New PLATO Analysis Evaluates the Influence of High-Sensitivity Troponin Biomarker Status in NSTE-ACS Patients Managed with Revascularization or Medical Management
AstraZenecaStephanie Jacobson +1 302 885 5924 mob: +1 302 379 0443Julia Walker +1 302 885 5172 mob: +1 610 350 8240orEd Seage +1 302 886 4065 mob: +1 302 373 1361
(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.
BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin above 100 mg daily.
Bleeding rates and adverse events were not assessed in this sub-group analysis. The primary safety end point in the PLATO study was Total Major Bleeding (11.6% for BRILINTA and 11.2% for clopidogrel). In PLATO, non-CABG major + minor bleeding events were more common with BRILINTA versus clopidogrel (8.7% vs 7% respectively). The rate of non-CABG-related major bleeding was higher for BRILINTA (4.5%) vs clopidogrel (3.8%). Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients treated with clopidogrel.
Specific findings from this post-hoc analysis include:
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AstraZeneca also offers a U.S. patient assistance program for BRILINTA through its AZ&Me Prescription Savings Program. To determine eligibility, patients can visit or call 1-800-AZandMe (292-6363).
BRILINTA is an oral antiplatelet treatment for ACS. BRILINTA is a direct-acting P2Y receptor antagonist in a chemical class called cyclopentyltriazolopyrimidines (CPTPs). BRILINTA works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic CV events, such as a heart attack or CV death, in patients with ACS.
BRILINTA is available in 90-mg tablets to be administered with a single 180-mg oral loading dose (two 90-mg tablets) followed by a twice daily, 90-mg maintenance dose. Following an initial loading dose of aspirin, BRILINTA should be used with a maintenance dose of 75 mg - 100 mg aspirin once daily, 81-mg aspirin dose in the US.
BRILINTA is a registered trademark of the AstraZeneca group of companies.
PLATO (elet Inhibition and Patient utcomes) was a large (18,624 patients in 43 countries), head-to-head patient outcomes study of BRILINTA versus clopidogrel, both given in combination with aspirin and other standard therapy. The study was designed to establish whether BRILINTA could achieve a clinically meaningful reduction in cardiovascular (CV) events in acute coronary syndrome (ACS) patients, above and beyond that afforded by clopidogrel. Patients were treated for at least 6 months and up to 12 months.
PLATO demonstrated that treatment with BRILINTA led to a significantly greater reduction in the primary end point – a composite of CV death, MI, or stroke – compared to patients who received clopidogrel (9.8% vs 11.7% at 12 months; 1.9% absolute risk reduction [ARR]; 16% relative risk reduction [RRR]; 95% CI, 0.77 to 0.92; <0.001). The difference in treatments was driven by CV death and MI with no difference in stroke. In PLATO, the absolute difference in treatment benefit versus clopidogrel was seen at 30 days and the Kaplan-Meier survival curves continued to diverge throughout the 12-month treatment period.
The PLATO study also demonstrated that treatment with BRILINTA for 12 months was associated with a 21% RRR in CV death (4% vs 5.1%; 1.1% ARR; =0.001) and a 16% RRR in MI compared to clopidogrel at 12 months (5.8% vs 6.9%; 1.1% ARR; <0.005).
The primary safety end point in the PLATO study was Total Major Bleeding (11.6% for BRILINTA and 11.2% for clopidogrel). In PLATO, non-CABG major + minor bleeding events were more common with BRILINTA versus clopidogrel (8.7% vs 7% respectively). The rate of non-CABG-related major bleeding was higher for BRILINTA (4.5%) vs clopidogrel (3.8%).
Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients treated with clopidogrel. Dyspnea was usually mild to moderate in intensity and often resolved during continued treatment.
ACS is an umbrella term for conditions that result from insufficient blood supply to the heart muscle. These conditions include unstable angina (UA), non–ST-elevation myocardial infarction (NSTEMI), and ST-elevation myocardial infarction (STEMI). The conditions are defined by ECG changes and heart muscle enzyme leakage. Non–ST-elevation acute coronary syndrome (NSTE-ACS) includes unstable angina (UA) and non–ST-elevation myocardial infarction (NSTEMI); the term is usually used before heart muscle enzymes have been analyzed.
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