EAST – AFNET 4 has been completed

The initial concept of EAST – AFNET 4 dates back
more than 10 years. While antiarrhythmic drugs
and catheter ablation made progress in clinical
practice, the question came up whether an early
and comprehensive rhythm control therapy has
the potential to prevent adverse outcomes in
patients with atrial fibrillation. Following this idea,
we initiated the EAST – AFNET 4 trial in 2009 with AFNET as

After 2 years of preparation, patient enrolment
started in summer of 2011. In the following 5
years, 2.789 patients from 135 study sites in 11
European countries were included into EAST – AFNET
4. All patients were followed-up for at least 3
years, as a long follow-up duration is essential for
robust study data.

In the beginning of March 2020, the observation
period was finished ahead of schedule. As the 3rd
interim analysis implicated sufficient power to end
the study, the trial sponsor, AFNET, decided to
end follow-up for all patients in the EAST – AFNET
4 trial.

During the subsequent final central follow-up,
data documentation was completed. This phase
was terminated by the official end of study (EOS)
on May 31st 2020.

As EAST – AFNET 4 is an event-driven trial the
collection and documentation of serious adverse
events (SAE) play a crucial role in order to achieve
high quality data. Every SAE was documented
in the eCRF and assessed by the Endpoint Review
Committee (ERC).

Currently all data are being analyzed by the study
statistician. The coordinating investigators will
present the findings in a hotline session at the
ESC congress this summer. The main publication of the study results is planned simultaneously
with the hotline session.

In addition to the main results paper, publications
of several sub-analyses are planned. Proposals for
sub-analyses are being evaluated by the EAST –
AFNET 4 steering committee.