No Increase in Ischaemic Events With Ticagrelor Monotherapy After 1 Month of Antiplatelet Therapy Following PCI: Presented at ACC

By Frances Morin

NEW ORLEANS -- March 21, 2019 -- Patients who are treated with just 1 month of dual antiplatelet therapy (DAPT) followed by ticagrelor (Brilinta) alone for 23 months after percutaneous coronary intervention (PCI) show no greater risk of ischaemic events compared with patients who receive DAPT for 1 year followed by aspirin monotherapy.

The findings were presented here at the 2019 Annual Meeting of the American College of Cardiology (ACC).

“Our results provide new evidence that discontinuation of aspirin after 30 days while continuing ticagrelor alone does not expose patients to a higher ischaemic risk…and may reduce the rates of myocardial infarction and stent thrombosis as compared with aspirin alone,” said Marco Valgimigli, MD, Swiss Cardiovascular Center, Bern, Switzerland.

While DAPT is effective in reducing the risk of cardiac and cerebrovascular ischaemic events in coronary disease, the risk of major bleeding with the long-term use DAPT is an important concern.

In the previous GLOBAL LEADERS trail, treatment with ticagrelor monotherapy for 23 months following 1 month of DAPT did not show a reduced rate of all-cause mortality versus DAPT for 1 year.

To conduct an independent adjudication of reported and unreported outcomes from that study -- rather than investigator reported endpoints -- the GLOBAL LEADERS Adjudication Sub-Study (GLASSY) trial was performed, which evaluated 7,585 patients from 20 top enrolling sites of the GLOBAL LEADERS trial.

“This is the first randomised trial with independent adjudication of endpoints comparing a strategy of short DAPT followed by ticagrelor monotherapy compared with standard of care consisting of DAPT for 12 months followed by aspirin monotherapy,” said Dr. Valgimigli.

At the 2-year follow-up, the experimental group of ticagrelor alone for 23 months showed non-inferiority to the 12-month DAPT group in the co-primary efficacy endpoint of prevention of all-cause death, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularisation (7.1% vs 8.4%).

There was meanwhile no significant difference between the 2 groups in terms of the co-primary safety endpoint of preventing adjudicated Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding, with the events identical in the 2 groups at 2 years (2.5% in each group).

[Presentation title: Impact of Ticagrelor Monotherapy Beyond 1 Month Versus Conventional Therapy on Adjudicated Ischemic and Bleeding Endpoints Following Drug-Eluting Stent Implantation. Primary Results of the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY)]

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