Bibliographical noteFunding Information:
The writing group has reviewed the results of the multicenter BASIL (Bypass Versus Angioplasty in Severe Ischaemia of the Leg) trial funded by the United Kingdom National Institute of Health Research and Health Technology Assessment Programme ( 54 ). During a 5-year period, 452 patients with severe limb ischemia (characterized by rest/night pain and tissue loss, such as skin ulceration and gangrene, and thus including patients defined by this PAD guideline syndrome term critical limb ischemia) were randomly assigned to an initial treatment strategy of either open surgery or balloon angioplasty. Major clinical outcomes evaluated in this trial were amputation-free survival and overall survival. The initial results published in 2005 indicated that in patients with severe limb ischemia due to infrainguinal disease, the short-term clinical outcomes between bypass surgery–first and balloon angioplasty–first were similar ( 54,55 ). These initial results showed that bypass surgery–first was one third more expensive and was associated with higher morbidity than balloon angioplasty–first.