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The results of clinical and registry studies on transcatheter aortic valve replacement are among the presentations slated for the late-breaking clinical trial sessions during the upcoming annual meeting of the American College of Cardiology meeting in Washington.
During an ACC telephone briefing on March 18, one of the meeting cochairs, Dr. Robert J. Siegel, said that results of a study comparing transcatheter placement of the CoreValve to surgical aortic valve replacement in 795 patients with severe aortic stenosis, was one of several studies that will be presented that represent "ongoing paradigm shifts" in the treatment of cardiovascular disease. 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 2014 for patients who are too ill or frail to undergo surgical aortic valve replacement.
Dr. Prediman K. Shah
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 Wayne State University, Detroit. This is a "very important" study, with results of 1-year outcomesin 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.
Other highlights of the late-breaking clinical trials sessions include:
• Data on the safety and effectiveness of renal artery denervation to treat uncontrolled hypertension in a clinical trial comparing the treatment with medical management in more than 500 patients (SYMPLICITY HTN-3) and in the real world (the Global SYMPLICITY Registry). Dr. Shah said the clinical trial, which had a rigorous design with a sham control, "will provide us some very unique insight" into what the role of renal denervation might be for patients with difficult to control hypertension despite multiple medications." Referring to the manufacturer’s recent announcement that SYMPLICITY HTN-3 did not meet its primary efficacy endpoint, Dr. Shah said there are unanswered questions that will hopefully be addressed in this session, including whether the negative results reflect a problem with the concept of renal denervation or the technique used in the study.
Dr. Robert J. Siegel
• The results of a European trial addressing whether a highly sensitive troponin test can be used to identify patients who present with chest pain in the emergency department who are at low risk and do not require hospitalization.
One-year follow-up results of the noninvasively or minimally invasively implanted Melody transcatheter pulmonary valve in children and adults with congenital heart disease, who have narrowing of the pulmonic valve, which Dr. Shah said has significant implications fore the increasing population of pediatric and adult survivors of congenital heart disease.
• Two-year outcomes of the NEXT study, which compared the Nobori biodegradable polymer stent with the Xience everolimus-eluting stent, in 3,200 patients. At 1 year, when the polymer was still present, there were no differences, but at 2 years, when the polymer is gone, it will be interesting to see whether outcomes are improved further "making it superior to one of our very popular stents we are using right now," Dr. Grines said.
