VIVA 2011: DURABILITY II Interim Results of SFA and Proximal Popliteal Artery Stenting in Long Lesions

October 18, 2011—Interim results from DURABILITY II, a study of a single, long stent for treating peripheral arterial disease in the superficial femoral artery (SFA) and proximal popliteal artery, were presented by Krishna Rocha-Singh, MD, in a late-breaking clinical trial session at the VIVA 2011: Vascular Interventional Advances meeting in Las Vegas, Nevada.

The background of the study is that angioplasty and stenting are options for revascularization of symptomatic femoral-popliteal disease, and that whereas angioplasty alone is effective in short lesions, longer lesions are often treated with stents. Because multiple overlapping stents are expensive and may be associated with stent fracture, the purpose of this trial was to evaluate the safety and efficacy of a single self-expanding stent up to 20 cm in length in patients with atherosclerotic disease of the SFA and proximal popliteal arteries.

Patients with lesions ≥ 4 cm and ≤ 18 cm were enrolled in this nonrandomized, prospective, multicenter trial that evaluated the Protégé EverFlex self-expanding peripheral stent system (Covidien, Mansfield, MA). The study's primary endpoints were the 30-day major adverse event rate and duplex ultrasound patency at 1 year. These data were compared to published performance goals. A preplanned interim analysis was conducted for the primary effectiveness endpoints when evaluable 1-year data was available for 70% (164) of required single-stent patients. A core laboratory reviewed angiograms, ultrasounds, and plain radiographs.

Dr. Rocha-Singh reported that 287 patients with stenotic, restenotic, or occluded lesions of the SFA or proximal popliteal arteries were enrolled at 44 investigational sites in the United States and Europe. The mean age of patients in the study was 68 years, with 66% of patients being male. Comorbidities included hypertension (88%), hyperlipidemia (86%), and diabetes (43%). The mean lesion length measured by the core laboratory was 89.1 mm. The mean normal-to-normal lesion length measured by sites was 109.6. Deployment of the stent at the intended treatment site was achieved in 99.3% of patients. No major adverse events occurred at 30 days. Primary duplex ultrasound stent patency at 1 year was 69.5% in single-stent patients when analyzed by simple proportions of patients patent; using Kaplan-Meier time-to-event analysis, it was 74.8%. The 1-year stent fracture rate was 0.5%.

The investigators concluded that interim results of the DURABILITY II study suggest that the stent is safe and effective for the treatment of long lesions of the superficial femoral and proximal popliteal arteries.