Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery

N Engl J MedPublished Randomised controlled trial

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 0.81–1.05

Authors' 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

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