Why the study?
Does P2Y12 inhibitor monotherapy after 3 months of DAPT reduce major adverse cardiac and cerebrovascular events in male and female patients undergoing PCI compared to 12 months of DAPT?
Does P2Y12 inhibitor monotherapy after 3 months of DAPT reduce major adverse cardiac and cerebrovascular events in male and female patients undergoing PCI compared to 12 months of DAPT?
The benefits of early aspirin withdrawal with ongoing P2Y12 inhibitor monotherapy after 3 months of DAPT are comparable in women and men undergoing PCI.
Short DAPT followed by P2Y12 monotherapy yields comparable outcomes in both sexes; extends evidence for sex-neutral de-escalation after PCI.
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: = 0.045) but the difference was not statistically significant when using the Bonferroni correction. The primary endpoints were similar between treatment groups in both sexes. 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.
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Shin et al. (2023) studied this question.
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