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Tranexamic Acid to Reduce Bleeding in Patients Treated with Non-Vitamin K Oral Anticoagulants Undergoing Dental Extraction: The EXTRACT-NOAC Randomized Clinical Trial

1University of Leuven, Leuven, Belgium, 2University Hospitals Leuven, Leuven, Belgium, 3Regional Hospital Heilig Hart Leuven, Leuven, Belgium, 4General Hospital St-Jan Genk, Genk, Belgium, 5University of Antwerp, Antwerp, Belgium, 6ZMACK Association, AZ Monica Antwerp, Antwerp, Belgium, 7Karolinska Institutet, Stockholm, Sweden

Abstract Number: PB0412

Meeting: ISTH 2021 Congress

Theme: Fibrinogen, Fibrinolysis and Proteolysis » Fibrinolytic Factors and Inhibitors

Background: Oral bleeding after dental extraction in patients on non-vitamin K oral anticoagulants (NOACs) is a frequent problem.

Aims: We investigated whether 10% tranexamic acid (TXA) mouthwash decreases post-extraction bleeding in patients treated with non-vitamin K oral anticoagulants.

Methods: The EXTRACT-NOAC study is a randomized, double blind, placebo-controlled, multi-center, clinical trial, approved by the Medical Ethics Committee of University Hospitals Leuven (ClinicalTrials.gov NCT03413891). Patients gave informed consent and were randomly assigned to 10% TXA or placebo mouthwash, and were instructed to use the mouthwash prior to dental extraction, and three times a day for three days thereafter. The primary outcome was the number of patients with any post-extraction oral bleeding up to day 7. Secondary outcomes include the number and type of bleeds. The primary outcome was analyzed using a chi-square test. The effect of treatment was estimated by the risk ratio.

Results: 218 patients were included in the full analysis set of which 106 patients were assigned to TXA (74.8 (±8.8) years; 81 men) and 112 to placebo (72.7 (±10.7) years; 64 men). Post-extraction bleeding occurred in 28 (26.4%) patients in the TXA group and in 32 (28.6%) patients in the placebo group (relative risk, 0.92; 95% confidence interval [CI], 0.60 to 1.42; P=.72). There were 46 bleeds in the TXA group and 85 bleeds in the placebo group (rate ratio, 0.57; 95% CI, 0.31 to 1.05; P=.07), Figure 1. Extraction-related bleeds (rate ratio 0.56; 95% CI, 0.32 to 0.96) and delayed bleeds (rate ratio, 0.32; 95% CI, 0.12 to 0.89) were lower in the TXA group.

Post-extraction oral bleeds in patients who suffered from one, two, three or ≥ four bleeds.

Conclusions: In patients on NOACs undergoing dental extracting, TXA mouthwash did not reduce the number of patients with post-extraction oral bleeding. TXA may reduce the number of extraction-related and delayed bleeds.

To cite this abstract in AMA style:

Ockerman A, Miclotte I, Vanhaverbeke M, Vanassche T, Belmans A, Vanhove J, Meyns J, Nadjmi N, Van Hemelen G, Winderickx P, Jacobs R, Politis C, PV. Tranexamic Acid to Reduce Bleeding in Patients Treated with Non-Vitamin K Oral Anticoagulants Undergoing Dental Extraction: The EXTRACT-NOAC Randomized Clinical Trial [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/tranexamic-acid-to-reduce-bleeding-in-patients-treated-with-non-vitamin-k-oral-anticoagulants-undergoing-dental-extraction-the-extract-noac-randomized-clinical-trial/. Accessed August 16, 2022.

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