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March 26, 2013JAMAOpen Access

Effect of Disodium EDTA Chelation Regimen on Cardiovascular Events in Patients With Previous Myocardial Infarction

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Key result

An intravenous chelation regimen with disodium EDTA modestly reduced the risk of adverse cardiovascular outcomes compared with placebo (26% vs 30%; HR 0.82; 95% CI 0.69-0.99; P=0.035).

Why the study?

Does an intravenous chelation regimen with disodium EDTA reduce cardiovascular events in stable patients with a history of MI?

Population

1708 patients aged 50 years or older who had experienced a myocardial infarction at least 6 weeks prior and…

Comparison

40 infusions of a 500-mL chelation solution… vs Placebo infusions administered on the same…

Design

RCT, 2 × 2 factorial randomized trial, Double-blind, placebo-controlled

Follow-up

median, 55 months

Authors

GLGervasio A. LamasCGChristine GoertzRBRobin Boineau

Discussion

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Overview

May warrant consideration in select post-MI patients; extends chelation evidence but does not support routine use.

Study Design

Type

RCT (n=1,708)

Blinding

Double-blind

Randomization

2 × 2 factorial

Multicenter

Yes

Structured PICO

Does an intravenous chelation regimen with disodium EDTA reduce cardiovascular events in stable patients with a history of MI?

P
Population
1,708 patients aged ≥50 years with a prior myocardial infarction and serum creatinine ≤2.0 mg/dL, followed for a median of 55 months.
I
Intervention
40 infusions of a 500-mL chelation solution (3 g of disodium EDTA, 7 g of ascorbate, B vitamins, electrolytes, procaine, and heparin). Infusions were administered weekly for 30 weeks, followed by 10 infusions 2 to 8 weeks apart.
C
Comparator
Placebo infusions administered on the same schedule.
O
Outcome
Composite of total mortality, recurrent MI, stroke, coronary revascularization, or hospitalization for anginacomposite

Main Result

Hazard Ratio: 0.82 (95% CI 0.69–0.99)

Absolute Event Rate: 26% vs 30%

p-value: p=.035

Intravenous chelation therapy with disodium EDTA modestly reduced the risk of adverse cardiovascular outcomes in stable patients with a prior MI, though the results are not sufficient to support routine clinical use.

Limitations

  • Study was not powered for total mortality comparison

Cite This Study

Lamas et al. (2013) conducted an RCT in Previous myocardial infarction (n=1,708). Disodium EDTA chelation regimen vs. Placebo was evaluated on Composite of total mortality, recurrent MI, stroke, coronary revascularization, or hospitalization for angina (HR 0.82, 95% CI 0.69-0.99, p=.035). An intravenous chelation regimen with disodium EDTA modestly reduced the risk of adverse cardiovascular outcomes compared with placebo (26% vs 30%; HR 0.82; 95% CI 0.69-0.99; P=0.035).

synapsesocial.com/papers/6a9696e50f79e4f014b2f963https://doi.org/10.1001/jama.2013.2107
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