Skip to main content

Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial.

Publication ,  Journal Article
Mark, DB; Anstrom, KJ; Clapp-Channing, NE; Knight, JD; Boineau, R; Goertz, C; Rozema, TC; Liu, DM; Nahin, RL; Rosenberg, Y; Drisko, J; Lee, KL ...
Published in: Circ Cardiovasc Qual Outcomes
July 2014

BACKGROUND: The National Institutes of Health.funded Trial to Assess Chelation Therapy (TACT) randomized 1708 stablecoronary disease patients aged .50 years who were .6 months post.myocardial infarction (2003.2010) to 40 infusions ofa multicomponent EDTA chelation solution or placebo. Chelation reduced the primary composite end point of mortality,recurrent myocardial infarction, stroke, coronary revascularization, or hospitalization for angina (hazard ratio, 0.82; 95%confidence interval, 0.69.0.99; P=0.035). METHODS AND RESULTS: In a randomly selected subset of 911 patients, we prospectively collected a battery of quality-of-life(QOL) instruments at baseline and at 6, 12, and 24 months after randomization. The prespecified primary QOL measures were the Duke Activity Status Index (Table I in the Data Supplement) and the Medical Outcomes Study Short-Form 36 Mental Health Inventory-5. All comparisons were by intention to treat. Baseline clinical and QOL variables were well balanced in the 451 patients randomized to chelation and in the 460 patients randomized to placebo. The Duke Activity Status Index improved in both groups during the first 6 months of therapy, but we found no evidence for a treatment-related difference (mean difference [chelation.placebo] during follow-up, 0.9 [95% confidence interval, .0.7 to 2.6; P=0.27]).There was no statistically significant evidence of a treatment-related difference in the Mental Health Inventory-5 during follow-up (mean difference, 1.0; 95% confidence interval, .0.1 to 2.0; P=0.08). None of the secondary QOL measures showed a consistent treatment-related difference. CONCLUSIONS: In stable, predominantly asymptomatic coronary disease patients with a history of myocardial infarction,EDTA chelation therapy did not have a detectable effect on QOL during 2 years of follow-up. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT00044213.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Circ Cardiovasc Qual Outcomes

DOI

EISSN

1941-7705

Publication Date

July 2014

Volume

7

Issue

4

Start / End Page

508 / 516

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Quality of Life
  • Middle Aged
  • Male
  • Humans
  • Follow-Up Studies
  • Female
  • Edetic Acid
  • Double-Blind Method
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Mark, D. B., Anstrom, K. J., Clapp-Channing, N. E., Knight, J. D., Boineau, R., Goertz, C., … TACT Investigators, . (2014). Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial. Circ Cardiovasc Qual Outcomes, 7(4), 508–516. https://doi.org/10.1161/CIRCOUTCOMES.114.000977
Mark, Daniel B., Kevin J. Anstrom, Nancy E. Clapp-Channing, J David Knight, Robin Boineau, Christine Goertz, Theodore C. Rozema, et al. “Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial.Circ Cardiovasc Qual Outcomes 7, no. 4 (July 2014): 508–16. https://doi.org/10.1161/CIRCOUTCOMES.114.000977.
Mark DB, Anstrom KJ, Clapp-Channing NE, Knight JD, Boineau R, Goertz C, et al. Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial. Circ Cardiovasc Qual Outcomes. 2014 Jul;7(4):508–16.
Mark, Daniel B., et al. “Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial.Circ Cardiovasc Qual Outcomes, vol. 7, no. 4, July 2014, pp. 508–16. Pubmed, doi:10.1161/CIRCOUTCOMES.114.000977.
Mark DB, Anstrom KJ, Clapp-Channing NE, Knight JD, Boineau R, Goertz C, Rozema TC, Liu DM, Nahin RL, Rosenberg Y, Drisko J, Lee KL, Lamas GA, TACT Investigators. Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial. Circ Cardiovasc Qual Outcomes. 2014 Jul;7(4):508–516.

Published In

Circ Cardiovasc Qual Outcomes

DOI

EISSN

1941-7705

Publication Date

July 2014

Volume

7

Issue

4

Start / End Page

508 / 516

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Quality of Life
  • Middle Aged
  • Male
  • Humans
  • Follow-Up Studies
  • Female
  • Edetic Acid
  • Double-Blind Method