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Dabigatran and Dental Extractions https://doi.org/10.5272/jimab.2017232.1536 Journal of IMAB Journal of IMAB - Annual Proceeding (Scientific Papers). 2017 Apr-Jun;23(2): ISSN: 1312-773X https://www.journal-imab-bg.org Case report DABIGATRAN AND DENTAL EXTRACTIONS Atanaska S. Dinkova1 ,Dimitar T. Atanasov1, Lyudmila G. Vladimirova-Kitova2 1) Department of Oral Surgery, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria 2) Clinic of Cardiology, UMBAL “St. George”, Medical University - Plovdiv, Bulgaria. SUMMARY INTRODUCTION For more than 50 years, vitamin K antagonists have In the last 5 years, new anticoagulants have been been the gold standard in the treatment of cardiovascular introduced in the clinical practice, displacing Vit. K an- and cerebrovascular diseases and in the prevention of their tagonists, due to their rapid onset of action, no need for complications. In the last 5 years new anticoagulants regular monitoring, few drug and food interactions, and a dabigatran, rivaroxaban and apixaban are rapidly imple- broad therapeutic range (prophylaxis and treatment of pul- mented in the clinical practice, displacing Vit. K antago- monary embolism and venous thrombosis, prophylaxis af- nists, due to numerous of advantages they have. Dabigatran ter orthopaedic surgery; prophylaxis and treatment of is the first and most widely used new oral anticoagulant, thromboembolism associated with atrial fibrillation and/ so it is important for the dentists to be aware of this drug. or prosthetic replacement of heart valves; reduction of the The purpose of this article is to review NOA dabi- risk of death, reinfarction and thromboembolic events af- gatran, its monitoring and reversal, and provides clinical ter myocardial infarction). [1, 2] advice on the management of patients who receives dabiga- Three types of NOAs have recently been approved tran and requires dental extractions. for use in the USA and Europe: dabigatran etexilate- direct Material and methods: The course of five patients thrombin inhibitor (DTI), rivaroxaban and apixaban- fac- on dabigatran who underwent teeth extraction was assessed. tor Xa inhibitors (FXaI). A fourth one FXaI, edoxaban, ob- The medical charts of these patients were investigated. tained the recent approval of the European Morning dose of dabigatran (Pradaxa) was omitted and MedicinesAgency in Europe (June 2015, 19th). [3] teeth extraction was performed ≥12 hours after the last in- take of the drug. Dabigatran etexilate (Pradaxa®) Results: Fourteen teeth were extracted in five pa- Dabigatran etexilate (Pradaxa®, Boehringer tients receiving Dabigatran with normal creatinine clear- Ingelheim, Spain) is the first orally administered direct ance. Extractions were performed ≥12 hours after the last thrombin inhibitor. It was the first approved NOA in 2008 administration of dabigatran. Only one patient has slightly by the EU and in 2010 by the Food and Drug Administra- prolonged bleeding, successfully controlled with local tion (FDA). It is a specific, reversible direct thrombin in- hemostatic measures. hibitor that, after oral administration, is rapidly absorbed Conclusions: Simple teeth extractions can be safely and converted to its active form, dabigatran, through es- performed ≥12 hours after the last administration of the terase catalysed hydrolysis in plasma. Mechanism of ac- medication in patients with normal creatinine clearance tion of dabigatran is to bind with the active site on free without significantly greater bleeding risk than conven- and clot-bound thrombin (factor IIa) so it cannot trans- tional oral anticoagulants. However, currently no estab- form fibrinogen into fibrin. [4] It has a rapid onset of ac- lished evidence-based guidelines for dental management tion with a peak plasma concentration at 0.5–4 h. Twenty of these patients are available and further clinical studies percent of the absorbed drug undergoes hepatic metabo- are needed. lism, while 80% is excreted unchanged via the renal sys- tem, and the dosage must be reduced for patients with re- Keywords: anticoagulants, dabigatran, dental ex- nal impairment (CrCl< 50 ml/min). The half - life elimi- traction, hemostasis. nation primarily is determined by renal function and in healthy patients is 12-14 h, 14-17 h in elderly, up to 18 hours in patients with CrCL between 30 and 50 ml/min and up to 27 h in a patient with severe renal dysfunction (creatinine clearance <15–30 ml/min). [5, 6, 7, 8] Creati- nine levels should also be considered even the medica- tion is discontinued before a surgical procedure. [7] (Ta- ble 1) 1536 https://www.journal-imab-bg.org J of IMAB. 2017 Apr-Jun;23(2) Table 1. Direct anticoagulant suspension time according to creatinine clearance value. [9, 10] Renal function Timing of discontinuation after last Dabigatran dose of dabigatran before surgery Groups (Creatinine clearance, half-life (hours) mL/min) Standard riskbleeding High risk ofbleeding Normal > 80 13 (11-22) 12 hours 2-4 days Mild renal failure > 50 to < 80 15 (12-34) 24 hours 2-4 days Moderate renal failure > 30 to <50 18 (13-23) > 48 hours 4 days Severe renal failure < 30a 27 (22-35) 2-5 days > 5 days Routine monitoring of the anticoagulant effect of aged with local haemostasis. [18] dabigatran is not required. In the case of emergency, the Morimoto I, and et al. extracted twenty-three teeth thrombin clotting time (TT) and the ecarin clotting time in 19 patients, including two surgical extractions. Among (ECT) are the most sensitive tests for quantifying antico- the 19 patients, nine ingested rivaroxaban, six apixaban, agulation rate.aPTT is less sensitive, especially for higher and four dabigatran. One patient on rivaroxaban had per- doses of dabigatran but because of its broad usage is rec- sistent postoperative bleeding following two surgical ex- ommended in case of emergency. [5, 9, 11, 12, 13, 14] tractions. Mild oozing was observed in five patients (two In October 2015, the U.S. Food and Drug Adminis- on rivaroxaban and three on apixaban). There were no tration approved antidote of dabigatran Idarucizumab, a bleeding episodes in the patients on dabigatran. They monoclonal antibody (Praxbind®, Boehringer Ingelheim concluded that NOAs can usually be continued in patients Pharmaceuticals, Inc., Germany) for the treatment of pa- undergoing tooth extraction. Conversely, patients with a tients on dabigatran etexilate when reversal of the anti- prolonged aPTT (for dabigatran) have a higher risk of coagulant effect is needed for emergency surgery/urgent bleeding, therefore, adequate local haemostasis and fol- procedures, or in life-threatening or uncontrolled bleed- low-up are required. [12] ing. [15] For minutesIdarucizumab completely reverse the Yoshikawa H, and et al. extracted 55 teeth in 19 anticoagulant activity of dabigatran in 88 to 98 % of pa- patients who continued to receive dabigatran. The mean tients. [16] aPTT was 45.4 seconds. In one patient the aPTT was pro- longed to more than 70 seconds. All patients underwent Drug-drug interactions tooth extraction 6 to 8 hours after dabigatran intake. Post- Dabigatran has limited clinically significant drug operative bleeding occurred in the patient whom aPTT and food interactions. Concomitant intake of Ketoco- was prolonged to more than 70 seconds. They concluded nazole, amiodarone and verapamil may increase the anti- that measurement of aPTT before extraction is essential coagulant effect of dabigatran, whilst rifampicin may de- and tooth extraction can be performed without cessation crease its effect. The risk of bleeding may be increased of dabigatran if the patient’s aPTT is controlled to less also by concomitant use of other anticoagulants, anti- than 2 times the reference value. [19] platelets, and salicylates.[8] Given that non-cox-selective Weitzet et al. in 2012 published a case study of a NSAIDs inhibit platelet aggregation, it may be prudent patient taking dabigatran which presented bleeding com- to avoid their use in patients taking dabigatran. Paraceta- plications. In the article, the authors did a systematic re- mol and opioid analgesics are appropriate alternatives. viewed and included recommendations for minor surgi- [17] cal procedures, such as no drug withdrawal in dental cleanings and extractions, and to do such procedures more Risk of Bleeding and dental procedures than 10 hours after taking the last dose of the drug.[20] The review of the literature reveals only a few pub- Romond et al. in 2013 published a case report of a lished cases of teeth extractions in patients receiving patient who had eight dental extractions and pre-pros- dabigatran. thetic surgery (alveoloplasty and remodeling of the tu- Breik O, and et al. reported five cases of teeth ex- berosity in the maxilla) who was also taking dabigatran. tractions in patients, receiving dabigartan. The cases of In that case, dabigatran was withdrawn 24 hours before single tooth extractions were managed without drug ces- the procedure, and surgery was performed under intrave- sation and there were no significant postoperative bleed- nous sedation and local haemostatic measures were taken, ing. In case 4 successful extractions of multiple teeth were such as the use of local anaesthesia with vasoconstrictor, performed after ceasing dabigatran for 48 hours. Case 5 gelatin sponges, suture and placement of the immediate reports significant postoperative bleeding in a patient who prosthesis. There was no excessive bleeding or clotting underwent a full-mouth extraction while still taking problems in this case. The authors noted that having
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