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Multicentre randomised controlled trial of the clinical and cost-effectiveness of a bypass-surgery-first versus a balloon-angioplasty-first revascularisation strategy for severe limb ischaemia due to infrainguinal disease. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial.

OBJECTIVE: To compare a 'bypass-surgery-first' with a 'balloon-angioplasty-first' revascularisation strategy in patients with severe limb ischaemia (SLI) due to infrainguinal disease requiring immediate/early revascularisation.

DESIGN: A stratified randomised controlled trial. A Delphi consensus study of vascular surgeons' and interventional radiologists' views on SLI treatment was performed before the trial.

SETTING: Twenty-seven UK hospitals.

PARTICIPANTS: Patients presenting with SLI as the result of infrainguinal atherosclerosis and who, in the opinion of the responsible consultant vascular surgeon and interventional radiologist, required and were suitable for both surgery and angioplasty.

INTERVENTIONS: Patients were randomised to either 'bypass-surgery-first' or 'balloon-angioplasty-first' revascularisation strategies.

MAIN OUTCOME MEASURES: The primary end point was amputation-free survival (AFS); secondary end points were overall survival (OS), health-related quality of life (HRQoL) and cost-effective use of hospital resources.

RESULTS: AFS at 1 and 3 years was not significantly different for surgery and angioplasty. Interim analysis showed that surgery was associated with significantly lower immediate failure, higher 30-day morbidity and lower 12-month reintervention rates than angioplasty; 30-day mortality was similar. Beyond 2 years from randomisation, hazard ratios (HRs) were significantly reduced for both AFS (adjusted HR 0.37; 95% CI 0.17 to 0.77; p = 0.008) and OS (HR 0.34; 95% CI 0.17 to 0.71; p = 0.004) for surgery relative to angioplasty. By 2008 all but four patients had been followed for 3 years, some for over 7 years: 250 (56%) were dead, 168 (38%) were alive without amputation and 30 (7%) were alive with amputation. Considering the follow-up period as a whole, AFS and OS did not differ between treatments but for patients surviving beyond 2 years from randomisation, bypass was associated with reduced HRs for AFS (HR 0.85; 95% CI 0.50 to 1.07; p = 0.108) and OS (HR 0.61; 95% CI 0.50 to 0.75; p = 0.009), equating to an increase in restricted mean OS of 7.3 months (p = 0.02) and AFS of 5.9 months (p = 0.06) during the subsequent follow-up period. Vein bypasses and angioplasties performed better than prosthetic bypasses. HRQoL was non-significantly better in the surgery group; amputation was associated with a significant reduction in HRQoL. Over the first year, hospital costs for bypass were significantly higher (difference 5420 pounds; 95% CI 1547 pounds to 9294 pounds) than for angioplasty. However, by 3 and at 7 years the differences in cost between the two strategies were no longer significant. Patients randomised to surgery lived, on average, 29 days longer at an additional average cost of 2310 pounds. A 36-month perspective showed not significantly different mean quality-adjusted life times for angioplasty and surgery. The Delphi study revealed substantial disagreement between and among surgeons and radiologists on the appropriateness of bypass surgery or balloon angioplasty.

CONCLUSIONS: The findings of our study suggest that in patients with SLI due to infrainguinal disease the decision whether to perform bypass surgery or balloon angioplasty first appears to depend upon anticipated life expectancy. Patients expected to live less than 2 years should usually be offered balloon angioplasty first as it is associated with less morbidity and cost, and such patients are unlikely to enjoy the longer-term benefits of surgery. By contrast, those patients expected to live beyond 2 years should usually be offered bypass surgery first, especially where a vein is available as a conduit. Many patients who could not undergo a vein bypass would probably have been better served by a first attempt at balloon angioplasty than prosthetic bypass. The failure rate of angioplasty in SLI is high (c. 25%) and patients who underwent bypass after failed angioplasty fared significantly worse than those who underwent surgery as their first procedure. The interests of a significant proportion of BASIL patients may have been best served by primary amputation followed by high-quality rehabilitation. Further research is required to confirm or refute the BASIL findings and recommendations; validate the BASIL survival prediction model in a separate cohort of patients with SLI; examine the clinical and cost-effectiveness of new endovascular techniques and devices; and compare revascularisation with primary amputation and with best medical and nursing care in those SLI patients with the poorest survival prospects.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN45398889.

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