The Efficacy And Safety Of Paclitaxel-coated Balloon In The Treatment Of Drug-eluting Stent In-stent Restenosis

Objective: This Study was to test the efficacy and safety of paclitaxel-coated balloon(PCB)and the second generation drug-eluting stent(DES)in the treatment of drug-eluting stent in-stent restenosis(ISR).Methods: This study enrolled patients that had got percutaneous coronary intervention(PCI)and implanted DES but suffered from angina pectoris recurrence recently and hospitalized the second hospital of Hebei Medical University from January 2014 to July 2015.Perform elective CAG after perfect pre-procedure preparation.If the results of coronary arteriography(CAG)meet the diagnosic criteria of ISR,the patients were divided into either PCB treatment group(experimental group)or the second generation DES implantation treatment group(control group)according to random number table.Collect informations of patients from the two groups: clinical baseline data,the numbers of ISR,the distribution of ISR in the coronary arteries,the pattern of ISR,the reference vessel diameter,the minimal lumen diameter of lesion,the percentage of diameter stenosis,whether use plain/cutting balloon to make predilation,the length,diameter,dilation pressure and time of PCB/DES,the success rate of surgery,whether applicate intravascular ultrasound(IVUS)/ optical coherence tomography(OCT),the minimal lumen diameter and percentage of diameter stenosis in device and segment in post-procedure.Follow up the reference vessel diameter of the lesions in the following 6 months,the late lumen loss(LLL)in device and segment,minmal lumen diameter and percentage of diameter stenosis,the percentage of binary restenosis,the distribution of binary ISR’patterns.The incidence of major adverse cardiac events(MACE)in the following 6 months and the changes of hs-CRP levels in pro-and post-procedure.The primary endpoint is LLL in device and segment within 6 months in post-procudure.Second endpoints includes the minimal lumen diameter of the lesions,the percentage of diameter stenosis,the rate of binary restenosis,the percentage of TVR and STEMI and the incidence of MACE during follow-up of 6 months.Besides,the author also focuses on the observation towards the changes of patients’ hs-CRP levels in pro-and post-procedure.Results:1 There were no differences between two groups’ clinical baseline data and basic treatments(P all>0.05).2 There were no significant differences between two groups on the distribution proportion of target vessel(LAD、LCX、RCA)and patterns of ISR,reference vessel diameter of lesions,minimal lumen diameter、length and percentage of diameter stenosis of lesions(P all>0.05).3 No differences were detected on device’ length or diameter between two groups(P all>0.05).Compared with the control group,the average pressure of PCB of experimental group was lower(7.79±2.40 atm vs.13.72±2.45 atm,P<0.0001)while the dilation time was longer(52.46±14.08 s vs.10.46±5.48 s,P<0.0001).Compared with the control group,in-device percentage of diameter stenosis of experimental group was higher in post-procedure(14.3±9.1% vs.8.0±9.6%,P=0.0165),the minimal lumen diameter of device in post-procedure was smaller(2.29±0.44 mm vs.2.53±0.42 mm,P=0.0427),Percentage of diameter stenosis in segment was higher in post-procedure(17.8±9.2% vs.12.3±9.2%,P=0.0313),there was a tendency of decrease in the minimal lumen diameter of segment,but didn’t yet reach statistical difference(2.23±0.44 mm vs.2.41±0.48 mm,P=0.1585).4 Follow up for 6 months,there were no differences of reference vessel diameters between two groups.No differences were found in the minimal lumen diameter,percentage of diameter stenosis and late lumen loss in device between two groups when compared with control group.(minimal lumen diameter 1.94±0.60 mm vs.2.17±0.68 mm,P=0.1971.percentage of diameter stenosis 26.4±20.5% vs.20.4±20.3%,P=0.2812.late lumen loss 0.30±0.48 mm vs.0.29±0.53 mm,P=0.9427).No differences were found in the minimal lumen diameter,percentage of diameter stenosis and late lumen loss in segment compared with control group.(minimal lumen diameter 1.86±0.64 mm vs.1.98±0.68 mm,P=0.5078.percentage of diameter stenosis 30.7±20.9% vs.27.1±21.4%,P=0.5331.late lumen loss 0.32±0.53 mm vs.0.31±0.57 mm,P=0.9472).There were no differences of the percentage of binary restenosis and the distribution of binary ISR’patterns in the coronary arteries between the patients from two groups(percentage of binary restenosis 13.6% vs.19.4%,P=0.9856.the distribution of binary ISR’patternsⅠ67% vs.43%,P=0.1325.Ⅱ33% vs.43%,P=0.6314.0% vs.14%,Ⅲ P=0.1750).5 There were no patients died in two groups during the period of 6 months.there were 1 patient with STEMI and 2 patients with TVR in control group,but no such case occurred in experimental group.The incidences of MACE has no differences between the two groups during the follow-up period(0% vs.12%,P = 0.2406).6 There were no differences of patients’ hs-CRP levels in two groups in pro-procedure(5.45±1.65mg/l vs.6.11±2.00mg/l,P=0.3009),but hs-CRP levels of patients from the control group increased more obviously than those of experimental group in post-procedure though hs-CRP of patients from two groups both rose.(two groups’ P value were all below 0.0001at12 thhour,24thhour,48 thhour,72thhour and96 th hour in post-procedure).Conclusions: PCB has similar efficacy and safety with the second generation DES in the treatment of DES-ISR.