| Objective To evaluate the efficacy and safety of drug-coated balloon(DCB)angioplasty versus plain old balloon angioplasty(POBA)in the treatment of femoropopliteal arteriosclerosis obliterans in northeast China.Methods According to the inclusion and exclusion criteria,48 patients with femoropopliteal arteriosclerosis obliterans admitted and treated from August 2013 to June 2017 in People's Hospital of liaoning Provincial were randomly divided into DCB group and POBA group,with 24 patients in each group.Compared the technical success rate,complication rate(aneurysm formation,hematoma,acute arterial thrombosis,etc.)and in-hospital mortality of the two groups.The patients were followed up by telephone,outpatient service and hospitalization at 6 and 12 months after the operation,compared the primary patency rate,target lesion revascularization(TLR)rate,Rutherford grading,ankle-brachial index(ABI),amputation rate and death rate between the two groups.All measurement data were expressed as mean standard deviation,and counting data were expressed as percentage.T test was used for the comparison of measurement data between the two groups,and chi-square test was used for the comparison of counting data.SPSS 25.0 statistical software was used to analyze the clinical data of the two groups.Results There were 21 males and 3 females in the DCB group,and 19 males and 5females in the POBA group,there was no significant difference in gender between the two groups(P > 0.05);The mean ages of DCB group and POBA group were(62.4 ±11.1)years and(61.2±12.5)years respectively(P > 0.05);The mean lesion length was(10.9±9.8)cm and(10.3±11.2)cm,respectively(P > 0.05);DCB combined with hypertension in 16 cases,diabetes in 10 cases,hyperlipidemia in 15 cases,smoking history in 14 cases,POBA combined with hypertension in 14 cases,diabetes in 11 cases,hyperlipidemia in 17 cases,smoking history in 13 cases.There was no significant difference between the two groups(P > 0.05).There was no significant difference between the two groups in other general demographic data,comorbidity,clinical manifestations and pathological features(P > 0.05).The technical success rate of both groups was 100%;no complications occurred in the DCB group;complications occurred in 2 patients in the POBA group,including 1 patient who had increased liver function on the second day after surgery and recovered to normal on the fifth day,which was judged to be related to device stimulation.Another patient had acute arterial embolism on the day after surgery,and the upper middle leg amputation was performed on the second day after the failure of conservative treatment.However,there was no significant difference in the incidence of complications between the two groups(0% vs.8.3%,P < 0.05).There was no hospital death in both groups.One week after operation,there was no significant difference in Rutherford grade improvement between the two groups,with an average improvement of 2 grades.There was no significant difference in ABI elevation(DCB0.45 + 0.22 vs.POBA 0.44 + 0.21,P > 0.05).One patient in DCB group was lost to follow-up,while amputated patients in POBA group were removed from the group.A total of 46 patients completed 12-month follow-up.At 6 months,the primary patency rate of DCB group was higher than that of POBA group(87.0% vs.52.2%,P < 0.05).Rutherford grade was improved in both groups compared with that before operation.18 patients in DCB group were improved by grade 2,5 patients were improved by grade 3,5patients in POBA group were improved by grade 1,and 18 patients were improved by grade 2.the difference between the two groups was statistically significant(P< 0.05).There were no TLR patients in DCB group and 4 patients in POBA group.However,there was no significant difference in TLR rate between the two groups(0% vs.17.4%,P > 0.05).The second patency rate was 100%.There was no significant difference in ABI between the two groups(0.77±0.19 vs.0.65±0.21,P > 0.05).No amputation or death occurred in both groups.At 12 months,the primary patency rate of DCB group was higher than that of POBA group(78.3% vs.43.5%,P < 0.05).Rutherford grade in the two groups was improved as a whole compared with that before operation.in DCB group,21 patients were improved by grade 2,2 patients were improved by grade 3,4 patients inPOBA group were improved by grade 1,and 17 patients were improved by grade 2.however,2 patients had the same grade as before operation,and the difference between the two groups was statistically significant(P < 0.05).One patient in DCB group received TLR,while 8 patients in POBA group received TLR.TLR rate in DCB group was lower than that in POBA group(4.3% vs.34.8%,P < 0.05).The second patency rate was 100%.There was no significant difference in ABI between the two groups(0.78±0.26 vs.0.70±0.16,P> 0.05).No amputation or death occurred in both groups.Conclusion In the treatment of femoropopliteal arteriosclerosis obliterans in northeast China,compared with POBA,DCB can significantly improve the primary patency rate and reduce the TLR rate.The safety of DCB deserves to be confirmed and it has a broad application prospect.The deficiency of this study lies in the small number of cases,which needs to be further evaluated in a large sample of randomized controlled studies. |
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