Bypass versus angioplasty in severe ischaemia of the leg (BASIL) trial: what are its implications?

Lack of Level I evidence from randomized controlled trials (RCT) means that the relative merits of surgical and endovascular revascularization strategies for severe limb ischemia (SLI) due to infrainguinal disease remain unclear. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial remains the only multicenter RCT to have compared the clinical and cost-effectiveness of bypass surgery (BSX)-first and balloon angioplasty (BAP)-first revascularization strategies for infrainguinal SLI. An intention to treat analysis shows that out to 2 years both strategies were associated with similar amputation-free (AFS) and overall survival (OS) rates, as well as improvements in health-related quality of life. In the short-term, BSX was significantly more morbid and expensive. However, for those patients who survived for 2 years after randomization, initial randomization to a BSX-first strategy was associated with a significant increase in subsequent OS of about 7 months and a nonsignificant increase in subsequent AFS of about 6 months. Vein BSX performed significantly better than prosthetic BSX in terms of AFS but not OS. For most patients BAP also appears preferable to prosthetic BSX. Patients who underwent BSX after a failed BAP-first strategy did not fare as well as those who received BSX as their first procedure. Patients who are expected to live less than 2 years should usually be offered BAP first, especially when the alternative is prosthetic BSX. Those expected to survive beyond this time horizon (approximately 75% of the BASIL cohort) should usually be offered BSX first, especially where vein is available. Further RCTs to confirm or refute these findings and recommendations are required.