|Modified Intention‐to‐Treat Analysis||PTA‐BMS||DES||P Valueb|
|Lesions with preserved patency||5 (13.5)||15 (32.6)||0.031|
|≤50% stenotic||5 (13.5)||15 (32.6)|
|>50% stenotic||2 (5.4)||0|
|Amputation/CLI‐related death/treatment in interim||30 (81.1)||29 (63.0)|
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 11 limbs in the PTA‐BMS group and 21 limbs in the DES group. Limbs/lesions in patients deceased due to unrelated causes were censored (27 limbs in PTA‐BMS, 21 limbs in DES). Follow‐up still ongoing for 6 limbs in the PTA‐BMS group and 5 limbs in the DES group.
↵b P value weighted by number of lesions per patient.