Johnson & Johnson subsidiary Cordis has presented promising results from the three-year STROLL study at the Abstracts and Late Breaking Clinical Trials session at the 26th Annual International Symposium on Endovascular Therapy (ISET).
The three-year clinical outcomes from the STROLL Trial (‘S.M.A.R.T. Vascular Stent Systems in the TReatment of Obstructive SuperficiaL FemoraL Artery Disease’) reported a sustained clinical and quality of life benefits, 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 77mm, 23.6% of patients presented with total occlusions in the SFA and 47% of patients were diabetic.
At three years, freedom from clinically driven target lesion revascularisation (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 positive clinical outcomes in the STROLL study, the clinical data showed an improvement in patient outcomes.
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 up to three years.
At three years, there was significant improvement on the peripheral artery questionnaire (PAQ) summary scale (mean change 28 points, p).
Cordis worldwide president Celine Martin said: “We are continuing to build on the legacy of this exceptional platform with our next-generation S.M.A.R.T. Flex Stent and look forward to delivering future innovations in self-expanding stents for patients suffering from peripheral artery disease.”
The S.M.A.R.T. stent is available in the US with iliac, proximal popliteal artery and SFA indications and provides a balance of radial force, scaffolding, and longitudinal stability.
Designed to optimise flexibility, fracture resistance and radial strength with predictable placement, the S.M.A.R.T. Flex Stent has received CE Mark approval for the treatment of vascular disease and FDA 510(k) approval for the palliative treatment of biliary strictures associated with malignant tumours.
The safety and effectiveness of this device for use in the vascular system in the US have not been established.
The S.M.A.R.T. Flex stent is also being evaluated in an investigational device exemption (IDE) study called the OPEN Trial to determine its safety and effectiveness in the treatment of patients with atherosclerosis in the SFA, or SFA disease.
The trial results are expected to support a premarket approval (PMA) application for an expanded indication to treat SFA disease in the US.
According to GlobalData estimates, the US peripheral vascular stents market was valued at $515.3m in 2012 and is expected to grow at a CAGR of 3.5% to reach $653.7m by 2019.
Image: Johnson & Johnson headquarters in New Brunswick, New Jersey, US. Photo: courtesy of Ekem.