Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk Patients

Study Overview
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Brief Summary
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Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation. Uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists. The investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (HBR) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.

Detailed Description
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For decades now, stroke prevention in patients with atrial fibrillation has largely consisted of chronic oral anticoagulation, often with no end in sight. This strategy, however, is associate with a high incidence of bleeding complications, especially when anticoagulation is associated with antiplatelet agents, as it occurs in patients with coronary artery disease undergoing percutaneous coronary intervention. Known as intermittent, on demand, or 'pill in the pocket' anticoagulation, the strategy of prescribing oral anticoagulation only when is actually needed, has gotten a feasibility boost from recent advancements in both medical therapy and rhythm monitoring technology. Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation. Uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists. The investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (HBR) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.

Official Title
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Safety and Efficacy of Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk (HBR) Patients With History of Paroxysmal Atrial Fibrillation

Conditions
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Ischemic Heart Disease, Atrial Fibrillation

Intervention / Treatment
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* Drug: Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban
* Drug: Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No chronic atrial fibrillation Coronary artery disease Percutaneous coronary intervention Exclusion Criteria: Contraindications to anticoagulation Pregnancy

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intermittent anticoagulation<br>Patients receiving anticoagulation only if continuous electrocardiographic monitoring detects an atrial fibrillation episode | Drug: Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban<br>* Patients will receive intermittent treatment with a novel oral anticoagulant drug<br>* Other names: INTERMITTENT GROUP;|
| Chronic anticoagulation<br>Patients receiving chronic oral anticoagulation regardless findings at continuous electrocardiographic monitoring | Drug: Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban<br>* Patients will receive chronic treatment with a novel oral anticoagulant drug<br>* Other names: CHRONIC GROUP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Outcome Event (MACE) | The time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia driven revascularization | Up to 1 year | 
| Days on anticoagulant treatment | The total number of days on anticoagulant treatment | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease