Clinical Benefit of EDTA-based Chelation Therapy and High-dose Oral Multivitamins and Multiminerals in TACT- An Expanded Comparison of 2 Factorial Groups

Lamas, et al. (See below for other contributors)

Background: Chelation therapy, in combination with high dose oral multivitamins and multiminerals (MV), has been used to treat atherosclerotic disease. This analysis of the NIH-funded Trial to Assess Chelation Therapy (TACT) focuses on the comparison of 2 treatment groups chelation + MV versus placebo infusions + placebo MV, evaluating a treatment strategy reflecting clinical practice, and not previously presented in detail.

Methods: TACT, a multi-center, double-blind, placebo-controlled, 2 X 2 factorial trial of EDTA chelation and MV enrolled 1708 patients age ≥ 50 years, MI ≥ 6 weeks prior, creatinine ≤ 2.0, assigned to 40 IV chelation or placebo infusions and a 28-component oral MV or placebo. Primary endpoint was death, MI, stroke, coronary revascularization, or hospitalization for angina. Secondary endpoint was cardiovascular mortality, MI, or stroke. We describe the intent-to-treat comparison of 2 factorial groups: chelation + MV (n=421) vs placebo chelation + placebo MV (n=437). Treatment comparisons were by log rank test.

Results: The median age was 65 years, 83% had prior coronary revascularization, and 73% were on statins. Key baseline characteristics were similar between groups. Primary endpoint occurred in 108 (26%) patients in the chelation + MV, and 139 (32%) in the placebo + placebo group (p=0.016). The 5-year Kaplan Meier estimates for the primary endpoint in the chelation + high-dose vitamin group was 31.9%, and in the placebo infusions + placebo vitamin group 40.2%. The secondary endpoint occurred in 39 (9%) of chelation + MV and in 58 (13%) of placebo + placebo (p=0.045). The point estimates for each component of the combined endpoints were all <1.0 and consistent with the overall effect (Table).

Conclusions: In stable patients with a history of MI on appropriate evidence based medical therapy, the beneficial effect of the combination of high-dose vitamins and chelation therapy was statistically significant and of potential clinical relevance.

chelation graph

Gervasio A Lamas1; Richard L Nahin2; Lauren Lindblad3; Christine Goertz4; Robin Boineau5; Terry Chappell6; Greg Flaker7; Theodore Rozema8; Tammy Born9; Mario Stylianou10; Eldrin F Lewis11; Daniel B Mark12; Kerry L Lee3

1 Div of Cardiology, Mount Sinai Med Cntr, Miami Beach, FL
2 31 Cntr Dr, MS 2182, National Cntr for Complementary and Alternative Medicine, Bethesda, MD
3 Biostatistics & Bioinformatics, Duke Clinical Rsch Institute, Durham, NC
4 Chiropractic Rsch, Palmer College of Chiropractic, Davenport, IA
5 HEART FAILURE & ARRHYTHMIAS BRANCH, National Heart, Lung and Blood Institute, Bethesda, MD
6 N/A, Celebration of Heath Association, Bluffton, OH
7 Cardiovascular Medicine, Univ of Missouri Health Care, Columbia, MO
8 N/A, Biogenesis Med Cntr, Landrum, SC
9 N/A, Born Preventive Health Care Clinic, Grand Rapids, MI
10 Biostatistics, National Heart, Lung and Blood Institute, Bethesda, MD
11 Cardiovascular Div, Brigham & Women’s Hosp, Boston, MA
12 Medicine – Cardiology, Duke Clinical Rsch Institute, Durham, NC

Mercury, Fish Oils, and the Risk of Myocardial Infarction

Eliseo Guallar, M.D., et al., 2002


It has been suggested that mercury, a highly reactive heavy metal with no known physiologic activity, increases the risk of cardiovascular disease. Because fish intake is a major source of exposure to mercury, the mercury content of fish may counteract the beneficial effects of its n–3 fatty acids…

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Nickel Concentrations in Serum of Patients with Acute Myocardial Infarction or Unstable Angina Pectoris.


Nickel was measured, by electrothermal atomic absorption spectrophotometry, in sera from (a) 30 healthy adults, (b) 54 patients with acute myocardial infarction, (c) 33 patients with unstable angina pectoris without infarction, and (d) five patients with coronary atherosclerosis who developed cardiac ischemia during treadmill exercise. Mean (and SD) concentrations in Group a were 0.3 (0.3) microgram/L (range less than 0.05-1.1 microgram/L). Within 72 h after hospital admission, hypernickelemia (Ni greater than or equal to 1.2 microgrheart-1414885-639x650am/L) was found in 41 patients of group b (76%) and in 16 patients of group c (48%). Hypernickelemia was found before and after exercise in one patient of Group d (20%). Peak values averaged 3.0 micrograms/L (range 0.4-21 micrograms/L) in Group b, 1.5 microgram/L (range less than 0.05-3.3 micrograms/L) in Group c. In Group b, the mean time interval between the peak values for creatine kinase activity and for nickel was 18 h. Serum nickel concentrations were unrelated to age, sex, time of day, cigarette smoking, medications, clinical complications, or outcome. Mechanisms and sources of release of nickel into the serum of patients with acute myocardial infarction or unstable angina pectoris are conjectural, but hypernickelemia may be related to the pathogenesis of ischemic myocardial injury.

Blood lead below 0.48 micromol/L (10 microg/dL) and mortality among US adults.

Menke A1, Muntner P, Batuman V, Silbergeld EK, Guallar E.


Background— Blood lead levels above 0.48 μmol/L (10 μg/dL) in adults have been associated with increased risk of cardiovascular, cancer, and all-cause mortality. The objective of the present study was to determine the association between blood lead levels below 0.48 μmol/L and mortality in the general US population.

Methods and Results— Blood leadlead-1565598-640x480 levels were measured in a nationally representative sample of 13 946 adult participants of the Third National Health and Nutrition Examination Survey recruited in 1988 to 1994 and followed up for up to 12 years for all-cause and cause-specific mortality. The geometric mean blood lead level in study participants was 0.12 μmol/L (2.58 μg/dL). After multivariate adjustment, the hazard ratios (95% CI) for comparisons of participants in the highest tertile of blood lead (≥0.17 μmol/L [≥3.62 μg/dL]) with those in the lowest tertile (<0.09 μmol/L [<1.94 μg/dL]) were 1.25 (1.04 to 1.51; Ptrend across tertiles=0.002) for all-cause mortality and 1.55 (1.08 to 2.24; Ptrend across tertiles=0.003) for cardiovascular mortality. Blood lead level was significantly associated with both myocardial infarction and stroke mortality, and the association was evident at levels >0.10 μmol/L (≥2 μg/dL). There was no association between blood lead and cancer mortality in this range of exposure.

Conclusions— The association between blood lead levels and increased all-cause and cardiovascular mortality was observed at substantially lower blood lead levels than previously reported. Despite the marked decrease in blood lead levels over the past 3 decades, environmental lead exposures remain a significant determinant of cardiovascular mortality in the general population, constituting a major public health problem.