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Conventional Versus Minimally Invasive Extracorporeal Circulation in Patients Undergoing Cardiac Surgery
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The COMICS trial is the largest randomized trial of minimally invasive extracorporeal circulation (MiECC) compared to conventional ECC (CECC). MiECC reduced the frequency of SAEs prespecified to qualify for the primary outcome. This finding was of borderline significance due to stopping recruitment early, but is consistent with the results of large-scale, published meta-analyses. MiECC improved a visual analogue quality-of-life measure. MiECC was safe with respect to other SAEs and adverse events that were reported. It did not reduce mortality, any SAE not included in the primary outcome, time to ICU or hospital discharge or transfusion of any red cells or any other blood product. However, all treatment effect estimates for these outcomes, except for hospital stay, favored MiECC; and the magnitude of the reductions in mortality and risk of any SAE not included in the primary outcome were consistent with the reduction in risk observed for the primary outcome.