MIAMI BEACH – At 2-year follow-up, the SMART stent was associated with a 75% primary patency rate in patients with obstructive superficial femoral artery disease.
The findings were noted in the STROLL study (SMART Vascular Stent Systems in the Treatment of Obstructive Superficial Femoral Artery Disease). The primary patency rate was 82% at 12 months and 75% at 24 months in 250 patients aged 30 years and older who were enrolled in the single-arm, multicenter study, Dr. William Gray reported at the International Symposium on Endovascular Therapy 2013.
At 12 months, 87% were free from target lesion revascularization; at 24 months, 80% were free from target lesion revascularization, said Dr. Gray, director of endovascular services at Columbia University Medical Center, New York.
No major adverse events were noted at 30 days after the index procedure, and the rate of stent fractures was 2% at 12 months, with no additional stent fractures occurring between 12 and 24 months.
All stent fractures were type 1, with no incidents of type II-V fractures, he reported.
Additionally, more than 80% of patients had improvement or normalization of peripheral artery disease outcomes as measured using Rutherford-Becker classification and ankle brachial index, he noted.
Study participants had de novo or restenotic native superficial femoral artery lesions or total occlusions of 4-15 cm (mean, 77 mm) in length, and reference vessel diameters of 4.0-6.0 mm. Nearly 24% had total occlusions, and 47% had diabetes.
All were treated using the SMART Control nitinol self-expanding stent system manufactured by Cordis. SMART stents have been approved for peripheral indication in international markets since 1999. In 2012, the SMART Control nitinol stent system, which was previously approved for use in the iliac arteries, was also approved by the U.S. Food and Drug Administration for use in the superficial femoral artery and/or the proximal popliteal artery.
The findings "speak well of the efficacy of the SMART stent," Dr. Gray said. Follow-up will continue until 3 years post procedure.
The STROLL study was sponsored by Cordis. Dr. Gray was a principal investigator for the study and serves as a paid advisory board member and consultant for Cordis.