Why the study?
The quality of evidence for invasive revascularization in intermittent claudication is low or very low, necessitating randomized controlled evaluation of its impact on quality of life.
Does an invasive treatment strategy improve health-related quality of life in patients with intermittent claudication compared to a noninvasive strategy?
Does an invasive treatment strategy improve health-related quality of life in patients with intermittent claudication compared to a noninvasive strategy?
An invasive treatment strategy for intermittent claudication significantly improves health-related quality of life and initial claudication distance at 1 year compared to noninvasive medical management.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The benefits of invasive treatment were demonstrated despite the use of current conservative management, including structured training advice and a vasoactive drug (cilostazol) with established effects on both [health-related QoL] and walking function in claudicants.”
Invasive strategy may enhance QoL in claudicants; leaves open durability, safety, and applicability beyond this cohort.
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.
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Nordanstig et al. (2014) studied this question.
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