|Modified Intention‐to‐Treat Analysis||PTA‐BMS||DES||P Valueb|
|Lesions with preserved patency||3 (8.6)||5 (11.6)||0.67|
|≤50% stenotic||3 (8.6)||5 (11.6)|
|>50% stenotic||1 (2.9)||0|
|Amputation/CLI‐related death/treatment in interim||31 (88.6)||36 (83.7)|
Values are n (%). BMS indicates bare metal stent; CLI, critical limb ischemia; DES, drug‐eluting stent; PTA, percutaneous transluminal angioplasty.
↵a Number of limbs/lesions with available diagnostic imaging and those with treatment failure. Imaging unavailable for 7 limbs in the PTA‐BMS group and 12 limbs in the DES group. Limbs/lesions in patients deceased due to unrelated causes were censored (30 limbs in PTA‐BMS, 28 limbs in DES). Follow‐up still ongoing for 11 limbs in the PTA‐BMS group and 12 limbs in the DES group.
↵b P value weighted by number of lesions per patient.