The National Heart, Lung, and Blood Institute (NHLBI) awarded an $84 million seven-year grant to the New York University Langone Medical Center to compare the effectiveness of two initial management strategies for patients with stable ischemic heart disease (SIHD) and substantial ischemia.
The ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial is designed to provide a head-to-head comparison of an invasive strategy versus a conservative strategy.
The trial will enroll 8,000 patients with SIHD and moderate to severe ischemia to compare a strategy of early routine cardiac catheterization followed by revascularization combined with optimal medical therapy (OMT) and lifestyle changes, with a strategy of OMT and lifestyle changes alone plus invasive procedures if warranted. More than 150 medical centers in the U.S. as well as hundreds of sites globally will participate in the trial.
“Given the potential for improved survival and fewer cardiac events as a result of revascularization and the significant expense and risks associated with invasive management, the role of an invasive strategy is critically important to define,” the investigators wrote in a summary of their proposed study. “Defining that role is among the top 100 U.S. priorities for comparative effectiveness research. The proposed ISCHEMIA trial will be a prospective, multicenter, international, randomized controlled trial that will directly address the need for an invasive strategy—cath and revascularization—in patients with SIHD.”
Judith S. Hochman, MD, clinical chief of the division of cardiology and co-director of the Clinical Translational Science Institute at the NYU Langone Medical Center, will lead as the study chair. The Duke Clinical Research Institute will serve as the statistical and data coordinating center and the Emory School of Medicine will serve as the ischemia imaging coordinating center.
“This multicenter, international study provides a unique research opportunity that could yield vital information to guide clinical practice and improve quality of life and overall medical care for large, diverse populations,” Susan B. Shurin, MD, acting director of the NHLBI, said in a news release.
The researchers wrote in their summary that they will test two hypotheses: “The trial hypothesis is that cardiac catheterization followed by complete revascularization plus optimal medical therapy is superior to OMT alone as the management strategy for patients with moderate-severe ischemia on stress imaging,” they wrote. “The hypothesis that the invasive strategy will improve quality of life will also be tested, as will cost-effectiveness.”