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首页> 外文期刊>Journal of Cardiothoracic Surgery >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
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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

机译:欧洲冠状动脉搭桥术多中心研究(E-CABG登记册):前瞻性临床登记册的研究方案和术后并发症的分类建议

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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
机译:背景技术冠状动脉外科手术的临床证据通常来自回顾性单一机构研究。在对这些患者进行治疗的关键问题的分析中,这可能会引入明显的偏见。为了避免此类方法的局限性,我们计划对E-CABG注册中心进行有关冠状动脉旁路移植术的欧洲多中心前瞻性研究。设计E-CABG注册中心是一项多中心研究,前瞻性地收集了来自六个欧洲国家(英格兰,意大利,芬兰,法国,德国,瑞典)的大学和社区医院的13个心脏外科中心的数据。将收集有关重大和次要立即术后不良事件的数据。在十年的随访期内,将收集有关晚期全因死亡率,中风,心肌梗塞和重复血运重建的数据。这些研究人员对任何重大的术后不良事件评分为0到10,其四舍五入的中位数用于将这些并发症的严重性分为四个等级。冠状动脉搭桥术后发生的每种并发症/干预措施的这些评分总和将用作累加评分,以进一步分层这些事件的预后重要性。讨论预计E-CABG注册中心将提供有价值的数据,用于识别与次优结果相关的危险因素和治疗策略。这些信息可以提高冠状动脉旁路移植术的安全性和耐用性。提议的术后并发症分类可能会成为一种有价值的研究工具,可以对此类并发症对这些患者预后的影响进行分层,并评估其治疗所需的资源负担。临床试验编号NCT02319083

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