Safety indicators associated with lower achieved doses of GDMT in patients with acute HF

December 4, 2023

Among acute HF patients receiving high-intensity care in the STRONG-HF trial, the occurrence of any safety indicator was associated with lower achieved doses of GDMT, but this did not affect the risk of 180-day HF readmission or all-cause mortality.

This summary is based on the publication of Tomasoni D et al. - Safety Indicators in Patients Receiving High-intensity Care After Hospital Admission for Acute Heart Failure: The STRONG-HF Trial. J Card Fail. 2023 Oct 9:S1071-9164(23)00342-1. doi: 10.1016/j.cardfail.2023.09.002.

Introduction and methods

Background and aim of the study

In the STRONG-HF trial, it was shown that a high-intensity care strategy of rapid uptitration of GDMT and close follow-up reduced the risk of 180-day HF rehospitalization or all-cause mortality in patients hospitalized for acute HF compared with usual care [1-2]. The aim of this subanalysis of the STRONG-HF trial was to investigate how safety indicators affect achieved doses of GDMT and clinical outcomes in patients receiving high-intensity care after hospitalization for acute HF.

Methods

The STRONG-HF trial was a multicenter, open-label trial in which patients with acute HF were randomized before discharge to a high-intensity care strategy of early up-titration of GDMT or usual care. In the high-intensity care arm (n=542), GDMT therapy (β-blockers, ACEi/ARBs/ARNI, or MRAs) was rapidly up-titrated to 50% of optimal doses within 2 days before anticipated discharge and to 100% of the optimal doses within 2 weeks after discharge. Patients had follow-up visits at week 1, 2, 3, and 6, and an additional safety visit 1 week after any up-titration. GDMT up-titration was delayed if prespecified safety indicators were present. These safety indicators included: eGFR of<30 mL/min/1.73 m² (n=28), serum potassium level of <5.0 mmol/L (n=149), SBP of >95 mmHg (n=51), heart rate of <55 bpm (n=46), and NT-proBNP of >10% higher than the value at randomization (n=223). Patients of the high-intensity care strategy were stratified into 2 groups based on the occurrence of any safety indicator at week 1, 2, 3 or 6.

Outcomes

The primary outcome of STRONG-HF was the composite of all-cause mortality or first HF rehospitalization at day 180.

Main results

  • A total of 229 patients (42.3%) had no safety indicator and 313 patients (57.7%) had ≥1 safety indicator at any follow-up visit. Patients who had ≥1 safety indicator were less likely to have a history of HF, and more often had ACS, severe HF symptoms, higher NYHA class at month 1, and a lower SBP and higher heart rate at baseline compared with patients without any safety indicator.
  • Lower percentages of optimal GDMT doses were achieved in patients with any safety indicator compared with patients without any safety indicator (mean difference: -11.0%; 95%CI: -13.6 to -8.4%; P<0.001). Differences between groups were evident from week 2.
  • The primary composite outcome occurred in 43 patients (15.0%) with any safety indicator and in 31 patients (14.2%) without any safety indicator (HR: 0.84; 95%CI: 0.48-1.46; P=0.54). No single safety indicator was associated with the primary outcome.
  • An eGFR of <30 mL/min/1.73 m² was associated with an increased risk of 180-day readmission for HF (adjusted HR: 3.60; 95%CI: 1.22-10.60; P=0.02).
  • Patients with any safety indicator had smaller improvements in EQ-5D VAS score compared with patients without any safety indicator (adjusted difference: -3.32 points; 95%CI: -5.97 to -0.66; P=0.015).

Conclusion

This analysis of the STRONG-HF trial showed that the occurrence of any safety indicator at any follow-up visit 1-6 weeks after discharge was associated with lower achieved GDMT doses in patients of the high-intensity care group. The occurrence of any safety indicator did not affect the incidence of the primary composite outcome.

References

1. Kimmoun A, Cotter G, Davison B, et al. Safety, Tolerability and efficacy of Rapid Optimization, helped by NT-proBNP and GDF-15, of Heart Failure therapies (STRONG-HF): rationale and design for a multicentre, randomized, parallel-group study. Eur J Heart Fail. 2019;Nov;21(11):1459-1467.

2. Mebazaa A, Davison B, Chioncel O, et al. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022;400(10367):1938-1952.

Find this article online at J Card Fail.

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