Original title: 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. Reference: Joakim Nordanstig et al. CIRCULATIONAHA.114.009867. Published online before print August 2014.
The quality of studies comparing invasive vs. non-invasive strategies in claudicants is low or very low and, most frequently, consist of one center series with a relatively small number of patients.
The aim of this prospective trial, randomized and controlled, was to test the hypothesis that an invasive strategy, when compared to standard medical treatment, could improve quality of life at one year in a group of unselected intermittent claudication patients.
After clinical assessment with Doppler ultrasound, an unselected intermittent claudication population was randomized to invasive treatment (n=79) vs. medical treatment (n=79).
Primary end point of this study was quality of life at 12 months with SF-36 and VascuQoL questionnaires. Secondary end point was treadmill walking performance.
Components tested with SF-36 questionnaire improved significantly in patients treated with the invasive strategy (p<0.001) and the same happened with VascuQoL results (p<0.01).
Claudication distance also improved significantly under invasive treatment, adding 124 m to treadmill walking performance vs. 50 m in the medical treatment group (p=0.003). Apart from symptoms, maximum walking distance was no different in both groups.
Conclusion
Invasive strategies improve quality of life at one year in patients with intermittent claudication compared to standard medical treatment.
Editorial Comment
Included patients presented stable intermittent claudication, which explains why end points such as death or amputation were not included. In most centers, these patients are treated with standard medical therapy and exercise training, reserving invasive strategies as a second course of action for those that will continue to suffer symptom limitations. Waiting affects quality of life in symptomatic patients and this is where the present study stands out. A long term follow up in addition to cost analysis is necessary to reach further and more definite conclusions for this vast patient population.
SOLACI