• F A Frans, S Bipat, J A Reekers, D A Legemate, M J W Koelemay, and SUPER Study Collaborators.
• Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
• Eur J Vasc Endovasc Surg. 2012 Apr 1; 43 (4): 466-71.

IntroductionTreatment of intermittent claudication (IC) due to peripheral arterial disease (PAD) is aimed at improving walking distance and includes secondary prevention of cardiovascular disease. Both supervised exercise therapy (SET) and percutaneous transluminal angioplasty (PTA) have proven to be effective in increasing maximum and pain-free walking distance in IC. However, the optimal treatment strategy in patients with IC due to iliac artery stenosis or occlusion remains unclear.ObjectiveTo compare the (cost-) effectiveness of initial PTA versus initial SET in patients with disabling IC due to an iliac artery obstruction.DesignIn a multicentre randomised controlled trial 400 consecutive patients with IC will be randomly assigned to PTA (with additional stent placement on indication) or SET. Primary outcomes are maximum walking distance and health-related quality of life measured using the disease-specific VascuQol instrument after 1 year. Secondary outcomes are pain-free walking distance, functional status, generic quality of life, complications related to each of the interventions, additional interventions, treatment failures and costs (cost-effectiveness and cost-utility) after 1 year.Conclusion And ImplicationsBased on the results of this proposed large study well-founded adjustments of existing guidelines on the treatment of iliac artery occlusive disease can be implemented (Clinical Trials.gov NCT01385774; Nederlands Trial Register NTR2776).Copyright © 2012 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

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