Peripheral Arterial Disease: Clinical and Cost Comparisons between Duplex US and Contrast-enhanced MR Angiography—A Multicenter Randomized Trial

Purpose: To prospectively determine the clinical and economic consequences of replacing duplex ultrasonography (US) with contrast material–enhanced magnetic resonance (MR) angiography for the initial imaging work-up of patients with peripheral arterial disease (PAD). Materials and Methods: This randomized multicenter study was approved by the institutional review board of each hospital, and all patients signed written informed consent prior to randomization. Patients with PAD who needed to undergo imaging work-up and who had an ankle-brachial pressure index (ABPI) of less than 0.90 were recruited by vascular surgeons between January 2002 and September 2003. Patients were randomly assigned to undergo contrast-enhanced MR angiography or duplex US. The primary outcome measure was cost. Secondary outcome measures included therapeutic confidence, changes in disease severity, and changes in quality of life (QOL) assessed during 6 months of follow-up. Indicators for disease severity were based on the Rutherford ...