(rivaroxaban)
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Last Updated: 06/27/2023
If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, XARELTOshould be stopped at least 24 hours before the procedure to reduce the risk of bleeding. In deciding whether a procedure should be delayed until 24 hours after the last dose of XARELTO, the increased risk of bleeding should be weighed against the urgency of intervention. XARELTO should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established. If oral medication cannot be taken after surgical intervention, consider administering a parenteral anticoagulant.1
XARELTO is a low-clearance drug, with a systemic clearance of approximately 10 L/hr in healthy volunteers following intravenous administration. The terminal elimination half-life of XARELTO is 5 to 9 hours in healthy subjects aged 20 to 45 years.1
The ADA does not provide specific guidelines on patients taking target-specific anticoagulant agents. A consensus paper issued by the ADA in 2012 states that the anticoagulation management of dental patients should be based on the type and complexity of the surgical procedure, the presence and degree of any renal impairment, and the presence of other risks for hemostasis (liver impairment, alcoholism, kidney failure, thrombocytopenia, hemophilia/other hematological disorders, cytotoxic medication).4
There is no increased risk of bleeding associated with continuation of anticoagulant therapy during minor procedures such as tooth extractions.4 For more complicated procedures such as oral/maxillofacial surgeries, administration of an anticoagulant agent should not be restarted until the risk of postoperative bleeding is minimal (eg, after a stable fibrin clot is formed), usually within 24-48 hours following surgery, because the onset of the anticoagulant effect of these drugs is rapid (compared with warfarin).5,10 Procedures with presumed bleeding risks are presented in Table: Dental Procedures and Associated Bleeding Risk.11
| Low |
| Moderate |
| High |
Gomez-Moreno et al (2016)2 conducted a prospective, randomized clinical trial to evaluate the incidence of bleeding complications after dental implant placement in patients taking uninterrupted XARELTO therapy.
Incidence over total numbers of teeth extracted | ||||||
---|---|---|---|---|---|---|
95% CI | vs No anticoagulants | vs Warfarin | vs Dabigatran | |||
Post-extraction bleeding incidences (%) | Lower (%) | Upper (%) | ||||
P value | P value | P value | ||||
No anticoagulants | 0.39 | 0.18 | 0.73 | |||
Warfarin | 3.63 | 2.16 | 5.67 | <0.001 | ||
Dabigatran | 1.65 | 0.34 | 4.74 | 0.051 | 0.221 | |
XARELTO | 3.41 | 0.71 | 9.64 | 0.008 | 1.000 | 0.395 |
Incidence over total numbers of study subjects | ||||||
95% CI | vs No anticoagulants | vs Warfarin | vs Dabigatran | |||
Post-extraction bleeding incidences (%) | Lower (%) | Upper (%) | ||||
P value | P value | P value | ||||
No anticoagulants | 0.39 | 0.16 | 0.81 | |||
Warfarin | 2.77 | 1.34 | 5.04 | <0.001 | ||
Dabigatran | 3.19 | 0.66 | 9.04 | 0.011 | 0.737 | |
XARELTO | 5.88 | 1.23 | 16.24 | 0.002 | 0.209 | 0.425 |
Abbreviations: CI, confidence interval |
Time of extraction | XARELTO | |||
---|---|---|---|---|
Taken in the morning | Post-extraction bleeding | Taken in the evening | Post-extraction bleeding | |
n (%) | n (%) | n (%) | ||
9-12 AM | 18 (31.0) | 3 | 3 (75.0) | 0 |
12-3 PM | 28 (48.3) | 0 | 1 (25.0) | 0 |
3-6 PM | 12 (20.7) | 0 | 0 | 0 |
*Values are n or n (%) |
Lababidi et al (2018)7 conducted a retrospective, controlled, cohort study to evaluate a noncessation protocol for patients taking (DOACs; XARELTO, n=26; apixaban, n=14; and dabigatran, n=3) compared to warfarin during dental extractions. Patients on DOAC therapy (n=43 underwent 53 dentoalveolar procedures) were compared to patients on uninterrupted warfarin therapy (n=50 underwent 59 dentoalveolar procedures). Under physician advice, 15 of the 53 dentoalveolar procedures were performed following perioperative cessation of a DOAC. Minor bleeding events were recorded in the warfarin (n=9) and noncessation DOAC group (n=4), 15.3% and 10.5%, respectively, showing no statistically significant difference (odds ratio: 0.65; P=0.56). Patients in the DOAC session group recorded no bleeding events.
Cocero et al (2019)8 conducted a retrospective cohort study of patients (N=100) undergoing tooth extractions while continuing DOACs (dabigatran, n=39; apixaban, n=37; XARELTO, n=24). Incidence of excessive bleeding occurring from a few hours up to 7 days following extractions was the primary endpoint. There was no bleeding in the patient population without comorbidities (0%; 95% CI: 0-8%). In patients with comorbidities, 4 bleeding cases were identified (6.25%; 95% CI: 2.5-15%; P=0.29); 3 cases were mild (2 with apixaban and 1 with XARELTO) and 1 was moderate (XARELTO). Extractions of couples and triples of multirooted teeth (P=0.004) significantly triggered bleeding in patients with comorbidities.
Miller et al (2018)9 conducted a retrospective cohort study of 12 patients on DOACs (XARELTO, n=7; apixaban, n=2; dabigatran, n=2; and edoxaban, n=1) undergoing 17 oral surgical procedures. In 52.9% of the cases (n=9), the DOAC was discontinued, vs 5.8% (n=1) and 41.2% (n=7) of cases in which the DOAC was continued or not recorded, respectively. There were no reports of bleeding complications for any of the patients.
A literature search of MEDLINE®, Embase®, BIOSIS Previews®, Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 07 June 2023.
1 | XARELTO (rivaroxaban) [Package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc; https://imedicalknowledge.veevavault.com/ui/approved_viewer?token=7994-2a7e16dc-2859-4486-a5a4-8838e35d61a6. |
2 | Gomez-Moreno G, Aguilar-Salvatierra A, Fernandez-Cejas E, et al. Dental implant surgery in patients in treatment with the anticoagulant oral rivaroxaban. Clin Oral Implants Res. 2016;27(6):730-733. |
3 | Hiroshi Iwabuchi, Natsuko Sawai Y., Yutaka Imai, et al. Frequency of hemorrhage after tooth extraction in patients treated with a direct oral anticoagulant: A multicenter cross-sectional study. PLOS ONE. 2022;17(4):e0266011. |
4 | Oral Health Topics: Anticoagulant Antiplatelet Medications and Dental Procedures. American Dental Association (ADA); 2012. http://www.ada.org/en/member-center/oral-health-topics/anticoagulant-antiplatelet-medications-and-dental. Accessed August 17, 2015. |
5 | Parameters of Care: Clinical Practice Guidelines for Oral and Maxillofacial Surgery. American Association of Oral and Maxillofacial Surgeries (AAOMS). http://www.aaoms.org/. Accessed August 17, 2015. |
6 | Ono Sachiko, Ishimaru Miho, Yokota Isao, et al. Risk of post-extraction bleeding with direct oral anticoagulant compared with warfarin: Retrospective cohort study using large scale claims data in Japan. Thrombosis Research. 2022;222(2023):24-30. |
7 | Lababidi E, Breik O, Savage J, et al. Assessing an oral surgery specific protocol for patients on direct oral anticoagulants: a retrospective controlled cohort study. Int J Oral Maxillofac Surg. 2018;47(7):940-946. |
8 | Cocero N, Basso M, Grosso S, et al. Direct Oral Anticoagulants and Medical Comorbidities in Patients Needing Dental Extractions: Management of the Risk of Bleeding. J Oral Maxillofac Surg. 2019;77(3):463-470. |
9 | Miller SG, Miller CS. Direct oral anticoagulants: A retrospective study of bleeding, behavior, and documentation. Oral Dis. 2018;24(1-2):243-248. |
10 | Firriolo F, Hupp W. Beyond warfarin: the new generation of oral anticoagulants and their implications for the management of dental patients. Oral Surg Oral Med Oral Pathol Oral Radio. 2012;113:431-441. |
11 | US Davis Medical Center. UC Davis Health System Anticoagulation Services Recommendations for anticoagulation management before and after dental procedures. UCDHS Pharmacy & Therapeutics Committee. June 2015. http://www.ucdmc.ucdavis.edu/anticoag/pdf/ AnticoagDentalProcedure.pdf. Accessed August 17, 2015. |