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动脉血运重建试验中体外循环手术与非体外循环手术的效果

Effects of on-pump and off-pump surgery in the Arterial Revascularization Trial.

作者信息

Taggart David P, Altman Douglas G, Gray Alastair M, Lees Belinda, Nugara Fiona, Yu Ly-Mee, Flather Marcus

机构信息

Nuffield Department of Surgery, University of Oxford, John Radcliffe Hospital, Oxford, UK

Centre for Statistics in Medicine, University of Oxford, Oxford, UK Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, Oxford, UK.

出版信息

Eur J Cardiothorac Surg. 2015 Jun;47(6):1059-65. doi: 10.1093/ejcts/ezu349. Epub 2014 Sep 12.

Abstract

OBJECTIVES

The Arterial Revascularization Trial (ART) is a randomized comparison of bilateral internal mammary artery (BIMA) versus single internal mammary artery (SIMA) grafting in coronary artery bypass graft (CABG) surgery and is one of the largest randomized trials of surgery ever conducted. ART is also one of the largest studies of contemporary CABG with a high proportion of off-pump surgeries (41%). The objective of this post hoc analysis was to evaluate the surgical process and 1-year outcomes for surgery performed on-pump compared with off-pump.

METHODS

ART randomized 3102 patients with multivessel coronary artery disease (CAD) to SIMA or BIMA grafts to determine if BIMA grafts have an additional survival advantage at 10 years. The 1-year interim analysis showed an overall very low mortality and major morbidity rate irrespective of whether the procedure was with an SIMA or BIMA. The surgical process and 1-year outcomes were analysed according to whether surgery was performed on-pump or off-pump.

RESULTS

Baseline variables were not statistically significantly different between on- and off-pump surgery within each treatment group after taking account of the effects of clustering by individual surgeons. At both 30 days and 1 year, there was a low incidence of death (1.2%, 2.3%), stroke (1.1%, 1.7%), myocardial infarction (MI) (1.4%, 1.9%), repeat revascularization (0.5%, 1.5%) and wound reconstruction (1.2%). A similar average number of grafts were performed with on- and off-pump surgery (median = 3), but the duration of surgery was 20-30 min and ventilation time ∼ 2 h shorter with off-pump surgery. Blood loss and platelet transfusions were lower in the off-pump group, with no difference in the need for balloon pump or renal support. Sternal wound reconstruction was similar with off-pump surgery in the SIMA group (0.5 vs 0.6%) and lower with off-pump surgery in the BIMA group (1.4 vs 2.2%). Repeat revascularization was marginally higher in off-pump patients at 30 days (0.8 vs 0.3%) and at 1 year (1.7 vs 1.3%).

CONCLUSIONS

The outcomes of contemporary CABG are excellent with low mortality, stroke, myocardial infarction and need for wound reconstruction and repeat revascularization whether performed on-pump or off-pump.

CLINICAL TRIAL REGISTRATION

Controlled-trials.com (ISRCTN46552265).

摘要

目的

动脉血运重建试验(ART)是一项在冠状动脉旁路移植术(CABG)中比较双侧乳内动脉(BIMA)与单侧乳内动脉(SIMA)移植的随机对照试验,是有史以来开展的最大规模的外科随机试验之一。ART也是当代CABG规模最大的研究之一,非体外循环手术比例较高(41%)。这项事后分析的目的是评估体外循环手术与非体外循环手术的手术过程及1年结局。

方法

ART将3102例多支冠状动脉疾病(CAD)患者随机分为接受SIMA或BIMA移植,以确定BIMA移植在10年时是否具有额外的生存优势。1年中期分析显示,无论手术采用SIMA还是BIMA,总体死亡率和主要发病率都非常低。根据手术是在体外循环还是非体外循环下进行,分析手术过程和1年结局。

结果

在考虑个体外科医生聚类效应后,各治疗组内体外循环手术与非体外循环手术的基线变量无统计学显著差异。在30天和1年时,死亡(1.2%,2.3%)、中风(1.1%,1.7%)、心肌梗死(MI)(1.4%,1.9%)、再次血运重建(0.5%,1.5%)和伤口重建(1.2%)的发生率均较低。体外循环手术与非体外循环手术的平均移植数量相似(中位数 = 3),但非体外循环手术的手术时间短20 - 30分钟,通气时间短约2小时。非体外循环组的失血量和血小板输注量较低,在使用球囊泵或肾脏支持方面无差异。在SIMA组,非体外循环手术的胸骨伤口重建情况相似(0.5%对0.6%),在BIMA组,非体外循环手术的胸骨伤口重建率较低(1.4%对2.2%)。非体外循环患者在30天(0.8%对0.3%)和1年(1.7%对1.3%)时再次血运重建率略高。

结论

当代CABG的结局良好,无论采用体外循环还是非体外循环手术,死亡率、中风、心肌梗死以及伤口重建和再次血运重建的需求都很低。

临床试验注册

Controlled-trials.com(ISRCTN46552265)

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