Sustained Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Lesions: 2-Year Follow-Up From the Zilver PTX Randomized and Single-Arm Clinical Studies

Abstract

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 lesions. The RCT compared the DES with percutaneous transluminal angioplasty (PTA) and provisional bare-metal stent (BMS) placement. Local drug delivery for superficial femoral artery lesions has been investigated with the intent of limiting restenosis similarly to DES for the coronary arteries. One-year outcomes of DES in the superficial femoral artery are promising, but longer-term benefits have not been established. In the RCT, patients were randomly assigned to primary DES implantation (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) placement. The single-arm study enrolled 787 patients with DES treatment. Compared with the control group, the primary DES group demonstrated significantly superior 2-year event-free survival (86.6% vs. 77.9%, p= 0.02) and primary patency (74.8% vs. 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% vs. 64.1%, p< 0.01) and achieved higher sustained clinical benefit (83.9% vs. 68.4%, p= 0.05). Two-year freedom from target lesion revascularization with primary DES placement was 80.5% in the single-arm study and 86.6% in the RCT. Two-year outcomes with the paclitaxel-eluting stent support its sustained safety and effectiveness in patients with femoropopliteal artery disease, including the long-term superiority of the DES to PTA and to provisional BMS placement. (Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery; NCT00120406; Zilver(®) PTX™ Global Registry; NCT01094678).