紫杉醇涂层球囊与普通球囊治疗腘动脉硬化闭塞症效果的倾向性评分匹配分析
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作者单位:

1.河北医科大学第一医院 血管外科,河北 石家庄 050011;2.首都医科大学宣武医院 普通外科,北京 100053

作者简介:

张红松,河北医科大学第一医院副主任医师,主要从事血管外科疾病方面的研究。

基金项目:

河北省卫健委2018年医学科学研究重点课题计划基金资助项目(20180243);河北省重点研发计划基金资助项目(20377732D)。


Efficacy of paclitaxel-coated balloon versus common balloon for popliteal arteriosclerosis obliterans: a propensity score matching analysis
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Affiliation:

1.Department of Vascular Surgery, the First Hospital of Hebei Medical University, Shijiazhuang 050011, China;2.Department of General Surgery, Xuanwu Hospital, Capital Medical University, Beijing 100053, China

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    摘要:

    背景与目的 药物涂层球囊(DCB)作为一种新的介入治疗技术已逐渐广泛应用,但目前主要集中在冠脉血管领域,在外周血管的应用研究相对较少,尤其是针对跨关节的腘动脉的研究更是罕见。因此,本研究比较DCB与普通球囊(CB)用于腘动脉硬化闭塞症中的近期疗效与远期预后,探讨DCB在该领域中的应用价值。方法 回顾性分析2014年3月—2020年4月河北医科大学第一医院血管外科行介入球囊扩张治疗的65例腘动脉硬化闭塞症患者临床资料,其中29例行DCB治疗(DCB组),36例行CB治疗(CB组)。采用1∶1倾向性匹配(PSM)方法对两组患者进行匹配,比较匹配后两组患者术后的腘动脉通畅率、踝肱指数(ABI)指标、Rutherford分级情况及截肢、血栓形成、血管内再狭窄等终点事件的发生情况。结果 两组共21对匹配成功,匹配后两组患者术前临床资料均衡可比(均P>0.05)。匹配后,两组患者术后3、6个月时腘动脉通畅率及ABI比较差异无统计学意义(均P>0.05),术后12个月,DCB组腘动脉通畅率、ABI明显高于CB组(65.71% vs. 49.55%;0.71 vs. 0.55,均P<0.05),而Rutherford分级明显优于CB组(P<0.05);DCB组患者术后1年截肢、血栓形成、血管内再狭窄等终点事件的总发生率低于CB组(23.81% vs. 57.14%,P<0.05);Log-rank检验结果显示,两组患者术后随访期间终点事件发生情况差异有统计学意义(χ2=5.654,P<0.05)。结论 DCB与CB治疗腘动脉硬化闭塞症的近期疗效相当,但远期DCB能够明显提高术后腘动脉通畅率、减少终点事件的发生。

    Abstract:

    Background and Aims Drug-coated balloon (DCB) as a new interventional therapeutic technique has been increasingly used. However, it is currently mainly used in the field of coronary artery disease therapy, while studies on its application in peripheral vascular diseases are relatively limited, and especially rare in popliteal artery that spans the joint. Therefore, this study was performed to compare the short-term efficacy and long-term outcomes of using DCB versus common balloon (CB) in the treatment of popliteal arteriosclerosis obliterans, and investigate the application value of DCB in this field.Methods The clinical data of 65 patients with popliteal arteriosclerosis obliterans undergoing interventional balloon dilatation in the Department of Vascular Surgery of the First Hospital of Hebei Medical University from March 2014 to April 2020 were retrospectively analyzed. Of the patients, 29 cases were treated with DCB (DCB group) and 36 cases were treated with CB (CB group). The two groups of patients were matched with propensity score matching (PSM) method at a 1∶1 ratio. After match, the postoperative patency rate of the popliteal artery, ankle-brachial index (ABI) and Rutherford classification as well as the occurrence of endpoint events such as amputation, thrombosis formation and intravascular restenosis were compared between the two groups of patients.Results Twenty-one pairs of patients in the two groups were successfully matched. The clinical data were balanced and comparable between the two groups after match (all P>0.05). After match, the popliteal artery patency rate and ABI at 3 and 6 months after surgery showed no significant difference between the two groups (all P>0.05). At 12 months after surgery, the popliteal artery patency rate and ABI were significantly higher in DCB group than those in CB group (65.71% vs. 49.55%; 0.71% vs. 0.55%, both P<0.05), and the Rutherford classification in DCB group was significantly superior to that in CB group (P<0.05). At one year after surgery, the overall incidence of endpoint events that included amputation, thrombosis formation and intravascular restenosis in DCB group was significantly lower than that in CB group (23.81% vs. 57.14%, P<0.05). The Log-rank test showed that there was a significant difference in the incidence of endpoint events between the two groups of patients (χ2=5.654, P<0.05).Conclusion DCB offers a similar CB short-term efficacy as CB in the treatment of popliteal arteriosclerosis obliterans, but DCB can significantly improve the popliteal artery patency rate and reduce the occurrence of endpoint events in long-term postoperative period.

    表 2 PSM后两组患者随访Rutherford分级比较[n=21,n(%)]Table 2 Comparison of Rutherford classification between the two groups of patients after PSM [n=21, n(%)]
    表 5 PSM后两组患者随访期间终点事件发生情况比较[n=21,n(%)]Table 5 Comparison of endpoint events between the two groups after PSM [n=21, n (%)]
    图1 两组患者随访终点事件发生风险曲线图Fig.1 Follow-up risk curve of endpoint events for the two groups of patients
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张红松,赵亚恒,郑丽华,张磊,张峰,贺新奇,彭军路,何兆鹏,张立科,杨艳,杨立新,赵珩,刘鹏.紫杉醇涂层球囊与普通球囊治疗腘动脉硬化闭塞症效果的倾向性评分匹配分析[J].中国普通外科杂志,2022,31(12):1597-1604.
DOI:10.7659/j. issn.1005-6947.2022.12.006

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  • 收稿日期:2021-09-14
  • 最后修改日期:2022-06-01
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  • 在线发布日期: 2023-01-08