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CardioVascular and Interventional Radiology
Published in: CardioVascular and Interventional Radiology 6/2018

Open Access 01-06-2018 | Clinical Investigation

Primary Stenting of the Superficial Femoral Artery in Patients with Intermittent Claudication Has Durable Effects on Health-Related Quality of Life at 24 Months: Results of a Randomized Controlled Trial

Authors: Hans I. V. Lindgren, Peter Qvarfordt, Stefan Bergman, Anders Gottsäter, The Swedish Endovascular Claudication Stenting Trialists

Published in: CardioVascular and Interventional Radiology | Issue 6/2018

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Abstract

Background

Intermittent claudication (IC) is commonly caused by lesions in the superficial femoral artery (SFA), yet invasive treatment is still controversial and longer term patient-reported outcomes are lacking. This prospective randomized trial assessed the 24-month impact of primary stenting with nitinol self-expanding stents compared to best medical treatment (BMT) alone in patients with stable IC due to SFA disease on health-related quality of life (HRQoL).

Methods

One hundred patients with stable IC due to SFA disease treated with BMT were randomized to either stent (n = 48) or control (n = 52) group. HRQoL assessed by Short Form 36 Health Survey (SF-36) and EuroQoL 5-dimensions (EQ5D) 24 months after treatment were primary outcome measures. Walking Impairment Questionnaire, ankle–brachial index (ABI), and walking distance were secondary outcomes.

Results

Significantly better SF-36 Physical Component Summary (P = 0.024) and physical domain scores such as Physical Function (P = 0.012), Bodily Pain (P = 0.002), General Health (P = 0.037), and EQ5D (P = 0.010) were reported in intergroup comparison between the stent and the control group. Both ABI (from 0.58 ± 0.11 to 0.85 ± 0.18; P < 0.001 in the stent group and from 0.63 ± 0.17 to 0.69 ± 0.18; P = 0.036 in the control group) and walking distance (from 170 ± 90 m to 616 ± 375 m; P < 0.001 in the stent group and from 209 ± 111 m to 331 ± 304 m; P = 0.006 in the control group) improved significantly in intragroup comparisons.

Conclusions

In patients with IC caused by lesions in the SFA, primary stenting compared to BMT alone was associated with significant improvements in HRQoL, ABI, and walking distance durable up to 24 months of follow-up.
Clinical Trial Registration http://​www.​clinicaltrials.​gov. Unique Identifier: NCT01230229
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Metadata
Title
Primary Stenting of the Superficial Femoral Artery in Patients with Intermittent Claudication Has Durable Effects on Health-Related Quality of Life at 24 Months: Results of a Randomized Controlled Trial
Authors
Hans I. V. Lindgren
Peter Qvarfordt
Stefan Bergman
Anders Gottsäter
The Swedish Endovascular Claudication Stenting Trialists
Publication date
01-06-2018
Publisher
Springer US
Published in
CardioVascular and Interventional Radiology / Issue 6/2018
Print ISSN: 0174-1551
Electronic ISSN: 1432-086X
DOI
https://doi.org/10.1007/s00270-018-1925-0

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