股浅动脉重建对下肢动脉硬化闭塞症治疗的随机病例对照研究

Randomized controlled trial to superficial femoral artery recanalization for lower extremity arteriosclerosis obliterans

目的:评价忽略股浅动脉重建治疗慢性下肢动脉硬化闭塞症的安全性和有效性。方法:应用前瞻性的随机病例对照研究方法对忽略股浅动脉重建治疗慢性下肢动脉硬化闭塞症的有效性和安全性进行评价,将北京大学第三医院2014年5月至2015年3月36例下肢动脉硬化闭塞症患者随机分为股浅动脉重建组(20条患肢)和非重建组(16条患肢),重建组均采用腔内治疗重建股浅动脉血运,非重建组均不重建股浅动脉,仅处理同时存在的髂动脉及股深动脉病变,比较两组患者临床疗效、并发症及治疗费用。结果:两组患者的年龄、性别构成、治疗前踝肱指数、TASC(trans-atlantic inter-sociery consensus)分级及Rutherford分级均具有可比性(P>0.05),术后1周内重建组显效率和总有效率均优于非重建组[75.0%vs.12.5%(P<0.001);90.0%vs.37.5%(P=0.001)],两组均无围手术期并发症及死亡病例。3个月随访时重建组显效率优于非重建组[65.0%vs.25.0%(P=0.017)],两组总有效率差异无统计学意义[85.0%vs.68.8%(P=0.422)];6个月和12个月随访时两组显效率及总有效率差异均无统计学意义[显效率60.0%vs.37.5%(P=0.180),80.0%vs.87.5%(P=0.672);总有效率60.0%vs.43.8%(P=0.332),85.0%vs.87.5%(P=1.000)],重建组治疗费用高于非重建组[(53 367.4±24 518.3)元vs.(30 397.5±15 354.4)元(P=0.011)]。重建组随访期间发现股浅动脉再狭窄/闭塞者8例,其中3例再次介入治疗,再次腔内治疗率为15.0%。结论:忽略股浅动脉重建治疗慢性下肢动脉硬化闭塞症安全、有效、经济,可以作为部分外周动脉疾病患者的首选治疗方法。

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 = 0. 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.