International Study of Comparative Health Effectiveness with Medical and Invasive Approaches–Chronic Kidney Disease (ISCHEMIA-CKD): Rationale and design
S Bangalore, DJ Maron, JL Fleg, SM O'Brien… - American heart …, 2018 - Elsevier
American heart journal, 2018•Elsevier
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 …
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 …
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.
Elsevier