下肢深静脉血栓形成导管溶栓术后髂静脉病变支架治疗的前瞻性对照性研究

目的观察下肢深静脉血栓形成(DVT)导管接触性溶栓(CDT)术后髂静脉支架治疗髂静脉病变的疗效。方法本研究为单中心前瞻性随机对照研究。155例下肢DVT患者经CDT治疗后,髂静脉远端主干静脉完全通畅,髂静脉残留狭窄大于50%者中的74例患者随机分为对照组和实验组:实验组45例行髂静脉支架置入,对照组29例髂静脉未置入支架。观察指标:深静脉通畅率,CEAP分类法中临床分级(C)变化,静脉临床严重程度计分(VCSS)变化及生活质量调查表(CIVIQ)评分。结果术后患者均获得随访,随访时间6～24个月。行静脉造影或彩超检查,实验组40例,对照组27例,实验组与对照组的终点通畅率比较差异有统计学意义[87.5%(35/40)vs29.6%(8/27),P<0.05];实验组与对照组的1年累积通畅率比较差异有显著统计学意义(86.0%vs54.8%,P<0.01)。实验组及对照组的CEAP分类法中临床分级(C)术前术后差值比较差异有统计学意义(1.61±0.21vs0.69±0.23,P<0.01)。随访终点实验组及对照组VCSS术后两组差值比较差异有统计学意义(7.57±0.27vs6.56±0.23,P<0.01)。实验组及对照组CIVIQ调查表终点评分比较差异均有统计学意义(22.67±3.01vs39.34±6.66,P<0.01)。结论髂静脉支架对下肢DVT导管溶栓术后治疗髂静脉病变能够提高深静脉的通畅率,提高疗效,提高生活质量。

The prospective controlled study of stents placement in the iliac vein after catheter-directed thrombolysis in deep venous thrombosis of lower extremity

Objective To observe the efficacy of the stents placement in the iliac vein after catheter-directed thrombolysis (CDT) in deep venous thrombosis (DVT) of lower extremity. Methods This was a single-center prospective randomized controlled study. One hundred and fifty-five cases with DVT of lower extremity were treated by CDT. Then 74 patients, whose main vein distal to iliac vein completely patent and the iliac vein residual stenosis > 50% were divided into control group and experimental group randomly,including 45 cases with stents placement in the experimental group and 29 cases without stent placement in the control group. The outcome measures were patency rate of deep vein, the clinical classification (C) changes of CEAP classification, changes of venous clinical severity score (VCSS), and score of chronic venous insufficiency questionnaire(CIVIQ). Results All patients were followed up with a time of 6～24 months and venography or color Doppler ultrasound examination were performed on 40 cases of the experimental group and 27 cases of the control group. There were statistical differences in the follow-up end patency rate[87.5%(35/40)vs 29.6%(8/27),P<0.05],the cumulative patency rate at 1-year after procedure(86.0% vs 54.8%,P<0.01),the difference of clinical classification (C) before and after procedure(1.61±0.21 vs 0.69±0.23,P<0.01),the difference of VCSS before and after procedure(7.57±0.27 vs 6.56±0.23,P<0.01)and the follow up end score of CIVIQ (22.67±3.01 vs 39.34±6.66,P<0.01)between the experimental and control group. Conclusions The iliac vein stent implantation can improve the patency rate,efficacy,quality of life after CDT treating DVT of lower extremity.