Cost Effectiveness of Endovascular Revascularisation vs. Exercise Therapy for Intermittent Claudication Due to Iliac Artery Obstruction

Nick S Van Reijen,D Nio,A Rijbroek,R.M Krol,H De Bruine,M.S Lemson,L.C Huisman,Roderik Metz,M.H Van Werkum,A.P Conijn,H.D.W.M Van De Pavoort,A.C Vahl,Jim A Reekers,M Van Der Jagt,L.G Van Der Hem,M.J.L Van Strijen,M.P.J.H Mallant,J Seegers,G.A Vos,A Van De Elst,Franceline A Frans,R.B.M Van Tongeren,R.H.J Kropman,P.B Veendrick,C.F.M Klok,V.J Leijdekkers,D.M Scharn,G.J Glade,Susan Van Dieren,B.H.P Elsman,N.A Koedam,R.H.W Van De Mortel,B.J Van Kelckhoven,J.A Van Der Vliet,D.A.F Van Den Heuvel,J.C Breek,Maarten Truijers ,Mare M.a Lensvelt ,Edward Hollander ,Jan Wille ,Peter Klemm ,M.j.w Koelemay ,G J M Akkersdijk ,P Poyck ,Otto M Van Delden ,Marcel G W Dijkgraaf ,Marc R.h.m Van Sambeek ,Joël Vos ,Krijn P Van Lienden ,Willem E Hellings ,Jan D Blankensteijn ,Theodore A.a Van Den Broek ,M.c Willems ,Birgit Keller ,E.g Vermeulen ,Marc Van Leersum ,Joost Gravendeel ,Luuk Smeets ,J G A M Blomjous ,Michiel A Schreve ,Arno M Wiersema ,Mirza M Idu ,Anliu Nie ,J-P P M De Vries ,Dink A Legemate ,Steven M.m Van Sterkenburg ,Richard Oosterhof-Berktas ,Ron Balm ,H.c.j.l Buscher ,Joep A.w Teijink ,Emma Zijlstra ,R.h.h Engelbert ,Arjan W.j Hoksbergen

doi:10.1016/j.ejvs.2021.10.048

Abstract

To compare cost effectiveness of endovascular revascularisation (ER) and supervised exercise therapy (SET) as primary treatment for patients with intermittent claudication (IC) due to iliac artery obstruction. Cost utility analysis from a restricted societal perspective and time horizon of 12 months. Patients were included in a multicentre randomised controlled trial (SUPER study, NCT01385774, NTR2648) which compared effectiveness of ER and SET. Health status and health related quality of life (HRQOL) were measured using the Euroqol 5 dimensions 3 levels (EQ5D-3L) and VascuQol-25-NL. Incremental costs were determined per allocated treatment and use of healthcare during follow up. Effectiveness of treatment was determined in quality adjusted life years (QALYs). The difference between treatment groups was calculated by an incremental cost utility ratio (ICER). Some 240 patients were included, and complete follow up was available for 206 patients (ER 111 , SET 95). The mean costs for patients allocated to ER were €4 031 and €2 179 for SET, a mean difference of €1 852 (95% bias corrected and accelerated [bca] bootstrap confidence interval 1 185 - 2 646). The difference in QALYs during follow up was 0.09 (95% bcaCI 0.04 - 0.13) in favour of ER. The ICER per QALY was €20 805 (95% bcaCI 11 053 - 45 561). The difference in VascuQol sumscore was 0.64 (95% bcaCI 0.39 - 0.91), again in favour of ER. ER as a primary treatment, results in slightly better health outcome and higher QALYs and HRQOL during 12 months of follow up. Although these differences are statistically significant, clinical relevance must be discussed due to the small differences and relatively high cost of ER as primary treatment.

Highlights

Treatment of patients with intermittent claudication (IC) due to peripheral arterial disease (PAD) is aimed at improvement of pain free and maximum walking distance and quality of life
In the CLEVER randomised controlled trials (RCTs) patients with iliac artery obstructions who were allocated to stenting showed improvement in walking time at 18 months of follow up similar to those treated with supervised exercise therapy (SET)
Complete health status and quality of life outcomes were retrievable in 206 patients, 111 patients allocated to endovascular revascularisation (ER) and 95 allocated to SET

Summary

Introduction

Treatment of patients with intermittent claudication (IC) due to peripheral arterial disease (PAD) is aimed at improvement of pain free and maximum walking distance and quality of life. ER conferred more improvement in health status and quality of life, at higher cost.[3,12,13] since the CLEVER study was terminated prematurely and only 32 patients in both groups had treadmill testing at the end of follow up, there is no strong evidence for superiority of one treatment over the other This might result in the situation that still a significant volume of patients with IC due to an iliac artery obstruction are primarily treated invasively, even when a sufficient infrastructure for SET, as in The Netherlands, is present.[14]

Methods

Results

Conclusion