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BRILINTA Included in 2011 Guidelines for the
Treatment of Acute Coronary Syndrome (ACS)

BRILINTA was included in 2011 practice guidelines for the treatment of ACS from the American College of Cardiology Foundation (ACCF), American Heart Association (AHA), and the Society for Cardiovascular Angiography and Interventions (SCAI).

BRILINTA is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with acute coronary syndrome (ACS) (unstable angina, non–ST-elevation myocardial infarction, or ST-elevation myocardial infarction). 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 PCI, it also reduces the rate of stent thrombosis.

BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin >100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin >100 mg daily.

The Class I recommendations for BRILINTA include:

2011 AHA/ACCF guideline for secondary prevention and risk reduction1*

Recommendation Class
A P2Y12 receptor antagonist in combination with aspirin is indicated in patients after ACS or PCI with stent placement. (Level of Evidence: A) 1
For patients receiving a bare-metal stent or drug-eluting stent during PCI for ACS, clopidogrel 75 mg daily, prasugrel 10 mg daily, or ticagrelor 90 mg twice daily should be given for at least 12 months. (Level of Evidence: A) 1
After PCI, it is reasonable to use 81 mg of aspirin per day in preference to higher maintenance doses. (Level of Evidence: B) 2a
 

*AHA/ACCF secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update.

2011 ACCF/AHA/SCAI guideline for PCI2†

Recommendation Class
A loading dose of a P2Y12 receptor inhibitor should be given to patients undergoing PCI with stenting. (Level of Evidence: A) Options include:
— Clopidogrel 600 mg (ACS and non-ACS patients) (Level of Evidence: B)
— Prasugral 60 mg (ACS patients) (Level of Evidence: B)
— Ticagrelor 180 mg (ACS patients) (Level of Evidence: B)		 1

The duration of P2Y12 inhibitor therapy after stent implantation should generally be as follows:

In patients receiving a stent (bare-metal stent or drug-eluting stent) during PCI for ACS, P2Y12 inhibitor therapy should be given for at least 12 months. (Level of Evidence: B)

Options include clopidogrel 75 mg daily, prasugrel 10 mg daily, and ticagrelor 90 mg twice daily. (Level of Evidence: B)

 1
After PCI, it is reasonable to use 81 mg of aspirin per day in preference to higher maintenance doses. (Level of Evidence: B) 2a
 

†2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention.

2011 ACCF/AHA guideline for CABG3‡

Recommendation Class
Aspirin (100 mg to 325 mg daily) should be administered to CABG patients preoperatively.(Level of Evidence: B) 1
In patients referred for elective CABG, clopidogrel and ticagrelor should be discontinued for at least 5 days before surgery (Level of Evidence: B) and prasugrel for at least 7 days (Level of Evidence: C) to limit blood transfusions. 1
 

‡2011 ACCF/AHA guideline for coronary artery bypass graft surgery.

Classifications of recommendations

  • Class 1 recommends that the procedure/treatment should be performed/administered.
  • Class 2a states that it is reasonable to perform procedure/administer treatment.
  • Level A is based on data derived from multiple randomized clinical trials or
    meta-analyses.
  • Level B is based on data derived from a single randomized clinical trial or nonrandomized studies.

NEXT: Dosage and Administration

 

IMPORTANT SAFETY INFORMATION ABOUT BRILINTA

WARNING: BLEEDING RISK

  • BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal, bleeding
  • Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage
  • Do not start BRILINTA in patients planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue BRILINTA at least 5 days prior to any surgery
  • Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of BRILINTA
  • If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events

WARNING: ASPIRIN DOSE AND BRILINTA EFFECTIVENESS

  • Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided. After any initial dose, use with aspirin 75 mg - 100 mg per day

CONTRAINDICATIONS

  • BRILINTA is contraindicated in patients with a history of intracranial hemorrhage and active pathological bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA is also contraindicated in patients with severe hepatic impairment because of a probable increase in exposure; it has not been studied in these patients. Severe hepatic impairment increases the risk of bleeding because of reduced synthesis of coagulation proteins

WARNINGS AND PRECAUTIONS

  • Moderate Hepatic Impairment: Consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor
  • Premature discontinuation increases the risk of MI, stent thrombosis, and death
  • Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients taking clopidogrel. Dyspnea resulting from BRILINTA is self-limiting. Rule out other causes
  • BRILINTA is metabolized by CYP3A4/5. Avoid use with strong CYP3A inhibitors and potent CYP3A inducers. Avoid simvastatin and lovastatin doses >40 mg
  • Monitor digoxin levels with initiation of, or any change in, BRILINTA therapy

ADVERSE REACTIONS

  • The most commonly observed adverse reactions associated with the use of BRILINTA vs clopidogrel were Total Major Bleeding (11.6% vs 11.2%) and dyspnea (14% vs 8%)
  • In clinical studies, BRILINTA has been shown to increase the occurrence of Holter-detected bradyarrhythmias. PLATO excluded patients at increased risk of bradycardic events. Consider the risks and benefits of treatment

INDICATIONS

BRILINTA is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with acute coronary syndrome (ACS) (unstable angina, non–ST-elevation myocardial infarction, or ST-elevation myocardial infarction). 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 PCI, it also reduces the rate of stent thrombosis.

BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin >100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin >100 mg daily.


Please read full Prescribing Information, including Boxed Warnings, and Medication Guide.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

REFERENCES:

  1. Smith SC Jr, Benjamin EJ, Bonow RO, et al. AHA/ACCF secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation [Published online ahead of print November 3, 2011]. Circulation. doi:10.1161/CIR.0b013e318235eb4d.
  2. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography Interventions [Published online ahead of print November 7, 2011]. J Am Coll Cardiol. doi:10.1016/j.jacc.2011.08.007.
  3. Hillis LD, Smith PK, Anderson JL, et al. 2011 ACCF/AHA guideline for coronary artery bypass graft surgery: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines [Published online ahead of print November 7, 2011]. J Am Coll Cardiol. doi:10.1016/j.jacc.2011.08.009.

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