Virginia Cardiovascular Associates, Manassas, VA (C.M.S.).
J Am Heart Assoc. 2012 Jun;1(3):e000547. doi: 10.1161/JAHA.111.000547. Epub 2012 Jun 22.
Omega-3 polyunsaturated fatty acids (n3-PUFAs) might have antiarrhythmic properties, but data conflict on whether n3-PUFAs reduce rates of atrial fibrillation (AF) after coronary artery bypass graft surgery (CABG). We hypothesized that n3-PUFAs would reduce post-CABG AF, and we tested this hypothesis in a well-powered, randomized, double-blind, placebo-controlled, multicenter clinical trial.
Patients undergoing CABG were randomized to pharmaceutical-grade n3-PUFAs 2 g orally twice daily (minimum of 6 g) or a matched placebo ≥24 hours before surgery. Gas chromatography was used to assess plasma fatty acid composition of samples collected on the day of screening, day of surgery, and postoperative day 4. Treatment continued either until the primary end point, clinically significant AF requiring treatment, occurred or for a maximum of 2 weeks after surgery. Two hundred sixty patients were enrolled and randomized. Before surgery, n3-PUFA dosing increased plasma n3-PUFA levels from 2.9% to 4% and reduced the n6:n3-PUFA ratio from 9.1 to 6.4 (both P<0.001). Similar changes were noted on postoperative day 4. There were no lipid changes in the placebo group. The rate of post-CABG AF was similar in both groups (30% n3-PUFAs versus 33% placebo, P=0.67). The post-CABG AF odds ratio for n3-PUFAs relative to placebo was 0.89 (95% confidence interval 0.52-1.53). There were no differences in any secondary end points.
Oral n3-PUFA supplementation begun 2 days before CABG did not reduce AF or other complications after surgery.
URL: http://www.clinicaltrials.gov Unique identifier: NCT00446966. (J Am Heart Assoc. 2012;1:e000547 doi: 10.1161/JAHA.111.000547.).
ω-3 多不饱和脂肪酸(n3-PUFA)可能具有抗心律失常作用,但关于 n3-PUFA 是否能降低冠状动脉旁路移植术后心房颤动(AF)的发生率,数据存在冲突。我们假设 n3-PUFA 会降低 CABG 后的 AF 发生率,并在一项具有充分效力的、随机的、双盲的、安慰剂对照的多中心临床试验中对此假设进行了检验。
接受 CABG 的患者被随机分为口服 2 g 制药级 n3-PUFA 两次/天(至少 6 g)或匹配的安慰剂组,至少在手术前 24 小时开始服用。气相色谱法用于评估筛选日、手术当天和术后第 4 天采集的样本中的血浆脂肪酸组成。治疗继续进行,直到主要终点(需要治疗的临床显著 AF)发生,或术后最多 2 周。共纳入 260 例患者并进行随机分组。术前,n3-PUFA 剂量增加了血浆 n3-PUFA 水平,从 2.9%增加到 4%,并降低了 n6:n3-PUFA 比值,从 9.1 降低到 6.4(均 P<0.001)。术后第 4 天也观察到了类似的变化。安慰剂组的脂质没有变化。两组的 CABG 后 AF 发生率相似(n3-PUFA 组为 30%,安慰剂组为 33%,P=0.67)。n3-PUFA 相对于安慰剂的 CABG 后 AF 比值比为 0.89(95%置信区间 0.52-1.53)。次要终点无差异。
在 CABG 前 2 天开始口服 n3-PUFA 补充剂并未降低术后 AF 或其他并发症的发生率。
网址:http://www.clinicaltrials.gov 唯一标识符:NCT00446966。