WASHINGTON – Results of a study comparing transcatheter placement of the CoreValve to surgical aortic valve replacement in 795 elderly patients with severe aortic stenosis is one of several studies that represent “ongoing paradigm shifts” in the treatment of cardiovascular disease, Dr. Robert J. Siegel said in a briefing in conjunction with the annual meeting of the American College of Cardiology. The patients, whose average age was 82 years, were enrolled at 45 U.S. centers, and were randomized to surgical treatment or treatment with the self-expanding CoreValve system, which was approved by the Food and Drug Administration in January for patients who are too ill or frail to undergo surgical aortic valve replacement. TAVR represents a “burgeoning field, and we can expect further expansion of TAVR technology into clinical practice,” said Dr. Siegel, director of the Cardiac Noninvasive Laboratory, Cedars-Sinai Medical Center, Los Angeles. Another meeting cochair, Dr. Prediman K. Shah, director of the Oppenheimer Atherosclerosis Research Center and Atherosclerosis Prevention and Treatment Center at Cedars Sinai, predicted that surgical aortic valve replacement will become rare, and that as delivery methods and valve design improve over the next several years, “it's going to be very hard to tell a patient, if they need an aortic valve, that surgery is their best option.” Results of the STS-ACC transcatheter valve registry, which has enrolled about 7,000 patients to date, will provide complementary data on TAVR, said Dr. Cindy L. Grines, the TCT-ACC-i2 chair, vice president, academic and clinical affairs at Detroit Medical Center Cardiovascular Institute, and professor of medicine at Wayne State University, Detroit. This is a “very important” study, with results of 1-year outcomes in patients at 224 different sites, a far larger population than the highly selected population enrolled in clinical trials, presumably with less well-trained operators, and the use of valves other than applications studied in the original trials, she said. The other studies that Dr. Siegel said represented paradigm shifts in treating cardiovascular disease are the CORP-2 trial, a multicenter study of patients with recurrent pericarditis comparing colchicine to placebo added to standard treatment. The third study is the 3-year follow-up results of the STAMPEDE trial, comparing the effects of bariatric surgery vs. intensive medical therapy on long-term glycemic control and diabetes complications.