Invasive Revascularization or Not in Intermittent Claudication

Invasive Revascularization or Not in Intermittent Claudication

Peripheral arterial disease (PAD) often causes exertion pain in the legs, intermittent claudication (CI) affecting> 10% of individuals> 65 years. A recent Swedish Health Technology Assessment Report identified only limited evidence for the effectiveness of invasive treatment for IC in patients already on exercise training. The prognosis for the extremity is usually benign and treatment therefore aims at improving quality of life. Invasive treatment can also cause serious complications. Coronary artery disease is common in IC patients increasing the risk with invasive treatment. In spite of these uncertain merits and potential risks, invasive procedures for IC are increasing and 37% of all invasive procedures for PAD in Sweden are performed for IC. The aim of this study is to evaluate the additional effects of modern invasive treatment in patients with intermittent claudication receiving modern best medical treatment (BMT). The primary hypothesis in the study is that invasive treatment in addition to BMT improves health related quality of life and walking performance compared to BMT only.

Inclusion Criteria:

• Patient with intermittent claudication (typical symptoms and ABI <0.9) seeking treatment
• Significant aortoiliac- and/or femoropopliteal lesion.
• Age 30-80 years

Exclusion Criteria:

• Invasive treatment contraindicated because of severe intercurrent disease.
• Two or more failed vascular reconstructions in the same leg.
• Employees unable to work because of intermittent claudication.
• Need for open reconstruction below the tibioperoneal trunc.
• Thromboembolic etiology (popliteal artery aneurysm; cardiac emboli)
• Other disease severely affecting walking performance.
• Body weight > 120 kilograms.
• Age <30 or > 80 years.