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

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

doi:10.1007/s00270-018-1925-0

Hans I V Lindgren, Anders Gottsäter + Show 3 more

Open Access

https://doi.org/10.1007/s00270-018-1925-0

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Abstract

BackgroundIntermittent 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).MethodsOne 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.ResultsSignificantly 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.ConclusionsIn 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 Registrationhttp://www.clinicaltrials.gov. Unique Identifier:NCT01230229

Highlights

Peripheral arterial disease (PAD) is a global problem and intermittent claudication (IC) affects 20–40 million individuals worldwide
In patients with Intermittent claudication (IC) caused by lesions in the superficial femoral artery (SFA), primary stenting compared to best medical treatment (BMT) alone was associated with significant improvements in health-related quality of life (HRQoL), ankle–brachial index (ABI), and walking distance durable up to 24 months of follow-up
Results of invasive treatment of IC patients due to suprainguinal disease are excellent [7], but invasive treatment of the most common form of IC, i.e., infrainguinal IC caused by lesions in the superficial femoral artery (SFA), is hampered by high restenosis rates [8] and considered controversial according to international guidelines [3, 4]

Summary

Introduction

Peripheral arterial disease (PAD) is a global problem and intermittent claudication (IC) affects 20–40 million individuals worldwide It is more common in high-income countries [1] with a prevalence of 7% in the Swedish. 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). Keywords Peripheral arterial disease Á Intermittent claudication Á Primary stenting Á Health-related quality of life Á Superficial femoral artery

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