Results of surgical ventricular reconstruction in a specialized center and in comparison to the STICH trial: Rationale and study protocol for a patient-level pooled analysis

Dataset from Gaudino M, Castelvecchio S, Rahouma M, Robinson NB, Audisio K, Soletti GJ, Garatti A, Benedetto U, Girardi LN, Menicanti L. Results of surgical ventricular reconstruction in a specialized center and in comparison to the STICH trial: Rationale and study protocol for a patient-level pooled analysis. J Card Surg. 2021 Feb;36(2):689-692. doi: 10.1111/jocs.15315. Epub 2021 Jan 13. PMID: 33438823. Abstract <strong>Introduction: </strong>Post-infarction left ventricular remodeling is associated with increased mortality in patients with ischemic heart disease. Surgical ventricular reconstruction (SVR) in addition to coronary artery bypass grafting (CABG) has been proposed to reduce left ventricular volume and improve clinical outcomes. The Surgical Treatment for Ischemic Heart Failure (STICH) trial found that the addition of SVR to CABG did not reduce the rates of death or rehospitalization in the 5 years after surgery compared to CABG alone. Like all randomized trials, STICH has limitations and it has been hypothesized that it may have underestimated the treatment effect of SVR. The aim of this study is to evaluate the results of SVR in one of the largest contemporary single-center series and to compare the results with those of the STICH trial using individual patient's data. <strong>Methods and analysis: </strong>Individual data of patients who underwent SVR with or without CABG will be obtained from San Donato University Hospital in Milan. Using multivariable Cox regression analysis, significant prognostic indicators in this cohort will be identified. We will then compare the San Donato cohort to individual patient's data from the SVR arm of Hypothesis 2 of the STICH trial and from both arms of the STICH Extended Study (STICHES). To reduce confounders, propensity score adjustment will be used for this comparison. The primary endpoint will be all-cause mortality. Data will be merged and analyzed independently at Weill Cornell Medicine in New York.本数据集源自Gaudino M、Castelvecchio S、Rahouma M、Robinson NB、Audisio K、Soletti GJ、Garatti A、Benedetto U、Girardi LN、Menicanti L的研究：《某专科中心外科心室重构术的治疗结果及与STICH试验的对比：患者个体数据汇总分析的依据与研究方案》，发表于*J Card Surg*，2021年2月；36(2):689-692，DOI: 10.1111/jocs.15315，2021年1月13日在线发表，PMID: 33438823。**摘要** **引言：** 缺血性心脏病患者发生梗死后左心室重构，与死亡率升高密切相关。在冠状动脉旁路移植术（coronary artery bypass grafting, CABG）基础上联合外科心室重构术（surgical ventricular reconstruction, SVR），被用于缩小左心室容积、改善患者临床结局。缺血性心力衰竭外科治疗（Surgical Treatment for Ischemic Heart Failure, STICH）试验发现，与单纯CABG相比，术中联合SVR并未降低术后5年的全因死亡或再住院率。与所有随机对照试验一样，STICH试验存在局限性，有研究假说认为该试验可能低估了SVR的治疗效应。本研究旨在纳入当前规模最大的单中心队列之一，评估SVR的临床疗效，并利用患者个体层面数据，将本中心队列结果与STICH试验结果进行对比。 **方法与分析：** 本研究将从米兰圣多纳托大学医院获取接受SVR联合或不联合CABG的患者个体数据。本研究将通过多变量Cox回归分析，识别该队列中的显著预后指标。随后，本研究将把圣多纳托队列与STICH试验假说2中SVR组的患者个体数据，以及STICH扩展研究（STICH Extended Study, STICHES）两组的患者个体数据进行对比。为减少混杂因素的影响，本研究将采用倾向得分调整法开展上述对比分析。本研究的主要终点为全因死亡率。数据将由纽约威尔康奈尔医学院独立合并并开展分析。