Randomized Comparison of Paclitaxel-Eluting Balloon Angioplasty Plus Stenting Versus Standard Balloon Angioplasty Plus Stenting Versus Directional Atherectomy for Symptomatic Femoral Artery Disease (ISAR-STATH)

Background —Atherosclerosis in the superficial femoral artery (SFA) is common in patients suffering from peripheral artery disease. Paclitaxel-eluting balloon (PEB) angioplasty, stenting and directional atherectomy (DA) have provided new options for the treatment of SFA disease, however the comparative efficacy remains uncertain. Methods —One hundred and fifty five patients with symptomatic peripheral artery disease with de novo SFA stenotic or occlusive lesions were randomized to treatment with plain balloon angioplasty (BA) followed by PEB angioplasty and stenting (n=48), BA followed by stenting (n=52) or directional DA with distal protection and bailout stenting (n=55). The primary endpoint of the study was percentage diameter stenosis after 6 months measured by angiography. Other endpoints included target lesion revascularization (TLR), thrombosis, ipsilateral amputation, binary restenosis and all-cause mortality at 6 and 24 months. Results —Baseline and lesion characteristics were comparable in all groups with a mean lesion length of 65.9±46.8 mm and 56% total occlusions. At 6 months angiography, the percent diameter stenosis was significantly lower in patients treated by PEB angioplasty followed by stent (34+31%) as compared with BA followed by stenting (56±29%, P=0.009) or DA (55±29%, P=0.007). Similarly, binary restenosis was significantly lower after treatment with PEB angioplasty as compared with BA or DA. Clinical follow-up at 24 months revealed improved TLR after PEB angioplasty followed by stenting as compared with BA followed by stenting or DA. No differences between the groups were found in target lesion thrombosis or mortality rates, and no patient underwent amputation. Conclusions —Treatment of de novo superficial femoral artery lesions with PEB angioplasty followed by stenting is superior to BA and stenting or DA regarding angiographic diameter stenosis at 6 months and TLR at 24 months. Clinical Trial Registration —URL: ClinicalTrials.gov Identifier: [NCT00986752][1] [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00986752&atom=%2Fcirculationaha%2Fearly%2F2017%2F04%2F14%2FCIRCULATIONAHA.116.025329.atom