American Heart Association
American Heart Association
Source/Disclosures
Source:

Ponikowski P, et al. Heart failure and atrial fibrillation: Vitamins, minerals, nutrients, and more. Presented at: American Heart Association Scientific Sessions; Nov. 13-17, 2020 (virtual meeting).


Disclosures: The study was funded by Vifor Pharma. Ponikowski reports he financial ties with Abbott Vascular, Amgen, AstraZeneca, Bayer, Berlin Chemie, Boehringer Ingelheim, Bristol-Myers Squibb, Cibiem, Impulse Dynamics, Merck, Novartis, Pfizer, RenalGuard Solutions, Servier and Vifor Pharma. Please see the study for the other authors’ relevant financial disclosures. Sweitzer reports she received research payments from Merck and Novartis and consultant fees from MyoKardia.

November 13, 2020
3 min read
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Iron supplementation for deficiency in acute HF lowers risk for future hospitalization

Source/Disclosures
Source:

Ponikowski P, et al. Heart failure and atrial fibrillation: Vitamins, minerals, nutrients, and more. Presented at: American Heart Association Scientific Sessions; Nov. 13-17, 2020 (virtual meeting).


Disclosures: The study was funded by Vifor Pharma. Ponikowski reports he financial ties with Abbott Vascular, Amgen, AstraZeneca, Bayer, Berlin Chemie, Boehringer Ingelheim, Bristol-Myers Squibb, Cibiem, Impulse Dynamics, Merck, Novartis, Pfizer, RenalGuard Solutions, Servier and Vifor Pharma. Please see the study for the other authors’ relevant financial disclosures. Sweitzer reports she received research payments from Merck and Novartis and consultant fees from MyoKardia.

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Supplementation in iron-deficient patients hospitalized with acute HF reduced subsequent HF hospitalization by approximately 26% compared with placebo, according to findings from the AFFIRM-AHF trial.

Moreover, supplementation with IV ferric carboxymaltose (Vifor Pharma) did not appear to affect CV mortality in this population, according to research presented at the virtual American Heart Association Scientific Sessions.

patient hooked up to an IV in a hospital bed
Source: Adobe Stock.

“Iron deficiency is common in patients with heart failure, being accompanied by exercise intolerance, poor quality of life, increased risk for hospitalization and high morbidity and mortality,” Piotr Ponikowski, MD, PhD, head of the department of heart diseases at Wroclaw Medical University in Wroclaw, Poland, said at a press conference. “Correction of iron deficiency [improves these] symptoms... but the effects of ferric carboxymaltose administered at hospital discharged in stabilized patients with acute heart failure and concomitant iron deficiency [are] unknown and this issue remains extremely important as hospitalizations due to acute heart failure represent a growing health care problem [and] iron deficiency is present in up to 75% of these patients.”

For this trial, simultaneously published in The Lancet, investigators enrolled 1,108 patients hospitalized with acute HF and an iron deficiency. After stabilization, participants were randomly assigned to receive IV ferric carboxymaltose or placebo at discharge and at 6 weeks and were followed for 52 weeks to determine the effect of iron supplementation on subsequent HF hospitalization and CV death.

Patients whose iron deficiency persisted received re-administration of IV ferric carboxymaltose at weeks 12 and 24.

At 52 weeks, there was a lower prevalence of total HF hospitalizations and CV death among the ferric carboxymaltose group compared with the placebo group (RR = 0.79; 95% CI, 0.62-1.01) that was primarily driven by reduction in HF hospitalization (RR for HF hospitalization = 0.74; 0.58-0.94; HR for CV death = 0.96; 955 CI, 0.7-1.32).

“In patients with iron deficiency stabilized after an episode of acute heart failure, treatment with ferric carboxymaltose reduced the risk of heart failure hospitalization with no apparent effect on the risk of cardiovascular death,” Ponikowski said during a press conference. “In this high-risk population, ferric carboxymaltose reduced the total number of heart failure hospitalizations irrespective of anemia status.”

Researchers also observed reduced risk for first HF hospitalization or CV death among patients who received iron supplementation (HR = 0.8; 95% CI, 0.66-0.98) in addition to lower prevalence of total CV hospitalizations and CV death (RR = 0.8; 95% CI, 0.64-1).

“The management and follow-up of patients was affected by the COVID-19 pandemic, and as we all know, it impacted health care services provided and had potential consequences on heart failure epidemiology being acknowledged as a serious and unpredictable threat to the conduct of clinical trials,” Ponikowski said during the press conference. “Based on the recommendations of the European Society of Cardiology, European Medicines Agency and U.S. Food and Drug Administration, the statistical analysis plan included a pre-COVID-19 sensitivity analysis, censoring patients in each country at the day when its first COVID-19 patient was reported.”

This prespecified sensitivity analysis identified the following statistically significant differences in favor of IV ferric carboxymaltose supplementation before the onset of COVID-19 in a patient’s country:

  • total HF hospitalizations and CV death (RR = 0.75; 95% CI, 0.59-0.96);
  • total HF hospitalizations (RR = 0.7; 95% CI, 0.55-0.9);
  • first HF hospitalization or CV death (HR = 0.79; 95% CI, 0.65-0.97);
  • total CV hospitalizations and CV death (RR = 0.77; 95% CI, 0.62-0.97).

In the sensitivity analysis, there was no difference between the groups in CV death (HR = 0.94; 95% CI, 0.68-1.29).

Discussant Nancy K. Sweitzer, MD, PhD, professor of medicine, chief of cardiovascular medicine and director at the Sarver Heart Center University of Arizona in Tucson and Editor-in-Chief, Circulation: Heart Failure, said during the press conference that the trial “is likely to change practice in acute heart failure. Chronic iron deficiency is one of the most common comorbidities found in heart failure patients and arguably the most common comorbidity in our acute heart failure population that was studied in this trial. In addition to the well-known and recognized effect of iron to improve oxygen carrying capacity in our patients, independent of anemia, iron deficiency also impairs cellular energetics and immune function in patients, both of which may be very important in this population.

“Since we really do not think that iron is involved in the pathophysiology of established chronic heart failure with low ejection fraction or acute heart failure with low ejection fraction, it makes sense that this would have an impact on a quality-of-life endpoint and a patient related outcome rather than on death itself,” Sweitzer said. “This is an incredibly important endpoint for our patients and for the population studied in this trial.”

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