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NOAC monotherapy in patients with concomitant indications for oral anticoagulation undergoing transcatheter aortic valve implantation

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Abstract

Aims

Antithrombotic therapy after transcatheter aortic valve implantation (TAVI) is highly controversial and guideline recommendations are not evidence based. We assessed efficacy and safety of non-vitamin K antagonist oral anticoagulant (NOAC) monotherapy in patients with concomitant indications for OAC undergoing TAVI.

Methods

Among more than 1300 TAVI patients since 2008, 154 patients were identified who received postinterventional NOAC monotherapy. Outcomes were compared to 172 patients treated with vitamin K antagonist (VKA) monotherapy. Thromboembolic as well as bleeding complications were analysed for 6 months after TAVI.

Results

Despite high CHA2DS2-Vasc (4.6 ± 1.2), HEMORR2HAGES (4.7 ± 1.9) and HASBLED (2.7 ± 0.8) scores only three major/life-threatening bleedings and four thromboembolic events occurred after NOAC therapy had been initiated post-TAVI. 12 patients (7.8%) died within 6 months after the procedure. Compared to patients being treated with VKA monotherapy, analysis of a combined end-point of post-procedural death, stroke, embolism and severe bleeding revealed no significant differences (17/154 vs. 14/172; p = 0.45).

Conclusions

The results of this study suggest that NOAC therapy without additional antiplatelet treatment is effective and safe in patients with concomitant indications for OAC undergoing TAVI.

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Abbreviations

AF:

Atrial fibrillation

DAPT:

Dual antiplatelet therapy

HALT:

Hypo-attenuated leaflet thickening

ICB:

Intracranial bleeding

LMWH:

Low molecular weight heparin

MPG:

Mean pressure gradient

NOAC:

Non-vitamin K antagonist oral anticoagulant

OAC:

Oral anticoagulation

PTT:

Partial thromboplastin time

SAPT:

Single antiplatelet therapy

SAVR:

Surgical aortic valve replacement

TAVI:

Transcatheter aortic valve implantation

TIA:

Transitory ischaemic attack

VKA:

Vitamin K antagonist

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Authors and Affiliations

  1. Department of Internal Medicine III, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany

    Nicolas A. Geis, Christina Kiriakou, Emmanuel Chorianopoulos, Hugo A. Katus & Raffi Bekeredjian

  2. Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany

    Lorenz Uhlmann

Authors
  1. Nicolas A. Geis
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  2. Christina Kiriakou
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  3. Emmanuel Chorianopoulos
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  4. Lorenz Uhlmann
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  5. Hugo A. Katus
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  6. Raffi Bekeredjian
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Corresponding author

Correspondence to Nicolas A. Geis.

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Conflict of interest

Nicolas A. Geis, Raffi Bekeredjian and Emmanuel Chorianopoulos are investigators in the ADVANCE II and SIMPLIFy TAVI trial. The other authors report no conflicts of interest regarding the content herein.

Ethical standards

All patients were informed about indication, specific risks and alternatives of TAVI and gave informed written consent to the procedure and pre- and post-interventional monitoring (data collection). The study protocol has been approved by the local ethics committee and has, therefore, been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.

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Geis, N.A., Kiriakou, C., Chorianopoulos, E. et al. NOAC monotherapy in patients with concomitant indications for oral anticoagulation undergoing transcatheter aortic valve implantation. Clin Res Cardiol 107, 799–806 (2018). https://doi.org/10.1007/s00392-018-1247-x

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  • DOI: https://doi.org/10.1007/s00392-018-1247-x

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