EAST – AFNET 4 is an investigator initiated trial (IIT) that compares two different treatment strategies in atrial fibrillation. The EAST – AFNET 4 trial will test whether an early, comprehensive, rhythm control therapy can prevent adverse cardiovascular outcomes in patients with atrial fibrillation (AF) compared to usual care. Thus, EAST – AFNET 4 aims to further reduce the residual cardiovascular risk in anticoagulated, rate controlled AF patients. The pan-European trial is conducted by the German Atrial Fibrillation NETwork (AFNET) in cooperation with the European Heart Rhythm Association (EHRA).

EAST – AFNET 4 is a prospective, parallel-group, randomized, open, blinded, end-point assessment trial. EAST – AFNET 4 tests the hypothesis that an earlier initiation of rhythm control therapy, when added to a comprehensive AF management strategy, has the potential to disrupt the vicious circles that maintain AF,  maintain sinus rhythm more effectively than the current pattern of delayed rhythm control therapy, and to reduce cardiovascular complications.

Patients are eligible for EAST – AFNET 4, if they meet the following criteria:

  • Recent onset AF, i.e. AF with a known history of ≤ 1 year prior to randomization and
  • Risk for stroke as evidenced by
    a) one of the following: age > 75 years, prior stroke or transient ischemic attack (TIA)
    b) two of the following: hypertension, diabetes mellitus, left ventricular hypertrophy, age > 65 years, female sex, peripheral artery disease, kidney disease (MDRD stage III or IV), stable heart failure (NYHA II or LVEF <50%), severe coronary artery disease (previous myocardial infarction, CABG or PCI)

Participants will be randomized into one of two groups receiving either early rhythm control 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 directly after randomization. The initial therapy will be selected by the investigator. Upon AF recurrence, both modalities will be combined.

Usual care will be conducted following the current 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.

The primary outcome parameter of EAST – AFNET 4 is a composite of cardiovascular death, stroke and hospitalization due to heart failure or acute coronary syndrome. All patients are followed up by 6-monthly central follow-up contacts via questionnaires and by outpatient follow-up visits at 12, 24 and 36 months.

The investigators plan to enrol 2.745 patients from 200 centers in 11 European countries. The first patient was enrolled on July 28, 2011, in Hamburg, Germany. We expect that patient enrolment will be continuing until 2016.