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Am Heart J. 2014 Jul;168(1):37-44.e5. doi: 10.1016/j.ahj.2014.02.012. Epub 2014 Apr 2.

EDTA chelation therapy alone and in combination with oral high-dose multivitamins and minerals for coronary disease: The factorial group results of the Trial to Assess Chelation Therapy.

Author information

1
The Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL. Electronic address: gervasio.lamas@msmc.com.
2
The National Heart, Lung, and Blood Institute, Bethesda, MD.
3
The Palmer Center for Chiropractic Research, Davenport, IA.
4
The Duke Clinical Research Institute, Durham, NC.
5
Biogenesis Medical Center, Landrum, SC.
6
The National Center for Complementary and Alternative Medicine, Bethesda, MD.
7
Celebration of Health Association, Bluffton, OH.
8
Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
9
The University of Kansas Medical Center, Kansas City, KS.

Abstract

BACKGROUND:

Disodium ethylenediaminetetraacetic acid (EDTA) reduced adverse cardiac outcomes in a factorial trial also testing oral vitamins. This report describes the intent-to-treat comparison of the 4 factorial groups overall and in patients with diabetes.

METHODS:

This was a double-blind, placebo-controlled, 2 × 2 factorial multicenter randomized trial of 1,708 post-myocardial infarction (MI) patients ≥50 years of age and with creatinine ≤2.0 mg/dL randomized to receive 40 EDTA chelation or placebo infusions plus 6 caplets daily of a 28-component multivitamin-multimineral mixture or placebo. The primary end point was a composite of total mortality, MI, stroke, coronary revascularization, or hospitalization for angina.

RESULTS:

Median age was 65 years, 18% were female, 94% were Caucasian, 37% were diabetic, 83% had prior coronary revascularization, and 73% were on statins. Five-year Kaplan-Meier estimates for the primary end point was 31.9% in the chelation + high-dose vitamin group, 33.7% in the chelation + placebo vitamin group, 36.6% in the placebo infusion + active vitamin group, and 40.2% in the placebo infusions + placebo vitamin group. The reduction in primary end point by double active treatment compared with double placebo was significant (hazard ratio 0.74, 95% CI 0.57-0.95, P = .016). In patients with diabetes, the primary end point reduction of double active compared with double placebo was more pronounced (hazard ratio 0.49, 95% CI 0.33-0.75, P < .001).

CONCLUSIONS:

In stable post-MI patients on evidence-based medical therapy, the combination of oral high-dose vitamins and chelation therapy compared with double placebo reduced clinically important cardiovascular events to an extent that was both statistically significant and of potential clinical relevance.

PMID:
24952858
PMCID:
PMC4069605
DOI:
10.1016/j.ahj.2014.02.012
[Indexed for MEDLINE]
Free PMC Article

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