The Vein Graft Surveillance Trial: rationale, design and methods. VGST participants.

Abstract

to compare the amputation rates, quality of life and health care costs in patients receiving duplex ultrasound scanning against clinical surveillance following femoropopliteal and femorocrural vein bypass. multi-centre, prospective, randomised controlled trial. 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 postoperatively. At each appointment patients are examined clinically; palpable pulses in the graft and crural vessels, presenting symptoms and their ankle-branchial pressure indices (ABPIs) measured. In the duplex group only, the results of the scan are monitored. The incidence of radiological and/or surgical interventions throughout the follow-up period are also noted. Quality of life is measured using the SF-36 and EuroQol questionnaires at the 6 and 18 month appointments. Hospital stays and resource use are documented for health economic analysis. the primary endpoint of this study is amputation or death from vascular causes; however, graft patency rates will also be compared between the groups. Quality of life and health economic data will be used to determine if there is any benefit in either arm in these outcomes between follow-up strategies. this large, randomised-controlled trial will hopefully provide direct evidence on the benefit of duplex surveillance for vein grafts in terms of limb salvage, quality of life of the patients and cost-benefit to the purchaser.