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  1. 1. Editorial Slides VP Watch, February 12, 2003, Volume 3, Issue 6 EDTA Chelating Therapy for Calcium Removal from Plaque; Beneficial or Harmful? Silvio Litovsky, MD Morteza Naghavi, MD Texas Heart Institute
  2. 2. – Studies show despite major advances in modern and evidence-based medicine, non- evidence-based “Alternative” medicine has kept a major role in the life of millions of patients. Coronary artery disease patients are no exception. – Some physicians and large number of patients have believed in some types of “alternative” medicine as an alternative or a complementary part of their therapy. One of these therapies involves chelation with EDTA.
  3. 3. – Since atherosclerotic plaque calcification and increased coronary calcium score are shown as risk factor, it has been advertised in public that EDTA calcium chelation therapy can be beneficial by removal of calcium from plaques.
  4. 4. • Claims of beneficial cardiovascular benefits of chelation therapy have been numerous, but randomized trials have failed to show any beneficial effect. 2,3,4
  5. 5. • Wallace Sampson5 has reviewed this topic in a very lucid review and the results are extremely discouraging.5 • As Sampson stated, the small amounts of calcium that are chelated are negligible to exert any beneficial effect on plaque.
  6. 6.  As highlighted in this issue of VP Watch, Anderson et al, from the University of Calgary, Alberta, Canada, studied the effect of chelation therapy on endothelial function (brachial endothelial function studies) in patients with coronary artery disease.1
  7. 7.  The study involved 53 patients enrolled in the PATCH (Program to Assess Alternative Treatment Strategies to Achieve Cardiac Health) study. Patients with positive treadmill tests were included in this double-blind, randomized, placebo- controlled study.  Half of the patients received EDTA 40mg/Kg in a solution administered over 3 hours, twice weekly for 15 weeks and once per month for an additional 3 months, for a total of 33 treatments.
  8. 8. Methods. • Primary end points were flow-mediated vasodilation (FMD) after the 1st and 33rd treatments compared to their baselines. All vasoactive medications (ACE inhibitors, beta- blockers, calcium-channel blockers, long- acting nitrates, and statins) were stopped 24 hours prior to the endothelial function studies. The tests were performed under basal conditions and following administration of nitroglycerin. All patients took oral multivitamin therapy.
  9. 9. There was no statistically significant difference between chelation-treated and placebo groups analyzed at the end of the first session and at the end of the study (33 sessions, 6 months)
  10. 10. There was no statistically significant difference between chelation-treated and placebo groups analyzed at the end of the first session and at the end of the study (33 sessions, 6 months)
  11. 11. • The main PATCH study was reported previously.2 The authors concluded that “based on exercise time to ischemia, exercise capacity, and quality of life measurements, there is no evidence to support a beneficial effect of chelation therapy in patients with ischemic heart disease, stable angina, and a positive treadmill test for ischemia”
  12. 12. Would chelation of calcium from atherosclerotic plaques be a positive outcome in patients with atherosclerosis? Several lines of evidence point against this being the case: 1.) Calcium deposition and removal from plaques are now known to be active events, not passive calcium deposition and removal. 6,7 2.) Calcium strengthens the physical properties of the plaque, making it less likely to rupture. The lipid core, angiogenesis and inflammatory cells (macrophages, lymphocytes, mast cells) are the villains that need to be taken care of, not the calcium that is a marker of disease and alone, not the risk.8
  13. 13. NIH Trial • Despite poor scientific rationales, National Institute of Health decided to invest 30 million dollars to launch a multi-center clinical trial on efficacy of EDTA chelation therapy. 9 put this as ref 9 • The trial is aimed to provide the final verdict on chelation therapy, though critics believe that no amount of negative data can stop supporters of chelation therapy.
  14. 14. Conclusion: • There is absolutely no evidence from clinical trials indicating any beneficial effect of chelation therapy with EDTA. • Moreover, theoretical questions make it extremely unlikely that chelation therapy would be capable of the type of benefits claimed by proponents of this technique.
  15. 15. Conclusion: • In the era of evidence based medicine where long standing routines such as hormone replacement therapy fall short in clinical trials, it is extremely important for a therapeutic claim such as EDTA for coronary disease to be tested in clinical trials before directly advertised in public.
  16. 16. Conclusion: • Professional societies and governmental agencies (mainly FDA) should do their utmost to ensure that the health of cardiovascular vulnerable patients is in the hands of responsible professionals that practice medicine based on rigorous evidence and science.
  17. 17. Questions: 1. Knowing the vascular biology of atherosclerotic plaque, does EDTA chelation therapy make sense? 2. If EDTA chelation therapy happens to reduce plaque clalcification, would it make the plaque more resistant to rupture or it would make it soft and more vulnerable to rupture?
  18. 18. Questions: 3. Knowing there are many other unproven therapies publicly presented to patients in the name of “alternative medicine”, some of which might be even harmful, what do you recommend to FDA and other regulatory affairs?