Key result
ISCHEMIA-CKD evaluates whether an initial invasive strategy reduces major ischemic events in advanced CKD.
Why the study?
Prior trials comparing optimal medical therapy with or without revascularization in stable ischemic heart disease largely excluded patients with advanced CKD, leaving the benefit of a routine invasive approach versus a conservative strategy in this high-risk group unknown.
Does an initial invasive strategy of cardiac catheterization and optimal revascularization added to optimal medical therapy reduce the composite of all-cause death or nonfatal myocardial infarction compared with a conservative strategy of optimal medical therapy alone in patients with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease?
RCT (n=777)
Open-label with blinded independent clinical events adjudication committee
1:1 randomization via central interactive voice response system (IVRS) and interactive web response system (IXRS)
Yes
Does an initial invasive strategy of cardiac catheterization and optimal revascularization added to optimal medical therapy reduce the composite of all-cause death or nonfatal myocardial infarction compared with a conservative strategy of optimal medical therapy alone in patients with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease?
This rationale and design paper outlines the ISCHEMIA-CKD trial, which will provide landmark randomized evidence on whether adding routine invasive revascularization to optimal medical therapy improves clinical outcomes in the historically excluded population of patients with advanced chronic kidney disease and stable ischemic heart disease.
Answers are grounded in this paper and cite their sources.
Trial design addresses evidence gap in advanced CKD; extends randomized evaluation of invasive strategy to this high-risk group.
Background Patients with chronic kidney disease (CKD) and stable ischemic heart disease are at markedly increased risk of cardiovascular events. Prior trials comparing a strategy of optimal medical therapy (OMT) with or without revascularization have largely excluded patients with advanced CKD. Whether a routine invasive approach when compared with a conservative strategy is beneficial in such patients is unknown. Methods ISCHEMIA‐CKD is a National Heart, Lung, and Blood Institute–funded randomized trial designed to determine the comparative effectiveness of an initial invasive strategy (cardiac catheterization and optimal revascularization [percutaneous coronary intervention or coronary artery bypass graft surgery, if suitable] plus OMT) versus a conservative strategy (OMT alone, with cardiac catheterization and revascularization [percutaneous coronary intervention or coronary artery bypass graft surgery, if suitable] reserved for failure of OMT) on long‐term clinical outcomes in 777 patients with advanced CKD (defined as those with estimated glomerular filtration rate <30 mL/min/1.73m2 or on dialysis) and moderate or severe ischemia on stress testing. Participants were randomized in a 1:1 fashion to the invasive or a conservative strategy. The primary end point is a composite of death or nonfatal myocardial infarction. Major secondary endpoints are a composite of death, nonfatal myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, or resuscitated cardiac arrest; angina control; and disease‐specific quality of life. Safety outcomes such as initiation of maintenance dialysis and a composite of initiation of maintenance dialysis or death will be reported. The trial is projected to have 80% power to detect a 22% to 24% reduction in the primary composite end point with the invasive strategy when compared with the conservative strategy. Conclusions ISCHEMIA‐CKD will determine whether an initial invasive management strategy improves clinical outcomes when added to OMT in patients with advanced CKD and stable ischemic heart disease.
No takes yet. Share an insight, caveat, or question.
Bangalore et al. (2018) conducted an RCT in Stable ischemic heart disease and advanced chronic kidney disease (n=777). Initial invasive strategy (cardiac catheterization within 30 days and optimal revascularization via PCI or CABG, if suitable) plus optimal medical therapy vs. Conservative strategy of optimal medical therapy alone, with cardiac catheterization and revascularization reserved for failure of medical therapy was evaluated on Composite of all-cause death or nonfatal myocardial infarction.
Synapse has enriched 10 related papers. Consider them for comparative context: