Ticagrelor Monotherapy in ACS Patients Undergoing PCI

Quick Takes

  • Among patients with ACS undergoing PCI, ticagrelor monotherapy, compared with ticagrelor plus aspirin, significantly reduces major bleeding without incremental ischemic risk over 9 months.
  • Ticagrelor monotherapy preserves the ischemic benefits of DAPT while avoiding aspirin-related bleeding yielding a net clinical benefit post ACS PCI.
  • A subgroup of patients with ACS who have extensive multivessel disease and persistent atherothrombotic risk factors may still benefit from long-term DAPT.

Study Questions:

What is the safety and efficacy of aspirin withdrawal followed by P2Y12 inhibitor monotherapy with ticagrelor after a 3-month course of dual antiplatelet therapy (DAPT) among patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI)?

Methods:

The investigators pooled individual patient data from randomized trials that included patients with ACS undergoing PCI treated with an initial 3-month course of DAPT followed by ticagrelor monotherapy versus continued ticagrelor plus aspirin. Patients sustaining a major ischemic or bleeding event in the first 3 months after PCI were excluded from analysis. The primary outcome was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding occurring between 3 and 12 months after index PCI. The key secondary endpoint was the composite of death, myocardial infarction (MI), or stroke. Hazard ratios (HRs) and 95% confidence intervals (CIs) were generated using Cox regression with a one-stage approach in the intention-to-treat population.

Results:

The pooled cohort (n = 7,529) had a mean age of 62.8 years, 23.2% were female, and 55% presented with biomarker-positive ACS. Between 3 and 12 months, ticagrelor monotherapy significantly reduced BARC 3 or 5 bleeding compared with ticagrelor plus aspirin (0.8% vs. 2.1%; HR, 0.37; 95% CI, 0.24–0.56; p < 0.001). Rates of all-cause death, MI, or stroke were not significantly different between groups (2.4% vs. 2.7%; HR, 0.91; 95% CI, 0.68–1.21; p = 0.515). Findings were unchanged among patients presenting with biomarker-positive ACS.

Conclusions:

The authors report that among patients with ACS undergoing PCI who have completed a 3-month course of DAPT, discontinuation of aspirin followed by ticagrelor monotherapy significantly reduced major bleeding without incremental ischemic risk compared with ticagrelor plus aspirin.

Perspective:

This patient-level pooled analysis reports that among patients with ACS undergoing PCI, ticagrelor monotherapy, compared with ticagrelor plus aspirin, significantly reduces major bleeding without incremental ischemic risk over 9 months. These data indicate that ticagrelor monotherapy preserves the ischemic benefits of DAPT while avoiding aspirin-related bleeding yielding a net clinical benefit post ACS PCI.

While these and other available data suggest that most patients benefit from withdrawal of aspirin between 2 weeks and 3 months after PCI, followed by P2Y12 monotherapy, there is likely a subgroup of patients with ACS who have extensive multivessel disease and persistent atherothrombotic risk factors who may still benefit from long-term DAPT. Such a strategy would be consistent with the European Society of Cardiology 2023 ACS guidelines, which provide a Class IIa recommendation for long-term DAPT, or a strategy of aspirin plus rivaroxaban 2.5 mg BID, in those who have a high risk of ischemic events without high bleeding risk.

Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Interventions and ACS

Keywords: Acute Coronary Syndrome, Percutaneous Coronary Intervention


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