Avoiding revascularization strategy versus revascularization with drug-coated balloon for the treatment of superficial femoral artery occlusive disease

J Interv Med. 2021 Mar 4;4(2):87-93. doi: 10.1016/j.jimed.2021.02.002. eCollection 2021 May.

Abstract

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.

Keywords: Drug-coated balloon; Peripheral artery disease; Superficial femoral artery.