Why the study?
Concerns remain that early aspirin cessation may cause harm in subsets at high risk of ischemic events after PCI.
Does P2Y12 inhibitor monotherapy after 3 months of DAPT reduce bleeding without increasing ischemic events in patients after PCI across different CHADS-P2A2RC risk strata compared to prolonged DAPT?
Does P2Y12 inhibitor monotherapy after 3 months of DAPT reduce bleeding without increasing ischemic events in patients after PCI across different CHADS-P2A2RC risk strata compared to prolonged DAPT?
P2Y12 inhibitor monotherapy after 3 months of DAPT reduces bleeding without increasing ischemic risk compared to prolonged DAPT, even in patients at high ischemic risk post-PCI.
Supports P2Y12 monotherapy after short DAPT even in high CHADS-P2A2RC risk; leaves open prospective validation of ischemic safety.
BACKGROUND AND OBJECTIVES: Concerns remain that early aspirin cessation may be associated with potential harm in subsets at high risk of ischemic events. This study aimed to assess the effects of P2Y12 inhibitor monotherapy after 3-month dual antiplatelet therapy (DAPT) vs. prolonged DAPT (12-month or longer) based on the ischemic risk stratification, the CHADS-P2A2RC, after percutaneous coronary intervention (PCI). METHODS: This was a sub-study of the SMART-CHOICE trial. The effect of the randomized antiplatelet strategies was assessed across 3 CHADS-P2A2RC risk score categories. The primary outcome was a major adverse cardiac and cerebral event (MACCE), a composite of all-cause death, myocardial infarction, or stroke. RESULTS: Up to 3 years, the high CHADS-P2A2RC risk score group had the highest incidence of MACCE (105 [12.1%], adjusted hazard ratio [HR], 2.927; 95% confidence interval [CI], 1.358-6.309; p=0.006) followed by moderate-risk (40 [1.4%], adjusted HR, 1.786; 95% CI, 0.868-3.674; p=0.115) and low-risk (9 [0.5%], reference). In secondary analyses, P2Y12 inhibitor monotherapy reduced the Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding without increasing the risk of MACCE as compared with prolonged DAPT across the 3 CHADS-P2A2RC risk strata without significant interaction term (interaction p for MACCE=0.705 and interaction p for BARC types 2, 3, or 5 bleeding=0.055). CONCLUSIONS: The CHADS-P2A2RC risk score is valuable in discriminating high-ischemic-risk patients. Even in such patients with a high risk of ischemic events, P2Y12 inhibitor monotherapy was associated with a lower incidence of bleeding without increased risk of ischemic events compared with prolonged DAPT. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02079194.
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Song et al. (2024) studied this question.
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