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. 2025 Jul;114(7):846-855.
doi: 10.1007/s00392-024-02517-z. Epub 2024 Aug 19.

Favorable safety profile of NOAC therapy in patients after tricuspid transcatheter edge-to-edge repair

Isabel A Hoerbrand  1 , Martin J Kraus  1 , Martin Gruber  1 , Nicolas A Geis  1 , Philipp Schlegel  1 , Norbert Frey  1   2 , Mathias H Konstandin  3   4
Affiliations

Favorable safety profile of NOAC therapy in patients after tricuspid transcatheter edge-to-edge repair

Isabel A Hoerbrand et al. Clin Res Cardiol. 2025 Jul.

Abstract

Background: Transcatheter edge-to-edge repair for severe tricuspid regurgitation (TR) is a new treatment option (t-TEER). Data on optimal antithrombotic therapy after t-TEER in patients with an indication for anticoagulation are scarce and evidence-based guideline recommendations are lacking. We sought to investigate efficacy and safety of novel oral anticoagulation (NOAC) and vitamin-K-antagonists (VKA) in patients undergoing t-TEER.

Methods: Among 78 consecutive patients with t-TEER of severe TR, 69 patients were identified with concomitant indication for oral anticoagulation. Outcomes of these patients treated with NOAC or VKA were compared over a median follow-up period of 327 (177-460) days.

Results: Despite elevated thromboembolic and bleeding risk scores (CHA2DS2-VASc 4.2 ± 1.1, HEMORR2HAGES 3.0 ± 1.0 and HAS-BLED 2.1 ± 0.8), only one major bleeding incidence occurred under NOAC therapy. The risk for overall (NOAC 8% vs. VKA group 26%, p = 0.044) and major bleeding events (NOAC 2% vs. VKA 21%, p = 0.010) was significantly lower in the NOAC compared to the VKA group. No significant difference was found between NOAC and VKA treatment in terms of mortality (NOAC 18% vs. VKA 16%, p = 0.865) or the combined endpoint of death, heart failure hospitalization, stroke, embolism, thrombosis, myocardial infarction, and severe bleeding (NOAC 48% vs. VKA 42%, p = 0.801). A comparison between apixaban (n = 27) and rivaroxaban (n = 16) treated patients revealed no significant differences between NOAC substances (all bleeding events apixaban 7% vs. rivaroxaban 13%, p = 0.638).

Conclusion: Results of this study indicate that NOACs may offer a favorable risk-benefit profile for patients with concomitant indication for anticoagulation therapy following t-TEER.

Keywords: Bleeding; NOAC; Oral anticoagulation; Transcatheter edge-to-edge repair; Transcatheter tricuspid valve repair; Tricuspid disease; Tricuspid regurgitation.

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Conflict of interest statement

Declarations. Conflict of interest: The authors report no conflict of interest. Ethics approval: The study is based on the principles outlined in the Declaration of Helsinki. Ethical approval was granted by the local Ethics Committee of the University Heidelberg. Informed consent: All patients gave written informed consent to the procedure and the clinical and scientific use of data.

Figures

Fig. 1
Fig. 1
a Mortality, b combined endpoint, c severe and d all bleeding events in patients treated with NOAK or VKA after t-TEER: Combined end-point composes of death, heart failure hospitalization, stroke, (pulmonary) embolism, thrombosis, myocardiac infarction and severe bleeding. Severe bleeding events (life-threatening and major) were defined as BARC-Grade ≥ 3 (Bleeding Academic Research Consortium). p values indicate significance from log-rank test over a median follow-up period of 327 days (interquartile range 177–460 days). NOAC novel oral anticoagulation, VKA vitamin K antagonist, t-TEER tricuspid transcatheter edge-to-edge repair
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References

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