MIAMI BEACH – Patency was superior with interwoven nitinol stents as compared with laser-cut nitinol stents and balloon angioplasty when used for the treatment of high-grade obstructive disease in the femoropopliteal region, based on the findings from a review of 100 consecutive cases.
The stent patency rate was 92% at a mean of about 15 months follow-up for the SUPERA 500 stents (IDEV Technologies) used in the SAKE trial (SUPERA Interwoven Nitinol Stent Outcomes in Above-Knee Interventions: A Single Center Experience). That patency rate is consistent with rates seen in multiple other prospective and retrospective studies of the SUPERA stent, Dr. Nemalan Selvaraj reported during a late-breaking abstract session at the International Symposium on Endovascular Therapy 2013.
In the SAKE trial, stent patency was defined by the need for revascularization based on clinical indications, including a fall in ankle brachial index or recurrent symptoms. In this series, ankle brachial index improved significantly from 0.57 at baseline to 0.81 at 12 months, said Dr. Salvaraj of Deborah Heart and Lung Center, Browns Mills, N.J.
Patients included in the study had Rutherford class 2-5 disease and were treated between March 2010 and September 2011. Mean lesion length was 144 mm (range, 40-460; median of 120 mm); 36% of the patients had diabetes and 50% were smokers.
In superficial femoral artery interventions, long-term patency rates are poor with balloon angioplasty alone. Laser-cut nitinol stents have improved patency rates, but stent fracture remains a problem, he noted.
The stent fracture rate with the interwoven nitinol stents has been 0% across numerous studies.
The study’s findings are limited by its clinically driven analysis. Duplex ultrasound confirmation was not used to confirm patency in many of the patients. Nonetheless, the findings suggest that interwoven nitinol stents are an option for treating high-grade obstructive disease above the knee, including cases involving complex anatomy, flexion points, and very long lesions, Dr. Salvaraj said.
Given the unique characteristics of these stents, further study in areas typically considered "no-stent zones," such as the common femoral artery and the popliteal artery at the level of knee flexion, is warranted, he concluded.
Dr. Salvaraj, who presented this data on behalf of principal investigator Dr. Richard C. Kovach, reported having no disclosures. Dr. Kovach has received grant or research funding from and/or been a speaker, trainer, consultant, investigator, or medical advisory board member for Spectranetics, Boston Scientific, IDEV, Medtronic, Angioscore, Lutonix, AngelMed/St. Jude, Avinger, Gore, Abbott, Bard, and Ostialcorp.