Three-Year Data Demonstrates Sustained Improvements in Health Related
Quality of Life in Patients with Superficial Femoral Artery Disease Treated
with the S.M.A.R.T.® Stent
FREMONT, Calif. -- October 8, 2013
Cordis Corporation announced today three-year health related Quality of Life
(QoL) data from the STROLL clinical trial that were presented during a
Late-Breaking Clinical Trials session at the Vascular Interventional Advances
(VIVA) 2013 Annual Meeting in Las Vegas. Results from the Quality of Life
analysis showed that patients with peripheral artery disease (PAD) in the
superficial femoral artery (SFA) treated with the S.M.A.R.T.^® Vascular Stent
Systems (S.M.A.R.T.^® Stent) experienced clinically meaningful improvements in
Quality of Life, including reduced pain in the affected leg(s), improved
social function and increased walking distance, that were maintained over the
three year study follow-up period.
An estimated 27 million people in Europe and North America alone suffer from
PAD, which is caused by the build-up of fatty substances that collect and
adhere to the linings of the arteries, in a process known as atherosclerosis.
The build-up causes the internal lining of the artery to thicken, narrowing
the artery and limiting blood flow to vital tissues and organs. Commonly
affected arteries include those located in the legs, arms, neck and kidneys.
The Quality of Life analysis included the 250 patients studied in the STROLL
clinical trial, a multicenter, prospective trial, which assessed the safety
and efficacy of the S.M.A.R.T.^® Stent. Patients enrolled in the trial had
Rutherford Class 2-4 symptoms and were treated with standard percutaneous
transluminal angioplasty with placement of one or more S.M.A.R.T.^® Stents.
“These new findings show the quality of life benefit was very large and
sustained over at least three years in patients with superficial femoral
artery disease treated with S.M.A.R.T.^® Stent,” said David Safley, MD,
Consulting Cardiologist at Saint Luke's Mid America Heart Institute and
Associate Professor of Medicine at the University of Missouri School of
Medicine - Kansas City, who presented the data at VIVA on behalf of the STROLL
Trial investigators. “Currently there are limited published reports evaluating
the impact and durability of these types of treatments on patient-reported
outcomes beyond one year, which makes these findings noteworthy to clinicians
evaluating treatment options for PAD patients.”
The analysis evaluated health status and quality of life using validated
patient assessment scales, including the Short Form 12 and EQ-5D (generic
health status), the Peripheral Artery Questionnaire (PAQ) and Walking
Impairment Questionnaire for PAD (specific health status). Quality of life was
assessed on all patients at baseline, one, six, 12, 24, and 36 months.
At one month follow-up, there was significant improvement on the PAQ summary
scale (mean change 31.4 points, p<0.001 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
three year follow-up (mean change 28 points, p<0.001).
“When coupled with the positive two year clinical outcomes reported earlier
this year, which demonstrated minimal or no recurrence of lower extremity
stenosis or occlusion in more than 80 percent 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,” said William A. Gray, MD, Director of Endovascular Services,
Cardiovascular Research Foundation, New York. “We will continue to build on
this robust data set with the presentation of the STROLL Trial three year
clinical data at a future medical congress.”
The S.M.A.R.T.^® Stent is available in the United States with both proximal
popliteal artery and SFA indications and provides an unmatched balance of
radial force, scaffolding, and longitudinal stability*. The company continues
to build on the legacy of this platform with its recent addition of the new
S.M.A.R.T.^® Flex Stent, the next innovation in peripheral stents 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 is CE Marked in Europe for the treatment of
vascular disease (iliac, SFA and popliteal) and received 510(k) clearance from
the U.S. Food and Drug Administration for the palliative treatment of biliary
strictures associated with malignant tumors.
"Based on both the long-term clinical and quality of life data, the benefits
of treatment with the S.M.A.R.T.^® Stent are compelling. We continue building
on the attributes of the S.M.A.R.T.^® Stent design with our next-generation,
self-expanding stent platform – the S.M.A.R.T.^® Flex Stent – an important new
addition to our portfolio," said Celine Martin, Worldwide President, Cordis
Corporation. "We are committed to addressing the unmet needs of patients
worldwide with the development of less invasive therapeutic options."
About Cordis Corporation
Cordis Corporation, part of the Johnson & Johnson Family of Companies, is a
worldwide leader in the development and manufacture of interventional vascular
technology. Through the company's innovation, research and development, Cordis
partners with interventional cardiologists worldwide to treat millions of
patients who suffer from vascular disease. More information about Cordis
Corporation can be found at www.cordis.com.
Dr. Gray is compensated for his services as a member of the company’s
Scientific Advisory Board and provides other consulting services.
* Cordis data on file
For Cordis Corporation:
(m) 213-215 5737
Press spacebar to pause and continue. Press esc to stop.