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Study Finds Pre-Hospital Administration Of Bivalirudin Substantially Improves Outcomes Compared To Heparin In Heart Attack



Study Finds Pre-Hospital Administration Of Bivalirudin Substantially Improves
            Outcomes Compared To Heparin In Heart Attack Patients

PR Newswire

SAN FRANCISCO, Oct. 30, 2013

Results of the EUROMAX Trial Presented at TCT 2013; Findings Simultaneously
Published in the New England Journal of Medicine

SAN FRANCISCO, Oct. 30, 2013 /PRNewswire-USNewswire/ -- According to a new
study, administering the blood thinner bivalirudin to patients experiencing an
ST-elevation myocardial infarction (STEMI, the most serious form of a heart
attack) in a pre-hospital setting can reduce the risk of death and major
bleeding complications compared to heparin with optional use of glycoprotein
IIb/IIIa inhibitors.

Findings from the EUROMAX trial were reported today at the 25^th annual
Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's
premier educational meeting specializing in interventional cardiovascular
medicine. Results of the trial were simultaneously published today in the New
England Journal of Medicine.

The EUROMAX trial evaluated the administration of anticoagulant therapy prior
to hospital admission by an emergency medical team. The trial compared a
heparin-based strategy (with or without glycoprotein IIb/IIIa receptor
inhibitors (GPIs) to a bivalirudin-based strategy. The primary endpoint was a
composite incidence of death or non-coronary-artery-bypass-graft related
protocol major bleeding at 30 days, assessed by intention to treat.

While bivalirudin has been compared to other blood thinners in hospital
settings, the EUROMAX study is the first to evaluate these anticoagulant
therapy options prior to hospital admission and in conjunction with newer
P2Y12 inhibitors such as prasugrel and ticagrelor. The randomized,
international, prospective, open-label ambulance trial enrolled 2,198 patients
with STEMI and intended for primary PCI, presenting either via ambulance or to
centers where PCI is not performed.

Patients either received bivalirudin (n=1,089) or heparin (n=1,109) at
guideline-recommended doses (with or without routine or bailout GPI).

After 30 days, patients that received bivalirudin, as compared with the
heparin group, experienced a significantly lower rate of death and major
bleeding (5.1 percent vs. 8.4 percent, respectively). The secondary composite
outcome of death, reinfarction and major bleeding at 30 days was also reduced
with bivalirudin (6.7 percent in the bivalirudin group compared to 9.1 percent
in the heparin group).  Despite a lower rate of bleeding complications in the
bivalirudin-treated patients, the risk of acute stent thrombosis was higher in
the bivalirudin group compared to the heparin group (1.1 percent vs. 0.2
percent, respectively), findings that parallel those observed in the
HORIZONS-AMI trial.

"The benefits of bivalirudin stemmed from a substantial reduction in major
bleeding and were robust and consistent across subgroups, regardless of the
adjunctive oral antiplatelet therapy or the arterial access route used for
angioplasty," said lead investigator Philippe Gabriel Steg, MD. Dr. Steg is
the Director of the Coronary Care Unit at the Hopital Bichat at Assistance
Publique - Hopitaux de Paris in France. 

"Findings from EUROMAX provide important additional insights into the role of
bivalirudin in the pre-hospital setting prior to primary PCI."

The EUROMAX trial was funded by The Medicines Company. Dr. Steg reported
research grant support from New York School of Medicine, Sanofi, and Servier;
speaking or consulting for Amarin, AstraZeneca, Bayer, Boehringer-Ingelheim,
Bristol-Myers Squibb, Daiichi-Sankyo, Glaxo-SmithKline, Lilly,  Medtronic,
Novartis, Otsuka, Pfizer, Sanofi, Servier, The Medicines Company, and Vivus;
and holds stock in Aterovax.

The results of the EUROMAX trial will be presented on Wednesday, October 30 at
9:30 AM PDT in the Main Arena (Moscone South, Esplanade Level, Esplanade
Ballroom) of The Moscone Center.

About CRF and TCT
The Cardiovascular Research Foundation (CRF) is an independent, academically
focused nonprofit organization dedicated to improving the survival and quality
of life for people with cardiovascular disease through research and education.
Since its inception in 1991, CRF has played a major role in realizing dramatic
improvements in the lives of countless numbers of patients by establishing the
safe use of new technologies and therapies in interventional cardiovascular
medicine. CRF is the sponsor of the Transcatheter Cardiovascular Therapeutics
(TCT) scientific symposium. Celebrating its 25^th anniversary this year, TCT
is the world's premier educational meeting specializing in interventional
cardiovascular medicine. For more information, visit www.crf.org and
www.tctconference.com.

SOURCE Cardiovascular Research Foundation

Website: http://www.crf.org/
Website: http://www.tctconference.com/
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