BACKGROUND: The aim was to summarize the results of all randomized clinical trials (RCTs) comparing percutaneous transluminal angioplasty (PTA) with (supervised) exercise therapy (SET) in patients with intermittent claudication (IC) to obtain the best estimates of their relative effectiveness. METHODS: A systematic review was performed of relevant RCTs identified from the Medline, Embase and Cochrane Library databases. Eligible RCTs compared PTA with SET, included patients with IC due to suspected or known aortoiliac and/or femoropopliteal artery disease, and compared their effectiveness in terms of functional outcome and/or quality of life (QoL). RESULTS: Eleven of 258 articles identified (reporting data on eight randomized clinical trials) met the inclusion criteria. One trial included patients with isolated aortoiliac artery obstruction, three trials studied those with femoropopliteal artery obstruction and five included those with combined lesions. Two trials compared PTA with advice on ET, four PTA with SET, two PTA plus SET with SET and two PTA plus SET with PTA. Although the endpoints in most trials comprised walking distances and QoL, pooling of data was impossible owing to heterogeneity. Generally, the effectiveness of PTA and SET was equivalent, although PTA plus SET improved walking distance and some domains of QoL scales compared with SET or PTA alone. CONCLUSION: As IC is a common healthcare problem, defining the optimal treatment strategy is important. A combination of PTA and exercise (SET or ET advice) may be superior to exercise or PTA alone, but this needs to be confirmed.

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