AstraZeneca has announced that ticagrelor, an oral antiplatelet medicine, received a class I recommendation from the European Society of Cardiology (ESC) in the revised “Guidelines on the Management of Acute Myocardial Infarction in Patients Presenting with Persistent ST-Segment Elevation (STEMI)” guidelines. Ticagrelor is known as Brilique in the European Union and Brilinta elsewhere.
For primary percutaneous coronary intervention, the guidelines now recommend ticagrelor with no restrictions for STEMI patients (Class I; LOE B). Prasugrel (Class I; LOE B) is recommended only for clopidogrel-naïve patients with no prior history of stroke/transient ischaemic attack and aged
Ticagrelor plus aspirin, or prasugrel plus aspirin, are recommended (over clopidogrel plus aspirin) in patients treated with percutaneous coronary intervention (Class I: LOE A). Treatment with ticagrelor is recommended for up to 12 months. In addition, the guidelines recommend antiplatelet therapy with low dose aspirin after STEMI indefinitely.
With this addition, ticagrelor is now recognised as a standard therapy for acute coronary syndromes patients within a total of 10 sets of US and global guidelines, including the ESC’s 2011 Guidelines for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation and 2010 Guidelines for Myocardial Revascularisation.
“The inclusion of ticagrelor in the ESC STEMI guidelines is recognition by the medical community of the established role of Brilinta in contemporary standard-of-care acute coronary syndromes management. These guideline updates underscore a growing acceptance amongst the medical community of the benefits of ticagrelor (plus low dose aspirin) for a broad range of acute coronary syndromes patients,” said James Ferguson, VP Global Medical Affairs, CV, AstraZeneca. “The recommendation from the ESC is another important step toward improving access for acute coronary syndromes patients to ticagrelor in Europe, where acute coronary syndromes affects an estimated 1.4 million people every year – more than all cancers combined.”
The inclusion of ticagrelor in the new ESC guidelines were based on data from PLATO (A study of platelet inhibition and patient outcomes), which demonstrated that treatment with ticagrelor plus aspirin led to a greater reduction in the primary end point – a composite of cardiovascular death, myocardial infarction, or stroke – compared to clopidogrel plus aspirin [9.8% vs. 11.7% at 12 months; 16% relative risk reduction (RRR); 95% CI, 0.77 to 0.92]. The difference in treatments was driven by cardiovascular death and myocardial infarction with no difference in stroke. The PLATO study also demonstrated that treatment with ticagrelor for 12 months was associated with a 21% RRR in cardiovascular death [4% vs. 5.1%; 1.1% absolute risk reduction (ARR)] and a 16% RRR in myocardial infarction compared to clopidogrel at 12 months (5.8% vs. 6.9%; 1.1% ARR). With ticagrelor, there was no increase in overall major/fatal bleeding over the course of one year of treatment (11.6% for ticagrelor versus 11.2% for clopidogrel); however, non-coronary artery bypass graft major bleeding was more common with ticagrelor versus clopidogrel (4.5% vs. 3.8%).
These updates to the “Guidelines on the Management of Acute Myocardial Infarction in Patients Presenting with Persistent ST-Segment Elevation” were presented at ESC on 27 August in Munich, Germany, and also published in the European Heart Journal.