Pressemitteilung

In the AXADIA – AFNET 8 trial, oral anticoagulation with the non-vitamin K antagonist oral anticoagulant (NOAC) Apixaban appeared equally safe and effective as vitamin K antagonists (VKA) in patients with atrial fibrillation (AF) and severe chronic kidney disease. The results were presented at the American Heart Association (AHA) congress on 06.11.2022 in Chicago, USA [1] and simultaneously published in Circulation [2].

AXADIA – AFNET 8 (A Safety Study Assessing Oral Anticoagulation with ApiXAban versus Vitamin KAntagonists in Patients with Atrial Fibrillation and End-Stage Kidney Disease on Chronic HemoDIAlysis Treatment) is an investigator-initiated trial with the objective of improving oral anticoagulation in patients with atrial fibrillation and chronic kidney disease on hemodialysis. It compared the NOAC Apixaban to VKA in these multimorbid patients.

Patients with atrial fibrillation (AF) and a history of stroke are at high risk of recurrent stroke and cardiovascular complications. A subgroup analysis of the EAST – AFNET 4 trial showed: Early rhythm control therapy is safe and particularly effective in this vulnerable patient group. The results were presented at the World Stroke Congress in Singapore on 26.10.2022 [1], [2].

The EAST – AFNET 4 (Early Treatment of Atrial Fibrillation for Stroke Prevention) trial investigated whether rhythm control therapy – using antiarrhythmic drugs or atrial fibrillation ablation – delivered within one year after AF diagnosis improves outcomes. The main study result, published in 2020 [3], demonstrated that early rhythm control therapy reduced cardiovascular events by 21% in patients with AF and comorbidities: Early rhythm control (ERC) with antiarrhythmic drugs and/or AF ablation reduced the primary outcome, a composite of cardiovascular death, stroke, and hospitalization for worsening heart failure or acute coronary syndrome, in 2789 patients with early AF and cardiovascular risk factors compared to usual care (UC) over a 5-year follow-up time.

The NOAH – AFNET 6 trial which is conducted to evaluate the potential benefit of oral anticoagulation in patients with atrial high rate episodes (AHRE) is going to be terminated prematurely. The reason for early termination is an observed trend towards futility for efficacy combined with expected safety concerns. Following a recommendation of the study scientific committees, on 2 September 2022, AFNET decided to orderly terminate the NOAH – AFNET6 trial in the coming weeks. The study results will be available next year.

A mediator analysis of the EAST – AFNET 4 trial dataset revealed the key factor for the effectiveness of early rhythm control (ERC) in patients with atrial fibrillation (AF): The presence of sinus rhythm at 12 months after randomization explains 81% of the outcome-reducing effect of ERC. Other factors, e. g. blood pressure or recurrent AF, only explain small portions of the effect. The results were presented by Professor Lars Eckardt, University Hospital Münster, Germany, at the annual congress of the European Society of Cardiology (ESC) in Barcelona, Spain, on 29.08.2022 [1], [2].

Subanalysis of the EAST – AFNET 4 trial: Patients with AF and high comorbidity burden benefit from early rhythm control

Early rhythm control is useful in patients with atrial fibrillation regardless of the AF pattern. Patients with first diagnosed atrial fibrillation benefit from early rhythm control therapy comparably to patients with paroxysmal or persistent AF. This is the result of a subgroup analysis of the EAST – AFNET 4 trial that was presented by Professor Andreas Goette, St. Vincenz Hospital Paderborn, at the American Heart Association (AHA) congress on 14.11.2021 in Boston [1].

Asymptomatic patients with atrial fibrillation (AF) benefit from early rhythm control therapy comparably to symptomatic patients. This is the result of a subgroup analysis of the EAST – AFNET 4 trial that was presented by Professor Stephan Willems, Asklepios Hospital St. Georg, Hamburg, at the annual congress of the European Society of Cardiology (ESC) on 27.08.2021 [1] and published in the European Heart Journal [2].

A subgroup analysis of the EAST – AFNET 4 study population revealed: Early initiation of rhythm control therapy is associated with clinical benefit in patients with heart failure and recently diagnosed atrial fibrillation. The new findings were presented by Dr. Andreas Rillig, UKE Hamburg, at the HRS congress on 30.07.2021 [1], [2].

Patients with newly diagnosed atrial fibrillation (AF) benefit from early rhythm control therapy, according to results of EAST – AFNET 4, an AFNET/EHRA trial presented in a Hot Line session today at ESC Congress 2020[1,2]. Early rhythm control therapy with antiarrhythmic drugs and/or AF ablation reduced a composite of cardiovascular death, stroke, and hospitalization for worsening heart failure or acute coronary syndrome in 2789 patients with early AF and cardiovascular risk factors compared to usual care over a 5-year follow-up time.