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March 30, 2020

Ticagrelor Monotherapy After PCI in Complex CAD Supported by TWILIGHT Substudy

March 30, 2020—George Dangas, MD, presented “Safety and Efficacy of Ticagrelor Monotherapy After Complex PCI: The TWILIGHT-COMPLEX Substudy” at the virtual conference of the American College of Cardiology’s annual scientific session together with World Congress of Cardiology (ACC.20/WCC). This study was simultaneously published online by Dr. Dangas et al in the Journal of the American College of Cardiology.

As reported in the ACC.20/WCC press release, the investigators found that patients with complex heart disease who stopped taking aspirin 3 months after the insertion of one or more coronary stents and then took ticagrelor alone for a 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 over the same period. The investigator-initiated study received funding from AstraZeneca, which manufactures ticagrelor.

In the announcement, Dr. Dangas commented, “Among patients with complex coronary artery disease (CAD) who completed 3 months of ticagrelor plus aspirin, ticagrelor monotherapy significantly reduced the incidence of clinically relevant bleeding without increasing the risk of additional heart attacks, strokes, or death compared with those who received ticagrelor plus aspirin.”

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 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. The results of the TWILIGHT trial were published last year by Roxana Mehran, MD, et al in The New England Journal of Medicine

At ACC.20/WCC, Dr. Dangas presented findings from a study that looked at the subgroup of randomly assigned patients who had complex CAD (2,342 patients or 33% of all the randomly assigned patients) and were at high risk for adverse events caused by arterial blockages. Patients were deemed to have complex CAD if they had blockages in three or more arteries or other complications that resulted in them receiving multiple stents.

In this subgroup, patients who received ticagrelor plus a placebo were less likely to have clinically significant bleeding compared with those who received ticagrelor plus aspirin (4.2% vs 7.7%). Severe or fatal bleeding occurred in 1.1% of patients receiving ticagrelor monotherapy compared with 2.6% of those treated with ticagrelor plus aspirin.

Dr. Dangas stated, “In this patient subset with complex heart disease, we found that it was okay to withdraw aspirin and that doing so reduced bleeding without increasing heart attacks or other complications.”

Additionally, he noted that rates of stent thrombosis were similar in the two groups of patients, which indicates that stopping aspirin did not cause an increase in this complication, “It is reassuring that we saw no difference between the groups for this complication.”

These findings are consistent with a subanalysis of TWILIGHT patients with acute coronary syndrome (ACS), which found that ticagrelor monotherapy lowered bleeding risk without increasing heart attacks, strokes, or death. That subanalysis was presented at the American Heart Association annual scientific meeting in November 2019. The current findings are consistent with these ACS findings, indicating that it is safe to withdraw aspirin after 3 months in both subgroups of patients.

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-segment elevation myocardial infarction were excluded from the trial, so the results do not apply to them. The patients enrolled in TWILIGHT had either a non–ST-segment elevation myocardial infarction or stable angina, advised the ACC.20/WCC announcement.

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