PCI: safety and efficacy of ticagrelor monotherapy after 1 month dual antiplatelet therapy

Takeaway

• In patients who underwent percutaneous coronary intervention (PCI) with drug-eluting stent, ticagrelor monotherapy after 1 month dual antiplatelet therapy (DAPT) was non-inferior to conventional therapy in preventing all-cause mortality, non-fatal myocardial infarction (MI), non-fatal stroke or urgent target vessel revascularisation (TVR) at 2 years.
• Ticagrelor therapy did not decrease the risk for major bleeding compared with conventional treatment.

Why this matters

• The GLOBAL LEADERS study demonstrated that DAPT with 90-mg ticagrelor twice daily plus 1 month aspirin followed by 23 month ticagrelor did not reduce the composite of all-cause death or MI compared with 1 year DAPT followed by aspirin alone.
• Future studies should focus on mechanisms responsible for better late outcomes in those who stop aspirin and continue ticagrelor monotherapy 1 month after PCI.

Study design

• Study included 7585 patients who underwent PCI from the 20 top-enrolling sites of the GLOBAL LEADERS study.
• Of 7585 patients, 3794 were allocated to the intervention group (1-month DAPT followed by 23 months ticagrelor) and 3791 to conventional group (1-year DAPT followed by aspirin alone).
• Coprimary outcomes were divided into:
  • efficacy outcomes: composite of death, MI, stroke and urgent TVR and
  • safety outcomes: Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding events.
• Funding: None disclosed.

Key results

• At 2 years, intervention therapy was non-inferior to convention therapy in reducing the rate of a composite of death, MI, stroke and urgent TVR (rate ratio [RR], 0.85; 95% CI, 0.72-0.99; P_{non-inferiority}<.001).
• Intervention vs conventional group did not differ in rates of BARC 3 or 5 bleeding (RR, 1.00; 95% CI, 0.75-1.33; P=.986).
• After 1 year post-PCI, intervention vs conventional group had reduction in the risk for:
  • MI (RR, 0.54; 95% CI, 0.33-0.88; P_interaction=.062),
  • composite of CV death or MI (RR, 0.69; 95% CI, 0.48-0.98; P_interaction=.196) and
  • definite stent thrombosis (RR, 0.14; 95% CI, 0.03-0.63; P_interaction=.007).

Limitations

• Study included consecutive patients from the highest enrolling sites, rather than randomly selected patients from all sites.
• Adherence to allocated treatment was lower in the intervention group.