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PLATO: Ticagrelor associated with reduced outcomes, mortality in patients with ACS
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Patients with acute coronary syndromes for whom an early invasive strategy was planned tended to benefit from ticagrelor and did not have an increase in bleeding, results from a study suggested.
Researchers for the PLATO trial enrolled 13,408 of 18,624 patients hospitalized for ACS. They randomly assigned patients to either ticagrelor (Brilinta, AstraZeneca) and placebo at a 180-mg loading dose followed by 90-mg twice daily (n=6,732) or clopidogrel (Plavix, Sanofi-Aventis) and placebo at a 300-mg to 600-mg loading dose (or continuation of the maintenance dose) followed by 75-mg daily (n=6,676) for six to 12 months. The researchers assigned all patients to aspirin. The primary study endpoint was a composite of CV death, MI or stroke.
The primary endpoint occurred in fewer patients in the ticagrelor group vs. the clopidogrel group at one year (9.0% vs. 10.7%; P=.0025). The rates of total major bleeding (11.6% vs. 11.5%; P=.8803) and severe bleeding (3.2% vs. 2.9%; P=.3785) did not differ between the clopidogrel group and the ticagrelor group.
“We estimate that use of ticagrelor instead of clopidogrel for one year in 1,000 patients with ACS and who are planned to undergo an invasive strategy at the start of drug treatment would lead to 11 fewer deaths, 13 fewer MI and six fewer cases of stent thrombosis without an increase in the rates of major bleeding or transfusion,” the researchers concluded. “These results also support the idea that increased inhibition of platelet P2Y12 receptors can achieve substantial reduction in the rate of mortality when not associated with an increase in the rate of major bleeding.”
In an accompanying editorial, Gregg W. Stone, MD, a cardiologist at Columbia University Medical Center, said that the PLATO results supported ticagrelor as a new potential standard of care in ACS, but noted that a personalized approach to drug selection is still preferable in some patients.
“Clopidogrel might still be appropriate for selected patients who are at relatively low risk of MI or stent thrombosis and/or high risk of major bleeding, and/or for whom noncompliance with ticagrelor because of cost or other considerations (eg, twice-daily dosing) is a concern,” Stone wrote. “Nonetheless, the introduction of ticagrelor, a more potent and effective agent which is as safe as its predecessor, is a landmark event that should redefine the care of patients with ACS.”
Cardiology Today has previously reported on the results from the PLATO study when they were presented at the American Heart Association 2009 Annual Scientific Sessions in Orlando, Fla.; at Transcatheter Cardiovascular Therapeutics 2009 in San Francisco; and the European Society of Cardiology Congress 2009 in Barcelona, Spain.
Cannon CP. Lancet. 2010;doi:10.1016/S0140-6736(09)62191-7.