Coronary disease & ACSMeta-analysis

De-escalation to ticagrelor monotherapy versus 12 months of dual antiplatelet therapy in patients with and without acute coronary syndromes: a systematic review and individual patient-level meta-analysis of randomised trials

LancetPublished

  • Systematic review and individual patient-level meta-analysis of randomised trials
  • centrally adjudicated endpoints
  • non-inferiority

De-escalation a median of 78 days (IQR 31-92) after intervention

Authors' conclusion

Our study found robust evidence that, compared with 12 months of DAPT, de-escalation to ticagrelor monotherapy does not increase ischaemic risk and reduces the risk of major bleeding, especially in patients with ACS.

Study context

Population
Patients undergoing PCI with a coronary drug-eluting stent, with and without acute coronary syndrome (ACS); long-term OAC indication excluded
Participants
24,407 patients · 6 trials
Comparison
De-escalation to ticagrelor monotherapy vs 12-month dual antiplatelet therapy (DAPT)
Outcome
Three ranked coprimary endpoints: MACCE (all-cause death, MI or stroke; non-inferiority, per-protocol); Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding and all-cause death (superiority, ITT)

Pooled result

MACCE:

  • Per-protocol
  • N = 23 256

Hazard ratio

0.91

95% CI 0.78–1.07

P = 0.0039 for non-inferiority

Events by group

Ticagrelor monotherapy vs DAPT
HR 0.91 (95% CI 0.78–1.07); P for non-inferiority = 0.0039

As reported in the abstract

Further pooled results

OutcomeTicagrelor monotherapyDAPTHR (95% CI)P value
All-cause death (coprimary, ITT) · τ2<0.0001 · intention-to-treat population · Kaplan-Meier estimates0.9%1.2%0.76 (0.59–0.98)P for superiority = 0.034

Heterogeneity by subgroup

MACCE by sex, possible benefit in women with ticagrelor monotherapy
P for interaction = 0.041
All-cause death by sex
P for interaction = 0.050
Bleeding by clinical presentation, benefit in ACS with ticagrelor monotherapy
P for interaction = 0.022

Safety

OutcomeTicagrelor monotherapyDAPTHR (95% CI)P value
BARC 3 or 5 bleeding (coprimary, ITT) · τ2=0.079 · intention-to-treat population · Kaplan-Meier estimates0.9%2.1%0.43 (0.34–0.54)P for superiority < 0.0001

Original publication

De-escalation to ticagrelor monotherapy versus 12 months of dual antiplatelet therapy in patients with and without acute coronary syndromes: a systematic review and individual patient-level meta-analysis of randomised trials. Lancet. Published 31 August 2024. doi:10.1016/s0140-6736(24)01616-7

Summarised from the published abstract; every number is checked against it