I ntermittent claudication (IC) is the most common symptomatic presentation in peripheral arterial disease, and ≈20 to 40 million individuals in the world experience classic IC symptoms.1 IC may also cause a substantial loss of walking function and thereby reduce health-related quality of life (HRQoL). As a manifestation of atherosclerosis, IC confers an increased risk for cardiovascular and cerebrovascular events and premature death. 2,3 This risk can be modified by medical intervention, and the leg symptoms can be reduced by exercise; thus, the generally accepted first-line treatment in patients with IC is risk factor modification, medical treatment, and exercise training. 4,5 Exercise training under supervision of a physiotherapist is often recommended because this approach has been shown to provide better short-term results (6-12 months) than with structured training advice alone. 6,7 However, current practice is different. Supervised exercise training programs are largely unavailable in most countries; hence, the majority of claudicants in Europe do not receive this treatment option. 8 Furthermore, a recent systematic review (National Institute for Health and Clinical Excellence) showed uncertain and probably very poor compliance to supervised training. 9 Health-economic modeling demonstrated that supervised training is cost-effective only when HRQoL results are extrapolated beyond the end of existing trial data and under the assumption of activity-induced benefits in terms of mortality and cardiovascular events.
Editorial see p 929 Clinical Perspective on p 947Background-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. The quality of evidence for invasive interventions in IC is still low or very low.9 Most available studies evaluating invasive treatment have used rather selective inclusion criteria, enrolling patients with vascular lesions (eg, in specific vessel segments, of a certain length and severity, and with suitable anatomy for endovascular treatment). [10][11][12][13] The low proportion of all referred claudicants included in most IC interventional trials makes it difficult to generalize results to the majority of IC patients.14 In this context, we sought to perform a "real world" study to test the hypothesis that an invasive (surgical or endovascular) treatment strategy compared with continued medical therapy improves HRQoL in relatively unselected IC patients receiving best medical treatment and structured (nonsupervised) training advice.
Methods
General Des...