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Randomized Comparison of High-Dose Oral Vitamins versus Placebo in the Trial to Assess Chelation Therapy (TACT). Gervasio A. Lamas, MD, FACC Professor of Clinical Medicine Columbia University Division of Cardiology Mount Sinai Medical Center Miami Beach, FL. For the TACT Investigators.

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Randomized Comparison of High-Dose Oral Vitamins versus Placebo in the Trial to Assess Chelation Therapy (TACT)

Gervasio A. Lamas, MD, FACC

Professor of Clinical Medicine

Columbia University Division of Cardiology

Mount Sinai Medical Center

Miami Beach, FL

For the TACTInvestigators

study organization
Study Organization

Funding agencies: NHLBI and NCCAM

Clinical Coordinating Center: Mount Sinai Medical Center, Miami Beach FL

Data Coordinating Center and EQOL Coordinating Center: Duke Clinical Research Institute

Clinical Events Committee: Brigham and Women’s Hospital

Central Pharmacy: Universal Arts, Miami FL

Vitamins: Douglas Labs, Pittsburgh PA

background
Background
  • TACT tested whether EDTA chelation reduced a composite cardiovascular endpoint in post-MI patients.
  • Chelation practitioners use high doses of anti-oxidant vitamins and minerals in conjunction with intravenous chelation.
  • Uncontrolled use of oral vitamins and minerals therefore constituted a potential confounder.
design rationale
Design Rationale
  • To clarify the relative contributions of high- dose vitamins and IV chelation, TACT was designed as a 2 x 2 factorial trial, with patients randomized to 4 groups:
    • Active oral vitamins + active IV chelation
    • Placebo oral vitamins + active IV chelation
    • Active oral vitamins + placebo IV chelation
    • Placebo oral vitamins + placebo IV chelation
tact high dose oral treatment
TACT: High-Dose Oral Treatment

3 caplets twice a day for the duration of the study.

Calcium

Iodine

Magnesium

Zinc

Selenium

Copper

Manganese

Chromium

Molybdenum

Potassium

Choline

Boron

Inositol

PABA

Vanadium

Citrus Flavonoids

Vitamin A

Vitamin C

Vitamin D3

Vitamin E

Vitamin K

Thiamin

Niacin

VitaminB6

Folate

Vitamin B12

Biotin

Panthothenic Acid

Double-blind active or placebo high dose vitamins were

shipped from a central pharmacy to sites.

Lamas GA, Goertz C, Boineau R, et. al. Design of the Trial to Assess Chelation Therapy (TACT). Am Heart J. 2012 Jan;163(1):7-12. 

eligibility
Eligibility
  • Age 50 or older
  • MI > 6 weeks prior
  • Creatinine <2.0 mg/dL
  • No coronary or carotid revascularization within 6 months
  • No active heart failure or heart failure hospitalization within 6 months
  • No cigarette smoking within 3 months
  • Signed informed consent
primary endpoint
Primary Endpoint
  • Primary composite endpoint: time to first occurrence of either death, MI, stroke, coronary revascularization, or hospitalization for angina
statistical plan
Statistical Plan
  • Designed to have 85% power to detect a 25% difference
  • Treatment comparisons as randomized (intent to treat)
  • Two-sided statistical testing
  • Log-rank test using time to first event
  • Prespecified analysis of factorial groups
tact primary endpoint results for edta chelation presented at aha 2012
TACT Primary Endpoint Resultsfor EDTA Chelation (presented at AHA 2012)

EDTA: Placebo

HR (95% CI)0.82 (0.69, 0.99)

P = 0.035

Death, MI, stroke, coronary revascularization, hospitalization for angina

tact vitamin primary endpoint results
TACT Vitamin Primary Endpoint Results

Vitamins: Placebo

HR (95% CI)0.89 (0.75, 1.07)

P = 0.212

37%

34%

Death, MI, stroke, coronary revascularization, hospitalization for angina

Median follow-up 55 months

subgroup results for vitamin analyses
Subgroup Results for Vitamin Analyses

0.25

0.5

1.0

2.0

4.0

High-Dose Vitamins Better

Placebo Better

tact primary endpoint factorial groups
TACT Primary Endpoint: Factorial Groups

EDTA Chelation/High-dose Vitamins vs. Placebo/Placebo

HR (95% CI): 0.74 (0.57, 0.95)

P = 0.016

Δ=8.3%

adherence
Adherence
  • 75.6% took study vitamins for at least 1 year.
    • The most common reason for discontinuation was patient refusal (75%)
    • Median duration of treatment: 33.4 months.
    • No difference in discontinuation rate in active vs placebo vitamins.
limitations
Limitations

Compliance with high-dose vitamin regimen was challenging, leading to some non-adherence.

High consent withdrawal rate (17%).

The therapeutic mechanisms by which high-dose vitamins and chelation might provide benefits are unclear.

summary
Summary
  • High dose oral vitamins reduced the composite outcome by 11%, which was not statistically significant.
  • When combined with EDTA chelation, the small vitamin benefit was additive, and the combined effect was statistically significant.
caveats
Caveats

The results of this study do not support the use of high-dose vitamin and mineral therapy as an adjunct to optimal evidence-based medical therapy in patients with prior myocardial infarction.

These findings should stimulate further research, but are not, by themselves, sufficient to recommend the routine use of chelation therapy and high-dose vitamins in post-MI patients.