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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

Lindgren, Hans I.V. LU ; Qvarfordt, Peter LU ; Bergman, Stefan LU ; Gottsäter, Anders LU and , (2018) In CardioVascular and Interventional Radiology 41(6). p.872-881
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... (More)

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 Registrationhttp://www.clinicaltrials.gov. Unique Identifier:NCT01230229

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author
organization
publishing date
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
CardioVascular and Interventional Radiology
volume
41
issue
6
pages
872 - 881
publisher
Springer
external identifiers
  • scopus:85043352895
ISSN
0174-1551
DOI
10.1007/s00270-018-1925-0
language
English
LU publication?
yes
id
350cbd1b-cbe7-47e1-91cd-34d2964443a6
date added to LUP
2018-03-29 14:33:20
date last changed
2019-04-23 04:30:12
@article{350cbd1b-cbe7-47e1-91cd-34d2964443a6,
  abstract     = {<p>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 &lt; 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 &lt; 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 Registrationhttp://www.clinicaltrials.gov. Unique Identifier:NCT01230229</p>},
  author       = {Lindgren, Hans I.V. and Qvarfordt, Peter and Bergman, Stefan and Gottsäter, Anders and , },
  issn         = {0174-1551},
  keyword      = {Health-related quality of life,Intermittent claudication,Peripheral arterial disease,Primary stenting,Superficial femoral artery},
  language     = {eng},
  number       = {6},
  pages        = {872--881},
  publisher    = {Springer},
  series       = {CardioVascular and Interventional Radiology},
  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},
  url          = {http://dx.doi.org/10.1007/s00270-018-1925-0},
  volume       = {41},
  year         = {2018},
}