REAFFIRM: An interim analysis

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Johannes Brachmann

The interim results of the REAFFIRM (Randomised Evaluation of Atrial Fibrillation treatment with Focal Impulse and Rotor Modulation guided procedures) trial showed there was no statistically significant difference in outcomes between the treatment and control arms. These results were presented by principal investigator Johannes Brachmann, (Klinikum Coburg GmbH, Germany) at the AF Symposium (11–13 January 2018, Orlando, USA).

Short term effectiveness, at zero to three months post procedure, was not different between the two arms. There was around 72% freedom from atrial fibrillation (AF) in the treatment arm and 74% freedom from AF in the control arm. At three to twelve months there was not a statistically significant difference between the two arms; there was approximately 75% freedom from AF in the treatment arm and 70% in the control arm.

Commenting on the results Brachman said, “The treatment arm, while it is not what we antici­pated in 2014, does fall in line with single centre reports. The control arm is somewhat surprising, in that it is better than anticipated.”

The trial had anticipated seeing approximately 60% freedom from AF recurrence in the treatment arm, based on the CONFIRM trial and the multicentre FIRM registry. In the control arm it was anticipated that there would be a 40% freedom from recurrence, based on the STAR AF II trials.

The REAFFIRM trial started in 2014 and is a prospective, multicentre, randomised study to assess the safety and effective­ness of focal impulse and rotor modulation (FIRM) procedures followed by conventional abla­tion including pulmonary vein isolation (PVI) vs. a standard PVI procedure for the treatment of persistent atrial fibrillation. It was designed to include an interim analysis so that once approximately 100 patients had been enrolled into each arm and reached 12 month follow-up analysis could be carried out. If FIRM procedures were shown to be beneficial and statistically significant the trial could then be stopped.

Three hundred and fifty participants have been enrolled and divided into two arms. The control arm received standard PVI ablation and the experimental arm received FIRM-guided procedure followed by standard catheter ablation including PVI. The aver­age age of participants, at interim analysis was 65 years old and they were predominately male.

The primary outcome measures were freedom from serious adverse events related to the procedure at 12-months post-procedure, single-procedure freedom from AF/AT recurrence at three month post index procedure and single-procedure free­dom from AF/AT recurrence at three to 12 months post index procedure. The secondary outcome measures were to evaluate the acute effective­ness of FIRM-guided procedures in eliminating the source of arrhythmia, as shown by no evidence of the source in FIRMap post-op, or reduc­tion of electrogram amplitude to <0.2mV immediately post procedure, and by quality of life data (EQ-5D and AFEQT) one to 12-months post procedure.

To be eligible they needed to have at least two documented episodes of atrial fibrillation in the three months prior to enrolment, be contraindicated to Class I or III anti-arrhythmic medication and have a left atrial diameter of greater than 6cm. They also had to have not previously received AF abla­tion, have no presence of structural heart disease, have an ejection fraction of less than 35% and have no history of myocardial infarction within the past three months.

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