Clinical trial NCT03012906: Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score >1 Undergoing Percutaneous Coronary Interventions
Official title: Prospective Multicenter Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score >1 Undergoing Percutaneous Coronary Interventions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Percutaneous Coronary Intervention
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing percutaneous coronary intervention (PCI)

Brief summary: 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 .


Eligibility criteria: 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).

Exclusion Criteria:

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

Primary outcomes:
measure: Number of deaths
timeFrame: 2 years
measure: Number of myocardial infarctions
timeFrame: 2 years
measure: Number of strokes
timeFrame: 2 years
Secondary outcomes:
measure: The prevalence of bleeding events
timeFrame: 2 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Catherine GEINDRE
role: STUDY_DIRECTOR
affiliation: Assistance Publique Hopitaux De Marseille
name: Laurent bonello
role: PRINCIPAL_INVESTIGATOR
References: