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July 31, 2011

NIH Funds ISCHEMIA Trial to Compare CAD Management Strategies

August 1, 2011—New York University Langone Medical Center announced that the National Heart, Lung, and Blood Institute of the National Institutes of Health has awarded an $84 million grant to fund a study of the comparative effectiveness of two initial management strategies for patients with coronary artery disease.

The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) study will be clinically coordinated from the Cardiovascular Clinical Research Center at NYU Langone Medical Center and chaired by Judith Hochman, MD. The Duke Clinical Research Institute will be the statistical and data coordinating center, and it will also serve as the coordinating center for the cost economics and quality-of-life analysis. Emory School of Medicine will be the ischemia imaging coordinating center.

ISCHEMIA is a randomized controlled trial that will study 8,000 patients with stable ischemic heart disease and moderate to severe ischemia at more than 150 medical centers in the United States and hundreds of sites in 33 countries worldwide. The trial seeks to determine whether a routine early invasive strategy (with cardiac catheterization followed by revascularization plus optimal medical therapy and lifestyle changes) is superior to a conservative strategy (ie, optimal medical therapy and reserving invasive procedures for failure of this strategy in patients with moderate to severe ischemia). The study will also assess whether invasive strategy improves angina-related quality of life.

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August 9, 2011

Two Studies Support Staged PCI for Multivessel Disease in STEMI Patients

July 29, 2011

Institute of Medicine Report Calls for Replacement of 510(k) Process, FDA to Hold Meeting for Public Comments