Two-year results from a randomized clinical trial of revascularization in patients with intermittent claudication.

BACKGROUND Intermittent claudication is associated with significant impairment of health-related quality of life. The use of revascularization techniques to improve health-related quality of life remains controversial. METHODS Patients with intermittent claudication due to iliac or femoropopliteal peripheral artery disease were enrolled in the IRONIC trial. They were randomized to either best medical therapy (BMT), including a structured, non-supervised exercise programme, or revascularization with either endovascular or open techniques in addition to BMT. The primary outcome was health-related quality of life at 2 years assessed using the Short Form 36 (SF-36(®) ) questionnaire. Secondary outcomes included VascuQoL questionnaire results, treadmill walking distances and achievement of patient-specified treatment goals. RESULTS Both randomized groups had improved health-related quality of life and treadmill walking distance at 2-year follow-up. Overall SF-36(®) physical component summary score, three SF-36(®) physical domain scores, overall VascuQoL score, and three of five VascuQoL domain scores showed significantly greater improvement in the group that also received invasive treatment. Intermittent claudication distance on a graded treadmill improved more in the revascularization + BMT group (117 versus 55 m; P = 0·003) whereas maximum walking distance and 6-min walk test distance were similar. Some 44 per cent of patients in the revascularization + BMT group reported they had fully achieved their treatment goal versus 10 per cent in the BMT group. CONCLUSION A revascularization strategy with unsupervised exercise improved health-related quality of life and intermittent claudication distance more than standard BMT and an unsupervised exercise programme in patients with lifestyle-limiting claudication. REGISTRATION NUMBER NCT01219842 (http://www.clinicaltrials.gov).