At the Vascular Interventional Advances (VIVA) 2014 meeting, Covidien announced nine-month results of the DURABILITY Iliac study and the addition of the iliac indication for its EverFlex stent. The nine-month results confirm the safety and effectiveness of the EverFlex and Protégé GPS self-expanding stent systems for the treatment of lesions of the common and external iliac arteries.
“The EverFlex and Protégé GPS self-expanding stent systems demonstrated strong patency rates even in difficult to treat calcified lesions in patients with iliac disease,” says Peter Faries, co-national principal investigator, Mount Sinai School of Medicine, New York. “This data, along with the robust EverFlex stent data in the superficial femoral artery, speaks to the clinical versatility of the system.”
The prospective, multi-centre, non-randomised clinical study, which was led by Faries and John Rundback, co-national principal investigator, Holy Name Medical Center, New Jersey, enrolled 75 patients at 15 centres in the USA and Europe. Nearly 68% of patients included in the trial had moderately to severely calcified lesions. The study demonstrated 100% device success, and the primary endpoint was met with no major adverse events at 30 days and a 1.3% major adverse event rate at nine months.
Secondary outcomes were also favorable. The nine-month primary patency by Kaplan-Meier analysis was 95%, and freedom from target vessel revascularisation was 98%. Additionally, investigators evaluated patient quality of life using two common screening tools for peripheral vascular disease, an ankle brachial index and walking impairment questionnaire. The data from the trial demonstrated significant improvements in ankle brachial index and walking impairment questionnaire scores at both 30 days and nine months when compared to the baseline.
The EverFlex and Protégé GPS self-expanding stent systems are Nitinol stent systems that expand to a predetermined diameter to restore blood flow. The EverFlex stent, which received iliac FDA approval in 2014, previously received biliary clearance in 2006, and superficial femoral artery and proximal popliteal approval in 2012.