Overview
Patients with Acute Coronary Syndrome associated with de novo atrial fibrillation are randomized to benefit from either a conventional therapy associating dual antiplatelet therapy (DAPT) and anticoagulant or DAPT and an implantable monitoring device with a follow-up by telecardiology
Description
Acute Coronary Syndrome associated with de novo atrial fibrillation is not uncommon. It worsens the short-term, medium-term and long-term prognosis. It is then usual, according to ESC recommendations, to add to the DAPT, an anticoagulant treatment, which is a source of iatrogenic events, in particular hemorrhagic events. However, recurrence is not a certainty. Albeit variable, its highest rate is estimated to be 38%. Consequently, a well-conducted screening of atrial fibrillation recurrence could allow to treat only selected recurrent patients. At present, this screening can be carried out in a reliable and minimally invasive way with an implantable device with telecardiology. We propose a study for these patients with ACS associated with de novo AF. The study will be multicenter, randomized, open-label, with two arms: patient conventionally treated (DAPT + AC) and patient treated by DAPT + implantable device and followed for two years by telecardiology. This patient will only reintegrate the first arm in case of AF recurrence.
Eligibility
Inclusion Criteria:
- Atrial fibrillation diagnosed before hospitalization for acute coronary syndrome, whether treated or not.
- Atrial fibrillation still present at inclusion time.
- Transient atrial fibrillation due to a reversible disorder (thyrotoxycosis, pulmonary embolism, recent surgery).
- Acute coronary syndrome that has not been revascularized.
- Acute coronary syndrome surgically treated (bypass).
- Patient already on anticoagulant therapy.
- Scheduled aortocoronary bypass.
- Creatinine clearance < 30 ml per minute.
Exclusion Criteria:
Pathologic criteria :
- Atrial fibrillation diagnosed before hospitalization for acute coronary syndrome, whether treated or not.
- Atrial fibrillation still present at inclusion time.
- Transient atrial fibrillation due to a reversible disorder (thyrotoxycosis, pulmonary embolism, recent surgery).
- Acute coronary syndrome that has not been revascularized.
- Acute coronary syndrome surgically treated (bypass).
- Patient already on anticoagulant therapy.
- Scheduled aortocoronary bypass.
- Creatinine clearance < 30 ml per minute.
Bleeding risks :
- Contraindications to anticoagulant therapy.
- Active internal hemorrhage, clinically significant bleeding, bleeding non accessible to compression or bleeding diathesis within 30 days prior to selection visit.
- Platelet count < 90000/µL at the selection visit.
- Bleeding event in the twelve months prior to inclusion.
- Bleeding events detected either clinically or biologically (hemoglobinemia < 10g/dl).
- Elective surgery.
Comorbidities :
- Cardiogenic shock.
- Hyperthyroidism.
- Prior history of significant liver disease (acute hepatitis, active chronic hepatitis, cirrhosis) or liver function disorder detected at selection visit.
- Significant mitral valvular heart disease.
General :
- Patient under 18.
- Non menopausal woman or without contraception.
- Patient whose physical and / or mental health may have an impact on the compliance to the study.
- Participation in another biomedical research study (interventional or noninterventional) or participation in a research study within the 30 days prior to inclusion.
- Protected adults (under judicial protection, guardianship, or supervision).