heartdiseasefacts.com
[ad_1]
April 7, 2024
3 minute read
Important points:
- Chelation therapy involves the intravenous infusion of drugs that bind to metals such as lead and cadmium and are excreted in the urine.
- Chelation therapy did not provide clinical benefit in diabetic patients after MI.
ATLANTA — In the TACT2 trial, chelation therapy lowered blood lead levels but did not improve cardiovascular disease outcomes in adults with diabetes and a previous heart attack.
“TACT2 does not support the use of edetate disodium chelation for risk reduction in patients with stable diabetes after MI.” Dr. Gervasio A. Lamas, Chief of Medicine at Mount Sinai Medical Center in Miami and Chief of Cardiology at Columbia University, said in a presentation on the latest clinical trials at the American College of Cardiology’s academic session.
Edetate disodium-based chelation is a treatment that draws lead and other toxic metals out of the body that are associated with CVD and stroke risk.
TACT2 results were published 10 years after the first TACT trial was published. (See Healio coverage here.) The TACT trial was conducted from 2003 to 2012 and included 1,702 patients with a previous myocardial infarction, with a median follow-up of 55 months, particularly those with diabetes. Person of. TACT2 was designed to replicate TACT findings in post-MI diabetic patients and measure the effects of repeated infusions of edetate disodium on blood lead and urinary cadmium, Lamas said.
There is no difference in the results
TACT2 was conducted from 2015 to 2020. The trial enrolled 1,000 patients (more than 90%) with type 2 diabetes with a history of MI at 88 sites in the United States and Canada. Patients were randomly assigned to receive 40 weekly infusions of edetate disodium or placebo.
The average age of participants was 67 years, 27% were female, and 61.5% were non-Hispanic white. Median time from MI to randomization was 5 years. The average HbA1c was 7.5%. Almost half of the patients were receiving insulin, and a quarter were receiving GLP-1 or SGLT2 inhibitors. Use of aspirin, warfarin, P2Y12 inhibitors, beta blockers, and statins was high.
Gervasio A. Lamas
“Edetate disodium did not provide any significant clinical benefit in terms of primary or secondary endpoints or all-cause mortality,” Dr. Lamas said.
During a median follow-up of 48 months, the primary endpoint of time to first occurrence of all-cause death, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina compared with chelation therapy. There was no significant difference between placebo. Approximately 35% of patients in both groups (adjusted HR = 0.93; 95% CI, 0.76-1.16; P = .53). Professor Lamas also reported that there were no significant differences in secondary endpoints including the primary composite endpoint of recurrent events, all-cause mortality, cardiovascular mortality, myocardial infarction, and stroke.
Lamas said subgroup analyzes did not identify any subgroups in which chelation therapy appeared to be more effective compared to placebo.
No safety issues were identified.
Decrease in blood concentration
Lamas said lead and cadmium are “ubiquitous environmental pollutants” and are also recognized risk factors for atherosclerosis.
“Pre-infusion blood lead levels, which are key to determining whether what we’re injecting lowers blood levels, didn’t change significantly over time in the placebo group. [but] inside [chelation therapy] group showed a significant reduction of more than 60%, which was highly significant (P < .001),” Lamas said.
Pre-injection cadmium levels did not change significantly over time.
Why is TACT and TACT2 different?
Mr. Lamas discussed possible reasons for the differences between the TACT and TACT2 exams.
“[National Health and Nutrition Examination Survey data] Please shed some light,” he said. “From 2003 to 2010, when TACT was in operation, blood lead levels in the United States were 17 µg/L. From 2015 to 2020, when TACT2 was in operation, public health interventions lowered blood lead levels. was 10 μg/L, a 41% decrease. TACT2 blood lead concentration was even lower at baseline at 9 μg/L.
“Our hypothesis is that blood lead levels have declined significantly since 2003, potentially reducing the potential therapeutic effect of further lowering blood lead levels,” Lamas said. he said.
Lamas also pointed out that different populations within North America may have excessive lead contamination. For example, one of the 88 facilities that enrolled patients in TACT2 was in Flint, Michigan, he said.
“If I had to do it all over again, I think lead level would be the entry standard,” Lamas said. “In developed countries, lead concentrations are probably in the range of 10 µg/L or less on average at the moment…while lead concentrations in poorer countries are in the range of 60 µg/L. In the country he is 14 µg / L.
“perhaps [the message is not] If you’re using a toxin-specific treatment rather than “chelation doesn’t work,” make sure that the toxin is present in the group you’re using. It has existed for a long time. Public health in the United States and Canada is so focused on lead levels that it no longer exists. ”
In discussing the results of TACT2, Dr. Richard Chazal, MACCThe cardiologist at Lee Health in Fort Myers, Fla., said this “should help clarify what the complex issues are for patients who come to us and ask.” [chelation therapy]”
perspective
Return to top
Suzanne J. Barron, MD, MSc, FSCAI
This was a conclusive and well-conducted trial showing no significant benefit to the population studied. I think we will probably choose to divert the resources to the next research study.
One of the things we’ve seen over the past few years is the explosion of new drugs. Besides statins, there are new lipid-lowering drugs, and anti-diabetic drugs, especially SGLT2 inhibitors and GLP-1 receptor agonists, have actually shown that cardiovascular mortality is significantly reduced with the use of these drugs. Shown. We have made a lot of progress in the past few years, which will impact CV mortality rates in the future.
Suzanne J. Barron, MD, MSc, FSCAI
Director of Interventional Cardiology Research
Massachusetts General Hospital
Disclosure: Mr. Baron reports receiving consultancy fees and honoraria from Abiomed, Boston Scientific, Edwards Lifesciences, Medtronic, Shockwave, and Zoll Mdican, and research grants from Abiomed, Acarix, and Boston Scientific.
Information source/disclosure information
collapse
Lamas GA, et al. Joint American College of Cardiology/New England Medical Journal Latest clinical trials III. Presentation location: American College of Cardiology Scientific Sessions. April 6-8, 2024. Atlanta.
Disclosure: Mr. Lamas and Mr. Chazal have not reported any relevant financial disclosures.
[ad_2]
Source link
