PB1372 - Rivaroxaban in patients with intestinal failure on parenteral nutrition (TINCRBEL study)

Tuesday, July 12, 2022

6:30 PM – 7:30 PM

Location: Exhibition

Presentation Format: In-Person

Presenting Author(s)

Tv

Thijs F. van Haaps

PhD-candidate
Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.
Amsterdam, Noord-Holland, Netherlands

Co-Author(s)

RB

Roisin Bavalia

MD, PhD
Amsterdam UMC location University of Amsterdam, Department of Vascular Medicine, the Netherlands
Amsterdam, Noord-Holland, Netherlands
RM

Ron A.A. Mathôt

Professor, Clinical pharmacologist, PharmD, PhD
Department of Hospital Pharmacy & Clinical Pharmacology, Amsterdam UMC – location AMC, The Netherlands.
Amsterdam, Noord-Holland, Netherlands
MS

Mireille J. Serlie

Prof.
Department of Endocrinology and Metabolism, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands
Amsterdam, Noord-Holland, Netherlands
Saskia Middeldorp, MD PhD

Professor
Department of Internal Medicine, Radboud university medical center, Nijmegen, The Netherlands
Nijmegen, Gelderland, Netherlands
Michiel Coppens, MD, PhD

Medical Specialist
Department of Vascular Medicine, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
Amsterdam, Noord-Holland, Netherlands

Background: Patients with intestinal failure (due to short bowel syndrome [SBS], other malabsorption or pseudo-obstruction) on parenteral nutrition require central venous access which puts them at high risk for thrombosis. As INR control on vitamin K antagonist is often poor in these patients, many are on subcutaneous heparin for secondary prevention. The direct oral anticoagulant rivaroxaban is resorbed proximally in the gastro-intestinal tract and might therefore be sufficiently resorbed.

Aims: To evaluate pharmacokinetics (PK) of rivaroxaban in patients on parenteral nutrition and to evaluate clinical outcome.

Methods: In this ongoing prospective cohort study, patients undergo a 6-point PK analysis within 2 weeks after starting rivaroxaban 20 mg. Patients with adequate resorption compared to reference ranges taken from patients without intestinal failure. Those within range were allowed to continue rivaroxaban and were followed clinically for at least six months. Those below range were extensively counselled and allowed to continue as a shared decision. Clinical outcomes include: thrombosis, major bleeding and death.

Results: Seventeen patients, median age 61 yrs (IQR: 44-70 yrs) are thus far included (10 with SBS). Anticoagulation was prescribed for VTE (n=16) or AF (n=1). After PK analysis, rivaroxaban was continued in 14 (82%) patients.
PK data are presented in Table 1. Mean Cmin was 37 ng/mL (90% CI 24-50), Cmax was 203 ng/mL (90% CI 155-251), and median Tmax was 3.0 hours. During a cumulative follow-up duration of 22.5 yrs thus far, no patients experienced thrombosis, major bleeding. One patient died at an elderly age, which was not related to the study drug.

Conclusion(s): These preliminary results suggest an adequate resorption of rivaroxaban in patients requiring parental nutrition due to SBS or intestinal malabsorption. Despite a high inter-individual variability, this patient population can be treated with rivaroxaban. However, future results of this study should confirm the current clinical outcomes.