Table 9. Patency Per Lesion at 4‐Year Follow‐up (Duplex)
Modified Intention‐to‐Treat AnalysisPTA‐BMSDESP Valueb
Lesions with preserved patency5 (13.5)15 (32.6)0.031
Ordinal score0.08
≤50% stenotic5 (13.5)15 (32.6)
>50% stenotic2 (5.4)0
Occluded02 (4.3)
Amputation/CLI‐related death/treatment in interim30 (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.