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Chelation Therapy and CVD Events – The TACT Trial

Article: Effect of Disodium EDTA Chelation Regiment on Cardiovascular Events in Patients with Previous Myocardial Infarction: The TACT Randomized Trial. JAMA. 2013;309(12):1241-1250.

Summary

Does chelation therapy help reduce the risk of CVD events in some patients?

Abstract

Importance Chelation therapy with disodium EDTA has been used for more than 50 years to treat atherosclerosis without proof of efficacy.

Objective To determine if an EDTA‑based chelation regimen reduces cardiovascular events.

Design, Setting, and Participants Double‑blind, placebo‑controlled, 2 ´ 2 factorial randomized trial enrolling 1708 patients aged 50 years or older who had experienced a myocardial infarction (MI) at least 6 weeks prior and had serum creatinine levels of 2.0 mg/dL or less. Participants were recruited at 134 US and Canadian sites. Enrollment began in September 2003 and follow‑up took place until October 2011 (median, 55 months). Two hundred eighty‑nine patients (17% of total; n=115 in the EDTA group and n=174 in the placebo group) withdrew consent during the trial.

Interventions Patients were randomized to receive 40 infusions of a 500‑mL chelation solution (3 g of disodium EDTA, 7 g of ascorbate, B vitamins, electrolytes, procaine, and heparin) (n=839) vs placebo (n=869) and an oral vitamin‑mineral regimen vs an oral placebo. Infusions were administered weekly for 30 weeks, followed by 10 infusions 2 to 8 weeks apart. Fifteen percent discontinued infusions (n=38 [16%] in the chelation group and n=41 [15%] in the placebo group) because of adverse events.

Main Outcome Measures The prespecified primary end point was a composite of total mortality, recurrent MI, stroke, coronary revascularization, or hospitalization for angina. This report describes the intention‑to‑treat comparison of EDTA chelation vs placebo. To account for multiple interim analyses, the significance threshold required at the final analysis was P = .036.

Results Qualifying previous MIs occurred a median of 4.6 years before enrollment. Median age was 65 years, 18% were female, 9% were nonwhite, and 31% were diabetic. The primary end point occurred in 222 (26%) of the chelation group and 261 (30%) of the placebo group (hazard ratio [HR], 0.82 [95% CI, 0.69‑0.99]; P = .035). There was no effect on total mortality (chelation: 87 deaths [10%]; placebo, 93 deaths [11%]; HR, 0.93 [95% CI, 0.70‑1.25]; P = .64), but the study was not powered for this comparison. The effect of EDTA chelation on the components of the primary end point other than death was of similar magnitude as its overall effect (MI: chelation, 6%; placebo, 8%; HR, 0.77 [95% CI, 0.54‑1.11]; stroke: chelation, 1.2%; placebo, 1.5%; HR, 0.77 [95% CI, 0.34‑1.76]; coronary revascularization: chelation, 15%; placebo, 18%; HR, 0.81 [95% CI, 0.64‑1.02]; hospitalization for angina: chelation, 1.6%; placebo, 2.1%; HR, 0.72 [95% CI, 0.35‑1.47]). Sensitivity analyses examining the effect of patient dropout and treatment adherence did not alter the results.

Conclusions and Relevance Among stable patients with a history of MI, use of an intravenous chelation regimen with disodium EDTA, compared with placebo, modestly reduced the risk of adverse cardiovascular outcomes, many of which were revascularization procedures. These results provide evidence to guide further research but are not sufficient to support the routine use of chelation therapy for treatment of patients who have had an MI.

Interview with Gervasio A. Lamas, MD, author of Effect of Disodium EDTA Chelation Regiment on Cardiovascular Events in Patients with Previous Myocardial Infarction: The TACT Randomized Trial.

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Quelatoterapia y episodios de ECV: el ensayo TACT

Artículo: Efecto de la quelación con EDTA disódico en episodios cardiovasculares en pacientes con infarto de miocardio previo: ensayo aleatorizado TACT. JAMA. 2013;309(12):1241-1250.

Summary

¿Reduce la quelatoterapia el riesgo de episodios de ECV en algunos pacientes?

Entrevista con Gervasio A. Lamas, MD, autor de Efecto de la quelación con EDTA disódico en episodios cardiovasculares en pacientes con infarto de miocardio previo: ensayo aleatorizado TACT.

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Traitement chélateur et événements cardiovasculaires – L'étude TACT

Article: Effet d'un traitement chélateur par EDTA disodique sur les événements cardiovasculaires chez les patients ayant été victimes d'un infarctus du myocarde - Étude randomisée TACT. JAMA. 2013;309(12):1241-1250.

Summary

Le traitement chélateur permet-il de diminuer le risque d'événements cardiovasculaires chez certains patients ?

Entretien avec Gervasio A. Lamas, MD, auteur de Effet d'un traitement chélateur par EDTA disodique sur les événements cardiovasculaires chez les patients ayant été victimes d'un infarctus du myocarde - Étude randomisée TACT.

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Terapia chelante ed eventi cardiovascolari: lo studio TACT

Articolo: Effetto della terapia chelante con EDTA disodico sugli eventi cardiovascolari nei pazienti con precedente infarto miocardico: studio clinico randomizzato TACT. JAMA. 2013;309(12):1241-1250.

Summary

La terapia chelante aiuta a ridurre il rischio di eventi cardiovascolari in alcuni pazienti?

Intervista a Gervasio A. Lamas, MD, autore di Effetto della terapia chelante con EDTA disodico sugli eventi cardiovascolari nei pazienti con precedente infarto miocardico: studio clinico randomizzato TACT.

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螯合疗法和 CVD 事件 — TACT 试验

文章: EDTA 二钠螯合疗法对既往心梗患者的心血管保护效果:TACT 随机试验。 JAMA. 2013;309(12):1241-1250.

Summary

螯合疗法是否有助于减少某些患者的 CVD 事件风险?

专访 Gervasio A. Lamas, MD, 作者 EDTA 二钠螯合疗法对既往心梗患者的心血管保护效果:TACT 随机试验。

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Chelation Therapy and CVD Events – The TACT Trial

статья: Effect of Disodium EDTA Chelation Regiment on Cardiovascular Events in Patients with Previous Myocardial Infarction: The TACT Randomized Trial. JAMA. 2013;309(12):1241-1250.

Summary

Перевод отсутствует.

Интервью с Gervasio A. Lamas, MD, автор Effect of Disodium EDTA Chelation Regiment on Cardiovascular Events in Patients with Previous Myocardial Infarction: The TACT Randomized Trial.

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Chelation Therapy and CVD Events – The TACT Trial

Artigo: Effect of Disodium EDTA Chelation Regiment on Cardiovascular Events in Patients with Previous Myocardial Infarction: The TACT Randomized Trial. JAMA. 2013;309(12):1241-1250.

Summary

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Entrevista com o Gervasio A. Lamas, MD, autor de Effect of Disodium EDTA Chelation Regiment on Cardiovascular Events in Patients with Previous Myocardial Infarction: The TACT Randomized Trial.

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Chelat-Therapie und kardiovaskuläre Ereignisse – Die TACT-Studie

Artikel: Die Wirkung einer Chelat-Behandlung mit Dinatrium-EDTA auf kardiovaskuläre Ereignisse bei Myokardinfarkt-Patienten. JAMA. 2013;309(12):1241-1250.

Summary

Senkt Chelat-Therapie das Risiko kardiovaskulärer Ereignisse bei einigen Patienten?

Interview mit Gervasio A. Lamas, MD, autor Die Wirkung einer Chelat-Behandlung mit Dinatrium-EDTA auf kardiovaskuläre Ereignisse bei Myokardinfarkt-Patienten.

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