Late-breaking research discussed in advance of upcoming ACC meeting

Of 2,216 abstracts and 22 late-breaking trials to be presented at the American College of Cardiology 63rd Annual Scientific Session and Expo, meeting co-chairs and committee members highlighted several studies that will be of particular interest to the cardiology community.

During a press briefing, ACC 2014 co-chair Prediman K. Shah, MD, FACC, Shapell and Webb chair in clinical cardiology and director of the Oppenheimer Atherosclerosis Research Center and Atherosclerosis Prevention and Treatment Center at Cedars Sinai Heart Institute, named the primary results of the SYMPLICITY HTN-3 trial as a key presentation at the meeting. Shah said that, while top-line results were already released, the upcoming presentation should address unanswered questions, including whether the observed results reflected a problem with the technology used in the study or with renal denervation itself.

Other research Shah discussed included 1-year follow-up data on the safety and efficacy of minimally-invasive implantation of the Melody transcatheter pulmonary valve (Medtronic) in children and adult survivors of congenital heart disease; a trial that assessed the use of biventricular pacing to synchronize right- and left-side heart activity; and a study that evaluated the use of a high-sensitivity biochemical assay of myocardial damage to triage patients presenting to the ED with chest pain.

Robert Siegel, MD, FACC, director of the Cardiac Noninvasive Laboratory at Cedars-Sinai Medical Center and ACC 2014 co-chair, discussed three trials that, he said, "represent ongoing paradigm shifts in the treatment of three aspects of CVD."

In a pivotal trial of 795 patients with severe aortic stenosis considered at high risk for surgery, patients were randomly assigned to receive the CoreValve self-expanding transcatheter aortic valve (Medtronic) or surgical valve replacement. "I believe this trial represents the growth and advancement of new TAVR technology," Siegel said.

Other trials of note, he said, include the multicenter, double blind corp-2 trial, which will assess the efficacy and safety of colchicine vs. placebo in addition to standard therapy among 240 patients with two or more recurrent incidences of pericarditis. Siegel also highlighted 3-year follow-up results from the STAMPEDE trial, which assessed the impact of bariatric surgery compared with intensive medical therapy on long-term glycemic control among patients with diabetes.

"This is a fascinating trial that has already provided new insights into the treatment and pathophysiology of obesity and diabetes," he said of the STAMPEDE study. "... This extension to the 3-year trial will gives us new and much-needed long-term data."

Cindy Grines

Cindy Grines, MD, FACC, vice president of academic and clinical affairs at Detroit Medical Center Cardiovascular Institute, ACC 2014 program committee member and TCT@ACC-i2 chair, discussed 1-year results from the Society of Thoracic Surgeons/ACC Transcatheter Valve Therapy Registry, which will provide insight on treatment outcomes within a large population of 7,000 patients with aortic valve disease who received TAVR at 224 sites.

Grines also highlighted two trials that assess the use of drug-eluting stents: NEXT, which compared biodegradable and durable polymer stents in 3,200 patients, for which data on patient outcomes at 2 years will be presented, and ZEUS, which compared zotarolimus-eluting and bare metal stents in 1,600 patients considered ineligible for DES.

Another unique late-breaking trial, Grines said, compared unfractionated heparin vs. bivalirudin among PCI recipients in a cohort of consecutive, unselected patients with acute MI, with delayed consent. Approximately 1,800 patients presenting with acute MI were randomized without consent, which was obtained 2 days later. This approach, Grines said, allowed researchers to obtain data from all cases of acute MI, regardless of circumstances that would have normally excluded them from analysis. She added that this is one of the few trials in which heparin was administered on its own, allowing for direct comparison between heparin and bivalirudin.

Grines also highlighted the MSC-HF trial, which assessed the use of mesenchymal stem cells in 60 patients with severe, chronic ischemic heart disease resulting in congestive HF.

"I think many of these trials are going to be dramatic," Grines said during the briefing. "If they are positive, they're absolutely going to revolutionize the way that we practice medicine."