AstraZeneca has announced results of a PLATO sub-analysis in Acute Coronary Syndrome (ACS) patients, those with ST Segment Elevation Myocardial Infarction (STEMI).
The sub-analysis showed that, compared to clopidogrel (Plavix/Iscover), treatment with ticagrelor (BRILINTA) resulted in a reduction of cardiovascular events for up to a year (ticagrelor vs clopidogrel, 9.3% vs 11.0%, P=0.02), without an increase in major bleeding (9.0% vs 9.3%, P=0.63). These efficacy findings were driven by a statistically significant reduction in heart attacks (4.7% vs 6.1%, P=0.01). For these STEMI patients, the benefit observed with ticagrelor increased over time.
Ticagrelor also demonstrated effects across several secondary efficacy endpoints including MI, stent thrombosis, and the composite of MI, stroke and all-cause mortality. There was an 18% relative reduction in all cause mortality at one year from 6.0 to 4.9% (P=0.04) with ticagrelor over clopidogrel.
The pre-specified sub-analysis of the ACS STEMI patients looked at approximately 45% (8,430 patients) of the overall PLATO study population. These data were presented today during the late-breaker session at the annual American Heart Association (AHA) Scientific Sessions in Orlando, FL.
Prof Gabriel Steg, cardiologist at Hopital Bichat, Assistance Publique – Hopitaux de Paris (AP-HP), professor of cardiology at the University Paris 7, and principal investigator of the PLATO STEMI sub-analysis, said: “Patients with STEMI need to undergo emergency PCI. They are particularly at risk of serious complications, so also require rapidly active antithrombotic agents. In PLATO, we studied a broad patient population to investigate ticagrelor’s efficacy in patients that are typical of those we see in clinical practice. As previously shown in patients undergoing invasive procedures, and now in STEMI patients, these results are consistent with the reduction of CV events without an increase in major bleeding, seen in the overall PLATO trial.”