|Modified Intention‐to‐Treat Analysis||PTA‐BMS||DES||P Valueb|
|Lesions with preserved patency||11 (24.4)||15 (31.3)||0.25|
|≤50% stenotic||11 (24.4)||15 (31.3)|
|>50% stenotic||4 (8.9)||2 (4.2)|
|Occluded||2 (4.4)||4 (8.3)|
|Amputation/CLI‐related death/treatment in interim||28 (62.2)||27 (56.3)|
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 29 limbs in the DES group. Limbs/lesions in patients deceased due to unrelated causes were censored (18 limbs in PTA‐BMS, 14 limbs in DES).
↵b P value weighted by number of lesions per patient.