避免血管再通策略与药物涂层球囊血管再通治疗股浅动脉闭塞性疾病的比较
Avoiding revascularization strategy versus revascularization with drug-coated balloon for the treatment of superficial femoral artery occlusive disease.
作者信息
Ren Hongcheng, Zhuang Jinman, Li Xuan, Li Tianrun, Luan Jingyuan, Wang Changming
机构信息
Department of Intervention Vascular Surgery, Peking University Third Hospital, Beijing 100191, China.
出版信息
J Interv Med. 2021 Mar 4;4(2):87-93. doi: 10.1016/j.jimed.2021.02.002. eCollection 2021 May.
OBJECTIVE
The aim of this study was to compare the efficacy, safety and treatment costs of superficial femoral artery revascularization (SFA) with drug-coated balloon(DCB) versus avoiding revascularization strategy for the treatment of symptomatic SFA disease.
METHODS
This retrospective single-center study reviewed 96 patients (113 limbs) with severe stenosis and occlusive SFA disease. All patients underwent either DCB(Group 1: n = 55 limbs) or nonrevascularization (Group 2: n = 58 limbs) between March 2015 and June 2019. The improvement of Rutherford class, walking impairment questionnaire score(WIQ), target limb reintervention, perioperative major adverse events, the catheterization laboratory cost and length of hospital stay were compared. The limb salvage and survival rates were calculated using the Kaplan-Meier method. Univariate and multivariate logistic regression analysis were performed to assess the association between factors and the improvement of Rutherford category at 12 months.
RESULTS
The median follow-up time of Groups 1 and 2 was 17 and 33 months, respectively. At 12 months, the Rutherford category significantly decreased in both groups (P < 0.001), with no significant difference (79.7% vs. 64.3%, P = 0.074). Furthermore, multivariate analysis showed that the selected therapeutic method was not an influential factor for the improvement of Rutherford class at 12 months. The WIQ overall score as well as three subscales scores (distance, speed and stair-climbing), the survival rate, limb salvage rate and the length of stay between the two groups were comparable. The perioperative adverse events rate and catheterization laboratory cost in Group 2 was significantly lower compared to Group 1 [(34253.69 ± 28172.87) yuan vs. (56936.76 ± 41278.36) yuan, P = 0.001].
CONCLUSIONS
This study suggests that avoiding superficial femoral artery revascularization strategy has favorable efficacy and safety outcomes compared to combining revascularization with DCB in selected patients.
目的
本研究旨在比较药物涂层球囊（DCB）治疗股浅动脉再血管化（SFA）与避免再血管化策略治疗有症状SFA疾病的疗效、安全性和治疗成本。
方法
这项回顾性单中心研究纳入了96例（113条肢体）患有严重狭窄和闭塞性SFA疾病的患者。在2015年3月至2019年6月期间，所有患者接受了DCB治疗（第1组：n = 55条肢体）或非再血管化治疗（第2组：n = 58条肢体）。比较两组患者的卢瑟福分级改善情况、步行障碍问卷评分（WIQ）、目标肢体再次干预情况、围手术期主要不良事件、导管室成本和住院时间。采用Kaplan-Meier法计算肢体挽救率和生存率。进行单因素和多因素逻辑回归分析，以评估各因素与12个月时卢瑟福分级改善之间的关联。
结果
第1组和第2组的中位随访时间分别为17个月和33个月。12个月时，两组的卢瑟福分级均显著降低（P < 0.001），但差异无统计学意义（79.7%对64.3%，P = 0.074）。此外，多因素分析显示，所选治疗方法不是12个月时卢瑟福分级改善的影响因素。两组的WIQ总分以及三个子量表评分（距离、速度和爬楼梯）、生存率、肢体挽救率和住院时间相当。第2组的围手术期不良事件发生率和导管室成本显著低于第1组[（34253.69 ± 28172.87）元对（56936.76 ± 41278.36）元，P = 0.001]。
结论
本研究表明，在部分患者中，与DCB再血管化治疗相比，避免股浅动脉再血管化策略具有良好的疗效和安全性。
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