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心脏不停跳与心脏停搏研究中(BHACAS 1和2)非体外循环与体外循环手术后的早期和中期结果:两项随机对照试验的汇总分析

Early and midterm outcome after off-pump and on-pump surgery in Beating Heart Against Cardioplegic Arrest Studies (BHACAS 1 and 2): a pooled analysis of two randomised controlled trials.

作者信息

Angelini Gianni D, Taylor Fiona C, Reeves Barnaby C, Ascione Raimondo

机构信息

Bristol Heart Institute, University of Bristol, Bristol, UK.

出版信息

Lancet. 2002 Apr 6;359(9313):1194-9. doi: 10.1016/S0140-6736(02)08216-8.

Abstract

BACKGROUND

Although no randomised controlled trial has assessed the midterm effects of coronary-artery bypass surgery on the beating heart, this technique is being used in more and more patients. We did two randomised trials to compare the short-term morbidity associated with off-pump and on-pump myocardial revascularisation. Our aim was to pool the results to assess midterm outcomes.

METHODS

From March, 1997, to November, 1999, we randomly allocated 200 patients to off-pump and 201 to on-pump coronary surgery. In Beating Heart Against Cardioplegic Arrest Study (BHACAS) 1, we excluded patients who had had myocardial infarction in the past month or who required grafting of the circumflex artery distal to the first obtuse marginal branch. In BHACAS 2, we included such patients. Primary outcomes were all-cause mortality and cardiac-related events at midterm follow-up (1-3 years). Analysis was by intention to treat.

FINDINGS

Analyses of combined data from both trials showed the following risk differences with off-pump compared with on-pump surgery: atrial fibrillation -25% (95% CI -33% to -16%); chest infection -12% (-19% to -5%); inotropic requirement -18% (-25% to -10%); transfusion of red blood cells -31% (-41 to -21); and hospital stay longer than 7 days -13% (-21 to -5). Mean follow-up was 25 0 months (SD 9.1) for BHACAS 1 and 13.7 months (5 5) for BHACAS 2. Four (2%) of 200 patients in the off-pump groups died from any cause, compared with seven (3%) of 201 in the on-pump group (hazard ratio 0.57, 95% CI 0.17-1.96). 33 (17%) of 200 patients in the off-pump group died or had a cardiac-related event, compared with 42 (21%) of 201 in the on-pump group (0.78, 0 49-1.22).

INTERPRETATION

Off-pump coronary surgery significantly lowers in-hospital morbidity without compromising outcome in the first 1-3 years after surgery compared with conventional on-pump coronary surgery.

摘要

背景

尽管尚无随机对照试验评估冠状动脉搭桥手术在心脏跳动状态下的中期效果,但越来越多的患者正在接受这种手术。我们进行了两项随机试验,比较非体外循环和体外循环心肌血运重建术相关的短期发病率。我们的目的是汇总结果以评估中期结局。

方法

从1997年3月至1999年11月,我们将200例患者随机分配至非体外循环冠状动脉手术组,201例患者随机分配至体外循环冠状动脉手术组。在非体外循环心脏不停跳与心脏停搏冠状动脉搭桥术研究(BHACAS)1中,我们排除了过去一个月内发生过心肌梗死或需要在第一钝缘支远端对旋支进行移植的患者。在BHACAS 2中,我们纳入了此类患者。主要结局是中期随访(1至3年)时的全因死亡率和心脏相关事件。分析采用意向性治疗。

结果

两项试验合并数据的分析显示,与体外循环手术相比,非体外循环手术有以下风险差异:房颤发生率降低25%(95%CI -33%至-16%);肺部感染发生率降低12%(-19%至-5%);使用正性肌力药物的需求降低18%(-25%至-10%);红细胞输血率降低31%(-41%至-21%);住院时间超过7天的发生率降低13%(-21%至-5%)。BHACAS 1的平均随访时间为25.0个月(标准差9.1),BHACAS 2的平均随访时间为13.7个月(5.5)。非体外循环组200例患者中有4例(2%)因任何原因死亡,体外循环组201例患者中有7例(3%)死亡(风险比0.57,95%CI 0.17 - 1.96)。非体外循环组200例患者中有33例(17%)死亡或发生心脏相关事件,体外循环组201例患者中有42例(21%)发生此类情况(0.78,0.49 - 1.22)。

解读

与传统的体外循环冠状动脉手术相比,非体外循环冠状动脉手术可显著降低住院期间的发病率,且不影响术后1至3年的结局。

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