ABBOTT PARK, Ill., April 11, 2018
/PRNewswire/ -- Abbott (NYSE: ABT) today announced the
initiation of a clinical trial evaluating long-term outcomes of
patients who undergo stent implantation guided by high-resolution
light-based imaging technology—called optical coherence tomography
(OCT)—compared to a common X-ray-guided technique called
angiography. The trial (ILUMIEN IV) is the first large-scale
randomized global study using Abbott's OCT imaging in patients with
high-risk, complex coronary artery disease. Patients in the study
will be randomized to either OCT-guided or traditional angiography
to guide placement of one or more XIENCE everolimus-eluting
coronary stents.
The first patient was enrolled by Franco Fabbiocchi, M.D.,
director of Invasive Cardiology Unit IV at IRCCS Centro
Cardiologico Monzino in Milan,
Italy.
During stent implantation guided by one of Abbott's OCT
platforms, physicians use high-resolution images taken directly
inside the patient's vessels to accurately measure dimension and
choose a stent that best fits the vessel. OCT is also used to help
physicians ensure the stent is fully expanded and is flush against
a vessel wall, which are both important factors in reducing stent
failure.1,2
The ILUMIEN IV trial will enroll up to 3,650 patients with
high-risk, complex disease at 125 centers in North America, Europe and Asia to determine if OCT-guided stent
procedures result in larger vessel diameters — thus, allowing
increased blood flow — and whether this will improve clinical
outcomes for patients compared to stent procedures guided by
angiography. Patients with complex disease may have multiple, or
totally blocked arteries, or other diseases such as diabetes; and
these patients account for an increasing number of cases.
"Today, most of the world uses angiography for stent
implantation using a two-dimensional view of the coronary artery to
assess a complex three-dimensional structure. Physicians need new
technology to help optimize percutaneous coronary intervention, and
OCT provides just that, the ability to look at the artery from the
outside-in and the inside-out," said Ziad
A. Ali, M.D., director of Intravascular Imaging and
Physiology at Columbia University
Medical Center's Center for Interventional Vascular Therapy and
co-principal investigator of the study. "I'm confident this
technology will have a positive impact on clinical practice around
the world and we hope to provide evidence for leading medical
organizations to update clinical guidelines for stent implantation
based on the results of this study."
"Abbott is committed to providing doctors and patients with
life-changing technology, and there is a growing body of evidence
that OCT-guided stent implantation may result in better outcomes
for patients," said Charles
Simonton, M.D., chief medical officer and divisional vice
president of Medical Affairs for Abbott's vascular business. "We're
excited to initiate this trial to generate the groundbreaking data
that would support use of OCT over angiography to achieve better
outcomes for patients with high-risk disease."
The ILUMIEN IV trial's focus on high-risk patients will build on
findings from the previous ILUMIEN series of trials which showed
stent procedures using OCT imaging resulted in superior stent
expansion and greater rates of procedural success compared to
angiography, and non-inferiority to intravascular ultrasound (IVUS)
in post-procedure minimal stent area (MSA).3 Those
trials also showed that use of the OCT high-resolution imaging
enabled physicians to better detect damage to artery walls, called
dissection, which sometimes happens during the placement of a stent
compared to IVUS or angiography, which could then be repaired as
necessary.4
About the Study:
ILUMIEN IV is a prospective,
single-blind, multi-center, randomized study that will evaluate
OCT-guided vs. angiography-guided coronary stent procedures in
complex and high-risk patients. The primary endpoints are
superiority of OCT-guided vs. angiography-guided stent implantation
in achieving a larger vessel opening (post procedural lumen
dimension) and improved clinical cardiovascular outcomes out to two
years, defined by target vessel failure (a composite endpoint of
cardiac death, target vessel myocardial infarction and
ischemia-driven target vessel revascularization).
About Optical Coherence Tomography Imaging:
OCT is an
intravascular imaging platform that uses light-based technology to
help doctors see and measure arteries from inside the vessel with
high precision. Physicians can assess and understand the degree of
disease and take necessary steps to treat it. With automated,
highly accurate measurements, OCT guides stent selection, placement
and deployment.
For U.S. Important Safety Information, visit:
https://www.vascular.abbott/content/dam/bss/divisionalsites/av/products/optis-integrated-and-mobile-software-isi.pdf.
About XIENCE:
XIENCE first received CE Mark in 2006
and FDA approval in 2008. Its safety profile is unprecedented with
consistent low rates of stent thrombosis, even in complex cases. A
special coating on XIENCE interacts with proteins in the blood to
reduce the risk for blood clots in the stent. For more information
about XIENCE, visit www.XienceStent.com/US.
For U.S. Important Safety Information, visit:
https://vascular.abbott.com/Xience-Stent-Safety.html#isi
About Abbott:
At Abbott, we're committed to helping
people live their best possible life through the power of health.
For more than 125 years, we've brought new products and
technologies to the world -- in nutrition, diagnostics, medical
devices and branded generic pharmaceuticals -- that create more
possibilities for more people at all stages of life. Today, 99,000
of us are working to help people live not just longer, but better,
in the more than 150 countries we serve.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
_______________________________
1 Mintz
GS, Weissman NJ. Intravascular ultrasound in the drug-eluting stent
era. J Am Coll Cardiol. 2006 Aug
1; 48(3):421-9.
2 Cook S, et al. Incomplete stent apposition and very
late stent thrombosis after drug-eluting stent implantation.
Circulation. 2007 May 8;
115(18):2426-34.
3 Decision Resources Group, July
2017. Data on file at Abbott.
4 Ali, Z. (2016, October). Optical Coherence Tomography
Compared to Intravascular Ultrasound and Angiography to Guide
Coronary Stent Implantation. The ILUMIEN III: OPTIMIZE PCI trial.
Presented at TCT 2016, Washington
D.C.
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