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ROMA 试验:为何需要开展此项试验。

The ROMA trial: why it is needed.

机构信息

Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York City, New York, USA.

University of Oxford, Oxford, UK.

出版信息

Curr Opin Cardiol. 2018 Nov;33(6):622-626. doi: 10.1097/HCO.0000000000000565.

DOI:10.1097/HCO.0000000000000565
PMID:30239376
Abstract

PURPOSE OF REVIEW

We herein summarize the current evidence on the clinical outcome associated with the use of single and multiple arterial grafts for coronary bypass surgery and the role and importance of the Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts (ROMA) trial.

RECENT FINDINGS

Observational evidence suggests that the use of multiple arterial grafts is associated with better clinical outcomes compared to the use of a single arterial graft. Randomized evidence is inconclusive; the 5-year interim analysis of the largest randomized trial on the topic did not show any clinical benefit associated with the use of bilateral versus single internal thoracic arteries, whereas a pooled analysis of the trials comparing the radial artery and the saphenous vein as a second graft showed a significant reduction in follow-up cardiac events using the radial artery. Hidden confounders and treatment allocation biases as well as methodological flaws are the most likely explanation of this contradiction.

SUMMARY

ROMA was conceived based on the lessons learned from a critical analysis of the existing randomized and observational evidence with the aim to provide a definitive answer to the question of the potential clinical benefit of multiple arterial grafts for coronary bypass.

摘要

目的综述

本文总结了目前关于冠状动脉旁路移植术中单支和多支动脉移植物应用与临床结局的关系的证据,以及随机比较单支与多支动脉移植物的临床结局(ROMA)试验的作用和重要性。

最近的发现

观察性证据表明,与使用单支动脉移植物相比,多支动脉移植物的使用与更好的临床结局相关。随机证据尚无定论;关于该主题的最大规模随机试验的 5 年中期分析并未显示使用双侧与单根内乳动脉相关的任何临床获益,而比较桡动脉和隐静脉作为第二支移植物的试验的汇总分析显示,使用桡动脉可显著减少随访期间的心脏事件。隐藏的混杂因素和治疗分配偏倚以及方法学缺陷是造成这种矛盾的最可能的解释。

总结

ROMA 是基于对现有随机和观察性证据进行批判性分析所得到的经验教训而构思的,旨在为多支动脉移植物在冠状动脉旁路移植术中的潜在临床获益这一问题提供明确的答案。

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