Bypass surgery and balloon angioplasty did not differ for amputation-free survival in severe limb ischemia.

M e t h o d s Design: Randomized controlled trial (Bypass versus angioplasty in severe ischaemia of the leg [BASIL] trial). Allocation: Unclear allocation concealment.* Blinding: Unblinded.* Follow-up period: 5 years. Setting: 27 hospitals in the United Kingdom. Patients: 452 patients (67% patients ≥ 70 y, 60% men) with severe limb ischemia (defined as rest pain or tissue loss [ulcer or gangrene]) for > 2 weeks who could be treated either by infrainguinal bypass surgery or balloon angioplasty based on their diagnostic images. Patients who required suprainguinal (aortoiliac) intervention were excluded. Intervention: Bypass surgery–first strategy (n = 228) or balloon angioplasty–first strategy (n = 224). Outcomes: Amputation-free survival (time to amputation of the trial leg above the ankle or all-cause mortality). Secondary outcomes were all-cause mortality, 30-day morbidity and mortality, re-intervention, health-related quality of life (HRQL), and use of hospital resources. Patient follow-up: 99% at 1 year and 98% at 5 years (intention-to-treat analysis).