药物涂层球囊治疗慢性威胁性肢体缺血患者膝下动脉病变的短期效果

Short-term outcomes of drug-coated balloon in infrapopliteal lesions of chronic limb threatening ischemia

目的探讨药物涂层球囊(DCB)治疗慢性威胁性肢体缺血(CLTI)患者膝下动脉病变的短期效果。方法收集2020年12月至2022年6月来自10家三甲医院的接受DCB治疗膝下动脉病变的231例CLTI患者的临床资料,共240条患肢。主要终点为免于重大不良事件(MAE)发生率,次要终点包括无截肢生存率(AFS)、免于大截肢率、生存率和免于临床驱动的靶肢体再干预(CD-TLR)率。使用Kaplan-Meier法评估治疗后6个月和1年时相关终点事件的发生率。结果231例患者的年龄为(72.3±9.73)岁,女性患者74例(32.03%)。240条患肢的329处膝下病灶接受了DCB治疗,115条(47.92%)肢体同时处理了膝上血管,无患者术中发生远端栓塞,中位随访时间为11个月。治疗后6个月时免于MAE发生率为85.90%(95%CI:81.34%~90.73%),AFS为90.14%(95%CI:86.21%~94.24%),免于大截肢率为95.80%(95%CI:93.14%~98.54%),生存率为93.82%(95%CI:90.62%~97.14%),免于CD-TLR率为94.57%(95%CI:91.48%~97.76%)。治疗后12个月时免于MAE发生率为73.95%(95%CI:67.56%~80.94%),AFS为81.26%(95%CI:75.46%~87.51%),免于大截肢率为94.92%(95%CI:91.80%~98.15%),生存率为85.4%(95%CI:79.94%~91.23%),免于CD-TLR率为90.48%(95%CI:85.96%~95.24%)。亚组分析提示是否同期干预膝上病变对研究的结果没有显著影响。结论DCB治疗CLTI患者膝下动脉病变具有良好的短期效果。

Objective To explore the short-term outcomes of drug-coated balloon(DCB)in infrapopliteal lesions of chronic limb threatening ischemia(CLTI)patients.Method Clinical data of 231 CLTI patients(including 240 affected limbs)from 10 hospitals who received DCB for infrapopliteal lesions between December 2020 and June 2022 were collected.The primary end point was freedom from major adverse event(MAE).Secondary end points included amputation-free survival(AFS),freedom from major amputation,survival,and freedom from clinically driven target limb reintervention(CD-TLR)rate.Kaplan-Meier analysis was used to evaluate the incidence of relevant end points at 6 months and 1 year after treatment.Result The average age of the 231 patients was(72.3±9.73)years old,and 74(32.03%)of them were female.A total of 329 lesions in 240 affected limbs were treated with DCB,and superior genicular blood vessels were treated concomitantly in 115(47.92%)limbs.No patient had distal embolization during the procedure.The median follow-up time was 11 months.At 6 months after treatment,the freedom from MAE rate was 85.90%(95%CI:81.34%-90.73%)and AFS was 90.14%(95%CI:86.21%-94.24%),the freedom from major amputation rate was 95.80%(95%CI:93.14%-98.54%),the survival rate was 93.82%(95%CI:90.62%-97.14%),and the freedom from CD-TLR rate was 94.57%(95%CI:91.48%-97.76%).At 12 months after treatment,the incidence of freedom from MAE and AFS were 73.95%(95%CI:67.56%-80.94%)and 81.26%(95%CI:75.46%-87.51%)respectively,the freedom from major amputation rate was 94.92%(95%CI:91.80%-98.15%),the survival rate was 85.40%(95%CI:79.94%-91.23%),and the freedom from CD-TLR rate was 90.48%(95%CI:85.96%-95.24%).Subgroup analysis showed that there was no significant effect of concomitant superior genicular lesions intervention on the results.Conclusion The DCB can achieve acceptable short-term outcomes in the treatment of infrapopliteal lesions in CLTI patients.