Direct oral anticoagulants (DOACs) have emerged over the past decade as important alternatives to traditional anticoagulants such as vitamin K antagonists (VKAs). Their increasing clinical use is attributed to predictable pharmacokinetics, fixed dosing without the need for frequent monitoring, fewer food and drug interactions, and a rapid onset and offset of action¹. Among them, rivaroxaban, a direct factor Xa inhibitor, is widely prescribed for stroke prevention in atrial fibrillation, venous thromboembolism management, and prophylaxis following orthopedic surgeries. However, while their advantages are clear, the inherent anticoagulant activity of DOACs creates challenges in surgical fields where bleeding risk must be balanced against thromboembolic prevention.

In oral and maxillofacial surgery, particularly tooth extractions², the peri-operative management of anticoagulated patients has long been an area of clinical uncertainty. For decades, guidelines on warfarin management, such as measuring the International Normalized Ratio (INR) before procedures and maintaining therapeutic ranges while using local hemostatic measures, have offered clinicians evidence-based strategies. In contrast, limited standardized protocols exist for patients on DOAC therapy³. The absence of routine laboratory monitoring parameters for DOACs further complicates risk stratification. With rivaroxaban’s widespread prescription, oral surgeons are increasingly confronted with patients who require dentoalveolar procedures under continuous anticoagulant therapy.⁴The central dilemma lies in the peri-operative balance between bleeding and thromboembolic complications. Interrupting anticoagulant therapy may reduce the risk of post-extraction hemorrhage but simultaneously exposes patients to potentially catastrophic thromboembolic events such as ischemic stroke or systemic embolism. Conversely, continuing rivaroxaban ensures ongoing thromboembolic protection but carries the risk of persistent post-operative bleeding⁵, which may prolong recovery, increase re-attendance rates for hemostatic interventions, and impair patient quality of life. Unlike VKAs, reversal of DOAC activity is challenging. Idarucizumab, an antidote for dabigatran, and andexanet alfa, for rivaroxaban and apixaban, are available but costly and not universally accessible, restricting their use to emergencies involving severe or life-threatening bleeding.⁶ Therefore, the clinician’s decision-making must often rely on local hemostatic measures, careful timing of the procedure relative to drug intake, and the individual patient’s risk profile.Existing evidence suggests that the risk of clinically significant bleeding after simple dental extractions in patients continuing DOAC therapy is relatively low. Several observational studies and systematic reviews have reported that the majority of post-extraction bleeding episodes can be managed effectively with local measures,⁷ such as pressure application, absorbable hemostatic dressings, suturing, or tranexamic acid mouth rinses⁸. Importantly, most patients do not require hospitalization, transfusion, or systemic reversal agents. However, these studies often involve small sample sizes, heterogeneous populations, and variable methodologies, limiting their generalizability. Moreover, some reports suggest that patients on rivaroxaban may have a slightly higher incidence of oozing or delayed bleeding compared to non-anticoagulated individuals, although clinically significant differences remain uncertain.The timing of rivaroxaban administration in relation to surgery is another critical factor. Given its short half-life of approximately 5–13 hours depending on renal function, some protocols advocate scheduling dental extractions at trough plasma levels (i.e., just before the next dose) to minimize bleeding risk without interrupting therapy.^9,10 Others recommend omitting a single pre-operative dose in higher-risk situations, though this strategy must be carefully balanced against thromboembolic risk. To date, no universally accepted consensus exists on whether rivaroxaban should be continued or temporarily withheld for minor oral surgical procedures.The clinical significance of this issue is magnified by the increasing prevalence of cardiovascular and thromboembolic diseases requiring long-term anticoagulation, particularly in the aging population⁸. Oral health professionals are therefore more likely than ever to encounter patients on rivaroxaban requiring extractions or other dentoalveolar interventions. A clear understanding of bleeding risk under continued therapy is essential for safe surgical planning, effective patient counseling, and rational use of healthcare resources.

AIM

Study of postoperative bleeding risk for oral surgery under continued rivaroxaban anticoagulant therapy.

This  prospective cross-sectional  study was conducted at department ofbiochemistry, Govt. Medical college, Kota,for 6 months. A total of 63 patients were included during the study period.Consecutive patients receiving rivaroxaban who required simple tooth extraction(s) were enrolled, provided they were managed without systemic interruption of anticoagulant therapy.Eligible participants were adults aged 18 years or older who had been on rivaroxaban therapy with diagnosis as non-valvular atrial fibrillation or venous thromboembolism for at least one month prior to the procedure. Patients were required to undergo single or multiple simple dental extractions not involving bone removal or complex surgical intervention, and all provided written informed consent prior to inclusion.Exclusion criteria included the use of other oral anticoagulants such as warfarin, dabigatran, apixaban, or edoxaban, or the use of dual anticoagulant therapy.  Further exclusions were applied to patients with known bleeding disorders, including hemophilia and platelet dysfunction, as well as those with thrombocytopenia (platelet count <100 × 10^9/L) or active gastrointestinal bleeding.

Table 1: Age wise distribution

In the present study of 63 patients, the majority (39.4%) belonged to the 50–60 years age group, followed by 28.6% above 60 years and 20.6% in the 26–50 years group. Only 11.1% of the patients were in the 18–25 years age group.

Table 2: Gender distribution

Out of 63 patients, 36 (57%) were males and 27 (43%) were females. This shows a slight male predominance among those undergoing oral procedures while on rivaroxaban therapy.

Table 3:Indication for rivaroxaban

The most common indication for rivaroxaban therapy among the study group was atrial fibrillation (47.6%), followed by deep vein thrombosis (23.8%) and pulmonary embolism (15.9%). Stroke (7.9%) and post-orthopedic prophylaxis (4.8%) were less frequent indications.

Table 4:Duration of rivaroxaban use

The majority of patients had been on rivaroxaban for less than 3 months (43%), followed by 3–9 months (33%), with fewer patients on therapy for 9–12 months (13%) or more than 12 months (11%). This indicates that most oral procedures were performed in patients relatively early in their anticoagulation course.

Table 5:Procedural Details

Among the 63 patients, single-tooth extractions were more common, performed in 40 patients (63.5%), while multiple extractions were carried out in 23 patients (36.5%).The majority of procedures were simple extractions using forceps or elevators (82.5%), with surgical extractions involving flap elevation or minor bone removal accounting for 17.5%.Regarding the site of extraction, maxillary and mandibular teeth were almost equally involved, with 49.2% and 50.8% of cases, respectively.

Table 6:Postoperative Outcomes

Among the 63 patients, 40% experienced no postoperative bleeding, while immediate bleeding within 24 hours occurred in 27% and delayed bleeding within 24–72 hours was observed in 14% of cases. Local hemostatic measures were required in 17% of patients, and only one patient (2%) required hospital admission for bleeding. 

Among the 63 patients undergoing oral procedures, the largest proportion was observed in the 50–60 years age group, comprising 39.4% of the study population.Patients above 60 years accounted for 28.6%, indicating a significant representation of older adults.Those aged between 26–50 years made up 20.6% of the participants, reflecting a moderate proportion of middle-aged individuals.Only 11.1% of the study population fell within the 18–25 years category, representing the youngest group.This distribution highlights that the majority of patients undergoing extractions while on rivaroxaban therapy belonged to the older age groups.In the present study, a total of 63 patients were included, out of which 36 were males and 27 were females.Males constituted 57% of the study population, whereas females accounted for 43%.This reflects a mild male predominance among patients undergoing oral procedures under rivaroxaban therapy.Similarly, in a study by Lee, JY., Park, SH¹¹. et al. included a total of 537 participants, comprising 300 males, accounting for 55.9% of the sample, and 237 females, representing 44.1%. The ages of the participants ranged widely, spanning from 18 to 94 years, reflecting a diverse adult population. The mean age of the entire cohort was 71.0 years, with a standard deviation of 9.63 years, indicating moderate variability in age distribution.

In this study, atrial fibrillation was the most frequent indication for rivaroxaban therapy, accounting for 47.6% of cases.Deep vein thrombosis was the second most common, seen in 23.8% of patients, while pulmonary embolism contributed to 15.9%.Stroke was reported as an indication in 7.9% of patients.Post-orthopedic prophylaxis represented the least common reason, observed in only 4.8% of the study population.This distribution highlights that the majority of patients were prescribed rivaroxaban for cardiovascular and thromboembolic conditions, particularly atrial fibrillation.

In the present study, the duration of rivaroxaban therapy varied among patients undergoing oral procedures. The largest proportion, 43%, had been on therapy for less than 3 months, followed by 33% who were on treatment for 3–9 months. Fewer patients had longer durations, with 13% on therapy for 9–12 months and 11% for more than 12 months. This distribution highlights that most patients underwent oral procedures relatively early in their anticoagulation course. Understanding therapy duration is important for anticipating bleeding risk and planning appropriate perioperative management.

In this study of 63 patients undergoing oral procedures, single-tooth extractions were the most frequent, performed in 40 patients, accounting for 63.5% of cases.Multiple extractions were carried out in 23 patients, representing 36.5% of the study population.The majority of procedures were simple extractions using forceps or elevators, comprising 82.5% of all cases.Surgical extractions, involving flap elevation or minor bone removal, accounted for 17.5% of procedures.Regarding the site of extraction, maxillary teeth were involved in 49.2% of cases, while mandibular teeth accounted for 50.8%.Similarly ,Bajkin, Branislav &Vujkov et.al. (2015)¹² took 125 patients receiving anticoagulant therapy into 1 of 3 groups. Group A had 54 patients who were highly anticoagulated (international normalized ratio [INR] ≥ 3.5) in whom up to 3 teeth were extracted. Group B had 60 patients with INR 2.0 to less than 3.5 in whom higher-risk dentoalveolar surgery (extraction of more than 3 teeth or other oral surgery procedure involving raising a mucoperiosteal flap, osteotomy, or biopsy) was performed. Group C had 11 patients whose INR values were 3.5 or higher and who required higher-risk dentoalveolar surgery.

In the present study, 25 patients (40%) did not experience any postoperative bleeding following oral procedures.Immediate bleeding within 24 hours was observed in 17 patients, accounting for 27% of cases.Delayed bleeding occurring between 24 and 72 hours was seen in 9 patients, representing 14% of the study population.Localhemostatic measures, such as pressure application, suturing, or topical agents, were required in 11 patients, making up 17% of cases.Only one patient (2%) experienced severe bleeding necessitating hospital admission.Similarly, in a study by Hanken, H., Gröbe, A., Heiland, M. et al¹³.Postoperative bleeding complications after oral surgery occurred significantly more often in patients under continued rivaroxaban therapy (11.5 %) than in the control cases without anticoagulation/antiplatelet medication (0.7 %). All of the bleeding events were manageable: Two of them were treated with local compression, three by applying new fibrin glue with (one case) or without (two cases) secondary sutures, one occurred during a weekend and was therefore treated under inpatient conditions with suture replacement. All postoperative bleeding episodes occurred during the first postoperative week.

The present study demonstrates that oral surgical procedures, including extractions, can be safely performed in patients on continued rivaroxaban therapy. The majority of patients were older adults, with a mild male predominance, and atrial fibrillation was the leading indication for anticoagulation, followed by deep vein thrombosis and pulmonary embolism. Single-tooth extractions and simple extractions were the most common procedures. Postoperative bleeding was observed in a proportion of patients but was mostly mild and effectively managed with local hemostatic measures, with only a very small fraction requiring hospital admission. These findings suggest that continuation of rivaroxaban during minor oral surgery is generally safe, and with appropriate monitoring and hemostatic precautions, the risk of significant bleeding is low. The study supports evidence-based guidance for clinicians to avoid unnecessary interruption of anticoagulation, thereby minimizing thromboembolic risk while maintaining patient safety during oral surgical procedures.

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