Abstract

OBJECTIVE: A prospective, multinational randomized controlled trial (RCT) and a complementary single-arm study evaluated the 2-year safety and effectiveness of a paclitaxel-coated drug-eluting stent (DES) in patients with superficial femoral artery (SFA) lesions. The RCT compared the DES to percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement. BACKGROUND: Local drug delivery for SFA lesions has been investigated with the intent of limiting restenosis similarly to DES for the coronary arteries. One-year outcomes of DES in the SFA are promising but longer-term benefits have not been established. METHODS: In the RCT, patients were randomly assigned to primary DES (n=236) or PTA (n=238). Acute PTA failure occurred in 120 patients, who underwent secondary randomization to DES (n=61) or BMS (n=59). The single-arm study enrolled 787 patients with DES treatment. RESULTS: Compared with the control group, the primary DES group demonstrated significantly superior 2-year event-free survival (86.6% versus 77.9%; p=0.02) and primary patency (74.8% versus 26.5%; p<0.01). In addition, the provisional DES group exhibited superior 2-year primary patency compared with the provisional BMS group (83.4% versus 64.1%; p<0.01) and achieved higher sustained clinical benefit (83.9% versus 68.4%; p=0.05). The 2-year freedom from target lesion revascularization with primary DES was 80.5% in the single-arm study and 86.6% in the RCT. CONCLUSIONS: The 2-year outcomes with the paclitaxel-eluting stent support its sustained safety and effectiveness in patients with femoropopliteal arterial disease, including the long-term superiority of the DES to PTA and to provisional BMS.

View details for DOI 10.1016/j.jacc.2013.03.034

View details for Web of Science ID 000320602200005

View details for PubMedID 23583245