The vein graft surveillance trial: Rationale, design and methods

Objectives: to compare the amputation rates, quality of life and health cav e costs in patients receiving duplex ultrasound scanning against clinical s urveillance following femoropopliteal and femorocrural vein bypass. Design: multi-centre, prospective, randomised controlled trial. Methods: 1200 patients with a patent vein graft at 30 days postoperatively will be randomised to either clinical or duplex follow-up. All patients are seen in an out-patient clinic at 6 weeks, then 3, 6, 9, 12 and 18 months p ostoperatively. At each appointment patients are examined clinically; palpa ble pulses in the graft and crural vessels, presenting symptoms and their a nkle-branchial pressure indices (ABPIs) measured. In the duplex group only, the results of the scan are monitored. The incidence of radiological and/o r surgical interventions throughout the follow-up period are also noted. Qu ality of life is measured using the SF-36 and EuroQol questionnaires at the 6 and 18 month appointments. Hospital stays and resource use are documente d for health economic analysis. Results: the primary endpoint of this study is amputation or death from vas cular causes; however, graft patency rates will also be compared between th e groups. Quality of life and health economic data will be used to determin e if there is any benefit in either arm in these outcomes between follow-up strategies. Conclusions: this large, randomised-controlled trial will hopefully provide direct evidence on the benefit of duplex surveillance for vein grafts in t er ms of limb salvage, quality of life of the patients and cost-benefit to the pur chaser.