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
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.