Angioplasty or Primary Stenting for Infrapopliteal Lesions: Results of a Prospective Randomized Trial

Abstract

Excellent results with small stents in coronary arteries have led endovascular therapists to their use in infrapopliteal vessels. However, to date no level I evidence exists to recommend primary stenting over infrapopliteal angioplasty alone. The aim of this randomized single-center trial was to compare their 1-year outcome. A total of 38 limbs in 35 patients with critical limb ischemia were randomized to angioplasty (22 pts) or primary stenting (16 pts). Target lesions were infrapopliteal occluded (36) or stenotic (20) lesions ranging from <2 to >15 cm in length. The mean age was 72 years. At 12 months, there was no statistical difference in survival (angioplasty, 69.3%; primary stenting, 74.7%), in limb salvage (angioplasty, 90%; primary stenting, 91.7%), or in primary and secondary patency (angioplasty, 66 and 79.5%; primary stenting, 56 and 64%) between the groups Renal insufficiency was the only significant negative predicting factor for limb salvage in both groups. In conclusion, the 1-year results for both groups were broadly similar. Stenting has its place in infrapopliteal angioplasty if the procedure is jeopardized by a dissection or recoil, but our results do not support primary stenting in all cases.

La revascularisation distale des diabétiques en ischémie critique

“…Les auteurs concluent donc que l'angioplastie-stenting a une place pour l'angioplastie infrapoplitée si la procédure est compliquée d'une dissection ou d'un échec mais pas en première intention [52][53][54].…”

Endovascular Intervention for Peripheral Artery Disease

“…Studies by others have demonstrated similar results. 97,98 Thus, DES seems to offer less repeat revascularization compared with BMS and possibly less amputation, but the value of its routine use compared with balloon angioplasty is less certain. Ongoing and future trials will hopefully clarify the clinical efficacy and cost-effectiveness of DES for this indication.…”

An Update on Methods for Revascularization and Expansion of the TASC Lesion Classification to Include Below-the-Knee Arteries: A Supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II)

“…Clinical data suggested that BMS had little clinical advantage over successful balloon angioplasty in patients with CLI. 76,77) As DES platforms became established in the coronary bed, this encouraged acquisition of preliminary infrapopliteal data regarding primary DES. 78,79) These data…”