Milestone in Cardiovascular Disease Treatment Published in Circulation

A landmark multicenter trial led by William W. O’Neill, M.D., voluntary professor of medicine, has instituted a new and improved treatment for symptomatic, complex, multivessel cardiovascular disease and left main coronary artery disease, especially for patients who before had nowhere else to turn.

The study, “A Prospective Randomized Clinical Trial of Hemodynamic Support with Impella 2.5 versus Intra-Aortic Balloon Pump in Patients Undergoing High-Risk Percutaneous Coronary Intervention: the PROTECT II Study,” published online August 30, and will be printed in an upcoming edition of Circulation, the journal of the American Heart Association.

“Today marks a very significant milestone in providing new clinical insight for cardiovascular disease patients considered too risky for conventional surgery,” said O’Neill, a renowned interventional cardiologist. “The PROTECT II publication in Circulation underscores the importance of this study’s observations to the clinical community.”

While coronary artery bypass is generally preferred, some patients are not candidates for the procedure. For these patients, percutaneous coronary revascularization with hemodynamic support is an option, but there currently is no systematic comparative evaluation of hemodynamic support devices for this indication.

The study, conducted at the Miller School and several other top-tier clinical sites, found improved outcomes for Impella-supported patients at 90 days.

Other study authors and locations included Neal S. Kleiman, M.D., Methodist DeBakey Heart and Vascular Center; Jeffrey Moses, M.D., Columbia University Medical Center New York Presbyterian Hospital; Jose P.S. Henriques, M.D., Ph.D., Academic Medical Center, Amsterdam; Simon Dixon, MBChB, Beaumont Hospital; Joseph Massaro, Ph.D., Harvard Clinical Research Institute; Igor Palacios, M.D., Massachusetts General Hospital; Brijeshwar Maini, M.D., Pinnacle Health Medical Center; Suresh Mulukutla, M.D., University of Pittsburgh Medical Center; Vladimir Dzavik, M.D., Toronto General Hospital; Jeffrey Popma, M.D., Beth Israel Deaconess Hospital; Pamela S. Douglas, M.D., Duke Clinical Research Institute; and Magnus Ohman, M.D., Duke University Medical Center.

“PROTECT II is a landmark clinical trial, and we are grateful to Dr. O’Neill and his colleagues for leading this study,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed, a leading provider of medical devices that provide circulatory support.

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