The ISCHEMIA-CKD Trial Results are Available!
To view the results of the ISCHEMIA-CKD Trial, click here.
What is the ISCHEMIA-CKD trial?
The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches—Chronic Kidney Disease trial (ISCHEMIA-CKD) is an international comparative effectiveness trial to determine the best way to manage chronic coronary disease in patients with advanced chronic kidney disease (eGFR <30 or on dialysis). Prior trials of strategy trials of revascularization versus medical therapy alone for chronic coronary disease have routinely excluded patients with CKD or enrolled a small proportion of such patients. As such, the evidence from randomized trials to drive decision making in this cohort is weak at best.
This is a multicenter clinical trial which has randomized 777 participants with advanced CKD with moderate to severe ischemia on stress testing. Participants were randomly assigned to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization (if feasible) plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT.
- The trial was designed to run seamlessly in parallel to the main ISCHEMIA trial.
- Trial Design: Randomized controlled trial
- Intervention: Invasive (INV) vs. Conservative (CON)
- Primary Endpoint: Death or myocardial infarction
- Length of Trial: 7 years
- Number of Patients Randomized: 777
- Patient Populations: Patients with moderate to severe cardiac ischemia on stress testing and advanced CKD (eGFR < 30 or on dialysis)
If you would like to hear more about the trial, please watch this brief video summary from the ISCHEMIA-CKD Principal Investigator.
Why is the ISCHEMIA-CKD trial important?
More than 500 million adults worldwide have chronic kidney disease and this number is projected to rise with increasing prevalence of diabetes, obesity and the elderly. Among patients with CKD, cardiovascular disease is the leading cause of death, 15-30 times higher than the age-adjusted cardiovascular mortality rate in the general population and is worse than that for patients in the general population who have cancers, heart failure, stroke or heart attack. Participants with CKD are 5-10 times more likely to die than to reach end stage renal disease (ESRD) requiring dialysis. Despite this, ~80% of contemporary coronary artery disease trials exclude CKD participants. Most of the treatments aimed at reducing their cardiovascular events are therefore extrapolated from cohorts without CKD. Consequently, the optimal management approach to these patients is unknown.
This trial set out to inform clinicians and patients about a common question they encounter: when a patient with advanced chronic kidney disease has a abnormal cardiac stress test: is it better to do an invasive angiogram (take a picture of the heart arteries) with the intention of opening or bypassing any blockages with stents or surgery plus optimal medical therapy, or is it better to optimize medical therapy and only consider the angiogram with stents or surgery if symptoms cannot be controlled? The ISCHEMIA-CKD trial showed showed that heart procedures added to taking medicines and making lifestyle changes did not result in a reduced rate of heart attack or death compared with medicines and lifestyle changes alone. The trial also showed that heart procedures did not reduce symptoms appreciably or improve the quality of life compared with medicines and lifestyle changes alone. These results do not apply to people having a heart attack or those with severe chest pain symptoms.
If you are a physician and would like more information, please click HERE.
Sponsor: National Heart, Lung, and Blood Institute
ISCHEMIA-CKD acknowledges the contributions (stent and FFR wire donation) of the following companies:
- Abbott Vascular
- St. Jude’s