Cordis Corporation today announced three-year clinical outcomes from the STROLL Trial at the Abstracts and Late Breaking Clinical Trials session at the 26 th Annual International Symposium on Endovascular Therapy (ISET). Results from the trial showed that patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) treated with the S.M.A.R.T. ® Vascular Stent System (S.M.A.R.T. ® Stent) experienced sustained clinical and quality of life benefits out to three years, including improvements in physical, psychological and social function.
“These results demonstrate that the S.M.A.R.T. ® Stent performs well in patients suffering from peripheral artery disease three years after treatment,” said Michael R. Jaff, D.O., lead author of the study and chair of the Institute for Health, Vascular and Stroke Care at Massachusetts General Hospital. “Patients had sustained improvements in walking distance and speed, and continued to experience enhanced health related quality of life.”
In the study, the average lesion length was 77 mm, 23.6% of patients had total occlusions in the superficial femoral artery 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. Patients in the STROLL Trial 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<0.001).