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术前冠状动脉介入治疗预防大型开放性血管或血管内手术后围手术期急性心肌梗死。

Preoperative coronary interventions for preventing acute myocardial infarction in the perioperative period of major open vascular or endovascular surgery.

机构信息

Department of Surgery, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.

Department of Surgery, Division of Vascular and Endovascular Surgery, Universidade Federal de São Paulo, São Paulo, Brazil.

出版信息

Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD014920. doi: 10.1002/14651858.CD014920.pub2.

Abstract

BACKGROUND

Postoperative myocardial infarction (POMI) is associated with major surgeries and remains the leading cause of mortality and morbidity in people undergoing vascular surgery, with an incidence rate ranging from 5% to 20%. Preoperative coronary interventions, such as coronary artery bypass grafting (CABG) or percutaneous coronary interventions (PCI), may help prevent acute myocardial infarction in the perioperative period of major vascular surgery when used in addition to routine perioperative drugs (e.g. statins, angiotensin-converting enzyme inhibitors, and antiplatelet agents), CABG by creating new blood circulation routes that bypass the blockages in the coronary vessels, and PCI by opening up blocked blood vessels. There is currently uncertainty around the benefits and harms of preoperative coronary interventions.

OBJECTIVES

To assess the effects of preoperative coronary interventions for preventing acute myocardial infarction in the perioperative period of major open vascular or endovascular surgery.

SEARCH METHODS

We searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE Ovid, Embase Ovid, LILACS, and CINAHL EBSCO on 13 March 2023. We also searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov.

SELECTION CRITERIA

We included all randomised controlled trials (RCTs) or quasi-RCTs that compared the use of preoperative coronary interventions plus usual care versus usual care for preventing acute myocardial infarction during major open vascular or endovascular surgery. We included participants of any sex or any age undergoing major open vascular surgery, major endovascular surgery, or hybrid vascular surgery.

DATA COLLECTION AND ANALYSIS

We used standard Cochrane methods. Our primary outcomes of interest were acute myocardial infarction, all-cause mortality, and adverse events resulting from preoperative coronary interventions. Our secondary outcomes were cardiovascular mortality, quality of life, vessel or graft secondary patency, and length of hospital stay. We reported perioperative and long-term outcomes (more than 30 days after intervention). We assessed the certainty of the evidence using the GRADE approach.

MAIN RESULTS

We included three RCTs (1144 participants). Participants were randomised to receive either preoperative coronary revascularisation with PCI or CABG plus usual care or only usual care before major vascular surgery. One trial enrolled participants if they had no apparent evidence of coronary artery disease. Another trial selected participants classified as high risk for coronary disease through preoperative clinical and laboratorial testing. We excluded one trial from the meta-analysis because participants from both the control and the intervention groups were eligible to undergo preoperative coronary revascularisation. We identified a high risk of performance bias in all included trials, with one trial displaying a high risk of other bias. However, the risk of bias was either low or unclear in other domains. We observed no difference between groups for perioperative acute myocardial infarction, but the evidence is very uncertain (risk ratio (RR) 0.28, 95% confidence interval (CI) 0.02 to 4.57; 2 trials, 888 participants; very low-certainty evidence). One trial showed a reduction in incidence of long-term (> 30 days) acute myocardial infarction in participants allocated to the preoperative coronary interventions plus usual care group, but the evidence was very uncertain (RR 0.09, 95% CI 0.03 to 0.28; 1 trial, 426 participants; very low-certainty evidence). There was little to no effect on all-cause mortality in the perioperative period when comparing the preoperative coronary intervention plus usual care group to usual care alone, but the evidence is very uncertain (RR 0.79, 95% CI 0.31 to 2.04; 2 trials, 888 participants; very low-certainty evidence). The evidence is very uncertain about the effect of preoperative coronary interventions on long-term (follow up: 2.7 to 6.2 years) all-cause mortality (RR 0.74, 95% CI 0.30 to 1.80; 2 trials, 888 participants; very low-certainty evidence). One study reported no adverse effects related to coronary angiography, whereas the other two studies reported five deaths due to revascularisations. There may be no effect on cardiovascular mortality when comparing preoperative coronary revascularisation plus usual care to usual care in the short term (RR 0.07, 95% CI 0.00 to 1.32; 1 trial, 426 participants; low-certainty evidence). Preoperative coronary interventions plus usual care in the short term may reduce length of hospital stay slightly when compared to usual care alone (mean difference -1.17 days, 95% CI -2.05 to -0.28; 1 trial, 462 participants; low-certainty evidence). We downgraded the certainty of the evidence due to concerns about risk of bias, imprecision, and inconsistency. None of the included trials reported on quality of life or vessel graft patency at either time point, and no study reported on adverse effects, cardiovascular mortality, or length of hospital stay at long-term follow-up.

AUTHORS' CONCLUSIONS: Preoperative coronary interventions plus usual care may have little or no effect on preventing perioperative acute myocardial infarction and reducing perioperative all-cause mortality compared to usual care, but the evidence is very uncertain. Similarly, limited, very low-certainty evidence shows that preoperative coronary interventions may have little or no effect on reducing long-term all-cause mortality. There is very low-certainty evidence that preoperative coronary interventions plus usual care may prevent long-term myocardial infarction, and low-certainty evidence that they may reduce length of hospital stay slightly, but not cardiovascular mortality in the short term, when compared to usual care alone. Adverse effects of preoperative coronary interventions were poorly reported in trials. Quality of life and vessel or graft patency were not reported. We downgraded the certainty of the evidence most frequently for high risk of bias, inconsistency, or imprecision. None of the analysed trials provided significant data on subgroups of patients who could potentially experience more substantial benefits from preoperative coronary intervention (e.g. altered ventricular ejection fraction). There is a need for evidence from larger and homogeneous RCTs to provide adequate statistical power to assess the role of preoperative coronary interventions for preventing acute myocardial infarction in the perioperative period of major open vascular or endovascular surgery.

摘要

背景

术后心肌梗死(POMI)与大手术有关,仍然是血管外科患者死亡和发病的主要原因,其发生率为 5%至 20%。在大血管外科的围手术期,除了常规围手术期药物(如他汀类药物、血管紧张素转换酶抑制剂和抗血小板药物)外,冠状动脉介入治疗(如冠状动脉旁路移植术(CABG)或经皮冠状动脉介入治疗(PCI))可能有助于预防急性心肌梗死。CABG 通过建立绕过冠状动脉阻塞的新血液循环途径,PCI 通过打开阻塞的血管。目前,对于术前冠状动脉介入治疗在预防大血管开放或血管内手术后围手术期急性心肌梗死的获益和危害尚不确定。

目的

评估术前冠状动脉介入治疗预防大血管开放或血管内手术围手术期急性心肌梗死的效果。

检索方法

我们于 2023 年 3 月 13 日在 Cochrane 血管专业注册库、CENTRAL、MEDLINE Ovid、Embase Ovid、LILACS 和 CINAHL EBSCO 进行了检索。我们还检索了世界卫生组织国际临床试验注册平台和 ClinicalTrials.gov。

选择标准

我们纳入了所有比较术前冠状动脉介入治疗加常规治疗与常规治疗预防大血管开放手术、大血管内手术或杂交血管手术围手术期急性心肌梗死的随机对照试验(RCT)或准 RCT。我们纳入了接受大血管开放手术、大血管内手术或杂交血管手术的任何性别或任何年龄的参与者。

数据收集和分析

我们使用了标准的 Cochrane 方法。我们主要关注的结局是急性心肌梗死、全因死亡率和术前冠状动脉介入治疗的不良事件。我们的次要结局是心血管死亡率、生活质量、血管或移植物二级通畅性和住院时间。我们报告了围手术期和长期(干预后 30 天以上)结局。我们使用 GRADE 方法评估证据的确定性。

主要结果

我们纳入了三项 RCT(1144 名参与者)。参与者被随机分配接受 PCI 或 CABG 加常规治疗或仅在大血管手术后接受常规治疗。一项试验招募了没有明显冠状动脉疾病证据的参与者。另一项试验选择了通过术前临床和实验室检测被归类为冠心病高危的参与者。我们排除了一项来自荟萃分析的试验,因为对照组和干预组的参与者都有资格接受术前冠状动脉再血管化。我们发现所有纳入的试验都存在很高的偏倚风险,其中一项试验存在其他偏倚的高风险。然而,在其他领域的偏倚风险较低或不清楚。我们没有观察到两组之间围手术期急性心肌梗死的差异,但证据非常不确定(风险比(RR)0.28,95%置信区间(CI)0.02 至 4.57;2 项试验,888 名参与者;非常低确定性证据)。一项试验显示,术前冠状动脉介入治疗加常规治疗组的长期(>30 天)急性心肌梗死发生率降低,但证据非常不确定(RR 0.09,95%CI 0.03 至 0.28;1 项试验,426 名参与者;非常低确定性证据)。与单独常规治疗相比,术前冠状动脉介入治疗加常规治疗组在围手术期的全因死亡率几乎没有影响,但证据非常不确定(RR 0.79,95%CI 0.31 至 2.04;2 项试验,888 名参与者;非常低确定性证据)。关于术前冠状动脉介入治疗对长期(随访:2.7 至 6.2 年)全因死亡率的影响,证据非常不确定(RR 0.74,95%CI 0.30 至 1.80;2 项试验,888 名参与者;非常低确定性证据)。一项研究报告没有与冠状动脉造影相关的不良影响,而另外两项研究报告了 5 例因血运重建而死亡的病例。与单独常规治疗相比,术前冠状动脉再血管化加常规治疗在短期(RR 0.07,95%CI 0.00 至 1.32;1 项试验,426 名参与者;低确定性证据)可能对心血管死亡率没有影响。与单独常规治疗相比,术前冠状动脉介入治疗加常规治疗可能会略微降低住院时间(平均差值-1.17 天,95%CI-2.05 至-0.28;1 项试验,462 名参与者;低确定性证据)。由于对偏倚、不精确性和不一致性的担忧,我们降低了证据的确定性。纳入的试验均未报告短期和长期随访时的生活质量或血管移植物通畅性,也没有研究报告不良事件、心血管死亡率或住院时间。

作者结论

与单独常规治疗相比,术前冠状动脉介入治疗加常规治疗可能对预防围手术期急性心肌梗死和降低围手术期全因死亡率没有影响,但证据非常不确定。同样,有限的、非常低确定性证据表明,术前冠状动脉介入治疗可能对降低长期全因死亡率没有影响。有非常低确定性证据表明,术前冠状动脉介入治疗加常规治疗可能预防长期心肌梗死,低确定性证据表明,与单独常规治疗相比,可能会略微降低住院时间,但不会降低短期的心血管死亡率。在试验中,术前冠状动脉介入治疗的不良影响报道得很差。生活质量和血管或移植物通畅性没有报道。我们最频繁地降低证据的确定性是因为存在高偏倚风险、不一致性或不精确性。没有分析的试验为可能从术前冠状动脉介入治疗中获益更多的特定患者亚组(如心室射血分数改变)提供了重要数据。需要有来自更大和更同质的 RCT 的证据,以提供足够的统计能力来评估术前冠状动脉介入治疗在预防大血管开放或血管内手术后围手术期急性心肌梗死中的作用。

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