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Plans For Largest Ever
Drug-Eluting Stent Randomized Clinical Trial Announced at EuroPCR
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Patrick
W. Serruys, MD |
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May 18, 2011 -- Paris,
France -- Plans for Global LEADERS ("LEADERS
II"),
the largest ever randomized clinical trial involving a head-to-head
comparison
between two drug-eluting stents (DES), were announced yesterday
during the opening session of EuroPCR by Co-Principal Investigator
Professor Patrick W. Serruys. The trial will enroll more than 10,000
patients from an "all-comers" population eligible for PCI,
allocated to receive either BioMatrix Flex™ (Biosensors’ Biolimus
A9™-eluting stent system with abluminal biodegradable polymer),
or the market-leading DES system with a durable polymer. |
Recruitment into the study, involving over 100 sites around the globe, is due
to start in early 2012, with data being collected for up to two years following
stent implantation.
The protocol of the study is currently under
development, and is likely to involve a "2x2 factorial" design, with
the second randomization being to either a short or long duration of
anti-platelet therapy. The primary endpoint will be a true clinical
evaluation, assessing patient safety. Global LEADERS will be independently
designed, implemented and analyzed by the study investigators, who
in addition to Prof. Serruys (Erasmus Medical Center, Rotterdam, Netherlands)
will include Co-Principal Investigator Professor Stephan Windecker
(University Hospital, Bern, Switzerland). The study will also have
regional Principal Investigators in Europe, South America and Asia.
Dr. Marco Valgimigli (University of Ferrara, Italy) will act as Principal
Investigator for the anti-platelet therapy portion of the study.
Global LEADERS aims to build on the concept
of the landmark LEADERS study, which was the first head-to-head randomized
trial between two limus DES in an "all-comers" patient population using clinical outcomes as its endpoint. LEADERS results suggested that a DES with biodegradable polymer could be safer in the long term than a DES with durable polymer – especially in high-risk patient populations – under
conditions which resemble those of routine clinical practice.
"I am delighted to be involved with this logical development of the original LEADERS study", commented Prof. Serruys. "By
continuing the concept of a head-to-head study against a widely-used
drug-eluting stent with durable polymer using a true clinical endpoint,
and involving nearly six times as many patients, we anticipate that
the study will be sufficiently powered to produce meaningful results
on the benefits of a drug-eluting stent with biodegradable polymer
in a broad range of pre-defined patient subgroups."
"Global LEADERS should provide us with further valuable information, in that it will evaluate the risks and benefits associated with a short versus a long duration course of anti-platelet therapy following DES implantation in a large number of patients",
added Prof. Windecker.
"We are delighted to once again have the opportunity to be involved in a truly ground-breaking study, which represents another first for Biosensors in the field of drug-eluting stent research" concluded Biosensors Co-CEO Jeffrey B. Jump. "LEADERS changed the mind-set of how DES trials were perceived, and established a new benchmark for their design. Now Global LEADERS will raise the bar again for DES trial design in a wider population".
The BioMatrix Flex stent system offers the unique
combination of Biolimus A9™ (BA9™), an anti-restenotic drug developed
and patented by Biosensors specifically for use with drug-eluting stents,
combined with a biodegradable poly-lactic acid (PLA) polymer abluminally
coated onto an advanced, highly flexible stent platform designed for
enhanced deliverability. BA9 has the highest lipophilic profile of
the common limus drugs, enabling rapid absorption by the tissue and
minimizing systemic exposure. The PLA polymer fully degrades into carbon
dioxide and water over a six to nine month period as it releases BA9.
About Biosensors International
Biosensors International develops, manufactures and markets innovative medical devices for interventional cardiology and critical care procedures. We aim to improve patients' lives through pioneering medical technology that pushes forward the boundaries of innovation.
With the increasing use of the BioMatrix™ family of drug-eluting stents, we are rapidly emerging as a leader in the global coronary stent market. The forthcoming launch of the Axxess™ self-expanding bifurcation drug-eluting stent and the development of the BioFreedom™ drug-coated
stent will further reinforce our market position.
All three stents incorporate Biolimus A9™ (BA9™),
an anti-restenotic drug developed and patented by Biosensors specifically
for use with drug-eluting stents. Both the BioMatrix stent family and
the Axxess stent feature a unique abluminal biodegradable polymer coating,
which fully degrades into carbon dioxide and water over a six-to-nine-month
period as it releases BA9. The BioMatrix stent family features workhorse
stent platforms for a broad range of lesions, and the Axxess stent
employs a self-expanding stent platform specifically designed for treating
bifurcation lesions. BioFreedom, a completely polymer-free stent abluminally
coated with BA9, is currently undergoing clinical evaluation.
Source: Biosensors International
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