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Eluting Coronary Stenting:
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Endeavor™
Drug-Eluting Coronary Stent
Information about the Endeavor™
Drug-Eluting Coronary Stent, which
represents a potential alternative
for treating patients with coronary
heart disease by reducing restenosis,
or the reclogging of coronary arteries.
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What
are Drug Eluting Stents?
Currently
there is much excitement in the cardiology
community about drug eluting stents which
are a promising new treatment for coronary
artery disease. This ingenious therapy involves
coating the outer aspect of a standard coronary
stent with a thin polymer containing medication
that can prevent the formation of scar tissue
at the site of coronary intervention. The
medication on the currently available stent
is known as sirolimus. Sirolimus had been
used previously to prevent rejection following
organ transplantation. These stents had
been studied extensively and had been shown
to dramatically decrease the chance of restenosis.
How
Well do Drug Eluting Stents Work?
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The
initial studies performed with these
stents were carried out in South America
and in Europe. Amazingly, patients
who received the stents had no renarrowing
at the site of treatment. |
A
larger study involving over 1,000 patients
was performed in the United States (Sirius
Trial). The interventional cardiologists
at Hartford Hospital participated in this
trial and enrolled some of their patients
in this study. The patients were randomly
assigned to receive either a drug eluting
stent or a standard bare metal stent. We
found that there was a dramatic difference
between the two groups. When the area within
the stent was examined only 3.2 percent
of the patients with the drug coated stent
had renarrowed versus 35.4 percent of the
patients who had received a standard stent.
This translated into a markedly reduced
need for repeat procedures in the patients
who received the drug eluting stent.
Abbott's
XIENCE V(TM) Drug-Eluting Coronary Stent
Superior To TAXUS(R) Stent In SPIRIT II
Clinical Trial
Positive six-month results of Abbott's SPIRIT
II clinical trial of the XIENCE(TM) V Everolimus
Eluting Coronary Stent System were presented
today at the World Congress of Cardiology
conference in Barcelona, Spain. Results
of the trial, which was conducted in Europe
and Asia Pacific, demonstrated superiority
of the XIENCE V stent system compared to
the TAXUS(R) paclitaxel- eluting coronary
stent system with respect to the study's
primary endpoint, which was angiographic
in-stent late loss at six months (0.11 +/-
0.27 mm for XIENCE V vs. 0.36 +/- 0.39 mm
for TAXUS, p<0.0001). Late loss is a
measure of the change in the vessel diameter
between the time immediately following stent
placement and at six months. Secondary
endpoints of the trial also demonstrated
positive results for the XIENCE V stent
system, including a statistically significant
reduction in percent diameter stenosis from
21 percent for TAXUS to 16 percent for XIENCE
V (p<0.001). The in-stent angiographic
binary restenosis rate for XIENCE V was
1.3 percent compared to 3.5 percent for
the TAXUS control. Angiographic binary restenosis
is the percentage of patients with occlusions
50 percent or greater at the time of six-month
follow up. The six-month MACE rate for the
XIENCE V stent was 2.7 percent, versus 6.5
percent for the TAXUS stent. As defined
in SPIRIT II, the MACE rate includes any
deaths, heart attacks or clinically driven
target lesion revascularizations within
the six-month period. The study also showed
a stent thrombosis rate for XIENCE V of
0.5 percent (n=1) at six months compared
to 1.3 percent (n=1) for that of TAXUS.
The device and procedural success rates
for the XIENCE V stent system were 98.8
and 99.1 percent, respectively. "The
excellent results demonstrate that in this
trial, the XIENCE V stent was not only non-inferior
but was also superior to the TAXUS stent,
and confirm the positive results from the
SPIRIT FIRST study," said Prof. Patrick
W. Serruys, M.D., of the Thoraxcenter, Erasmus
University Hospital, Rotterdam, principal
investigator of the SPIRIT II clinical trial.
"The stent system's impressive safety
and efficacy data, combined with its highly
deliverable platform, will make XIENCE V
an attractive new drug-eluting stent for
physicians and patients in Europe."
XIENCE
V, which has received CE Mark approval,
is currently an investigational device in
the United States and Japan. The system
utilizes everolimus, which has been shown
to reduce tissue proliferation in the coronary
vessels following stent implantation, and
is based upon the highly deliverable and
proven MULTI-LINK VISION(R) coronary stent
platform."These
positive clinical results reinforce our
confidence in the XIENCE V stent system,"
said John M. Capek, Ph.D., president, Cardiac
Therapies, Abbott Vascular. "The upcoming
XIENCE V launch, combined with our robust
drug- eluting stent pipeline, firmly positions
Abbott Vascular as a leader in the global
vascular market." SPIRIT
II is a 300-patient randomized, single-blind,
prospective clinical trial evaluating XIENCE
V versus the TAXUS paclitaxel-eluting coronary
stent system. Results of the SPIRIT II trial
will provide additional clinical data to
support the launch of XIENCE V in several
countries outside the United States.
About
the SPIRIT Family of Trials
The
SPIRIT FIRST study of the XIENCE V Stent
System showed positive results through two
years with no MACE events between one and
two years for patients with de novo native
coronary artery lesions. SPIRIT II and SPIRIT
III are large-scale pivotal clinical trials
comparing XIENCE V to the TAXUS paclitaxel
eluting coronary stent system. SPIRIT IV,
which recently enrolled its first patient,
will evaluate the safety and efficacy of
the XIENCE V Stent System for the treatment
of coronary artery disease in a more complex
patient population in the United States.
SPIRIT V is a planned international clinical
trial that will provide additional clinical
experience with XIENCE V in approximately
3,000 patients at 100 clinical sites throughout
Europe, Asia, Canada and Latin America.
About
Abbott Vascular's Drug-Eluting Stent Program
Abbott
Vascular's drug-eluting stent program consists
of two flagship products: the XIENCE V Everolimus
Eluting Coronary Stent System and the ZoMaxx(TM)
Drug-Eluting Coronary Stent System. Both
systems include advanced stent platforms
and controlled release of a drug from the
-olimus class. The ZoMaxx drug-eluting stent
system features zotarolimus, a compound
proprietary to Abbott, and Abbott's TriMaxx(TM)
stainless steel and tantalum stent platform,
which has received CE Mark approval and
is available for sale in Europe and select
other geographies. ZoMaxx is an investigational
device in Europe and in the United States.
Abbott Vascular is also developing a bioabsorbable
drug-eluting stent and drug-eluting stents
that release a combination of drugs.
In
April 2006, Abbott acquired the vascular
intervention and endovascular solutions
businesses of Guidant Corporation, which
had been the predominant U.S. market leader
in metallic stents since the introduction
of the company's first stent system in 1997.
About
Abbott Vascular
Abbott
Vascular, a division of Abbott, is one of
the world's leading vascular care businesses.
Abbott Vascular is uniquely focused on advancing
the treatment of vascular disease and improving
patient care by combining the latest medical
device innovations with world-class pharmaceuticals,
investing in research and development, and
advancing medicine through training and
education. Headquartered in Northern California,
Abbott Vascular offers a comprehensive portfolio
of vessel closure, endovascular and coronary
products that are recognized internationally
for their safety, effectiveness and ease
of use in treating patients with vascular
disease. For more information, visit http://www.abbott.com.
About
Abbott
Abbott
(NYSE: ABT) is a global, broad-based health
care company devoted to the discovery, development,
manufacture and marketing of pharmaceuticals
and medical products, including nutritionals,
devices and diagnostics. The company employs
65,000 people and markets its products in
more than 130 countries.
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