Edetate Disodium-Based Chelation for Patients With a Previous Myocardial Infarction and Diabetes: TACT2 Randomized...

Area of Science:

• Cardiovascular Medicine
• Clinical Trials
• Toxicology

Background:

• Previous research (TACT trial) suggested edetate disodium (EDTA) chelation therapy reduced cardiovascular disease (CVD) events by 18% in patients with prior myocardial infarction (MI).
• The current study aimed to replicate these findings specifically in individuals with diabetes and a history of MI.

Purpose of the Study:

• To evaluate the efficacy of EDTA-based chelation therapy in reducing cardiovascular events in patients with diabetes and a history of MI.
• To compare the effects of EDTA chelation infusions versus placebo in this specific patient population.

Main Methods:

• A double-masked, placebo-controlled, multicenter trial involving 959 participants aged 50 years or older with diabetes and prior MI.
• Participants received 40 weekly infusions of either EDTA-based chelation solution or a matching placebo.
• The primary endpoint was a composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina, with a median follow-up of 48 months.

Main Results:

• No significant difference in the primary composite endpoint was observed between the chelation group (35.6%) and the placebo group (35.7%) (adjusted HR, 0.93; 95% CI, 0.76-1.16).
• Specific CVD events like CV death, MI, or stroke also showed no significant reduction with chelation.
• EDTA chelation effectively reduced median blood lead levels from 9.03 μg/L to 3.46 μg/L (P < .001), indicating successful lead removal.

Conclusions:

• Despite effectively reducing blood lead levels, EDTA chelation therapy was not effective in reducing cardiovascular events in patients with diabetes and a history of MI.
• The findings suggest that EDTA chelation may not be a beneficial treatment for secondary prevention of CVD in this high-risk diabetic population.