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May 3, 2026American Heart Journal0 citationsOpen Access

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

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EWEva C. I. WoeldersBYBahram YosofiDPDenise A M Peeters

Key Result

Ticagrelor monotherapy directly after primary PCI for STEMI resulted in major adverse cardiac and cerebral events in 3.1% of patients versus 2.0% with DAPT (HR 1.54; 95% CI 0.26-9.24).

Key Points

  • This study aims to evaluate the safety of ticagrelor monotherapy in STEMI patients following primary PCI compared to DAPT.
  • Conducted as a randomized multicenter open-label pilot study
  • Involved 200 STEMI patients, randomized to receive either ticagrelor monotherapy or dual antiplatelet therapy
  • Safety outcomes were assessed at three months post-PCI.
  • Major adverse cardiac and cerebral events occurred in 3.1% of the ticagrelor group versus 2.0% in the DAPT group (HR: 1.54; 95% CI: 0.26-9.24)
  • Clinically relevant bleeding was observed in 4.2% of the ticagrelor group versus 8.9% in the DAPT group (HR: 0.46; 95% CI: 0.14-1.48)
  • Clinically relevant non-access site bleeding in 2.0% of the ticagrelor group versus 7.9% in the DAPT group (HR: 0.25; 95% CI: 0.05-1.19)

Study Design

Type

RCT (n=200)

Blinding

open-label

Randomization

randomized

Multicenter

Yes

Structured PICO

Does ticagrelor monotherapy directly after primary PCI improve safety and reduce bleeding compared to DAPT in STEMI patients?

P
Population
200 STEMI patients directly after primary PCI
I
Intervention
Ticagrelor monotherapy directly after primary PCI
C
Comparator
Dual antiplatelet therapy (DAPT)
O
Outcome
Safety (major adverse cardiac and cerebral events, clinically relevant bleeding, and clinically relevant non-access site bleeding) at three monthssafety

In a pilot study of STEMI patients after primary PCI, ticagrelor monotherapy showed no significant difference in ischemic events compared to DAPT, with a tendency toward reduced bleeding, though the small sample size precludes definitive safety conclusions.

Main Result

Effect estimate: HR 1.54 (95% CI 0.26-9.24)

Absolute Event Rate: 3.1% vs 2%

Limitations

  • safety cannot be confirmed given the small number of events
  • small number of events

Abstract

This randomized multicenter open-label pilot study assessed the safety of ticagrelor monotherapy directly after primary PCI versus dual antiplatelet therapy (DAPT) in 200 STEMI patients. At three months, major adverse cardiac and cerebral events occurred in 3.1% of the experimental group (n=99) versus 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% versus 8.9% (HR: 0.46, 95%CI: 0.14-1.48), and clinically relevant non-access site bleeding in 2.0% versus 7.9% (HR:0.25, 95%CI: 0.05-1.19). 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. Clinical Trial Registration: ClinicalTrials.gov ID: NCT05986968 https://www.clinicaltrials.gov/study/NCT05986968.

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Cite This Study

Woelders et al. (2026) conducted an RCT in ST-elevation myocardial infarction (n=200). ticagrelor monotherapy vs. dual antiplatelet therapy (DAPT) was evaluated on major adverse cardiac and cerebral events (HR 1.54, 95% CI 0.26-9.24). Ticagrelor monotherapy directly after primary PCI for STEMI resulted in major adverse cardiac and cerebral events in 3.1% of patients versus 2.0% with DAPT (HR 1.54; 95% CI 0.26-9.24).

synapsesocial.com/papers/69f6e62e8071d4f1bdfc6ceehttps://doi.org/10.1016/j.ahj.2026.107460
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