Early Treatment of Atrial Fibrillation for Stroke Prevention Trial (EAST)

Atrial Fibrillation Network (AFNET)

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation; Stroke

Treatments: Other: early standardised rhythm control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01288352

2010-021258-20 (EudraCT Number)

EAST- AFNET 4

Details and patient eligibility

About

EAST prospectively tests the hypothesis that an early, structured rhythm control therapy based on antiarrhythmic drugs and catheter ablation can prevent atrial fibrillation (AF) related complications in patients with AF when compared to usual care.

Patients will be randomized to early therapy or usual care. In the early therapy group, patients will receive either catheter ablation (usually by pulmonary vein isolation), or adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be selected by the local investigator. Upon AF recurrence, both modalities will be combined.

Usual care will be conducted following the 2010European Society of Cardiology ( ESC )guidelines for AF treatment. Early rhythm control therapy will be guided by Electrocardiogram (ECG) monitoring.

Enrollment: 2,789 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Recent-onset AF (≤ 1 year prior to enrolment)

2. At least one ECG within recent 12 months that documents AF whereas the AF episode must last longer than 30 sec.

3. One of the following:

   • age > 75 years or
   • prior stroke or transient ischemic attack

   OR two of the following:

   • age > 65 years,
   • female sex,
   • arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mmHg),
   • diabetes mellitus (treated by drugs or insulin) or impaired glucose tolerance
   • severe coronary artery disease (previous myocardial infarction, CABG or PCI)
   • stable heart failure (NYHA II or LVEF <50%),
   • left ventricular hypertrophy on echocardiography (more than 15 mm wall thickness),
   • chronic kidney disease (MDRD stage III or IV),
   • peripheral artery disease.

4. Provision of signed informed consent.

5. Age ≥ 18 years.

Exclusion criteria

1. Any disease that limits life expectancy to less than 1 year.
2. Participation in another clinical trial, either within the past two months or ongoing
3. Previous participation in the EAST trial.
4. Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intra-uterine device (IUD)] or sterile women can be randomized.
5. Breastfeeding women.
6. Drug abuse.
7. Prior AF ablation or surgical therapy of AF.
8. Previous therapy failure on amiodarone, e.g. patients who suffered from symptomatic recurrent AF that required escalation of therapy while on amiodarone.
9. Patients not suitable for rhythm control of AF.
10. Severe mitral valve stenosis.
11. Prosthetic mitral valve.
12. Clinically relevant hepatic dysfunction requiring specific therapy.
13. Clinically manifest thyroid dysfunction requiring therapy. After successful treatment of thyroid dysfunction, patients may be enrolled when their thyroid function is controlled.
14. Severe renal dysfunction (stage V, requiring or almost requiring dialysis).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,789 participants in 2 patient groups

Usual care

No Intervention group

Description:

Usual care closely follows the suggestions laid out in the current European Society of Cardiology (ESC) guidelines for AF treatment. In addition to antithrombotic therapy and therapy of underlying heart disease, usual care usually consists of an initial attempt to control symptoms by rate control therapy. Rhythm control interventions are recommended when symptoms can not be controlled by optimal rate control therapy in the usual care group.

early standardised rhythm control

Other group

Description:

Patients in the early therapy group will be treated following the same therapeutic recommendations of the ESC guidelines as the usual care group. In addition, rhythm control therapy will be initiated early with the aim of preventing recurrence and delaying or preventing progression of AF. Early-onset rhythm control therapy can consist of: 1. Optimal antiarrhythmic drug therapy (Dronedarone, Amiodarone, Flecainide, Propafenone), 2. Catheter ablation with the aim of pulmonary vein isolation (PVI), 3. Antiarrhythmic drug therapy and catheter ablation may be supplemented by early cardioversion in patients with persistent AF. All individual treatment decisions will be taken by the treating study physician considering the labelling of the procedures and drugs and patient preferences.

Treatment:

Other: early standardised rhythm control