SAN DIEGO and MARLBOROUGH, Mass., Sept. 22, 2018 /PRNewswire/ -- Today, Boston
Scientific (NYSE: BSX) announced positive 12-month data from the
IMPERIAL trial, the first head-to-head drug-eluting stent trial in
the superficial femoral artery (SFA). Results were presented during
a late-breaking clinical trial session at the 30th Transcatheter
Cardiovascular Therapeutics (TCT), the annual scientific symposium
of the Cardiovascular Research Foundation, in San Diego, and at the annual Cardiovascular
and Interventional Radiological Society of Europe (CIRSE) congress in Lisbon, Portugal. The clinical findings will
be published in The Lancet.
The IMPERIAL trial evaluated the Eluvia™ Drug-Eluting
Vascular Stent System versus the Zilver® PTX®
Drug-Eluting Peripheral Stent in patients with symptomatic
peripheral artery disease (PAD). PAD occurs when fatty or calcified
atherosclerotic material, called plaque, builds up on the walls of
the arteries of the legs, restricting blood flow and causing pain,
swelling, ulceration and in some cases, the need for amputation of
the affected limb. Stents are commonly used to restore and maintain
blood flow, reducing symptoms and improving quality of life.
In the IMPERIAL trial, the Eluvia stent, which utilizes a
drug-polymer combination to offer sustained release of the drug
paclitaxel, exhibited superior rates of primary patency, a measure
of the target vessel remaining unobstructed at 12 months, and thus
able to provide sufficient blood flow to the lower
limbs.1 Patients in the Eluvia arm of the study also
experienced higher rates of freedom from target lesion
revascularization (TLR), thus reducing their need for repeat
procedures at one year, when compared to those treated with the
drug-coated Zilver PTX. Key findings from the IMPERIAL trial
include:
- Patients treated with the Eluvia stent had a statistically
significant difference in the primary patency rate of 88.5 percent,
compared to 79.5 percent in patients treated with the Zilver PTX
(p=0.0119);2
- Data demonstrated that the Eluvia stent had half the TLR rate
at 4.5 percent, in contrast to 9.0 percent observed within the
Zilver PTX cohort;
- Over 95 percent of patients who received the Eluvia stent were
free of major adverse events at one year, compared to 91.0 percent
of patients who received the Zilver PTX.
"These impressive clinical outcomes suggest that sustained
elution of paclitaxel, delivered by the Eluvia stent, better
matched the timing of restenosis in the SFA that can occur months
later, thereby reducing the need for repeat interventions," said
William Gray, M.D., system chief,
Division of Cardiovascular Disease at Main Line Health, president,
Lankenau Heart Institute in Wynnewood,
Pennsylvania, and co-principal investigator of the IMPERIAL
trial. "Based on these findings, we believe that the Eluvia stent
can be a preferred therapy option when treating patients with
arterial blockages in the superficial femoral or proximal popliteal
arteries."
The IMPERIAL trial is a global, multi-center, randomized
controlled trial that included 465 patients with superficial
femoral artery (SFA) and proximal popliteal artery (PPA) lesions up
to 140mm in length. It is the first head-to-head trial comparing
two different drug-eluting stent systems for the treatment of
PAD.
"We are pleased by the superior results exhibited by the Eluvia
stent," said Ian Meredith, M.D.,
executive vice president and global chief medical officer, Boston
Scientific. "The results from the IMPERIAL trial add to the growing
body of evidence supporting the use of the Eluvia stent as a
frontline therapy for patients, even those suffering from the most
challenging cases of superficial femoral artery disease."
The Eluvia Stent System received CE Mark in February of 2016. In
the U.S., the Eluvia Stent System is an investigational device and
is not available for sale.
- Superiority determined in Post Hoc Superiority Analysis.
12-Month Primary Patency rate of 86.8 percent in the Eluvia arm vs.
77.5 percent in the Zilver PTX arm (p-value = 0.0144).
- Kaplan Meier Estimate
About Boston Scientific
Boston Scientific transforms
lives through innovative medical solutions that improve the health
of patients around the world. As a global medical technology leader
for more than 35 years, we advance science for life by providing a
broad range of high performance solutions that address unmet
patient needs and reduce the cost of healthcare. For more
information, visit www.bostonscientific.com and connect on Twitter
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CONTACTS:
Timette Nevala
Media Relations
Boston Scientific Corporation
(763) 494-1284 (office)
Timette.Nevala@bsci.com
Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com
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