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STROLL: S.M.A.R.T. stent safe, effective at 2 years
New 2-year data from the STROLL trial demonstrate the durability of clinical outcomes with the S.M.A.R.T. Nitinol Self-Expandable Vascular Stent System for the treatment of patients with obstructive superficial femoral artery disease.
Results from the nonrandomized, prospective, single-arm STROLL trial were presented at the 25th Annual International Symposium on Endovascular Therapy. To study the efficacy and safety of the S.M.A.R.T. stent (Cordis Corp.), researchers enrolled 250 patients aged older years and older with de novo or restenotic native superficial femoral artery lesions or total occlusions of ≥4 cm to ≤15 cm and reference vessel diameters of ≥4 mm to ≤6 mm. Patients were evaluated at 30 days, 6 months and 12 months after stent implantation.
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 revascularization. The primary safety endpoint was 30-day freedom from major adverse events, a composite of all-cause death, index limb amputation and clinically driven TLR.
William A. Gray, MD, from the Cardiovascular Research Foundation, New York, N.Y., and colleagues reported that patients had a mean lesion length of 77 mm, 23.6% presented with total occlusions and 47% had diabetes. Freedom from clinically driven TLR at 2 years was 80.3%. At 2 years, the primary patency rate was 74.9% by Kaplan Meier estimate. The primary duplex patency rate was 83.5%, according to a press release.
Other results presented included a low rate of stent fractures (2%) at 1 year and no additional fractures reported at 2 years. All stent fractures were type 1 and there were no incidents of more severe type 2 to 4 fractures.
There were no major adverse events at 30 days after the index procedure.
In addition, clinical data showed improvement in patient outcomes, including minimal or no signs of peripheral arterial disease in more than 80% of patients and normal ankle brachial index in four of five patients at 2 years.
“The 2-year data from the pivotal STROLL trial highlight not only the durability of the clinical outcomes such as patency and target lesion revascularization using the S.M.A.R.T. stent in the femoro-popliteal vessels, but also the associated patient outcomes such as Rutherford classification,” Gray stated in the release.
The STROLL trial will follow patients out to 3 years, with mandatory X-ray and duplex ultrasonography at all key follow-up points, according to the release.
The FDA approved the S.M.A.R.T. stent for use in the superficial femoral artery and/or the proximal popliteal artery in November 2012, making it the first stent in the United States available for use in both indications.
For more information:
Gray WA. Poster #58. Presented at: 25th Annual International Symposium on Endovascular Therapy (ISET); Jan. 19-23, 2013; Miami, Fla.
Disclosure: Gray reports that he is a consultant and member of the Cordis Corp. scientific advisory board.