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主要术后不良事件和心肌损伤对残疾和生存的影响:ENIGMA-II 试验的计划亚分析。

Implication of Major Adverse Postoperative Events and Myocardial Injury on Disability and Survival: A Planned Subanalysis of the ENIGMA-II Trial.

机构信息

From the Department of Anesthesia and Pain Management, University Health Network, University of Toronto, Toronto, Ontario, Canada.

Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada.

出版信息

Anesth Analg. 2018 Nov;127(5):1118-1126. doi: 10.1213/ANE.0000000000003310.

DOI:10.1213/ANE.0000000000003310
PMID:29533264
Abstract

BACKGROUND

Globally, >300 million patients have surgery annually, and ≤20% experience adverse postoperative events. We studied the impact of both cardiac and noncardiac adverse events on 1-year disability-free survival after noncardiac surgery.

METHODS

We used the study cohort from the Evaluation of Nitrous oxide in Gas Mixture of Anesthesia (ENIGMA-II) trial, an international randomized trial of 6992 noncardiac surgical patients. All were ≥45 years of age and had moderate to high cardiac risk. The primary outcome was mortality within 1 postoperative year. We defined 4 separate types of postoperative adverse events. Major adverse cardiac events (MACEs) included myocardial infarction (MI), cardiac arrest, and myocardial revascularization with or without troponin elevation. MI was defined using the third Universal Definition and was blindly adjudicated. A second cohort consisted of patients with isolated troponin increases who did not meet the definition for MI. We also considered a cohort of patients who experienced major adverse postoperative events (MAPEs), including unplanned admission to intensive care, prolonged mechanical ventilation, wound infection, pulmonary embolism, and stroke. From this cohort, we identified a group without troponin elevation and another with troponin elevation that was not judged to be an MI. Multivariable Cox proportional hazard models for death at 1 year and assessments of proportionality of hazard functions were performed and expressed as an adjusted hazard ratio (aHR) and 95% confidence intervals (CIs).

RESULTS

MACEs were observed in 469 patients, and another 754 patients had isolated troponin increases. MAPEs were observed in 631 patients. Compared with control patients, patients with a MACE were at increased risk of mortality (aHR, 3.36 [95% CI, 2.55-4.46]), similar to patients who suffered a MAPE without troponin elevation (n = 501) (aHR, 2.98 [95% CI, 2.26-3.92]). Patients who suffered a MAPE with troponin elevation but without MI had the highest risk of death (n = 116) (aHR, 4.29 [95% CI, 2.89-6.36]). These 4 types of adverse events similarly affected 1-year disability-free survival.

CONCLUSIONS

MACEs and MAPEs occur at similar frequencies and affect survival to a similar degree. All 3 types of postoperative troponin elevation in this analysis were associated, to varying degrees, with increased risk of death and disability.

摘要

背景

在全球范围内,每年有超过 3 亿患者接受手术,但仅有≤20%的患者经历不良术后事件。我们研究了心脏和非心脏不良事件对非心脏手术后 1 年无残疾生存的影响。

方法

我们使用了来自 Evaluation of Nitrous oxide in Gas Mixture of Anesthesia(ENIGMA-II)试验的研究队列,这是一项针对 6992 名非心脏手术患者的国际随机试验。所有患者年龄均≥45 岁,且具有中高度心脏风险。主要结局是术后 1 年内的死亡率。我们定义了 4 种不同类型的术后不良事件。主要不良心脏事件(MACE)包括心肌梗死(MI)、心脏骤停和心肌血运重建伴或不伴肌钙蛋白升高。MI 使用第三个通用定义进行定义,并进行了盲法裁决。第二队列由肌钙蛋白升高但不符合 MI 定义的患者组成。我们还考虑了经历主要不良术后事件(MAPE)的患者队列,包括计划外入住重症监护病房、延长机械通气、伤口感染、肺栓塞和中风。从该队列中,我们确定了一组无肌钙蛋白升高和另一组肌钙蛋白升高但不被判定为 MI 的患者。对 1 年死亡进行多变量 Cox 比例风险模型分析,并对风险函数的比例性进行评估,结果表示为调整后的危险比(aHR)和 95%置信区间(CI)。

结果

469 例患者发生 MACE,754 例患者发生孤立性肌钙蛋白升高。631 例患者发生 MAPE。与对照组患者相比,发生 MACE 的患者死亡风险增加(aHR,3.36 [95%CI,2.55-4.46]),与未发生肌钙蛋白升高的 MAPE 患者(n=501)相似(aHR,2.98 [95%CI,2.26-3.92])。发生 MAPE 且伴有肌钙蛋白升高但无 MI 的患者死亡风险最高(n=116)(aHR,4.29 [95%CI,2.89-6.36])。这 4 种不良事件同样对 1 年无残疾生存产生影响。

结论

MACE 和 MAPE 发生的频率相似,对生存的影响程度也相似。本分析中所有 3 种术后肌钙蛋白升高的类型均不同程度地与死亡和残疾风险增加相关。

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