August 1st, 2011

Going Beyond COURAGE: NHLBI Funds the ISCHEMIA Study

The NHLBI has awarded an $84 million grant to fund the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA). The trial will randomize 8,000 patients with stable ischemic heart disease and moderate-to-severe ischemia. Two different treatment strategies will be compared:

  1. An invasive strategy, consisting of early routine cardiac catheterization followed by revascularization plus optimal medical therapy (OMT) and lifestyle changes.
  2. A conservative strategy of OMT and lifestyle changes in which invasive procedures will be performed only after failure of OMT.

In addition, ISCHEMIA will assess whether the invasive strategy is better able to improve angina-related quality of life.

NYU’s Judith Hochman is the study chair.

4 Responses to “Going Beyond COURAGE: NHLBI Funds the ISCHEMIA Study”

  1. Anil Virmani, MD, DRM says:

    I hope this study will surely give the guidelines and finally bring an end to the huge controversy of conservative vs invasive strategy for stable IHD.

    Competing interests pertaining specifically to this post, comment, or both:

  2. David Powell , MD, FACC says:

    I assume the degree of ischemia will be measured scintigraphically. All patients will undergo coronary angiography, as in COURAGE? I also wonder whether patients are told results of their angiograms. I would not be surprised if an angiographer’s delivery of results to patients affects angina.

    • David, we’ll have more on this next week but the short answer here is that the whole point of the trial is that patients in the conservative arm will not undergo automatic angiography. This is the chief difference between COURAGE and ISCHEMIA, I think, because in COURAGE patients in both the conservative and invasive arms first underwent angiography.

  3. So I need to know. If the ISCHEMIA study fails to show benefit from revascularization, will we eliminate our search for ischemia in asymptomatic patients, stop doing routine nuclear stress imaging and focus primarily on optimizing medical management? Will we reserve revascularization to patients with symptoms refractory to optimal medical management.

    Or instead, will we do as we did with RITA II and Courage and continue to find reasons to discard the RCT data and maintain our current practice of screening asymptomatic patients for ischemia and revascularizing all angina prior to a trial of medical management?

    I suspect that the ISCHEMIA trial will show a small mortality benefit in patients with profound ischemia. However if we did a better job of screening for pre-symptomatic atherosclerosis with CAC and carotid US, it would be making a dramatically better investment than continuing to spend massive resources treating late stage disease.