Edetate Disodium–Based Chelation for Patients With a Previous Myocardial Infarction and Diabetes: TACT2 Randomized Clinical Trial
Primary resultResult — go to the resultAdjusted hazard ratio 0.93 95% CI 0.76–1.16Authors' conclusion
Despite effectively reducing blood lead levels, EDTA chelation was not effective in reducing cardiovascular events in stable patients with coronary artery disease who have diabetes and a history of MI.
Study context
- Population
- Patients aged ≥50 years with DM and myocardial infarction (MI) ≥6 weeks before recruitmentreceived ≥1 infusion
- Participants
- 959 patients
- Comparison
- EDTA-based chelation vs placebo infusions
- Chelationn = 483
- Placebon = 476reference
- Primary endpoint
- Composite of:
- All-cause mortality
- MI
- Stroke
- Coronary revascularization
- Hospitalization for unstable angina
- Follow-up
- Median 48 months
Methodological details2 × 2 factorial, double-masked, placebo-controlled, multicenter (88 sites, US and Canada)
- 2 × 2 factorial
- Double-masked
- Placebo-controlled
- Multicenter (88 sites, US and Canada)
Primary result
As reported in the abstract
Adjusted hazard ratio
0.93
95% CI 0.76–1.16
P = 0.53
Events by treatment group
Chelationvs Placebo
adjusted HR 0.93 (95% CI 0.76–1.16); P = 0.53
Further findings
Primary end point, 5-year cumulative incidence
| Outcome | Chelation | Placebo | Adjusted HR (95% CI) | |
|---|---|---|---|---|
| CV death, MI or stroke | 18.4% | 19.7% | 0.89 (0.66–1.19) | |
| All-cause death | 17.4% | 17.6% | 0.96 (0.71–1.30) | |
| 0.512Adjusted hazard ratio (log scale) |
| Outcome | Chelation | Placeboμg/L |
|---|---|---|
| Blood lead level, baseline to infusion 40 | median 3.46 μg/L | 8.7 |
| Baseline | 9.03 μg/L | 9.3 |
- Blood lead level, baseline to infusion 40 — Chelation reduced median blood lead levels
- P < .001
Original publication
Edetate Disodium–Based Chelation for Patients With a Previous Myocardial Infarction and Diabetes: TACT2 Randomized Clinical Trial. JAMA. Published 10 September 2024. doi:10.
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