Cordis has reported three-year clinical outcomes from the STROLL Trial at the Abstracts and Late Breaking Clinical Trials session at the 26th Annual International Symposium on Endovascular Therapy (ISET).
The results from the STROLL Trial (S.M.A.R.T. Vascular Stent Systems in the TReatment of Obstructive SuperficiaL FemoraL Artery Disease) showed sustained clinical and quality of life benefits out to three years, including improvements in physical, psychological and social function in patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA).
In the study, the average lesion length was 77 mm, 23.6% of patients had total occlusions in the SFA and 47% of patients were diabetic.
At three years, freedom from clinically driven target lesion revascularization (TLR) was 78.5% and the primary patency rate was 72.3% by Kaplan Meier estimate.
The stent fracture rate remained low at 3.6% and all stent fractures were Type I, least severe, with no incidents of more severe stent fractures (Type II-V). The mean ankle-brachial index (ABI) improved from 0.66±0.15 at baseline to 0.93±0.18 at one year and remained at 0.92±0.20 at three years.
In addition to the excellent clinical outcomes in the STROLL study, the patients’ also experienced clinically meaningful improvements in patient reported Health Related Quality of Life (HRQOL), such as pain, walking distance and walking speed that were maintained out to three years.
At three years, there was significant improvement on the (Peripheral Artery Questionnaire) PAQ summary scale (mean change 28 points, p)