EDTA chelation therapy alone and in combination with oral high-dose multivitamins and minerals for coronary disease: The factorial group results of the Trial to Assess Chelation Therapy

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• 作者：Gervasio A. Lamas ; MD^a ; ^j ; ^{gervasio.lamas@msmc.com" class="auth_mail} ; Robin Boineau ; MD ; MA^b ; ^j ; Christine Goertz ; DC ; PhD^c ; ^j ; Daniel B. Mark ; MD ; MPHⁱ ; ^j ; Yves Rosenberg ; MD^b ; ^j ; Mario Stylianou ; PhD^b ; ^j ; Theodore Rozema ; MD^d ; ^j ; Richard L. Nahin ; PhD ; MPH^e ; ^j ; L. Terry Chappell ; MD^f ; ^j ; Lauren Lindblad ; MSⁱ ; ^j ; Eldrin F. Lewis ; MD^g ; ^j ; Jeanne Drisko ; MD^h ; ^j ; Kerry L. Lee ; PhDⁱ ; ^j
• 刊名：American Heart Journal
• 出版年：July 2014
• 年：2014
• 卷：168
• 期：1
• 页码：37-44.e5
• 全文大小：594 K

文摘

Disodium ethylenediaminetetraacetic acid (EDTA) reduced adverse cardiac outcomes in a factorial trial also testing oral vitamins. This report describes the intent-to-treat comparison of the 4 factorial groups overall and in patients with diabetes.

Methods

This was a double-blind, placebo-controlled, 2 × 2 factorial multicenter randomized trial of 1,708 post–myocardial infarction (MI) patients ≥50 years of age and with creatinine ≤2.0 mg/dL randomized to receive 40 EDTA chelation or placebo infusions plus 6 caplets daily of a 28-component multivitamin-multimineral mixture or placebo. The primary end point was a composite of total mortality, MI, stroke, coronary revascularization, or hospitalization for angina.

Results

Median age was 65 years, 18% were female, 94% were Caucasian, 37% were diabetic, 83% had prior coronary revascularization, and 73% were on statins. Five-year Kaplan-Meier estimates for the primary end point was 31.9% in the chelation + high-dose vitamin group, 33.7% in the chelation + placebo vitamin group, 36.6% in the placebo infusion + active vitamin group, and 40.2% in the placebo infusions + placebo vitamin group. The reduction in primary end point by double active treatment compared with double placebo was significant (hazard ratio 0.74, 95% CI 0.57-0.95, P = .016). In patients with diabetes, the primary end point reduction of double active compared with double placebo was more pronounced (hazard ratio 0.49, 95% CI 0.33-0.75, P < .001).

Conclusions

In stable post-MI patients on evidence-based medical therapy, the combination of oral high-dose vitamins and chelation therapy compared with double placebo reduced clinically important cardiovascular events to an extent that was both statistically significant and of potential clinical relevance.