SAPT Versus DAPT in Incomplete Revascularization After CABG

Study Overview
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Brief Summary
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The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary artery bypass graft surgery (CABG). Before hospital discharge, patients will be 1:1 randomized to SAPT (acetylsalicylic acid 100 mg/die) or DAPT (acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die). DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter. Primary endpoint is the evaluation of cardiac-related mortality at 5 years from hospital discharge.

Official Title
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Single Versus Dual Antiplatelet Therapy in Patients With Incomplete Revascularization After Coronary Artery Bypass Graft Surgery

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: acetylsalicylic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...) incomplete myocardial revascularization, defined by anatomic or functional criteria obtained informed consent Exclusion Criteria: acute coronary syndrome < 12 months from surgery dual antiplatelet therapy at hospital admission planned procedure to complete myocardial revascularization (e.g. hybrid approach) intolerance / unable to take acetylsalicylic acid or ticagrelor preoperative atrial fibrillation impaired compliance planned pregnancy history of gastrointestinal bleeding chronic kidney disease (eGFR < 30 mL/min/1.73 m2) chronic liver disease severe heart failure at hospital admission active malignancy alcohol abuse any clinical condition not compatible with the treatment Exit Criteria: postoperative atrial fibrillation requiring anticoagulation postoperative hemorrhagic events (stroke, GI bleeding) occurrence of contraindications to acetylsalicylic acid or ticagrelor surgical treatment requiring DAPT withdrawn patient decision

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAPT<br>Dual antiplatelet therapy: acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die | Drug: Ticagrelor<br>* 90 mg bis in die<br>* Other names: Brilique;Drug: acetylsalicylic acid<br>* 100 mg die<br>|
| Active Comparator: SAPT<br>Single antiplatelet therapy: acetylsalicylic acid 100 mg/die | Drug: acetylsalicylic acid<br>* 100 mg die<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac-related mortality |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Overall mortality and non-cardiac-related mortality | 5 years | 
| Major adverse cardiac and cerebrovascular events (MACCEs) | cardiac-related mortality, myocardial infarction, repeated vessel revascularization, hospitalization for heart failure, major arrhythmias, stroke | 5 years | 
| Major adverse hemorrhagic events (MAHEs) | stroke, gastrointestinal bleeding, life-threatening bleeding | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery bypass grafting, incomplete revascularization, coronary artery disease, dual antiplatelet therapy