Short-term outcomes of ticagrelor monotherapy after primary percutaneous coronary intervention for ST-elevation myocardial infarction: A randomized pilot study.

BACKGROUND

Ticagrelor monotherapy after a short period of dual antiplatelet therapy (DAPT) has shown to be safe and effective after percutaneous coronary intervention (PCI), including primary PCI in ST-elevation myocardial infarction (STEMI). However, direct omission of aspirin could further reduce bleeding risk. We aimed to assess the safety of ticagrelor monotherapy directly after primary PCI regarding ischemic events, and to investigate the effect on clinical bleeding events.

METHODS

In this multicenter open-label pilot study, 200 STEMI patients were 1:1 randomized to ticagrelor monotherapy versus ticagrelor plus aspirin, directly after primary PCI. Major adverse cardiac and cerebral events (MACCE) and bleeding were assessed at 3 months.

RESULTS

At 3 months, major adverse cardiac and cerebral events occurred in 3.1% of the experimental group (n = 99) vs 2.0% in the control group (n = 101) (HR: 1.54; 95% CI: 0.26-9.24), clinically relevant bleeding was observed in 4.2% vs 8.9% (HR: 0.46, 95% CI: 0.14-1.48), and clinically relevant non-access site bleeding in 2.0% vs 7.9% (HR: 0.25, 95% CI: 0.05-1.19).

CONCLUSIONS

Although no significant difference in ischemic events was observed between the novel concept of ticagrelor monotherapy and DAPT, safety cannot be confirmed given the small number of events. Additionally, there was a tendency for a reduction in clinically relevant non-access site bleeding events.