Editor's Choice - Randomised Clinical Trial of Supervised Exercise Therapy vs. Endovascular Revascularisation for Intermittent Claudication Caused by Iliac Artery Obstruction: The SUPER study

Mark J W Koelemay; Nick S van Reijen; Susan van Dieren; Franceline A Frans; Erik J G Vermeulen; Hessel C J L Buscher; Jim A Reekers; SUPER Study Collaborators; Robert de Bie

doi:10.1016/j.ejvs.2021.09.042

Editor's Choice - Randomised Clinical Trial of Supervised Exercise Therapy vs. Endovascular Revascularisation for Intermittent Claudication Caused by Iliac Artery Obstruction: The SUPER study

Mark J W Koelemay^*, Nick S van Reijen, Susan van Dieren, Franceline A Frans, Erik J G Vermeulen, Hessel C J L Buscher, Jim A Reekers, SUPER Study Collaborators, Robert de Bie

^*Corresponding author for this work

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

Abstract

OBJECTIVE: International guidelines recommend supervised exercise therapy (SET) as primary treatment for all patients with intermittent claudication (IC), yet primary endovascular revascularisation (ER) might be more effective in patients with iliac artery obstruction.

METHODS: This was a multicentre RCT including patients with IC caused by iliac artery stenosis or occlusion (NCT01385774). Patients were allocated randomly to SET or ER stratified for maximum walking distance (MWD) and concomitant SFA disease. Primary endpoints were MWD on a treadmill (3.2 km/h, 10% incline) and disease specific quality of life (VascuQol) after one year. Additional interventions during a mean follow up of 5.5 years were recorded.

RESULTS: Between November 2010 and May 2015, 114 patients were allocated to SET, and 126 to ER. The trial was terminated prematurely after 240 patients were included. Compliance with SET was 57/114 (50%) after six months. Ten patients allocated to ER (8%) did not receive this intervention. One year follow up was complete for 90/114 (79%) SET patients and for 104/126 (83%) ER patients. The mean MWD improved from 187 to 561 m in SET patients and from 196 to 574 m in ER patients (p = .69). VascuQol sumscore improved from 4.24 to 5.58 in SET patients, and from 4.28 to 5.88 in ER patients (p = .048). Some 33/114 (29%) SET patients had an ER within one year, and 2/114 (2%) surgical revascularisation (SR). Some 10/126 (8%) ER patients had additional ER within one year and 10/126 (8%) SR. After a mean of 5.5 years, 49% of SET patients and 27% of ER patients underwent an additional intervention for IC.

CONCLUSION: Taking into account the many limitations of the SUPER study, both a strategy of primary SET and primary ER improve MWD on a treadmill and disease specific Qol of patients with IC caused by an iliac artery obstruction. It seems reasonable to start with SET in these patients and accept a 30% failure rate, which, of course, must be discussed with the patient. Patients continue to have interventions beyond one year.

Original language	English
Pages (from-to)	421-429
Number of pages	9
Journal	European Journal of Vascular and Endovascular Surgery
Volume	63
Issue number	3
DOIs	https://doi.org/10.1016/j.ejvs.2021.09.042
Publication status	Published - Mar 2022

Keywords

Exercise Therapy
Humans
Iliac Artery
Intermittent Claudication/etiology
Peripheral Arterial Disease/complications
Quality of Life
Treatment Outcome
Walking

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Koelemay, M. J. W., van Reijen, N. S., van Dieren, S., Frans, F. A., Vermeulen, E. J. G., Buscher, H. C. J. L., Reekers, J. A., SUPER Study Collaborators, & de Bie, R. (2022). Editor's Choice - Randomised Clinical Trial of Supervised Exercise Therapy vs. Endovascular Revascularisation for Intermittent Claudication Caused by Iliac Artery Obstruction: The SUPER study. European Journal of Vascular and Endovascular Surgery, 63(3), 421-429. https://doi.org/10.1016/j.ejvs.2021.09.042

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title = "Editor's Choice - Randomised Clinical Trial of Supervised Exercise Therapy vs. Endovascular Revascularisation for Intermittent Claudication Caused by Iliac Artery Obstruction: The SUPER study",

abstract = "OBJECTIVE: International guidelines recommend supervised exercise therapy (SET) as primary treatment for all patients with intermittent claudication (IC), yet primary endovascular revascularisation (ER) might be more effective in patients with iliac artery obstruction.METHODS: This was a multicentre RCT including patients with IC caused by iliac artery stenosis or occlusion (NCT01385774). Patients were allocated randomly to SET or ER stratified for maximum walking distance (MWD) and concomitant SFA disease. Primary endpoints were MWD on a treadmill (3.2 km/h, 10% incline) and disease specific quality of life (VascuQol) after one year. Additional interventions during a mean follow up of 5.5 years were recorded.RESULTS: Between November 2010 and May 2015, 114 patients were allocated to SET, and 126 to ER. The trial was terminated prematurely after 240 patients were included. Compliance with SET was 57/114 (50%) after six months. Ten patients allocated to ER (8%) did not receive this intervention. One year follow up was complete for 90/114 (79%) SET patients and for 104/126 (83%) ER patients. The mean MWD improved from 187 to 561 m in SET patients and from 196 to 574 m in ER patients (p = .69). VascuQol sumscore improved from 4.24 to 5.58 in SET patients, and from 4.28 to 5.88 in ER patients (p = .048). Some 33/114 (29%) SET patients had an ER within one year, and 2/114 (2%) surgical revascularisation (SR). Some 10/126 (8%) ER patients had additional ER within one year and 10/126 (8%) SR. After a mean of 5.5 years, 49% of SET patients and 27% of ER patients underwent an additional intervention for IC.CONCLUSION: Taking into account the many limitations of the SUPER study, both a strategy of primary SET and primary ER improve MWD on a treadmill and disease specific Qol of patients with IC caused by an iliac artery obstruction. It seems reasonable to start with SET in these patients and accept a 30% failure rate, which, of course, must be discussed with the patient. Patients continue to have interventions beyond one year.",

keywords = "Exercise Therapy, Humans, Iliac Artery, Intermittent Claudication/etiology, Peripheral Arterial Disease/complications, Quality of Life, Treatment Outcome, Walking",

author = "Koelemay, {Mark J W} and {van Reijen}, {Nick S} and {van Dieren}, Susan and Frans, {Franceline A} and Vermeulen, {Erik J G} and Buscher, {Hessel C J L} and Reekers, {Jim A} and {SUPER Study Collaborators} and {de Bie}, Robert",

year = "2022",

month = mar,

doi = "10.1016/j.ejvs.2021.09.042",

language = "English",

volume = "63",

pages = "421--429",

journal = "European Journal of Vascular and Endovascular Surgery",

issn = "1078-5884",

publisher = "Elsevier Saunders",

number = "3",

}

Koelemay, MJW, van Reijen, NS, van Dieren, S, Frans, FA, Vermeulen, EJG, Buscher, HCJL, Reekers, JA, SUPER Study Collaborators & de Bie, R 2022, 'Editor's Choice - Randomised Clinical Trial of Supervised Exercise Therapy vs. Endovascular Revascularisation for Intermittent Claudication Caused by Iliac Artery Obstruction: The SUPER study', European Journal of Vascular and Endovascular Surgery, vol. 63, no. 3, pp. 421-429. https://doi.org/10.1016/j.ejvs.2021.09.042

Editor's Choice - Randomised Clinical Trial of Supervised Exercise Therapy vs. Endovascular Revascularisation for Intermittent Claudication Caused by Iliac Artery Obstruction: The SUPER study. / Koelemay, Mark J W; van Reijen, Nick S; van Dieren, Susan et al.
In: European Journal of Vascular and Endovascular Surgery, Vol. 63, No. 3, 03.2022, p. 421-429.

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

TY - JOUR

T1 - Editor's Choice - Randomised Clinical Trial of Supervised Exercise Therapy vs. Endovascular Revascularisation for Intermittent Claudication Caused by Iliac Artery Obstruction

T2 - The SUPER study

AU - Koelemay, Mark J W

AU - van Reijen, Nick S

AU - van Dieren, Susan

AU - Frans, Franceline A

AU - Vermeulen, Erik J G

AU - Buscher, Hessel C J L

AU - Reekers, Jim A

AU - SUPER Study Collaborators

AU - de Bie, Robert

PY - 2022/3

Y1 - 2022/3

N2 - OBJECTIVE: International guidelines recommend supervised exercise therapy (SET) as primary treatment for all patients with intermittent claudication (IC), yet primary endovascular revascularisation (ER) might be more effective in patients with iliac artery obstruction.METHODS: This was a multicentre RCT including patients with IC caused by iliac artery stenosis or occlusion (NCT01385774). Patients were allocated randomly to SET or ER stratified for maximum walking distance (MWD) and concomitant SFA disease. Primary endpoints were MWD on a treadmill (3.2 km/h, 10% incline) and disease specific quality of life (VascuQol) after one year. Additional interventions during a mean follow up of 5.5 years were recorded.RESULTS: Between November 2010 and May 2015, 114 patients were allocated to SET, and 126 to ER. The trial was terminated prematurely after 240 patients were included. Compliance with SET was 57/114 (50%) after six months. Ten patients allocated to ER (8%) did not receive this intervention. One year follow up was complete for 90/114 (79%) SET patients and for 104/126 (83%) ER patients. The mean MWD improved from 187 to 561 m in SET patients and from 196 to 574 m in ER patients (p = .69). VascuQol sumscore improved from 4.24 to 5.58 in SET patients, and from 4.28 to 5.88 in ER patients (p = .048). Some 33/114 (29%) SET patients had an ER within one year, and 2/114 (2%) surgical revascularisation (SR). Some 10/126 (8%) ER patients had additional ER within one year and 10/126 (8%) SR. After a mean of 5.5 years, 49% of SET patients and 27% of ER patients underwent an additional intervention for IC.CONCLUSION: Taking into account the many limitations of the SUPER study, both a strategy of primary SET and primary ER improve MWD on a treadmill and disease specific Qol of patients with IC caused by an iliac artery obstruction. It seems reasonable to start with SET in these patients and accept a 30% failure rate, which, of course, must be discussed with the patient. Patients continue to have interventions beyond one year.

AB - OBJECTIVE: International guidelines recommend supervised exercise therapy (SET) as primary treatment for all patients with intermittent claudication (IC), yet primary endovascular revascularisation (ER) might be more effective in patients with iliac artery obstruction.METHODS: This was a multicentre RCT including patients with IC caused by iliac artery stenosis or occlusion (NCT01385774). Patients were allocated randomly to SET or ER stratified for maximum walking distance (MWD) and concomitant SFA disease. Primary endpoints were MWD on a treadmill (3.2 km/h, 10% incline) and disease specific quality of life (VascuQol) after one year. Additional interventions during a mean follow up of 5.5 years were recorded.RESULTS: Between November 2010 and May 2015, 114 patients were allocated to SET, and 126 to ER. The trial was terminated prematurely after 240 patients were included. Compliance with SET was 57/114 (50%) after six months. Ten patients allocated to ER (8%) did not receive this intervention. One year follow up was complete for 90/114 (79%) SET patients and for 104/126 (83%) ER patients. The mean MWD improved from 187 to 561 m in SET patients and from 196 to 574 m in ER patients (p = .69). VascuQol sumscore improved from 4.24 to 5.58 in SET patients, and from 4.28 to 5.88 in ER patients (p = .048). Some 33/114 (29%) SET patients had an ER within one year, and 2/114 (2%) surgical revascularisation (SR). Some 10/126 (8%) ER patients had additional ER within one year and 10/126 (8%) SR. After a mean of 5.5 years, 49% of SET patients and 27% of ER patients underwent an additional intervention for IC.CONCLUSION: Taking into account the many limitations of the SUPER study, both a strategy of primary SET and primary ER improve MWD on a treadmill and disease specific Qol of patients with IC caused by an iliac artery obstruction. It seems reasonable to start with SET in these patients and accept a 30% failure rate, which, of course, must be discussed with the patient. Patients continue to have interventions beyond one year.

KW - Exercise Therapy

KW - Humans

KW - Iliac Artery

KW - Intermittent Claudication/etiology

KW - Peripheral Arterial Disease/complications

KW - Quality of Life

KW - Treatment Outcome

KW - Walking

U2 - 10.1016/j.ejvs.2021.09.042

DO - 10.1016/j.ejvs.2021.09.042

M3 - Article

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SN - 1078-5884

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SP - 421

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JO - European Journal of Vascular and Endovascular Surgery

JF - European Journal of Vascular and Endovascular Surgery

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Koelemay MJW, van Reijen NS, van Dieren S, Frans FA, Vermeulen EJG, Buscher HCJL et al. Editor's Choice - Randomised Clinical Trial of Supervised Exercise Therapy vs. Endovascular Revascularisation for Intermittent Claudication Caused by Iliac Artery Obstruction: The SUPER study. European Journal of Vascular and Endovascular Surgery. 2022 Mar;63(3):421-429. doi: 10.1016/j.ejvs.2021.09.042