| Object:1.To explore the effect of in-stent restenosis patterns on the prognosis of drug-coated coronary balloon catheters for the treatment of restenosis.2.To study the effect of OCT-guided drug-coated coronary balloon catheters angioplasty and in-stent restenotic lesions tissue stucture and histological on the prognosis of in-stent restenosis.Methods:1.From December 2014 to December 2016,a retrospective analysis of 160 DCB treated DES-ISR lesions.The types of restenosis were divided into two groups according to Mehran classification:focal type 58 cases,which were focal group;non-focal,diffuse,proliferative and obstructive 102 cases,which were the non-focal group.Quantitative coronary angiography analysis(QCA)was performed by two experienced interventional cardiologists and selected the most severe non-perspective projection end-diastolic film frames.Measure the parameters before the intervention,immediately after the intervention and at the angiographic follow-up,including the reference diameter,the Minimum lumen diameter,the percentage of diameter stenosis,and the length of the lesion.Collecting the OCT parameters of the patients who underwent OCT examination,including:homogeneity or heterogeneity of tissue structure,high or low tissue back reflection,minimum lumen area,neoatherosclerotic plaque,intimal hyperplasia,and lumen area immediately after DCB application.The primary end point was the rate of binary restenosis at 9 months of angiographic follow-up,and the secondary end point was the major adverse cardiac events(MACE)at 36 months of follow-up.2.Continuous variables are expressed as mean±standard deviation or median(interquartile range).Categorical variables are reported in frequency and percentage.The Kolmogorov-Smirnov test was used for the normal distribution.The comparison of continuous variables uses student’s t test or Mann-Whitney test.The comparison between categorical variables uses two-tailed Fisher exact test or Pearson chi-square test.Multivariate logistic regression analysis was used to determine the independent predictors of binary restenosis and MACE after DCB angioplasty.The Kaplan-Meier method was used to evaluate the MACE-free situation for 36 months.All statistical analysis uses SPSS version 19(IBM Corporation,Somers,NY,USA).The inspection adopts two-sided inspection,and the inspection level is set at P<0.05.Results:1.Comparison of general dataComparison between the focal group and the non-focal group:There was no statistically significant difference between male gender(82.8%vs 81.4%,P=0.827)and age([59.3±10.1]yrs vs[61.7±10.2]yrs,P=0.416).In terms of risk factors,the proportion of hypertension in the focal group was significantly lower than that in the non-focal group(39.7%vs 63.7%,P=0.003).There was no statistically significant difference in the incidence of diabetes between the focal group and the non-focal group(41.4%vs 27.5%,P=0.071).There was no statistically significant difference in the proportion of smoking history between the focal group and the non-focal group(44.8%vs 39.2%,P=0.488).There was no statistically significant difference in left ventricular ejection fraction([59.17±6.29]%vs[60.43±5.44]%,P=0.183)between the focal group and the non-focal group.2.Comparison of lesion characteristics between the focal group and the non-focal groupThere was no statistically significant difference([4.59±4.13]yrs vs[5.10±3.61]yrs,P=0.406)in duration of stent implantation between the focal group and the non-focal group.In terms of the number of diseased vessels,patients in the non-focal group were dominated by three lesions,and the difference was statistically significant(41.4%vs 62.7%,P=0.033)compared with those in the focal group.In terms of the lesion location,descending branches were dominant in both the focal group and the non-focal group,but there was no statistically significant difference between the two groups(48.3%vs 59.8%,P=0.331).The difference in lesion length between the focal group and the non-focal group was statistically significant([10.45±6.56]mm vs.[19.26±10.18]mm,P<0.001).3.Differences in OCT manifestations of in-stent restenosis between the focal group and the non-focal groupOf the 150 ISR patients,24 underwent preoperative OCT and guided lesion preparation and the use of drug-eluting coronary balloon catheters.There were 9 cases in the focal group and 15 cases in the non-focal group.The restenosis lesions in both groups showed no significant differences in tissue structure(homogeneity χ2=0.120,P=0.729;heterogeneity χ2=2.552,P=0.206;layered χ2=2.822,P=0.093)and backscattering(high backscattering χ2=3.546,P=0.060;low backscattering χ2=2.505,P=0.113).4.Comparison of lesion preparation between the focal group and the non-focal groupThe proportion of patients in the focal group and the non-focal group using cutting balloons during lesion preparation was not statistically significant difference(77.6%vs 72.5%,P=0.713).5.Comparison of the use of drug-coated coronary balloon catheter between the focal group and the non-focal groupThere was a statistically significant difference between the focal type group and the non-focal type group in the length of the drug-coated coronary balloon catheter([25.07±5.64]mm vs[33.55±18.10]mm,P=0.000).The diameter([3.08±0.32]mm vs[3.08±0.38]mm,P=0.895),expansion pressure([8.83±1.77]atm vs[9.25±2.15]atm,P=0.198)and filling time([63.10±9.67]s vs[62.65±9.76]s,P=0.775),there was no statistical significance.6.Comparison of angiographic follow-up between the focal group and the non-focal groupThere were no statistically significant differences in angiographic follow-up duration([10.15±5.47]momths vs[10.60±6.60]momths,P=0.665)and follow-up ratio(93.7%vs 94.1%)between the focal group and the non-focal group.The difference of late lumen loss([0.27±0.22]mm vs[0.45±0.58]mm,P=0.006)between the focal group and the non-focal group was statistically significant.The incidence of binary restenosis(3.7%vs 33.3%,P=0.003)was significantly different between the focal group and the non-focal group.7.Effects of OCT-guided DCB application on prognosisFocal patients who underwent OCT had no recurrence of restenosis or MACE during follow-up.The incidence of restenosis and MACE was significantly lower in the OCT-guided non-focal group than in the non-OCT-guided group P=0.001(χ2=11.689)。8.Effects of in-stent restenosis histological characteristics on prognosisCorrelation analysis showed that the backscatter of OCT in restenosis tissues was correlated with MACE,high backscatter was negatively correlated with MACE(r=-0.535,P=0.007),and low backscatter was positively correlated with MACE(r=-0.589,P=0.002).Logistic regression analysis showed that low backscattering tissue was an independent risk factor for MACE.9.Comparison of clinical prognosis between the focal group and the non-focal groupThere was no significant difference in the duration of clinical follow-up([22.45±9.28]momths vs[22.90±9.07]months,P=0.762)between the focal group and the non-focal group.The overall incidence of major adverse cardiovascular events(MACE)(6.9%vs 20.6%,P=0.022)was significantly different between the focal group and the non-focal group.10.Analysis of independent risk factors for binary restenosis after drug-coated coronary balloon angioplastyType of in-stent restenosis(OR:13.033,95%C.I.[2.441-69.573],P=0.003)and immediate residual stenosis(OR:1.142,95%C.I.[1.070-1.218],P=0.000)were independent risk factors for in-stent restenosis after drug-coated coronary balloon angioplasty.11.Independent risk factor analysis of major adverse cardiovascular events after drug-coated coronary balloon angioplastyType of in-stent restenosis(OR:0.260,95%C.I.[0.071-0.595],P=0.043)and diabetes mellitus(OR:5.045,95%C.I.[1.179-21.590],P=0.029)were independent risk factors for major adverse cardiovascular events after drug-coated coronary balloon angioplasty with in-stent restenosis.12.Survival analysis results of the focal group and the non-focal groupAt the median follow-up time of 36 months after drug-coated coronary balloon angioplasty,the incidence of MACE free was significantly higher in the focal group than in the non-focal group(93.1%vs.79.4%,Log Rank=4.335,P=0.037).Conclusion:1.patients with local in-stent restenosis have better angiography results and clinical prognosis than those with non-local drug-eluting restenosis after drug-coated coronary balloon catheters therapy.2.Diabetes mellitus is a major independent risk factor for adverse cardiovascular events after stent restenosis treated with drug-coated balloon catheter angioplasty.3.Patients with OCT-guided drug-coated coronary balloon catheters applied in stent restenosis have a good prognosis.Patients with lesions of low backscattering on OCT has a poor prognosis. |
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