Serelaxin improved dyspnea and reduced mortality similarly in acute heart failure patients with and without atrial fibrillation, and trended toward reducing stroke in the atrial fibrillation group.
RCT (n=1,161)
Double-blind
Randomized
Yes
Does serelaxin improve dyspnea and clinical outcomes in acute heart failure patients with and without atrial fibrillation?
Serelaxin demonstrated similar efficacy and safety in acute heart failure patients regardless of the presence of atrial fibrillation, with a potential signal for reduced stroke risk in those with atrial fibrillation.
Effect estimate: Mean difference 541.11 (95% CI 33.79, 1048.44)
Absolute Event Rate: 2500.48% vs 1959.37%
p-value: p=0.0366
BACKGROUND: Atrial fibrillation (AFib) is a common comorbidity in HF and affects patients' outcome. We sought to assess the effects of serelaxin in patients with and without AFib. METHODS: In a post hoc analysis of the RELAX-AHF trial, we compared the effects of serelaxin on efficacy end points, safety end points and biomarkers in 1161 patients with and without AFib on admission electrocardiogram. RESULTS: AFib was present in 41.3% of patients. Serelaxin had a similar effect in patients with and without AFib, including dyspnea relief by visual analog scale through day 5 mean change in area under the curve, 541.11 (33.79, 1048.44), p = 0.0366 in AFib versus 361.80 (-63.30, 786.90), p = 0.0953 in non-AFib, interaction p = 0.5954 and all-cause death through day 180 HR = 0.42 (0.23, 0.77), p = 0.0051 in AFib versus 0.90 (0.53, 1.52), p = 0.6888 in non-AFib, interaction p = 0.0643. Serelaxin was similarly safe in the two groups and induced similar reductions in biomarkers of cardiac, renal and hepatic damage. Stroke occurred more frequently in AFib patients (2.8 vs. 0.8%, p = 0.0116) and there was a trend for lower stroke incidence in the serelaxin arm in AFib patients (odds ratios, 0.31, p = 0.0759 versus 3.88, p = 0.2255 in non-AFib, interaction p = 0.0518). CONCLUSIONS: Serelaxin was similarly safe and efficacious in improving short- and long-term outcomes and inducing organ protection in acute HF patients with and without AFib.
Filippatos et al. (Wed,) conducted a rct in Acute heart failure with and without atrial fibrillation (n=1,161). Serelaxin vs. Placebo was evaluated on Dyspnea improvement by visual analog scale area under the curve (VAS-AUC) through day 5 in patients with atrial fibrillation (Mean difference 541.11, 95% CI 33.79, 1048.44, p=0.0366). Serelaxin improved dyspnea and reduced mortality similarly in acute heart failure patients with and without atrial fibrillation, and trended toward reducing stroke in the atrial fibrillation group.