ISAR-STATH Compares Interventional Treatments of SFA Disease
ISAR-STATH is a randomized comparison of paclitaxel-eluting balloon (PEB) angioplasty with stenting versus plain balloon angioplasty (BA) with stenting versus directional atherectomy (DA) for the treatment of superficial femoral artery (SFA) disease.
The background of the study is that PEB with stenting and DA have provided new options for the treatment of SFA disease but the comparative efficacy of these interventional strategies remains uncertain. Under the leadership of Chair Adnan Kastrati, MD, the study was conducted in Munich, Germany, at the Deutsches Herzzentrum and the Klinikum rechts der Isar.
As summarized in Circulation, the ISAR-STATH trial enrolled 155 patients with symptomatic peripheral artery disease caused by de novo SFA stenotic or occlusive lesions. These patients were randomized to treatment with plain BA followed by PEB angioplasty and stenting (n = 48), or BA and stenting (n = 52), or DA with distal protection and bailout stenting (n = 55).
The primary endpoint of the study was percent diameter stenosis after 6 months as measured by angiography. Other endpoints included target lesion revascularization (TLR), thrombosis, ipsilateral amputation, binary restenosis, and all-cause mortality at 6 and 24 months.
The investigators reported that 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-month angiography, the percent diameter stenosis was significantly lower in patients treated with PEB angioplasty and stenting (34% ± 31%) as compared with BA angioplasty and stenting (56% ± 29%; P = .009) or DA (55% ± 29%; P = .007). Similarly, binary restenosis was significantly lower after treatment with PEB and stenting as compared with BA and stenting or DA.
Clinical follow-up at 24 months revealed a lower risk for TLR after PEB angioplasty and stenting as compared with BA and stenting or DA. There was no difference in terms of target lesion thrombosis and mortality among groups, and no patient underwent amputation.
Treatment of de novo SFA lesions with PEB angioplasty and stenting is superior to BA angioplasty and stenting or DA in terms of angiographic diameter stenosis at 6 months and TLR at 24 months, concluded the ISAR STATH investigators in Circulation.