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Published on: November 24, 2014
Protective effects of tranexamic acid on clopidogrel before coronary artery bypass grafting: a multicenter randomized
Jia Shi1, Hongwen Ji, Facheng Ren
1State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Peking Union Medical College, China.
Insights
Clopidogrel increases bleeding and transfusion needs during coronary artery bypass grafting (CABG). Tranexamic acid effectively reduces these risks, particularly in patients with recent clopidogrel exposure.
Area of Science:
- Cardiovascular Surgery
- Pharmacology
- Transfusion Medicine
Background:
- Excessive bleeding and transfusion post-coronary artery bypass grafting (CABG) are linked to increased morbidity and mortality.
- Patients on antiplatelet agents like clopidogrel face heightened risks.
- Understanding the interplay between clopidogrel and antifibrinolytics is crucial for optimizing patient outcomes.
Purpose of the Study:
- To investigate the impact of clopidogrel exposure on bleeding and transfusion requirements in CABG patients.
- To evaluate the efficacy of tranexamic acid in mitigating these risks.
- To assess the interaction between clopidogrel and tranexamic acid.
Main Methods:
- A multicenter, randomized, blinded trial involving 552 patients undergoing on-pump CABG.
- Patients were stratified based on preoperative clopidogrel exposure (≤7 days, >7 days, none).
- Intervention involved tranexamic acid administration versus placebo.
Main Results:
- Clopidogrel significantly increased blood loss, major bleeding, and red blood cell (RBC) transfusion volumes and exposure.
- Tranexamic acid administration led to significant reductions in blood loss, major bleeding, and RBC transfusion metrics.
- The benefits of tranexamic acid were more pronounced in patients with recent clopidogrel exposure.
Conclusions:
- Preoperative clopidogrel use elevates bleeding and transfusion risks in CABG patients.
- Tranexamic acid effectively reduces these risks, offering additional protection for patients with recent clopidogrel exposure.
- This study highlights the importance of managing antiplatelet therapy and utilizing tranexamic acid in CABG procedures.
Importance:
Excessive bleeding and transfusion increase morbidity and mortality in patients receiving coronary artery bypass grafting (CABG), especially in those exposed to antiplatelet agents.
Objective:
To evaluate the influence and interaction of clopidogrel bisulfate and tranexamic acid on bleeding and transfusion outcomes.
Design:
A multicenter randomized and blinded trial.
Setting:
Seven medical centers across China.
Participants:
Patients eligible for randomization were 1173 men and women aged 18 to 85 years undergoing primary and isolated on-pump CABG; 570 adults were randomized and 552 were analyzed. Patients were recruited and stratified into 3 levels according to preoperative clopidogrel exposure (clopidogrel ingestion ≤7 days, clopidogrel discontinuation >7 days, and nonexposure).
Intervention:
Patients were randomized to receive tranexamic acid (10-mg/kg-1 bolus and 10-mg/kg-1/h-1 maintenance dose) or placebo.
Main Outcome Measure:
The primary outcomes included blood loss, major bleeding, and red blood cell (RBC) transfusion volume and exposure.
Results:
As compared with controls, clopidogrel increased blood loss (mean difference [MD], 270 mL; 95% CI, 135 to 404 mL), major bleeding (risk difference [RD], 18.5; 95% CI, 7.85 to 29.2), volume of RBCs transfused (MD, 2.97 U; 95% CI, 1.51 to 4.43 U), and RBC transfusion exposure (RD, 17.9; 95% CI, 8.51 to 27.2). As compared with placebo, tranexamic acid reduced blood loss (MD, -278 mL; 95% CI, -380 mL to -176 mL), major bleeding (RD, -19.5; 95% CI, -27.7 to -11.4), volume of RBCs transfused (MD, -2.58 U; 95% CI -3.61 U to -1.55 U), and RBC transfusion exposure (RD, -18.9; 95% CI, -26.4 to -11.4). Subgroup analysis demonstrated a significantly enhanced effect of tranexamic acid especially in patients with impaired platelet function.
Conclusions And Relevance:
Preoperative clopidogrel exposure increased bleeding and transfusion requirements in patients receiving on-pump CABG. Tranexamic acid reduced this risk and provided extra protection selectively in the patients with persistent clopidogrel exposure within 7 days before surgery. TRIAL REGISTRATIONL clinicaltrials.gov Identifier: NCT01060163.
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