In new guidelines from the European Society of Cardiology (ESC), prasugrel – a once daily oral antiplatelet medicine – received a Class I recommendation for use in patients undergoing percutaneous coronary intervention after experiencing a non-ST-segment elevation acute coronary syndrome (which comprises non-ST segment elevation myocardial infarction or NSTEMI and unstable angina.
The highest available recommendation, Class I recognises that prasugrel (Efient, Daiichi Sankyo) is considered a “beneficial, useful and effective” treatment option for first line use in these patients.
The Guidelines Committee endorsed the use of prasugrel in unstable angina/NSTEMI patients (especially those with diabetes) who are clopidogrel naive in whom coronary anatomy is known and who are proceeding to percutaneous coronary intervention. The guidelines were presented at the ESC Congress 2011 in Paris and are published in the European Heart Journal.
“Unstable angina and NSTEMI patients are at high risk of cardiovascular events, and they often represent a challenge in clinical practice. There is a significant body of evidence which showed that prasugrel can form part of an appropriate management strategy to minimise risk for these patients,” said Gilles Montalescot, head of the Cardiac Care Unit at Pitie-Salpetriere Hospital, Paris, France. “The guidelines, based on the latest clinical evidence, set out clear recommendations that offer alternative treatment options, such as prasugrel, for treating some of these high risk patients.”
In the updated guidelines – titled Management of acute coronary syndromes in patients presenting without persistent ST-segment elevation – prasugrel was recommended regardless of a patient’s genetic status, and the guidelines state prasugrel does not appear to be affected by CYP inhibitors, including proton pump inhibitors.
This new recommendation is based on the clinical evidence for prasugrel in unstable angina/NSTEMI patient population in the TRITON-TIMI 38 study, which led to a level of evidence ’B’ (data derived from a single randomised clinical trial). In the TRITON-TIMI 38 study, which included 10,074 patients with chest pain at rest or experiencing NSTEMI (74% of the study population), treatment with prasugrel produced a statistically significant 18% reduction in the relative risk of the combined endpoint of cardiovascular death, nonfatal heart attack or nonfatal stroke compared with clopidogrel. In this patient population, the incidence of non-CABG-related TIMI major (2.2% with prasugrel vs. 1.6% with clopidogrel) and minor (2.3% with prasugrel and 1.6% with clopidogrel) bleeding was statistically significantly higher in patients treated with prasugrel compared to clopidogrel.
Granted marketing authorisation by the European Commission in February 2009, prasugrel, co-administered with acetylsalicylic acid, is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention.