Multi Vessel Coronary Artery Disease
Conditions
Keywords
Antiplatelets, Coronary artery bypass surgery
Brief summary
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
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.
Interventions
DRUGTicagrelor
direct-acting oral P2Y12-receptor antagonist
DRUGClopidogrel
platelet aggregation inhibitor
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. patients aged 19 years or older 2. undergoing elective OPCAB surgery with multi-vessel coronary artery disease.
Exclusion criteria
1\) patient had aspirin resistance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early graft patency | 1 year after OPCAB | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with resistance with clopidogrel as assessed by VeriofyNowP2Y12 assay | 7 day after surgery | The cut-off PRU value was 188 PRU |
| Mediastinal Bleeding | up to 4 weeks | total drainage counts (ml) from median tubes |
| degree of resistance | 7 day after surgery | 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. |
| 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 | — |
| Total hospital day from admission to discharge | up to 4 weeks | — |
Countries
South Korea
Contacts
Primary ContactYoung-Nam Youn
Outcome results
None listed