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

Lancet (London, England)2026-02-04PubMed
Total: 85.5Innovation: 7Impact: 0Rigor: 0Citation: 0

Summary

In a 4,897-patient randomized trial stratified by ARC-HBR, 1-month DAPT was not noninferior to 3 months in high bleeding risk patients, whereas 3 months was noninferior to 12 months in non-HBR with less bleeding. These results support 3-month DAPT for non-HBR PCI and argue against ultra-short 1-month DAPT in HBR.

Key Findings

  • In HBR patients, 1-month DAPT failed noninferiority vs 3 months for net adverse clinical events (HR 1.34; 95% CI 1.04–1.71).
  • In non-HBR patients, 3-month DAPT was noninferior to 12 months for NACE and MACCE and reduced bleeding (HR 0.63 for bleeding).
  • Trial enrolled 4,897 patients across 50 centers with hierarchical coprimary endpoints and ITT analysis.

Clinical Implications

For non-HBR PCI patients, default to 3-month DAPT to lower bleeding without excess ischemic risk; avoid 1-month DAPT in HBR given failure of noninferiority. Integrate ARC-HBR stratification into discharge planning.

Why It Matters

Large, contemporary RCT directly informs duration of DAPT after PCI by bleeding risk, with immediate practice implications.

Limitations

  • Open-label design may introduce performance/ascertainment bias
  • Population restricted to East Asian centers; generalizability may vary

Future Directions

Test applicability in non–East Asian populations and integrate platelet function/genetic testing to refine ultra-short DAPT strategies in HBR subgroups.

Study Information

Study Type
RCT
Research Domain
Treatment
Evidence Level
I - Large multicenter randomized controlled trial with prespecified endpoints
Study Design
OTHER