药物涂层球囊与药物洗脱支架在冠状动脉重度狭窄并钙化结节介入治疗中疗效观察

Applications of drug-coated balloon and drug-eluting stent in percutaneous coronary intervention for severe stenosis and calcified nodules of coronary artery

目的比较冠状动脉重度狭窄合并钙化结节患者经皮冠状动脉介入治疗(PCI)中应用药物涂层球囊与药物洗脱支架的效果及安全性,探讨药物涂层球囊的应用价值。方法2021年1月—2022年6月阜外华中心血管病医院行PCI的冠状动脉重度狭窄合并钙化结节患者82例,应用药物涂层球囊者35例为球囊组,应用药物洗脱支架者47例为支架组。2组均于PCI前、后即刻行血管内超声检查,记录PCI前最大钙化弧度、最小管腔面积、最小管腔直径、钙化长度、钙化结节处管腔面积、钙化结节凸向管腔长度,PCI后最小管腔面积、相对膨胀率、对称率、即刻管腔获得面积、钙化结节处管腔面积;比较2组病变部位、病变类型、血管狭窄程度、PCI预处理方法;记录PCI预处理后冠状动脉夹层发生情况及PCI后慢血流/无复流、支架贴壁不良、冠状动脉穿孔、支架脱载、急性心肌梗死等并发症发生情况。随访至2023年5月,记录主要心血管不良事件(MACE)发生情况。结果2组年龄、体质量指数、合并症,男性、吸烟、饮酒比率及PCI前血管最大钙化弧度、最小管腔面积、最小管腔直径、钙化长度、钙化结节处管腔面积、结节凸向管腔长度比较差异均无统计学意义(P>0.05)。球囊组PCI预处理行冠状动脉腔内斑块旋磨术比率(51.43%)高于支架组(21.28%)(χ^(2)=10.572,P=0.005),PCI后最小管腔面积[4.00(3.58,4.51)mm^(2)]、即刻管腔获得面积[2.03(2.58,2.63)mm^(2)]、钙化结节处管腔面积[4.32(3.90,5.00)mm^(2)]均小于支架组[4.88(4.21,5.42)、2.50(2.00,3.23)、5.20(4.60,6.87)mm^(2)](P<0.05),相对膨胀率[93.20(88.89,95.64)%]高于支架组[87.83(80.03,94.25)](Z=2.423,P=0.015),病变部位、病变类型、血管狭窄程度及对称率与支架组比较差异均无统计学意义(P>0.05)。球囊组PCI预处理后A/B型冠状动脉夹层发生率(42.86%)高于支架组(21.28%)(χ^(2)=4.408,P=0.036)。球囊组PCI预处理后发生C型冠状动脉夹层1例,支架组PCI后发生慢血流/无复流1例、支架贴壁不良3例。2组PCI后均未发生冠状动脉穿孔、支架脱载、急性心肌梗死和死亡等严重并发症。随访至2023年5月,球囊组4例发生MACE,支架组3例发生MACE。结论冠状动脉重度狭窄合并钙化结节患者PCI应用药物涂层球囊、药物洗脱支架均可有效开通病变血管,药物涂层球囊可避免支架贴壁不良,不增加术后MACE的发生风险。

Objective To compare the therapeutic efficacy and safety of drug-coated balloon and drug-eluting stent in percutaneous coronary intervention(PCI)on severe stenosis and calcified nodules of coronary artery,and to explore the application value of drug-coated balloon.Methods Eighty-two patients with severe coronary artery stenosis and calcified nodules were performed PCI in Fuwai Central China Cardiovascular Hospital from January 2021to June 2022,among whom 35patients used drug-coated balloon(balloon group)and 47patients used drug-eluting stent(stent group).Intravascular ultrasound examinations were performed before and after PCI in both groups to measure the maximum calcification arc,minimum lumen area,minimum lumen diameter,calcification length,lumen area of calcified nodule and protruding length of calcified nodules before PCI,and the minimum lumen area,relative expansion rate,symmetry rate,immediate lumen gain area and lumen area of calcified nodule after PCI.The lesion location,lesion type,stenosis degree and PCI pre-treatment strategies were compared between two groups.The occurrences of coronary artery dissection after PCI pre-treatment,and postoperative complications such as slow flow/no reflow,incomplete stent apposition,coronary artery perforation,stent dislodgment,and acute myocardial infarction were recorded.The follow-up continued till May2023to record the major adverse cardiovascular events(MACEs).Results There were no significant differences in the age,body mass index,comorbidity,proportions of males,smoking history and alcohol consumption history,and pre-PCI vascular parameters including maximum calcification arc,minimum lumen area,minimum lumen diameter,calcification length,lumen area of calcified nodule,and nodule protruding length between two groups(P>0.05).The rate of coronary transluminal rotational atherectomy in PCI pre-treatment was higher in balloon group(51.43%)than that in stent group(21.28%)(χ^(2)=10.572,P=0.005),the post-PCI minimum lumen area,immediate lumen gain area and lumen area of calcified nodule were larger in balloon group[4.00(3.58,4.51),2.03(2.58,2.63),4.32(3.90,5.00)mm^(2)]than those in stent group[4.88(4.21,5.42),2.50(2.00,3.23),5.20(4.60,6.87)mm^(2)](P<0.05),the relative expansion rate was higher in balloon group[93.20(88.89,95.64)%]than that in stent group[87.83(80.03,94.25)%](Z=2.423,P=0.015),while the lesion location,lesion type and stenosis degree in PCI pre-treatment showed no significant differences between two groups(P>0.05).After PCI pre-treatment,the incidence of A/B-type dissections was higher in balloon group(42.86%)than that in stent group(21.28%)(χ^(2)=4.408,P=0.036).After PCI pre-treatment,C-type dissection developed in 1 patient in balloon group,slow flow/no flow developed in 1 patient in stent group,and incomplete stent apposition developed in 3patients in stent group.No serious complications occurred after PCI in two groups,such as coronary artery perforation,stent dislodgment,acute myocardial infarction and death.The follow-up till May 2023showed MACEs developed in 4patients in balloon group and 3patients in stent group.Conclusion Both drugcoated balloon and drug-eluting stent can effectively open the diseased vessels in patients with severe coronary artery stenosis and calcified nodules,and the drug-coated balloon is superior to the drug-eluting stent in preventing incomplete stent apposition and reducing the risk of MACEs after PCI.