Patients suffering from chronic kidney disease (CKD) and stable ischemic heart disease are known to be at a considerably higher risk of experiencing cardiovascular events. While previous studies have explored optimal medical therapy (OMT) with and without revascularization, these trials have often excluded individuals with advanced CKD. Therefore, the question of whether an early invasive approach offers benefits compared to a conservative strategy in this specific patient group remains unanswered. The National Institutes of Health (NIH) plays a crucial role in supporting comparative health research to address critical clinical questions like this. The ISCHEMIA-CKD trial, a significant undertaking funded by the NIH, is specifically designed to evaluate the comparative effectiveness of these two treatment strategies in patients with advanced CKD.
The ISCHEMIA-CKD trial is a randomized study funded by the National Heart, Lung, and Blood Institute, aiming to assess the effectiveness of an initial invasive strategy versus a conservative strategy for managing patients with advanced CKD and moderate to severe ischemia. The study enrolled 777 participants with advanced CKD, defined as having an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m2 or being on dialysis, and who also presented with moderate or severe ischemia based on stress testing. Participants were randomly assigned in a 1:1 ratio to either the invasive or conservative treatment pathway. The invasive strategy involved cardiac catheterization and optimal revascularization (including percutaneous coronary intervention or coronary artery bypass graft surgery when appropriate) in addition to OMT. Conversely, the conservative strategy consisted of OMT alone, with cardiac catheterization and revascularization reserved only for cases where OMT failed to manage symptoms effectively. The primary outcome being measured is a composite of death or nonfatal myocardial infarction. Key secondary outcomes include a broader composite of death, nonfatal myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, or resuscitated cardiac arrest, as well as angina control and disease-specific quality of life. Furthermore, safety outcomes, such as the initiation of maintenance dialysis and a composite of dialysis initiation or death, will also be carefully monitored and reported. The trial is statistically powered at 80% to detect a meaningful 22% to 24% reduction in the primary composite endpoint with the invasive strategy compared to the conservative approach, highlighting its robust design for comparative health assessment.
In conclusion, the ISCHEMIA-CKD trial is poised to provide critical insights into whether an initial invasive management strategy, when added to optimal medical therapy, leads to improved clinical outcomes for patients with advanced CKD and stable ischemic heart disease. This Nih Comparative Health initiative is essential for establishing evidence-based guidelines and optimizing treatment strategies for this complex and high-risk patient population.
