The most recent results of the multicentre, non-randomised, single-arm prospective STROLL trial were presented at the 26th annual International Symposium on Endovascular Therapy (ISET, 18–22 January, Miami, USA). The trial is studying the safety and efficacy of the S.M.A.R.T. stent (Cordis) in patients with obstructive superficial femoral artery disease.
According to the results presented at ISET, patients enrolled in the STROLL (S.M.A.R.T. nitinol self-expanding stent in the treatment of obstructive superficial femoral artery disease) trial maintain improved quality of life—including being able to walk farther—three years after being treated with stents to open up their blocked leg arteries.
“It is impressive that the stent continued to perform so well even three years after treatment,” said Michael R Jaff, professor of Medicine at Harvard Medical School, Boston, USA, and lead author of the study. “Patients still felt much better and walked farther and faster than they did before treatment.”
Femoropopliteal arteries remained open in nearly 75% of stented patients and these patients continued to enjoy improved quality of life, according to the study.
In the study, self-expanding S.M.A.R.T. stents were placed in obstructions in the superficial femoral artery of 250 patients. The average lesion length was 7.7cm and 23.6% of lesions were total occlusions. Forty seven per cent of patients were diabetic. Three years after treatment, the primary patency was 72.7% by Kaplan Meier estimate. While 3.6% of stents had fractured, all were type I fractures, meaning they caused no problems and continued to keep the arteries open. Blood pressure in the legs remained significantly improved, with almost no change over three years. Further, patients maintained their improved health-related quality of life as measured by several factors, including symptoms and walking distance and speed.
Patients ≥30 years of age with de novo or restenotic native superficial femoral artery lesion(s) or total occlusions with length ≥4cm to ≤15cm, and reference vessel diameters of ≥4mm to ≤6mm were included in the study. Secondary endpoints cover a variety of morphological, clinical and haemodynamic outcomes. The 24-month primary patency rate for the S.M.A.R.T.stent was 74.9% and the primary duplex patency rate (PSVR ≥2.5) was 83.5%. There were no major adverse events at 30 days after the initial index procedure. There was also a low rate of stent fractures noted at 12 months (2%) with no additional fractures reported out to 24 months. All stent fractures were type I.