1. (p < 0.05 for paclitaxel angioplasty vs. either control)
ISAR-STATH
Trial design: Patients with SFA disease were randomized to paclitaxel-eluting balloon angioplasty plus stenting (n = 48) vs. plain balloon angioplasty plus stenting (n = 52) vs. directional atherectomy with distal protection and bailout stenting (n = 55).
Results
(p < 0.05 for paclitaxel angioplasty vs. either control)
Percent diameter stenosis at 6 months: 34% of the paclitaxel-eluting balloon angioplasty plus stenting group vs. 56% of the plain balloon angioplasty plus stenting group vs. 55% of the directional atherectomy with distal protection and bailout stenting group (p = for paclitaxel-eluting balloon plus stent vs. plain balloon angioplasty plus stent group and p = for paclitaxel-eluting balloon plus stent vs. directional atherectomy group) 56 55 % 34
Conclusions
Among patients with symptomatic superficial femoral artery disease, paclitaxel-eluting balloon angioplasty plus stenting appeared to be superior to plain balloon angioplasty plus stenting or to directional atherectomy with distal embolic protection plus bailout stenting
Paclitaxel angioplasty plus stent
Plain angioplasty plus stent
Directional atherectomy with distal protection
Ott I, et al. Circulation 2017;135: