Every year, as many as one adult in 1,000 experiences the onset of severe lower limb ischemia. This condition causes significant morbidity and mortality and higher health care costs. Because of the aging of the population and the increasing prevalence of diabetes and other conditions, the incidence of severe limb ischemia is expected to increase. Surgery generally provides good long-term clinical outcomes but has significant morbidity, mortality, and resource costs. Balloon angioplasty has lower rates of morbidity and mortality and reduced costs, can be done more quickly, and preserves collateral circulation. Previous studies comparing the two treatments have had serious methodologic problems. Surgeons at 27 British hospitals collaborated in the BASIL (bypass versus angioplasty in severe ischemia of the leg) trial to compare the outcomes of the two approaches.

All patients presented to participating hospitals with rest pain or tissue damage (i.e., ulcer or gangrene) caused by arterial insufficiency. Patients were eligible for the study if they could be treated equally well by either technique (determined by the attending surgeon and radiologist). The etiology and suitability for treatment were confirmed by diagnostic imaging. Treatment allocation was made randomly by the central organizers of the study. Within the allocation to bypass surgery or balloon angioplasty, physicians used their preferred techniques and equipment for the diagnosis and treatment of each patient. Research nurses followed surviving patients for more than five years. The primary outcome was time to death or time to above-knee amputation of the involved leg, whichever occurred first. Secondary outcomes included 30-day morbidity and mortality, need for reintervention, quality of life, and use of hospital resources.

Of the 452 patients randomized, 228 were assigned to bypass surgery and 224 to balloon angioplasty. Only 30 percent were younger than 70 years; 25 percent were 80 years or older. About one third were current smokers, more than 40 percent were former smokers, nearly one half had diabetes, and about 20 percent had significant evidence of other vascular disease (e.g., angina, previous myocardial infarction or stroke, history of peripheral vascular disease). Of the 228 patients assigned to surgery, 195 had an initial procedure as randomized and 33 received a second intervention (23 angioplasty, 10 repeat surgery). Of the 224 assigned to angioplasty, 216 received the initial procedure and 59 required a second intervention (13 repeat angioplasty, 46 surgery). Data were reported on all randomized patients by intention to treat.

After 5.5 years, 55 percent of participants were alive without amputation, 29 percent were dead without amputation, 8 percent were alive with amputation of the index leg, and 8 percent were dead after amputation. The amputation-free survival rates did not differ significantly between the two treatment groups. At one year, 56 percent of those who underwent surgery and 50 percent of those receiving angioplasty were alive without amputation. Surgery was associated with a lower reintervention rate than angioplasty (18 versus 26 percent, respectively). By intention to treat analysis, amputation-free survival for those randomized to surgery was 68 percent at one year and 57 percent at three years. The comparable figures for those randomized to angioplasty were 71 and 52 percent, respectively. Rates of mortality and serious morbidity were higher for the surgical group in the six months after surgery, but this trend was reversed after a longer follow-up.

Patients in both groups recorded improved quality-of-life scores within three months of intervention, after which little further improvement in scores occurred. A weak trend toward better quality-of-life scores was seen in the surgical group, but it was not statistically significant. Surgically treated patients had significantly higher health care leg, whichever occurred first. Secondary outcomes included 30-day morbidity and mortality, need for reintervention, quality of life, and use of hospital resources.

Of the 452 patients randomized, 228 were assigned to bypass surgery and 224 to balloon angioplasty. Only 30 percent were younger than 70 years; 25 percent were 80 years or older. About one third were current smokers, more than 40 percent were former smokers, nearly one half had diabetes, and about 20 percent had significant evidence of other vascular disease (e.g., angina, previous myocardial infarction or stroke, history of peripheral vascular disease). Of the 228 patients assigned to surgery, 195 had an initial procedure as randomized and 33 received a second intervention (23 angioplasty, 10 repeat surgery). Of the 224 assigned to angioplasty, 216 received the initial procedure and 59 required a second intervention (13 repeat angioplasty, 46 surgery). Data were reported on all randomized patients by intention to treat.

After 5.5 years, 55 percent of participants were alive without amputation, 29 percent were dead without amputation, 8 percent were alive with amputation of the index leg, and 8 percent were dead after amputation. The amputation-free survival rates did not differ significantly between the two treatment groups. At one year, 56 percent of those who underwent surgery and 50 percent of those receiving angioplasty were alive without amputation. Surgery was associated with a lower reintervention rate than angioplasty (18 versus 26 percent, respectively). By intention to treat analysis, amputation-free survival for those randomized to surgery was 68 percent at one year and 57 percent at three years. The comparable figures for those randomized to angioplasty were 71 and 52 percent, respectively. Rates of mortality and serious morbidity were higher for the surgical group in the six months after surgery, but this trend was reversed after a longer follow-up.

Patients in both groups recorded improved quality-of-life scores within three months of intervention, after which little further improvement in scores occurred. A weak trend toward better quality-of-life scores was seen in the surgical group, but it was not statistically significant. Surgically treated patients had significantly higher health care costs, mainly because of much greater use of intensive and high-dependency care and longer hospital stays. In the surgery group, 23 percent required high-dependency care and 4 percent were admitted to intensive care units within one year of randomization. In the angioplasty group, only one patient (0.5 percent) required intensive care, and 16 (7.4 percent) needed high-dependency care. The mean hospital costs for the first year were one third higher for the surgical patients.

The authors conclude that both strategies provide comparable results for suitable patients with severe infrainguinal ischemic disease, but surgery has significantly greater hospital-related costs in the short term.