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欧洲冠状动脉搭桥术多中心研究(E-CABG 注册研究):一项前瞻性临床注册研究方案及术后并发症分类建议

European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG registry): Study Protocol for a Prospective Clinical Registry and Proposal of Classification of Postoperative Complications.

作者信息

Biancari Fausto, Ruggieri Vito G, Perrotti Andrea, Svenarud Peter, Dalén Magnus, Onorati Francesco, Faggian Giuseppe, Santarpino Giuseppe, Maselli Daniele, Dominici Carmelo, Nardella Saverio, Musumeci Francesco, Gherli Riccardo, Mariscalco Giovanni, Masala Nicola, Rubino Antonino S, Mignosa Carmelo, De Feo Marisa, Della Corte Alessandro, Bancone Ciro, Chocron Sidney, Gatti Giuseppe, Gherli Tiziano, Kinnunen Eeva-Maija, Juvonen Tatu

机构信息

Department of Surgery, Oulu University Hospital, Oulu, Finland.

Division of Cardiothoracic and Vascular Surgery, Pontchaillou University Hospital, Rennes, France.

出版信息

J Cardiothorac Surg. 2015 Jun 30;10:90. doi: 10.1186/s13019-015-0292-z.

Abstract

BACKGROUND

Clinical evidence in coronary surgery is usually derived from retrospective, single institutional series. This may introduce significant biases in the analysis of critical issues in the treatment of these patients. In order to avoid such methodological limitations, we planned a European multicenter, prospective study on coronary artery bypass grafting, the E-CABG registry.

DESIGN

The E-CABG registry is a multicenter study and its data are prospectively collected from 13 centers of cardiac surgery in university and community hospitals located in six European countries (England, Italy, Finland, France, Germany, Sweden). Data on major and minor immediate postoperative adverse events will be collected. Data on late all-cause mortality, stroke, myocardial infarction and repeat revascularization will be collected during a 10-year follow-up period. These investigators provided a score from 0 to 10 for any major postoperative adverse events and their rounded medians were used to stratify the severity of these complications in four grades. The sum of these scores for each complication/intervention occurring after coronary artery bypass grafting will be used as an additive score for further stratification of the prognostic importance of these events.

DISCUSSION

The E-CABG registry is expected to provide valuable data for identification of risk factors and treatment strategies associated with suboptimal outcome. These information may improve the safety and durability of coronary artery bypass grafting. The proposed classification of postoperative complications may become a valuable research tool to stratify the impact of such complications on the outcome of these patients and evaluate the burden of resources needed for their treatment.

CLINICAL TRIALS NUMBER

NCT02319083.

摘要

背景

冠状动脉手术的临床证据通常来自回顾性的单中心系列研究。这可能在分析这些患者治疗中的关键问题时引入显著偏差。为避免此类方法学限制,我们计划开展一项关于冠状动脉搭桥术的欧洲多中心前瞻性研究,即E-CABG注册研究。

设计

E-CABG注册研究是一项多中心研究,其数据前瞻性地收集自位于六个欧洲国家(英国、意大利、芬兰、法国、德国、瑞典)的大学和社区医院的13个心脏外科中心。将收集术后即刻发生的主要和次要不良事件的数据。在10年随访期内将收集晚期全因死亡率、中风、心肌梗死和再次血运重建的数据。这些研究者对任何术后主要不良事件给出0至10分的评分,其四舍五入后的中位数用于将这些并发症的严重程度分为四个等级。冠状动脉搭桥术后发生的每种并发症/干预的这些评分总和将用作进一步分层这些事件预后重要性的累加评分。

讨论

E-CABG注册研究有望提供有价值的数据,以识别与欠佳结局相关的危险因素和治疗策略。这些信息可能会提高冠状动脉搭桥术的安全性和耐久性。提议的术后并发症分类可能成为一种有价值的研究工具,用于分层此类并发症对这些患者结局的影响,并评估其治疗所需的资源负担。

临床试验编号

NCT02319083。

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