Questioning Unfounded Clinical Trials: The Case of NEWTON-CABG CardioLink-5

Об этом видео: Questioning Unfounded Clinical Trials: The Case of NEWTON-CABG CardioLink-5

At the recent European Society of Cardiology Congress 2025, the results of the NEWTON-CABG CardioLink-5 study were presented. This trial aimed to evaluate whether early and intensive LDL cholesterol lowering with evolocumab could reduce the failure of saphenous vein grafts (SVGs) after coronary artery bypass grafting (CABG). The outcome was negative: despite a significant reduction in LDL cholesterol, evolocumab did not reduce SVG disease at 24 months.
From a clinical standpoint, the necessity of this study is questionable. It is well established that vein grafts, including those studied here, have high failure rates due to vein graft disease — a progressive process marked by pathological changes that impair graft function and patency over time.
In contrast, arterial grafts such as the left internal mammary artery (LIMA) do not undergo these changes. This explains why arterial grafts consistently demonstrate superior long-term patency: more than 90% remain open at 10 years, compared to only 50–60% for saphenous vein grafts.
Given this widely accepted evidence, it is concerning that a large-scale trial like NEWTON-CABG CardioLink-5 was conducted. The study appears to overlook decades of research and surgical practice favoring arterial grafts.
Safeguards are needed to prevent such trials from moving forward without strong justification. Before launching costly and resource-intensive human studies, there should be a clear foundation of preclinical and experimental data. The NEWTON-CABG CardioLink-5 trial serves as a reminder of the importance of critically evaluating the rationale behind clinical trials to ensure they are scientifically sound, clinically relevant, and ethically justified.