Munich, Germany (ots/PRNewswire)
International Group, Ltd ("Biosensors", "Company"), (Bloomberg:
BIG:SP), (Singapore:B20) today announced that a next-generation
drug-eluting stent, developed by Biosensors, has demonstrated equal
safety and efficacy as compared to Johnson & Johnson's industry
leading drug-eluting stent, CYPHER SELECT(TM) ("Cypher"), based upon
nine-month clinical and angiographic follow-up data. The results of
the landmark study were presented today at the 2008 European Society
of Cardiology Congress and published concurrently on-line by the
prestigious UK medical journal The Lancet.
LEADERS (Limus Eluted from A Durable versus ERodable Stent
coating) is the first head-to-head randomized study between the two
drug-eluting stent systems (DES) in a 'real world, all comers'
population using clinical results as its primary endpoint.
This multi-centre European study randomized 1,707 patients
eligible for percutaneous coronary intervention (PCI) for symptomatic
coronary disease to receive either a Biosensors Biolimus-eluting DES
with an abluminal biodegradable polymer coating, or a Cypher
Sirolimus-eluting DES with a durable polymer. In total, 2,472
coronary lesions were treated. Inclusion criteria were broad,
reflecting routine clinical practice, without limitations regarding
type of coronary vessel, lesion length or number of treated lesions.
Patient conditions known as "off-label indications", including acute
coronary syndromes, saphenous vein grafts and previously treated
lesions were also included in the trial.
The primary endpoint of the study was non-inferiority of the
composite of cardiac death, myocardial infarction, and
clinically-driven target vessel revascularization ("TVR") at nine
months follow-up. In addition, 25 percent of all patients were
randomly assigned to undergo angiographic follow-up at nine months.
The principal endpoint of the pre-specified angiographic sub-group
was in-stent percent diameter stenosis at nine months.
During the first nine months, 9.2 percent of patients receiving
the Biosensors DES, and 10.5 percent of patients given the Cypher DES
experienced a clinical adverse event that could be included in the
primary composite endpoint, thus demonstrating that the Biosensors
stent was non-inferior to the Cypher stent. A favorable trend towards
the Biosensors stent was non-significant at the nine months follow-up
endpoint. As anticipated, clinical event rates were higher in LEADERS
compared with previous DES trials performed in patients with only
on-label indications, because the LEADERS trial design permitted
inclusion of any patient eligible for PCI. As a result, rates of
death, myocardial infarction and stent thrombosis were similar for
both stent types, but were 2.6% higher when compared to the earlier,
less inclusive trials.
In the angiographic sub-group, there were no significant
differences at 9 months between the in-stent percent diameter
stenosis observed in the two patient groups, but there was a
non-significant trend favoring the Biosensors stent.
"The results from LEADERS are very significant as they
demonstrate for the first time that a drug-eluting stent with an
abluminal biodegradable polymer is as safe and effective at nine
months as a conventional drug-eluting stent with a durable polymer,
considered to be the most effective, under conditions which resemble
those of routine clinical practice", commented LEADERS Principal
Investigator Professor Stephan Windecker, University Hospital, Bern,
Switzerland. "Longer-term follow-up of the patients in LEADERS or
studies of a similar nature are now needed to confirm the theoretical
advantage of the abluminal biodegradable polymer in terms of reduced
risk of late thrombosis."
Mike Kleine, President & CEO of Biosensors added, "We are
tremendously encouraged by the results of LEADERS, believing this to
be just the first in a series of studies which will ultimately
confirm our drug-eluting stent technology, with its unique
combination of anti-restenotic drug and abluminal biodegradable
polymer, as the new industry standard."
Although funded by Biosensors, LEADERS was independently
developed, implemented and analyzed by the study investigators.
Moreover, data management and analysis were performed by an
independent academic institution.
Biosensors develops, manufactures and markets innovative medical
devices used in interventional cardiology and critical care
procedures. Biosensors has developed a pipeline of next-generation
products that are set to gain market share from traditional therapies
such as conventional DES, bare-metal stents and open-heart surgery.
It has three separate drug-eluting stent programs, BioMatrix(TM),
Axxion(TM), and BioFreedom(TM), a completely polymer-free
For further information about Biosensors, please visit:
ots Originaltext: Biosensors International
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