In patients with ACS, BRILINTA demonstrated superior CV event reduction at 12 months in PLATO1,2

PLATO primary efficacy end point

Composite of CV death, MI,* or stroke at 12 months1,2

The PLATO Study with ACS Patients
The PLATO Study with ACS Patients

*Excluding silent MI.

 

Hazard ratio derived from a Cox proportional-hazards model on data from the primary and secondary end points.2

 

NNT=number needed to treat and is calculated as 1/ARR.

 

     

  • Events per 1000 patient years for BRILINTA vs clopidogrel: 111 vs 131, respectively
  • BRILINTA and clopidogrel were studied with aspirin and other standard therapies2
  •  

In patients with prior MI, BRILINTA 60 mg + aspirin had superior CV event reduction at 3 years vs aspirin in PEGASUS1,4

PEGASUS primary efficacy end point

Composite of CV death, MI, or stroke at 3 years1,4

The PEGASUS Study with MI Patients
The PEGASUS Study with MI Patients
  • Events per 1000 patient years for BRILINTA 60 mg plus aspirin vs aspirin: 26 vs 31, respectively

Patients were treated for at least 12 months and up to 48 months with a median follow-up time of 33 months1

  • BRILINTA was studied in patients already on standard CV therapies in the PEGASUS trial4

*Due to rounding, the ARR is 1.27% and not 1.2%.

NNT=number needed to treat and is calculated as 1/ARR.

PLATO STUDY DESIGN

PLATO was a randomized, international, double-blind, controlled comparative study in patients with ACS hospitalized with or without ST-segment elevation, with an onset of symptoms within 24 hours (N=18,624). The study compared BRILINTA (180-mg loading dose, 90 mg twice daily thereafter) to clopidogrel (300-mg to 600-mg loading dose, 75 mg daily thereafter) for the prevention of thrombotic CV events (CV death, MI, or stroke). Study period was 12 months, with median duration of therapy of 277 days. BRILINTA and clopidogrel were studied with aspirin and other standard therapies.1,2

PEGASUS STUDY DESIGN

PEGASUS-TIMI 54 compared BRILINTA (90 mg twice daily or 60 mg twice daily) vs placebo, each given with low-dose aspirin (75 to 150 mg), for the prevention of thrombotic CV events (CV death, MI, or stroke) in 21,162 patients ≥50 years of age with a history of MI (1 to 3 years prior to randomization). Patients also had at least 1 risk factor for thrombotic CV events (age ≥65 years, diabetes mellitus requiring medication, at least 1 other prior MI, evidence of multivessel coronary artery disease, or creatinine clearance <60 mL/min). Only the 60-mg dose strength is approved for use in patients with a history of MI 1 year after an ACS event. Patients were treated for at least 12 months and up to 48 months with a median follow-up time of 33 months.1,4

ACS=acute coronary syndrome; ARR=absolute risk reduction; CI=confidence interval; CKD=chronic kidney disease; CV=cardiovascular; HR=hazard ratio; K-M=Kaplan-Meier; MI=myocardial infarction; NSTEMI=non–ST-elevation myocardial infarction; PEGASUS=Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin; PLATO=PLATelet inhibition and patient Outcomes; RRR=relative risk reduction; TIMI=Thrombolysis in Myocardial Infarction.

References
  1. BRILINTA® (ticagrelor) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2021.
  2. Wallentin L, Becker RC, Budaj A, et al; for the PLATO Investigators. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009;361(11):1045-1057 and Supplementary Appendix.
  3. Data on file, REF-51076, AstraZeneca Pharmaceuticals LP.
  4. Bonaca MP, Bhatt DL, Cohen M, et al; for the PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015;372(19):1791-1800.