Highlights from

ACC 2019

American College of Cardiology Annual Scientific Session & Expo

New Orleans 16-18 March 2019

Ticagrelor monotherapy safe after dual antiplatelet therapy

Data from the GLASSY 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.

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 as compared with 1 year of DAPT followed by aspirin [1]. By design, all clinical endpoints in the GLOBAL LEADERS trial were investigator reported without central adjudication. The GLOBAL LEADERS Adjudication 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 [2]. Non-inferiority and superiority testing for the co-primary efficacy and safety endpoints was performed at a 0.025 significance level to preserve nominal alpha error at 5%.

Study design

Participating sites 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 total number of 15,991 participants in the GLOBAL LEADERS study) who were assigned to the experimental (n=3,794) or control (n= 3,791) groups.

Results

At 2 years, the experimental group met the non-inferiority criteria for the co-primary efficacy endpoint (7.1% vs 8.4%, rate ratio 0.85 [95% CI 0.72-0.99]; pnoninferiority<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%, rate ratio 1.00 [95% CI 0.75-1.33]; P=0.99.

Implications

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 versus aspirin alone. Additionally, the experimental treatment did not increase the risk of major bleeding.

  1. Vrancxks P, et al. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. Lancet 2018;392:940-949.
  2. Valgimigli M, et al. Impact of Ticagrelor Monotherapy Beyond One Month Versus Conventional Therapy On Adjudicated Ischemic And Bleeding Endpoints Following Drug Eluting Sent Implantation. Primary Results of the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY). Abstract 408-16. ACC 2019, 16-18 March, New Orleans, USA.

The content and interpretation of these conference highlights are the views and comments of the speakers/authors.