Therapeutic Effect Of Drug-eluting Balloon On Coronary Small Vessel Disease

Objective: In recent years,the incidence of coronary small vessel disease has increased year by year.Drug eluting stent(DES)in small coronary disease is the main treatment method.After DES implantation,it often combines higher dissection,rupture and perforation rate and long-term restenosis in stent and so on.Many clinical trials have proven the drug eluting balloon(DEB)as an emerging clinical technology can be applied for the treatment of coronary in-stent restenosis.However,large-scale randomized clinical controlled studies are still lacking to confirm the safety,efficacy and advantages of DEB in small vessel disease.Therefore,we designed this single-center clinical study to investigate the safety and efficacy of DEB in the treatment of coronary small artery disease,and to try to summarize some of the clinical features of patients with coronary small vessels,and provide further scientific basis for subsequent clinical treatment.Method:(1)92 patients who were diagnosed as coronary heart disease after coronary angiography in our hospital and were single lesions were divided into large blood vessel group(luminal diameter > 2.75 mm)and small blood vessel group(luminal diameter ?2.75mm)according to angiographic results.Collecting the clinical data of patients is to summarize the clinical features of patients with small vessel disease by comparing;(2)80 patients who were diagnosed as coronary small vessel disease by coronary angiography in our hospital,were divided into DEB group(30 cases),DES group(30 cases),and general balloon group(20 cases)according to the differences of the treatment method.The clinical baseline data and coronary angiography(including preoperative lesion evaluation,the data of intraoperative instrument and postoperative situation)were recorded.Angiographic was followed-up at 12 months and clinical endpoint events at 6 and 12 months.Tukey-HSD test was used to analyze the differences between the data groups.Post hoc test and/or Bonferroni test were used to analyze the differences between the data groups.The cumulative MACE survival curves were plotted by Kaplan-Meier method.The survival data of MACE about the three groups was tested by Logrank method.Finally,the safety and effectiveness of DEB in small vessel disease were verified.Results(1)The proportion of female patients in the small blood vessel group and the proportion of patients with diabetes were higher,compared with the larger blood vessel group(proportion of female patients: 53.2% vs 28.9%,P =0.018;proportion of patients with diabetes: 40.4% vs.15.6%,P =0.008).Through using the Post hoc test,it was found that small vascular disease is easy to be found in the circumflex artery,and the larger vascular disease is easy to be found in the anterior descending branch(P <0.05).(2)Cystatin C(0.98 ± 0.36mg/L VS.0.79 ± 0.16mg/L,P =0.002),uric acid(368.66 ± 70.36?mol/L VS.316.02±66.65?mol/L,P <0.001)and complement C1q(214.04 ± 32.91mg/L VS.187.65 ± 28.51mg/L,P <0.001)in the serum of patients with small vascular disease were significantly elevated in comparison with the larger blood vessel group.(3)There were no significant differences between the three groups of preoperative and intraoperative lesions.The minimum lumen diameter and the minimum lumen stenosis rate were different(P < 0.001).There was no significant difference in the minimum lumen diameter and the minimum lumen stenosis after PCI in the DEB group and the DES group,but they were superior to the normal balloon group(P <0.001).(4)The results followed-up by angiography at 12 months showed that there was no significant difference in the minimum lumen diameter and restenosis rate between the DEB and the DES,but it was superior to the normal balloon group(P <0.001),and the late lumen loss of the DEB group was significantly lower than that of the DES group(0.12 ± 0.32 mm VS.0.38 ± 0.46 mm,P =0.044)and the normal balloon group(0.12 ± 0.32 mm VS.0.73 ± 0.45 mm,P <0.001).(5)After 6 months,the results of clinic events were found that there was no significant difference in the incidence of MACE between the three groups.At 12 months,the incidence of MACE and TVR(Target vessel revascularization)in the DEB group and the DES group were significantly lower than those in the normal balloon group(MACE: P =0.011,TVR: P =0.014),but there was no significant difference between the DEB group and the DES group(P >0.05).Conclusions(1)The proportion of women in small vessel group is significantly higher than that of the large blood vessel group,and there are more patients with diabetes found in small vessel group.The coronary small vascular disease is easyly located in the circumflex artery.(2)The levels of CysC,UA and C1 q in the serum of patients with coronary small vessel disease are higher in conparison with others.(3)DEB is a safe and effective treatment for coronary small artery disease.(4)Whether it is in the process of immediately or long-trem postoperative PCI,DEB and DES for small coronary vessel disease are more advantageous than ordinary balloons.(5)DEB is not inferior to DES for coronary small vessel disease,and its late lumen loss is superior to DES.