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Coronary disease & ACSRandomised controlled trial

Dual antiplatelet therapy after percutaneous coronary intervention according to bleeding risk (HOST-BR): an open-label, multicentre, randomised clinical trial

LancetPublished

  • Randomised controlled trial
  • open-label
  • multicentre
  • non-inferiority
  • stratified by bleeding risk
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Authors' conclusion

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.

Study context

Population
Patients aged ≥19 years after PCI with drug-eluting stent at 50 centres in South Korea, stratified by ARC high bleeding risk1,598 high bleeding risk (HBR), 3299 non-HBR
Participants
4,897 patients
Comparison
Shorter vs longer DAPT after PCI, by bleeding risk stratum
  • HBR 1-month DAPTn = 798
  • HBR 3-month DAPTn = 800reference
  • Non-HBR 3-month DAPTn = 1,649
  • Non-HBR 12-month DAPTn = 1,650reference
Primary endpoint
Three coprimary endpoints, hierarchical: net adverse clinical events (all-cause death, MI, stent thrombosis, stroke or major bleeding); MACCE (CV death, MI, definite or probable stent thrombosis or ischaemic stroke); any actionable non-surgical bleeding
Follow-up
1 year after randomisation

Primary result

As reported in the abstract

Coprimary endpoints · 1 year

HBR 1-month DAPT

144 [18.4%]

Net adverse clinical events · MACCE 74 (9.8%) · Bleeding 105 (13.8%)

HBR 3-month DAPT

110 [14.0%]

Net adverse clinical events · MACCE 44 (5.8%) · Bleeding 122 (15.8%)

Non-HBR 3-month DAPT

47 [2.9%]

Net adverse clinical events · MACCE 36 [2.2%] · Bleeding 120 [7.4%]

Non-HBR 12-month DAPT

72 [4.4%]

Net adverse clinical events · MACCE 37 [2.3%] · Bleeding 190 [11.7%]

Hazard ratio (95% CI)P value
HBR 1-month DAPT vs HBR 3-month DAPTnet adverse clinical events; non-inferiority not reached
1.337(1.043–1.713)
P = 0.82 for non-inferiority
Non-HBR 3-month DAPT vs Non-HBR 12-month DAPTnet adverse clinical events; non-inferior
0.657(0.455–0.949)
P < 0.0001 for non-inferiority
Non-HBR 3-month DAPT vs Non-HBR 12-month DAPTMACCE; non-inferior
0.984(0.622–1.558)
P = 0.0082 for non-inferiority
Non-HBR 3-month DAPT vs Non-HBR 12-month DAPTbleeding; superior
0.631(0.502–0.793)
P < 0.0001

Safety

OutcomeHBR 1-month DAPTHBR 3-month DAPTNon-HBR 3-month DAPTNon-HBR 12-month DAPTHR (95% CI)P value
Any actionable non-surgical bleeding (coprimary) · 1 year13.8%15.8%7.4%11.7%0.631 (0.502–0.793)P < 0.0001

Original publication

Dual antiplatelet therapy after percutaneous coronary intervention according to bleeding risk (HOST-BR): an open-label, multicentre, randomised clinical trial. Lancet. Published 23 October 2025. doi:10.1016/s0140-6736(25)01571-5
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Summarised from the published abstract; every number is checked against it