BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Biosensors International Release: BioMatrix Flex™ Improves Clinical Outcomes Compared to Cypher® Select™ for Up to Five Years


10/24/2012 10:06:31 AM

Miami, USA, 24 October 2012 – Biosensors International has announced five-year results from the LEADERS trial, showing improved long-term clinical outcomes for BioMatrix Flex™, Biosensors’ Biolimus A9™-eluting stent system with a biodegradable polymer coating, compared to Cypher® Select™, Johnson & Johnson’s sirolimus-eluting stent system with a durable polymer. BioMatrix Flex significantly reduced the risk of clinical events compared with Cypher Select, which was associated with a reduced risk of very late stent thrombosis (VLST).

The final report from LEADERS was presented yesterday by Professor Patrick W. Serruys, Erasmus Medical Center, Rotterdam, The Netherlands, at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

“As a result of LEADERS, most drug-eluting stents currently being developed use biodegradable polymer technology”, commented Principal Investigator Professor Stephan Windecker, University Hospital, Bern, Switzerland. “BioMatrix was one of the pioneering stent platforms to use a biodegradable polymer applied to the abluminal surface only.”

Results at five years demonstrated that the relative risk of MACE (Major Adverse Cardiac Events) was 17% lower in patients treated with BioMatrix Flex than in those treated with Cypher Select (22.3% vs. 26.1%; Psup = 0.071). During the one to five year period, BioMatrix Flex was also associated with a significant 74% reduction in definite VLST compared with Cypher Select (0.66% vs. 2.5%; Psup = 0.003). The study had an excellent follow-up rate of 96.5%.

“Results from LEADERS have helped patients to benefit from our superior technology, as this was the first study to actually show that a drug-eluting stent with a biodegradable polymer was better than one with a durable polymer”, added Jeffrey B. Jump, President of Biosensors’ Cardiovascular Business Unit.

The initial results from LEADERS, presented at the European Society of Cardiology (“ESC”) congress in 2008 and simultaneously published in The Lancet1, demonstrated BioMatrix Flex to be non-inferior to Cypher Select in respect of the primary endpoint, incidence of MACE at nine months. The four-year results, published in The Lancet in 20112, reinforced the long-term benefits of BioMatrix Flex. Compared with Cypher Select, it significantly reduced the risk of cardiac events, which was associated with a reduced risk of VLST.

LEADERS has achieved a series of notable firsts: it was the first head-to-head randomized clinical study (RCT) between two limus-eluting stents; the first RCT between two stents to involve an “all-comers” patient population; and the first RCT between two stents to be independently monitored and assessed by its investigators.

References

1. Windecker S. et al. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non inferiority trial. The Lancet 2008; 372 No. 9644:1163-1173.

2. Stefanini GG, Kalesan B, Serruys PW et al. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial. The Lancet 2011; 378: 1940 - 1948.



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES