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

Objective: To determine if an EDTA-based chelation regimen reduces cardiovascular events. V体育安卓版.

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 V体育ios版. 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. VSports最新版本.

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. V体育平台登录.

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 VSports注册入口. 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 V体育官网入口. 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. .

Trial registration: clinicaltrials. gov Identifier: NCT00044213 VSports在线直播. .