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2016: An active, exciting year in cardiology
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The past year has been a very active and exciting one in CVD and CV medicine. We have had major successes on several fronts. Not only was this true in the areas summarized in our annual Top 10 stories of the year (see Sidebar below), but in other areas as well.
Among other fields, notable advancements occurred in CV management of patients with diabetes, high BP, transcatheter aortic valve replacement, cardio-oncology, high LDL, stent technology and pacing technology. We are very fortunate to have talented people investigating a wide variety of issues that could lead to improved heart health for individuals around the world.
Diabetes and CV management
The diabetes story has been extraordinary. Several new classes of agents, principally sodium/glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) agonists, have now been clearly shown to be associated with a reduction in CV events. Just recently, the FDA for the first time granted an indication to a diabetes drug, empagliflozin (Jardiance, Boehringer Ingelheim), for reduction of risk for CV death.
We are also seeing more cardiology practices starting to pay attention to glycemic management. In my view, this has been very reminiscent of what happened in the late 1980s and early 1990s with statins and cholesterol. Initially statins were principally used by lipidologists and endocrinologists, and by the mid to late ’90s, cardiologists started to embrace the use of them. My suspicion is that with the continuing shortage of endocrinologists, among the most scarce specialty, over the years, somebody else has to care for patients with diabetes. Who is better to do this than cardiologists? They are well-trained in internal medicine, and the principal outcomes of diabetes are CV-related.
BP in older individuals
BP is an extremely important indicator of CV health, and is becoming even more important now that emerging data have prompted concerns about midlife BP levels related to dementia in older people. It also appears that prehypertension is now emerging as a major concern. Many experts are now advocating drug treatment for prehypertension to prevent the emergence of “frank hypertension.”
The main results of the SPRINT trial, presented in late 2015, prompted all sorts of discussion about the optimal BP targets for older individuals and those at CV risk. Further analyses of the SPRINT data emerged in 2016, including one showing that treating BP to a lower target benefited those aged 75 years and older. I expect this issue to remain prominent in 2017, when the American College of Cardiology and the American Heart Association are scheduled to publish a new guideline on management of BP.
Emerging fields
Cardio-oncology is a growing field that most cardiologists are embracing, especially as newer cancer therapies are being implemented. Our colleagues the oncologists are doing a better job at keeping patients with cancer alive, but an unintended consequence is that we are seeing more CV problems in that population.
We are also seeing patients with HIV, hepatitis C and other chronic virus infections live longer, leading to more focus on CV conditions in those patients. This is a new field that is poised to explode in the next couple of years.
Other hot topics
It is very encouraging that TAVR has been demonstrated to be safe and effective in patients at lower surgical risk than had previously been studied. We have to have something less invasive than open-heart surgery to offer our lower-risk patients with aortic stenosis. We certainly hope things move in the same direction for patients with mitral valve insufficiency over the next few years.
The lack of decline in CV deaths is a major concern, particularly when one analyzes those statistics in detail. Not only is there a lack of decline in the overall U.S. population, but in some segments, CV deaths are actually rising, particularly in younger women and minority individuals. This is something that certainly deserves our attention.
The new Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) payment system for physicians is a major development in how cardiologists manage their practices, and we are waiting with “eyes wide open” to see what changes may come with the new administration. For more details on this topic, I strongly recommend reading the excellent piece by L. Samuel Wann, MD, MACC, FESC, editor of our Practice Management section, on page 28 of this issue.
The HOPE-3 study had some interesting implications for BP and lipid management in intermediate-risk patients. It’s disappointing that a BP-lowering regimen wasn’t associated with much benefit in this population unless they already had elevated BP. Somehow, they missed the sweet spot, and it’s not clear whether this was due to too-late timing or another unknown issue. However, use of rosuvastatin (Crestor, AstraZeneca) did confer CV benefits in this cohort. I don’t believe that this dispels the concept that better and earlier management of BP and LDL is still critically important in this older patient population.
Although we have new recommendations for dual antiplatelet therapy duration, I don’t believe all the dust has settled yet. Stay tuned for more insights on this topic.
The PRECISION trial, which found no elevated CV risk among those assigned celecoxib vs. those assigned ibuprofen or naproxen, was an enormous effort. It went on for well more than 10 years and was estimated to cost hundreds of millions of dollars, but unfortunately the dropout rate exceeded 25%, which makes it very difficult to interpret its results. The fact that celecoxib dosing was fixed at a relatively modest dose due to regulatory guidelines, whereas ibuprofen and naproxen were used in relatively high doses, also makes the result a little less clear.
A bright future
Fueled by strong, compelling research and the development of new drugs and devices, the discipline of cardiology has come a long way in recent years; for a sense of just how far, read this issue’s cover story on 20 years of progress in the field. Given all the exhilarating activity going on right now, we can expect more of the same in 2017 and beyond.
- For more information:
- Carl J. Pepine, MD, MACC, is Chief Medical Editor of Cardiology Today and Eminent Scholar Emeritus and professor in the division of cardiovascular medicine at the University of Florida, Gainesville. He can be reached at Cardiology Today, 6900 Grove Road, Thorofare, NJ 08086; email: cardiology@healio.com.
Disclosure: Pepine reports serving as an investigator on the PRECISION trial sponsored by Pfizer.
Perspective
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Allan S. Jaffe, MD
I think the fact that we are starting to tackle optimal BP targets is key. There are very likely many subsets of individuals who would benefit. If we could get that part right and then implement more wide-spread treatment, we could have a major impact on health in the U.S. and around the world.
Getting into the issue of fats vs. sugar is important as we determine the optimal strategy for prevention of CVD. A paper published in JAMA Internal Medicine showing the sugar industry had sponsored research to downplay the role of sugar and emphasize the role of fat in heart disease generated much discussion. We obviously overreacted to fat at one point in time, but we need better approaches because it is unlikely one size will fit all.
Perspective
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Barry H. Greenberg, MD
A highlight of 2016 was the new guideline recommendations issued by the ACC, AHA and Heart Failure Society of America and by the European Society of Cardiology. While the document released by the ESC was a full-blown update of their existing guideline, the one from the American groups provided recommendations about the use of a limited number of new drugs, specifically, ivabradine (Corlanor, Amgen; given a Class IIa recommendation) and the sacubitril/valsartan combination (Entresto, Novartis; given a Class I recommendation). The release from the groups was coordinated, as the addition of these two new agents was perceived to be an important additional treatment option that could lead to improved outcomes in thousands of patients with HF in Europe and the U.S. The incorporation of these drugs into both guidelines was based on the results of the SHIFT study (ivabradine) and PARADIGM-HF (sacubitril/valsartan), both of which were positive for the new therapies that were being tested.
Perspective
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Joseph S. Alpert, MD
Although the PRECISION study was controversial and elicited a lot of discussion, I was relieved that the nonsteroidal anti-inflammatory drugs caused so few CV events. Many of my patients are elderly and have concomitant CAD and osteoarthritis with a lot of joint discomfort. Often, NSAIDs help relieve their discomfort. I tell them that it is OK to use the NSAIDs but to try to keep the dosing as low and infrequent as possible and to use acetaminophen to supplement the NSAID dose.
The expansion of TAVR to patients at intermediate risk or low risk for surgery is good news since many of my patients with critical aortic stenosis are quite elderly and are not anxious to undergo a thoracotomy. I envision a future where most patients with aortic stenosis will be treated with TAVR.
I think that it is encouraging that, as shown in the EXCEL trial, many subsets of patients with left main CAD can be safely treated in the catheterization laboratory and not require thoracotomy for CABG. Clearly, there will be a number of unstable or anatomically unsuitable candidates for PCI who will need urgent CABG.
I was the chairman of the Data Safety and Monitoring Committee for the PIONEER-AF PCI trial of low-dose and very low-dose rivaroxaban (Xarelto, Janssen Pharmaceuticals) regimens as alternatives to conventional therapy in patients with atrial fibrillation undergoing PCI. I saw the data unblinded as the trial unfolded. There was reduced bleeding in the group assigned low-dose rivaroxaban and clopidogrel soon after the trial was initiated. This benefit persisted to the end of the trial and has convinced me that my older patients who need anticoagulation and antiplatelet therapy should have a reduced dose of a Factor Xa blocking anticoagulant combined with a single antiplatelet agent, clopidogrel. Hopefully, more clinical trials will be done focusing on low-dose anticoagulation when combined with antiplatelet agents.
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