ESC 2023 Update: Dual-antiplatelet therapy should remain standard strategy after stent implantation

There were two primary endpoints: 1) major bleeding events (defined as Bleeding Academic Research Consortium [BARC] type 3 or 5) at 1 month for superiority; and 2) cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) at 1 month for non-inferiority. The major secondary endpoint was a composite of the co-primary bleeding and cardiovascular endpoints (cardiovascular death, myocardial infarction, definite stent thrombosis, stroke, or major bleeding) at 1 month representing net clinical benefit.

The full analysis set population consisted of 5,966 patients (no-aspirin group: 2,984 patients; DAPT group: 2,982 patients). The average age was 71.6 years and 23.4% were women. At 1 month, the no aspirin strategy was not superior to DAPT for the co-primary bleeding endpoint (4.47% vs. 4.71%; hazard ratio [HR], 0.95; 95% confidence interval [CI], 0.75-1.20; p for superiority=0.66). The no-

aspirin strategy was non-inferior to DAPT with a relative 50% margin for the co-primary cardiovascular endpoint (4.12% vs. 3.69%; HR, 1.12; 95% CI, 0.87-1.45; p for non-inferiority=0.01).

There was no between-group difference in the incidence of all-cause death (2.28% vs. 2.11% in the no-aspirin and DAPT groups, respectively). The major secondary endpoint occurred in 7.14% patients in the no-aspirin group and 7.38% patients in the DAPT group, with no between-group difference, indicating a similar effect on net clinical benefit for both groups.

There was an excess of any coronary revascularisation (1.15% vs. 0.57%) and definite or probable stent thrombosis (0.71% vs. 0.44%) in the no-aspirin group compared with the DAPT group, while definite stent thrombosis was not different between the 2 groups (0.47% vs. 0.37%). In a subgroup analysis stratified by ACS and non-ACS, the excess risk of cardiovascular events in the no-aspirin group compared with the DAPT group was seen in patients with ACS, but not in those without ACS.

Study author Dr. Masahiro Natsuaki of Saga University, Japan said: “The aspirin-free strategy compared with the DAPT strategy failed to reduce major bleeding within 1 month after PCI, but it was non-inferior for the co-primary cardiovascular endpoint with a relative 50% margin. Aspirin used for a limited period of 1 month after PCI as a component of DAPT might have exerted a protective effect on vulnerable coronary lesions, particularly in patients with ACS, without a large increase in major bleeding. DAPT should remain the standard strategy for PCI even in the new-generation drug eluting stent era.”