Late-breaking trial results from TCT 2019 show ticagrelor monotherapy after three months of dual antiplatelet therapy was associated with a lower incidence of bleeding without ischemic harm in high-risk patients who underwent percutaneous coronary intervention (PCI). The findings were also published Sept 26 in the New England Journal of Medicine.

The TWILIGHT trial involved 9,006 patients of whom 7,119 were randomized to either ticagrelor plus aspirin or ticagrelor plus placebo three months after PCI and treatment with dual antiplatelet therapy. The primary endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding. Roxana Mehran, MD, FACC, and colleagues also evaluated the composite endpoint of death from any cause, nonfatal myocardial infarction or nonfatal stroke.

Overall results found ticagrelor monotherapy was associated with a lower incidence of clinically relevant bleeding than ticagrelor plus aspirin, with no higher risk of death, myocardial infarction, or stroke at one year. Specifically, between randomization and one year, the primary endpoint occurred in 4.0 percent of patients randomly assigned to receive ticagrelor plus placebo and 7.1 percent of patients assigned to receive ticagrelor plus aspirin (hazard ratio, 0.56; 95 percent confidence interval [CI], 0.45 to 0.68; P<0.001). The difference in risk between the groups was similar for BARC type 3 or 5 bleeding (1.0 percent in ticagrelor/placebo group; 2.0 percent in ticagrelor/aspirin group). Death from any cause, nonfatal myocardial infarction or nonfatal stroke was 3.9 percent in both groups.

Mehran, et al., note that "monotherapy with a P2Y12 inhibitor after a minimum period of dual antiplatelet therapy is an emerging approach to reduce the risk of bleeding after PCI." As such, they suggest these new findings, in aggregate, "show that a transition to an antiplatelet strategy of treatment with ticagrelor alone after a 3-month course of dual antiplatelet therapy in high-risk patients who had undergone PCI provided a clinical benefit of less bleeding without ischemic harm."

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: TCT19, Transcatheter Cardiovascular Therapeutics, Aspirin, Percutaneous Coronary Intervention, Angiography

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