BRILINTA (ticagrelor) Receives Additional Class I Recommendation In Updated ACCF/AHA Guidelines For The Management Of UA/NSTEMI Patients

AstraZeneca (NYSE: AZN) announced today that a combined panel of experts from the American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) have updated their guidelines to include a Class I recommendation for the use of the oral antiplatelet medicine, BRILINTA ^® (ticagrelor) tablets in patients with Unstable Angina (UA) or Non–ST-Elevation Myocardial Infarction (NSTEMI) managed both invasively and non-invasively.

“This Guidelines update is yet another strong recommendation for BRILINTA by clinical and scientific leadership within the Cardiology community. We are pleased that the Guidelines recognize the important benefits that BRILINTA provides in the treatment of a broad range of patients with UA/NSTEMI,” said James Ferguson, MD, Executive Director, Medical Affairs and Strategic Development, US, and Vice President for Global Medical Affairs. “This expert consensus is another valued milestone illustrating how our standards of care continue to evolve, and how medications, such as BRILINTA, can very quickly become an important part of those standards.”

A Class I recommendation is the highest recommendation provided by the guidelines committee.

Specific recommendations within the guidelines relating to BRILINTA include :

Class I

Patients with definite UA/NSTEMI at medium or high risk and in whom an initial invasive strategy is selected should receive dual antiplatelet therapy on presentation. (Level of Evidence (LOE): A) Aspirin should be initiated on presentation. (LOE: A) The choice of a second antiplatelet therapy to be added to aspirin on presentation includes 1 of the following:

Before PCI:

• Clopidogrel (LOE: B); or
• Ticagrelor (LOE: B); or
• An IV GP IIb/IIIa inhibitor. (LOE: A)

At the time of PCI:

• Clopidogrel if not started before PCI (LOE: A); or
• Prasugrel (LOE: B); or
• Ticagrelor (LOE: B); or
• An IV GP IIb/IIIa inhibitor. (LOE: A)

For UA/NSTEMI patients in whom an initial conservative (i.e., non-invasive) strategy is selected, clopidogrel or ticagrelor should be added to aspirin and anticoagulant therapy as soon as possible after admission and administered for up to 12 months. (LOE: B)

For UA/NSTEMI patients in whom an initial conservative strategy is selected, if recurrent symptoms/ischemia, heart failure or serious arrhythmias subsequently appear, then diagnostic angiography should be performed. (LOE: A) Either an IV GP IIb/IIIa inhibitor (LOE: A), clopidogrel (loading dose followed by daily maintenance dose [LOE: B]), or ticagrelor (loading dose followed by daily maintenance dose [LOE: B]) should be added to aspirin and anticoagulant therapy before diagnostic angiography (upstream). (LOE: C)

A loading dose of P2Y ₁₂ receptor inhibitor therapy is recommended for UA/NSTEMI patients for whom PCI is planned. One of the following regimens should be used:

• Clopidogrel 600 mg should be given as early as possible before or at the time of PCI (LOE: B) or
• Prasugrel 60 mg should be given promptly and no later than 1 hour after PCI once coronary anatomy is defined and a decision is made to proceed with PCI (LOE: B) or
• Ticagrelor 180 mg should be given as early as possible before or at the time of PCI. (LOE: B)

The duration and maintenance dose of P2Y12 receptor inhibitor therapy should be as follows:

• In UA/NSTEMI patients undergoing PCI, either clopidogrel 75 mg daily, prasugrel 10 mg daily, or ticagrelor 90 mg twice daily should be given for at least 12 months. (LOE: B)
• If the risk of morbidity because of bleeding outweighs the anticipated benefits afforded by P2Y ₁₂ receptor inhibitor therapy, earlier discontinuation should be considered. (LOE: C)

Class IIa

After PCI, it is reasonable to use 81 mg per day of aspirin in preference to higher maintenance doses. (LOE: B)

NOTES TO EDITORS:

BRILINTA Indication

BRILINTA is indicated to reduce the rate of thrombotic CV events in patients with acute coronary syndrome (ACS: unstable angina [UA], non-ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). BRILINTA has been shown to reduce the rate of a combined end point of CV death, myocardial infarction (MI), or stroke compared to clopidogrel. 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.

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