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Long-term Results of a Randomized Trial of Stenting of the Superficial Femoral Artery for Intermittent Claudication.

Open AccessPublished:January 11, 2023DOI:https://doi.org/10.1016/j.ejvs.2023.01.004
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      Abstract

      Objectives

      Primary stenting of the superficial femoral artery (SFA) in intermittent claudication (IC) increased health-related quality of life (HRQoL) after 12 and 24 months in this trial. We now present an extended follow-up of HRQoL 36 and 60 months after randomization.

      Design

      Multicenter randomized controlled trial conducted at seven vascular clinics in Sweden between 2010 and 2020. Registered at clinicaltrials.gov, ID: NCT01230229.

      Materials

      One hundred patients randomized to either primary stenting and best medical treatment (BMT) [n = 48] or BMT alone [n=52] followed for 60 months.

      Methods

      HRQoL assessed by the Short-Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 36 and 60 months after randomization was the primary outcome. Walking Impairment Questionnaire (WIQ) score, reinterventions, progression to chronic limb threatening ischaemia (CLTI), amputation, and death were secondary outcomes.

      Results

      At 36 months follow-up the stent group (n = 32) had significantly better scores in the SF-36 domain Role Physical (RP, p = .023) and the Physical Component Summary (PCS, p = .032) compared to the control group (n = 30), however, there was no significant difference in EQ5D scores (p = .523). WIQ was significantly better in the stent group compared to the control group (p = .029) at 36 months. At 60 months follow-up no significant difference in HRQoL was seen between stent (n = 31) and control group (n = 32). Crossover from control to stent group was 25% at 60 months. There were no differences in progression to CLTI, amputation (2.1% vs 1.9%) or mortality (14.6% vs 15.4%) between groups.

      Conclusions

      In patients with IC caused by isolated SFA lesions, primary stenting conferred benefits in HRQoL until 36 months from treatment compared with BMT alone, but these benefits were no longer detectable at 60 months where a high crossover rate affected the power of the final analysis.

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