Analysis of phase III TWILIGHT trial for Brilinta showed reduced risk of bleeding in acute coronary syndromes.- AstraZeneca

New results from a pre-specified subgroup analysis of the TWILIGHT trial showed that Brilinta (ticagrelor) monotherapy, from AstraZeneca, reduced the risk of clinically relevant bleeding compared to dual antiplatelet therapy (DAPT) over 12 months in high-risk patients with non-ST elevation acute coronary syndromes (NSTE-ACS). Results of the NSTE-ACS subgroup analysis showed that ticagrelor monotherapy was associated with a 53% relative reduction in the risk of the primary endpoint � Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding � over one year, with an absolute risk reduction of 4.0%, compared to ticagrelor plus aspirin (3.6% vs. 7.6%, HR 0.47; 95% CI: 0.36-0.61).

Also seen was the BARC 3 or 5 bleeding for ticagrelor monotherapy versus ticagrelor plus aspirin at one year (0.8% vs. 2.1%). Thrombolysis in Myocardial Infarction (TIMI) major bleeding at one year was 0.5% for ticagrelor plus placebo and 1.0% for ticagrelor plus aspirin. Rates of the key secondary endpoint � composite outcome of all-cause death, myocardial infarction (MI) or stroke � were similar between the two groups at one year (4.3% for ticagrelor plus placebo and 4.4% for ticagrelor plus aspirin [HR 0.97; 95% CI: 0.74-1.28]). Rates of other secondary endpoints also were similar between the two groups at one year � all-cause death (1.0% for ticagrelor plus placebo and 1.5% for ticagrelor plus aspirin), MI (3.1% and 3.1%), ischemic stroke (0.5% and 0.3%), and definite or probable stent thrombosis (0.4% and 0.6%). Results of the TWILIGHT sub-analysis were presented in a late breaker oral presentation on 17 November 2019 at the American Heart Association (AHA) Scientific Sessions 2019.

Comment: 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.