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American Heart Association Late-Breaking Clinical Trial Report: New Reversible Oral Drug Reduces Cardiac Events in Primary PCI Patients
Date:11/15/2009

Since ticagrelor is a more potent agent than one of the American Heart Association/American College of Cardiology guidelines recommended medications, clopidogrel, bleeding was a concern. "The good news is that there was no sign of increased major bleeding regardless of how we defined it," he said.

Following up to one year, 9.3 percent of the ticagrelor group met the primary endpoint, compared to 11 percent of the clopidogrel group -- a 15 percent relative risk reduction for the investigational group. The patients in Steg's analysis had STEMI and were scheduled to receive primary PCI -- also known as angioplasty -- and stenting during the acute phase of their heart attacks. The 4,201 patients randomized to the test group received 180 milligrams (mg) of ticagrelor during PCI, followed by 90 mg twice daily for six to 12 months. The other 4,229 patients received 300 mg of clopidogrel with a provision for an additional 300 mg during PCI, followed by 75 mg daily for six to 12 months. All patients in the trial also received daily aspirin therapy.

"STEMI is really the most acute form of coronary disease and represents roughly 40 percent of the patient group enrolled in the larger PLATO trial," Steg said. "It is a common condition, and it is a high-risk condition for which the standard of care, clopidogrel, has clear drawbacks."

"Clopidogrel's drawbacks include a slower onset of effectiveness, which is not suited to the need for rapid effect in STEMI, and a modest and inconsistent anti-platelet effect -- many patients respond well, but a sizeable unresponsive group remains at high risk of blood clots despite therapy," Steg said. Clopidogrel also binds permanently to the platelets' P2Y12 receptors, so its effect lasts seven to 10 days after the medication is stopped. In contrast, ticagrelor's effect is direct and reversible, he said. "With ticagrelor, there is an actual disassociation between the drug and the P2Y12 r
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SOURCE American Heart Association
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