P2Y12 inhibitor monotherapy is a novel antiplatelet strategy after short duration DAPT

The primary objective of the study by Hahn et al. was to compare P2Y12 inhibitor monotherapy after 3 months of dual antiplatelet therapy (DAPT) with 12 months of DAPT in a broad spectrum of patients receiving current generation drug-eluting stents (DES).

The working hypothesis was that P2Y12 inhibitor monotherapy after 3 months of DAPT would be non-inferior to 12 months of DAPT at 12 months after the index procedure [1].

This prospective, multicentre, randomised, open-label, non-inferiority trial included almost 3,000 patients (mean age 65 years, 27% female) who underwent percutaneous coronary intervention (PCI) with DES. They were randomised 1:1 to either DAPT for 3 months (n=1,495) or 12 months (n=1,498). In the former group, after 3 months, aspirin was discontinued and P2Y12 inhibitor monotherapy was continued. Stratification was performed by type of DES used (i.e. cobalt-chromium everolimus-eluting stent vs platinum-chromium everolimus-eluting stent vs biodegradable polymer sirolimus-eluting stent). The primary endpoint was 12-month major adverse cardiac and cerebrovascular events (MACCE; a composite of all-cause death, myocardial infarction, or stroke). The mean duration of aspirin was 96 days in the P2Y12 inhibitor group and 365 days in the DAPT group.

The results showed that the primary outcome (MACCE) at 12 months was 2.9% for 3 months of DAPT vs 2.5% for 12 months of DAPT (P=0.007 for non-inferiority; P=0.46 for superiority). The rate for all-cause death was 1.4% vs 1.2% (P=0.61), respectively, and for MI 0.8% vs 1.2% (P=0.28) (see Table).

Table: Clinical outcomes after 3 months vs 12 months of dual antiplatelet therapy [1]



Major bleeding was defined as BARC type 3-5 bleeding. Net adverse clinical and cerebral events were defined as MACCE plus BARC type 2-5 bleeding.

The authors concluded that in this prospective, open-label, randomised trial, P2Y12 inhibitor monotherapy after 3 months of DAPT was non-inferior to 12 months of DAPT for the primary endpoint of MACCE at 12 months after the index procedure. The 3-month landmark analysis and per-protocol analysis showed consistent results. Moreover, P2Y12 inhibitor monotherapy was associated with lower risk of bleeding compared with prolonged DAPT. Although these results need to be validated in well powered blinded trials, these data raise the hypothesis that P2Y12 inhibitor monotherapy after short duration of DAPT may be a novel antiplatelet strategy balancing ischaemic and bleeding risk in patients undergoing PCI.

1. Hahn J-Y, et al. Abstract 410-16. ACC 2019, 16-18 March, New Orleans, USA.



Posted on 6 June, 201927 March, 2024