Resumption of anticoagulant therapy after major bleeding and recurrence of hemorrhagic complications in patients with atrial fibrillation with a high risk of stroke and thromboembolism (based on the results of 20 years of observation)

Aim.To analyze the frequency of resumption of anticoagulant therapy (ACT) after major and clinically significant bleeding among AF patients who received oral anticoagulants and were observed in the Department of clinical problems of atherothrombosis from 1999 to 2019 within the retro-prospective register Regata-2, and to search for clinical factors associated with recurrence of hemorrhagic complications among patients who resumed anticoagulant therapy after a bleeding episode. Materials and methods.In cohort study of patients with high-risk AF with absolute indications for ACT we enrolled 290 AF patients (130 women and 160 men) aged 32 to 85 years (the average age was 65.188.89 years). During the follow-up period, 92 patients developed hemorrhagic complications, and 73 of them resumed ACT. 35 of the 73 patients who resumed ACT developed a relapse of major/clinically significant bleeding. Results.The frequency of resuming ACT after the first hemorrhagic complication increased over time from 75% in the period from 19992003 to 90% in the period 20152019. We were not able to establish an exact relationship between the presence of concomitant pathology and the decision to resume the ACT after bleeding. The only reliable reason for refusing to resume the ACT was the patients categorical reluctance. Among patients who had recurrent hemorrhagic complications, the total score on the Charleson comorbidity scale was significantly higher (4.232.01vs3.521.43;p=0.0425). Patients with recurrent bleeding were significantly more likely to suffer from CKD with a decrease in GFR less than 60 ml/min/1.73 sq. m, and also had a history of erosive and ulcerative lesions of the gastrointestinal tract. There was also a significant Association of recurrent bleeding with the use of proton pump inhibitors. Subgroups of patients who switched from warfarin to taking direct oral anticoagulants after the first bleeding and subsequent recurrent bleeding did not differ in basic clinical characteristics from patients without bleeding after changing the anticoagulant. According to multiple regression analysis, NSAIDs showed a tendency to develop a relapse of B/C bleeding on the background of direct oral anticoagulants in patients who underwent GO on the background of warfarin therapy (b=0.4524,p=0.0530). Conclusion.During the 20-year follow-up, the frequency of all major and clinically significant bleeding was 2.6/100 patients-years, the frequency of first bleeding was 5.86/100 patients-years, while the frequency of repeated hemorrhagic complications was 7.06/100 patients-years. Patients with a high thromboembolic risk should receive anticoagulants, provided that the modifiable risk factors for bleeding are carefully corrected.

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Abstract WMP119: Short Term Use of Direct Oral Anticoagulants is Not Associated With Decreased Bleeding in High Risk Patients Following Percutaneous Left Atrial Appendage Closure

Stroke ◽

10.1161/str.51.suppl_1.wmp119 ◽

2020 ◽

Vol 51 (Suppl_1) ◽

Author(s):

Salman Farhat ◽

Demilade Adedinsewo ◽

Susie Sennhauser ◽

Jeffrey Winder ◽

Najiyah Salwa ◽

...

Keyword(s):

High Risk ◽

Left Atrial ◽

Left Atrial Appendage ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Left Atrial Appendage Closure ◽

Short Term ◽

Device Placement ◽

Clinically Significant

Introduction: Percutaneous left atrial appendage closure is well established as an alternative to anticoagulation therapy for stroke prophylaxis among patients with non-valvular atrial fibrillation (NVAF) with relative or absolute contraindications to anticoagulation. Only the Watchman® (BSC) device has FDA approval for this indication. There are no current guidelines on the choice of short term antithrombotic therapy following placement of the Watchman® device. The landmark Watchman® clinical trials utilized warfarin and aspirin in the first 45 days to facilitate endothelialization; however these studies were started prior to direct oral anticoagulants (DOAC) becoming widely available. Our main objective was to compare bleeding outcomes with warfarin vs. DOACs following Watchman® device placement. Methods: We conducted a retrospective chart review of all patients who received a Watchman® device at all three Mayo Clinic sites (MN, FL, AZ) between January 2010 and December 2018 with follow up for outcomes at 45 days or 6 weeks following procedure. We conducted bivariate analysis using t-tests and chi-square tests as appropriate. A logistic regression model was constructed to evaluate the effect of anticoagulant choice on bleeding and thromboembolic outcomes. Clinically significant bleeding was defined as bleeding leading to interruption of anticoagulation regimen or requiring transfusion. Results: 232 patients were identified (33% female), mean age in years, CHADS2VASC score and HASBLED scores were 77, 5 and 4 respectively. Overall, 39% were initiated on non-warfarin therapies and 11% had a significant bleeding episode during follow up. There was no difference in clinically significant bleeding events (11% vs. 12%; OR 0.92, 95% CI: 0.32 – 2.65) with short term DOAC use compared to warfarin. Patients who received a Watchman® due to GI bleeding were more likely to have a bleeding event in the first 6 weeks following Watchman® (OR: 4.08, 95% CI: 1.30 – 12.75). Conclusion: This observational study demonstrates no significant difference in bleeding episodes with DOACs compared to warfarin during the first 6 weeks following Watchman® device placement in patients at high risk for bleeding. Larger prospective studies are needed.

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Comparative Analysis of Antithrombotic Therapy in In-Patients with Atrial Fibrillation

Rational Pharmacotherapy in Cardiology ◽

10.20996/1819-6446-2019-15-1-49-53 ◽

2019 ◽

Vol 15 (1) ◽

pp. 49-53

Author(s):

V. I. Petrov ◽

O. V. Shatalova ◽

A. S. Gerasimenko ◽

V. S. Gorbatenko

Keyword(s):

Atrial Fibrillation ◽

High Risk ◽

Anticoagulant Therapy ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Thromboembolic Complications ◽

Antithrombotic Agents ◽

Cardiology Department ◽

Number Of Patients

Aim. To study the frequency of prescribing antithrombotic agents in patients with non-valvular atrial fibrillation (AF) who were hospitalized in the cardiology department of a multidisciplinary hospital.Material and methods. A retrospective one-time study of medical records of 765 patients with non-valvular AF treated in the cardiology department of a multidisciplinary hospital in 2012 and 2016 was performed.Results. All patients were stratified in three groups depending on the CHA2DS2-VASc score. The frequency of prescribing antithrombotic agents was evaluated in each group. A low risk of thromboembolic complications was found in 1% (n=3) of patients in 2012 and 0.6% (n=3) in 2016. All these patients received antithrombotic agents. CHA2DS2-VASc=1 was found in 6% (n=15) of patients with AF in 2012 and in 3.4% (n=17) in 2016. A significant number of patients in this group received anticoagulant therapy with vitamin K antagonists (warfarin) or with direct oral anticoagulants. A high risk of thromboembolic complications (CHA2DS2-VASc≥2) was found in 93% of patient (n=245) in 2012 and in 96% (n=482) in 2016. Anticoagulant therapy was prescribed in 70.2% (n=172) patients with high risk in 2012 and 80% (n=387) in 2016. However, some patients with high risk of thromboembolic complications did not have the necessary therapy.Conclusion. Positive changes in the structure and frequency of prescribing anticoagulant drugs in patients with AF and a high risk of thromboembolic complications were found during the years studied.

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Evaluation of Direct Oral Anticoagulants for the Treatment of Venous Thromboembolism in the Oncology Population

Blood ◽

10.1182/blood.v128.22.5026.5026 ◽

2016 ◽

Vol 128 (22) ◽

pp. 5026-5026

Author(s):

Jessica Hedvat ◽

Christina Howlett ◽

James K. McCloskey ◽

Ruchi Jain

Keyword(s):

Venous Thromboembolism ◽

High Risk ◽

Cancer Patients ◽

Bleeding Episode ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Package Insert ◽

Increased Risk ◽

Clinically Significant ◽

Risk For Bleeding

Abstract INTRODUCTION: Anticoagulant management of cancer-associated thrombosis is challenging since this patient population is concurrently at an increased risk for bleeding. The use of direct oral anticoagulants [(DOACs) dabigatran, rivaroxaban, apixaban] is not recommended for the treatment of venous thromboembolism (VTE) in cancer patients since there is limited data in this patient population. Despite limited evidence for use, DOACs are commonly prescribed due to ease of administration and lack of required laboratory monitoring. The objective of this study was to evaluate the practice and safety patterns of the DOACs when used for VTE treatment in the oncology population at Hackensack University Medical Center (HackensackUMC). METHODS: This study was a retrospective chart review of adult cancer patients treated at HackensackUMC who received dabigatran, rivaroxaban, or apixaban for the treatment of VTE. The protocol was reviewed and approved by the Institutional Review Board. Patients were identified through a computer generated report of the DOACs which included patients on all inpatient adult oncology floors at HackensackUMC from January 2013 to October 2015. Patients were included in this study if they were 18 years of age or older, admitted to an oncology floor, receiving a DOAC for VTE treatment for at least 48 hours, and had active cancer. Patients were excluded from this study if they were receiving hemodialysis or receiving a DOAC exclusively for the indication of atrial fibrillation. The primary outcomes of this study included the percentage of patients who were receiving a DOAC dosage consistent with that of the package insert and the percentage of patients who experienced clinically significant bleeding. The secondary outcomes of this study included the percentage of patients who had their DOAC held for thrombocytopenia and high risk procedures. Descriptive statistics were used to analyze study outcomes. RESULTS: Of the 126 patients screened, 39 patients were included. Thirty-five patients were on rivaroxaban and 4 patients were on apixaban (Table 1). Ten of 39 patients (26%) were not receiving a DOAC dosage consistent with that of the package insert. Of these 10 patients identified, the majority were receiving a lower DOAC dose than is recommended in the package insert. Our assumption is that these patients received a lower than recommended dose due to concerns for increased risk of bleeding. No patients experienced clinically significant bleeding. Four of 39 patients (10%) experienced a minor bleeding episode, all of which were gastrointestinal and/or genitourinary bleeds (Table 2). Four of 14 thrombocytopenic patients (29%) did not have their DOAC dose held for thrombocytopenia (none of which experienced a bleeding episode). All patients had their DOACs appropriately held for all procedures. CONCLUSION: Increased education and awareness on manufacturer recommended dosing of DOACs is warranted for oncology prescribers. Despite the increased risk for bleeding in cancer patients, no clinically significant bleeding events were identified in our patient cohort. To our knowledge, this is the first study to evaluate the use of DOACs for VTE treatment in patients with cancer at a high risk for bleeding. This data suggests that the use of DOACs may be safe to use for VTE treatment in the oncology population. This study may provide foundation for larger, randomized, controlled trials to determine whether DOACs should be used for VTE treatment in cancer patients. Disclosures Howlett: Eisai: Honoraria; Amgen: Honoraria; Pfizer: Honoraria; Sandoz: Honoraria; Teva: Speakers Bureau. McCloskey:Ariad: Consultancy, Speakers Bureau; Amgen: Speakers Bureau; Novartis: Speakers Bureau.

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Optimal duration of anticoagulant therapy in patients with venous thromboembolism

Italian Journal of Medicine ◽

10.4081/itjm.2018.1077 ◽

2018 ◽

Vol 12 (4) ◽

pp. 235-244

Author(s):

Gualtiero Palareti

Keyword(s):

Venous Thromboembolism ◽

High Risk ◽

Anticoagulant Therapy ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Severe Disease ◽

Direct Oral Anticoagulants ◽

Late Complications ◽

Risk Of Recurrence ◽

Risk Of Bleeding

Venous thromboembolism, a frequent and severe disease, has clinically important early and late complications and a strong tendency to recur. Anticoagulant therapy is the mainstay of treatment, performed by immediate administration of: i) parenteral anticoagulants followed by vitamin K antagonists, either dabigatran or edoxaban, two direct oral anticoagulants (DOACs); or ii) direct rivaroxaban or apixaban, two DOACs that can be used as single-drug approach. Treatment should last no less than 3 months in all patients though how long it should last thereafter is a more complex issue. The risk of recurrence results from several event- or patient-associated factors. Some patients have low risk and may be treated for 3 to 6 months only. Others (the majority) have a high risk of recurrence (approximately 50% in 10 years). Unfortunately, the protective effect of anticoagulation against recurrence is present only during treatment and is lost when therapy is stopped. For this reason, international guidelines recommend that there is no pre-definite period of anticoagulation (e.g. 1 or 2 years, and so on) in patients at high risk and suggest instead indefinite (extended) anticoagulation, provided there is no high risk of bleeding. When the decision is difficult, adjunctive criteria may be adopted, such as male sex and abnormal D-dimer assessed after anticoagulation is stopped, to identify patients at high risk who need indefinite therapy. The use of DOACs, especially at lower doses with a lower risk of bleeding, may make indefinite anticoagulation for patients easier.

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Laboratory bleeding predictors in elderly patients with atrial fibrillation taking direct oral anticoagulants

Medical Council ◽

10.21518/2079-701x-2019-21-40-43 ◽

2020 ◽

pp. 40-43

Author(s):

M. A. Gabitova ◽

P. M. Krupenin ◽

A. A. Sokolova ◽

D. A. Napalkov ◽

V. V. Fomin

Keyword(s):

Atrial Fibrillation ◽

Elderly Patients ◽

Anticoagulant Therapy ◽

Patient Monitoring ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Laboratory Methods ◽

Increased Risk ◽

Hemorrhagic Events ◽

Clinically Significant

Atrial fibrillation (AF) is one of the most common arrhythmias in patients ≥75 years of age. The increased risk of thrombosis due to age and the large number of concomitant diseases makes it evident that anticoagulant therapy is necessary. However, the same factors increase the risk of hemorrhagic complications, which are among the most dangerous side effects of anticoagulant therapy. That is why it is very important to identify patients with the highest probability of bleeding, whether large or small clinically significant and minor. The purpose of our study was to study the prognostic value of laboratory methods of examination with regard to the development of hemorrhagic events in elderly patients with AF taking direct oral anticoagulants (DOAC). The study enrolled 102 patients ≥75 years of age with AF of non-valve etiology taking dabigatran, apixaban, rivaroxaban at full or reduced doses. Anticoagulants were administered by outpatient and inpatient physicians. Both previous experience with DOAC prior to inclusion in the trial (if DOAC was previously prescribed) and prospective patient monitoring after inclusion in the trial were analyzed. The minimum analyzed period of DOAC intake was 18 months. Patients who underwent (n = 19) and did not undergo (n = 83) hemorrhagic events (all events were considered small by ISTH criteria) did not differ in any of the laboratory indicators potentially considered as predictors of hemorrhagic events.

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Direct oral anticoagulants (DOAC) versus warfarin and enoxaparin in ovarian vein thrombosis.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e14698 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e14698-e14698

Author(s):

Fahrettin Covut ◽

Tariq Zuheir Kewan ◽

Oscar Perez ◽

Hassan Awada ◽

Arslan Babar ◽

...

Keyword(s):

Cumulative Incidence ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Ovarian Vein ◽

Bleeding Events ◽

Predisposing Factor ◽

Vein Thrombosis ◽

Clinically Significant ◽

Ovarian Vein Thrombosis

e14698 Background: Ovarian vein thrombosis (OVT) is a rare condition that is commonly associated with malignancy. Efficacy and safety profile of DOAC in OVT has not been compared with warfarin and low-molecular-weight-heparin in the literature. Methods: We reviewed patients who were diagnosed with OVT between 11/2012 and 1/2018 and had follow-up imaging with computed tomography to assess resolution of thrombus. The outcomes of interests were thrombus resolution, recurrent thromboembolic events, and 1-year cumulative incidence of clinically significant bleeding events. Cumulative incidence was calculated with death and discontinuation of therapeutic anticoagulation as competing risks. Results: We identified 36 patients, 17 (47%) had right, 14 (39%) had left, and 5 (14%) had bilateral OVT. Median age and body mass index at diagnosis were 47 (range: 25 - 86) and 28 (range: 19 – 43), respectively. At least one predisposing factor was identified for 32 (92%) patients, 16 (44%) had underlying active malignancy. Overall, 27 (75%) patients achieved complete or partial recanalization at follow up CT after median of 4 months (range: 1 – 13) from initiation of anticoagulation. Ten (28%) and 11 (31%) patients were treated with DOAC and warfarin after median of 3 and 2 days of anticoagulation with unfractionated heparin or enoxaparin, and follow up CT after median of 6 and 4 months showed complete/partial recanalization rates of 70% and 55%, respectively (p = 0.47). Whereas, 15 patients received enoxaparin and follow up CT after median of 3 months showed that 93% of patients achieved complete/partial recanalization (p = 0.12 between DOAC vs enoxaparin cohorts). Recurrent thromboembolic event has not occurred in any patient during median follow-up of 14 months (range: 3 – 71). One-year cumulative incidence of clinically significant any bleeding for DOAC cohort versus warfarin and enoxaparin cohorts was 10% (95% CI: 9 – 28) versus 18% (95% CI: 12 – 41), p = 0.64, and 25% (95% CI: 4 – 46), p = 0.42, respectively. Conclusions: Apixaban and rivaroxaban showed similar risk-benefit ratio as warfarin and enoxaparin, hence, they can be considered as alternatives for OVT patients.

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Optimal duration of anticoagulant therapy in patients with venous thromboembolism

Italian Journal of Medicine ◽

10.4081/item.2018.1077 ◽

2018 ◽

Author(s):

Gualtiero Palareti

Keyword(s):

Venous Thromboembolism ◽

High Risk ◽

Anticoagulant Therapy ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Severe Disease ◽

Direct Oral Anticoagulants ◽

Late Complications ◽

Risk Of Recurrence ◽

Risk Of Bleeding

Venous thromboembolism (VTE), a frequent and severe disease, has clinically important early and late complications and a strong tendency to recur. Anticoagulant therapy is the mainstay of treatment, performed by immediate administration of: a) parenteral anticoagulants followed by vitamin K antagonists (VKAs), either dabigatran or edoxaban, two direct oral anticoagulants (DOACs); or b) direct rivaroxaban or apixaban, two DOACs that can be used as single-drug approach. Treatment should last no less than 3 months in all patients though how long it should last thereafter is a more complex issue. The risk of recurrence results from several event- or patient-associated factors. Some patients have low risk and may be treated for 3 to 6 months only. Others (the majority), have a high risk of recurrence (approximately 50% in 10 years). Unfortunately, the protective effect of anticoagulation against recurrence is present only during treatment and is lost when therapy is stopped. For this reason, international guidelines recommend there be no pre-definite period of anticoagulation (e.g. 1 or 2 years, and so on) in patients at high risk and suggest instead indefinite (extended) anticoagulation, provided there is no high risk of bleeding. When the decision is difficult, adjunctive criteria may be adopted, such as male sex and abnormal Ddimer assessed after anticoagulation is stopped, to identify patients at high risk who need indefinite therapy. The use of DOACs, especially at lower doses with a lower risk of bleeding, may make indefinite anticoagulation for patients easier.

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CHOICE OF DIRECT ORAL ANTICOAGULANTS BASED ON THE INDIVIDUAL APPROACH

Translational Medicine ◽

10.18705/2311-4495-2018-5-6-10-22 ◽

2019 ◽

Vol 5 (6) ◽

pp. 10-22

Author(s):

O. I. Efimova ◽

T. V. Pavlova

Keyword(s):

Atrial Fibrillation ◽

Anticoagulant Therapy ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Bleeding Risk ◽

Individual Characteristics ◽

Hemorrhagic Complication ◽

Complication Risk ◽

Stable Coronary Heart Disease ◽

The Individual

This review article deals with the comparison of different modes of anticoagulant therapy, taking into account the risk profile and the individual characteristics of patients with atrial fibrillation. This paper analyzes the efficacy and safety of direct oral anticoagulants in different clinical situations. Modifiable and unmodifiable bleeding risk factors are evaluated based on the hemorrhagic complication risk assessment scales for patients taking anticoagulants. The evidence base for anticoagulant therapy in the presence of a single episode of atrial fibrillation is represented. Regimens and terms of initiation of anticoagulant therapy after a cardioembolic stroke or transient ischemic attack are considered. In addition, great attention is paid to the problem of early prescription of anticoagulants after intracranial hemorrhage. For patients at high risk of gastrointestinal bleeding or impaired renal function, an optimal strategy for reducing thromboembolic complications is evaluated. Anticoagulant therapy is also evaluated in patients with stable coronary heart disease, including after coronary stenting.

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The association of anticoagulation therapy characteristics with left atrial thrombus lysis in patients with nonvalvular persistent atrial fibrillation

Jounal of arrhythmology ◽

10.35336/va-2021-2-11-17 ◽

2021 ◽

Vol 28 (2) ◽

pp. 11-17

Author(s):

E. S. Mazur ◽

V. V. Mazur ◽

N. D. Bazhenov ◽

Yu. A. Orlov

Keyword(s):

Atrial Fibrillation ◽

Transesophageal Echocardiography ◽

Anticoagulant Therapy ◽

Left Atrial ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Persistent Atrial Fibrillation ◽

Dissolution Time ◽

To Receive

Purpose. The aim of this study was to reveal the effect of the duration and characteristics of anticoagulant therapy on the clot dissolution in the left atrial appendage (LAA) in patients with persistent atrial fibrillation (AF).Material and methods. The repeat transesophageal echocardiography was performed in 68 patients with persistent AF, because the thrombus was detected in the LAA during the first examination. Of these, 37 (54.4%) patients started or continued to receive warfarin and 31 (45.6%) patients continued to receive the direct oral anticoagulants. Transesophageal echocardiography was repeated after 3-5 weeks. One follow-up examination was for 53 patients, two follow-up examination was for 11 patients and three follow-up examination was for 4 patients. Cox regression analysis was performed to identify factors affecting the likelihood of clot dissolution and Kaplan-Meier survival analyses with log-rank tests were used to compare the clot dissolution time.Results. The chance of the LAA thrombus lysis is 50% after 35.0 ± 3.7 days of receiving anticoagulants. This time is reduced to 30.0 ± 1.4 days for small thrombus (no more than 18 mm), and it increases to 45.0 ± 7.4 days (p = 0.038) for large thrombus. The dissolution time of small thrombus depends on the characteristics of the treatment: the median of the dissolution curve is 24.0 ± 3.7 days when the patients received the direct oral anticoagulants, and the median of the dissolution curve is 40.0 ± 7.2 days (p = 0.009), if the patients received warfarin. The dependence of the dissolution time of large thrombus on the characteristics of treatment did not found.Conclusion. The LAA thrombus dissolution time in patients with atrial fibrillation depends on their size, and the dissolution time of small thrombi depends on the characteristics of anticoagulant therapy.

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Anticoagulant therapy in patients with congenital FXI deficiency

Blood Advances ◽

10.1182/bloodadvances.2021005695 ◽

2021 ◽

Author(s):

Carlos Bravo-Perez ◽

M. Jose José Serna ◽

Julio Esteban ◽

Eugenia Fernandez-Mellid ◽

Emilia Fontanes-Trabazo ◽

...

Keyword(s):

Atrial Fibrillation ◽

Anticoagulant Therapy ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Bleeding Risk ◽

Drug Dosing ◽

Bleeding Episodes ◽

Bleeding History

The bleeding phenotype of FXI deficiency is unpredictable. Bleeding is usually mild, and mostly occurs after injury. Although FXI deficiency renders antithrombotic protection, some patients might eventually develop thrombosis or atrial fibrillation, requiring anticoagulant therapy. There is almost no evidence on the bleeding risk in this scenario. Our retrospective study of 269 Caucasian FXI-deficient subjects (1995-2021) identified 15 cases requiring anticoagulation. They harbored eight different F11 variants, mainly in heterozygosis (one case was homozygote) and had mild-moderate deficiency (FXI:C:20-70%). Two subjects (13.3%) had bleeding history before anticoagulation. Atrial fibrillation was the main indication (12/15,80%). Fourteen patients started therapy with vitamin K antagonists (VKA), but four were on direct oral anticoagulants (DOACs) at the end of follow-up. Over more than 1000 months of anticoagulation, two mild bleeding episodes in two patients (13.3%,95%CI:3.7-37.9%) were recorded. No major/fatal events were reported. "Pre-post" bleeding localization and severity did not change despite treatment. On VKA, drug dosing and management were also standard, unaltered by FXI deficiency. We provide the largest description of anticoagulant use in FXI deficiency, and the first cases receiving DOACs. While further studies are needed, our observations suggest that moderate FXI deficiency does not interfere with anticoagulant management nor bleeding risk.

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