Randomized controlled trial to superficial femoral artery recanalization for lower extremity arteriosclerosis obliterans / 北京大学学报(医学版)

ABSTRACT

Objective:To evaluate the safety and effectiveness of neglecting superficial femoral artery (SFA) recanalization for chronic lower extremity arteriosclerosis obliterans (ASO).Methods:Thirty-six cases treated for severe stenosis or occlusion of superficial femoral artery resulted from ASO were randomly divided into 2 groups.Twenty of them were treated by endovascular reconstruction of superficial femoral artery and the other 16 cases were not treated with their superficial femoral artery,but were only treated with the accompanied iliac and/or profunda femoral artery lesion.Results:There was no significant difference between the two groups on mean age,gender,ABI before treatment,accompanied diseases,Rutherford classification and trans-atlantic inter-society consensus (TASC) classification (P ＞ 0.05).One week after operation,the reconstruction group had better marked effect and total effective rate [75.0％ vs.12.5％ (P ＜0.001);90.0％ vs.37.5％ (P =0.001)] and lower no effective rate [10.0％ vs.62.5％ (P =0.001)],There was no significant difference between the two groups on effective rate [15.0％ vs.25.0％ (P =0.675)].The deteriorate cases in both groups were zero,and there was no morbidity of complications and death in both groups during the perioperative period.In the 3-month follow up,the reconstruction group had a better marked effect rate [65.0％ vs.25.0％ (P =0.017)];There was no significant difference between the two groups on the effective rate,no effective rate and total effective rate [20.0％ vs.43.8％ (P=O.124);15.0％ vs.31.3％ (P =0.422);85.0％ vs.68.8％ (P =0.422)].The deteriorate cases and morbidity of complications and death in both groups during the perioperative period were still zero.In the 6-and 12-month follow ups,there were no significant differences between the two groups on marked effect and total effective rate [60.0％ vs.37.5％ (P =0.180),80.0％ vs.87.5％(P=0.672);60.0％ vs.43.8％(P=0.332),85.0％ vs.87.5％(P=1.000)].The deteriorate case was zero in both groups,and there was no morbidity of complications and death in both groups.The limb salvage rate in both groups was 100％ during the whole follow up period.The reconstruction group had a higher cost [(53 367.4 ± 24 518.3) yuan vs.(30 397.5 ± 15 354.4) yuan(P =0.011)].There were 8 cases of SFA restenosis/ reocclusion during the follow up,three of which accepted another endovascular treatment,and the reoperation rate was 15.0％.while in the nonreconstruction group,there was no case that needed another endovascular therapy,and the reoperation rate was zero.Conclusion:Only dealing with accompanied iliac and profunda artery lesion and neglecting superficial femoral artery reconstruction is a safe,effective and inexpensive therapy for chronic lower extremity arteriosclerosis obliterans,and should be the preferred alternative for some patients.