Leading Israeli cardiologists blocking their country’s participation in planned NIH-funded ISCHEMIA trial

A group of prominent Israeli cardiologists is blocking their country’s participation in the ISCHEMIA trial, the planned NIH-funded follow-up to COURAGE. At a recent meeting of Israeli hospital cardiology department directors, according to an article in the Israeli newspaper Haaretz by Dan Even, the directors recommended that Israel not take part in the trial.

ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) is designed to settle an important and controversial question left unresolved by COURAGE: whether an aggressive revascularization strategy is preferable to optimal medical therapy in stable patients with moderate-to-severe ischemia who have not undergone angiography. 6,000 patients will be randomized to either catheterization with revascularization if feasible plus optimal medical therapy (OMT) versus OMT alone. Judith Hochman is the Study Chair, David Maron the PI, and William Boden, Robert Harrington, Gregg Stone and David Williams are the co-PI’s. The trial is scheduled to be submitted to NIH in early February.

The Haaretz article quotes an unidentified “senior Israeli cardiologist ” as calling the decision “shameful: It excludes Israel from prestigious international research for financial considerations. Cardiology departments fear exploring the extent of unnecessary catheterizations, as these increase the scope of the cardiology departments’ activity.”

In response, participants in the meeting “said they turned down the idea of participating in the study due to fears that it would be hard to recruit patients, who would have to agree to having their course of treatment randomly assigned.”

Other knowledgeable observers have expressed concern over the ability of the ISCHEMIA investigators to recruit enough patients for the trial. Asked one expert: “when the rubber hits the road will investigators be willing to randomize patients with severe ischemia?”

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