Long Term Results of a Randomised Trial of Stenting of the Superficial Femoral Artery for Intermittent Claudication

Thordur Gunnarsson; Stefan Bergman; Håkan Pärsson; Anders Gottsäter; Hans Lindgren

doi:10.1016/j.ejvs.2023.01.004

Long Term Results of a Randomised Trial of Stenting of the Superficial Femoral Artery for Intermittent Claudication

Thordur Gunnarsson, Stefan Bergman, Håkan Pärsson, Anders Gottsäter, Hans Lindgren

Research output: Contribution to journal › Article › peer-review

Abstract

Objective: Primary stenting of the superficial femoral artery (SFA) in intermittent claudication (IC) has been shown to increase health related quality of life (HRQoL) after 12 and 24 months. An extended follow up of HRQoL 36 and 60 months after randomisation is presented. Methods: A multicentre randomised controlled trial was conducted at seven vascular clinics in Sweden between 2010 and 2020. One hundred patients randomised to either primary stenting and best medical treatment (BMT; n = 48) or BMT alone (n = 52) were followed for 60 months. HRQoL, assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 36 and 60 months after randomisation, was the primary outcome. Walking Impairment Questionnaire (WIQ) score, re-interventions, progression to chronic limb threatening ischaemia (CLTI), amputation, and death were secondary outcomes. Results: At the 36 month follow up, the stent group (n = 32) had statistically significantly better scores in the SF-36 domain “Role Physical” (p = .023) and the Physical Component Summary (p = .032) compared with the control group (n = 30); however, there was no statistically significant difference in EQ5D scores (p = .52). WIQ was statistically significantly better in the stent group compared with the control group (p = .029) at 36 months. At the 60 month follow up, no statistically significant difference in HRQoL was seen between patients in the stent (n = 31) and control groups (n = 32). Crossover from the control group to the 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. Conclusion: In patients with IC caused by isolated SFA lesions, primary stenting conferred benefits to HRQoL until 36 months from treatment vs. BMT alone, but these benefits were no longer detectable at 60 months, where a high crossover rate affected the power of the final analysis.

Original language	English
Pages (from-to)	513-519
Journal	European journal of vascular and endovascular surgery
Volume	65
Issue number	4
Early online date	2023
DOIs	https://doi.org/10.1016/j.ejvs.2023.01.004
Publication status	Published - 2023

Subject classification (UKÄ)

Cardiology and Cardiovascular Disease

Free keywords

Health related quality of life
Intermittent claudication
Long term follow up
Stent treatment
Superficial femoral artery

Access to Document

10.1016/j.ejvs.2023.01.004

1 Doctoral Thesis (compilation)

Long-term results of invasive treatment of intermittent claudication and perioperative hemodynamic monitoring of the lower limb
Gunnarsson, T. S., 2025, Lund: Lund University, Faculty of Medicine. 110 p.
Research output: Thesis › Doctoral Thesis (compilation)

Open Access
File

1 Supervision of PhD students

Peripheral arterial disease, long-time results of invasive treatment of intermittent claudication and the value of intraoperative transcutaneous oximetry.
Gottsäter, A. (First/primary/lead supervisor), Lindgren, H. (Joint second supervisor), Bergman, S. (Joint second supervisor) & Pärsson, H. (Joint second supervisor)
2019 May 1 → …
Activity: Examination and supervision › Supervision of PhD students

Cite this

@article{01668b61284244899ba029595bb6aa57,

title = "Long Term Results of a Randomised Trial of Stenting of the Superficial Femoral Artery for Intermittent Claudication",

abstract = "Objective: Primary stenting of the superficial femoral artery (SFA) in intermittent claudication (IC) has been shown to increase health related quality of life (HRQoL) after 12 and 24 months. An extended follow up of HRQoL 36 and 60 months after randomisation is presented. Methods: A multicentre randomised controlled trial was conducted at seven vascular clinics in Sweden between 2010 and 2020. One hundred patients randomised to either primary stenting and best medical treatment (BMT; n = 48) or BMT alone (n = 52) were followed for 60 months. HRQoL, assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 36 and 60 months after randomisation, was the primary outcome. Walking Impairment Questionnaire (WIQ) score, re-interventions, progression to chronic limb threatening ischaemia (CLTI), amputation, and death were secondary outcomes. Results: At the 36 month follow up, the stent group (n = 32) had statistically significantly better scores in the SF-36 domain “Role Physical” (p = .023) and the Physical Component Summary (p = .032) compared with the control group (n = 30); however, there was no statistically significant difference in EQ5D scores (p = .52). WIQ was statistically significantly better in the stent group compared with the control group (p = .029) at 36 months. At the 60 month follow up, no statistically significant difference in HRQoL was seen between patients in the stent (n = 31) and control groups (n = 32). Crossover from the control group to the 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. Conclusion: In patients with IC caused by isolated SFA lesions, primary stenting conferred benefits to HRQoL until 36 months from treatment vs. BMT alone, but these benefits were no longer detectable at 60 months, where a high crossover rate affected the power of the final analysis.",

keywords = "Health related quality of life, Intermittent claudication, Long term follow up, Stent treatment, Superficial femoral artery",

author = "Thordur Gunnarsson and Stefan Bergman and H{\aa}kan P{\"a}rsson and Anders Gotts{\"a}ter and Hans Lindgren",

year = "2023",

doi = "10.1016/j.ejvs.2023.01.004",

language = "English",

volume = "65",

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T1 - Long Term Results of a Randomised Trial of Stenting of the Superficial Femoral Artery for Intermittent Claudication

AU - Gunnarsson, Thordur

AU - Bergman, Stefan

AU - Pärsson, Håkan

AU - Gottsäter, Anders

AU - Lindgren, Hans

PY - 2023

Y1 - 2023

N2 - Objective: Primary stenting of the superficial femoral artery (SFA) in intermittent claudication (IC) has been shown to increase health related quality of life (HRQoL) after 12 and 24 months. An extended follow up of HRQoL 36 and 60 months after randomisation is presented. Methods: A multicentre randomised controlled trial was conducted at seven vascular clinics in Sweden between 2010 and 2020. One hundred patients randomised to either primary stenting and best medical treatment (BMT; n = 48) or BMT alone (n = 52) were followed for 60 months. HRQoL, assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 36 and 60 months after randomisation, was the primary outcome. Walking Impairment Questionnaire (WIQ) score, re-interventions, progression to chronic limb threatening ischaemia (CLTI), amputation, and death were secondary outcomes. Results: At the 36 month follow up, the stent group (n = 32) had statistically significantly better scores in the SF-36 domain “Role Physical” (p = .023) and the Physical Component Summary (p = .032) compared with the control group (n = 30); however, there was no statistically significant difference in EQ5D scores (p = .52). WIQ was statistically significantly better in the stent group compared with the control group (p = .029) at 36 months. At the 60 month follow up, no statistically significant difference in HRQoL was seen between patients in the stent (n = 31) and control groups (n = 32). Crossover from the control group to the 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. Conclusion: In patients with IC caused by isolated SFA lesions, primary stenting conferred benefits to HRQoL until 36 months from treatment vs. BMT alone, but these benefits were no longer detectable at 60 months, where a high crossover rate affected the power of the final analysis.

AB - Objective: Primary stenting of the superficial femoral artery (SFA) in intermittent claudication (IC) has been shown to increase health related quality of life (HRQoL) after 12 and 24 months. An extended follow up of HRQoL 36 and 60 months after randomisation is presented. Methods: A multicentre randomised controlled trial was conducted at seven vascular clinics in Sweden between 2010 and 2020. One hundred patients randomised to either primary stenting and best medical treatment (BMT; n = 48) or BMT alone (n = 52) were followed for 60 months. HRQoL, assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 36 and 60 months after randomisation, was the primary outcome. Walking Impairment Questionnaire (WIQ) score, re-interventions, progression to chronic limb threatening ischaemia (CLTI), amputation, and death were secondary outcomes. Results: At the 36 month follow up, the stent group (n = 32) had statistically significantly better scores in the SF-36 domain “Role Physical” (p = .023) and the Physical Component Summary (p = .032) compared with the control group (n = 30); however, there was no statistically significant difference in EQ5D scores (p = .52). WIQ was statistically significantly better in the stent group compared with the control group (p = .029) at 36 months. At the 60 month follow up, no statistically significant difference in HRQoL was seen between patients in the stent (n = 31) and control groups (n = 32). Crossover from the control group to the 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. Conclusion: In patients with IC caused by isolated SFA lesions, primary stenting conferred benefits to HRQoL until 36 months from treatment vs. BMT alone, but these benefits were no longer detectable at 60 months, where a high crossover rate affected the power of the final analysis.

KW - Health related quality of life

KW - Intermittent claudication

KW - Long term follow up

KW - Stent treatment

KW - Superficial femoral artery

U2 - 10.1016/j.ejvs.2023.01.004

DO - 10.1016/j.ejvs.2023.01.004

M3 - Article

C2 - 36642399

AN - SCOPUS:85147576651

SN - 1078-5884

VL - 65

SP - 513

EP - 519

JO - European journal of vascular and endovascular surgery

JF - European journal of vascular and endovascular surgery

IS - 4

ER -

Long Term Results of a Randomised Trial of Stenting of the Superficial Femoral Artery for Intermittent Claudication

Abstract

Subject classification (UKÄ)

Free keywords

Access to Document

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Research output

Long-term results of invasive treatment of intermittent claudication and perioperative hemodynamic monitoring of the lower limb

Activities

Peripheral arterial disease, long-time results of invasive treatment of intermittent claudication and the value of intraoperative transcutaneous oximetry.

Cite this