Abstract 11054: Clinical Benefit of EDTA-based Chelation Therapy and High-dose Oral Multivitamins and Multiminerals in TACT- An Expanded Comparison of 2 Factorial Groups
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.
- © 2013 by American Heart Association, Inc.