双导丝球囊治疗股腘动脉病变的前瞻性随机对照研究

A prospective randomized controlled study on the treatment of femoropopliteal artery lesions with vascutrak balloon

目的:评价双导丝球囊治疗股腘动脉病变的近期临床效果及安全性。方法:选取我中心股腘动脉病患者67例,随机分为双导丝球囊组(35例)及普通球囊组(32例)分别进行介入治疗。两组患者间性别比例、年龄、术前踝肱指数(ABI)、Rutherford分级2/3/4/5、病变长度、吸烟比例、以及合并糖尿病、高血压、冠心病、心功能不全、肾功能不全、高脂血症比例,差异无统计学意义。比较两组患者支架置入率,术后ABI增加值、卢瑟福分级改善率、再狭窄率、LLL及TRL。结果:双导丝球囊组支架置入率为62.9%低于普通球囊组的84.4%;12个月随访结果显示,双导丝球囊组ABI增加值0.31(0.16,0.39)及卢瑟福分级改善率88.6%均高于普通球囊组,而再狭窄率17.1%、LLL 0.5(0.1,0.9)mm及TRL11.4%均低于普通球囊组,差异有统计学意义;两组的截肢率及全因死亡率,差异无统计学意义。结论:双导丝球囊治疗股腘动脉病变临床效果显著且安全。

Objective:To evaluate the efficacy and safety of vascutrak balloon in the treatment of femoropopliteal artery disease.Methods:Sixty-seven patients with femoropopliteal artery lesions were randomly divided into two groups:vascutrak balloon group(35 cases)and plain old balloon group(32 cases).Sex ratio,age,preoperative ABI,Rutherford rating of 2/3/4/5,lesion length,smoking ratio,diabetes mellitus,hypertension,coronary heart disease,heart failure,renal insufficiency,hyperlipidemia,There was no statistical difference.The rate of stent implantation,the increase of ABI after operation and Rutherford grade improvement rate,restenosis rate,LLL and TRL were compared between the two groups.Results:The rate of stent implantation in the vascutrak balloon group was 62.9%lower than that in the plain old balloon group(88.4%).The result of 12 months follow-up showed that the increased value of ABI and the improvement rate of Rutherford grade in vascutrak balloon group were larger than the plain old balloon group,were 0.31(0.16,0.39)and 88.6%were,while the restenosis rate of 17.1%,LLL 0.5(0.1,0.9)mm and TRL 11.4%were lower than those of plain old balloon group.The difference isstatistically significant;There was no significant difference in amputation rate and all-cause mortality between the two groups.Conclusions:Vascutrak balloon is effective in the treatment of femoropopliteal artery disease and safe.