Meta-analysis of secure randomised controlled trials of β-blockade to prevent perioperative death in non-cardiac surgery.

Meta-analysis of secure randomised controlled trials of β-blockade to prevent perioperative death in non-cardiac surgery.
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DOI:
10.1136/heartjnl-2013-304262
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发表时间:
2014-03
期刊:
Heart (British Cardiac Society)
影响因子:
--
通讯作者:
Francis DP
Francis DP
中科院分区:
其他
文献类型:
--
作者:
Bouri S;Shun-Shin MJ;Cole GD;Mayet J;Francis DP

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目前欧洲和美国指南建议,在接受高风险或中等风险手术或血管手术的心脏事件风险患者中,围手术期开始β受体阻滞剂疗程。荷兰超声心动图心脏风险评估应用应力超声心动图(DECREASE)系列试验,这方面的证据基石,不再安全。因此,我们使用安全数据对β受体阻滞剂在非心脏手术中围手术期死亡率、非致死性心肌梗死、卒中和低血压方面的随机对照试验进行了荟萃分析。对非心脏手术前开始使用β受体阻滞剂的随机对照试验进行了检查。主要结局为30天或出院时的全因死亡率。 对DECREASE试验进行了单独分析。9项安全试验共10529例患者,其中291例死亡,符合标准。 手术前开始β受体阻滞剂疗程导致30天全因死亡率风险增加27%(p=0.04)。DECREASE系列研究实质上与安全试验对死亡率影响的荟萃分析相矛盾(差异p=0.05)。在安全性试验中,β受体阻滞剂减少了非致命性心肌梗死(RR 0.73,p=0.001),但增加了卒中(RR 1.73,p=0.05)和低血压(RR 1.51,p<0.00001)。这些结果被一项大型试验所主导。指南机构应该立即撤回基于虚构数据的建议。这不应因责任分配的争议而受阻。进行良好的试验表明,从目前指南推荐的围手术期β受体阻滞开始,死亡率增加了27%,具有统计学意义。任何剩余的热心者最好将他们的精力投入到进一步的随机试验中,该试验应该仔细设计并诚实地进行。
Current European and American guidelines recommend the perioperative initiation of a course of β-blockers in those at risk of cardiac events undergoing high- or intermediate-risk surgery or vascular surgery. The Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography (DECREASE) family of trials, the bedrock of evidence for this, are no longer secure. We therefore conducted a meta-analysis of randomised controlled trials of β-blockade on perioperative mortality, non-fatal myocardial infarction, stroke and hypotension in non-cardiac surgery using the secure data. The randomised controlled trials of initiation of β-blockers before non-cardiac surgery were examined. Primary outcome was all-cause mortality at 30 days or at discharge. The DECREASE trials were separately analysed. Nine secure trials totalling 10 529 patients, 291 of whom died, met the criteria. Initiation of a course of β-blockers before surgery caused a 27% risk increase in 30-day all-cause mortality (p=0.04). The DECREASE family of studies substantially contradict the meta-analysis of the secure trials on the effect of mortality (p=0.05 for divergence). In the secure trials, β-blockade reduced non-fatal myocardial infarction (RR 0.73, p=0.001) but increased stroke (RR 1.73, p=0.05) and hypotension (RR 1.51, p<0.00001). These results were dominated by one large trial. Guideline bodies should retract their recommendations based on fictitious data without further delay. This should not be blocked by dispute over allocation of blame. The well-conducted trials indicate a statistically significant 27% increase in mortality from the initiation of perioperative β-blockade that guidelines currently recommend. Any remaining enthusiasts might best channel their energy into a further randomised trial which should be designed carefully and conducted honestly.
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