■在2013年,评估螯合疗法(TACT)的试验报告说,基于乙二胺四乙酸二钠(EDTA)的螯合在1708例先前心肌梗死(MI)的患者中显着降低了18%的心血管疾病(CVD)事件。
■在患有糖尿病和先前MI的个体中复制TACT的发现。
■A2×2阶乘,双面蒙面,安慰剂对照,在美国和加拿大的88个地点进行多中心试验,涉及50岁或50岁以上的参与者,患有糖尿病,并且在招募前至少6周出现MI,比较了基于EDTA的螯合与安慰剂输注对CVD事件的影响,并比较了高剂量口服多种维生素和矿物质与口服安慰剂的影响.本文报道了螯合与安慰剂输注的比较。
符合条件的参与者被随机分配到每周40次输注基于EDTA的螯合溶液或匹配的安慰剂,每天两次口服,高剂量复合维生素和矿物质补充剂或匹配的安慰剂60个月。本文介绍了螯合研究。
■主要终点是全因死亡率,MI,中风,冠状动脉血运重建,或因不稳定型心绞痛住院。中位随访时间为48个月。对接受至少1次指定输注的患者进行初步比较。
■在959名参与者中(平均年龄,67年[IQR,60-72岁];27%的女性;78%的白人,10%黑色,和20%的西班牙裔),483接受至少1次螯合输注,476接受至少1次安慰剂输注。主要终点事件发生在螯合组的172名参与者(35.6%)和安慰剂组的170名参与者(35.7%)(调整后的风险比[HR],0.93;95%CI,0.76-1.16;P=.53)。5年主要事件累积发生率螯合组为45.8%,安慰剂组为46.5%。CV死亡,MI,或卒中事件发生在螯合组的89名参与者(18.4%)和安慰剂组的94名参与者(19.7%)(调整后的HR,0.89;95%CI,0.66-1.19)。螯合组84名参与者(17.4%)和安慰剂组84名参与者(17.6%)发生了任何原因的死亡(调整后的HR,0.96;95%CI,0.71-1.30)。螯合作用使中位血铅水平从基线时的9.03μg/L降低至输注40时的3.46μg/L(P<.001)。安慰剂组相应水平分别为9.3μg/L和8.7μg/L,分别。
■尽管有效地降低了血铅水平,在患有糖尿病和MI病史的稳定冠状动脉疾病患者中,EDTA螯合物不能有效减少心血管事件。
■ClinicalTrials.gov标识符:NCT02733185。
UNASSIGNED: In 2013, the Trial to Assess Chelation Therapy (TACT) reported that edetate disodium (EDTA)-based chelation significantly reduced cardiovascular disease (CVD) events by 18% in 1708 patients with a prior myocardial infarction (MI).
UNASSIGNED: To replicate the finding of TACT in individuals with diabetes and previous MI.
UNASSIGNED: A 2 × 2 factorial, double-masked, placebo-controlled, multicenter trial at 88 sites in the US and Canada, involving participants who were 50 years or older, had diabetes, and had experienced an MI at least 6 weeks before recruitment compared the effect of EDTA-based chelation vs placebo infusions on CVD events and compared the effect of high doses of oral multivitamins and minerals with oral placebo. This article reports on the chelation vs placebo infusion comparisons.
UNASSIGNED: Eligible participants were randomly assigned to 40 weekly infusions of an EDTA-based chelation solution or matching placebo and to twice daily oral, high-dose multivitamin and mineral supplements or matching placebo for 60 months. This article addresses the chelation study.
UNASSIGNED: The primary end point was the composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina. Median follow-up was 48 months. Primary comparisons were made from patients who received at least 1 assigned infusion.
UNASSIGNED: Of the 959 participants (median age, 67 years [IQR, 60-72 years]; 27% females; 78% White, 10% Black, and 20% Hispanic), 483 received at least 1 chelation infusion and 476 at least 1 placebo infusion. A primary end point event occurred in 172 participants (35.6%) in the chelation group and in 170 (35.7%) in the placebo group (adjusted hazard ratio [HR], 0.93; 95% CI, 0.76-1.16; P = .53). The 5-year primary event cumulative incidence rates were 45.8% for the chelation group and 46.5% for the placebo group. CV death, MI, or stroke events occurred in 89 participants (18.4%) in the chelation group and in 94 (19.7%) in the placebo group (adjusted HR, 0.89; 95% CI, 0.66-1.19). Death from any cause occurred in 84 participants (17.4%) in the chelation group and in 84 (17.6%) in the placebo group (adjusted HR, 0.96; 95% CI, 0.71-1.30). Chelation reduced median blood lead levels from 9.03 μg/L at baseline to 3.46 μg/L at infusion 40 (P < .001). Corresponding levels in the placebo group were 9.3 μg/L and 8.7 μg/L, respectively.
UNASSIGNED: Despite effectively reducing blood lead levels, EDTA chelation was not effective in reducing cardiovascular events in stable patients with coronary artery disease who have diabetes and a history of MI.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT02733185.