title: 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.
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.
authors: The Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL. Electronic address: gervasio.lamas@msmc.com.
authors: Gervasio A
authors: GA
authors: Lamas
authors: The National Heart, Lung, and Blood Institute, Bethesda, MD.
authors: Robin
authors: R
authors: Boineau
authors: The Palmer Center for Chiropractic Research, Davenport, IA.
authors: Christine
authors: C
authors: Goertz
authors: The Duke Clinical Research Institute, Durham, NC.
authors: Daniel B
authors: DB
authors: Mark
authors: The National Heart, Lung, and Blood Institute, Bethesda, MD.
authors: Yves
authors: Y
authors: Rosenberg
authors: The National Heart, Lung, and Blood Institute, Bethesda, MD.
authors: Mario
authors: M
authors: Stylianou
authors: Biogenesis Medical Center, Landrum, SC.
authors: Theodore
authors: T
authors: Rozema
authors: The National Center for Complementary and Alternative Medicine, Bethesda, MD.
authors: Richard L
authors: RL
authors: Nahin
authors: Celebration of Health Association, Bluffton, OH.
authors: L
authors: L
authors: Terry Chappell
authors: The Duke Clinical Research Institute, Durham, NC.
authors: Lauren
authors: L
authors: Lindblad
authors: Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
authors: Eldrin F
authors: EF
authors: Lewis
authors: The University of Kansas Medical Center, Kansas City, KS.
authors: Jeanne
authors: J
authors: Drisko
authors: The Duke Clinical Research Institute, Durham, NC.
authors: Kerry L
authors: KL
authors: Lee
mesh_terms: D000284:Administration, Oral; D000368:Aged; D002614:Chelating Agents / Q000008:administration & dosage; D015913:Chelation Therapy / Q000379:methods*; D003327:Coronary Disease / Q000188:drug therapy* / Q000401:mortality; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004492:Edetic Acid / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D008903:Minerals / Q000008:administration & dosage*; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014815:Vitamins / Q000008:administration & dosage*
chemical_list: D002614:Chelating Agents; D008903:Minerals; D014815:Vitamins; D004492:Edetic Acid