Three-Year DURABILITY II Results Support Single-Stent Strategy for Symptomatic SFA/PPA Disease

February 25, 2015—Krishna J. Rocha-Singh, MD, et al conducted an evaluation of longer-term safety and efficacy of a single self-expanding stent up to 20 cm in length in patients with atherosclerotic disease of the superficial femoral artery (SFA) and proximal popliteal artery (PPA) and concluded that this treatment provides reasonable long-term outcomes when intervention is required for symptomatic SFA and PPA disease. The study’s findings are available online ahead of print in Catheterization and Cardiovascular Interventions.

As summarized in Catheterization and Cardiovascular Interventions, the DURABILITY II study enrolled 287 patients (mean age, 68 years; 66% male) who were treated with the EverFlex self-expanding peripheral stent system (Medtronic). Patients were followed through 3 years with yearly core lab–adjudicated duplex ultrasonography for patency, radiographic assessment of stent fractures, and resting ankle-brachial indexes.

According to the investigators, the DURABILITY II is the first investigational device exemption trial to report 3-year duplex Doppler-defined stent patency and clinically driven target lesion revascularization (CD-TLR) outcomes in long SFA and proximal popliteal lesions, and it demonstrated acceptable stent patency and freedom from CD-TLR with a low fracture rate. The 3-year freedom from CD-TLR was 70% with an overall stent fracture rate of 0.9%, reported the investigators in Catheterization and Cardiovascular Interventions.