药物洗脱球囊与药物洗脱支架治疗冠状动脉支架内再狭窄的效果及预后对比

Efficacy and outcomes of drug-coated balloon vs drug-eluting stent in treatment of coronary in-stent restenosis

目的比较药物洗脱球囊(DCB)与药物洗脱支架(DES)治疗冠脉支架内再狭窄(ISR)的效果及对预后的影响。方法选取2017年2月至2019年2月本院收治的ISR患者60例为研究对象,随机分为观察组、对照组,均30例,观察组予以DCB治疗,对照组予以DES治疗,比较两组基线资料、冠脉内超声结果、支架特征,并对比其治疗及随访1年后冠脉内超声结果、主要不良心血管事件发生率、预后情况。结果观察组与对照组的基线资料比较差异均无统计学意义(P>0.05);观察组冠脉支架再狭窄病变特征与对照组比较差异无统计学意义(P>0.05);观察组术中平均扩张压低于对照组,而扩张时间较对照组延长,观察组支架内管腔狭窄率、节段内管腔狭窄率高于对照组,而支架内晚期管腔丢失、支架内最小管腔直径较对照组小(P<0.05);术后随访1年,观察组支架内管腔狭窄率、支架内最小管腔直径、支架内晚期管腔丢失、二次再狭窄率、总MACE事件发生率、全因死亡率、STEMI、TVR发生率与对照组比较差异无统计学意义(P>0.05)。结论发生ISR时,采用DCB可获得与DES治疗相似的临床疗效,且安全性好,为ISR避免再次支架植入提供新治疗策略。

Objective To compare therapeutic efficacy of drug-coated balloon(DCB)and drug-eluting stent(DES)in coronary in-stent restenosis(ISR)and their impacts on prognosis.Methods Included in this study were 60 ISR patients admitted to the hospital between February 2017 and February 2019.The subjects were randomized into the study group and control group randomly(n=30) each.The study group was treated with DCB,while the control group was treated with DES.The general information,intra-coronary ultrasound findings and stent features at baseline,intra-coronary ultrasound findings immediately and at the 1-year follow-up after treatment,incidence of major adverse cardiovascular events(MACE),and prognosis were compared between the two groups.Results There were no significant differences in general information(P>0.05),intra-coronary ultrasound findings and stent features at baseline between the two groups(P>0.05).After the procedure,the study group showed lower mean inflation pressure,prolong inflation time,more ISR and in-segment restenosis,less late in-stent lumen loss and smaller minimum in-stent lumen diameter,compared with the control group(P<0.05).After 1-year follow-up,there were no significant differences in in-stent luminal stenosis,minimum in-stent lumen diameter,late in-stent and in-segment lumen loss,secondary,total incidence of MACE,all-cause mortality,ST-elevation myocardial infarction(STEMI)or target vessel revascularization(TVR)between the two groups(P>0.05).Conclusion The use of DCB may result in therapeutic efficacy clinically comparable to DES in ISR,with favorable safety.This offers new treatment strategies for ISR for avoidance of re-stenting.