CONFERENCE UPDATE: ESC 2024

Ticagrelor alone after drug-eluting coronary stenting halves major bleeding risks in PCI patients regardless of ACS status

03 Dec 2024

STUDY DESIGN 

The 2023 ESC guidelines advocate for a standard treatment of 12-month dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) as a Class I recommendation with a high level of evidence.1 For those who may benefit from shorter DAPT regimens depending on their specific high bleeding risk factors, a shorter course of less than 12 months may also be recommended.1 Furthermore, the selection of single antiplatelet therapy following the cessation of DAPT has been recognized as an important factor that may influence outcomes when comparing abbreviated vs. standard DAPT regimens.

A systematic review and individual patient data (IPD) level meta-analysis of randomized trials with centrally adjudicated endpoints were conducted to assess the efficacy and safety of ticagrelor monotherapy at 90mg twice daily following short-term dual antiplatelet therapy (DAPT) compared to a full 12-month DAPT regimen in patients undergoing percutaneous coronary intervention (PCI).1 Studies that were randomized before the common DAPT phase were censored.1 The final review included the GLASSY, SMART-CHOICE, TICO, TWILIGHT, T-PASS, ULTIMATE-DAPT studies.1 

The presentation reported three ranked co-primary endpoints.1 The first was major adverse cardiovascular or cerebrovascular events (MACCE), a composite of all-cause death, myocardial infarction (MI), or stroke evaluated for non-inferiority.1 The second and third co-primary endpoints were Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding and all-cause death, both of which were assessed for superiority in the intention-to-treat (ITT) population.1 Additionally, trial sequential analysis was performed on the three co-primary endpoints.1 

 

FINDINGS 

Co-primary endpoints: 

  • The three co-primary endpoints were non-inferiority in MACCE, and superiority in BARC type 3 or 5 bleeding and all-cause death
  • Ticagrelor monotherapy was non-inferior to DAPT (HR=0.91; 95% CI: 0.78-1.07; pnon-inferiority=0.0039), suggesting comparability to 12-month DAPT in terms of preventing MACCE
  • Ticagrelor monotherapy reduced the risk of major bleeding by 57% compared to DAPT (HR=0.43; 95% CI: 0.34-0.54; p<0.0001)
  • There was a significant reduction in all-cause mortality with ticagrelor (HR=0.76; 95% CI: 0.59-0.98; p=0.034) but the finding was considered inconclusive in the sequential analysis1 

Subgroup analyses: 

  • The outcomes were similar in the subgroups with ACS (ST-elevation MI, non-ST-elevation MI, unstable angina)1 
  • Ticagrelor monotherapy was non-inferior to DAPT (HR=0.89; 95% CI: 0.74-1.06), again suggesting comparability to 12-month DAPT in terms of preventing MACCE1 
  • There was a 66% reduction in major bleeding risk with ticagrelor monotherapy compared to DAPT (HR=0.34; 95% CI: 0.26-0.45)1 
  • Ticagrelor monotherapy resulted in a reduction in all-cause mortality (HR=0.74; 95% Cl: 0.55-0.99), although this finding was inconclusive in the sequential analyses1 

 

Professor Marco Valgimigli 
Cardiocentro Ticino Institute 
Lugano, Switzerland 

We provide conclusive evidence that DAPT de-escalation to ticagrelor monotherapy preserves the fatal and non-fatal ischemia and halves major bleeding risks compared with 1-year DAPT 


References
  1. Valgimigli M, et al. Ticagrelor monotherapy or DAPT after drug-eluting coronary stenting in patients with or without acute coronary syndrome. A patient-level meta-analysis of randomized controlled trials. Presented at the European Society of Cardiology Congress 2024; Aug 30-Sep 2, 2024.
TICAGRELOR
ASPIRIN
DUAL ANTIPLATELET THERAPY
SINGLE ANTIPLATELET THERAPY
CORONARY STENTING
ACUTE CORONARY SYNDROME (ACS)
BLEEDING


Related Articles