Acute Coronary Syndrome, Atrial Fibrillation, Hemorrhage, Thrombosis
Conditions
Keywords
dual anti-platelet therapy, angioplasty
Brief summary
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.
Interventions
DIAGNOSTIC_TESTBlood panel
* 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
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient on anti-coagulating therapy before or during hospitalization for atrial fibrillation * Patient hospitalized in the cardiology ward admitted for acute or chronic coronary syndrome requiring coronary angioplasty * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan
Exclusion criteria
* The subject is in a period of exclusion determined by a previous study * The patient has already been included into this study * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * Patient pregnant, parturient or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Month 12 | Number of patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of stent thrombosis | Month 1 | Number of patients |
| Occurrence of stroke | Month 1 | Number of patients |
| Occurrence of myocardial infarction | Month 1 | Number of patients |
| Occurrence of death from any cause | Month 1 | Number of patients |
| Occurrence of revascularization of the target lesion without death | Month 1 | Number of patients |
| Occurrence of peripheral embolism | Month 1 | Number of patients |
| Stroke risk | Month 1 | ABCD2 score |
| Intrinsic imputability of transient ischemic attack | Month 12 | According to French pharmacovigilance scale from I0 (incompatible) to I4 (very likely) |
| Extrinsic imputability of transient ischemic attack | Month 12 | According to French pharmacovigilance scale from B0 (Effect appearing quite new after exhaustive research) to B3 (notable effect) |
| Intrinsic imputability of hemorrhagic eccent | Month 12 | According to French pharmacovigilance scale from I0 (incompatible) to I4 (very likely) |
| Extrinsic imputability of hemorrhagic eccent | Month 12 | According to French pharmacovigilance scale from B0 (Effect appearing quite new after exhaustive research) to B3 (notable effect) |
| Bleeding Academic Research Consortium Score | Month 1 | Classified according to subcategories; 1-5; 2-5; or 3-5 |
| Number of anti-platelet aggregations taken | Month 1 | Number |
| 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 | Month 1 | Number of patients |
| Duration of triple therapy | Month 1 | — |
| Dose of anti-platelet aggregation and the anticoagulants | Month 1 | — |
| Global drug compliance | Month 1 | Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance |
| Compliance with antiplatelet and anticoagulant therapy | Month 1 | Girerd score specific to anticoagulation/antiplatelet: where 0 = good observance, 1/2 = slight observance problems, 2.5+ = poor observance |
| Thrombin generation test | Inclusion | Kinetic fluorimetry curve, (ST Genesia® analyzer) |
| Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban) | Inclusion | Measured with STA-R® Plus |
| International Normalized Ratio (INR) for patients under if anti-vitamin K therapy | Inclusion | Measured with STA-R® Plus |
| D-dimers level | Month 1 | D-Dimer Exclusion assay |
| Fibrin monomers level | Month 1 | STA-Liatest FM |
| Platelet aggregation test | Inclusion | Platelet inhibition under aspirin and/or P2Y12 inhibitor |
| Association between ischemic an/ord hemorrhagic events and adherence to antiplatelet therapy and anticoagulant medication initiated after stent placement | Month 12 | Rate |
| Concordance rate between the drug compliance score and the biological assessment | Inclusion | — |
| Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants | Month 1 | — |
Countries
France
Outcome results
None listed