|BRILINTA 60 mg + aspirin (N=7045)||aspirin (N=7067)||HR (95% CI)|
|N (PATIENTS WITH EVENT)||K-M %||N (PATIENTS WITH EVENT)||K-M %|
|CV death//¶||174||2.9||210||3.4||0.83 (0.68-1.01)|
|All-cause mortality¶||289||4.7||326||5.2||0.89 (0.76-1.04)|
//The numbers of first events for the components CV death, MI, or stroke are the actual numbers of first events for each component and do not add up to the number of events in the composite end point.
¶Secondary end points.
#Prespecified exploratory end points.
|BRILINTA 60 mg + aspirin (N=6958)||aspirin (N=6996)|
|N (%) PATIENTS WITH EVENT||EVENTS/100 PATIENT-YEARS||N (%) PATIENTS WITH EVENT||EVENTS/100 PATIENT-YEARS|
|TIMI MAJOR**||115 (1.7)||0.78||54 (0.8)||0.34|
|FATAL††||11 (0.2)||0.08||12 (0.2)||0.08|
|INTRACRANIAL HEMORRHAGE||28 (0.4)||0.19||23 (0.3)||0.14|
|TIMI MAJOR OR MINOR‡‡||168 (2.4)||1.15||72 (1.0)||0.45|
**TIMI major: fatal bleeding or any intracranial bleeding or clinically overt signs of hemorrhage associated with a drop in Hb of ≥5 g/dL or a fall in Hct of ≥15%.
††Fatal: a bleeding event that directly led to death within 7 days.
‡‡TIMI minor: clinically apparent with 3-5 g/dL decrease in Hb.
†Composite of CV death, MI, or stroke.
PEGASUS was designed to test the hypothesis that long-term therapy with BRILINTA added to low-dose aspirin reduces the risk of thrombotic CV events among patients with a history of MI.
PEGASUS was a randomized, double-blind, placebo-controlled clinical trial. Patients underwent randomization at 1161 sites in 31 countries. The trial was designed as a collaboration among the TIMI Study Group, the executive and steering committees, and AstraZeneca, the trial sponsor. The study compared BRILINTA (90 mg twice daily or 60 mg twice daily) vs placebo, each given with low-dose aspirin, 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) and at least 1 of the following risk factors for thrombotic CV events: age of 65 years or older, diabetes mellitus requiring medication, at least 1 other prior MI, evidence of multivessel coronary artery disease, or creatinine clearance <60 mL/min. Patients were treated for at least 12 months and up to 48 months with a median follow-up time of 33 months. Patients were excluded if they required renal dialysis, had a previous intracranial hemorrhage, had gastrointestinal bleeding within 6 months, had a known bleeding diathesis or coagulation disorder, or required treatment with anticoagulants.
BRILINTA is indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction. For at least the first 12 months following ACS, it is superior to clopidogrel.
BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.
In the management of ACS, initiate BRILINTA treatment with a 180-mg loading dose. Administer 90 mg twice daily during the first year after an ACS event. After one year administer 60 mg twice daily. Use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.