Drug Coated Balloon With Paclitaxel For The Treatment Of Peripheral Artery Disease Early And Midterm Results

Objective To evaluate the Safety and Efficacy of the drug coated balloon(DCB)with paclitaxel In patients with peripheral artery disease(PAD).Methods the clinical data of 30 patients,who were diagnosed as PAD and treated with DCB and the clinical data of 39 patients,who were diagnosed as PAD and treated with PTA(stent),from July 2015 to April 2017 in Department of Vascular Surgery,The Affiliated Hospital of medical college Qingdao University,were retrospectively analyzed.22 males and 8 females patients were in the DCB series,the mean age of patients was 69.5 years,and the Rutherford's categories were 1evel 3 to 5.Moderate intermittent claudication(Rutherford's level 2)was 7(23.3%),severe intermittent claudication(Rutherford's level 3)was 11 cases(36.7%),ischemic rest pain(Rutherford's level 4)was 9 cases(30%),ulcer or gangrene(Rutherford's level)3 cases(10%).33 males and 6 females patients were in the PTA(stent)series,the mean age of patients was 72.7 years,and the Rutherford's categories were 1evel 3 to 5.Moderate intermittent claudication(Rutherford's level 2)was 12(30.7%),severe intermittent claudication(Rutherford's level 3)was 11 cases(36.7%),ischemic rest pain(Rutherford's level 4)was 12 cases(30.7%),ulcer or gangrene(Rutherford's level)4cases(13.3%).Patients were followed Up at 6 Month postoperative.The mean efficacy end point were target lesion revascularization,Rutherford's level,intermittent claudication distance,ABI,amputation?and clinical alive.Results A total of 30 patients(30 limbs)were performed successfully with the application of drug coated balloon.In one of the patients,arterial dissection was formed,affecting the blood flow of the lower extremities,and implanted a remedial stent.A total of 39 patients were formed with PTA and stents,with a total of 39 limbs,and the stent was successfully implanted.After the first day of the operation,we measured the value of ABI,DCB group: the preoperative0.39 0.099 increase to 0.84 0.035(t=4.305,P < 0.05).PTA+ Stent group: the preoperative 0.28 0.033 increase to postoperative 0.87 amp 0.025(t=14.175,P < 0.05).During follow-up,compared with preoperative,6 months after operation,there was no significant difference in ABI growth between DCB group and PTA+ stent group,t=0.352(P > 0.05).There was no significant difference in Rutherford classification between the two groups before operation(P > 0.05),and 3 patients in group DCB were not significantly improved after operation compareed with 5 cases in the PTA+ stent group. The rest of the patients achieved mild intermittent claudication.There was no significant difference in the Rutherford grading between the two groups in 6 months after operation6 months later,both series ABI decline compare with in hospital.DCB series ABI:0.750.18 compare PTA(stent)ABI : 0.730.21,t=0.352,P>0.05,no statistic difference.Both series' claudication distance get improvement obviously.Rate of 6 month's restenosis:3/30 in DCB series compare with 5/39 in PTA(stent)series.The DCB group had 3 patients with vascular stenosis.2 patients gets intervention again,1 cases get conservative treatment,The reintervention rate was 6.7%,the PTA+ stent group 5patients had target vessel stenosis,5 patients were re intervention,reintervention rate of12.8%.No amputation or death occurred in all two groups.The first stage patency rate of target vessel in group DCB and PTA+ stent group 6 months after operation was 90% and87.2%,respectively.The results of intentional statistical analysis showed that there was no significant difference between the target vascular patency rate of the DCB group and the PTA+ stent group(P > 0.05).Complications: group DCB: 1 cases get pseudoaneurysm of the femoral artery accompanied by fever and 1 cases get simple fever.The PTA+ stent :1 cases get acute myocardial infarction and 1 cases get skin Ulceration afer prelum.After the treatment,the complications were controlled effectively.Conclusion :DCB with Paclitaxel is safe and effective in patients with PAD.