AstraZeneca (NYSE: AZN) today announced results from a post-hoc analysis of a sub-group of the PLATO study. This new analysis evaluated outcomes in 9,946 patients with non–ST-elevation acute coronary syndrome (NSTE-ACS) managed with or without in-hospital revascularization in relation to measurements at randomization of high-sensitivity troponin-T (hs-TnT), a biomarker test that may be a more sensitive indicator of ongoing heart muscle damage than previously available troponin tests.
This study was presented today at the American Heart Association (AHA) Scientific Sessions in Los Angeles, CA. In the 86.3% (n= 8,587) of NSTE-ACS patients in PLATO with elevated hs-TnT, BRILINTA ® (ticagrelor) tablets reduced the composite of cardiovascular (CV) death, myocardial infarction (MI), and stroke, consistent with the results for the overall population of the PLATO study. In the 13.7% (n=1,359) patients with normal hs-TnT, the confidence intervals around the hazard ratios were broad. Because of the limited number of patients without hs-TnT elevation, uncertainties remain regarding the effects of ticagrelor versus clopidogrel on outcomes in hs-TnT normal subgroups.
“Hs-TnT is an important new biomarker that provides a much better ability to identify patients with ongoing myocardial damage. This biomarker allowed identification of NSTE-ACS patients with low levels of myocardial damage that would not have been detected by previous testing,” said James Ferguson, MD, Executive Director, Medical Affairs and Strategic Development, and Vice President for Global Medical Affairs. “This analysis of PLATO shows BRILINTA reduced the rate of thrombotic CV events in those NSTE-ACS patients with elevated hs-TNT, both when managed with revascularization as well as when managed medically.”
BRILINTA is indicated to reduce the rate of thrombotic CV events in patients with ACS (unstable angina [UA], non–ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). In PLATO, BRILINTA has been shown to reduce the rate of a combined end point of CV death, MI, or stroke compared to clopidogrel. In PLATO, the difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with an artery-opening procedure known as percutaneous coronary intervention (PCI), BRILINTA reduces the rate of stent thrombosis.