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

Introduction: 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.Methods and Analysis: 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.