Clinical effects sGC stimulator in HFrEF after a worsening HF event unaffected by AF status

Vericiguat in patients with atrial fibrillation and heart failure with reduced ejection fraction: insights from the VICTORIA trial

Presented at the ESC HF 2021 by Prof. Piotr Ponikowski, MD, PhD (Wroclaw, Poland)

Introduction and methods

The VICTORIA trial has previously demonstrated that vericiguat, a soluble guanylate cyclase (sGC) stimulator, added to standard therapy significantly reduced the primary composite outcome of CV death or first HF hospitalization in patients with HFrEF after a worsening HF event, compared to placebo. There was a high prevalence of AF in the VICTORIA trial: 45% Of included patients reported a history of AF. The aim of the current analysis of the VICTORIA trial was to investigate whether there was a relation between clinical outcomes and AF status at baseline and to evaluate whether the treatment effects of vericiguat were related to AF status at baseline. Another aim was to investigate the effect of development of new-onset AF post-randomization on clinical outcomes.

The VICTORIA trial included patients with chronic HF, NYHA class II-IV, LVEF<45%, elevated BNP/NT-proBNP, who had a recent hospitalization for HF or received IV diuretic. Patients (n=5050) were randomized (1:1) to vericiguat (target dose 10 mg) or placebo in addition to guideline-based HF therapy. The VICTORIA AF study included 5010 patients with recorded AF status and classified them into three categories: not known AF (53%), intermittent AF (only a history of AF but without AF on ECG at randomization, 20%), and AF present on ECG at randomization (27%).

Results

• There was no association between AF status and the primary composite outcome of CV death or HF hospitalization. Only patients with intermittent AF had an increased risk for CV death as compared to those without AF.

• Vericiguat was effective across the whole spectrum of patients, irrespective of AF status.

• New-onset AF over a median follow-up of 10.8 months occurred in 345 (9.4%) patients. 163 (6.1%) Had no history of AF and 182 (18.3%) had intermittent AF (P<0.0001).

• The incidence of new-onset AF was similar in the vericiguat and placebo groups (7.5 per 100 person-years vs. 8.7 per 100 person-years, respectively. Adjusted HR 0.93, 95%CI 0.75-1.16, P=0.51).

• Among all patients, development of new-onset AF was associated with a higher risk of the primary composite outcome of CV death or HF hospitalization, compared to no development of new-onset AF (aHF 2.16, 95%CI 1.76-2.67). This association was observed in both treatment groups (vericiguat group: aHR 2.11, 95% CI: 1.58-2.81, and placebo group: aHR 2.23, 95% CI: 1.66-2.98). Similar results were obtained for the individual components of the primary outcome.

Conclusion

The beneficial clinical outcome of vericiguat in HFrEF after a worsening HF event was unaffected by AF status at baseline. New-onset AF was common, evenly distributed across treatment groups, and associated with an increased risk for CV death or HF hospitalization irrespective of treatment arm.

-Our coverage of ESC HF 2021 is based on the information provided during the congress –

The results of this study were simultaneously published in Eur J Heart Fail.