Table 12, Summary of Findings by Outcome — Safety and Adverse Events - Intravenous Iron Preparations for Patients Undergoing Elective Surgery: A 2022 Update

Table 12Summary of Findings by Outcome — Safety and Adverse Events

Study citation and design	Study findings
Chaudhry et al. (2021)¹⁸ SR (1 RCT, Brisbe et al. 2014)	Rate of adverse events IV iron group = 33% Oral iron group = 32%
Chaudhry et al. (2021)¹⁸ SR (1RCT, Yoo et al. 2019)	Rate of adverse events IV iron group = 0% Control group = 0%
Elhenawy et al. (2021)¹⁹ SR with MA (Based on 2 included study)	Effects of IV iron therapy versus placebo or standard of care on the occurrence of associated serious adverse effects Total IV iron group events = 85 Total placebo or standard of care group events = 91 Risk ratio (95% CI) = 0.96 (0.44 to 2.10); P = 0.92; I² = 0%
Elhenawy et al. (2021)¹⁹ SR with MA (Based on 7 included studies)	Effect of IV iron therapy versus placebo or standard of care on the occurrence of non-serious adverse effects (random effects model) Total IV iron group events = 412 Total placebo or standard of care group events = 401 Risk ratio (95% CI) = 1.13 (0.78 to 1.65); P = 0.52; I² = 0%
Jones et al. (2021)²⁰ SR (1 RCT, Kim et al. 2017)	Proportion of patients experiencing adverse events, n/N (%)^a IV iron group = 15/222 (6.8%) Placebo = 1/223 (0.4)
Jones et al. (2021)²⁰ SR (1 RCT, Padmanabhan et al. 2019)	Proportion of patients experiencing adverse events, n/N (%)^a IV iron group = 0/20 Oral iron group = 3/20 (15%)
Jones et al. (2021)²⁰ SR (1 RCT, Park et al. 2019)	Proportion of patients experiencing adverse events, n/N (%)^a IV iron group = 0/29 Placebo group = NR
Jones et al. (2021)²⁰ SR (1 RCT, Richards et al. 2019)	Proportion of patients experiencing adverse events, n/N (%)^a IV iron group = 11/237 (5%) Placebo group = 5/237 (5%)
Fung et al. (2022)²² RCT	Number of patients experiencing any surgical complications, n (%) IV iron group = 11 (55%) Control group = 8 (40%) P = 0.342 Number of patients experiencing surgical complication grade 0, 1, 2, or 3 IV iron group = 9;7;3;1 Control group = 12;6;2;0 P = 0.636 Hospital readmission within 30 days, n (%) IV iron group = 1 (5%) Control group = 1 (5%) P = 1.00
Kvaslerud et al. (2022)²³ RCT	Number of adverse events between IV iron group (N = 73) and Placebo group (N = 75) IV iron group = 53 Placebo group = 66 Number of serious adverse events between IV iron group (N = 73) and Placebo group (N = 75) IV iron group = 37 Placebo group = 49
Shokri et al. (2022)²⁴ RCT	Incidence of adverse cardiovascular events between IV iron group (N = 40) and placebo group (N = 40), n (%) IV iron group = 5 (12.5%) Placebo group = 7 (17.5%) P = 0.531 Incidence of prolonged ventilation between IV iron group (N = 40) and placebo group (N = 40), n (%) IV iron group = 2 (5%) Placebo group = 6 (15%) P = 0.136 Incidence of heart failure between IV iron group (N = 40) and placebo group (N = 40), n (%) IV iron group = 1 (2.5%) Placebo group = 3 (7.5%) P = 0.305 Incidence of stroke between IV iron group (N = 40) and placebo group (N = 40), n (%) IV iron group = 0 Placebo group = 1 (2.5%) P = 0.314
Thin et al. (2021)²⁵ RCT	Number of patients readmitted during 6-month follow-up between IV iron group (N = 13) and oral iron group (N = 12), n (%) IV iron group = 4 (30.8%) Oral iron group = 4 (33.3%) P = 0.9
Ploug et al. (2022)²⁶ Retrospective cohort study	All complications rate between IV iron group (N = 122) and control group (N = 48), n (%) IV iron group = 31 (25%) Control group = 4 (8%) P = 0.01 All surgical complications rate between IV iron group (N = 122) and control group (N = 48), n (%) IV iron group = 24 (20%) Control group = 4 (8%) P = 0.05 All medical complications rate between IV iron group (N = 122) and control group (N = 48), n (%) IV iron group = 10 (8%) Control group = 1 (2%) P = 0.13
Quarterman et al. (2021)³⁰ Retrospective cohort study	Number of cerebrovascular accidents from each group, n (%) Anemic and received IV iron treatment group (N = 190) = 7 (3.7%) Anemic and did not receive IV iron treatment or not iron deficient group (N = 581) = 11 (1.9%); P = 0.17 vs IV iron treatment group Not anemic group (N = 2093) = 24 (1.2%); P = 0.01 vs IV iron treatment group Number of renal replacement therapy procedures from each group, n (%) Anemic and received IV iron treatment group (N = 190) = 7 (6.7%) Anemic and did not receive IV iron treatment or not iron deficient group (N = 581) = 9 (1.6%); P = 0.08 vs IV iron treatment group Not anemic group (N = 2093) = 13 (0.6%); P < 0.001 vs IV iron treatment group Number of re-operations from each group, n (%) Anemic and received IV iron treatment group (N = 190) = 9 (4.7%) Anemic and did not receive IV iron treatment or not iron deficient group (N = 581) = 24 (4.1%); P = 0.72 vs IV iron treatment group Not anemic group (N = 2093) = 73 (3.5%); P = 0.36 vs IV iron treatment group
Mortality
Elhenawy et al. (2021)¹⁹ SR with MA	Effect of IV iron therapy versus placebo or standard of care on 30-day mortality (random effects model based on 4 included studies) Total IV iron group events = 303 Total placebo or standard of care group events = 284 Risk ratio (95%CI) = 1.10 (0.60 to 2.00); P = 0.76; I² = 0% Effect of IV iron therapy versus placebo or standard of care on mortality ≥ 2 months post-hospital discharge (based on 2 studies) Total IV iron group events = 164 Total placebo or standard of care group events = 155 Risk ratio (95% CI) = 1.18 (0.63 to 2.19); P = 0.60; I² = 0%
Jones et al. (2021)²⁰ SR (1 RCT, Padmanabhan et al. 2019)	Proportion of postoperative mortality, n/N (%)^a IV iron group = 1/20 (5%)^b Oral iron group = 0/29
Jones et al. (2021)²⁰ SR (1 RCT, Richards et al. 2019)	Proportion of postoperative mortality, n/N (%)^a IV iron group = 12/238 (5%) Placebo group = 10/236 (4%)
Kvaslerud et al. (2022)²³ RCT	Number of deaths between IV iron group (N = 73) and Placebo group (N = 75) IV iron group = 2 Placebo group = 5
Shokri et al. (2022)²⁴ RCT	Mortality rate between IV iron group (N = 40) and placebo group (N = 40), n (%) IV iron group = 2 (5%) Placebo group = 3 (7.5%) P = 0.644
Ploug et al. (2022)²⁶ Retrospective cohort study	30-day mortality rate between IV iron group (N = 122) and control group (N = 48), n (%) IV iron group = 1 (1%) Control group = 0 P = 0.72 90-day mortality rate between IV iron group (N = 122) and control group (N = 48), n (%) IV iron group = 2 (2%) Control group = 3 (6%) P = 0.14
Evans et al. (2021)²⁸ Retrospective cohort study	Number of deaths for each group, n (%) IV treatment responsive group (N = 24) = 0 IV treatment unresponsive group (N = 51) = 1 (2%) Untreated anemic group (N = 72) = 3 (6%); P = 0.012 vs non-anemic group Non-anemic group (N = 300) = 3 (1%)
Quarterman et al. (2021)³⁰ Retrospective cohort study	Number of in-hospital mortality from each group, n (%) Anemic and received IV iron treatment group (N = 190) = 3 (1.6%) Anemic and did not receive IV iron treatment or not iron deficient group (N = 581) = 14 (2.4%); P = 0.78 vs IV iron treatment group Not anemic group (N = 2093) = 17 (0.8%); P = 0.23 vs IV iron treatment group
Triphaus et al. (2021)³¹ Prospective cohort study	Mortality rate for each group, n (%) Anemic, iron deficient and IV iron treatment group (N = 184) = 7 (3.8%) Iron deficient and IV iron treatment group (N = 55) = 3 (5.5%) Anemic and no treatment group (N = 461) = 27 (5.9%) Not anemic and no treatment group (N = 1028) = 31 (3%)
Infection
Elhenawy et al. (2021)¹⁹ SR with MA (Based on 2 included studies)	Effect of IV iron therapy versus placebo or standard of care on postoperative infection occurrence (random effects model) Total IV iron group events = 143 Total placebo or standard of care group events = 132 Risk ratio (95% CI) = 0.64 (0.30 to 1.40); P = 0.27; I² = 0%
Fung et al. (2022)²² RCT	Number of patients experiencing infection, n (%) IV iron group = 6 (30%) Control group = 4 (20%) P = 0.465
Kvaslerud et al. (2022)²³ RCT	Number of infections during IV treatment between IV iron group (N = 73) and Placebo group (N = 75) IV iron group = 5 Placebo group = 6
Shokri et al. (2022)²⁴ RCT	Incidence of infection between IV iron group (N = 40) and placebo group (N = 40), n (%) IV iron group = 3 (7.5%) Placebo group = 5 (12.5%) P = 0.456
Ploug et al. (2022)²⁶ Retrospective cohort study	All infectious complications rate between IV iron group (N = 122) and control group (N = 48), n (%) IV iron group = 10 (8%) Control group = 1 (2%) P = 0.14
Quarterman et al. (2021)³⁰ Retrospective cohort study	Number of sternal wound infections from each group, n (%) Anemic and received IV iron treatment group (N = 190) = 7 (3.7%) Anemic and did not receive IV iron treatment or not iron deficient group (N = 581) = 16 (2.8%); P = 0.51 vs IV iron treatment group Not anemic group (N = 2093) = 42 (2%); P = 0.12 vs IV iron treatment group

: CI = confidence interval; EPO = erythropoietin; IV = intravenous; MA = meta-analysis; N = number; NR = not reported; RCT = randomized controlled trial; SR = systematic review; vs = versus.
^a: Statistical significance between groups was not provided by Jones et al. (2021)
^b: Mortality in this population was due to unrelated causes.

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Intravenous Iron Preparations for Patients Undergoing Elective Surgery: A 2022 Update: Rapid Review [Internet].

Hill S, Severn M; Authors.

Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2022 Nov.

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