Effects of extended-release metoprolol succinate inpatients undergoing non-cardiac surgery (POISE trial):: a randomised controlled trial
Effects of extended-release metoprolol succinate inpatients undergoing non-cardiac surgery (POISE trial):: a randomised controlled trial
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DOI：
10.1016/s0140-6736(08)60601-7
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发表时间：
2008-05-01
期刊：
影响因子：
168.9
通讯作者：
Choi, Peter
中科院分区：
文献类型：
--
作者：
Devereaux, P. J.;Yang, Homer;Choi, Peter
背景 在接受非心脏手术的患者中进行的β受体阻滞剂试验报告了相互矛盾的结果。这项随机对照试验在 23 个国家的 190 家医院进行，旨在调查围手术期 β 受体阻滞剂的影响。 方法 我们通过计算机随机化电话服务将 8351 名患有动脉粥样硬化疾病或有动脉粥样硬化风险且正在接受非心脏手术的患者随机分配接受缓释琥珀酸美托洛尔 (n=4174) 或安慰剂 (n=4177)。研究治疗在手术前 2-4 小时开始，持续 30 天。患者、医疗保健提供者、数据收集者和结果裁决者对治疗分配情况不知情。主要终点是心血管死亡、非致命性心肌梗死和非致命性心脏骤停的复合终点。分析是按意向治疗进行的。该试验已在 ClinicalTrials.gov 注册，编号为 NCT00182039。 结果 所有 8351 名患者均纳入分析； 8331 名（99.8%）患者完成了 30 天的随访。美托洛尔组达到主要终点的患者少于安慰剂组（美托洛尔组有 244 名患者 [5.8%]，安慰剂组有 290 名患者 [6.9%]；风险比 0. 84，95% CI 0. 70-0.99；p=0.0399）。美托洛尔组中发生心肌梗塞的患者少于安慰剂组（176 [4.2%] vs 239 [5.7%] 患者；0 .73、0.60-0.89；p=0. 0017）。然而，美托洛尔组的死亡人数多于安慰剂组（129 [3 . 1%] vs 97 [2.3%] 患者；1 . 33, 1.03-1.74；p=0.0317）。美托洛尔组比安慰剂组有更多患者发生中风（41 [1. 0%] vs 19 [0.5%] 患者；2.17, 1.26-3.74；p=0.0053）。 解释 我们的结果强调了假设围手术期 β 受体阻滞剂治疗方案有益且无实质性损害的风险，以及在围手术期进行大型随机试验的重要性和必要性。患者不太可能接受围手术期缓释美托洛尔相关的风险。资助加拿大健康研究所；澳大利亚联邦政府国家健康与医学研究委员会；西班牙健康研究所（Ministerio de Sanidad y Consumo）；英国心脏基金会；阿斯利康。
Background Trials of beta blockers in patients undergoing non-cardiac surgery have reported conflicting results. This randomised controlled trial, done in 190 hospitals in 23 countries, was designed to investigate the effects of perioperative beta blockers.Methods We randomly assigned 8351 patients with, or at risk of, atherosclerotic disease who were undergoing non-cardiac surgery to receive extended-release metoprolol succinate (n=4174) or placebo (n=4177), by a computerised randomisation phone service. Study treatment was started 2-4 h before surgery and continued for 30 days. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal cardiac arrest. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00182039.Findings All 8351 patients were included in analyses; 8331 (99.8%) patients completed the 30-day follow-up. Fewer patients in the metoprolol group than in the placebo group reached the primary endpoint (244 [5.8%] patients in the metoprolol group vs 290 [6.9%] in the placebo group; hazard ratio 0 . 84, 95% CI 0 . 70-0.99; p=0.0399). Fewer patients in the metoprolol group than in the placebo group had a myocardial infarction (176 [4.2%] vs 239 [5.7%] patients; 0 .73, 0.60-0.89; p=0. 0017). However, there were more deaths in the metoprolol group than in the placebo group (129 [3 . 1%] vs 97 [2.3%] patients; 1 . 33, 1.03-1.74; p=0.0317). More patients in the metoprolol group than in the placebo group had a stroke (41 [1 . 0%] vs 19 [0.5%] patients; 2.17, 1.26-3.74; p=0.0053).Interpretation Our results highlight the risk in assuming a perioperative beta-blocker regimen has benefit without substantial harm, and the importance and need for large randomised trials in the perioperative setting. Patients are unlikely to accept the risks associated with perioperative extended-release metoprolol.Funding Canadian Institutes of Health Research; Commonwealth Government of Australia's National Health and Medical Research Council; Instituto de Salud Carlos III (Ministerio de Sanidad y Consumo), Spain; British Heart Foundation; AstraZeneca.