Preoperative Intravenous Iron to Treat Anemia in Major Surgery - PREVENTT

Sep 14, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
UK National Institute of Health Research Health Technology Assessment Program
Date Published:
09/04/2020
Date Updated:
09/14/2020
Original Posted Date:
09/14/2020
References

Contribution To Literature:

The PREVENTT trial failed to show that intravenous iron was superior to placebo at improving outcomes.

Description:

The goal of the trial was to evaluate intravenous iron compared with placebo among patients with anemia undergoing major abdominal surgery.

Study Design

  • Randomized
  • Parallel
  • Double-Blind

Eligible patients undergoing major abdominal surgery were randomized to intravenous iron infusion (n = 244) versus placebo infusion (n = 243) 10-42 days before surgery.

  • Total number of enrollees: 487
  • Duration of follow-up: 6 months
  • Mean patient age: 65 years
  • Percentage female: 58%
  • Percentage with diabetes: 16%

Inclusion criteria:

  • Patients >18 years of age undergoing major abdominal surgery
  • Hemoglobin <13 mg/dl for men or <12 mg/dl for women

Exclusion criteria:

  • Laparoscopic surgery
  • Concurrent infection
  • Body weight <50 kg (<110 lbs)
  • Chronic liver disease
  • Another cause for anemia
  • Acquired iron overload
  • Known family of hemochromatosis or thalassemia
  • Transferrin saturation >50%

Principal Findings:

The co-primary outcome, blood transfusion or death at 6 months, occurred in 29% of the iron group compared with 28% of the placebo group (p = 0.84).

The co-primary outcome, number of blood transfusions at 30 days, was in 105 in the iron group compared with 111 in the placebo group (p < 0.001).

Secondary outcomes:

  • All-cause death at 6 months: 5% of the intravenous iron group compared with 4% of the placebo group (p = nonsignificant)
  • Readmission to the hospital for complications at 6 months: 13% of the intravenous iron group compared with 22% of the placebo group (p < 0.05)

Interpretation:

Among patients with anemia undergoing major abdominal surgery, preoperative iron transfusion failed to improve outcomes. Iron transfusion compared with placebo did not reduce the number of blood transfusions or the incidence of death or blood transfusion. Iron transfusion was associated with a reduction in readmission for complications. Preoperative iron deficiency anemia was not a requirement for study participation. It is possible that anemia represented a marker of frailty among many enrolled subjects; therefore, it is not surprising that intravenous iron did not improve outcomes.

References:

Richards T, Baikady RR, Clevenger B, et al. Preoperative intravenous iron to treat anemia before major abdominal surgery (PREVENTT): a randomized, double-blind, controlled trial. Lancet 2020;Sep 4:[Epub ahead of print].

Clinical Topics: Geriatric Cardiology, Prevention

Keywords: Anemia, Anemia, Iron-Deficiency, Blood Transfusion, Frail Elderly, Hemoglobins, Infusions, Intravenous, Iron, Patient Readmission, Preoperative Care, Primary Prevention, Elective Surgical Procedures


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