Dual Antiplatelet Therapy in Patients With Clopidogrel Resistance Following Off-Pump Coronary Artery Bypass

Study Overview
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Brief Summary
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Ticagrelor, a direct-acting oral P2Y12-receptor antagonist, provides greater and more consistent platelet inhibition than clopidogrel. This study aimed to compare outcomes of ticagrelor plus aspirin versus clopidogrel plus aspirin 1 year after off-pump coronary artery bypass grafting (OPCAB) in patients with clopidogrel resistance.

Detailed Description
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Between November 2014 and November 2020, 1739 patients underwent OPCAB. Aspirin (100mg daily) and clopidogrel (75mg daily) were administered beginning at aday 1 after surgery. On the 7th postoperative day, the clopidogrel resistance was evaluated by point-of-care assay. Among them, the patients had clopidogrel resistance were enrolled in this study. Investigators divide them into two groups [A: ticagrelor, B; clopidogrel]. Primary endpoint was all-cause of mortality 1 year after OPCAB. Secondary endpoint included major adverse cardiovascular events (MACE: cardiac death, myocardial infarction, or stroke). Multivariate Cox regression was used to evaluate predictors of end points.

Official Title
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Dual Antiplatelet Therapy in Patients With Clopidogrel Resistance Following Off-Pump Coronary Artery Bypass: Prospective, Randomized Controlled Trial

Conditions
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Multi Vessel Coronary Artery Disease

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged 19 years or older undergoing elective OPCAB surgery with multi-vessel coronary artery disease. Exclusion Criteria: 1) patient had aspirin resistance

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 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
Interventional Model Description: Postoperative cardiac surgery, patients were randomized to receive ticagrelor or clopidogrel (n=102), respectively. The selected agent was applied in the operating room.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor<br> | Drug: Ticagrelor<br>* direct-acting oral P2Y12-receptor antagonist<br>* Other names: brilinta;|
| Active Comparator: Clopidogrel<br> | Drug: Clopidogrel<br>* platelet aggregation inhibitor<br>* Other names: plavix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early graft patency | graft occlusion rate diagnosed by CT exam, at follow-up angiography, grafts were evaluated by use of the usual definition of patency and were assessed for FitzGibbon patency with the A, B, and O classification system in which FitzGibbon A is an excellent/unimpaired graft, Bis an impaired graft with a stenosis >50% reducing the caliber of the graft to <50% of the target artery diameter, and O is a completely occluded graft. | 1 year after OPCAB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of resistance | Platelet reactivity was assayed using the VeriofyNowP2Y12 assay (Accumetrics Inc, San Diego, CA) which is a cartridge-based assay that specifically measures the direct effects of clopidogrel on the platelet P2Y12 receptor. The results are expressed as P2Y12 reaction units (PRUs) for clopidogrel. The cut-off PRU value was 188 PRU and the details were described previous study. | 7 day after surgery | 
| Number of patients with resistance with clopidogrel as assessed by VeriofyNowP2Y12 assay | The cut-off PRU value was 188 PRU | 7 day after surgery | 
| Mediastinal Bleeding | total drainage counts (ml) from median tubes | up to 4 weeks | 
| Total hospital day from admission to discharge |  | up to 4 weeks | 
| rate of postoperative stroke of myocardial infarction |  | Participants will be followed during 1 years from operation | 
| rate of postoperative morbidity/ mortality |  | Participants will be followed during 5 years from operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiplatelets, Coronary artery bypass surgery