Chelation Therapy for ASCVD: Not Recommended
Chelation therapy is not recommended for treating atherosclerotic cardiovascular disease (ASCVD) based on the most recent and highest quality guidelines, which explicitly state it provides no benefit for claudication symptoms and carries significant safety risks including hypocalcemia, renal failure, and death. 1
Current Guideline Recommendations
The 2024 ACC/AHA Lower Extremity PAD Guidelines provide a Class III: No Benefit recommendation (the strongest recommendation against use) for chelation therapy in treating claudication in patients with chronic symptomatic peripheral artery disease 1. This represents the most definitive current guidance against chelation therapy for any manifestation of ASCVD.
For stable ischemic heart disease, the 2014 ACC/AHA guidelines upgraded chelation from "Class III: No Benefit" to "Class IIb: Uncertain Benefit," stating that "the usefulness of chelation therapy is uncertain for reducing cardiovascular events" 1. However, the writing committee explicitly concluded that "the usefulness of chelation therapy in cardiac disease is highly questionable" despite this technical upgrade 1.
Evidence Base and Critical Limitations
The TACT Trial Findings
The Trial to Assess Chelation Therapy (TACT) compared disodium EDTA chelation versus placebo in post-MI patients and showed:
- Modest reduction in composite endpoint: 26% chelation group vs 30% placebo group (HR 0.82,95% CI 0.69-0.99, p=0.035) 1
- No individual endpoint showed significant benefit (mortality, MI, stroke, revascularization, or hospitalization for angina) 1
- Subgroup analysis in diabetics: 39% reduction in composite endpoint (HR 0.61,95% CI 0.45-0.83) 1
Critical Methodological Flaws
The TACT investigators themselves did not recommend routine use despite positive composite findings, citing 1:
- High withdrawal rate (18% lost to follow-up)
- 50% more patients withdrew from chelation than placebo, raising concerns about unmasking of treatment assignments that could have influenced subjective outcomes like revascularization decisions 1
- Absence of adequate scientific basis for the therapy
- Possibility of false positive outcome 1
Studies in Peripheral Vascular Disease
A Cochrane review of 5 studies including patients with PAD found 2:
- No difference in maximal or pain-free walking distance at 3 months (MD -31.46,95% CI -87.63 to 24.71) 2
- No difference in ankle-brachial pressure index (MD 0.02,95% CI -0.03 to 0.06) 2
- No improvement in quality of life measures 2
An earlier study of 84 patients with stable angina showed no differences in exercise time to ischemia, exercise capacity, or quality-of-life scores 1.
Safety Concerns
Disodium EDTA carries significant risks, particularly when infused too rapidly 1:
- Hypocalcemia
- Renal failure
- Death
FDA approval status: EDTA is approved only for iron overload and lead poisoning—not for cardiovascular disease 1.
Clinical Bottom Line
Do Not Use Chelation Therapy Because:
The 2024 guidelines provide the strongest recommendation against its use (Class III: No Benefit) for PAD/claudication 1
No proven benefit on hard clinical outcomes (mortality, MI, stroke) in any adequately powered study 1, 2
The single "positive" trial (TACT) had fatal methodological flaws that invalidate its findings, acknowledged by the investigators themselves 1
Significant safety risks including renal failure and death 1
Not FDA-approved for cardiovascular disease 1
Exception Requiring Further Study
The diabetic subgroup finding in TACT (39% risk reduction) represents a post-hoc analysis that requires prospective validation before any clinical application 1. Until such data exist, chelation should not be used even in diabetic patients with ASCVD.
What to Use Instead
For proven cardiovascular risk reduction in ASCVD patients 3:
- Beta-blockers for prior MI or heart failure
- ACE inhibitors for hypertension, diabetes, LV dysfunction, or chronic kidney disease
- Statins for hyperlipidemia
- Dietary approaches emphasizing vegetables, fruits, whole grains, and reduced saturated fat