HOST - DAPT Duration According the Bleeding Risk

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Disease, Acute Myocardial Infarction, Stable Angina

Intervention / Treatment
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* Drug: Dual antiplatelet agent duration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. The patient in whom the Bleeding Risk (according to the ARC-HBR classification) can be calculated. The patient has a working diagnosis of coronary artery disease which has been treated with percutaneous coronary intervention. Exclusion Criteria: Hypersensitivity to aspirin or P2Y12 inhibitors Patients in whom coroanry artery disease has been decided to be medically managed without a coronary stent. Positive pregnancy test or is known to be pregnant 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.)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBR - 1M DAPT<br>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<br>* 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).<br>|
| Active Comparator: HBR - 3M DAPT<br>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<br>* 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).<br>|
| Experimental: LBR - 12M DAPT<br>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<br>* 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).<br>|
| Active Comparator: LBR - 3M DAPT<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Oriented Composite Event | POCE; the composite of Death, Myocardial Infarction (MI), Stent thrombosis, Stroke, Revascularization, or ISTH Bleeding event | 1-year after percutaneous coronary intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major-Adverse Cardiovascular Event | MACE; the composite of Cardiac Death, Myocardial Infarction (MI), Stent thrombosis, or Revascularization | 1-year after percutaneous coronary intervention | 
| Any bleeding event | Bleeding events, defined by the ISTH (International Society on Thrombosis and Haemostasis) classification | 1-year after percutaneous coronary intervention | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutenous coronary intervention, dual antiplatelet therapy, bleeding risk