Improved Quality of Life After One Year With an Invasive Versus a Non-Invasive Treatment Strategy in Claudicants: One Year Results of the IRONIC Trial
Background—The quality of evidence for invasive revascularization in intermittent claudication (IC) is low or very low. This prospective randomized controlled study tested the hypothesis that an invasive treatment strategy (INV) versus continued non-invasive treatment (NON) improves health-related quality of life after one year in unselected IC patients.
Methods and Results—Following clinical and duplex ultrasound assessment, unselected IC patients requesting treatment for claudication were randomly assigned to INV (n=79) or NON (n=79). Primary endpoint was health-related quality of life after one year, assessed with SF-36 and VascuQoL, and secondary endpoints included walking distances on a graded treadmill. SF-36 physical component summary (p<0.001) and two SF-36 physical subscales improved significantly more in the INV versus the NON group. Overall VascuQoL score (p<0.01) and three out of five domain scores improved significantly more in the INV versus the NON group. Intermittent claudication distance (ICD) improved significantly in INV (+124 m) versus NON (+50 m) group, p=0.003, while the change in maximum walking distance (MWD) was not significantly different between groups.
Conclusions—An invasive treatment strategy improves health-related quality of life and ICD after one year in patients with stable lifestyle-limiting claudication receiving current medical management. Long-term follow-up data and health-economic assessments are warranted to further establish the role for revascularization in IC.
Clinical Trial Registration Information—ClinicalTrials.gov. Identifier: NCT01219842.
- walking capacity
- peripheral artery disease
- intermittent claudication
- health-related quality of life
- Received March 6, 2014.
- Revision received June 21, 2014.
- Accepted June 27, 2014.