Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology

Study Overview
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Brief Summary
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Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month of Direct Oral Anticoagulant (DAOC) or Vitamin K Antagonist (VKA)) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon taking part to the study will be included in this prospective observational study. The main composite outcome is the occurrence rate of hemorrhagic and/or thromboembolic events during the peri-procedural period (between 5 days before surgery plus 30 days after the invasive procedure). 0. The secondary end-points will consist of identifying risk factors for bleeding during the peri-procedural period, risk factors for thromboembolic events during the peri-procedural period, the peri-procedural management of each treatment (VKA or DOAC), the prescribers involved in the possible change of anticoagulant prescription prior the oral surgery All outcome events will be blindly adjudicated by a central independent adjudication committee.

Detailed Description
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Manager Centre de Pharmaco-épidémiologie de l'AP-HP Title Survey about oral anticoagulant peri-procedural management in patients undergoing an oral surgery, implantology or periodontology Acronym PRADICO Investigator Coordinator Isabelle MAHE Number of investigational sites 100 Number of patients 2000 Population Patients receiving oral anticoagulant undergoing an oral surgery, implantology or periodontology Research calendar Duration of inclusions: 1 year Duration of follow up: 30 days Study duration: 13 months Selection criteria Inclusion criteria : Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon member of the SFCO (Société Française de Chirurgie Orale) or a periodontologist member of the SFPIO (Société Française de Parodontologie et d'Implantologie Orale) taking part to the study. Each investigator will include 10 patients treated with long-term DOAC, and 10 consecutive patients treated with long-term VKA. For the DOAC group, inclusion will be continued until the inclusion of 333 patients for each molecule (apixaban, rivaroxaban, edoxaban). Non-inclusion criteria : Patients receiving both VKA and antiplatelet agents Patients receiving both direct oral anticoagulant and antiplatelet agents Objectives Primary aim: To assess the composite rate of thromboembolic and bleeding events occurring within the peri-procedural period, in patients on long-term DOAC and VKA and undergoing an oral surgery, implantology or periodontology. Secondary aims : To identify risk factors for bleeding during the peri-procedural period To identify risk factors for thromboembolic events during the peri-procedural period To describe the peri-procedural management of each treatment (VKA or DOAC) To identify prescribers involved in the possible change of anticoagulant prescription prior the oral surgery To compare the risk of bleeding on DOAC and on VKA To compare the risk of thromboembolic complications on DOAC and on VKA To evaluate the net clinical benefit of DOAC compared to VKA treatment Endpoints Primary endpoint : A composite outcome: the occurrence rate of hemorrhagic and/or thromboembolic events during the peri-procedural period. Secondary endpoints : Incidence of bleeding events incidence of thromboembolic events net clinical benefit of DOAC compared to VKA Methodology Prospective observational non interventional multicentric cohort study in adult population under long-term anticoagulant treatment (DOAC or VKA) and undergoing an oral, periodontal or implant surgery, by liberal practitioners or oral specialists at hospital. Statistical analysis The occurrence rate of hemorrhagic or thromboembolic events during peri-procedural period will be calculated globally and in each group (VKA or DOAC) as a percentage with 95% CI. Financements Company's grant BMS DAIICHI SANKYO

Official Title
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Survey About Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology

Conditions
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Oral Anticoagulants, Invasive Procedure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon member of the SFCO taking part to the study. Each investigator will include 10 patients treated with long-term direct oral anticoagulants, and 10 consecutive patients treated with long-term Vitamin K Antagonists. For the oral anticoagulants group, inclusion will be continued until the inclusion of 333 patients for each molecule (apixaban, rivaroxaban, edoxaban). Exclusion Criteria: Patients receiving both Vitamin K Antagonists and antiplatelet agents Patients receiving both direct oral anticoagulant and antiplatelet agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vitamin K Antagonists (VKA)<br>Patients on VKA | |
| Direct Oral Anticoagulant (DOAC)<br>Patients on OAD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence rate of bleeding or thromboembolic events during the peri-procedural period | the occurrence rate of bleeding or thromboembolic events during the peri-procedural period defined as the period between 5 days before surgery plus 30 days after the invasive procedure (if no anticoagulant interruption) or 30 days after the resumption of oral anticoagulant (in case of an anticoagulant interruption). | Each patient will be followed for 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk factors for bleeding in the peri-procedural period | To identify risk factors for bleeding in the peri-procedural period | Each patient will be followed for 30 days. | 
| risk factors for thromboembolic events in the peri-procedural period | To identify risk factors for thromboembolic events in the peri-procedural period | Each patient will be followed for 30 days. | 
| peri-procedural management of each treatment (VKA, and each DOAC) | To describe the peri-procedural management of each treatment (VKA, and each DOAC) | Each patient will be followed for 30 days. | 
| prescribers involved in the possible change of anticoagulant prescription prior the oral surgery | To identify prescribers involved in the possible change of anticoagulant prescription prior the oral surgery | Each patient will be followed for 30 days. | 
| risk of bleeding on DOAC and on VKA | To compare the risk of bleeding on DOAC and on VKA | Each patient will be followed for 30 days. | 
| risk of thromboembolic complications on DOAC and on VKA | To compare the risk of thromboembolic complications on DOAC and on VKA | Each patient will be followed for 30 days. | 
| net clinical benefit of DOAC compared to VKA treatment | To evaluate the net clinical benefit of DOAC compared to VKA treatment | Each patient will be followed for 30 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periprocedural period, Anticoagulant treatment, Thromboembolic events, Bleeding events