Abstract 11546: Clinical Benefit of EDTA Chelation Therapy in Patients With Diabetes in the Trial to Assess Chelation Therapy (TACT)
Chelation therapy has been used to treat atherosclerotic disease. We reported the results of an NIH-funded trial demonstrating a significant reduction of a combined cardiovascular endpoint in post-myocardial infarction (MI) patients treated with EDTA-based chelation compared with placebo. We report more detailed analyses of the effect of chelation compared to placebo on cardiovascular clinical outcomes among diabetic (DM) patients.
Methods: TACT, a multi-center, double-blind, placebo-controlled, 2 X 2 factorial trial of EDTA chelation and high-dose vitamins, enrolled 1708 pts aged ≥ 50 years with an MI at least 6 weeks prior and creatinine ≤ 2.0. Protocol prespecified a comparison of chelation with placebo in DM patients. Median duration of follow-up was 55 months. The primary endpoint was death from any cause, MI, stroke, coronary revascularization, or hospitalization for angina. The major secondary clinical endpoint was cardiovascular death, MI, or stroke. The log rank test was used for treatment comparisons.
Results: TACT enrolled 538 (31%) DM patients of whom 265 were randomized to EDTA chelation. Baseline characteristics of DM patients including obesity, hypertension, hypercholesterolemia, heart failure, peripheral vascular disease, stroke and prior CABG were similar between treatment groups. 76% of DM patients were on statins and 93% were on antiplatelet or antithrombotic therapy. Treatment for DM included oral hypoglycemic agents (70%) and insulin (30%). EDTA chelation led to a reduction in the primary endpoint (37% vs. 25%; p=0.002), and the prespecified secondary endpoint (17% vs. 11%; p=0.043, Table). Hazard ratio point estimates comparing chelation vs. placebo for each component of the composite endpoints were all <1.0 and consistent with the overall effect.
Conclusions: In diabetic patients with prior MI, age ≥ 50, and creatinine ≤ 2.0 treated with standard therapies, EDTA-based chelation reduced cardiovascular events.
- © 2013 by American Heart Association, Inc.