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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EDisodium ethylene diamine tetra acetic acid (EDTA) binds divalent cations and permits renal excretion. The data for chelation have been mixed with some case reports and case series reporting benefit and other studies suggesting no benefit or even harm, particularly when rapid infusions cause hypocalcemia. This article reports the results of the Trial to Assess Chelation Therapy [TACT; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00044213\u0026amp;atom=%2Fspmdc%2F12%2F18%2F9.atom\u0022\u003ENCT00044213\u003C\/a\u003E].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EMyocardial Infarction\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EDisodium ethylene diamine tetra acetic acid (EDTA) binds divalent cations and permits renal excretion. A 1956 study reported improvement of angina with disodium EDTA [Clarke CN et al. \u003Cem\u003EAm J Med Sci\u003C\/em\u003E 1956]. By 2007, its use had increased to more than 100,000 patients in the United States. The data for chelation have been mixed with some case reports and case series reporting benefit and other studies suggesting no benefit or even harm, particularly when rapid infusions cause hypocalcemia. Gervasio A. Lamas, MD, Mount Sinai Medical Center, Miami Beach, Florida, USA, reported the results of the Trial to Assess Chelation Therapy [TACT; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00044213\u0026amp;atom=%2Fspmdc%2F12%2F18%2F9.atom\u0022\u003ENCT00044213\u003C\/a\u003E].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe TACT trial enrolled 1708 patients from 2003 through 2010 [Lamas GA et al. \u003Cem\u003EAm Heart J\u003C\/em\u003E 2012]. Patients were eligible if they were aged \u226450 years, had a myocardial infarction (MI) at least 6 months prior to enrollment, and creatinine \u22642.0 mg\/dL. They were randomly assigned to chelation therapy or placebo, and high-dose vitamins or placebo in a 2\u00d72 factorial design. The patients were scheduled to receive 40 infusions of at least 3 hours each given as 30 weekly infusions and followed by 10 maintenance infusions 2 to 8 weeks apart. The chelation infusions consisted of 3 g disodium EDTA adjusted downward based on estimated glomerular filtration rate.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe primary endpoint was a composite of death, MI, stroke, coronary revascularization, and hospitalization for angina. Data were analyzed according to the intention-to-treat principle. Because of multiple reviews of the interim data by the Data and Safety Monitoring Board, the final level of statistical significance was p\u0026lt;0.036.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003ESixty-five percent of patients received all 40 infusions, and 76% received at least 30 infusions. A total of 79 patients (38 chelation, 41 placebo) discontinued infusions due to adverse events (AEs). Short infusions were administered in 611 instances. Four unexpected severe AEs possibly or definitely related to study therapy occurred\u20142 in the placebo arm (1 death) and 2 in the chelation arm (1 death).\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe primary endpoint event rate was significantly reduced in patients receiving chelation versus placebo (26.5% vs 30.0%; HR, 0.82; 95% CI, 0.69 to 0.99; p=0.035; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). There was directional consistency among the components of the primary endpoint in favor of chelation versus placebo (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/13107\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/13107\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/13107\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EComponents of the Primary Endpoint.\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/18\/9\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Primary Endpoint Results.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-152215524\u0022 data-figure-caption=\u0022Primary Endpoint Results.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/18\/9\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/18\/9\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/18\/9\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/13083\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-9\u0022 class=\u0022first-child\u0022\u003EPrimary Endpoint Results.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission from GA Lamas, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-10\u0022\u003ESubgroup analyses suggested that chelation was superior to placebo in patients with anterior MI (HR, 0.63; 95% CI, 0.47 to 0.86; interaction p=0.03) and diabetes (HR, 0.61; 95% CI, 0.45 to 0.83; interaction p=0.02).\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003ELimitations of the TACT trial include the modest statistical significance, with the upper CI of the HR for the primary endpoint of 0.99, missing data (17% of patients withdrew consent), and revascularization being the most common efficacy event.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EDr. Lamas concluded that, within the safety net provided by TACT, chelation therapy appears to be safe. The 10-component disodium EDTA chelation and ascorbate regimen demonstrated some evidence of a potentially important treatment signal in post-MI patients already on evidence-based therapy. The TACT trial results are unexpected and additional research is needed to confirm or refute the results and explore possible mechanisms of benefit.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EThough the results of the TACT trial are interesting, they should be interpreted with caution as Elliot Antman, MD, Chairman of the AHA Scientific Sessions 2012, Brigham and Women\u0027s Hospital, Boston, Massachusetts, USA, pointed out in a formal statement: \u201cAs intriguing as the results are, they\u0027re unexpected and should not be interpreted as an indication to adopt chelation therapy into clinical practice. Much more information is needed about which elements of the complex infusion mixture might provide benefit; the marked discordance between the observed treatment effect in diabetics versus nondiabetics needs to be understood\u2026.TACT raises more questions that must be answered before we are ready to act on the observations that were reported.\u201d\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/12\/18\/9.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzn5y2\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzn5y2\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzn5y2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}