Abstract 16630: Clinical Benefit of Chelation Therapy in Post-MI Patients With Diabetes and Peripheral Artery Disease
Introduction: The NIH-funded Trial to Assess Chelation Therapy (TACT) reported a clinical benefit of ethylene diamine tetraacetic acid (EDTA)-based chelation on cardiovascular (CV) outcomes in post-MI patients with diabetes (DM). Post-MI diabetic patients with peripheral artery disease (PAD) have particularly high risk.
Methods: TACT, a multi-center, double-blind, placebo-controlled, trial of EDTA chelation, enrolled patients (pts) age > 50 years with an MI at least 6 weeks prior and creatinine < 2.0. 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. The analysis was adjusted for baseline covariates. This is a non-prespecified subgroup comparison.
Results: TACT enrolled 1708 pts, of which 303 (18%) had PAD. EDTA chelation reduced the primary endpoint by a similar extent in pts with (hazard ratio (HR) 0.7) and without PAD (HR 0.87, p for interaction 0.38). Among the 633 (37%) of patients with DM, 153 (24%) had PAD. There were 81 assigned to EDTA and 72 to placebo. Baseline characteristics including obesity, hypertension, hypercholesterolemia, heart failure, stroke and prior CABG were similar between treatment groups. Creatinine was higher in the placebo group (median 1.2 v 1.0; p=0.003). There were 80% on statins, 92% on antiplatelet or antithrombotic therapy, and 32% treated with insulin. EDTA chelation led to a reduction in the primary endpoint (46% vs. 22%; p=0.002, Figure), and total mortality (25% v. 11%, p=0.032). HR point estimates comparing chelation vs. placebo for each component of the composite endpoint were all <1.0 and consistent with the overall effect.
Conclusions: In post-MI pts with DM and PAD treated with standard therapies, EDTA-based chelation therapy markedly reduced cardiovascular events.
Author Disclosures: G.A. Lamas: None. E. Escolar: None. R. Boineau: None. R. Nahin: None. C. Goertz: None. D. Mark: Consultant/Advisory Board; Modest; Medtronic, Somahlution, St. Jude, Janssen. Research Grant; Significant; Lilly, Medtronics, Inc., AstraZeneca, Gilead, Bristol Myers Squibb, AGA Medical. P. Golden: None. D. Merritt: None. Y. Rosenberg: None. L. Lindblad: None. K. Lee: None.
- © 2014 by American Heart Association, Inc.