The purpose of this study is to evaluate the safety and efficacy of apixaban for the prevention of thromboembolism in adult patients with congenital heart disease (CHD) and non-valvular atrial arrhythmias (AA)
Adult patients with congenital heart disease (ACHD) represent a rapidly growing population due to the progress of surgical techniques and optimal medical management. Non-valvular atrial arrhythmias (AA) carries a significant burden for long-term morbidity and potentially mortality in ACHD patients. AA occur three times more frequently in ACHD compared to the general population. When complicating ACHD, AA convey a twofold increase in the risk for stroke, contributing to an up to 100-fold higher prevalence of stroke in the ACHD population compared to age-matched healthy controls. At present, the European Society of Cardiology (ESC) Guidelines suggest oral anticoagulation (OAC) in all adult patients with AA and intracardiac repair, cyanosis, Fontan palliation, or systemic right ventricle. In the remaining ACHD patients with AA, OAC is suggested if CHA2DS2-Vasc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65 to 74 years, sex category) score is ≥1 (Class of recommendation IIa, level of evidence C). Non-vitamin K oral anticoagulants (NOACs) are increasingly preferred over vitamin-K antagonists (VKAs) in most clinical scenarios due to improved safety (with regard to intracranial and other major bleeding) and efficacy (prevention of embolic stroke or systemic embolism) along with the convenience they offer for patients and physicians (fixed dose, no food and drug interactions, no INR monitoring). On the other hand, scarce data is available on the use of NOAC in ACHD. In order to address this gap in evidence, we propose a prospective multicenter single arm, observational cohort trial, which will provide data on the efficacy and safety of apixaban used for the prevention of thromboembolism in ACHD patients with AA.
Study Type
OBSERVATIONAL
Enrollment
218
Attikon University Hospital
Athens, Greece
Mitera Children's Hospital
Athens, Greece
Onassis Cardiac Surgery Centre
Athens, Greece
AHEPA University Hospital
Thessaloniki, Greece
Stroke, systemic or pulmonary arterial thromboembolism and intracardiac thrombosis.
The composite endpoint of all-cause stroke, systemic and pulmonary embolism and intracardiac thrombosis
Time frame: up to 58 months
Major bleeding
Defined as clinically overt bleeding that is associated with: * A fall in hemoglobin of 2 g/dL or more * A transfusion of ≥2 units of packed red blood cells or whole blood * Bleeding in a critical site: intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal * Death (fatal bleeding)
Time frame: up to 58 months
Transient ischemic attack
Defined as new neurologic symptoms or deficit lasting less than 24 hours with no new infarction on neuroimaging (if available).
Time frame: up to 58 months
Myocardial infarction
Defined as the detection of a significant rise/fall of Troponin in association with symptoms of ischemia, ECG changes, proof of ischemia on imaging or intracoronary thrombus at angiography. \[Fourth definition of myocardial infarction; European Society of Cardiology (ESC) 2018\]
Time frame: up to 58 months
Death from cardiovascular causes
Cardiovascular deaths were classified as deaths due to: ischemic stroke, hemorrhagic stroke, systemic or pulmonary embolism, other cardiovascular (i.e., myocardial infarction, sudden death, heart failure) and unobserved deaths.
Time frame: up to 58 months
Τhe composite of major and clinically relevant nonmajor bleeding
Clinically relevant nonmajor bleeding bleeding=bleeding that is clinically overt, that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event, that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.
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Time frame: up to 58 months
Τhe composite of stroke, systemic or pulmonary arterial thromboembolism and intracardiac thrombosis, transient ischemic attack, myocardial infarction, or cardiovascular death
Time frame: up to 58 months