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Primary Stenting of the Superficial Femoral Artery in Intermittent Claudication Improves Health Related Quality of Life, ABI and Walking Distance : 12 Month Results of a Controlled Randomised Multicentre Trial

Lindgren, H. LU ; Qvarfordt, P. LU ; Åkesson, M.; Bergman, S. LU ; Gottsäter, A. LU and , (2017) In European Journal of Vascular and Endovascular Surgery 53(5). p.686-694
Abstract

Background: Invasive treatment of intermittent claudication (IC) because of severe atherosclerotic stenosis or occlusion in the superficial femoral artery (SFA) is controversial. This prospective randomised trial was performed to assess the impact on health related quality of life (HRQoL) of primary stenting with nitinol self expanding stents compared with best medical treatment alone in patients suffering from stable IC due to SFA disease. Methods: One hundred patients with stable IC caused by SFA disease from seven Swedish hospitals treated with best medical treatment (BMT) were randomised to either the stent (n = 48) or the control (n = 52) group. Change in HRQoL assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5... (More)

Background: Invasive treatment of intermittent claudication (IC) because of severe atherosclerotic stenosis or occlusion in the superficial femoral artery (SFA) is controversial. This prospective randomised trial was performed to assess the impact on health related quality of life (HRQoL) of primary stenting with nitinol self expanding stents compared with best medical treatment alone in patients suffering from stable IC due to SFA disease. Methods: One hundred patients with stable IC caused by SFA disease from seven Swedish hospitals treated with best medical treatment (BMT) were randomised to either the stent (n = 48) or the control (n = 52) group. Change in HRQoL assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 12 months after treatment was the primary outcome measure. Improvement in the Walking Impairment Questionnaire (WIQ), ankle brachial index (ABI), and walking distance were secondary outcomes. Results: HRQoL improved significantly. In the stent group the following SF-36 domains improved: Physical Function, 19 points (p < .001); Bodily Pain, 14 points (p = .001); General Health, 6 points (p = .019); Vitality, 10 points (p = .004); Physical Component Summary, 6.5 points (p < .001); EQ5D, 0.14 points (p = .008); and WIQ 22 points (p < .001). They were unchanged in the control group. Both ABI (from 0.58 ± 0.11 to 0.86 ± 0.19, p < .001, in the stent group and from 0.63 ± 0.17 to 0.70 ± 0.20, p = .005, in the control group) and walking distance (WD) (from 171 ± 90 meters to 613 ± 381 meters, p < .001, in the stent group and from 209 ± 106 m to 335 ± 321 meters, p = .012, in the control group) improved, and at 12 months both the ABI (p < .001) and the WD (p = .001) were higher in the stent group. Conclusions: In patients with IC caused by lesions in the SFA, the addition of primary stenting to BMT was associated with significant improvement in HRQoL, ABI, and walking distance after 12 months follow-up compared with BMT alone.

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organization
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type
Contribution to journal
publication status
published
subject
keywords
Health Related Quality of Life, Intermittent claudication, Peripheral arterial disease, Primary stenting, Superficial femoral artery
in
European Journal of Vascular and Endovascular Surgery
volume
53
issue
5
pages
686 - 694
publisher
Elsevier
external identifiers
  • scopus:85016416483
  • wos:000401678900016
ISSN
1078-5884
DOI
10.1016/j.ejvs.2017.01.026
language
English
LU publication?
yes
id
5a038fd0-26ed-48c5-b21c-89209a873008
date added to LUP
2017-04-19 14:35:32
date last changed
2017-09-18 13:32:42
@article{5a038fd0-26ed-48c5-b21c-89209a873008,
  abstract     = {<p>Background: Invasive treatment of intermittent claudication (IC) because of severe atherosclerotic stenosis or occlusion in the superficial femoral artery (SFA) is controversial. This prospective randomised trial was performed to assess the impact on health related quality of life (HRQoL) of primary stenting with nitinol self expanding stents compared with best medical treatment alone in patients suffering from stable IC due to SFA disease. Methods: One hundred patients with stable IC caused by SFA disease from seven Swedish hospitals treated with best medical treatment (BMT) were randomised to either the stent (n = 48) or the control (n = 52) group. Change in HRQoL assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 12 months after treatment was the primary outcome measure. Improvement in the Walking Impairment Questionnaire (WIQ), ankle brachial index (ABI), and walking distance were secondary outcomes. Results: HRQoL improved significantly. In the stent group the following SF-36 domains improved: Physical Function, 19 points (p &lt; .001); Bodily Pain, 14 points (p = .001); General Health, 6 points (p = .019); Vitality, 10 points (p = .004); Physical Component Summary, 6.5 points (p &lt; .001); EQ5D, 0.14 points (p = .008); and WIQ 22 points (p &lt; .001). They were unchanged in the control group. Both ABI (from 0.58 ± 0.11 to 0.86 ± 0.19, p &lt; .001, in the stent group and from 0.63 ± 0.17 to 0.70 ± 0.20, p = .005, in the control group) and walking distance (WD) (from 171 ± 90 meters to 613 ± 381 meters, p &lt; .001, in the stent group and from 209 ± 106 m to 335 ± 321 meters, p = .012, in the control group) improved, and at 12 months both the ABI (p &lt; .001) and the WD (p = .001) were higher in the stent group. Conclusions: In patients with IC caused by lesions in the SFA, the addition of primary stenting to BMT was associated with significant improvement in HRQoL, ABI, and walking distance after 12 months follow-up compared with BMT alone.</p>},
  author       = {Lindgren, H. and Qvarfordt, P. and Åkesson, M. and Bergman, S. and Gottsäter, A. and , },
  issn         = {1078-5884},
  keyword      = {Health Related Quality of Life,Intermittent claudication,Peripheral arterial disease,Primary stenting,Superficial femoral artery},
  language     = {eng},
  month        = {03},
  number       = {5},
  pages        = {686--694},
  publisher    = {Elsevier},
  series       = {European Journal of Vascular and Endovascular Surgery},
  title        = {Primary Stenting of the Superficial Femoral Artery in Intermittent Claudication Improves Health Related Quality of Life, ABI and Walking Distance : 12 Month Results of a Controlled Randomised Multicentre Trial},
  url          = {http://dx.doi.org/10.1016/j.ejvs.2017.01.026},
  volume       = {53},
  year         = {2017},
}