Eur Heart J. 1995 Dec;16(12):1825-32.
To evaluate the effect of long-term treatment with metoprolol after coronary bypass grafting on death and cardiac events.
Patients in western Sweden on whom coronary artery bypass grafting was performed between June 1988 and June 1991 were evaluated for inclusion during the first 3 weeks after surgery. Major exclusion criteria were age > 75 years, concomitant valve surgery, traditional contraindications to beta-blockers and unwillingness to participate. Patients were randomized in a double-blind fashion to 100 mg of metoprolol/placebo daily for 2 weeks and thereafter 200 mg daily for 2 years.
Of 2365 patients who were operated on, 967 were randomized to either metoprolol (n = 480) or placebo (n = 487). Primary end points (death, non-fatal myocardial infarction, unstable angina pectoris, need for coronary artery bypass grafting or percutaneous transluminal angioplasty), were reached by 42 patients in the metoprolol group (8.8%), as compared with 39 in the placebo group (8.0%) (P = 0.73). Of all the patients randomized to metoprolol, 34% withdrew from blind treatment prematurely compared with 44% for placebo (P < 0.01).
Prophylactic treatment with metoprolol over a 2-year period after coronary artery bypass grafting did not reduce death or the development of cardiac events. However, the 95% confidence limits ranged from the possibility of a 30% reduction in events to a 68% increase in events if patients were treated with metoprolol as compared with placebo.
评估冠状动脉搭桥术后长期使用美托洛尔治疗对死亡和心脏事件的影响。
对1988年6月至1991年6月在瑞典西部接受冠状动脉搭桥手术的患者,在术后前3周进行纳入评估。主要排除标准为年龄>75岁、同期瓣膜手术、β受体阻滞剂的传统禁忌证以及不愿参与。患者以双盲方式随机分组,先每日服用100 mg美托洛尔/安慰剂,共2周,之后每日服用200 mg,持续2年。
在接受手术的2365例患者中,967例被随机分为美托洛尔组(n = 480)或安慰剂组(n = 487)。美托洛尔组有42例患者(8.8%)达到主要终点(死亡、非致命性心肌梗死、不稳定型心绞痛、需要再次进行冠状动脉搭桥手术或经皮腔内血管成形术),安慰剂组为39例(8.0%)(P = 0.73)。在所有随机分配到美托洛尔组的患者中,34%提前退出盲法治疗,而安慰剂组为44%(P < 0.01)。
冠状动脉搭桥术后2年使用美托洛尔进行预防性治疗并未降低死亡或心脏事件的发生率。然而,与安慰剂相比,如果患者接受美托洛尔治疗,95%置信区间的范围为事件发生率可能降低30%至增加68%。