Hot Line: DAPT should remain the standard strategy for PCI
27 Aug 2023
As presented by Doctor Masahiro Natsuaki (Saga University - Saga, Japan) in a Hot Line session yesterday, the STOPDAPT-3 trial sought to answer if aspirin could be removed from dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI).
The rationale behind the trial was the high incidence of major bleeding within the 1-month DAPT period after PCI in clinical practice, particularly in patients with acute coronary syndrome (ACS) or high bleeding risk (HBR).1 In single-arm studies, aspirin-free prasugrel or ticagrelor monotherapy following successful new-generation drug-eluting stent implantation was not associated with any stent thrombosis in selected low-risk patients with or without ACS.2–4 It was hypothesised that removing aspirin from the DAPT regimen might reduce bleeding events early after PCI without compromising the risk of CV events; however, the efficacy and safety of this strategy had not been proven in randomised trials.
The STOPDAPT-3 trial included 5,966 patients with ACS or who met the criteria for HBR defined by the Academic Research Consortium who were about to undergo PCI with cobalt-chromium everolimus-eluting stents. They were randomised to receive either prasugrel 3.75 mg/day monotherapy or DAPT with aspirin 81–100 mg/day and prasugrel, after a loading dose of prasugrel 20 mg in both groups. The average age was 71.6 years and 23.4% were women. There were two primary endpoints: 1) major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 1 month for superiority; and 2) CV events (CV death, myocardial infarction [MI], definite stent thrombosis or stroke) at 1 month for non-inferiority.
At 1 month, the no-aspirin strategy was not superior to DAPT for the co-primary bleeding endpoint (4.47% versus 4.71%; hazard ratio [HR] 0.95; 95% CI 0.75 to 1.20; p for superiority=0.66).
For the co-primary CV endpoint, the no-aspirin strategy was non-inferior to DAPT with a relative 50% margin (4.12% versus 3.69%; HR 1.12; 95% CI 0.87 to 1.45; p for non-inferiority=0.01). There was no between-group difference in the incidence of all-cause death (2.28% with no aspirin and 2.11% with DAPT).
The major secondary endpoint – a composite of the co-primary bleeding and CV endpoints at 1 month – occurred in 7.14% of patients in the no-aspirin group and 7.38% of patients in the DAPT group, with no between-group difference, indicating a similar effect on net clinical benefit. There was an excess of any coronary revascularisation (1.15% versus 0.57%) and definite or probable stent thrombosis (0.71% versus 0.44%) in the no-aspirin group compared with the DAPT group, while definite stent thrombosis was not different between the groups (0.47% versus 0.37%). In a subgroup analysis stratified by ACS and non-ACS, the excess risk of CV events in the no-aspirin group compared with the DAPT group was seen in patients with ACS, but not in those without ACS.
Dr. Natsuaki comments, “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 CV 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.”
ESC guidelines recommend 6 months of DAPT in HBR patients with ACS and 12 months of DAPT in non-HBR patients with ACS after PCI.5 In patients with non-ACS, 1 to 3 months of DAPT is recommended in HBR patients after PCI.
References
- Natsuaki M, et al. Circ J. 2021;85:1928–1941.
- Kogame N, et al. JACC Cardiovasc Interv. 2020;13:2251–2262.
- Muramatsu T, et al. Circ J. 2023;87:857–865.
- van der Sangen NMR, et al. EuroIntervention. 2023;19:63–72.
- Valgimigli M, et al. Eur Heart J. 2018;39:213–260.
