Cordis's S.M.A.R.T. Stent Supported by 3-Year Quality-of-Life Data

October 8, 2013—Cordis Corporation (Bridgewater, NJ) announced that 3-year health-related Quality of Life (QoL) data from the STROLL clinical trial were presented during a late-breaking clinical trials session at the VIVA 2013: Vascular Interventional Advances conference being held October 8–11 in Las Vegas, Nevada. David Safley, MD, presented the data at VIVA on behalf of the STROLL trial investigators.

According to the company, results from the QoL analysis showed that patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) treated with the company's S.M.A.R.T. vascular stent systems experienced clinically meaningful improvements in QoL, including reduced pain in the affected leg(s), improved social function, and increased walking distance. The improvements were maintained over the 3-year study follow-up period.

The QoL analysis included the 250 patients studied in the STROLL clinical trial, a multicenter, prospective trial that assessed the safety and efficacy of the S.M.A.R.T. stent. Patients enrolled in the trial had Rutherford class 2 to 4 symptoms and were treated with standard percutaneous transluminal angioplasty with placement of one or more S.M.A.R.T. stents.

Dr. Safley commented in the company's press release, “These new findings show the QoL benefit was very large and sustained over at least 3 years in patients with SFA disease treated with S.M.A.R.T. stent. Currently, there are limited published reports evaluating the impact and durability of these types of treatments on patient-reported outcomes beyond 1 year, which makes these findings noteworthy to clinicians evaluating treatment options for PAD patients.” Dr. Safley is Consulting Cardiologist at Saint Luke's Mid America Heart Institute in Kansas City, Missouri and Associate Professor of Medicine at the University of Missouri School of Medicine—Kansas City.

Cordis stated that the analysis evaluated health status and QoL using validated patient assessment scales, including the Short Form 12 and EQ-5D (generic health status), the Peripheral Artery Questionnaire (PAQ), and the Walking Impairment Questionnaire for PAD (specific health status). QoL was assessed on all patients at baseline, 1, 6, 12, 24, and 36 months.

At 1-month follow-up, there was significant improvement on the PAQ summary scale (mean change, 31.4 points; P < .001 vs baseline; minimum clinically important difference = 8 points), as well as most other disease-specific and generic scales. Additionally, there was significant improvement on the PAQ summary scale, as well as most other scales that were sustained through the 3-year follow-up (mean change, 28 points; P < .001).

Also commenting in the Cordis press release, William A. Gray, MD, who is Director of Endovascular Services at the Cardiovascular Research Foundation in New York, New York, stated, “When coupled with the positive 2-year clinical outcomes reported earlier this year, which demonstrated minimal or no recurrence of lower extremity stenosis or occlusion in more than 80% of treated patients with high patency and low target lesion revascularization rates, these impressive results further validate the use of the S.M.A.R.T. stent in the treatment of these patients.”

Dr. Gray added, “We will continue to build on this robust data set with the presentation of the STROLL trial 3-year clinical data at a future medical congress.”

Cordis advised that the S.M.A.R.T. stent is available in the United States with both proximal popliteal artery and SFA indications. This approval was announced in November 2012. The company stated that the device provides a balance of radial force, scaffolding, and longitudinal stability.

Building on this platform, Cordis recently added the S.M.A.R.T. Flex stent to its portfolio of peripheral stents. The S.M.A.R.T. Flex stent is designed to optimize flexibility, fracture resistance, and predictable placement while maintaining the tissue-to-metal ratio and radial strength of the S.M.A.R.T. stent. The S.M.A.R.T. Flex Stent has received European CE Mark approval for the treatment of vascular disease (iliac, SFA, and popliteal) and received 510(k) clearance from the US Food and Drug Administration for the palliative treatment of biliary strictures associated with malignant tumors, noted the company.