One-month DAPT after biodegradable-polymer everolimus-eluting stent implantation in women at high-bleeding risk: Insights from the POEM trial

Catheter Cardiovasc Interv. 2024 Nov;104(6):1129-1138. doi: 10.1002/ccd.31255. Epub 2024 Oct 3.

Abstract

Aims: We conducted a prespecified subanalysis of the POEM trial to assess the association between sex and clinical outcomes following a short 1-month dual-antiplatelet-therapy (DAPT) period after percutaneous coronary intervention (PCI) with bioresorbable polymer everolimus-eluting stent (BP-EES) among patients at high bleeding risk (HBR).

Background: Shortening the DAPT period after PCI is an effective bleeding avoidance strategy with contemporary drug-eluting stents. Whether sex affects the risk of adverse events following PCI is still debated.

Methods: Patients at HBR undergoing PCI with BP-EES were enrolled and treated with 1-month DAPT. If anticoagulation was needed, study participants received an oral anticoagulant (OAC) in addition to a P2Y12 inhibitor for 1 month, followed by OAC only thereafter. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 12 months. We report sex-based outcomes of patients included in the POEM study.

Results: We enrolled 129 (29.1%) women and 314 (70.9%) men. Women were older, with lower hemoglobin levels, and worse renal function. Accordingly, they had a trend for a greater number of HBR criteria fulfilled and a higher PARIS bleeding score. However, they were not at a significantly higher risk for the primary endpoint (men vs. women: 5.17% vs. 3.94%; HR 1.30; 95% CI: 0.48-3.54, p = 0.61), or any of the hemorrhagic and ischemic secondary endpoints.

Conclusions: This prespecified subanalysis of the POEM trial suggests that 1-month DAPT following PCI with BP-EES may be a safe and effective therapeutic strategy for women at HBR.

Keywords: biodegradable polymer; high bleeding risk; percutaneous coronary intervention; sex; short DAPT; women.

Publication types

  • Multicenter Study
  • Comparative Study

MeSH terms

  • Absorbable Implants*
  • Administration, Oral
  • Aged
  • Anticoagulants / administration & dosage
  • Anticoagulants / adverse effects
  • Coronary Artery Disease* / diagnostic imaging
  • Coronary Artery Disease* / mortality
  • Coronary Artery Disease* / therapy
  • Coronary Thrombosis / etiology
  • Coronary Thrombosis / prevention & control
  • Drug Administration Schedule*
  • Drug-Eluting Stents*
  • Dual Anti-Platelet Therapy*
  • Everolimus* / administration & dosage
  • Everolimus* / adverse effects
  • Female
  • Hemorrhage* / chemically induced
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention* / adverse effects
  • Percutaneous Coronary Intervention* / instrumentation
  • Percutaneous Coronary Intervention* / mortality
  • Platelet Aggregation Inhibitors* / administration & dosage
  • Platelet Aggregation Inhibitors* / adverse effects
  • Prospective Studies
  • Prosthesis Design*
  • Purinergic P2Y Receptor Antagonists / administration & dosage
  • Purinergic P2Y Receptor Antagonists / adverse effects
  • Risk Assessment
  • Risk Factors
  • Sex Factors
  • Time Factors
  • Treatment Outcome

Substances

  • Everolimus
  • Platelet Aggregation Inhibitors
  • Purinergic P2Y Receptor Antagonists
  • Anticoagulants