Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 23532240 · doi:10.1001/jama.2013.2107
What was done
A double-blind, placebo-controlled, 2 × 2 factorial randomized trial (TACT) enrolled 1,708 patients aged 50 or older with a prior myocardial infarction (≥6 weeks earlier) and serum creatinine ≤2.0 mg/dL across 134 US and Canadian sites. Participants were randomized to 40 infusions of a 500-mL chelation solution (3 g disodium EDTA, 7 g ascorbate, B vitamins, electrolytes, procaine, and heparin; n = 839) versus placebo (n = 869), along with oral vitamin-mineral therapy versus oral placebo. Infusions were administered weekly for 30 weeks, followed by 10 infusions spaced 2 to 8 weeks apart, with a median follow-up of 55 months. The prespecified primary composite end point included total mortality, recurrent MI, stroke, coronary revascularization, or hospitalization for angina, evaluated at a significance threshold adjusted to P = .036.
What was found
The primary composite end point occurred in 222 patients (26%) in the chelation group and 261 (30%) in the placebo group (hazard ratio [HR] 0.82, 95% CI 0.69–0.99; P = .035). There was no significant difference in total mortality (10% vs 11%; HR 0.93, 95% CI 0.70–1.25; P = .64). Component rates for chelation versus placebo were: recurrent MI 6% vs 8% (HR 0.77, 95% CI 0.54–1.11); stroke 1.2% vs 1.5% (HR 0.77, 95% CI 0.34–1.76); coronary revascularization 15% vs 18% (HR 0.81, 95% CI 0.64–1.02); and hospitalization for angina 1.6% vs 2.1% (HR 0.72, 95% CI 0.35–1.47).
Why it matters
This trial offers randomized trial data on intravenous EDTA chelation for stable post-MI patients, demonstrating a modest reduction in composite cardiovascular events. However, the findings are not considered sufficient to support routine clinical use without further confirmatory research.
Limits
Consent was withdrawn by 289 participants (17% overall; 115 chelation, 174 placebo), and 15% discontinued infusions due to adverse events. The primary end point reached borderline statistical significance (P = .035 vs threshold P = .036), and the study was underpowered for mortality and individual composite components. The study population was predominantly male (82%) and white (91%).
Cited by
- partial The NIH funded a $30 million trial called TACT evaluating IV EDTA chelation, which found it to be effective in preventing heart disease and heart attacks.