药物涂层球囊在前降支开口原位病变应用的临床研究

Clinical research on drug-coated balloon in the treatment of left anterior descending artery ostial lesions

目的:探讨药物涂层球囊(drug-coated balloon, DCB)治疗冠状动脉(冠脉)前降支开口原位病变的安全性与有效性。方法:收集2014年10月—2020年12月于郑州大学第一附属医院心内科造影显示前降支开口部位严重狭窄并接受冠脉介入治疗患者共146例,根据手术处理方式分为DCB组59例,药物洗脱支架(DES)组69例,DCB+补救性DES(联合组)18例,并对他们进行随访和冠脉造影定量分析(quantitative coronary angiography analysis, QCA)。结果:DCB组术后即刻及随访时最小管腔直径分别为(2.61±0.42) mm、(2.36±0.66) mm,小于DES组(3.05±0.43) mm、(2.81±0.74) mm及联合组(2.83±0.41) mm、(2.48±0.63) mm(P<0.05)。DCB组术后即刻直径狭窄程度为0.21(0.13,0.26),明显高于DES组0.10(0.07,0.15)和联合组0.09(0.07,0.19)(P<0.05),而在晚期管腔丢失方面,3组之间无统计学差异(P>0.05)。住院及随访期间,3组患者主要不良心血管事件及其他临床不良事件发生率无明显差异(P>0.05)。结论:与DES比较,DCB治疗前降支开口病变具有相似的安全性和有效性。使用DCB后进行补救性DES置入也是安全、有效的。

Objective To explore the safety and efficacy of drug-coated balloon(DCB) in the treatment of in situ lesions of the left anterior descending artery(LAD).Methods A total of 146 patients with severe stenosis at the ostium of LAD confirmed by coronary angiography from October 2014 to December 2020 were enrolled. They were divided into three groups based on treatment strategy: DCB group(n=59), DES group(n=69), and DCB with bail-out stenting(combination) group(n=18). All patients were followed up and underwent quantitative coronary angiography analysis(QCA).Results The DCB group had a lower minimum lumen diameter(MLD) at immediate postoperative and follow-up time points, with values of 2.61±0.42 mm and 2.36±0.66 mm, respectively, compared to the DES group(3.05±0.43 mm and 2.81±0.74 mm) and the combination group(2.83±0.41 mm and 2.48±0.63 mm)(P < 0.05). The immediate postoperative diameter stenosis(DS) of the DCB group was 0.21(0.13, 0.26), which was significantly higher than that of the DES group[0.10(0.07, 0.15)]and the combination group[0.09(0.07, 0.19)](P < 0.05). However, there was no statistical difference in late lumen loss among the three groups(P>0.05). During hospitalization and follow-up, there was no significant differences in the incidence of major adverse cardiac events(MACE) and other clinical adverse events among the three groups(P>0.05).Conclusion Compared with DES, DCB treatment for LAD ostial lesions has similar safety and efficacy. The use of DCB followed by bail-out stenting is also safe and effective.