].Front Bioeng Biotechnol,2019,7:366.DOI:10.3389/fbioe.2019.00366.
• [17]Wang YC,Kao HL,Wu CK,et al.Lesion impacts on longterm outcomes in patients implanted with bioresorbable vascular scaffold[J].J Formos Med Assoc,2022,121(8):1458-1465.DOI:10.1016/j.jfma.2021.10.012.
• [18]Anadol R,Lorenz L,Weissner M,et al.Characteristics and outcome of patients with complex coronary lesions treated with bioresorbable scaffolds:three-year follow-up in a cohort of consecutive patients[J].EuroIntervention,2018,14(9):e1011-e1019.DOI:10.4244/EIJ-D-17-00410.