生物可吸收支架串联置入在急性冠脉综合征患者中的安全性分析:一项单中心回顾性研究

Safety analysis of bioresorbable scaffolds implanted in series connection in patients with acute coronary syndrome:a single-center retrospective study

目的评价生物可吸收支架(BRS)串联置入的安全性。方法本研究为回顾性队列研究,入选北部战区总医院2019年7月至2022年4月接受择期经皮冠状动脉介入治疗(PCI)并置入Neovas支架的急性冠脉综合征患者377例,其中串联BRS组63例和单BRS组314例。比较两组的PCI相关资料及随访期间全因死亡、心原性死亡、非致死性心肌梗死、靶血管血运重建、卒中及美国出血学术研究联合会(BARC)定义的2~5型出血,以及主要心脑血管不良事件(MACCE)、净不良事件的发生情况。其中,MACCE包括全因死亡、非致死性心肌梗死、靶血管血运重建及卒中,净不良事件包括MACCE及BARC 2~5型出血。手术即刻成功定义为支架成功置入的前提下,残余狭窄<20%且PCI术后靶血管达心肌梗死溶栓治疗血流3级。对串联BRS组的11例接受光学相干断层成像(OCT)检查患者的影像进行分析。结果最终入选的377例患者的年龄为(52.5±10.7)岁,其中男性比例80.4%(303/377)。2组的手术即刻成功率均为100%,串联BRS组的≥50%狭窄病变血管数、靶血管数、SYNTAX评分、后扩张球囊数、导丝数、支架总长度、对比剂用量及手术时长等均高于单BRS组(P均<0.05)。串联BRS组与单BRS组比较血管内超声及OCT应用比例差异无统计学意义(P均>0.05)。单BRS组1例患者于术后住院期间发生缺血性卒中,两组住院期间无死亡、非致死性心肌梗死、靶血管血运重建及BARC 2~5型出血事件发生。随访时间352.0(193.0,421.0)d。随访期内全因死亡[0比0.6%(2/314),P=1.000]、心原性死亡[0比0.3%(1/314),P=1.000]、非致死性心肌梗死[0比1.0%(3/314),P=1.000]、靶血管血运重建[3.2%(2/63)比1.6%(5/314),P=0.736]、BARC 2~5型出血[3.2%(2/63)比5.7%(18/314),P=0.604]及MACCE[3.2%(2/63)比2.9%(9/314),P=0.894]、净不良事件[6.3%(4/63)比8.6%(27/314),P=0.553]的发生率2组间比较差异均无统计学意义。串联BRS组11例(17.5%)患者的OCT分析结果显示,3例(27.3%)为BRS首尾紧密相连的无重叠连接,即刻支架膨胀率(95.47±0.04)%;8例(72.7%)为BRS重叠连接,即刻支架膨胀率(90.32±0.44)%。结论在中低危的急性冠脉综合征患者中,冠状动脉长病变串联置入BRS安全可行,可获得与置入单枚BRS相同的近期疗效。

Objective Evaluate the safety of the bioresorbable scaffold(BRS)series implanted.Methods This is a cohort study,which included 377 patients with acute coronary syndrome(ACS)who underwent elective percutaneous coronary intervention(PCI)with Neovas-BRS implantation from July 2019 to April 2022 at the Northern Command General Hospital.The patients were divided into the series BRS group(n=63)and single BRS group(n=314).We compared PCI related data between two groups,as well as all-cause death,cardiac death,non-fatal myocardial infarction,target vessel revascularization,stroke,and bleeding of type 2 to 5 defined by the Bleeding Academic Research Consortium of America(BARC)during follow-up.We also compared the major adverse cardiovascular and cerebrovascular events(MACCE),which includes all-cause death,non-fatal myocardial infarction,target vessel revascularization and stroke,as well as the net adverse clinical events(NACE),which includes MACCE and bleeding of BARC type 2 to 5.Procedural immediate success was defined as a residual stenosis of<20%with successful stent implantation and post-PCI target vessel flow grade up to TIMI 3.The images of 11 patients in the series BRS group who underwent optical coherence tomography(OCT)were analyzed.Results A total of 377 patients were finally enrolled,aged(52.5±10.7)years,including 80.4%(303/377)males.The immediate success rate of PCI was 100%in both groups.The number of≥50%stenotic lesions,number of target vessels,SYNTAX score,number of post-application expansion balloons,number of guidewires,total stent length,contrast volume and operation time were higher in the series BRS group than in the single BRS group(all P<0.05).There was no significant difference in the proportion of intravascular ultrasound and OCT application between the two groups.One patient in the single BRS group had an ischemic stroke during postoperative hospitalization,but there were no death,non-fatal myocardial infarction,target vessel revascularization,or BARC 2 to 5 bleeding events occurred during hospitalization in both groups.Follow up time was 352.0(193.0,421.0)days.There was no statistically significant difference between the two groups in the incidence of all-cause death(0 vs.0.6%(2/314),P=1.000),cardiogenic death(0 vs.0.3%(1/314),P=1.000),nonfatal myocardial infarction(0 vs.1.0%(3/314),P=1.000),target lesion revascularization(3.2%(2/63)vs.1.6%(5/314),P=0.736),BARC type 2 to 5 bleeding(3.2%(2/63)vs.5.7%(18/314),P=0.604),MACCE(3.2%(2/63)vs.2.9%(9/314),P=0.894),and NACE(6.3%(4/63)vs.8.6%(27/314),P=0.553)during the follow-up period.OCT results of the 11(17.5%)patients in the series BRS group indicated that 3 patients(27.3%)achieved non-overlapping connection,and the immediate stent expansion rate was(95.47±0.04)%.In 8 patients with BRS overlapping connections,immediate stent expansion rate was(90.32±0.44)%.Conclusion In patients with low to intermediate-risk ACS,serial implantation of RBS in long coronary lesions is safe and feasible,and achieves the similar short-term outcomes as single BRS implantation.