Gaudino Mario, Castelvecchio Serenella, Rahouma Mohamed, Robinson N Bryce, Audisio Katia, Soletti Giovanni J, Garatti Andrea, Benedetto Umberto, Girardi Leonard N, Menicanti Lorenzo
Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, New York, USA.
Department Cardiac Surgery, IRCCS Policlinico San Donato, Milan, Italy.
J Card Surg. 2021 Feb;36(2):689-692. doi: 10.1111/jocs.15315. Epub 2021 Jan 13.
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.
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.
心肌梗死后左心室重构与缺血性心脏病患者死亡率增加相关。除冠状动脉旁路移植术（CABG）外，还提出了手术心室重建术（SVR）以减少左心室容积并改善临床结局。缺血性心力衰竭外科治疗（STICH）试验发现，与单纯CABG相比，CABG联合SVR在术后5年内并未降低死亡率或再住院率。与所有随机试验一样，STICH存在局限性，据推测其可能低估了SVR的治疗效果。本研究的目的是评估当代最大的单中心系列之一中SVR的结果，并使用个体患者数据将结果与STICH试验的结果进行比较。
将从米兰圣多纳托大学医院获取接受或未接受CABG的SVR患者的个体数据。使用多变量Cox回归分析，确定该队列中的显著预后指标。然后，我们将把圣多纳托队列与STICH试验假设2的SVR组以及STICH扩展研究（STICHES）两组的个体患者数据进行比较。为减少混杂因素，此比较将使用倾向评分调整。主要终点将是全因死亡率。数据将在纽约威尔康奈尔医学院进行合并和独立分析。
