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March 30, 2020

Subanalysis of TWILIGHT Trial Shows Benefit of Ticagrelor Without Aspirin in Patients With Diabetes After PCI

March 30, 2020—Patients with diabetes who stopped taking aspirin 3 months after the insertion of a coronary stent and then took the antiplatelet medication ticagrelor alone for 1 year had fewer episodes of bleeding and no increase in heart attacks, stroke, or other adverse events caused by blockages in the arteries, compared with patients who took both aspirin and ticagrelor for 1 year.

The American College of Cardiology announced that these findings from an analysis of the TWILIGHT trial were presented by Dominick J. Angiolillo, MD, at ACC.20/WCC Virtual, the ACC's Annual Scientific Session Together with World Congress of Cardiology. This investigator-initiated study received funding from AstraZeneca, which manufactures ticagrelor. The study findings were simultaneously published online in the Journal of the American College of Cardiology.

Dr. Angiolillo commented, “In patients with diabetes, treatment with ticagrelor alone significantly reduced clinically relevant bleeding compared with ticagrelor plus aspirin, without increasing the risk for additional heart attacks, strokes, or death. These findings are consistent with the overall results of the TWILIGHT trial and were seen across all types of diabetes patients, irrespective of their clinical presentation and the treatment they were receiving for their diabetes.” The results of the TWILIGHT trial were published last year in The New England Journal of Medicine (2019;381:2032–2042).

The TWILIGHT trial was designed to test whether ticagrelor alone or ticagrelor plus aspirin more effectively reduced bleeding without increasing the risk for heart attacks, stroke, death, or other adverse events caused by arterial blockages in patients who had received at least one stent and were at high risk for adverse events. The trial was composed of 9,006 patients who had received at least one stent and were at high risk for bleeding or another arterial blockage. The patients were enrolled at 187 medical centers in 11 countries, including the United States, Canada, the United Kingdom, India, Israel, China and five European countries. Results showed that ticagrelor alone reduced clinically relevant bleeding more than ticagrelor plus aspirin without increasing the risk of death, heart attack, or stroke.

In the current analysis presented at ACC.20/WCC Virtual, the investigators looked just at the subgroup of randomly assigned patients in the TWILIGHT trial who had diabetes (2,620 patients; 37% of all the randomly assigned patients).

The investigators found that patients in this subgroup who received ticagrelor plus a placebo were less likely to have clinically significant bleeding compared with those who received ticagrelor plus aspirin (4.5% vs 6.7%).

On the secondary endpoint of death, heart attack, or stroke, patients receiving ticagrelor plus a placebo did better than those who received ticagrelor plus aspirin (4.6% vs 5.9%). Although this reduction was not statistically significant, it offered some reassurance that patients were not harmed by the elimination of aspirin, noted Dr. Angiolillo. He added, “Our primary goal was to ensure that dropping aspirin would reduce bleeding without increasing deaths, heart attacks, or strokes. That goal was met.”

One of the limitations of these findings is that patients’ treating physicians made the diagnosis of diabetes, which was not confirmed by laboratory testing. Also, patients with ST-elevation myocardial infarction were excluded from the trial, so the results do not apply to them. The patients enrolled in TWILIGHT had had either a non-ST-elevation myocardial infarction or stable angina.

Further research is needed to identify the best treatment for patients like those treated in the TWILIGHT trial after they have completed a year on ticagrelor monotherapy. "What should we do after 1 year? Should patients continue on a lower dose of ticagrelor? This is currently an unanswered question," stated Dr. Angiolillo in the ACC announcement.

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