Three-Year Clinical Follow-Up Presented for the DURABILITY II Study

October 9, 2013—Krishna Rocha-Singh, MD, presented the 3-year clinical follow-up data from the DURABILITY II study at the VIVA 2013: Vascular Interventional Advances conference being held October 8–11 in Las Vegas, Nevada. DURABILITY II was a prospective, multicenter, nonrandomized study to evaluate the safety and efficacy of a single EverFlex self-expanding nitinol stent (Covidien, Mansfield, MA) in patients with Rutherford class 2-4 claudication and femoropopliteal atherosclerotic lesions up to 20 cm in length, compared to VIVA Physician's percutaneous transluminal angioplasty (PTA) objective performance criteria (OPC) for safety and efficacy.

The study enrolled 287 patients (mean age, 68 years; 66% male) at 44 centers in the United States and Europe. The mean lesion length, as adjudicated by an independent core laboratory, was 8.9 cm and included 48.1% occluded arteries with 43.2% severely calcified lesions. A single stent was implanted in 95% of subjects, and 5% received multiple stents. Subjects were followed yearly for 3 years with independent ultrasound core lab–adjudicated duplex ultrasound to determine stent patency, radiograms of the stented extremity in flexion, and extension to assess stent fractures and ankle brachial indices.

The duplex Doppler-assessed patency (peak systolic velocity ratio < 2.0) rate at 3 years was 60%; freedom from loss of primary patency was significantly higher for lesions ≤ 8 cm compared to lesions > 8 cm (71% vs 50.5%, P = .0001). No difference in patency was observed between single-stent and multistent recipients.

The 3-year freedom from target lesion revascularization (TLR) was 70%. When stratified by lesions ≤ 8 cm or > 8 cm, the freedom from TLR was statistically significant (80% vs 61%, respectively; P = .0003). The 3-year stent fracture rate was 0.9%.

To the investigators' knowledge, this is the first report of combined 3-year assessment duplex Doppler defined primary stent patency, clinically driven TLR, and stent fracture rates in long, complex femoropopliteal lesions in Rutherford class 2-4 claudicants. These data demonstrate that implantation of a single, long EverFlex stent is a reasonable, durable treatment option in this challenging patient cohort.