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Safety and Feasibility of Treatment with Rivaroxaban for Non-Canonical Indications: A Case Series Analysis

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Abstract

Background and objectives

The new oral anticoagulants (NOACs) are used for the prevention of thromboembolic complications in patients with non-valvular atrial fibrillation (AF) and those at risk of deep venous thrombosis. Their rapid onset of action and predictable pharmacokinetic and pharmacodynamic profiles make them the optimal alternative to warfarin in the treatment of these two categories of patients. Unfortunately, however, NOACs cannot be used in patients with valvular AF or valvular cardiac prostheses. Although mechanical valves are effectively a contraindication to NOAC use due to several pathophysiological mechanisms that promote the use of warfarin rather than NOACs, few data exist regarding the use of such new pharmacological compounds on patients with cardiac biological valves or those who have undergone mitral repair or tubular aortic graft implantation.

Methods

Our case series involved 27 patients [mean age 70 ± 10 years; mean CHA2DS2-VASc (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke/transient ischemic attack (doubled), Vascular disease, Age 65–74 years, Sex category): 6 ± 1.4; and mean HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile international normalized ratios, Elderly, Drugs or alcohol): 4 ± 1] with AF and biological prostheses, repaired mitral valves, or tubular aortic graft who were treated with the factor Xa inhibitor rivaroxaban due to inefficacy or adverse effects of warfarin.

Results

The mean left ventricular ejection fraction was 48 ± 9 %, the left atrial diameter was 46.5 ± 7 mm, and the estimated glomerular filtration rate was 45 ± 21 mL/min/1.73 m2. The mean duration of treatment was 15 ± 2 months. No relevant complications or recurrent thromboembolic events occurred. Three patients had recurrent nose bleeding and two had hematuria that led to reduction of the rivaroxaban dose by the treating physician to 15 mg once a day after 4 months of therapy. No further bleeding episode was recorded after escalating the dose.

Conclusions

Rivaroxaban is a valuable treatment option for patients with biological prostheses, repaired mitral valves, or a tubular aortic graft in order to prevent thromboembolic complications.

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Authors and Affiliations

  1. Salvatore Maugeri Foundation I.R.C.C.S., Telese Terme, Benevento, Italy

    Domenico Acanfora, Chiara Acanfora, Marialaura Longobardi, Giuseppe Furgi & Bernardo Lanzillo

  2. Section of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, School of Medicine, University of Bari, Piazza G. Cesare 11, 70124, Bari, Italy

    Pietro Scicchitano, Ilaria Dentamaro, Annapaola Zito & Marco Matteo Ciccone

  3. San Francesco Hospital, Telese Terme, Benevento, Italy

    Gerardo Casucci

  4. Department of Geriatrics, Campus Bio-Medico University, Rome, Italy

    Raffaele Antonelli Incalzi

Authors
  1. Domenico Acanfora
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  2. Chiara Acanfora
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  3. Pietro Scicchitano
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  4. Marialaura Longobardi
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  5. Giuseppe Furgi
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  6. Gerardo Casucci
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  7. Bernardo Lanzillo
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  8. Ilaria Dentamaro
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  9. Annapaola Zito
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  10. Raffaele Antonelli Incalzi
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  11. Marco Matteo Ciccone
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Corresponding author

Correspondence to Marco Matteo Ciccone.

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Funding

No funding was received for this study.

Conflicts of interest

Domenico Acanfora, Chiara Acanfora, Pietro Scicchitano, Marialaura Longobardi, Giuseppe Furgi, Gerardo Casucci, Bernardo Lanzillo, Ilaria Dentamaro, Annapaola Zito, Raffaele Antonelli Incalzi, and Marco Matteo Ciccone declare no conflicts of interest.

Ethical approval

This study was performed in accordance with the 1964 Helsinki declaration (and its amendments), and the Local Ethical Committee or institutional review board which approved the study.

Informed consent

Written informed consent was obtained from patients before enrolment.

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Acanfora, D., Acanfora, C., Scicchitano, P. et al. Safety and Feasibility of Treatment with Rivaroxaban for Non-Canonical Indications: A Case Series Analysis. Clin Drug Investig 36, 857–862 (2016). https://doi.org/10.1007/s40261-016-0436-5

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  • DOI: https://doi.org/10.1007/s40261-016-0436-5

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