Ticagrelor monotherapy safe after dual antiplatelet therapy

Data from the GLASSY trial, an adjudication sub-study of the GLOBAL LEADERS trial, showed that ticagrelor monotherapy after 1 month of dual antiplatelet therapy (DAPT) was non-inferior to conventional DAPT in the prevention of all-cause death, non-fatal myocardial infarction (MI), non-fatal stroke, or urgent target-vessel revascularisation (TVR) at 2 years [1].

Results from the GLOBAL LEADERS trial showed that ticagrelor with 1 month of aspirin did not reduce the composite of death or Q-wave myocardial infarction compared with 1 year of DAPT followed by aspirin [2]. By design, all clinical endpoints in the GLOBAL LEADERS trial were investigator-reported without central adjudication. The sub-study GLASSY was designed to prospectively implement an independent central adjudication process of both reported events and potentially unreported event triggers to further assess the impact of this novel experimental treatment in a large stratified sample of patients included in the GLOBAL LEADERS trial.

Participating sites for GLASSY included Germany, Poland, the Netherlands, the United Kingdom, Belgium, Switzerland, Austria, Italy, and Bulgaria with a final population of 7,585 patients (which was 47.5% of the 15,991 participants in the GLOBAL LEADERS study) who were assigned to the experimental (n=3,794) or control (n= 3,791) groups. At 2 years, the experimental group met the non-inferiority criteria for the co-primary efficacy endpoint (7.1% vs 8.4%, respectively; rate ratio 0.85; 95% CI, 0.72-0.99; P<0.001) but failed to show superiority at the pre-specified alpha of 0.025 (P=0.0465). Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding events were identical in the 2 study groups (2.5% vs 2.5%, respectively; rate ratio 1.00; 95% CI, 0.75-1.33; P=0.99). Additionally, the experimental treatment did not increase the risk of major bleeding.

These results provide new evidence that discontinuation of aspirin after 30 days while continuing ticagrelor alone does not expose patients to a higher ischaemic risk compared with a standard DAPT for 1 year, and it may reduce the rates of MI and stent thrombosis vs aspirin alone.

1. Valgimigli M, et al. Abstract 408-16. ACC 2019, 16-18 March, New Orleans, USA.
2. Vrancxks P, et al. Lancet 2018;392:940-949.

Posted on 6 June 20195 August 2021