Harmonizing Optimal Strategy For Treatment of Coronary Artery Diseases–Bleeding Risk - HOST-BR

Mar 29, 2025
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Author/Summarized by Author:
Carlos A Vergara Sanchez, MD
Summary Reviewer:
Fred M. Kusumoto, MD, FACC; R. Scott Wright, MD, FACC
Trial Sponsor:
Medtronic and Abbott Vascular; Ministry of Health & Welfare, Republic of Korea
Date Presented:
03/29/2025
Date Updated:
03/29/2025
Original Posted Date:
03/29/2025
References

Contribution To Literature:

The HOST-BR trial demonstrated that for patients at either high or low risk of bleeding, 3 months is the optimal duration of treatment to reduce adverse events without increasing bleeding risk following stent implantation.

Description:

The goal of the trial was to determine the optimal duration of dual antiplatelet therapy (DAPT) for patients who were stratified by high or low bleeding risk after receiving percutaneous coronary intervention (PCI) with drug-eluting stent (DES).

Study Design

Participants from 53 centers in South Korea first underwent PCI with DES. Then they were randomly assigned to different durations of DAPT: 1 month vs. 3 months in the high bleeding risk (HBR) group (n=1,598) and 3 months vs. 12 months in the low bleeding risk (LBR) group (n=3,299). Bleeding risk was assigned based on Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria. Use of specific P2Y12 inhibitor was at the physician’s discretion. Clopidogrel was mainly used as the P2Y12 inhibitor at discharge.

  • Total number of enrollees: 4,897
  • Duration of follow-up: 12 months
  • Mean patient age: HBR group, 73 years; LBR group, 63 years
  • Percentage female: HBR group, 23%; LBR group, 20%

Inclusion criteria:

  • Age ≥19 years
  • Had PCI with stent implantation
  • Agreement of written informed consent

Exclusion criteria:

  • Patients with a history of allergic reactions or contraindications to any of the following: aspirin, clopidogrel, prasugrel, ticagrelor, heparin, cobalt chromium, sirolimus
  • Pregnant women

Principal Findings:

Three coprimary endpoints were evaluated across low and high bleeding risk strata outcome:

Primary endpoint High bleeding risk (n=1,598) Low bleeding risk (n=3,299)
Net adverse clinical events (NACE): all-cause death, myocardial infarction (MI), stent thrombosis, stroke, major bleeding 30 days: 18.4%
90 days: 14.0%
HR, 1.34 (CI, 1.04-1.71)
p=0.022		 90 days: 2.9%
12 months: 4.4%
HR, 0.66 (CI, 0.46-0.95)
p=0.025
p for noninferiority <0.001
Major adverse cardiac or cerebral events (MACCE): cardiovascular disease, MI, stent thrombosis, ischemic stroke 30 days: 9.8%
90 days: 5.8%
HR, 1.72 (CI, 1.19-2.5)
p=0.04		 90 days: 2.2%
12 months: 2.3%
HR, 0.98 (CI, 0.62-1.56)
p=not significant
p for noninferiority= 0.008
BARC bleeding (2, 3, 5) at 12 months 30 days: 13.8%
90 days: 15.8%
HR, 0.85 (CI, 0.66-1.11)
p=not significant		 90 days: 2.2%
12 months: 11.7%
HR, 0.63 (CI, 0.50-0.79)
p<0.001

Interpretation:

In patients with high bleeding risk, the use of 3 months of DAPT reduced the NACE and MACCE, compared to patients who received 1 month of DAPT at a trend of slightly higher bleeding rates.

In patients at low bleeding risk, the use of 3 months of DAPT resulted in less bleeding and lower rates of NACE but not MACCE. Both outcomes showed noninferiority compared to 12 months. 

The results of this study guide clinical practice especially for patients with high bleeding risk for the duration of DAPT therapy, recognizing that 3 months is the shortest, safest duration to maintain DAPT even in patients with higher bleeding risk.

References:

Presented by Dr. Hyo-Soo Kim at the American College of Cardiology Annual Scientific Session (ACC.25), Chicago, IL, March 29, 2025.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease

Keywords: ACC25, ACC Annual Scientific Session, Coronary Artery Disease, Platelet Aggregation Inhibitors, Stents


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