Two‐year results from a randomized clinical trial of revascularization in patients with intermittent claudication. Issue 10 (25th May 2016)

• Record Type: Journal Article
• Authors: Nordanstig, J.; Taft, C.; Hensäter, M.; Perlander, A.; Österberg, K.; Jivegård, L.
• Is Part Of: British journal of surgery. Volume 103:Issue 10(2016)
• Page Start: 1290
• Page End: 1299
• Publication Date: 2016-05-25
• Subjects: Surgery -- Periodicals; 617.005
• DOI: 10.1002/bjs.10198
• Languages: English
• ISSNs: 0007-1323

Abstract

Abstract: 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 ). Abstract : Revascularization better than unsupervised exercise alone