|Modified Intention‐to‐Treat Analysis||PTA‐BMS||DES||P Valueb|
|Lesions with preserved patency||8 (20.5)||20 (37.7)||0.036|
|≤50% stenotic||8 (20.5)||20 (37.7)|
|>50% stenotic||2 (5.1)||2 (3.8)|
|Occluded||1 (2.6)||2 (3.8)|
|Amputation/CLI‐related death/treatment in interim||28 (71.8)||29 (54.7)|
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 19 limbs in the PTA‐BMS group and 22 limbs in the DES group. Limbs/lesions in patients deceased due to unrelated causes were censored (22 limbs in PTA‐BMS, 19 limbs in DES).
↵b P value weighted by number of lesions per patient.