AstraZeneca has announced that the Phase IV independent TWILIGHT trial, Brilinta (ticagrelor) monotherapy reduced bleeding complications with no increased risk of ischaemic events in patients with diabetes undergoing percutaneous coronary intervention.
The oral, reversible, direct-acting P2Y12 receptor antagonist reduced the risk of clinically relevant bleeding over 12 months, compared to aspirin plus Brilinta in high-risk coronary patients.
One subgroup analysis (TWILIGHT-DM) included patients with diabetes who had undergone a successful percutaneous coronary intervention (PCI), and the other (TWILIGHT-COMPLEX) included patients who had successfully undergone a complex PCI. Ultimately, in both subgroups, Brilinta monotherapy was associated with lower rates of clinically relevant bleeding without increasing the risk of ischaemic events, between months three and 15 post PCI.
Specifically, Brilinta monotherapy was associated with a 44% lower risk of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding over a year, with an absolute risk reduction of 3.1% compared to Brilinta plus aspirin.
Further, the risk of death from any cause, heart attack or stroke was similar in both groups, at 3.9% vs. 3.9%.
“Patients who receive dual antiplatelet therapy after a percutaneous coronary intervention have a higher risk of death due to bleeding in the two years after the procedure” explained Mene Pangalos, executive vice president, BioPharmaceuticals R&D. “These new TWILIGHT data showed that withdrawing aspirin and continuing treatment with Brilinta alone reduced bleeding complications in high-risk patients, while still maintaining a similar effect on ischaemic events.”
Acute coronary syndrome (ACS) is a type of cardiovascular disease that occurs when a blood clot forms as a result of plaque rupture or erosion in the arteries of the heart, causing a severe reduction (unstable angina) or complete blockage (myocardial infarction) of blood supply to the heart muscle.
