Long-term results of plaque excision combined with aggressive pharmacotherapy in high-Risk patients with advanced peripheral artery disease (SAVE a LEG registry)

Background In United States alone there are more than 12 million people with peripheral artery disease (PAD). Long-term outcomes of plaque excision in high-risk population (patients with diabetes and patients with end stage renal disease on dialysis) are scarce. Methods Since November 2003, we treated 225 consecutive patients (138 male, mean age: 66.3 ± 12.4, range: 29–93) with SilverHawkTM plaque excision for critical limb ischemia or disabling claudication. A total of 367 procedures were performed treating 832 lesions (157 restenotic, 675 de novo). One hundred fifty-five patients (68.9%) were diabetics, 74 (32.9%) were on dialysis. All patients were treated with statins, clopidogrel, aspirin, and aggressive glycemic control. The primary endpoint for our study was target lesion revascularization (TLR), and the secondary endpoint was an assessment of major adverse events (all cause death, amputation, TLR). Results The average time of observation was 2.2 ± 1.2 years. Procedural success rate was 99.4% with