RCT: Chelation Fails to Reduce Cardiovascular Events in Post-MI Patients with Diabetes – JAMA

Study Design and Population: This double-masked, placebo-controlled randomized clinical trial (RCT) included 959 participants aged 50 or older with diabetes and a history of myocardial infarction (MI) from 88 sites in the US and Canada. Participants were randomly assigned to receive either 40 weekly infusions of an EDTA-based chelation solution or a placebo infusion. The median follow-up period was 48 months.

Main Findings: The trial found no significant reduction in major adverse cardiovascular events (MACE) with EDTA-based chelation compared to placebo. The primary endpoint, a composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina, occurred in 35.6% of the chelation group and 35.7% of the placebo group (HR, 0.93; 95% CI, 0.76-1.16; P = .53). However, chelation did reduce median blood lead levels by 61%, from 9.0 μg/L at baseline to 3.5 μg/L by the 40th infusion (P < .001).

Implications for Practice: Despite the significant reduction in blood lead levels, EDTA-based chelation did not reduce cardiovascular events in this high-risk population. These findings suggest that while chelation therapy may lower lead levels, it does not translate into cardiovascular benefits for patients with diabetes and a history of MI, challenging its use in this context.

Reference: Lamas, G. A., Anstrom, K. J., Navas-Acien, A., et al. (2024). Edetate Disodium–Based Chelation for Patients With a Previous Myocardial Infarction and Diabetes: TACT2 Randomized Clinical Trial. JAMA. doi:10.1001/jama.2024.11463.