叶酸、维生素B12和维生素B6降低同型半胱氨酸治疗对经皮冠状动脉介入治疗后临床结局的影响：瑞士心脏研究：一项随机对照试验

Effect of homocysteine-lowering therapy with folic acid, vitamin B12, and vitamin B6 on clinical outcome after percutaneous coronary intervention: the Swiss Heart study: a randomized controlled trial.

作者信息

Schnyder Guido, Roffi Marco, Flammer Yvonne, Pin Riccardo, Hess Otto Martin

机构信息

Division of Cardiology, Swiss Cardiovascular Center Bern, University Hospital, Switzerland.

出版信息

JAMA. 2002 Aug 28;288(8):973-9. doi: 10.1001/jama.288.8.973.

DOI:10.1001/jama.288.8.973

PMID:12190367

Abstract

CONTEXT

Plasma homocysteine level has been recognized as an important cardiovascular risk factor that predicts adverse cardiac events in patients with established coronary atherosclerosis and influences restenosis rate after percutaneous coronary intervention.

OBJECTIVE

To evaluate the effect of homocysteine-lowering therapy on clinical outcome after percutaneous coronary intervention.

DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind placebo-controlled trial involving 553 patients referred to the University Hospital in Bern, Switzerland, from May 1998 to April 1999 and enrolled after successful angioplasty of at least 1 significant coronary stenosis (> or = 50%).

INTERVENTION

Participants were randomly assigned to receive a combination of folic acid (1 mg/d), vitamin B12 (cyanocobalamin, 400 micro g/d), and vitamin B6 (pyridoxine hydrochloride, 10 mg/d) (n = 272) or placebo (n = 281) for 6 months.

MAIN OUTCOME MEASURE

Composite end point of major adverse events defined as death, nonfatal myocardial infarction, and need for repeat revascularization, evaluated at 6 months and 1 year.

RESULTS

After a mean (SD) follow-up of 11 (3) months, the composite end point was significantly lower at 1 year in patients treated with homocysteine-lowering therapy (15.4% vs 22.8%; relative risk [RR], 0.68; 95% confidence interval [CI], 0.48-0.96; P =.03), primarily due to a reduced rate of target lesion revascularization (9.9% vs 16.0%; RR, 0.62; 95% CI, 0.40-0.97; P =.03). A nonsignificant trend was seen toward fewer deaths (1.5% vs 2.8%; RR, 0.54; 95% CI, 0.16-1.70; P =.27) and nonfatal myocardial infarctions (2.6% vs 4.3%; RR, 0.60; 95% CI, 0.24-1.51; P =.27) with homocysteine-lowering therapy. These findings remained unchanged after adjustment for potential confounders.

CONCLUSION

Homocysteine-lowering therapy with folic acid, vitamin B12, and vitamin B6 significantly decreases the incidence of major adverse events after percutaneous coronary intervention.

摘要

背景

血浆同型半胱氨酸水平已被公认为是一种重要的心血管危险因素，可预测已确诊冠状动脉粥样硬化患者的不良心脏事件，并影响经皮冠状动脉介入治疗后的再狭窄率。

目的

评估降低同型半胱氨酸治疗对经皮冠状动脉介入治疗后临床结局的影响。

设计、地点和参与者：一项随机、双盲、安慰剂对照试验，涉及1998年5月至1999年4月转诊至瑞士伯尔尼大学医院的553例患者，这些患者在至少一处严重冠状动脉狭窄（≥50%）成功血管成形术后入选。

干预措施

参与者被随机分配接受叶酸（1毫克/天）、维生素B12（氰钴胺，400微克/天）和维生素B6（盐酸吡哆醇，10毫克/天）联合治疗（n = 272）或安慰剂（n = 281），为期6个月。

主要结局指标

主要不良事件的复合终点，定义为死亡、非致命性心肌梗死和再次血管重建的需求，在6个月和1年时进行评估。

结果

平均（标准差）随访11（3）个月后，接受降低同型半胱氨酸治疗的患者在1年时的复合终点显著降低（15.4%对22.8%；相对风险[RR]，0.68；95%置信区间[CI]，0.48 - 0.96；P = 0.03），主要是由于靶病变血管重建率降低（9.9%对16.0%；RR，0.62；95%CI，0.40 - 0.97；P = 0.03）。降低同型半胱氨酸治疗组的死亡（1.5%对2.8%；RR，0.54；95%CI，0.16 - 1.70；P = 0.27）和非致命性心肌梗死（2.6%对4.3%；RR，0.60；95%CI，0.24 - 1.51；P = 0.27）有非显著减少趋势。在对潜在混杂因素进行调整后，这些结果保持不变。