Assessment of the Incidence of Hemorrhagic and Ischemic Events in Post-angioplasty in Anticoagulated Coronary Patients with Atrial Fibrillation (FACOREV)

Evaluation De L'incidence Des Évènements Hémorragiques Et Ischémiques En Post-angioplastie Chez Des Patients Coronariens Anticoagulés Dans Le Cadre D'une Fibrillation Auriculaire

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 Overview

• Status: Completed
• Conditions: Hemorrhage; Thrombosis; Atrial Fibrillation; Acute Coronary Syndrome
• Intervention / Treatment: Diagnostic test: Blood panel

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients at least 18 years of age admitted for hospitalization in the cardiology department of the Nîmes Hospital for angioplasty as part of an acute or chronic coronary syndrome and being anticoagulated before or during their hospitalization for a paroxysmal, persistent or permanent atrial fibrillation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with atrial fibrillation	Diagnostic test: Blood 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Month 6
Occurrence of stent thrombosis	Number of patients	Month 1
Occurrence of stent thrombosis	Number of patients	Month 6
Occurrence of stent thrombosis	Number of patients	Month 12
Occurrence of stroke	Number of patients	Month 1
Occurrence of stroke	Number of patients	Month 6
Occurrence of stroke	Number of patients	Month 12
Occurrence of myocardial infarction	Number of patients	Month 1
Occurrence of myocardial infarction	Number of patients	Month 6
Occurrence of myocardial infarction	Number of patients	Month 12
Occurrence of death from any cause	Number of patients	Month 1
Occurrence of death from any cause	Number of patients	Month 6
Occurrence of death from any cause	Number of patients	Month 12
Occurrence of revascularization of the target lesion without death	Number of patients	Month 1
Occurrence of revascularization of the target lesion without death	Number of patients	Month 6
Occurrence of revascularization of the target lesion without death	Number of patients	Month 12
Occurrence of peripheral embolism	Number of patients	Month 1
Occurrence of peripheral embolism	Number of patients	Month 6
Occurrence of peripheral embolism	Number of patients	Month 12
Stroke risk	ABCD2 score	Month 1
Stroke risk	ABCD2 score	Month 6
Stroke risk	ABCD2 score	Month 12
Intrinsic imputability of transient ischemic attack	According to French pharmacovigilance scale from I0 (incompatible) to I4 (very likely)	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)	Month 12
Intrinsic imputability of hemorrhagic eccent	According to French pharmacovigilance scale from I0 (incompatible) to I4 (very likely)	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)	Month 12
Bleeding Academic Research Consortium Score	Classified according to subcategories; 1-5; 2-5; or 3-5	Month 1
Bleeding Academic Research Consortium Score	Classified according to subcategories; 1-5; 2-5; or 3-5	Month 6
Bleeding Academic Research Consortium Score	Classified according to subcategories; 1-5; 2-5; or 3-5	Month 12
Number of anti-platelet aggregations taken	Number	Month 1
Number of anti-platelet aggregations taken	Number	Month 6
Number of anti-platelet aggregations taken	Number	Month 12
Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants		Month 1
Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants		Month 6
Anatomical Therapeutic Chemical class of anti-platelet aggregation and the anticoagulants		Month 12
Duration of triple therapy		Month 1
Duration of triple therapy		Month 6
Duration of triple therapy		Month 12
Dose of anti-platelet aggregation and the anticoagulants		Month 1
Dose of anti-platelet aggregation and the anticoagulants		Month 6
Dose of anti-platelet aggregation and the anticoagulants		Month 12
Global drug compliance	Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance	Month 1
Global drug compliance	Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance	Month 6
Global drug compliance	Girerd score where 0 = good observance, 1/2 = slight observance problems, 3+ = poor observance	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	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	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	Month 12
Thrombin generation test	Kinetic fluorimetry curve, (ST Genesia® analyzer)	Inclusion
Thrombin generation test	Kinetic fluorimetry curve, (ST Genesia® analyzer)	Month 6
Thrombin generation test	Kinetic fluorimetry curve, (ST Genesia® analyzer)	Month 12
Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)	Measured with STA-R® Plus	Inclusion
Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)	Measured with STA-R® Plus	Month 6
Residual plasma concentration of direct oral anticoagulants (dabigatran, rivaroxaban and apixaban)	Measured with STA-R® Plus	Month 12
International Normalized Ratio (INR) for patients under if anti-vitamin K therapy	Measured with STA-R® Plus	Inclusion
International Normalized Ratio (INR) for patients under if anti-vitamin K therapy	Measured with STA-R® Plus	Month 6
International Normalized Ratio (INR) for patients under if anti-vitamin K therapy	Measured with STA-R® Plus	Month 12
D-dimers level	D-Dimer Exclusion assay	Month 1
D-dimers level	D-Dimer Exclusion assay	Month 6
D-dimers level	D-Dimer Exclusion assay	Month 12
Fibrin monomers level	STA-Liatest FM	Month 1
Fibrin monomers level	STA-Liatest FM	Month 6
Fibrin monomers level	STA-Liatest FM	Month 12
Platelet aggregation test	Platelet inhibition under aspirin and/or P2Y12 inhibitor	Inclusion
Platelet aggregation test	Platelet inhibition under aspirin and/or P2Y12 inhibitor	Month 6
Platelet aggregation test	Platelet inhibition under aspirin and/or P2Y12 inhibitor	Month 12
Association between ischemic an/ord hemorrhagic events and adherence to antiplatelet therapy and anticoagulant medication initiated after stent placement	Rate	Month 12
Concordance rate between the drug compliance score and the biological assessment		Inclusion
Concordance rate between the drug compliance score and the biological assessment		Month 6
Concordance rate between the drug compliance score and the biological assessment		Month 12

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Alexia Janes, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): October 11, 2023
• Study Completion (Actual): September 29, 2024

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: angioplasty; dual anti-platelet therapy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Embolism and Thrombosis; Myocardial Ischemia; Thrombosis; Atrial Fibrillation; Hemorrhage; Acute Coronary Syndrome
• Other Study ID Numbers: LOCAL/2020/AJ-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No