New PLATO Sub-Analysis of CABG Patients Presented at ACC
In this study, 48% fewer deaths reported among heart bypass patients taking ticagrelor (BRILINTA(TM)/BRILIQUE(TM)) as compared to clopidogrel
ATLANTA, March 16 /PRNewswire-FirstCall/ -- AstraZeneca
(NYSE:AZN) today announced results of a new
analysis of the PLATO (A Study of PLATelet Inhibition and Patient
Outcomes) study which showed there were fewer deaths in patients
with acute coronary syndromes (ACS) who took the investigational
oral antiplatelet ticagrelor (BRILINTA(TM)/BRILIQUE(TM)) within
seven days prior to having heart bypass surgery (coronary artery
bypass graft, CABG) compared to those who took clopidogrel.(1)
These data were presented today at the American College of
Cardiology (ACC) meeting in Atlanta, Georgia.
"The CABG sub-analysis represents current clinical management of
patients with ACS,"(1) said Dr. Claes Held, PhD, Associate
Professor of Cardiology at the Uppsala Clinical Research Center and
Department of Cardiology, and the sub-study's lead researcher. "The
effects of ticagrelor compared to clopidogrel showed a reduction of
total mortality by 51% and CV death by 48%."(1)
This analysis included 1261 patients who were on study
medication up to seven days prior to stopping study medication due
to the need for urgent CABG surgery at any time after their ACS
event.(1) The patients randomized to ticagrelor had a significantly
lower rate of total and CV death than those randomized to
clopidogrel treatment:
-- Total mortality was reduced by 51% (RRR; p<0.01) with ticagrelor (4.6%
of 632) compared to clopidogrel (9.2% of 629)(1)
-- CV death was reduced by 48% (RRR; p<0.01) with ticagrelor (4.0% of
632) compared to clopidogrel (7.5% of 629)(1)
-- Rate of the primary endpoint (composite of CV death, myocardial
infarction, or stroke) from the time of CABG was 10.5% (66/632) with
ticagrelor and 12.6% (79/629) with clopidogrel (HR 0.84; CI 0.60-1.16,
p=0.29)(1)
Additionally, there was no significant difference in
CABG-related major bleeding for ticagrelor compared to
clopidogrel,(1) according to both the PLATO and TIMI bleeding
criteria respectively (81% for ticagrelor vs. 80% for clopidogrel,
and 59% for ticagrelor vs. 58% for clopidogrel for PLATO-defined
and TIMI-defined, respectively).
"These treatment comparisons were consistent with the effects
seen in the overall PLATO trial," said Dr. Claes Held.(1,2)
About CABG (Coronary Artery Bypass Grafting)
CABG surgery is advised for certain ACS patients, including
those who are not candidates for percutaneous coronary intervention
(PCI). It is not always known which ACS patients will be advised
for CABG surgery at the time of initiating oral antiplatelet
therapy.(3) These patients have significant narrowing and blockages
of the heart arteries (coronary artery disease).(4) CABG is a type
of heart surgery that reroutes, or "bypasses," blood around clogged
arteries to improve blood flow and oxygen to the heart.(5)
About PLATO CABG analysis
In the PLATO study, a double-dummy, double-blind randomized
trial comparing ticagrelor plus aspirin with clopidogrel plus
aspirin in patients with ACS, 1899 patients underwent CABG during
the trial.(1) The trial recommended administration of
ticagrelor/placebo-clopidogrel to be withheld for 24-72 hours and
clopidogrel/placebo-ticagrelor for 5 days prior to CABG surgery. In
the exploratory analysis, 1261 patients received study-drug up to
seven days prior to CABG surgery.(1) The analysis counted events
occurring from after the CABG procedure until the end of the
study.(1)
Primary results from PLATO were presented at the European
Society of Cardiology and simultaneously published in The New
England Journal of Medicine in August 2009.(2)
About BRILINTA(TM)/BRILIQUE(TM)
Ticagrelor (BRILINTA(TM)/BRILIQUE(TM)) is an investigational
oral antiplatelet treatment for ACS. Ticagrelor, a
cyclo-pentyl-triazolo-pyrimidines (CPTP), is in a chemical class of
anti-platelet agents that works differently than thienopyridines,
such as clopidogrel and prasugrel, by binding reversibly to the
P2Y12 receptor. Ticagrelor is the first reversibly binding oral ADP
receptor antagonist.
Ticagrelor is currently under regulatory review in the US and in
Europe. BRILINTA and BRILIQUE are trademarks of the AstraZeneca
group of companies.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical
business with a primary focus on the discovery, development and
commercialization of prescription medicines. As a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory and
inflammation, oncology and infectious disease medicines,
AstraZeneca generated global revenues of $32.8 billion in 2009. In
the United States, AstraZeneca is a $14.8 billion healthcare
business.
For more information about AstraZeneca in the US or our
AZ&Me(TM) Prescription Savings programs, please visit:
www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).
References:
(1)Held. Ticagrelor Versus Clopidogrel In Patients With Acute
Coronary Syndromes Treated With Coronary Artery Bypass Surgery:
Results from The Plato Trial. Presented at 59th Annual Scientific
Session, March 16, 2010; Atlanta Georgia. ACC Abstract Number
10-A-9909-ACC.
(2) Wallentin L, Becker R, et al. Ticagrelor versus Clopidogrel
in Patients with Acute Coronary Syndromes. N Engl J Med 2009; 361:
1-13.
(3) Kushner, F., Hand, M., et al. 2009 Focused Updates: ACC/ AHA
Guidelines for the Management of Patients with ST-Elevation
Myocardial Infection (Updating the 2004 Guideline and 2007 Focused
Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary
Intervention (Updating the 2005 Guideline and 2007 Focused Update):
A Report of the American College of Cardiology Foundation/American
Heart Association Task Force on Practice Guidelines. Circulation
2009; 120: 2271-2306.
(4) American Heart Association. Acute Coronary Syndrome.
Available at: http://www.americanheart.org/presenter.jhtml?identifier=3010002.
Accessed on February 24, 2010.
(5) American Heart Association. Cardiac Procedures and Surgeries
at a glance. Available at: http://www.americanheart.org/presenter.jhtml?identifier=3054086.
Accessed on February 24, 2010.
Source: AstraZeneca
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Posted: March 2010
