Informations générales (source: ClinicalTrials.gov)
Prospective Multicenter Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score >1 Undergoing Percutaneous Coronary Interventions
Observational [Patient Registry]
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
janvier 2017
juillet 2019
29 juin 2024
Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and
requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc >1 are
required to receive triple antithrombotic therapy . This triple therapy includes dual
antiplatelet therapy with clopidogrel and aspirin in combination with an oral
anticoagulant with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC).
Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the
coagulation cascade have demonstrated non inferiority compared to VKA to prevent
thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc >1 .
Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA.
Overall they seem to result in a lower bleeding rate compared to VKA in association with
antiplatelet agents.
Recently European guidelines regarding patients requiring chronic anticoagulant therapy
and undergoing coronary stent implantation have been updated. However they are based on
an expert consensus because of the scarce data available.
These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel
and aspirin in combination with the lower dose of OAC or VKA with a target INR between 2
and 2.5 . The triple therapy should be prescribed for 1 to 6 months depending on the
bleeding and thrombotic risk and the clinical setting. In patients with high bleeding
risk the guidelines suggest that a sole antiplatelet agent could be used in addition to
anticoagulation following the WOEST study . In the recently published ESC guidelines on
the management of atrial fibrillation, despite the lack of new data, the expert advocate
triple therapy followed by dual antiplatelet therapy in most patients for 12 months.
The recently published PIONEER study reinforced the possibility of the use of rivaroxaban
in these patients. In this trial including ACS and not ACS patients undergoing PCI
rivaroxaban 15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less
clinically relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel
and similar efficacy .
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille - 13354 - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. age over 18 years old
2. signed informed consent
3. requiring PCI (with stent placement) with subsequent need for antiplatelet therapy
4. FA requiring chronic anticoagulation (CHA2DS2-VASc >1, except women with a score
=1).
1. age over 18 years old
2. signed informed consent
3. requiring PCI (with stent placement) with subsequent need for antiplatelet therapy
4. FA requiring chronic anticoagulation (CHA2DS2-VASc >1, except women with a score
=1).
1. pregnancy or lactation
2. age <18 or not able to give an informed consent
3. no informed consent
4. no health insurance
5. prisoners
6. contra indication to antiplatelet therapy
7. intra cardiac thrombus
8. active bleeding Known bleeding diathesis (i.e. history of ICH, GI bleeding)
9. severe kidney failure (eGFR < 30 mL/min/1.73 m²)
10. severe hepatic failure (Child-Pugh class B or C)
11. contra indication to OAC or VKA
12. hypertrophic myocardiopathy
13. valvular prosthesis
14. history of peptic ulcer