Background
The Zilver PTX stent with polymer-free paclitaxel coating is the first drug-eluting stent approved (currently CE marked, investigational in the United States and Japan) for the superficial femoral artery (SFA). The Zilver PTX study is a multicenter, multinational, prospective, randomized trial comparing the safety and effectiveness of the Zilver PTX stent to balloon angioplasty (PTA) and bare metal stenting (BMS).
Methods
Patients with de novo or restenotic SFA lesions were randomized to treatment with either PTA or Zilver PTX. Patients randomized to the PTA group who experienced acute PTA failure (e.g., >30% residual stenosis) underwent secondary randomization and were provisionally stented with Zilver BMS or Zilver PTX. Study endpoints were event-free survival (EFS) and primary patency by duplex ultrasound core laboratory analysis (peak systolic velocity ratio <2.0). Patients successfully treated with PTA were not evaluated with duplex ultrasonography beyond 12 months.
Methods
Patients with de novo or restenotic SFA lesions were randomized to treatment with either PTA or Zilver PTX. Patients randomized to the PTA group who experienced acute PTA failure (e.g., >30% residual stenosis) underwent secondary randomization and were provisionally stented with Zilver BMS or Zilver PTX. Study endpoints were event-free survival (EFS) and primary patency by duplex ultrasound core laboratory analysis (peak systolic velocity ratio <2.0). Patients successfully treated with PTA were not evaluated with duplex ultrasonography beyond 12 months.
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