WASHINGTON, DC — The American College of Cardiology(ACC) has released its best guess as to the biggest stories in cardiovascular medicine in 2014, among them a reminder of some of the big trial results cardiologists have been looking forward to seeing for years.
1. The Affordable Care Act's individual mandate for health insurance coverage, which takes effect January 1. This is something ACC leaders believe cardiologists will be watching closely. Back in the summer of 2012, heartwire polled cardiologists on what they thought of the Affordable Care Act . Given the rocky rollout, some opinions may have changed. But as the ACC points out today, the legislation does mean "some heart disease patients may see a cardiologist for the first time as they get access to care through plans established because of the ACA."
2. A permanent fix to the Sustainable Growth Rate. "Congress seems closer than ever to passing a fix to the flawed formula for calculating physician pay under Medicare enacted almost two decades ago," the ACC predicts. Earlier this month, the US Senate passed yet another three-month "doc fix," but the ACC thinks these stopgaps may actually become a thing of the past.
3. The rise of PCSK9 inhibitors. As reported by heartwire , recently released top-line results for two of the first phase 3 trials in this arena ( MENDEL-2 and DESCARTES ) indicate that the studies ofevolocumab (Amgen, Thousand Oaks, CA), the human monoclonal antibody for proprotein convertase subtilisin-kexin type 9 (PCSK9), had met their primary end points; competing agents are also in hot pursuit. "The new class could have a big impact on the treatment of patients not able to tolerate statin medications or those with very high LDL who have not responded to other treatments," an ACC statement reads.
4. Guidelines, guidelines, guidelines. If 2013 was the year of guideline release, 2014 is the year of implementation, the ACC predicts. Without out doubt, 2014 will also be a year of guideline debate, with questions about the cholesterol guidelines and CVD risk prediction tool spilling over into the new year. Plus, the American Heart Association (AHA) and ACC have also announced they are moving ahead with their own hypertension guidelines—this on top of the three other hypertension guidelines released in 2013.
5. New options for degenerative mitral-valve disease. In October, the FDA approved the MitraClip(Abbott Vascular) for patients with symptomatic degenerative mitral regurgitation deemed high risk for mitral-valve surgery. In 2014, says ACC, the college will work with the Society of Thoracic Surgeons to add a mitral module to the National Cardiovascular Data Registry TVT Registry and begin reporting data in 2014.
6. The new oral anticoagulants. These drugs have dominated the "what's-hot" lists in cardiology news for several years now; the ACC predicts expanded use of these agents in patients with atrial fibrillation or venous thromboembolic disease. While some observers are raising questions as to just what the absolute benefits of these new drugs over warfarin might be, the ACC states that the newer drugs, "which cost more per dose, improve outcomes compared with warfarin and do not require extensive monitoring or dietary/medication restrictions."
7. The Dual Antiplatelet Therapy Study (DAPT) . This massive study examining 12 vs 30 months of DAPT poststenting is due out in 2014. The results "may impact the duration of such treatment following coronary stenting across a wide spectrum of patients," the ACC says. As reported by heartwire , this trial got plenty of press even before it started enrolling patients. At this year's AHA meeting, investigators were already reporting some early (unblinded) insights from the trial.
8. Renal denervation for resistant hypertension. Toppling transcatheter aortic-valve replacement (TAVR) from its perch, renal denervation is rapidly becoming the most-talked-about new frontier for interventional cardiology. As the ACC notes, the first phase 3 results for a renal denervation trial (Medtronic-sponsored SYMPLICITY HTN-3 ) are expected in early 2014. Investigation into the procedure has proceeded amid debate over efficacy and patient selection. And in a surprising announcement last month, one of the other major device companies in this space, St Jude Medical, announced it was calling off its US multicenter trial of its multielectrode renal-denervation system, saying it was suffering from slow enrollment.
9. Finally, the ACC predicted the continued growth of cardio-oncology. "This cardiology subspecialty is focused on the cardiovascular manifestations of cancer and complications of its treatment" and is offered at select US hospitals. In 2014, says the ACC, "look for it to expand rapidly to more hospitals across the country." A session devoted to this topic at the 2013 European Society of Cardiology meeting prompted one theheart.org blogger to say she had the "impulse to rush home to change my clinical practice."
heartwire , meanwhile, has its eye on several other cardiology tidbits. One, the long-awaited results fromIMPROVE-IT with ezetimibe (Zetia, Merck); results from the ARRIVE trial, comparing aspirin 100 mg daily vs placebo in patients at moderate risk of developing cardiovascular disease; and results from the 20,000 patient Vitamin D and Omega-3 (VITAL) trial. On the FDA front, US approval of the MedtronicCoreValve transcatheter valve is widely anticipated for early 2014, while US regulators will also likely make a decision on the recent near-unanimous recommendation of its advisory panel to approve theWatchman left-atrial appendage occluder (Boston Scientific).
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