Trials of endovascular treatment for superficial femoral artery occlusive lesions: a call for medically managed control patients.

BACKGROUND

The prevalence of occlusive peripheral vascular disease in the superficial femoral artery approaches 20% in patients over the age of 60. Symptomatic peripheral arterial disease (intermittent claudication) is present in 3% to 7% of patients over the age of 60. The attraction of minimally invasive, percutaneous endovascular angioplasty (PTA) for this large number of patients has resulted in multiple trials of new PTA +/- stenting devices. The purpose of this report is to determine whether trials should include controlled patients who have optimal medical management including supervised exercise.

METHODS AND

RESULTS

In 2007 through 2008, there were 12 active trials of PTA and stent with 9 of the trials randomized and 6 trials using PTA as the control arm. No trial used a medically managed group. Between 1990 and 2008, a search of PubMed disclosed six publications (five randomized trials) comparing PTA +/- stent with medically (exercise) managed claudicants. None of the medically managed patient groups experienced a significant increase in ABI, whereas endovascular patients had an early increase in ABI, which was variably sustained to 1 and 2 years. However, after 6 months, the maximum walking distance was significantly increased in the exercised patients and remained longer than that of the interventional group in four of five trials at 1 to 2 years.

CONCLUSION

Endovascular treatment was superior to medical treatment in functional outcome at 1 year in only one of the five randomized trials for claudication. In the other four trials, medical treatment produced a greater maximum walking distance at 1 to 2 years. Current trials lack optimal medical controls. New trials of PTA + stent should include a medically managed group of patients in a supervised exercise program as the comparator arm. The outcome measure should be maximum walking distance to demonstrate added functional benefit of the new device.