Sex-Based Outcomes of P2Y12 Inhibitor Monotherapy After Three Months of Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention.

BACKGROUND

In patients undergoing percutaneous coronary intervention (PCI) in the SMART-CHOICE trial, P2Y12 inhibitor monotherapy after three months of dual antiplatelet therapy (DAPT) achieved clinical outcomes comparable to those of 12 months of DAPT. Nonetheless, the effects of sex on these outcomes remain unknown.

METHODS

This open-label, non-inferiority, randomized study, conducted in 33 hospitals in South Korea, included 2,993 patients undergoing PCI with drug-eluting stents. Patients were randomly assigned to receive DAPT (aspirin plus a P2Y12 inhibitor) for three months then P2Y12 inhibitor alone for nine months, or DAPT for the entire 12 months. The primary endpoints were major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) 12 months after the index procedure. The bleeding endpoints were Bleeding Academic Research Consortium (BARC) bleeding types 2 to 5.

RESULTS

Of the patients, 795 (26.6%) were women, who were older and had a higher prevalence of hypertension, diabetes, and dyslipidemia than men. The sexes exhibited comparable primary endpoints (adjusted hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.55-1.55;

CONCLUSION

In both sexes undergoing PCI, P2Y12 inhibitor monotherapy after three months of DAPT achieved similar risks of the primary endpoints and the bleeding events compared with prolonged DAPT. Therefore, the benefits of early aspirin withdrawal with ongoing P2Y12 inhibitors may be comparable in women and men.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02079194.

Informations de copyright

© 2023 The Korean Academy of Medical Sciences.

Déclaration de conflit d'intérêts

Joo-Yong Hahn reports receiving grants from Abbott Vascular, Boston Scientific, Biotronik, Korean Society of Interventional Cardiology, and Medtronic; and speaker's fees from AstraZeneca, Daiichi Sankyo, and Sanofi-Aventis. Hyeon-Cheol Gwon reports receiving research grants from Abbott Vascular, Boston Scientific, and Medtronic; and speaker's fees from Abbott Vascular, Boston Scientific, and Medtronic. All other authors declare that they have no conflicts of interest.