HOST - DAPT Duration According the Bleeding Risk (HOST-BR)

Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases - DAPT Duration According the Bleeding Risk

• Dual antiplatelet agent therapy (DAPT) is essential in treating PCI patients. DAPT can minimize thrombotic adverse events that occur not only at the stented lesion, but along the whole coronary tree. However, DAPT has a critical side effect of increasing bleeding complications. Addressing the clinical imperatives of lowering bleeding while preserving ischemic benefit requires therapeutic strategies that decouple thrombotic from hemorrhagic risk.
• Recently, the ARC definition of high bleeding risk (HBR) has been published, so as to stress the need of optimal DAPT treatment in HBR patients. Due to the definitely higher bleeding risk in HBR patients, it would be rather more straight forward to titrate the optimal DAPT duration in these patients. In this line, many studies are in progress on HBR patients, with an ultra-short DAPT duration (i.e. Leaders free, Onyx ONE, Master DAPT, Xience 28, Xience 90, Evolve short DAPT trial, etc.).
• As a counteract to the definition of HBR, there is a concept of LBR. Due to the relatively vague ischemic/bleeding risk in LBR patients, balancing ischemic and bleeding complications post-PCI is more difficult in LBR patients, which may be a more important dilemma for clinicians. In this regards, limited evidence exists on the optimal duration of DAPT in LBR patients. Various previous studies that have evaluated the optimal DAPT in PCI populations, did not have the concept of HBR or LBR, making interpretation difficult.
• Therefore, this study is planning to compare the efficacy and safety of different DAPT durations, in patients stratified according to the ARB-HBR definition.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Stable Angina; Acute Myocardial Infarction
• Intervention / Treatment: Drug: Dual antiplatelet agent duration

• Study Type: Interventional
• Enrollment (Estimated): 4900
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• Inclusion Criteria:

  1. The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.
  2. The patient in whom the Bleeding Risk (according to the ARC-HBR classification) can be calculated.
  3. The patient has a working diagnosis of coronary artery disease which has been treated with percutaneous coronary intervention.

• Exclusion Criteria:

  1. Hypersensitivity to aspirin or P2Y12 inhibitors
  2. Patients in whom coroanry artery disease has been decided to be medically managed without a coronary stent.
  3. Positive pregnancy test or is known to be pregnant
  4. Any other reason the investigator deems the subject to be unsuitable for the study (e.g., Any life-threatening condition with life expectancy less than 6months, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HBR - 1M DAPT; Patients who receive percutaneous coronary intervention for coronary artery disease, and who have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 1 month or 3 month DAPT duration.	Drug: Dual antiplatelet agent duration; Patients who receive percutaneous coronary intervention for coronary artery disease will be randomized to arms with different DAPT strategies. The randomization will be stratified according to the High bleeding risk (defined according to the ARC-HBR criteria).
Active Comparator: HBR - 3M DAPT; Patients who receive percutaneous coronary intervention for coronary artery disease, and who have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 1 month or 3 month DAPT duration.	Drug: Dual antiplatelet agent duration; Patients who receive percutaneous coronary intervention for coronary artery disease will be randomized to arms with different DAPT strategies. The randomization will be stratified according to the High bleeding risk (defined according to the ARC-HBR criteria).
Active Comparator: LBR - 12M DAPT; Patients who receive percutaneous coronary intervention for coronary artery disease, and who do NOT have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 3 month or 12 month DAPT duration.	Drug: Dual antiplatelet agent duration; Patients who receive percutaneous coronary intervention for coronary artery disease will be randomized to arms with different DAPT strategies. The randomization will be stratified according to the High bleeding risk (defined according to the ARC-HBR criteria).
Experimental: LBR - 3M DAPT; Patients who receive percutaneous coronary intervention for coronary artery disease, and who do NOT have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 3 month or 12 month DAPT duration.	Drug: Dual antiplatelet agent duration; Patients who receive percutaneous coronary intervention for coronary artery disease will be randomized to arms with different DAPT strategies. The randomization will be stratified according to the High bleeding risk (defined according to the ARC-HBR criteria).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net Adverse Clinical Events	NACE; the composite of All-cause Death, Myocardial Infarction (MI), Stent thrombosis, Stroke, or Major Bleeding event	1-year after percutaneous coronary intervention
Any bleeding event	Bleeding events, defined by the BARC (Bleeding Academic Research Consortium) or ISTH (International Society on Thrombosis and Haemostasis) classification	1-year after percutaneous coronary intervention
Major-Adverse Cardiac or Cerebral Events	MACCE; the composite of Cardiac Death, Myocardial Infarction (MI), Stent thrombosis, Ischemic Stroke	1-year after percutaneous coronary intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication compliance	Medication compliance to the allocated DAPT regimen: A 'Pill count adherence' will be used to calculate medication compliance. This will be calculated by the following formula: '[(quantity dispensed)-(quantity remaining)] over (Prescribed number of tablets between dates of interview)'.	1-year after percutaneous coronary intervention
Coronary thrombotic event	Myocardial Infarction, Stent thrombosis	1-year after percutaneous coronary intervention
All-cause death	Death due to any cause	1-year after percutaneous coronary intervention
Cardiac death	Death due to cardiac cause	1-year after percutaneous coronary intervention
Non-cardiac death	Death due to non-cardiac cause	1-year after percutaneous coronary intervention
Cardiovascular death	Death due to cardiovascular cause	1-year after percutaneous coronary intervention
Non-cardiovascular death	Death due to non-cardiovascular cause	1-year after percutaneous coronary intervention
Any myocardial infarction	Any myocardial infarction event (Clinically irrelevant periprocedural myocardial infarction will NOT be added to analysis)	1-year after percutaneous coronary intervention
Target vessel related myocardial infarction	Any myocardial infarction related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'	1-year after percutaneous coronary intervention
Non-Target vessel related myocardial infarction	Any myocardial infarction NOT related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'	1-year after percutaneous coronary intervention
Any revascularization	Any coronary revascularization event	1-year after percutaneous coronary intervention
Non-Target vessel revascularization	Any revascularization event NOT related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'	1-year after percutaneous coronary intervention
Target vessel revascularization	Any revascularization event related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'	1-year after percutaneous coronary intervention
Any stroke	Any cerebrovascular event	1-year after percutaneous coronary intervention
Any ischemic stroke	Any ischemic cerebrovascular event	1-year after percutaneous coronary intervention
Any hemorrhagic stroke	Any hemorrhagic cerebrovascular event	1-year after percutaneous coronary intervention
Major bleeding	Major bleeding events, defined by the ISTH (International Society on Thrombosis and Haemostasis) classification	1-year after percutaneous coronary intervention

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Hanyang University Seoul Hospital

Publications and helpful links

General Publications

• Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available.
• Rodeghiero F, Tosetto A, Abshire T, Arnold DM, Coller B, James P, Neunert C, Lillicrap D; ISTH/SSC joint VWF and Perinatal/Pediatric Hemostasis Subcommittees Working Group. ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders. J Thromb Haemost. 2010 Sep;8(9):2063-5. doi: 10.1111/j.1538-7836.2010.03975.x. No abstract available.
• Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC. Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention. Circulation. 2019 Jul 16;140(3):240-261. doi: 10.1161/CIRCULATIONAHA.119.040167. Epub 2019 May 22.
• Kang J, Park KW, Palmerini T, Stone GW, Lee MS, Colombo A, Chieffo A, Feres F, Abizaid A, Bhatt DL, Valgimigli M, Hong MK, Jang Y, Gilard M, Morice MC, Park DW, Park SJ, Jeong YH, Park J, Koo BK, Kim HS. Racial Differences in Ischaemia/Bleeding Risk Trade-Off during Anti-Platelet Therapy: Individual Patient Level Landmark Meta-Analysis from Seven RCTs. Thromb Haemost. 2019 Jan;119(1):149-162. doi: 10.1055/s-0038-1676545. Epub 2018 Dec 31.
• Costa F, Van Klaveren D, Feres F, James S, Raber L, Pilgrim T, Hong MK, Kim HS, Colombo A, Steg PG, Bhatt DL, Stone GW, Windecker S, Steyerberg EW, Valgimigli M; PRECISE-DAPT Study Investigators. Dual Antiplatelet Therapy Duration Based on Ischemic and Bleeding Risks After Coronary Stenting. J Am Coll Cardiol. 2019 Feb 26;73(7):741-754. doi: 10.1016/j.jacc.2018.11.048.
• Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation. 2016 Sep 6;134(10):e123-55. doi: 10.1161/CIR.0000000000000404. Epub 2016 Mar 29. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2020
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 13, 2022
• First Submitted That Met QC Criteria: November 26, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: bleeding risk; dual antiplatelet therapy; percutenous coronary intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Ischemia; Chest Pain; Angina Pectoris; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hemorrhage; Myocardial Infarction; Infarction; Angina, Stable; Platelet Aggregation Inhibitors
• Other Study ID Numbers: 2002-150-1105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no pre-defined plan to share IPD, however, any relevant inquiry should be emailed to Dr. Hyo-Soo Kim or Dr. Jeehoon Kang.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No