Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial.
Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial.
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DOI：
10.1161/circoutcomes.114.000977
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发表时间：
2014-07
期刊：
影响因子：
--
通讯作者：
TACT Investigators
中科院分区：
文献类型：
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作者：
Mark DB;Anstrom KJ;Clapp-Channing NE;Knight JD;Boineau R;Goertz C;Rozema TC;Liu DM;Nahin RL;Rosenberg Y;Drisko J;Lee KL;Lamas GA;TACT Investigators
The NIH-funded Trial to Assess Chelation Therapy (TACT) randomized 1708 stable coronary disease patients age 50 or older who were at least 6 months post myocardial infarction (2003-2010) to 40 infusions of a multicomponent EDTA chelation solution or placebo. Chelation reduced the primary composite endpoint of mortality, recurrent myocardial infarction, stroke, coronary revascularization, or hospitalization for angina (hazard ratio 0.82, 95% confidence interval 0.69-0.99, p=0.035). In a randomly selected subset of 911 patients, we prospectively collected a battery of QOL instruments at baseline and 6, 12, and 24 months post-randomization. The pre-specified primary QOL measures were the Duke Activity Status Index (DASI)(eTable 1) and the Medical Outcomes Study Short-Form 36 Mental Health Inventory (MHI-5). All comparisons were by intention-to-treat. Baseline clinical and QOL variables were well balanced in the 451 patients randomized to chelation and the 460 to placebo. The DASI improved in both groups over the first 6 months of therapy but we found no evidence for a treatment-related difference [mean difference (chelation-placebo) over follow-up 0.9 (95% CI -0.7 to 2.6, p=0.27)]. There was no statistically significant evidence of a treatment-related difference in the MHI-5 during follow-up (mean difference 1.0, 95% CI -0.1 to 2.0, p=0.08). None of the secondary QOL measures showed a consistent treatment-related difference. In stable, predominantly asymptomatic coronary disease patients with a history of myocardial infarction, EDTA chelation therapy did not have a detectable effect on quality of life over two years of follow-up.
