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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).

Publication ,  Journal Article
Escolar, E; Lamas, GA; Mark, DB; Boineau, R; Goertz, C; Rosenberg, Y; Nahin, RL; Ouyang, P; Rozema, T; Magaziner, A; Nahas, R; Lewis, EF ...
Published in: Circ Cardiovasc Qual Outcomes
January 2014

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. METHODS AND 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00044213.

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Published In

Circ Cardiovasc Qual Outcomes

DOI

EISSN

1941-7705

Publication Date

January 2014

Volume

7

Issue

1

Start / End Page

15 / 24

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Risk Factors
  • Oxidation-Reduction
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Incidence
  • Humans
  • Glycation End Products, Advanced
  • Female
 

Citation

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Escolar, E., Lamas, G. A., Mark, D. B., Boineau, R., Goertz, C., Rosenberg, Y., … Lee, K. L. (2014). 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). Circ Cardiovasc Qual Outcomes, 7(1), 15–24. https://doi.org/10.1161/CIRCOUTCOMES.113.000663
Escolar, Esteban, Gervasio A. Lamas, Daniel B. Mark, Robin Boineau, Christine Goertz, Yves Rosenberg, Richard L. Nahin, et al. “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).Circ Cardiovasc Qual Outcomes 7, no. 1 (January 2014): 15–24. https://doi.org/10.1161/CIRCOUTCOMES.113.000663.
Escolar E, Lamas GA, Mark DB, Boineau R, Goertz C, Rosenberg Y, et al. 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). Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):15–24.
Escolar, Esteban, et al. “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).Circ Cardiovasc Qual Outcomes, vol. 7, no. 1, Jan. 2014, pp. 15–24. Pubmed, doi:10.1161/CIRCOUTCOMES.113.000663.
Escolar E, Lamas GA, Mark DB, Boineau R, Goertz C, Rosenberg Y, Nahin RL, Ouyang P, Rozema T, Magaziner A, Nahas R, Lewis EF, Lindblad L, Lee KL. 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). Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):15–24.

Published In

Circ Cardiovasc Qual Outcomes

DOI

EISSN

1941-7705

Publication Date

January 2014

Volume

7

Issue

1

Start / End Page

15 / 24

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Risk Factors
  • Oxidation-Reduction
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Incidence
  • Humans
  • Glycation End Products, Advanced
  • Female