Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery
An erratum to this article was published (N Engl J Med, 22 Feb 2018 ↗)
Primary resultResult — go to the resultRelative risk 0.92 95% CI 0.81–1.05Authors' conclusion
Among patients undergoing coronary-artery surgery, tranexamic acid was associated with a lower risk of bleeding than was placebo, without a higher risk of death or thrombotic complications within 30 days after surgery. Tranexamic acid was associated with a higher risk of postoperative seizures.
Study context
- Population
- Patients scheduled for coronary-artery surgery at risk for perioperative complications4,631 underwent surgery with outcomes data
- Participants
- 4,662 patients
- Comparison
- Tranexamic acid vs placebo
- Tranexamic acidn = 2,311
- Placebon = 2,320reference
- Primary endpoint
- Composite of:
- Death
- Thrombotic complications (nonfatal MI, stroke, PE, renal failure or bowel infarction)
- Follow-up
- Within 30 days after surgery
Methodological details2-by-2 factorial, placebo-controlled
- 2-by-2 factorial
- Placebo-controlled
Primary result
As reported in the abstract
Relative risk
0.92
95% CI 0.81–1.05
P = 0.22
Events by treatment group
Tranexamic acid vs Placebo
RR 0.92 (95% CI 0.81–1.05); P = 0.22
Further findings
Total units of blood products transfused during hospitalization
P < 0.001
Safety
Major hemorrhage or cardiac tamponade leading to reoperation
P = 0.001
Seizures · Fisher's exact test
P = 0.002
Original publication
Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery. N Engl J Med. Published 23 October 2016. doi:10. 1056/ nejmoa1606424
Summarised from the published abstract; every number is checked against it