Cordis announced on 21 January 2013 the presentation of the two-year STROLL study results at the Abstracts and Late Breaking Clinical Trials session at ISET 2013, Miami, USA.
William A Gray, director of Endovascular Services, Cardiovascular Research Foundation, New York, presented the results of the STROLL study (S.M.A.R.T. Vascular Stent Systems in the treatment of obstructive superficial femoral artery disease) on behalf of the study investigators. The STROLL study assessed the safety and efficacy of the S.M.A.R.T. Vascular Stent Systems (S.M.A.R.T. stent) in treating patients with obstructive superficial femoral artery disease.
“The two-year data from the pivotal STROLL trial highlight not only the durability of the clinical outcomes such as patency and target lesion revascularisation using the S.M.A.R.T. Stent in the femoropopliteal vessels, but also the associated patient outcomes such as Rutherford classification,” said Gray.
In the study, the average lesion length was 77mm, 23.6% of patients presented with total occlusions and 47% of patients were diabetic. Freedom from clinically driven target lesion revascularisation at two years was 80.3%. The 24-month primary patency rate for the S.M.A.R.T. Stent was 74.9% by Kaplan Meier estimate. 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, least severe, and there were no incidents of more severe stent fractures (type II–V).
In addition to the excellent clinical outcomes in the STROLL study, the clinical data showed an improvement in patient outcomes. This included minimal or no signs of peripheral arterial disease in more than 80% of patients (as measured using Rutherford-Becker classification), and normal ankle brachial index in four of five patients at two years.
“The exceptional two-year results in the STROLL study confirm the long-term efficacy of the S.M.A.R.T. Vascular Stent Systems in the treatment of peripheral arterial disease,” said Shlomi Nachman, Worldwide President, Cordis Corporation. “Beyond the clinical results, the excellent patient outcomes observed at one year were sustained through the second year. The unique design of the S.M.A.R.T. Vascular Stent contributed to these results and we look forward to continuing to build on its legacy.”
STROLL is a multicentre, non-randomised, single-arm, prospective trial comparing the safety and efficacy of the S.M.A.R.T. Stent with a previously published objective performance goal. 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. The 12-month primary patency endpoint was defined as no relevant flow reduction by duplex ultrasonography determined by independent core lab, and no interim clinically driven target lesion revascularisation. The primary safety endpoint was 30-day freedom from major adverse events, a composite of all-cause death, index limb amputation and clinically driven target lesion revascularisation. Secondary endpoints cover a variety of morphological, clinical and hemodynamic outcomes. The STROLL Study will follow patients out to three years with mandatory X-ray and duplex ultrasonography at all key follow-up points.
Late last year, the FDA approved the S.M.A.R.T. Control Vascular Stent Systems for use in the superficial femoral artery and/or the proximal popliteal artery. The S.M.A.R.T. Stent, which has been approved for peripheral indication in international markets since 1999, is now the first stent in the United States with both Iliac and superficial femoral artery indications.
