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Dual antiplatelet therapy after percutaneous coronary intervention according to bleeding risk (HOST-BR): an
Jeehoon Kang1, Kyung Woo Park1, Jung-Kyu Han1
1Seoul National University Hospital, Seoul, South Korea; Seoul National University College of Medicine, Seoul, South Korea.
Insights
For high bleeding risk patients, 1-month dual antiplatelet therapy (DAPT) after stenting was not non-inferior to 3-month DAPT. For non-high bleeding risk patients, 3-month DAPT was non-inferior to 12-month DAPT and reduced bleeding.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Optimal duration of dual antiplatelet therapy (DAPT) post-coronary stenting varies by bleeding risk.
- Establishing evidence-based DAPT durations is crucial for patient outcomes.
Purpose of the Study:
- To evaluate the optimal duration of DAPT following coronary stenting, stratified by patient bleeding risk.
- To compare short-term versus longer-term DAPT regimens in high bleeding risk (HBR) and non-high bleeding risk (non-HBR) populations.
Main Methods:
- An open-label, multicentre, randomised clinical trial involving 4897 patients undergoing percutaneous coronary intervention with drug-eluting stents.
- Patients were stratified into HBR or non-HBR groups. HBR patients received 1-month vs. 3-month DAPT; non-HBR patients received 3-month vs. 12-month DAPT.
- Coprimary endpoints included net adverse clinical events, major adverse cardiac or cerebral events, and actionable bleeding at 1 year.
Main Results:
- In the HBR group, 1-month DAPT did not achieve non-inferiority compared to 3-month DAPT for net adverse clinical events.
- In the non-HBR group, 3-month DAPT was non-inferior to 12-month DAPT for net adverse clinical events and major adverse cardiac or cerebral events.
- The 3-month DAPT regimen in the non-HBR group demonstrated superiority in reducing bleeding events compared to the 12-month regimen.
Conclusions:
- One-month DAPT is insufficient for East Asian patients with high bleeding risk following coronary stenting.
- A 3-month DAPT duration is effective and safer than a 12-month duration for patients without high bleeding risk.
- These findings guide personalized DAPT strategies based on individual bleeding risk profiles.
Background:
The optimal duration of dual antiplatelet therapy (DAPT) after coronary stenting according to bleeding risk is not well established. We aimed to evaluate the optimal duration of DAPT after coronary stenting according to bleeding risk.
Methods:
In this open-label, multicentre, randomised clinical trial, patients aged 19 years and older who received percutaneous coronary intervention with a drug-eluting stent at 50 high-volume cardiology centres in South Korea were stratified into high bleeding risk (HBR) or non-HBR strata, according to Academic Research Consortium for High Bleeding Risk criteria. Patients in the HBR stratum were randomly assigned (1:1) to 1-month or 3-month DAPT, and those in the non-HBR stratum were randomly assigned (1:1) to 3-month or 12-month DAPT. The three coprimary endpoints were net adverse clinical events (all-cause death, myocardial infarction, stent thrombosis, stroke, or major bleeding), major adverse cardiac or cerebral events (cardiovascular death, myocardial infarction, definite or probable stent thrombosis, or ischaemic stroke), and any actionable non-surgical bleeding at 1 year after randomisation. Primary endpoints were assessed in hierarchical order in the intention-to-treat population. This study is registered with cris.nih.go.kr, KCT0005356, and ClinicalTrials.gov, NCT05631769, and is complete.
Findings:
From July 24, 2020, to Sept 25, 2023, 4897 patients were enrolled (1598 in the HBR stratum and 3299 in the non-HBR stratum). In the HBR stratum, 1-month compared with 3-month DAPT did not reach non-inferiority for net adverse clinical events (144 [18·4%] of 798 vs 110 [14·0%] of 800 patients; hazard ratio [HR] 1·337 [95% CI 1·043-1·713]; p=0·82 for non-inferiority). Major adverse cardiac or cerebral events occurred in 74 (9·8%) patients in the 1-month DAPT group and 44 (5·8%) in the 3-month group; bleeding occurred in 105 (13·8%) patients in the 1-month group and 122 (15·8%) in the 3-month group. In the non-HBR stratum, 3-month was non-inferior to 12-month DAPT regarding net adverse clinical events (47 [2·9%] of 1649 vs 72 [4·4%] of 1650 patients; HR 0·657 [0·455-0·949]; p<0·0001 for non-inferiority) and major adverse cardiac or cerebral events (36 [2·2%] vs 37 [2·3%]; HR 0·984 [0·622-1·558]; p=0·0082 for non-inferiority), and superior for bleeding (120 [7·4%] vs 190 [11·7%]; HR 0·631 [0·502-0·793]; p<0·0001).
Interpretation:
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.
Funding:
Medtronic and Abbott.
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