The Effect of an EDTA-based Chelation Regimen on Patients With Diabetes Mellitus and Prior Myocardial Infarction in the Trial to Assess Chelation Therapy (TACT)


Esteban Escolar, MD, Gervasio A. Lamas, MD, Daniel B. Mark, MD, MPH, Robin Boineau, MD, MA, Christine Goertz, DC, PHD, Yves Rosenberg, MD, Richard L. Nahin, PhD, MPH, Pamela Ouyang, MBBS, Theodore Rozema, MD, Allan Magaziner, DO, Richard Nahas, MD, Eldrin F. Lewis, MD, MPH, Lauren Lindblad, MS and Kerry L. Lee, PhD
Author Affiliations

From the Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami Beach, FL (E.E., G.A.L.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., Y.R.); Palmer Center for Chiropractic Research, Davenport, IA (C.G.); The National Center for Complementary and Alternative Medicine, Bethesda, MD (R.L.N.); Johns Hopkins University, Baltimore, MD (P.O.); Biogenesis Medical Center, Landrum, SC (T.R.); Magaziner Center for Wellness, Cherry Hill, NJ (A.M.); Seekers Centre for Integrative Medicine, Ottawa, ON (R.N.); Brigham and Women’s Hospital and Harvard Medical School, Boston, MA (E.F.L.); and Duke Clinical Research Institute, Durham, NC (D.B.M., K.L.L., L.L.).
Correspondence to Gervasio A. Lamas, MD, Columbia University, Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Rd, Suite 2070A, Miami Beach, FL 33140. E-mail Esta dirección de correo electrónico está protegida contra spambots. Usted necesita tener Javascript activado para poder verla.

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Abstract

Background—The Trial to Assess Chelation Therapy (TACT) showed clinical benefit of an EDTA-based infusion regimen in patients aged ≥50 years with prior myocardial infarction. Diabetes mellitus before enrollment was a prespecified subgroup.

Methods and Results—Patients received 40 infusions of EDTA chelation or placebo. A total of 633 (37%) patients had diabetes mellitus (322 EDTA and 311 placebo). EDTA reduced the primary end point (death, reinfarction, stroke, coronary revascularization, or hospitalization for angina; 25% versus 38%; hazard ratio, 0.59; 95% confidence interval [CI], 0.44–0.79; P<0.001) for over 5 years. The result remained significant after Bonferroni adjustment for multiple subgroups (99.4% CI, 0.39–0.88; adjusted P=0.002). All-cause mortality was reduced by EDTA chelation (10% versus 16%; hazard ratio, 0.57; 95% CI, 0.36–0.88; P=0.011), as was the secondary end point (cardiovascular death, reinfarction, or stroke; 11% versus 17%; hazard ratio, 0.60; 95% CI, 0.39–0.91; P=0.017). However, after adjusting for multiple subgroups, those results were no longer significant. The number needed to treat to reduce 1 primary end point over 5 years was 6.5 (95% CI, 4.4–12.7). There was no reduction in events in non–diabetes mellitus (n=1075; P=0.877), resulting in a treatment by diabetes mellitus interaction (P=0.004).

Conclusions—Post–myocardial infarction patients with diabetes mellitus aged ≥50 demonstrated a marked reduction in cardiovascular events with EDTA chelation. These findings support efforts to replicate these findings and define the mechanisms of benefit. However, they do not constitute sufficient evidence to indicate the routine use of chelation therapy for all post–myocardial infarction patients with diabetes mellitus.

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