Adverse events in patients taking apixaban or rivaroxaban who have undergone bariatric surgery: a retrospective case series.
Administration, Oral
Adult
Anticoagulants
/ adverse effects
Atrial Fibrillation
/ drug therapy
Bariatric Surgery
/ adverse effects
Dabigatran
/ therapeutic use
Hemorrhage
/ chemically induced
Humans
Pyrazoles
Pyridones
/ adverse effects
Retrospective Studies
Rivaroxaban
/ adverse effects
Thromboembolism
/ drug therapy
Thrombosis
/ drug therapy
Anticoagulants
Atrial fibrillation
Bariatric surgery
Direct oral anticoagulants
Safety
Venous thromboembolism
Journal
Journal of thrombosis and thrombolysis
ISSN: 1573-742X
Titre abrégé: J Thromb Thrombolysis
Pays: Netherlands
ID NLM: 9502018
Informations de publication
Date de publication:
Apr 2022
Apr 2022
Historique:
accepted:
12
09
2021
pubmed:
25
9
2021
medline:
13
4
2022
entrez:
24
9
2021
Statut:
ppublish
Résumé
Clinical trials comparing direct oral anticoagulants (DOAC) to warfarin excluded patients with a history of bariatric surgery. The anatomic changes from bariatric procedures have several effects on drug absorption which can have serious consequences for these patients. We sought to describe real-world use of DOACs among adults that had a history of bariatric surgery or underwent a bariatric surgery while receiving a DOAC. We conducted a retrospective case series of adult patients, at a large academic medical center, who initiated any DOAC in 2016 thru 2019 and had a history of bariatric surgery or underwent a bariatric surgery while receiving a DOAC. Thrombotic and bleeding events were described using summary statistics and bleeding severity was described using the International Society on Thrombosis and Haemostasis criteria. Twenty-eight patients met the inclusion criteria of having bariatric surgery (Roux-en-Y gastric bypass, sleeve gastrectomy or gastric band) and receiving a DOAC. Twenty (71.4%) were prescribed apixaban and eight (28.6%) were prescribed rivaroxaban. Seven patients (25%) experienced at least one clinically relevant non-major bleeding event, including one patient (3.6%) that had a major bleeding event. Two patients (7.1%) had a thromboembolic event. Coagulation laboratory studies were infrequently performed at the time of the bleeding or clotting events. Among patients with a history of bariatric surgery, use of DOACs were commonly associated with clinically relevant non-major bleeding events and less commonly associated with major bleeding and thromboembolic events. Larger studies may offer further insight into the overall safety and efficacy of DOAC therapy in patients that have undergone bariatric surgery. The specific role of coagulation laboratory studies warrants further evaluation.
Identifiants
pubmed: 34559367
doi: 10.1007/s11239-021-02573-6
pii: 10.1007/s11239-021-02573-6
doi:
Substances chimiques
Anticoagulants
0
Pyrazoles
0
Pyridones
0
apixaban
3Z9Y7UWC1J
Rivaroxaban
9NDF7JZ4M3
Dabigatran
I0VM4M70GC
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
601-606Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
Références
Chai-Adisaksopha C, Hillis C, Isayama T, Lim W, Iorio A, Crowther M (2015) Mortality outcomes in patients receiving direct oral anticoagulants: a systematic review and meta-analysis of randomized controlled trials. J Thromb Haemost 13(11):2012–2020. https://doi.org/10.1111/jth.13139
doi: 10.1111/jth.13139
pubmed: 26356595
Hakeam HA, Al-Sanea N (2017) Effect of major gastrointestinal tract surgery on the absorption and efficacy of direct acting oral anticoagulants (DOACs). J Thromb Thrombolysis 43(3):343–351. https://doi.org/10.1007/s11239-016-1465-x
doi: 10.1007/s11239-016-1465-x
pubmed: 28050755
American Society for Metabolic and Bariatric Surgery website (2020) https://asmbs.org/resources/estimate-of-bariatric-surgery-numbers
Martin KA, Lee CR, Farrell TM, Moll S (2017) Oral anticoagulant use after bariatric surgery: a literature review and clinical guidance. Am J Med 130(5):517–524. https://doi.org/10.1016/j.amjmed.2016.12.033
doi: 10.1016/j.amjmed.2016.12.033
pubmed: 28159600
pmcid: 5401640
Mahlmann A, Gehrisch S, Beyer-Westendorf J (2013) Pharmacokinetics of rivaroxaban after bariatric surgery: a case report. J Thromb Thrombolysis 36(4):533–5. https://doi.org/10.1007/s11239-013-0891-2
doi: 10.1007/s11239-013-0891-2
pubmed: 23417780
Kröll D, Nett PC, Borbély YM, Schädelin S, Bertaggia Calderara D, Alberio L, Stirnimann G (2018) The effect of bariatric surgery on the direct oral anticoagulant rivaroxaban: the extension study. Surg Obes Relat Dis 14(12):1890–1896. https://doi.org/10.1016/j.soard.2018.08.025
doi: 10.1016/j.soard.2018.08.025
pubmed: 30396779
Moore KT, Kröll D (2017) Influences of obesity and bariatric surgery on the clinical and pharmacologic profile of rivaroxaban. Am J Med 130(9):1024–1032. https://doi.org/10.1016/j.amjmed.2017.05.011
doi: 10.1016/j.amjmed.2017.05.011
pubmed: 28601546
Kröll D, Stirnimann G, Vogt A, Lai DLL, Borbély YM, Altmeier J, Schädelin S, Candinas D, Alberio L, Nett PC (2017) Pharmacokinetics and pharmacodynamics of single doses of rivaroxaban in obese patients prior to and after bariatric surgery. BrJ Clin Pharmacol 83(7):1466–1475. https://doi.org/10.1111/bcp.13243
doi: 10.1111/bcp.13243
Rottenstreich A, Barkai A, Arad A, Raccah BH, Kalish Y (2018) The effect of bariatric surgery on direct-acting oral anticoagulant drug levels. Thromb Res 163:190–195. https://doi.org/10.1016/j.thromres.2017.11.006
doi: 10.1016/j.thromres.2017.11.006
pubmed: 29157916
Leven C, Hoffmann C, Roche C, Couturaud F, Thereaux J, Lacut K (2021) Impact of bariatric surgery on oral anticoagulants pharmacology, and consequences for clinical practice: a narrative review. Fundam Clin Pharmacol 35(1):53–61. https://doi.org/10.1111/fcp.12587
doi: 10.1111/fcp.12587
pubmed: 32621292
Hanauer DA, Mei Q, Law J, Khanna R, Zheng K (2015) Supporting information retrieval from electronic health records: a report of University of Michigan’s nine-year experience in developing and using the electronic medical record search engine (EMERSE). J Biomed Inform 55:290–300. https://doi.org/10.1016/j.jvi.2015.05.003
doi: 10.1016/j.jvi.2015.05.003
pubmed: 25979153
pmcid: 4527540
Schulman S, Kearon C (2005) Subcommittee on control of anticoagulation of the scientific and standardization committee international society on thrombosis and haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non‐surgical patients. J Thromb Haemost 3:692–694. https://doi.org/10.1111/j.1538-7836.2005.01204.x
doi: 10.1111/j.1538-7836.2005.01204.x
Kaatz S, Ahmad D, Spyropoulos AC, Schulman S, Subcommittee on Control of Anticoagulation (2015) Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost 13(11):2119–2126. https://doi.org/10.1111/jth.13140
doi: 10.1111/jth.13140
Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L, ARISTOTLE Committees Investigators (2011) Apixaban versus warfain in patients with atrial fibrillation. N Engl J Med 365(11):981–992. https://doi.org/10.1056/NEJMoa1107039
doi: 10.1056/NEJMoa1107039
pubmed: 21870978
Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI, AMPLIFY Investigators (2013) Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med 369(9):799–808. https://doi.org/10.1056/NEJMoa1207541
doi: 10.1056/NEJMoa1207541
pubmed: 23808982
Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI, for the AMPLIFY-EXT Investigators (2013) Apixaban for the extended treatment of acute venous thromboembolism. N Engl J Med 368(8):699–708. https://doi.org/10.1056/NEJMoa1207541
doi: 10.1056/NEJMoa1207541
pubmed: 23216615
Tomaselli GF, Mahaffey KW, Cuker A, Dobesh PP, Doherty JU, Eikelboom JW, Florido R, Hucker W, Mehran R, Messé SR, Pollack CV Jr, Rodriguez F, Sarode R, Siegal D, Wiggins BS (2017) 2017 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants: a report of the American college of cardiology task force on expert consensus decision pathways. J Am Coll Cardiol 70(24):3042–3067. https://doi.org/10.1016/j.jacc.2017.09.1085
doi: 10.1016/j.jacc.2017.09.1085
pubmed: 29203195
Samuelson B, Cuker A, Siegal D, Crowther M, Garcia D (2017) Laboratory assessment of the anticoagulant activity of direct oral anticoagulants: a systematic review. Chest 151(1):127–138. https://doi.org/10.1016/j.chest.2016.08.1462
doi: 10.1016/j.chest.2016.08.1462
pubmed: 27637548