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

M.j.w Koelemay ,A.P Conijn,Nick S Van Reijen,C.F.M Klok,T.A Van Den Broek,H.W Slis,J Seegers,D.M Scharn,G.A Vos,S.M Van Sterkenburg,V.J Leijdekkers,B.J Van Kelckhoven,J.A Van Ostayen,S.S Van Der Voort,B.H.P Elsman,B Honing,Erik J.G Vermeulen,A.C Vahl,R.H.H Engelbert,J.P.M.M De Vries,N.A Koedam,M.R Van Sambeek,A Moolhuijzen,R.B.M Van Tongeren,R.H.J Kropman,R.M Krol,T Pels Rijcken,Jim A Reekers,R.C Van Nieuwenhuizen,P.B Veendrick,M Van Der Jagt,M.H Van Werkum,J.A Van Der Vliet,L.G Van Der Hem,D Nio,R.H Van De Mortel,Franceline A Frans,A Rijbroek,J.H.D De Bruine,H.J Van De Rest,M.J Mallant,M.A Van Egmond,M.S Lemson,H.D Van De Pavoord,L.C Huisman,Susan Van Dieren,Joël Vos ,Peter Klemm ,M.c Willems ,Jan D Blankensteijn ,H.c.j.l Buscher ,Dink A Legemate ,Emma Zijlstra ,Joost Gravendeel ,P Poyck ,Edwin Geleijn ,J.c Breek ,Ron Balm ,Michiel A Schreve ,Birgit Keller ,Michel M.p.j Reijnen ,Rob J De Haan ,Otto M Van Delden ,G J M Akkersdijk ,Marcel G W Dijkgraaf ,Luuk Smeets ,Marco J Van Strijen ,Arno M Wiersema ,Auguste Van Poelgeest ,Richard Oosterhof-Berktas ,J G A M Blomjous ,Anliu Nie ,Alfons G A Kamphuis ,Leo J Schultze Kool ,Christianne J Buskens ,Alexander D Montauban Van Swijndregt ,Roderik Metz ,Willem E Hellings ,Cjam Zeebregts ,Shandra Bipat ,Krijn P Van Lienden ,Arjan W.j Hoksbergen ,Edward Hollander ,Marc Van Leersum ,Rosemarie Met ,Mirza M Idu ,Daniel A Van Den Heuvel ,Joep A.w Teijink ,Rob A De Bie ,J.c.n.m Aarts ,Jan Wille ,Rutger J Lely ,Hans Van Overhagen

doi:10.1016/j.ejvs.2021.09.042

Abstract

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. 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. 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. 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.

Highlights

Patients with intermittent claudication (IC) caused by peripheral arterial disease (PAD) have leg pain during exertion, which disappears after a short rest
Five patients had spontaneous resolution of a groin haematoma and one of a transient thrombosis of the common femoral artery (CFA), one patient had an iliac artery dissection that was treated by repeat angioplasty the day, in one patient a stent migrated to Please cite this article as: Koelemay MJW et al, Randomised Clinical Trial of Supervised Exercise Therapy vs. Endovascular Revascularisation for Intermittent Claudication Caused by Iliac Artery Obstruction: The SUPervised exercise therapy vs. ER (SUPER) study, European Journal of Vascular and Endovascular Surgery, https://doi.org/10.1016/ j.ejvs.2021.09.042
The SUPER study was conducted with the intention to provide definitive evidence on the relative effectiveness of supervised exercise therapy (SET) and ER for symptom relief in patients with IC caused by

Summary

Introduction

Patients with intermittent claudication (IC) caused by peripheral arterial disease (PAD) have leg pain during exertion, which disappears after a short rest. As patients with IC may feel impaired by a limited pain free walking distance (PFWD), treatment is aimed at symptom relief to improve quality of life. Several effective treatment modalities for patients with IC are available including supervised exercise therapy (SET), and endovascular (ER) and surgical revascularisation (SR). Current international guidelines recommend SET as first line treatment in patients with IC.[1] This recommendation is supported by evidence from 10 randomised controlled trials (RCT) comparing a wide variety of SET programmes with ER in a total of 1 087 patients with IC.[2] Appreciation of this research is hampered by the RCTs including patients with obstructions in both the aorto-iliac and femoropopliteal arteries, comparing SET with ER alone or in various combinations, and using a variety of SET programmes. The primary endpoints walking distance and quality of life were measured with a variety of exercise tests and questionnaires to assess quality of life (Qol).[2,3]

Methods

Results

Conclusion