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American Heart Association Late-Breaking Clinical Trial Report: New Blood Thinner for Angioplasty Patients Not Superior for Primary Endpoint, but Did Reduce Death and Stent Thrombosis
Date:11/15/2009

"However, a number of secondary endpoints had very interesting and informative findings. For instance, all-cause death as a stand-alone endpoint was reduced significantly from 0.7 percent in controls to 0.2 percent (67% reduction) in the cangrelor group.

"It is intriguing, of course, but it is a secondary endpoint and needs to be interpreted with some caution given that the primary endpoint was not met and the number of deaths overall was low."

Furthermore, acute stent thrombosis (blood clots that form within the stent) was significantly reduced in the test group.

"That's something that interventional cardiologists really worry about because stent thrombosis is often associated with a recurrent heart attack or death," said Bhatt, who is also director of the integrated interventional cardiovascular program at Brigham and Women's Hospital and the VA Boston Healthcare System and a faculty member at Harvard Medical School in Boston, Mass. "Acute stent thrombosis was reduced from 0.6 percent in controls to 0.2 percent in the test group (69% reduction), again a significant benefit. So there seems to be a plausible mechanism by which mortality may have been reduced since stent thrombosis was reduced."

Researchers found no difference in endpoints between test and control groups for severe bleeding and need for blood transfusion. However, less severe bleeding was significantly higher with the new agent, 5.4 percent vs. 3.4 percent in controls, an indication of the investigational drug's potency, Bhatt said. Because it's reversible and is delivered through an intravenous line, bleeding events can be ended quickly after the drug is no longer administered.

Clopidogrel is given orally and is irreversible -- once it binds to a platelet it remains for the life of that blood cell, usually 7 to 10 days. That puts clopidogrel patients at higher risk of bleeding complications if they need emergency surgery, he said.


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SOURCE American Heart Association
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