Study Overview

 Study Details

The purpose of the ISCHEMIA-CKD trial was to determine the best management strategy for patients with moderate to severe cardiac ischemia on stress testing and advanced chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] <30 or on dialysis).

This is a multicenter clinical trial which has randomized 777 patients 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 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 ran seamlessly in parallel to the main ISCHEMIA trial as a companion ancillary trial.

Study Design: Randomized controlled trial

Intervention: Invasive (INV) vs. Conservative (CON).

Primary Endpoint: Death or myocardial infarction

Length of Study: 7 years

Number of Patients: 777

Patient Populations: Patients with moderate to severe cardiac ischemia on stress testing and advanced CKD (eGFR < 30 or on dialysis)

Background and Design

Download slides for the background and design of the trial.

Contrast Induced Acute Kidney Injury 

Patients with advanced CKD are at higher risk for contrast-induced acute kidney injury. The unique design of the trial, with randomization upstream of cath prevented contrast agent exposure in 50% of randomized patients (those randomized to CON). For patients randomized to INV, measures to minimize the risk of contrast-induced acute kidney injury are outlined in the manual of operations. Utilizing ultra low volume contrast protocols and intravascular ultrasound, -cath and coronary stent placement can be performed with as little as 20-30 cc of contrast.

 

ISCHEMIA Trial Results Presented at AHA 2019

AHA Presentation Slides
Video of the ISCHEMIA Results Presentation at the AHA
A Song Written by Dr. David Maron Celebrating ISCHEMIA
ISCHEMIA Trial Results
ISCHEMIA-CKD Trial Results

Video of the ISCHEMIA Results Presentation at the AHA

A Song Written by Dr. David Maron Celebrating ISCHEMIA!

ISCHEMIA Trial Results

ISCHEMIA included people who had an abnormal stress test showing moderate to severe ischemia of the heart. Ischemia is when there is reduced blood flow to the heart due to narrowing caused by cholesterol deposits inside heart arteries. Reduced blood flow may cause chest pain symptoms, or “angina”.

ISCHEMIA compared two standard ways to treat ischemia to see if one was better at reducing the risk of heart attack or death, or improving symptoms.

  1. One treatment method used medicines and lifestyle changes along with initial heart procedures consisting of cardiac catheterization followed by stent placement or surgery to improve blood flow, when feasible.
  2. The other treatment method also used medicines and recommended lifestyle changes. Heart procedures were only used if symptoms could not be controlled with medication.

The ISCHEMIA trial showed that heart procedures added to taking medicines and making lifestyle changes did not reduce the overall rate of heart attack or death compared with medicines and lifestyle changes alone. However, for people with chest pain symptoms, heart procedures improved symptoms better than medicines and lifestyle changes alone. The more symptomatic the patient is with chest pain to begin with, the more symptoms improved after getting a stent or bypass surgery.

These results apply to people with stable symptoms. They do not apply to people having a heart attack, when emergency stent procedures save lives.

Where to find additional information

Articles with detailed results will be published in medical journals starting in early 2020. Links to these articles will be posted on the ISCHEMIA website as they become available.

ISCHEMIA-CKD Trial Results

ISCHEMIA-CKD included people who had advanced kidney disease and an abnormal stress test showing moderate to severe ischemia of the heart. Ischemia is when there is reduced blood flow to the heart due to narrowing caused by cholesterol deposits inside heart arteries. Reduced blood flow may cause chest pain symptoms, or “angina”. Advanced kidney disease refers to people who are on dialysis or whose kidney function is markedly reduced.

ISCHEMIA-CKD compared two standard ways to treat ischemia to see if one was better at reducing the risk of heart attack or death, or improving symptoms.

  1. One treatment method used medicines and lifestyle changes along with heart procedures consisting of cardiac catheterization followed by stent placement or surgery to improve blood flow, when feasible.
  2. The other treatment method also used medicines and recommended lifestyle changes. Heart procedures were only used if symptoms could not be controlled with medication.

The ISCHEMIA-CKD trial 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.

Where to find additional information

Articles with detailed results will be published in medical journals starting in early 2020. Links to these articles will be posted on the ISCHEMIA-CKD website as they become available.

AHA Presentation Slides

ISCHEMIA & ISCHEMIA-CKD presentation slides with the results are posted on here: 

ISCHEMIA Clinical Outcomes (ppt, pdf)
ISCHEMIA QOL Results (ppt, pdf)
ISCHEMIA-CKD Clinical Outcomes (ppt, pdf)
ISCHEMIA-CKD QOL Results (ppt, pdf)

Proposed Trials of Potential Interest

Proposed/Planning

1. ISCHEMIA-Heart Failure Planning Study

ISCHEMIA-Heart Failure Planning Study UPDATE

Drs. Judith Hochman, Sripal Bangalore, John Spertus, and Stuart Katz are pleased to provide an update on the ISCHEMIA-Heart Failure Planning Study funded by NHLBI (R34 HL14 1621-01A1). All the planned questionnaires of the planning study have now been completed, including site surveys, screening logs, physician and patient surveys. Based on preliminary analysis of the data, there is consistent evidence to support study feasibility and enthusiasm for the potential importance of the study on clinical practice. As an example, we have included the response from our Clinician Survey regarding the following question: Does the proposed clinical trial to compared CABG vs. PCI address an important gap in knowledge?

95.7% of the 303 respondents indicated “Yes." Analysis of physician survey and patient survey responses are ongoing. Additional updates will be provided as new data become available.

  • The ISCHEMIA Coordinating Center at NYU is currently planning for a new study! Drs. Stuart Katz, Judith Hochman, and Sripal Bangalore are pleased to introduce the ISCHEMIA-Heart Failure planning study funded by NHLBI (R34 HL141621-01A1). This study will explore the feasibility of conducting a future randomized clinical trial to evaluate revascularization strategies in patients with ischemic cardiomyopathy and reduced left ventricular ejection fraction.
  • Who will be asked to participate? ISCHEMIA sites that have reported onsite PCI and CABG capabilities. Are opportunities available to contribute to the proposed trial? Pilot data are currently being collected through various methods, such as interviews and surveys, and from a variety of sources, including industry experts, ISCHEMIA sites, and patients. We may reach out to your site to participate in the collection of pilot data as these opportunities arise. How will we use the pilot data? All pilot data collected will be used to optimize study design for a future international multisite clinical trial to compare the effects of myocardial revascularization with coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) on clinical outcomes in patients with ischemic cardiomyopathy with reduced ejection fraction. Interested in learning more? Please contact us at ISCHEMIA-HF@nyulangone.org to learn more about this exciting pilot study.

 

2. CABG-PCI-SHOCK

  • Myocardial infarction (MI) complicated by cardiogenic shock is associated with high mortality and is the main reason patients die with MI. The 35-45% 30-day mortality rate with PCI has persisted for decades despite advances in anti-thrombotic pharmacology, use of left ventricular support, and PCI techniques. Multi-vessel PCI in patients with MI and cardiogenic shock results in higher mortality compared with PCI of the culprit lesion only. Non-randomized studies, including SHOCK trial data, suggest potential benefit from complete revascularization and cardioprotective measures employed with CABG in patients with multi-vessel CAD and cardiogenic shock. We are planning a multicenter, randomized trial of initial infarct-only PCI for rapid reperfusion versus multi-vessel CABG immediately after cardiac catheterization with/without percutaneous infarct-related artery (IRA) reperfusion (such as balloon angioplasty and/or mechanical thrombectomy) in patients with MI, multi-vessel CAD, and cardiogenic shock. Participants in both groups may undergo placement of a LV support device of choice, and those randomly assigned to initial infarct-only PCI may have staged non-IRA PCI at a later date. For trial planning purposes we would appreciate your participation in a brief 5-minute internet-based survey (http://is.gd/CABG_SHOCK) to determine contemporary management of cardiogenic shock and to assess the feasibility of the proposed multi-center trial. Participation in the survey is voluntary. Your responses to the questions will help guide study design and may be considered during site selection for trial participation. Click on the link to participate: http://is.gd/CABG_SHOCK

Biorepository

The ISCHEMIA biorepository is a collection of genetic and biomarker samples from randomized participants in the ISCHEMIA and ISCHEMIA-CKD trials. The biorepository will prove an invaluable resource to advance understanding of diagnosis, pathogenesis and outcomes of patients with stable ischemic heart disease. We anticipate this repository will provide a wealth of opportunities for future investigations.

Currently, there are samples from approximately 700-1,000 participants in the biorepository across 6 different sample types.

  • DNA (whole blood and/or saliva)
  • Whole blood RNA
  • Buffy coat
  • Red blood cells
  • Plasma
  • Serum

Investigators interested in learning more about the ISCHEMIA biorepository should contact us at ischemiabiorepository@nyulangone.org.

Biorepository Publications

  • Biomarkers and cardiovascular events in patients with stable coronary disease in the ISCHEMIA Trials. American Heart Journal. December 2023 Link

Key Timelines

ISCHEMIA Participant Follow-up and Final Results Presentation Timeline

  • Closeout Visits Completed by: June 30th, 2019
  • All Visit Data Entered in InForm by: July 15th, 2019
  • InForm Database Lock: September 30th, 2019
  • Final Results Presentation: AHA, November 16th, 2019 

Date for Last Participant Enrolled (1/31/2018)

The last participant was randomized into the ISCHEMIA & ISCHEMIA-CKD trials on January 31st, 2018. Enrollment for the CIAO-ISCHEMIA trial continued until July 12th, 2018.

 

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