Coronary disease & ACSRandomised controlled trial
Edetate Disodium–Based Chelation for Patients With a Previous Myocardial Infarction and Diabetes
- Randomised controlled trial
- 2 × 2 factorial
- double-masked
- placebo-controlled
- multicenter (88 sites, US and Canada)
Authors' 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
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
Chelation vs 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 | Estimate |
|---|---|---|---|
| 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. JAMA. Published 10 September 2024. doi:10.1001/jama.2024.11463
Summarised from the published abstract; every number is checked against it