Differences in efficacy and safety between new oral anticoagulants (NOAC) and vitamin K antagonist (VKA) in real practice remain uncertain. The few existing ambulatory studies did not answer all NOAC specific issues, such as prescription habits and motives, patients characteristics, biological monitoring, as well as the occurrence of major and minor thromboembolic events, especially in France where warfarin is less frequently prescribed. Therefore, in order to describe clinical and follow up characteristics of patients receiving oral anticoagulants, the investigators will set up a national prospective cohort to compare the occurrence of thromboembolic events between VKA and NOAC in primary care.
The method includes the use of a national prospective observational cohort, involving 444 general practitioners From april to december 2014, health data of any adult patient consulting a general practitioner and receiving an oral anticoagulant treatment has been entered in a database. Each patient received an information for agreement to participate to the study (agreement for stastical analysis of their health data during one year follow up). In March 2015, half of those patients will be chosen (stratification), using a matched stratification process, and will be followed up over one year. Every three months, data regarding the occurrence of therapeutics changes, episodes of excessive bleeding, and thromboembolic events will be collected by general practitioners. The data will be analysed by: - describing the characteristics of patients receiving oral anticoagulant treatment; - describing the changes of medications over the year ; - comparing the occurrence of episodes of excessive bleeding ; - comparing the occurrence of thromboembolic events in patients using VKA versus patients using NOAC.
Study Type
OBSERVATIONAL
Enrollment
4,162
each three months during one year of follow up, general practioners will entered health data in database (hemorrhagic events, changes of medication, biological data...)
Office-based practitioner
Albens, France
Office-based practitioner
Bordeaux, France
Office-based practitioner
Chablis, France
Office-based general practitioner
Dessenheim, France
Office-based general practitioner
Dijon, France
Office-based practitioner
Clinical characteristics
The profile of patients receiving VKA or NOAC will be described by the following variables: * Molecule, duration, dosage * Indication: Atrial fibrillaton valvular or not / DVT / PE / Other, Prevention / Treatment * Age, sex, weight, height * Medication adherence ( as perceived by the GP ) * Renal function * CHA2DS2-VASc Score * HAS-BLED Score * RIETE score * unstable INR * Comorbidities: anemia, diabetes, kidney disease, liver disease, hypertension, heart failure, stroke, peripheral vascular desease, myocardial infarction (MI). * Concomitant treatments: NSAIDs, antiplatelets, other treatments with potentials interactions
Time frame: at baseline
Bleeding events
Compare annual impact of bleeding events between patients receiving NOAC and VKA. Bleeding will be collected according to the International Society on Thrombosis and Haemostasis (ISTH) and BARC classification
Time frame: at baseline, 3, 6, 9 and 12 months
Thrombotic events
Compare annual impact of thrombotic events (Ischemic stroke, DVT, PE, acute coronary syndrome) between patients receiving NOAC and VKA on further indications : non-valvular ACFA (excluding mitral regurgitation grade 3 and 4), preventing DVT / PE , DVT/ EP treatment
Time frame: at baseline, 3, 6, 9 and 12 months
Death
Describe the causes of death (including EP or cardiac events)
Time frame: at baseline, 3, 6, 9 and 12 months
Therapeutic classes
Describe the changes of therapeutic classes and reasons in NOAC and VKA treated population. Changes in indication for medicines, changes in mode and type of anticoagulant therapy
Time frame: at baseline, 3, 6, 9 and 12 months
Bleeding score
Assess the relevance of different scores to predict the risk of bleeding. Comparison of the diagnostic performance of different classical scores by studying the corresponding AUC ROC curves
Time frame: at baseline, 3, 6, 9 and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Flumet, France
Office-based practitioner
Gémenos, France
Office-based general practitioner
Grenay, France
Office-based general practitioner
Guesnain, France
Office-based general practitioner
Hatten, France
...and 23 more locations