MEDIA BRIEFING
17th September 2007
ARRIVE
A major multinational trial of aspirin
as prevention of first heart attack and stroke
European Society of Cardiology Congress, Vienna – 31/8/07
to 5/9/07
Bayer Health Care has launched a major trial to examine the benefits
of low-dose aspirin in preventing a first heart attack or stroke
in patients with moderate cardiovascular risk. ARRIVE (Aspirin
to Reduce Risk of Initial Vascular Events) is one of the largest
studies of its type ever to be conducted in this population.(a)
“With ARRIVE, we expect to significantly expand the existing
strong body of evidence supporting use of aspirin for primary
prevention of cardiovascular disease events – this time
in a moderate risk population,” said Dr Michael Gaziano,
chairman of the committee overseeing the study. “There are
many patients, such as those in the ARRIVE trial, who do not have
a history of events or symptomatic disease, but instead have cardiovascular
disease risk profiles sufficiently high enough that they will
likely benefit from treatment with aspirin. These moderate risk
patients would be appropriate candidates for consideration of
aspirin therapy.”
Investigators have begun to recruit an estimated 12,000 participants
at more than 400 sites in Germany, Italy, Spain, the UK and the
US. The major endpoints of the 5-year trial are the incidence
of fatal and non-fatal heart attacks and strokes. Completion and
reporting of study results is anticipated in 2013.
ARRIVE will utilize an innovative model for estimating cardiovascular
risk. Developed from the main risk assessment models in current
use, it takes into account the differences in risk between high-risk
and low-risk countries.(b) Bayer is working to evolve and refine
the methodology and make it available to clinicians worldwide
as a tool that can be used in routine practice. Availability of
a simple robust method to predict cardiovascular disease risk
of individual patients internationally will help broaden the appropriate
use of aspirin.
“At least 20 million people survive heart attacks and strokes
every year; many require continuing, costly care and are at high
risk for recurrences and death(1)(c). That is why it is so important
to prevent a first cardiovascular disease event,” said Dr
Wes Cetnarowski, Senior Vice President of Bayer Global Research
& Development. “Aspirin is an effective and economical
risk reduction strategy; it is already recognised worldwide as
cornerstone therapy for prevention of second heart attack and
ischaemic stroke. Its broader use in appropriate patients could
reduce tens of thousands of first events and untold financial
resources in both direct and indirect healthcare costs. With the
ARRIVE trial, Bayer continues its commitment to work in partnership
with the scientific community to advance initiatives that bring
the benefits of aspirin to a larger number of appropriate patients,
and help reduce the global burden of cardiovascular disease.”
ENDS
Notes for editors
a. Moderate risk is defined as a 20-30 percent cardiovascular
disease event risk over ten years; or a 10-20 percent coronary
heart disease event over the same period
b. The success of the trial depends on recruiting a large number
of patients who meet the stringent entry criteria. The new risk
assessment tool models overall risk on a blend of individual risk
(risk of coronary heart disease, plus risk of stroke, plus risk
of cardiovascular death), combining elements of four existing
risk calculator methods: Framingham and PROCAM for coronary heart
disease, Framingham Stroke for stroke risk, and SCORE for cardiovascular
death.
c. According to the World Health Organization, heart disease and
stroke are the leading causes of death worldwide, accounting for
17.5 million, or 30 percent, of all deaths each year.(2) By 2020,
heart disease and stroke will become the leading cause of both
death and disability worldwide.(3) In addition, the related financial
burdens are enormous; in the EU alone, annual expenses associated
with direct and indirect costs of all cardiovascular disease were
estimated at 169 billion Euro in 2006 (4)
References
1. World Health Organization, second sentence under “Extent
of Problem,”
http://www.who.int/dietphysicalactivity/publications/facts/cvd/en/
2. World Health Organization, first bullet under “Facts,”
http://www.who.int/dietphysicalactivity/publications/facts/cvd/en/
3. World Health Organization, third paragraph, second sentence,
http://www.who.int/mediacentre/news/releases/2004/pr68/en/
4. Leal J, Luengo-Fernandez R. Economic burden of cardiovascular
diseases in the enlarged European Union. Eur Heart J, (2006) 27,
1610–1619
