Improved quality of life after 1 year with an invasive versus a noninvasive treatment strategy in claudicants: one-year results of the Invasive Revascularization or Not in Intermittent Claudication (IRONIC) Trial.

BACKGROUND: The quality of evidence for invasive revascularization in intermittent claudication is low or very low. This prospective, randomized, controlled study tested the hypothesis that an invasive treatment strategy versus continued noninvasive treatment improves health-related quality of life after 1 year in unselected patients with intermittent claudication. METHODS AND RESULTS: After clinical and duplex ultrasound assessment, unselected patients with intermittent claudication requesting treatment for claudication were randomly assigned to invasive (n=79) or noninvasive (n=79) treatment groups. Primary end point was health-related quality of life after 1 year, assessed with Medical Outcomes Study Short Form 36 version 1 and Vascular Quality of Life Questionnaire, and secondary end points included walking distances on a graded treadmill. The Medical Outcomes Study Short Form 36 version 1 physical component summary (P<0.001) and 2 Medical Outcomes Study Short Form 36 version 1 physical subscales improved significantly more in the invasive versus the noninvasive treatment group. Overall, Vascular Quality of Life Questionnaire score (P<0.01) and 3 of 5 domain scores improved significantly more in the invasive versus the noninvasive treatment group. Intermittent claudication distance improved significantly in the invasive (+124 m) versus the noninvasive (+50 m) group (P=0.003), whereas the change in maximum walking distance was not significantly different between groups. CONCLUSIONS: An invasive treatment strategy improves health-related quality of life and intermittent claudication distance after 1 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 intermittent claudication.

Six-minute walk test closely correlates to "real-life" outdoor walking capacity and quality of life in patients with intermittent claudication.

OBJECTIVE: We used outdoor walking distance measured during 40 minutes as "real-life" outdoor walking capacity in 49 patients with intermittent claudication (IC). The outdoor walking distance was measured by a global positioning system application for a smartphone. The relationships of self-reported maximum walking distance (SR-MWD), the MWD on a graded treadmill test, and the 6-minute maximum walk distance (6MWD) vs outdoors walking capacity were investigated. Also studied were the associations of SR-MWD, MWD, and 6MWD with health-related quality of life assessed with the disease-specific instrument the Vascular Quality of Life Questionnaire (VascuQoL). METHODS: In this prospective observational cohort study, 49 IC patients underwent an outdoor walking capacity test for 40 minutes, and MWD and 6MWD were measured. SR-MWD was recorded, and all subjects completed the VascuQoL questionnaire. Associations between the different walk estimates and outdoor walking capacity and health-related quality of life were investigated by correlation analysis (Spearman ρ). RESULTS: Outdoor walking distance during 40 minutes was a median 2495 m (range, 1110-3300 m). SR-MWD correlated moderately and MWD correlated strongly to outdoor walking capacity (r = 0.56 and r = 0.65; P < .001, respectively). The 6MWD test showed the largest correlation to the outdoor walking capacity (r = 0.78; P < .001). The 6MWD was the only test that showed correlations with the VascuQoL sum score (r = 0.53; P < .01) and all of the domain scores, whereas SR-MWD and MWD showed weak correlations to the VascuQoL. CONCLUSIONS: The distance walked during the 6-minute walk test is closely correlated to outdoor walking capacity and health-related quality of life in IC patients. Our data support the use of 6MWD for routine clinical evaluation of walking capacity in IC patients.