药物涂层球囊与药物洗脱支架治疗冠状动脉原发病变的疗效与安全性比较

Efficacy comparison of primary percutaneous coronary intervention by drug-coated balloon angioplasty or drug-eluting stenting in acute myocardial infarction patients with de novo coronary lesions

目的对比药物球囊(DCB)与药物洗脱支架(DES)在接受急诊冠状动脉介入治疗(PCI)的急性心肌梗死(AMI)患者中的有效性与安全性。方法本研究为回顾性研究,连续入选2016年1月至2019年5月在首都医科大学附属北京朝阳医院接受急诊PCI的AMI患者380例,其中接受DCB治疗者180例(DCB组),置入DES者200例(DES组)。比较两组患者的预后,主要指标包括院内及出院后3个月内的主要不良心血管事件(MACE),即由心原性死亡、非致命性心肌梗死、靶血管血运重建(TVR)及支架内血栓形成构成的复合指标。次要指标包括:(1)PCI治疗前后梗死相关血管的TIMI血流分级及其心肌灌注(TMP)分级;(2)PCI治疗后0.5~2 h内心电图ST段回落程度,即ST段回落率(取ST段抬高最显著的导联,计算在治疗后ST段下降的比率;或ST段压低最显著的导联,在治疗后ST段恢复的比率),将ST段回落率<50%定义为ST段回落不良;(3)术中冠状动脉夹层的发生情况;(4)心肌酶升高峰值;(5)院内及出院后3个月内的出血事件发生率。基于倾向性评分逆概率加权法(IPTW),应用logistic回归模型比较两种介入治疗方法对MACE发生的影响。结果两组患者在性别、年龄、冠心病危险因素、心肌梗死类型与部位、靶血管及介入治疗手术资料等方面差异均无统计学意义(P均>0.05)。DCB组分叉病变的比率明显高于DES组(P<0.05);DCB组的球囊直径较DES组的支架直径小,而长度更长(P均<0.05)。两组住院期间各死亡1例;与DES组比较,DCB组住院期间心肌梗死发生率[2.8%(5/180)比0.5%(1/200),P=0.10]和TVR比率[2.8%(5/180)比0.5%(1/200),P=0.10]更高,但差异无统计学意义,且大多与迟发夹层相关;两组住院期间MACE发生率差异无统计学意义[3.3%(6/180)与1.0%(2/200),P=0.15]。出院后3个月内,两组均未发生MACE。两组患者的术后TIMI血流分级、TMP分级、心电图ST段回落不良率及心肌酶峰值差异均无统计学意义(P均>0.05)。DCB组的术中冠状动脉夹层发生率高于DES组[8.3%(15/180)比3.0%(6/200),P=0.02],但是多为B型以下夹层,无需特殊处理。两组的出血发生率差异无统计学意义(P=0.91)。采用倾向性评分控制混杂因素后,logistic回归分析结果显示对于接受急诊PCI的AMI患者,采用DES及DCB治疗,院内发生MACE的风险差异无统计学意义(以DCB为对照,OR=0.35,95%CI0.08~1.43,P=0.13)。结论对于接受急诊PCI治疗的AMI患者,使用DCB与DES同样安全、有效。使用DCB治疗者的术中冠状动脉夹层发生率高于DES,但多为B型以下。另外,因迟发性冠状动脉夹层致使DCB的在院心肌梗死发生率偏高,须密切关注与高度警惕DCB后的迟发冠状动脉夹层问题。

ObjectiveTo compare the safety profile,angiographic and clinical outcomes between drug-coated balloon(DCB)only strategy versus drug eluting stent(DES)implantation in primary percutaneous coronary intervention(PCI)for acute myocardial infarction(AMI)patients.MethodsA total of 380 AMI patients who underwent primary PCI in Beijing Chaoyang Hospital from January 2016 to May 2019 were enrolled.They were allocated into DEB group(n=180)or DES group(n=200).The Primary endpoint was the major adverse cardiac events(MACE)in hospital and within 3 months after discharge,the composite event of cardiac death,non-fatal myocardial infarction(MI),target vessel revascularization(TVR)and in stent thrombosis.The secondary endpoints included:(1)TIMI blood flow grade and myocardial perfusion grade(TMP grade)of infarct-related vessels before and after PCI.(2)The degree of ST segment resolution(STR)between half hour and two hours after PCI,and STR was represented by percentage of summed ST-segment reduction between baseline and post-PCI.Using the most significant lead of ST segment elevation,calculating the rate of decline in the ST segment after treatment;or the most significant lead of the ST segment depression,to calculate the rate of recovery in the ST segment after treatment.STR<50%was defined as incomplete STR.(3)The occurrence of coronary artery dissection during operation.(4)The peak value of myocardial enzymes.(5)The incidence of bleeding in hospital and within 3 months after discharge.The inverse probability weighting method based on propensity score(IPTW)was used to compare the effects of the two treatments on MACE occurrence in the logistic regression model.ResultsThere was no significant difference in sex,age,risk factors of coronary heart disease,type and site of AMI,interventional therapy data(P>0.05)between the two groups.The ratio of bifurcation lesions in DCB group was significantly higher than that in DES group,and the diameter of the DCB was smaller while the length was longer than that of DES(all P<0.05).One death occurred in each group during hospitalization.Compared with the DES group,the incidence of MI[2.8%(5/180)vs.0.5%(1/200),P=0.10]and TVR[2.8%(5/180)vs.0.5%(1/200),P=0.10]in the DCB group during hospitalization showed an increasing trend,and were mostly associated with delayed coronary dissection.The incidence of MACE was similar between the two groups(3.3%(6/180)and 1.0%(2/200),P=0.15)during hospitalization.There was no MACE occurred in the two groups within 3 months after discharge.There was no significant difference between the two groups in TIMI grade,TMP grade,incomplete STR rate and peak value of myocardial enzyme(all P>0.05).The incidence of coronary artery dissection was significantly higher in DCB group than in DES group(8.3%(15/180)and 3.0%(6/200),P=0.02),but most of them were type B or A dissection and did not need special treatment.There was no significant difference in bleeding event between the two groups(P=0.91).Logistic regression analysis showed that there was no difference in the risk of MACE during hospitalization between DES and DCB groups for AMI patients receiving PCI(compared with DCB,OR=0.35,95%CI 0.08-1.43,P=0.13).ConclusionsThe initial safety and efficacy profiles of DCB are similar with those of DES for the AMI patients during PCI.The study highlights that the incidence of coronary dissection(type A or B)is higher post DCB treatment than post DES,but it does not affect blood flow.However,the incidence of in-hospital MI due to delayed coronary dissection trends to be higher post DCB.So we should pay close attention to the risk of delayed coronary dissection after DCB in AMI patients with de novo lesion.