Dental management considerations for a patient taking dabigatran etexilate: a case report

doi:10.1016/j.oooo.2013.05.001

Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology

Volume 116, Issue 3, September 2013, Pages e191-e195

https://doi.org/10.1016/j.oooo.2013.05.001 Get rights and content

Dabigatran is a direct thrombin inhibitor approved to help prevent thrombotic events in patients with atrial fibrillation. As a rather new drug approval, information on management of bleeding during dental surgery in patients taking dabigatran is sparse. In this case report, a 67-year old male with a positive history for atrial fibrillation, coronary artery disease, intermittent angina, hypertension, type 2 diabetes and normal renal function was taking dabigatran 150 mg, 2 times daily. He underwent 8 surgical extractions, alveoloplasty and tuberosity reduction. Per guidelines prescribed by van Ryn et al., the patient's dabigatran was held the night before surgery and resumed the day after. Adverse outcomes were not observed during the procedure or in the 7-month postoperative period. This case suggests that due to its short half-life, dabigatran can be temporarily discontinued 24 h prior to elective oral surgery with consent of the physician and restarted the following day resulting in minimal complications.

Section snippets

Case

A 67-year-old white male initially presented to the Veterans Affairs dental clinic for routine care. He was not in pain, but had not visited a dentist in some time and knew his teeth were in poor condition. His medical history was positive for atrial fibrillation and coronary artery disease with intermittent angina in addition to hypertension, type 2 diabetes, hyperlipidemia, obesity (5′11″, 241 lbs.), benign prostate hypertrophy, hypothyroidism, posttraumatic stress disorder, insomnia and

Discussion

This case report suggests that multiple extractions can be successfully completed on a patient taking dabigatran. Eight extractions, alveoloplasty and tuberosity reduction were performed under IV moderate sedation without any complication. Local hemostatic measures included use of local anesthetic with epinephrine 1:100,000, placement of absorbable gelatin sponges, primary closure and insertion of an immediate prosthesis. Prolonged bleeding was not observed in the postoperative period, healing

References (21)

J. Ansell et al.
The pharmacology and management of the vitamin K antagonists: the seventh ACCP conference on antithrombotic and thrombolytic therapy
Chest
(2004)
S.M. Jafri
Periprocedural thromboprophylaxis in patients receiving chronic anticoagulation therapy
Am Heart J
(2004)
A.H. Jeske et al.
Lack of a scientific basis for routine discontinuation of oral anticoagulation therapy before dental treatment
J Am Dent Assoc
(2003)
M.J. Wahl
Myths of dental surgery in patients receiving anticoagulant therapy
J Am Dent Assoc
(2000)
F.J. Firriolo et al.
Beyond warfarin: the new generation of oral anticoagulants and their implications for the management of dental patients
Oral Surg Oral Med Oral Pathol Oral Radiol
(2012)
J.W. Little
New oral anticoagulants: will they replace warfarin?
Oral Surg Oral Med Oral Pathol Oral Radiol
(2012)
FDA News Release: FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation
(2010)
J. Stangier
Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate
Clin Pharmacokinet
(2008)
J. van Ryn et al.
Dabigatran etexilate—a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity
Thromb Haemost
(2010)
Pradaxa (dabigatran etexilate) Revolutionizes Stroke Prevention in Atrial Fibrillation
(2011)

There are more references available in the full text version of this article.

Cited by (25)

Postoperative bleeding associated with antiplatelet and anticoagulant drugs: A retrospective study
2019, Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
To examine postoperative bleeding in patients taking antiplatelet and anticoagulant medications after invasive periodontal procedures.
This 6-year retrospective study collected data from the electronic health records of patients who underwent invasive periodontal procedures at the College of Dentistry, University of Kentucky Lexington, from January 1, 2011 through April 1, 2017. Records were included when the medical history was current, an invasive periodontal procedure was performed, an antiplatelet or anticoagulant medication was taken, and a postoperative visit was documented.
Four hundred and fifty-six patients (age range 22–89 years; mean age 66.1 years; 58% male) met the inclusion criteria and underwent 867 invasive periodontal procedures. Antiplatelet medications, warfarin, a direct oral anticoagulant, or a combination of these drugs were taken during 484 scaling and root planing procedures, 218 implant placements, 53 open flap debridements, 16 gingival grafts, 15 lateral windows, and 71 other. Medications were continued in 99.6% of patients during the procedure. Postoperative bleeding occurred after three procedures (0.35%) and resolved with local hemostatic measures. Medications were temporarily discontinued in four instances (range 1–5 days); none of these patients experienced postoperative bleeding.
Postoperative bleeding was infrequent in patients who underwent an invasive periodontal procedure while taking an antiplatelet or anticoagulant drug.
Postoperative bleeding risk of direct oral anticoagulants after oral surgery procedures: a systematic review and meta-analysis
2018, International Journal of Oral and Maxillofacial Surgery
Citation Excerpt :
Thirteen articles were been included in the systematic review: two retrospective case–control studies23,24, five prospective case–control studies25–29, three cross-sectional studies30–32, two case series33,34 and a case report35; while the meta-analysis included only six studies: five prospective case–control studies25–29 and a retrospective case–control study23. The studies were published in the last 4 years, with two studies in 201730,32, nine studies in 201623–29,31,34, one study in 201433 and one study in 201335. Table 2 also describes the study characteristics of the included articles.
Direct oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban; DOACs) have been introduced to improve safety and superior therapeutic value compared to their predecessors such as warfarin or enoxaparin. The aim of this systematic review and meta-analysis was to assess the postoperative bleeding risk of DOACs during oral surgery procedures. Systematic searches were performed in electronic databases including PubMed, Scopus, Web of Science and Cochrane Library. Thirteen studies were included in the qualitative synthesis: two retrospective case–control studies, five prospective case–control studies, three cross-sectional studies, two case series and a case report; while only six studies were statistically analysed. The risk ratio of postoperative bleeding in DOACs patients was significantly greater than in healthy patients (3.04; 95% confidence interval (CI) = 1.31–7.04). This is especially true for rivaroxaban (4.13; 95% CI = 1.25–13.69), and less so for dabigatran which presented a risk ratio similar to that of healthy patients (1.00; 95% CI = 0.21–4.82). However, further research is required to support these results. Both apixaban and edoxaban were excluded from statistical analysis due to the lack of clinical studies.
The mythology of anticoagulation therapy interruption for dental surgery
2018, Journal of the American Dental Association
Continuous anticoagulation therapy is used to prevent heart attacks, strokes, and other embolic complications. When patients receiving anticoagulation therapy undergo dental surgery, a decision must be made about whether to continue anticoagulation therapy and risk bleeding complications or briefly interrupt anticoagulation therapy and increase the risk of developing embolic complications. Results from decades of studies of thousands of dental patients receiving anticoagulation therapy reveal that bleeding complications requiring more than local measures for hemostasis have been rare and never fatal. However, embolic complications (some of which were fatal and others possibly permanently debilitating) sometimes have occurred in patients whose anticoagulation therapy was interrupted for dental procedures.
Although there is now virtually universal consensus among national medical and dental groups and other experts that anticoagulation therapy should not be interrupted for most dental surgery, there are still some arguments made supporting anticoagulation therapy interruption. An analysis of these arguments shows them to be based on a collection of myths and half-truths rather than on logical scientific conclusions. The time has come to stop anticoagulation therapy interruption for dental procedures.
Management of dental extraction in patients undergoing anticoagulant oral direct treatment: a pilot study
2016, Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
The main goal of this study was to compare the incidence of postoperative bleeding events after dental extractions between patients treated with direct oral anticoagulants (DOACs) and those treated with vitamin K antagonists (VKAs) without withdrawal of oral anticoagulant therapy (OAT). Our second objective was to evaluate the risk factors affecting postoperative hemorrhage after tooth extraction in patients taking DOACs.
This prospective observational study included 51 patients who were being treated with oral anticoagulants and required dental extractions. They were divided into two groups: 31 patients receiving a DOAC and 20 control patients taking VKA with an international normalized ratio between 2.0 and 3.0. In both groups, extractions were performed under continued OAT, and the same local hemostatic measures were applied. All procedures were performed in an outpatient facility. A bleeding event was defined as persistent oozing or marked hemorrhage over 20 minutes after tooth extraction despite local hemostasis procedures or all bleeding episode occurring during the first postoperative week.
Five patients taking DOACs had seven bleeding episodes, and four patients receiving VKAs had five bleeding episodes during the postoperative follow-up period. The difference in the number of bleeding events between the two groups was not statistically significant (adjusted odds ratio = 0.77; 95% confidence interval 0.19-3.19; P = .723).
Eleven (91.67%) bleeding events were mild and controlled by mechanical compression with gauzes, and one (8.33 %) was managed with a revision of the wound, application of fibrin glue, and resuturing. No bleeding required hospitalization or blood transfusion. All bleeding episodes occurred during the first 3 postoperative days.
According to our preliminary outcome data, dental extractions can be performed safely in an outpatient facility in patients treated with DOAC by applying local hemostatic measures, without interrupting or modifying OAT.
An evidence summary of the management of patients taking direct oral anticoagulants (DOACs) undergoing dental surgery
2016, International Journal of Oral and Maxillofacial Surgery
Citation Excerpt :
The latter, written prior to widespread use of the drugs, discussed rivaroxaban and dabigatran only and was based largely on speculative expert opinion rather than scientific fact.87 A very recent review article, published in September 2015,88 summarizes many of the papers already discussed above.61,66,70,71,73,74,77,78 Many of the important papers discussed above have been omitted, possibly due to the lack of a structured search methodology, and two papers that give no reference to dental procedures have been included.24,89
Direct oral anticoagulant (DOAC) drugs (dabigatran, rivaroxaban, and apixaban) have emerged in the last decade to overcome some of the drawbacks of existing medications. To date, little is known about the dental management of patients taking these drugs. This study was undertaken to establish the evidence for the management of patients undergoing dental procedures while taking these medications. A rapid review approach was used to identify clinical and scientific research related to dental surgery performed in patients taking DOACs in order to produce an evidence summary. The rapid review did not identify any systematic reviews or original clinical trials and the overall quality of evidence found was poor. Most of the literature consisted of non-structured review articles and guidance documents based on assumptions from non-dental data and expert opinion, and recommendations on best practice varied throughout. The findings from the review of the literature varied considerably. Currently, recommendations are based on poor quality scientific data and clinical trials are required to establish best evidence-based practice guidance.
Epistaxis and dabigatran, a new non-vitamin K antagonist oral anticoagulant
2014, Acta Otorrinolaringologica Espanola
Dabigatrán es un nuevo anticoagulante no antivitamina K con efecto antitrombina. Se le atribuyen menos efectos secundarios hemorrágicos, pero no presenta antídoto que revierta su función ni tiempos de coagulación específicos que lo monitoricen.
Estudio longitudinal observacional prospectivo anotando las características epidemiológicas, clínicas y terapéuticas más relevantes entre los sujetos tratados con dabigatrán que manifestaron epistaxis. Se compararon resultados frente a un grupo de casos de epistaxis bajo terapia anticoagulante con acenocumarol y otro de epistaxis en controles no anticoagulados.
Desde su inclusión en el Sistema Nacional de Salud hace casi 3 años dabigatrán ha hecho acudir a urgencias de nuestro centro a 19 sujetos por epistaxis, frente a 59 por acenocumarol y 144 no anticoagulados, con ingresos hospitalarios del 26, 28 y 14%, respectivamente. En 3 de los 5 ingresados tratados con dabigatrán se detectó insuficiencia renal, previamente no documentada. Precisaron transfusión de hemoderivados el 80% de los tratados con dabigatrán, 58% con acenocumarol y 23% no anticogulados, y procedimientos invasivos el 80, 35 y 21%, respectivamente. Aunque el riesgo hemorrágico fue menor para dabigatrán, la estancia hospitalaria fue mayor frente a acenocumarol, y este frente a no anticoagulados.
Dabigatrán ofrece menos casos severos de epistaxis que acenocumarol, pero resultan más difíciles de controlar y revertir.
Dabigatran is a new non-vitamin K antagonist (VKA) anticoagulant with anti-thrombin action, with supposedly fewer haemorrhagic complications. However, there are actually no established agents to reverse its effect, nor specific coagulation time tests for monitoring it.
An observational prospective study was developed, noting epidemiological, clinical and therapeutic features among subjects with epistaxis treated with dabigatran. Results were compared with a group of epistaxis cases of individuals under anticoagulant therapy with VKA (acenocoumarol) and a control group without anticoagulation.
Since its inclusion in our health system almost 3 years ago, 19 patients with epistaxis and concomitant use of dabigatran have been attended at the Emergency Unit in our hospital, as against 59 under VKA therapy and 144 without anticoagulation, with a mean admittance rate of 26%, 28% and 14%, respectively. In 3 out of 5 individuals admitted due to dabigatran treatment, previously unobserved renal failure was detected. Blood transfusion was needed in 80% of patients using dabigatran, 58% using VKA and 23% without anticoagulation. Invasive procedures to control nosebleed were required in 80%, 35% and 21%, respectively. Although haemorrhagic risk was lower in dabigatran cases, they showed the longest stay in the hospital when compared to the other groups.
With dabigatran, there are fewer cases of severe epistaxis than with acenocoumarol, but controlling them is more difficult.

View all citing articles on Scopus

View full text

Oral medicineOnline only articleDental management considerations for a patient taking dabigatran etexilate: a case report

Section snippets

Case

Discussion

Chest

Am Heart J

J Am Dent Assoc

J Am Dent Assoc

Oral Surg Oral Med Oral Pathol Oral Radiol

Oral Surg Oral Med Oral Pathol Oral Radiol

FDA News Release: FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation

Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate

Clin Pharmacokinet

Dabigatran etexilate—a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity

Thromb Haemost

Pradaxa (dabigatran etexilate) Revolutionizes Stroke Prevention in Atrial Fibrillation

Oral medicine
Online only article
Dental management considerations for a patient taking dabigatran etexilate: a case report