药物涂层球囊在真实世界中治疗冠状动脉原发病变的有效性和安全性分析

Efficacy and Safety of Drug Coated Balloon for Coronary de Novo Lesions in Real World

目的:分析药物涂层球囊在真实世界中治疗冠状动脉原发病变的有效性和安全性。方法:连续入选2020年1月至2021年6月在中国医学科学院阜外医院接受药物涂层球囊治疗的冠状动脉原发病变患者912例,根据病变血管直径分为大血管病变组(血管直径≥2.75 mm,n=337)和小血管病变组(血管直径<2.75 mm,n=575)。通过病历查询记录患者基线资料、介入治疗数据,以及住院期间及随访期间的主要不良心脑血管事件。主要不良心血管事件(MACE)定义为心原性死亡、非致死性急性心肌梗死、靶病变血运重建的复合终点。结果:912例患者共有940支冠状动脉原发病变。共使用药物涂层球囊974个,平均直径(2.6±0.8)mm,平均长度(21.0±6.0)mm,平均压力(10.0±3.8)atm(1atm=101.325kPa)。940支冠状动脉原发病变中343支病变血管直径≥2.75mm,597支病变血管直径<2.75mm。住院期间,2例(0.2%)急性ST段抬高型心肌梗死患者经急诊经皮冠状动脉介入治疗后死于心脏破裂。1例(0.1%)患者因冠状动脉血肿导致急性血管闭塞进行了靶病变血运重建给予药物洗脱支架治疗。5例患者在药物涂层球囊治疗后即刻出现C型夹层接受药物洗脱支架治疗。平均随访(23.4±4.2)个月期间,MACE发生率为1.9%(17例)。15例(1.6%)患者进行了靶病变血运重建(其中1例行冠状动脉旁路移植术),1例(0.1%)患者心原性死亡,1例(0.1%)患者发生非致死性急性心肌梗死,2例(0.2%)患者因出血性脑卒中死亡,1例(0.1%)患者因缺血性脑卒中死亡。大血管病变组和小血管病变组MACE发生率差异无统计学意义(1.8%vs.1.9%,P>0.05)。结论:药物涂层球囊治疗冠状动脉原发病变安全、有效。病变血管直径≥2.75 mm和病变血管直径<2.75 mm的患者MACE发生率差异无统计学意义。

Objectives:To analyze the efficacy and safety of drug coated balloon for coronary de novo lesions in real world.Methods:We enrolled consecutive patients with coronary de novo lesions treated with drug coated balloons from January 2020 to June 2021 in Fuwai Hospital.The baseline data,procedure data and in-hospital cardiac events were collected through case query.All patients were followed up by clinical visit or telephone call.Major adverse cardiac events(MACE)were defined as the composite of the cardiac death,acute myocardial infarction,target lesion revascularization.According to the diameter of the blood vessels,the patients are divided into the large vessel lesion group(vessel diameter≥2.75 mm,n=337),and the small vessel lesion group(vessel diameter<2.75 mm,n=575).Results:There were 940 coronary de novo lesions in 912 patients.A total of 974 drug balloons were used,average diameter was(2.6±0.8)mm,average length was(21.0±6.0)mm,average pressure was(10.0±3.8)atm.Among the 940 primary coronary artery lesions,343 lesions had a diameter≥2.75 mm,and 597 lesions had a diameter<2.75 mm.During hospitalization,two patients with acute ST-segment elevation myocardial infarction died of cardiac rupture after emergency coronary interventional treatment,acute vessel closure because of coronary hematoma occurred in 1 patient and bailout drug-eluting stent was used in this patient,five patients received salvage stent treatment due to type C dissection immediately after drug coated balloon treatment.During follow-up,Target lesion revascularization(TLR)occurred in 15(1.6%)patients(including coronary artery bypass grafting in 1 patient).Nonfatal acute myocardial infarction occurred in 1 patient,cardiac death occurred in 1 patient,2 patients died of cerebral hemorrhage,1 patient died of cerebral infarction,MACE rate was 1.9%(17/912).MACE rate during follow-up was similar between large vessels group and small vessels group(1.8%vs.1.9%,P>0.05).Conclusions:Our study indicates that drug coated balloon for coronary de novo lesion is safe and effective.There is no difference of MACE rate between large vessel group and small vessel group.