【作者】 王杰；

【导师】 韩战营；

【作者基本信息】 郑州大学 ， 内科学（心血管）（专业学位）， 2025， 硕士

【摘要】 背景急性心肌梗死(Acute myocardial infarction,AMI)是冠状动脉疾病最严重的类型,其发病急,进展快,如不及时干预,严重影响患者预后。对于AMI患者,及时再灌注治疗以恢复冠脉血运是治疗的关键。经皮冠状动脉介入治疗(Percutaneous coronary intervention,PCI)因适用范围广、创伤小且疗效确切,在AMI再灌注治疗领域得到了临床的广泛认可。目前采用新一代药物洗脱支架(Drug-eluting stent,DES)的PCI已成为AMI的主要治疗策略。然而,DES的应用仍面临一些挑战如支架内再狭窄、支架内血栓形成以及长期双联抗血小板治疗导致出血风险增加等问题。为解决这些问题,药物涂层球囊(Drug-coated balloon,DCB)应运而生。DCB通过球囊扩张技术,在不植入永久性器械的情况下,将抗增殖药物迅速且均匀地输送到血管壁内。这种方法避免了金属聚合物持续刺激血管内皮,减少了血管炎症,降低了血栓形成的风险。同时,DCB的使用能够保留血管内皮的正常功能,为患者提供了一种治疗新选择。目前已经有多项研究证实DCB治疗AMI安全有效。但DCB的使用对于血管条件要求较高,心肌梗死急性期时,梗死相关动脉中存在大量血栓,且血管内皮受炎症影响导致水肿和舒缩功能障碍,都会在一定程度上影响DCB涂层药物向血管壁的输送,可能降低急诊DCB治疗效果,而延迟DCB则可避免这些问题,因此理论上效果可能优于急诊DCB。但有关急诊DCB和延迟DCB两种不同的治疗策略是否存在疗效上的明显差异,目前尚缺乏相关研究。目的1.探讨采用单纯DCB策略治疗急性心肌梗死时,不同的DCB应用时机(急诊和延迟)疗效是否有差异。2.探索急性心肌梗死患者单纯DCB治疗术后1年靶病变血运重建的危险因素。方法本研究回顾性连续入选2021年1月份-2023年12月份就诊于郑州大学第一附属医院并于发病24小时内或发病后7-14天行单纯DCB治疗的急性心肌梗死患者,根据DCB应用时机分为急诊组(发病24小时内)和延迟组(发病后7-14天)。通过电子病历系统收集所有患者的临床基线数据、手术资料及冠脉造影图像。利用定量冠状动脉造影分析软件测定DCB治疗前、术后即刻及随访时的造影相关指标,并对这三次造影影像的相关指标进行计算和分析。通过电话随访收集患者术后1年的不良事件发生情况。纳入多种可能影响终点的变量进行多因素Logistic回归分析以探究TLR相关危险因素。结果1.研究纳入患者204例,其中急诊DCB组74人,延迟DCB组130人。急诊DCB组的男性比例低于延迟DCB组(75.68%vs 86.92%,P=0.040);急诊DCB组和延迟DCB组的STEMI比例相近(70.27%vs 62.31%,P=0.251);其他既往史及危险因素方面两组差异不显著(P>0.05)。在检验指标方面,急诊DCB组平均甘油三酯水平高于延迟DCB组[1.60(1.10,2.48)mmol/Lvs 1.35(0.90,1.79)mmol/L,P=0.006];急诊DCB组心功能指标NT-proBNP小于延迟DCB组[208.50(121.47,865.96)pg/ml vs 578.00(217.00,1433.00)pg/ml,P=0.001],LVEF、eGFR、HbA1C、LDL-C、CRP等两组无差异。用药方面,急诊组替格瑞洛应用比例更高(79.73%vs 61.54%,P=0.007),其余药物使用两组没有显著差异。2.在病变特征方面,延迟DCB组术前罪犯血管TIMI血流3级的比例更高(22.97%vs 60.00%,P<0.001);急诊DCB组和延迟DCB组均以前降支为主(43.24%vs 43.41%,P=0.981),多支病变比例相近(36.49%vs 39.23%,P=0.698);急诊DCB组高血栓负荷比例显著高于延迟DCB组(28.38%vs 11.54%,P=0.002)。在病变处理方面,急诊DCB组使用药物球囊的数量少于延迟DCB组(1.05±0.23 vs 1.25±0.50,P=0.002);急诊组冠脉内溶栓的比例更高(8.11%vs 0.00%,P=0.004),同时急诊组(9.46%)血栓抽吸的比例高于延迟组(2.31%),但差异无统计学意义(P=0.053);急诊DCB组应用IVUS的比例较低(9.59%vs 21.54%,P=0.031),两组在其余处理方面如动脉入路、药物球囊直径及长度、预处理球囊的使用、完全性血运重建比例等无明显差异(P均>0.05)。3.急诊DCB组和延迟DCB组中位造影随访时间分别为12个月和11个月,完成冠脉造影复查的比例为28.9%。急诊DCB组和延迟DCB组术前的最小管腔直径[0.00(0.00,0.25)mm vs 0.00(0.00,0.25)mm,P=0.234]和直径狭窄率[100.00(87.89,100.00)%vs 100.00(82.57,100.00)%,P=0.393]相近。两组术后即刻的最小管腔直径(1.92±0.41mmvs 1.90±0.43mm)、直径狭窄率[13.24(12.01,25.67)%vs 15.70(12.82,20.54)%]和管腔获得(1.78±0.48mmvs 1.66±0.50mm)无明显差异(P均>0.05)。随访时两组在最小管腔直径(1.87±0.69mm vs 1.69±0.80mm)、直径狭窄率[22.14(14.32,34.62)%vs 23.48(11.80,57.44)%]、晚期管腔丢失[-0.02(-0.21,0.15)mm vs-0.01(-0.36,0.70)mm]、管腔净获得[1.82(1.27,2.04)mm vs 1.62(0.97,2.12)mm]、晚期管腔增大比例(50.00%vs51.35%)方面的差异均无统计学意义(P>0.05)。4.住院期间所有患者均未发生MACE事件。随访期间,两组TLR发生率无统计学差异(6.94%vs 10.32%,P=0.427)。两组心源性死亡、非致命性心肌梗死、心力衰竭、TVR等事件发生率均无明显差异(P均>0.05)。5.多因素Logistic回归分析提示:高血栓负荷将增加DCB术后1年TLR的风险(OR=3.833,95%CI:1.188-12.365,P=0.025),其他因素均与术后 1 年TLR发生无关。亚组分析的结果提示:在STEMI和NSTEMI两个亚组中,急诊DCB策略和延迟DCB策略术后1年的TLR发生率无统计学差异(P均>0.05)。结论1.对接受单纯DCB治疗的AMI患者,急诊DCB治疗和延迟DCB治疗术后1年的TLR和MACE发生率没有明显差异。2.对接受单纯DCB治疗的AMI患者,高血栓负荷是术后1年TLR的独立危险因素。更多还原

【Abstract】 BackgroundAcute myocardial infarction(AMI)is the most serious type of coronary artery disease.It has an acute incidence and rapid progress.If timely intervention is not done,it will seriously affect the patient’s prognosis.For AMI patients,timely reperfusion treatment to restore coronary blood circulation is the key to treatment.Percutaneous coronary intervention(PCI)has been widely recognized in the field of AMI reperfusion treatment due to its wide application range,low trauma and accurate efficacy.Currently,PCI using a new generation of drug-eluting stent(DES)has become the main therapeutic strategy for AMI.However,the application of DES still faces some challenges,including intrastent restenosis,intrastent thrombosis,and the potential risk of bleeding from long-term dual antiplatelet therapy.To solve these problems,drug-coated balloons(DCB)emerged.DCB uses balloon expansion technology to deliver antiproliferative drugs quickly and evenly into the blood vessel wall without implanting permanent devices.This treatment avoids the continuous irritation of metal polymers in the vascular endothelium,reduces vascular inflammation,and reduces the risk of thrombosis.At the same time,the use of DCB can retain the normal function of the vascular endothelium,providing patients with a new treatment option.There have been several studies that have confirmed that DCB is safe and effective in treating AMI.However,the use of DCB has high requirements for vascular conditions.In the acute stage of myocardial infarction,there are a large number of thrombosis in the infarction-related arteries,and the vascular endothelium is affected by inflammation and causes edema and comfort dysfunction,which will affect the delivery of DCB coated drugs to the blood vessel wall to a certain extent,which may reduce the therapeutic effect of emergency DCB,and delaying DCB can avoid these problems.Therefore,the theoretical effect may be better than emergency DCB.However,there is currently a lack of relevant research on whether there are obvious differences in efficacy between two different treatment strategies,emergency DCB and delayed DCB.Object1.Explore whether there are differences in the efficacy of different DCB application timing(emergency and delay)when using a simple DCB strategy to treat acute myocardial infarction.2.Exploring the risk factors of target lesion revascularization in patients with acute myocardial infarction 1 year after DCB treatment.MethodsThis study was retrospectively selected for patients with acute myocardial infarction who visited Hospital from January 2021 to December 2023 and underwent DCB treatment within 24 hours of onset or 7-14 days after onset.According to the timing of DCB application,the It is divided into emergency group(within 24 hours of onset)and delay group(7-14 days after onset).Clinical baseline data,surgical data and coronary angiography images of all patients were collected through the electronic medical record system.Quantitative coronary angiography software was used to determine the contrast-related indicators before,immediately after DCB treatment,and at follow-up visits,and the relevant indicators of these three contrast images were calculated and analyzed.The incidence of adverse events in patients 1 year after surgery was collected by telephone follow-up.Multiple variables that may affect endpoints were included for multifactorial Logistic regression analysis to explore TLR-related risk factors.Results1.The study included 204 patients,including 74 in the emergency DCB group and 130 in the delayed DCB group.The proportion of males in the emergency DCB group was lower than that in the delayed DCB group(75.68%vs 86.92%,P=0.040);the proportion of STEMI in the emergency DCB group and the delayed DCB group was similar(70.27%vs 62.31%,P=0.251);other previous The differences between the two groups were not significant in history and risk factors(P>0.05).In terms of test indicators,the average triglyceride level in the emergency DCB group was higher than that in the delayed DCB group[1.60(1.10,2.48)mmol/L vs 1.35(0.90,1.79)mmol/L,P=0.006];the cardiac function index NT-proBNP in the emergency DCB group was less than that in the delayed DCB group[208.50(121.47,865.96)pg/ml vs 578.00(217.00,1433.00)pg/ml,P=0.001],and there was no difference between the two groups,including LVEF,eGFR,HbA1C,LDL-C,and CRP.In terms of medication use,the proportion of ticagrelor application in the emergency group was higher(79.73%vs 61.54%,P=0.007),and there was no significant difference between the remaining medication use groups.2.In terms of lesion characteristics,the proportion of preoperative vascular TIMI blood flow level 3 of criminals in delayed DCB group was higher(22.97%vs 60.00,P<0.001);both the emergency DCB group and the delayed DCB group were mainly LAD(43.24%vs 43.41%,P=0.981),the proportion of multiple lesions is similar(36.49%vs 39.23%,P=0.698);the proportion of hyperthrombotic load in the emergency DCB group was significantly higher than that in the delayed DCB group(28.38%vs 11.54%,P=0.002)In terms of lesion management,the number of drug balloons used in the emergency DCB group was less than that in the delayed DCB group(1.05±0.23 vs 1.25±0.50,P=0.002);the proportion of intracoronary thrombolysis in the emergency group was higher(8.11%vs 0.00%,P=0.004),and the proportion of thrombus aspiration in the emergency group(9.46%)was higher than the other group(2.31%),but the difference was not statistically valuable(P=0.053);the proportion of IVUS applied in the emergency DCB group was relatively high.Low(9.59%vs 21.54%,P=0.031),there were no significant differences between the two groups in other treatments such as arterial approach,drug balloon diameter and length,use of pretreated balloons,and proportion of complete revascularization(P>0.05).3.The median follow-up time of the emergency DCB group and the delayed DCB group was 12 months and 11 months,respectively,and the proportion of coronary angiography reexamination was 28.9%.The minimum lumen diameter[0.00(0.00,0.25)mm vs 0.00(0.00,0.49)mm,P=0.234]and diameter stenosis rate[100.00(87.89,100.00)%vs 100.00(82.57,100.00)%,P=0.393]were similar.There was no significant difference between the minimum lumen diameter(1.92±0.41 mm vs 1.90±0.43 mm),diameter stenosis rate[13.24(12.01,25.67)%vs 15.70(12.82,20.54)%]and lumen acquisition(1.78±0.48 mm vs 1.66±0.50 mm)(both P>0.05).At follow-up,there was no significant difference between the two groups in the minimum lumen diameter(1.87±0.69mm vs 1.69 ± 0.80mm),diameter stenosis rate[22.14(14.32,34.62)%vs 23.48(11.80,57.44)%],late lumen loss[-0.02(-0.21,0.15)mm vs-0.01(-0.36,0.70)mm],net lumen acquisition[1.82(1.27,2.04)mm vs 1.62(0.97,2.12)mm],and late lumen enlargement(50.00%vs 51.35%)(P>0.05).4.No MACE incident occurred in all patients during hospitalization.Follow-up data indicated no meaningful statistical variation in TLR rates between the groups(6.94%vs 10.32%,P=0.427).The incidence of cardiac death,non-lethal MI,HF occurrences,and revascularization of the intended vessels were also similar across both groups.5.Multivariate Logistic regression analysis suggested that high thrombosis burden will increase the risk of TLR 1 year after DCB surgery(OR=3.833,95%CI:1.188-12.365,P=0.025),and other factors were not related to the occurrence of TLR 1 year after surgery.The results of the subgroup analysis showed that there was no statistical difference in the incidence of TLR in the two subgroups of STEMI and NSTEMI in the emergency DCB strategy and the delayed DCB strategy 1 year after surgery(P>0.05)Conclusion1.There was no significant difference in the incidence of TLR and MACE in patients with AMI who received DCB treatment alone and delayed DCB treatment 1 year after surgery.2.For AMI patients treated with DCB alone,hyperthrombotic burden is an independent risk factor for TLR 1 year after surgery.更多还原