Journal of Thrombosis and Thrombolysis

, Volume 45, Issue 4, pp 543–549 | Cite as

Direct-acting oral anticoagulant drug level monitoring in clinical patient management

  • Amihai Rottenstreich
  • Netanel Zacks
  • Geffen Kleinstern
  • Bruria Hirsh Raccah
  • Batia Roth
  • Nael Da’as
  • Yosef Kalish
Article
  • 250 Downloads

Abstract

The role of drug-level monitoring among patients using direct-acting oral anticoagulant (DOAC) is unclear. We aimed to investigate its ‘real-life’ utilization and effect on clinical management. A review of records of patients who underwent DOAC level testing during 2013–2017. Overall, 212 patients (median age 77 years) underwent 292 DOAC measurements [apixaban (n = 147), rivaroxaban (n = 102), dabigatran (n = 43)]. Monitoring volume increased by 460% during study period. DOAC level testing was performed during routine follow-up in 51 (17.5%) cases, whereas the remaining 241 (82.5%) measurements were performed due to selected clinical circumstances, most commonly: bleeding (n = 60), perioperative status (n = 45), breakthrough thrombosis (n = 37) and renal failure (n = 35). Drug levels were within the expected range in 210 (71.9%), above the expected range in 62 (21.2%) and lower than expected range in 20 (6.8%). In multivariate analysis, older age (P = 0.005), lower glomerular filtration rate (P = 0.001) and lower body mass index (P = 0.006) were associated with DOAC levels above the expected range. Clinical decisions were affected by DOAC monitoring following most (140/241, 58.1%) measurements for which we identified an indication for testing; yet only rarely when monitoring was performed during routine follow-up (7.8%, 4/51) (P < 0.0001). While no benefit of routine DOAC monitoring was observed, drug level measurement has an important role in the management of patients in selected circumstances. Age, body weight and creatinine clearance were found to be significant predictors of drug levels. Future studies are warranted to establish associations between drug levels and outcomes, and better delineate the role of DOAC monitoring.

Keywords

Monitoring Direct-acting oral anticoagulants Drug levels Real life Management 

Abbreviations

BMI

Body mass index

DOAC

Direct acting oral anticoagulant

eGFR

Estimated glomerular filtration rate

Notes

Acknowledgements

Netanel Zacks’s participation in this study was performed in fulfillment of research requirements toward the MD degree. We thank Ms. Cindy Cohen for her editorial assistance.

Author's Contributions

All authors-study concept, design, review and approval of the final manuscript. AR, NZ, BHR, GK, BR and YK reviewed the literature and wrote the paper. Authors AR, YK, ND and NZ collected the data.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflicts of interest.

Ehical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This study was approved by the local institutional review board of Hadassah Medical Center Helsinki Committee (IRB approval number No. HMO 0126-17).

Informed consent

Informed consent was obtained from all individual participants included in the study.

Supplementary material

11239_2018_1643_MOESM1_ESM.doc (40 kb)
Supplementary material 1 (DOC 40 KB)

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Hematology DepartmentHadassah-Hebrew University Medical CenterJerusalemIsrael
  2. 2.Department of Health Sciences ResearchMayo ClinicRochesterUSA
  3. 3.Department of CardiologyHadassah University HospitalJerusalemIsrael
  4. 4.Division of Clinical Pharmacy, Faculty of Medicine, School of Pharmacy, Institute for Drug ResearchHebrew University of JerusalemJerusalemIsrael
  5. 5.Internal Medicine Division, Hematology UnitShaare Zedek Medical CenterJerusalemIsrael

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