BLEEDINGǁ AT 12 MONTHS, there was no significant difference in Total Major Bleeding (which includes Fatal and Life-threatening bleeding) for BRILINTA plus aspirin vs clopidogrel plus aspirin (11.6% vs 11.2%).
There was a somewhat greater risk of Non–CABG¶-related Major plus Minor Bleeding for BRILINTA plus aspirin vs clopidogrel plus aspirin (8.7% vs 7.0%) and Non–CABG-related Major Bleeding (4.5% vs 3.8%), respectively.
PLATOǁ trial did not show an advantage for BRILINTA compared with clopidogrel for CABG-related Bleeding (Total Major 85.8% vs 86.9% and Fatal/Life-threatening 48.1% vs 47.9%, respectively).ǁ1
When antiplatelet therapy was stopped 5 days before CABG, Major Bleeding occurred in 75% of patients treated with BRILINTA and 79% of patients on clopidogrel.
AT 12 MONTHS, BRILINTA plus aspirin significantly reduced the primary composite end point of cardiovascular (CV) death, myocardial infarction (MI*), or stroke by 16% RRR† (ARR‡ 1.9%) vs clopidogrel plus aspirin. The difference between treatments was driven by CV death and MI with no difference in stroke.§1
CV death secondary end point: RRR with BRILINTA plus aspirin was 21% (ARR 1.1%) vs clopidogrel plus aspirin.§1
BRILINTA is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with acute coronary syndrome (ACS) (unstable angina [UA], non–ST-elevation MI [NSTEMI], or ST-elevation MI [STEMI]). BRILINTA has been shown to reduce the rate of a combined end point of CV death, 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 percutaneous coronary intervention (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.