Press Release - Mar 10, 2013
New Anti-clotting Drug More Effective than Current Treatment
Cangrelor, a novel intravenous anti-clotting
medication, proves better across a broad population of patients receiving
coronary stent procedures
A
new and experimental anti-clotting drug, cangrelor, proved better than the
commonly used clopidogrel and was significantly
more effective at preventing blood clots in a large trial of patients who
underwent coronary stent procedures. These
data, from the phase III CHAMPION PHOENIX study, were presented at the American
College of Cardiology's 62nd Annual Scientific Session and published
simultaneously in the New England Journal
of Medicine.
Researchers
report that the new drug, which is administered intravenously, reduced the odds of complications from stenting procedures. Specifically, those who received cangrelor had a
lower combined incidence of death, myocardial infarction, ischemia-driven
revascularization, or stent thrombosis at 48 hours after randomization.
"We
are very excited about the potential for this new medication to reduce
complications in patients receiving coronary stents for a wide variety of
indications. In addition to being much quicker to take effect and more potent
than currently available treatment options, this intravenous drug is reversible
and has a fast offset of action, which could be an advantage if emergency
surgery is needed." said Deepak L. Bhatt, MD, MPH, lead author of the study,
director of the Integrated Interventional Cardiovascular Program at Brigham and
Women's Hospital (BWH) and chief of cardiology at VA Boston Healthcare System,
as well as professor of medicine at Harvard Medical School.
In
this randomized double-blind trial, researchers compared the novel IV drug
cangrelor against the oral clopidogrel standard of care in approximately 11,000
patients at 153 centers around the world.
The study included a wide selection of patients with different types of
heart attack, angina, and other conditions for which people undergo percutaneous
coronary intervention (PCI), as long as they did not have high risk for bleeding
or recent exposure to other anti-clotting drugs.
Researchers
report significantly better performance by cangrelor compared with clopidogrel:
-
A
22 percent reduction in the odds of death, myocardial infarction,
ischemia-driven revascularization, or stent thrombosis at 48 hours after
randomization: 4.7 percent vs. 5.9 percent
-
A
38 percent reduction in the odds of stent thrombosis at 48 hours: 0.8 percent
vs. 1.4 percent
-
Both
treatment arms showed a quite low, statistically comparable incidence in severe
bleeding at 48 hours: 0.16 percent vs. 0.11 percent.
Coronary
artery stents are used in the majority of patients who undergo percutaneous
coronary intervention (PCI), a common medical procedure used to treat arteries
in the heart that have become narrowed or blocked due to coronary artery
disease, which affects an estimated 14 million Americans. During this procedure, patients are regularly
given oral doses of an anti-clotting agent to prevent blood clotting. Both
cangrelor and clopidogrel interfere with the P2Y12 receptor, a
platelet-surface protein that helps regulate blood clotting.
"We
are encouraged by these compelling results, especially as it relates to the
safety data, and believe that this drug has the potential to offer dramatic
benefits to our patients" said Robert A. Harrington, M.D., chairman of medicine
at Stanford University School of Medicine and co-chair of the study.
The
company plans to file for approval with the Food and Drug Administration using
data from CHAMPION PHOENIX and the earlier BRIDGE trial.
The
Medicines Company sponsored the CHAMPION PHOENIX trial and provided a research
grant to the Duke Clinical Research Institute for the statistical analyses and
event adjudication. Both Bhatt and Harrington reported
receiving institutional grants from The Medicines Company. Harrington reported
receiving grants and travel support to attend meetings for the trial from the
company.
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