单纯药物涂层球囊治疗非复杂性冠状动脉大血管原位长病变的安全性及有效性

Safety and effectiveness of drug-coated balloon-alone strategy for uncomplex de novo diffuse-long lesion in macrovascular coronary artery

目的对比药物涂层球囊(drug-coated balloon,DCB)与药物洗脱支架(drug-eluting stents,DES)对冠状动脉(简称冠脉)大血管原位长病变的疗效,并探讨DCB作为其常规治疗方式的可能性。方法纳入102例接受冠脉介入治疗且为非复杂性大血管原位长病变的冠心病患者,根据介入策略分为药物球囊治疗组(DCB组)和药物支架治疗组(DES组)。利用定量血流分数(quantitative flow ratio,QFR)技术,分析术前、术后即刻及术后1年随访时的病变特点,比较DCB与DES的疗效。结果(1)两组临床资料差异均无统计学意义。(2)两组患者手术血管位置、单支病变及分叉病变占比、抗血小板药物使用等方面比较,差异均无统计学意义;在预处理方面,DCB组使用棘突球囊占比明显高于DES组(P<0.05)。(3)QFR分析结果显示,两组术前的参考血管直径、病变长度和病变面积狭窄率差异均无统计学意义(均P>0.05);术后即刻,DCB组的最小管腔直径[(2.57±0.27)mm vs.(2.95±0.46)mm,P<0.01]及QFR增益[0.22(0.17,0.53)vs.0.27(0.20,0.63),P=0.001]均小于DES组,残余面积狭窄率明显高于DES组[(27.80±7.29)%vs.(13.08±6.93)%,P<0.01];随访时,虽然DCB组病变面积狭窄率高于DES组[38.76(30.56,48.16)%vs.27.14(20.22,34.75)%,P<0.01],但其晚期管腔丢失小于DES组[0.19(0.05,0.30)mm vs.0.25(0.15,0.39)mm,P=0.030],且两组最小管腔直径的差异无统计学意义(P>0.05)。(4)随访期间两组主要不良心血管事件(major adverse cardiovascular events,MACE)发生率的差异均无统计学意义(均P>0.05)。结论QFR指导DCB治疗非复杂性冠脉大血管原位长病变的疗效及MACE发生率与DES相仿,但鉴于本研究样本量小,DCB在冠脉大血管原位长病变的临床应用仍需更多证据支持。

Objective To compare the efficacy of drug-coated balloon(DCB) and drug-eluting stents(DES) for de novo diffuse-long lesion in macrovascular coronary artery,so as to explore the chances of DCB as a routine therapy.Methods We enrolled 102 patients with uncomplex de novo diffuse-long lesions in macrovascular coronary artery who had undergone coronary intervention therapy.They were divided into DCB group and DES group according to intervention strategies.Quantitative flow ratio(QFR) technology was used to analyze the characteristics of lesions before intervention,immediately after intervention and during one-year follow-up after intervention.The curative effect was compared between DCB and DES.Results(ⅰ) There were no statistically significant differences in clinical data.(ⅱ) There were no statistically significant differences between the two groups in the site of intervention vessels,the proportion of single-vessel and bifurcated lesions,and the use of antiplatelet drugs.In terms of pretreatment,the proportion of non-slip element balloon used in the DCB group was significantly higher than that in the DES group(P<0.05).(ⅲ) The results of QFR analysis showed that there were no statistically significant differences in the reference vessel diameter,lesion length,and stenosis rate of lesion area before intervention between the two groups(P>0.05).Immediately after intervention,the minimum lumen diameter [(2.57±0.27)mm vs.(2.95±0.46)mm,P<0.01],and QFR gain [0.22(0.17,0.53) vs.0.27(0.20,0.63),P=0.001] in the DCB group were both lower than those in the DES group,while the stenosis rate of residual area was significantly higher than that in the DES group [(27.80±7.29)% vs.(13.08±6.93)%,P<0.01].During follow-up,Although the stenosis rate of lesion area in the DCB group was higher than that in the DES group [38.76(30.56,48.16)% vs.27.14(20.22,34.75)%,P<0.01],the late lumen loss was smaller than that in the DES group [0.19(0.05,0.30)mm vs.0.25(0.15,0.39)mm,P=0.030].The minimum lumen diameter did not vary significantly between groups(P>0.05).(ⅳ) There was no statistically significant difference in the incidence of major adverse cardiovascular events(MACE) between the two groups during follow-up(all P>0.05).Conclusion The efficacy and the incidence of MACE of DCB guided by QFR are similar to that of DES for uncomplex de novo diffuse-long lesion in macrovascular coronary artery.However,in consideration of the small sample size of this study,more evidences are needed to support the clinical application of DCB for de novo diffuse-long lesion in macrovascular coronary artery.