Atrial fibrillation (AF) is a supraventricular arrhythmia characterized by uncoordinated and fast atrial activity, and coronary artery disease (chronic and acute coronary syndrome) is characterized by a generally atheromatous narrowing of the coronary arteries. Angioplasty is necessary to restore arterial circulation in coronary artery disease. A dual anti-aggregating therapy is then initiated in these patients in parallel with treatment of AF with anticoagulation. This triple therapy exposes the patient to an increased risk of hemorrhage. The combination of oral anticoagulation with antiplatelet inhibitor in long-term anticoagulated patients requiring stent placement has been studied in several recent trials (e.g. WOEST, PIONEER AF PCI, REDUAL PCI and AUGUSTUS). The results of these studies have formed the basis of the European recommendations of 2017 and 2020, whereby the therapeutic strategy depends on the risk of hemorrhage or ischemia. However, the hemorrhagic risk assessment factors included in the scores overlap with those for ischemic risk. It is therefore difficult to determine the predominant risk for each patient. Thus, uncertainties persist as to the optimal duration of a triple therapy and the optimal recommended dose. In this study, the investigators aim to establish an inventory of the current practices by evaluating the incidence of hemorrhagic and ischemic events in post-angioplasty in anticoagulated coronary patients in the context of atrial fibrillation.
Study Type
OBSERVATIONAL
Enrollment
122
* Thrombin generation test * Residual plasma concentration of dabigatran, rivaroxaban and/or apixaban (direct oral anticoagulants) * International Normalized Ratio (if anti-vitamin K therapy is prescribed) * Platelet aggregation test
CHU de Nîmes
Nîmes, France
Incidence of at least one event from the composite clinical benefit endpoints: death, non-fatal myocardial infarction, ischemic stroke, or major bleeding defined by a Bleeding Academic Research Consortium (BARC) score ≥2
Number of patients
Time frame: Month 12
Incidence of at least one event from the composite clinical benefit endpoints: death, non-fatal myocardial infarction, ischemic stroke, or major bleeding defined by a Bleeding Academic Research Consortium (BARC) score ≥2
Number of patients
Time frame: Month 1
Incidence of at least one event from the composite clinical benefit endpoints: death, non-fatal myocardial infarction, ischemic stroke, or major bleeding defined by a Bleeding Academic Research Consortium (BARC) score ≥2
Number of patients
Time frame: Month 6
Occurrence of stent thrombosis
Number of patients
Time frame: Month 1
Occurrence of stent thrombosis
Number of patients
Time frame: Month 6
Occurrence of stent thrombosis
Number of patients
Time frame: Month 12
Occurrence of stroke
Number of patients
Time frame: Month 1
Occurrence of stroke
Number of patients
Time frame: Month 6
Occurrence of stroke
Number of patients
Time frame: Month 12
Occurrence of myocardial infarction
Number of patients
Time frame: Month 1
Occurrence of myocardial infarction
Number of patients
Time frame: Month 6
Occurrence of myocardial infarction
Number of patients
Time frame: Month 12
Occurrence of death from any cause
Number of patients
Time frame: Month 1
Occurrence of death from any cause
Number of patients
Time frame: Month 6
Occurrence of death from any cause
Number of patients
Time frame: Month 12
Occurrence of revascularization of the target lesion without death
Number of patients
Time frame: Month 1
Occurrence of revascularization of the target lesion without death
Number of patients
Time frame: Month 6
Occurrence of revascularization of the target lesion without death
Number of patients
Time frame: Month 12
Occurrence of peripheral embolism
Number of patients
Time frame: Month 1
Occurrence of peripheral embolism
Number of patients
Time frame: Month 6
Occurrence of peripheral embolism
Number of patients
Time frame: Month 12
Stroke risk
ABCD2 score
Time frame: Month 1
Stroke risk
ABCD2 score
Time frame: Month 6
Stroke risk
ABCD2 score
Time frame: Month 12
Intrinsic imputability of transient ischemic attack
According to French pharmacovigilance scale from I0 (incompatible) to I4 (very likely)
Time frame: Month 12
Extrinsic imputability of transient ischemic attack
According to French pharmacovigilance scale from B0 (Effect appearing quite new after exhaustive research) to B3 (notable effect)
Time frame: Month 12
Intrinsic imputability of hemorrhagic eccent
According to French pharmacovigilance scale from I0 (incompatible) to I4 (very likely)
Time frame: Month 12
Extrinsic imputability of hemorrhagic eccent
According to French pharmacovigilance scale from B0 (Effect appearing quite new after exhaustive research) to B3 (notable effect)
Time frame: Month 12
Bleeding Academic Research Consortium Score
Classified according to subcategories; 1-5; 2-5; or 3-5
Time frame: Month 1
Bleeding Academic Research Consortium Score
Classified according to subcategories; 1-5; 2-5; or 3-5
Time frame: Month 6
Bleeding Academic Research Consortium Score
Classified according to subcategories; 1-5; 2-5; or 3-5
Time frame: Month 12
Number of anti-platelet aggregations taken
Number
Time frame: Month 1
Number of anti-platelet aggregations taken
Number
Time frame: Month 6
Number of anti-platelet aggregations taken
Number
Time frame: Month 12
Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants
Time frame: Month 1
Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants
Time frame: Month 6
Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants
Time frame: Month 12
Duration of triple therapy
Time frame: Month 1
Duration of triple therapy
Time frame: Month 6
Duration of triple therapy
Time frame: Month 12
Dose of anti-platelet aggregation and the anticoagulants
Time frame: Month 1
Dose of anti-platelet aggregation and the anticoagulants
Time frame: Month 6
Dose of anti-platelet aggregation and the anticoagulants
Time frame: Month 12
Global drug compliance
Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance
Time frame: Month 1
Global drug compliance
Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance
Time frame: Month 6
Global drug compliance
Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance
Time frame: Month 12
Compliance with antiplatelet and anticoagulant therapy
Girerd score specific to anticoagulation/antiplatelet: where 0 = good observance, 1/2 = slight observance problems, 2.5+ = poor observance
Time frame: Month 1
Compliance with antiplatelet and anticoagulant therapy
Girerd score specific to anticoagulation/antiplatelet: where 0 = good observance, 1/2 = slight observance problems, 2.5+ = poor observance
Time frame: Month 6
Compliance with antiplatelet and anticoagulant therapy
Girerd score specific to anticoagulation/antiplatelet: where 0 = good observance, 1/2 = slight observance problems, 2.5+ = poor observance
Time frame: Month 12
Thrombin generation test
Kinetic fluorimetry curve, (ST Genesia® analyzer)
Time frame: Inclusion
Thrombin generation test
Kinetic fluorimetry curve, (ST Genesia® analyzer)
Time frame: Month 6
Thrombin generation test
Kinetic fluorimetry curve, (ST Genesia® analyzer)
Time frame: Month 12
Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)
Measured with STA-R® Plus
Time frame: Inclusion
Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)
Measured with STA-R® Plus
Time frame: Month 6
Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)
Measured with STA-R® Plus
Time frame: Month 12
International Normalized Ratio (INR) for patients under if anti-vitamin K therapy
Measured with STA-R® Plus
Time frame: Inclusion
International Normalized Ratio (INR) for patients under if anti-vitamin K therapy
Measured with STA-R® Plus
Time frame: Month 6
International Normalized Ratio (INR) for patients under if anti-vitamin K therapy
Measured with STA-R® Plus
Time frame: Month 12
D-dimers level
D-Dimer Exclusion assay
Time frame: Month 1
D-dimers level
D-Dimer Exclusion assay
Time frame: Month 6
D-dimers level
D-Dimer Exclusion assay
Time frame: Month 12
Fibrin monomers level
STA-Liatest FM
Time frame: Month 1
Fibrin monomers level
STA-Liatest FM
Time frame: Month 6
Fibrin monomers level
STA-Liatest FM
Time frame: Month 12
Platelet aggregation test
Platelet inhibition under aspirin and/or P2Y12 inhibitor
Time frame: Inclusion
Platelet aggregation test
Platelet inhibition under aspirin and/or P2Y12 inhibitor
Time frame: Month 6
Platelet aggregation test
Platelet inhibition under aspirin and/or P2Y12 inhibitor
Time frame: Month 12
Association between ischemic an/ord hemorrhagic events and adherence to antiplatelet therapy and anticoagulant medication initiated after stent placement
Rate
Time frame: Month 12
Concordance rate between the drug compliance score and the biological assessment
Time frame: Inclusion
Concordance rate between the drug compliance score and the biological assessment
Time frame: Month 6
Concordance rate between the drug compliance score and the biological assessment
Time frame: Month 12
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