title: The effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT).
abstract: BACKGROUND
  The Trial to Assess Chelation Therapy (TACT) showed clinical benefit of an EDTA-based infusion regimen in patients aged ≥50 years with prior myocardial infarction. Diabetes mellitus before enrollment was a prespecified subgroup.
  
  
  RESULTS
  Patients received 40 infusions of EDTA chelation or placebo. A total of 633 (37%) patients had diabetes mellitus (322 EDTA and 311 placebo). EDTA reduced the primary end point (death, reinfarction, stroke, coronary revascularization, or hospitalization for angina; 25% versus 38%; hazard ratio, 0.59; 95% confidence interval [CI], 0.44-0.79; P<0.001) over 5 years. The result remained significant after Bonferroni adjustment for multiple subgroups (99.4% CI, 0.39-0.88; adjusted P=0.002). All-cause mortality was reduced by EDTA chelation (10% versus 16%; hazard ratio, 0.57; 95% CI, 0.36-0.88; P=0.011), as was the secondary end point (cardiovascular death, reinfarction, or stroke; 11% versus 17%; hazard ratio, 0.60; 95% CI, 0.39-0.91; P=0.017). However, after adjusting for multiple subgroups, those results were no longer significant. The number needed to treat to reduce 1 primary end point over 5 years was 6.5 (95% CI, 4.4-12.7). There was no reduction in events in non-diabetes mellitus (n=1075; P=0.877), resulting in a treatment by diabetes mellitus interaction (P=0.004).
  
  
  CONCLUSIONS
  Post-myocardial infarction patients with diabetes mellitus aged ≥50 demonstrated a marked reduction in cardiovascular events with EDTA chelation. These findings support efforts to replicate these findings and define the mechanisms of benefit. However, they do not constitute sufficient evidence to indicate the routine use of chelation therapy for all post-myocardial infarction patients with diabetes mellitus.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00044213.
authors.affiliation: Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL.
authors.forename: Esteban
authors.initials: E
authors.lastname: Escolar
authors.forename: Gervasio A
authors.initials: GA
authors.lastname: Lamas
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Mark
authors.forename: Robin
authors.initials: R
authors.lastname: Boineau
authors.forename: Christine
authors.initials: C
authors.lastname: Goertz
authors.forename: Yves
authors.initials: Y
authors.lastname: Rosenberg
authors.forename: Richard L
authors.initials: RL
authors.lastname: Nahin
authors.forename: Pamela
authors.initials: P
authors.lastname: Ouyang
authors.forename: Theodore
authors.initials: T
authors.lastname: Rozema
authors.forename: Allan
authors.initials: A
authors.lastname: Magaziner
authors.forename: Richard
authors.initials: R
authors.lastname: Nahas
authors.forename: Eldrin F
authors.initials: EF
authors.lastname: Lewis
authors.forename: Lauren
authors.initials: L
authors.lastname: Lindblad
authors.forename: Kerry L
authors.initials: KL
authors.lastname: Lee
mesh_terms: D000367:Age Factors; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D002614:Chelating Agents / Q000627:therapeutic use*; D048909:Diabetes Complications / Q000150:complications* / Q000378:metabolism; D004311:Double-Blind Method; D004492:Edetic Acid / Q000627:therapeutic use*; D005260:Female; D017127:Glycation End Products, Advanced / Q000378:metabolism; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications* / Q000378:metabolism / Q000517:prevention & control*; D010084:Oxidation-Reduction; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D002614:Chelating Agents; D017127:Glycation End Products, Advanced; D004492:Edetic Acid
keywords: diabetes mellitus; myocardial infarction; secondary prevention