基于真实世界证据的药物涂层球囊治疗冠脉支架内再狭窄病变的临床使用评价

Clinical evaluation of drug-coated balloon treatment for coronary stent restenosis based on real-world evidence

目的探讨真实世界中不同紫杉醇药物涂层球囊(Drug Coated Balloon,DCB)在治疗冠脉支架内再狭窄病变中的临床疗效。方法选择2022年1月—2022年12月接受介入治疗的冠脉支架内再狭窄且有完整随访记录的患者75例为研究对象,根据DCB生产厂家的不同,分为国产组和进口组。根据相关临床资料,对其安全性、有效性及经济性等指标进行统计学分析。结果两组靶病变所处靶血管分布比较,差异无统计学意义(P<0.05)。靶病变的预处理及DCB处理相关内容比较,仅扩张压力方面,国产组略大于进口组,差异有统计学意义,其余指标差异均无统计学意义(P<0.05)。两组患者术中及随访阶段心血管不良事件均未发生。两组DCB使用个数、DCB费用、住院天数及费用方面,差异无统计学意义(P<0.05)。结论DCB在冠脉ISR病变介入治疗中使用效果较好,术后随访情况有待进一步跟踪,真实世界数据有待扩充。

Objective To investigate the clinical effect of different paclitaxel drug coated balloon(DCB)in the treatment of coronary stent restenosis(ISR)in the real world.Methods A total of 75 patients with coronary stent restenosis who received interventional therapy from January 2022 to December 2022 with complete follow-up records were selected as subjects,and divided into domestic group and imported group according to DCB manufacturers.According to relevant clinical data,safety,effectiveness and economy were analyzed statistically.Results There was no significant difference in the target vascular distribution between the two groups(P<0.05).Compared with the pretreatment of target lesions and DCB treatment,only the expansion pressure in the domestic group was slightly greater than that in the imported group,the difference was statistically significant,while the differences in other indicators were not statistically significant(P<0.05).No adverse cardiovascular events occurred in both groups during operation and during follow-up.There was no significant difference in the number of DCB users,DCB cost,hospitalization days and cost(P<0.05).Conclusion DCB is effective in interventional therapy of coronary ISR lesions.Postoperative follow-up needs to be further tracked and real-world data needs to be expanded.