Yanagawa Bobby, Mazine Amine, Tam Derrick Y, Verma Subodh
Division of Cardiac Surgery, St Michael's Hospital, Toronto, Ontario, Canada.
Curr Opin Cardiol. 2018 Mar;33(2):178-183. doi: 10.1097/HCO.0000000000000495.
There is a growing emphasis on the conduct of large-scale, multicenter randomized controlled trials (RCTs) to guide decision-making in cardiac surgery. Here we review recent landmark RCTs in cardiac valvular surgery.
RCTs are the gold-standard level of data in medicine. However, there are unique challenges of conducting large-scale surgical trials including funding, blinding, generalizability, nonstandardization of the surgical technique, crossover, among others. Thus, the vast majority of clinical outcomes data in cardiac surgery are mainly from observational studies and most prospective data are small, single-center trials. The Cardiothoracic Surgery Network is the largest platform focused on the conduct of high-quality, multicenter cardiac surgical trials, which has already produced several seminal guideline-changing and practice-changing contributions to the surgical approach to functional mitral regurgitation, aortic stenosis, atrial fibrillation, and neuroprotective surgical adjuncts.
There continues to be great interest in the conduct of high-quality, RCTs to help guide surgical management of patients with valvular heart disease.
为指导心脏外科手术决策，开展大规模、多中心随机对照试验（RCT）的重要性日益凸显。在此，我们对近期心脏瓣膜手术领域具有里程碑意义的RCT进行综述。
RCT是医学数据的金标准。然而，开展大规模外科试验存在诸多独特挑战，包括资金、盲法、普遍性、手术技术的非标准化、交叉等问题。因此，心脏外科的绝大多数临床结局数据主要来自观察性研究，且大多数前瞻性数据来自小型单中心试验。心胸外科手术网络是专注于开展高质量多中心心脏外科试验的最大平台，该平台已在功能性二尖瓣反流、主动脉瓣狭窄、心房颤动及神经保护手术辅助治疗的手术方法方面，做出了多项具有开创性、改变指南及改变实践的贡献。
开展高质量RCT以帮助指导心脏瓣膜病患者的手术治疗，仍然备受关注。
