The optimal duration of dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) requires a careful balance between reducing ischaemic events and minimising bleeding risk. The HOST-BR trial was designed to evaluate the ideal DAPT duration in patients stratified by their bleeding risk.¹

This open-label, multicentre, randomised clinical trial enrolled 4,897 patients who had received a drug-eluting stent at 50 centres in South Korea between 2020 and 2023. Patients were stratified into either a high bleeding risk (HBR) or non-HBR group, based on the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria.²

Patients in the HBR stratum (n=1,598) were randomly assigned to either 1-month or 3-month DAPT. Those in the non-HBR stratum (n=3,299) were randomised to 3-month or 12-month DAPT. The study assessed three co-primary endpoints at 1 year: net adverse clinical events (NACE; a composite of all-cause death, myocardial infarction, stent thrombosis, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCE), and any actionable non-surgical bleeding.

In the HBR stratum, 1-month DAPT did not meet the criteria for non-inferiority compared to 3-month DAPT for the primary NACE endpoint. The NACE rate was 18.4% in the 1-month group versus 14.0% in the 3-month group (hazard ratio [HR] 1.337; 95% CI 1.043–1.713; p=0.82 for non-inferiority). MACCE occurred in 9.8% and 5.8% of patients, respectively.

In the non-HBR stratum, 3-month DAPT was found to be non-inferior to 12-month DAPT for both NACE (2.9% vs 4.4%; HR 0.657; 95% CI 0.455–0.949; p<0.0001 for non-inferiority) and MACCE (2.2% vs 2.3%; HR 0.984; 95% CI 0.622–1.558; p=0.0082 for non-inferiority). Furthermore, the 3-month DAPT regimen was superior in reducing bleeding events compared to the 12-month regimen (7.4% vs 11.7%; HR 0.631; 95% CI 0.502–0.793; p<0.0001).

The HOST-BR investigators concluded that, “In east Asian patients with HBR, 1-month DAPT did not reach non-inferiority to 3-month DAPT for net adverse clinical events. In patients without HBR, 3-month DAPT was non-inferior to 12-month DAPT regarding net adverse clinical events and major adverse cardiac or cerebral events, and superior for bleeding.”¹ These findings suggest that a 3-month DAPT duration may be a preferable strategy for patients without a high bleeding risk following PCI.

This study was funded by Medtronic and Abbott.

References

1. Kang J, Park KW, Han J-K, et al. Dual antiplatelet therapy after percutaneous coronary intervention according to bleeding risk (HOST-BR): an open-label, multicentre, randomised clinical trial. Lancet. 2025. https://doi.org/10.1016/S0140-6736(25)01571-5.

2. Urban P, Mehran R, Colleran R, et al. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk. Eur Heart J. 2019;40:2632-2653. https://doi.org/10.1093/eurheartj/ehz372.

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