Controversy remains regarding the optimal antiplatelet regimen in patients with acute
coronary syndrome (ACS). This study sought to investigate the efficacy and safety
of P2Y12 inhibitor monotherapy compared with conventional dual antiplatelet therapy
(DAPT) and aspirin monotherapy in patients with ACS undergoing percutaneous coronary
intervention. Data on 4,453 patients were pooled from SMART-DATE and SMART-CHOICE
randomized trials. Antiplatelet therapy regimens were categorized as P2Y12 inhibitor
monotherapy (P2Y12 inhibitor monotherapy after 3-month DAPT), conventional DAPT (12-month
or longer DAPT), and aspirin monotherapy (aspirin monotherapy after 6-month DAPT).
The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE,
a composite of all-cause death, myocardial infarction, and stroke). Inverse-probability
of treatment-weighted (IPTW) analysis was performed. At 1 year, patients in the P2Y12
inhibitor monotherapy had a comparable risk of MACCE compared with those in the conventional
DAPT (IPTW-adjusted hazard ratio [HR], 0.655; 95% confidence interval [CI] 0.393 to
1.094; p = 0.106), and tended to have a lower risk of MACCE than those in the aspirin
monotherapy (IPTW-adjusted HR, 0.606; 95% CI, 0.347 to 1.058; p = 0.078). The adjusted
hazard for the Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding was
significantly lower in P2Y12 inhibitor monotherapy than in conventional DAPT (IPTW-adjusted
HR, 0.341; 95% CI, 0.190 to 0.614; p < 0.001) and in aspirin monotherapy (IPTW-adjusted
HR, 0.359; 95% CI, 0.182 to 0.708; p = 0.003). In conclusion, among patients with
ACS undergoing PCI, P2Y12 inhibitor monotherapy after 3-month DAPT reduced risk of
bleeding compared with conventional DAPT and aspirin monotherapy after 6-month DAPT
without increasing MACCE.
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Article info
Publication history
Published online: May 16, 2021
Received in revised form:
March 15,
2021
Received:
December 30,
2020
Footnotes
Acknowledgment: This study was supported by unrestricted grants from the Korean Society of Interventional Cardiology (grant number 2013-3), Abbott Vascular, Biotronik, and Boston Scientific.
Clinical Trial Registration: ClinicalTrials.gov Identifier - NCT01701453 and NCT02079194
Identification
Copyright
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