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1-Month or 3-Month DAPT in Women and Men at High Bleeding Risk Undergoing PCI
Vijay Kunadian1, Mauro Gitto2, Birgit Vogel3
1Translational and Clinical Research Institute, Newcastle University and Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.
Insights
Short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is safe for high bleeding risk patients. One-month DAPT showed similar ischemic event rates and numerically lower bleeding compared to three-month DAPT, regardless of sex.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Short dual antiplatelet therapy (DAPT) reduces bleeding and maintains ischemic protection in high bleeding risk (HBR) patients post-percutaneous coronary intervention (PCI).
- Evaluating optimal DAPT duration is crucial for balancing efficacy and safety in HBR patients undergoing PCI.
Purpose of the Study:
- To compare one-month versus three-month DAPT regimens followed by aspirin monotherapy in women and men at HBR undergoing PCI.
- To assess the safety and efficacy of short DAPT durations in a sex-stratified manner.
Main Methods:
- Analysis of data from three prospective, international studies (XIENCE Short DAPT Program) involving HBR patients treated with XIENCE everolimus-eluting stents.
- Primary endpoint: composite of death or myocardial infarction (MI) at one year.
- Key secondary endpoint: Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding.
Main Results:
- Among 3,364 patients (34.3% women), one-year rates of death or MI were similar between women and men (7.6% vs 8.1%).
- One-month and three-month DAPT demonstrated comparable risks for death or MI in both women and men (P for interaction = 0.783).
- One-month DAPT showed numerically lower BARC types 2-5 bleeding in both sexes, though not statistically significant after propensity score stratification (P for interaction = 0.378).
Conclusions:
- One-month and three-month DAPT regimens are associated with similar ischemic event risks in HBR patients undergoing PCI with everolimus-eluting stents, irrespective of sex.
- One-month DAPT led to numerically less clinically relevant bleeding in both men and women, although the difference was not statistically significant post-stratification.
Background:
In patients at high bleeding risk (HBR), short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is associated with reduced bleeding and preserved ischemic protection.
Objectives:
The aim of this study was to compare 2 short DAPT regimens, followed by aspirin monotherapy, in women and men at HBR undergoing PCI.
Methods:
Data from 3 prospective, international studies (XIENCE Short DAPT Program) including patients at HBR undergoing PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (XIENCE) were analyzed. The primary endpoint was the composite of death or myocardial infarction (MI) at 1 year. The key secondary endpoint was Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding.
Results:
Among 3,364 patients, 1,154 (34.3%) were women. At 1 year, the rates of death or MI (7.6% vs 8.1%) and BARC types 2 to 5 bleeding (9.5% vs 9.2%) were similar in women and men. One-month and 3-month DAPT conferred a similar risk for death or MI in women (adjusted HR: 0.86; 95% CI: 0.54-1.36) and men (adjusted HR: 1.04; 95% CI: 0.75-1.44) (P for interaction = 0.783). In both sexes, BARC types 2 to 5 bleeding was numerically lower with 1-month DAPT, although not significant after propensity score stratification (women: 7.1% vs 11.2%; adjusted HR: 0.66; 95% CI: 0.43-1.02; men: 8.5% vs 9.7%; adjusted HR: 0.78; 95% CI: 0.57-1.06) (P for interaction = 0.378).
Conclusions:
Among patients at HBR undergoing PCI with everolimus-eluting stents, 1- and 3-month DAPT was associated with similar risk for ischemic events irrespective of sex. In both women and men, 1-month DAPT resulted in less clinically relevant bleeding, although the bleeding risk difference was not significant after propensity score stratification.
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