Ticagrelor (Brilinta; AstraZeneca) monotherapy was associated with a lower risk of clinically relevant bleeding compared with ticagrelor plus low-dose aspirin in high-risk patients following percutaneous coronary intervention (PCI) and ≥3 months of dual antiplatelet therapy, according to findings from the phase 4 TWILIGHT study.
In the TWILIGHT trial, patients (N=7119) were randomized to receive either ticagrelor or ticagrelor plus aspirin for 12 months after 3 months of dual antiplatelet therapy. The primary end point of the study was the time to first occurrence of clinically relevant bleeding, defined as Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding; secondary end points included the time to first occurrence of confirmed all-cause death, non-fatal myocardial infarction (MI) or stroke.
Results showed that ticagrelor monotherapy was associated with a 44% lower risk of BARC 2, 3, or 5 bleeding over 12 months with an absolute risk reduction of 3.1% compared with ticagrelor plus aspirin. Additionally, between the months of 3 and 15, 4% of patients treated with ticagrelor monotherapy experienced BARC type 2, 3, or 5 bleeding compared with 7.1% for ticagrelor plus aspirin (hazard ratio [HR] 0.56; 95% CI, 0.45 to 0.68; P <.001). BARC type 3 or 5 bleeding also occurred in 1% of the ticagrelor group vs 2% of the ticagrelor plus aspirin group (HR 0.49; 95% CI, 0.33 to 0.74). Both treatment arms experienced similar rates of all-cause death, MI or stroke at 3.9% (HR 0.99; 95% CI 0.78 to 1.25; non-inferiority P <.001).
Full detailed data from the trial was presented on September 26, 2019 at Transcatheter Cardiovascular Therapeutics (TCT) 2019 and published in the New England Journal of Medicine.
“In high-risk PCI patients, further ischemic events remain a life-threatening concern. As seen in TWILIGHT, in patients who tolerated 3 months of dual antiplatelet therapy, lowering the risk of major bleeding while preserving the ischemic benefit using ticagrelor monotherapy is an important clinical advance for these patients,” said Roxana Mehran, TWILIGHT’s Global Principal Investigator and Director of the Center for Interventional Cardiovascular Research and Clinical Trials at Mount Sinai Heart and Professor of Cardiology, and Population Health Science and Policy, at Icahn School of Medicine at Mount Sinai.
The trial was funded by AstraZeneca.