Biosensors DES Demonstrates Equivalent Safety and Efficacy to Industry Leading
DES in First 'Real World, All Comers' Clinical Study
MUNICH, Germany, September 1 /PRNewswire-FirstCall/ -- Biosensors
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 drug-eluting stent.
For further information about Biosensors, please visit:
http://www.biosensors.com
SOURCE Biosensors International Group, Ltd
For further information, or to arrange interviews, please contact on-site:
Richard Kenyon, richard@rkpr.co.uk, +44-7831-569940; Alexander Watson,
alexander.watson@ketchum.com, +44-7712-675990; Michelle Collias,
m.collias@biosensors.com, +41-798-204112, Andrew Wong,
awong@iconinternational.com.sg, +65-6220-2623; Adeline Goh,
agoh@iconinternational.com.sg, +65-6220-2623; Roxanne Toh,
rtoh@iconinternational.com.sg, +65-6220-2623
