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2017: Guidelines take prominence; much less focus on new drug discoveries
The past year was a very interesting one, especially in comparison to previous years recently. I would not call it a fantastic year, but an intriguing one.
The top 10 stories of the year in cardiology as voted by our Editorial Board reflect new knowledge across many different subspecialties (see Graphic). One trend running through them is that it is pretty clear now that we have moved away from new drug development in the CV space.
While the results of the FOURIER trial spurred interest in PCSK9 inhibitors, and by the end of the year gained evolocumab (Repatha, Amgen) a new indication for reduction of CV events in high-risk patients, access to these PCSK9 therapies remained an issue as insurance companies routinely reject or delay requests for coverage. There were few other new developments with CV drugs.
The CANTOS trial drew much interest, as it should, for its demonstration that inflammation plays a significant role in CVD. Finally proving the inflammation hypothesis is one of the biggest stories in cardiology in recent years. That hypothesis has been around for approximately 200 years but did not have any direct proof to support it until now.
Unfortunately, the consensus appears to be that the drug studied (canakinumab, Novartis) is not going to be commercially available for management of CVD.
Hypertension guideline impact
This was also an interesting year because we have for the first time since the 2003 guideline authored by the Seventh Joint National Committee, a new BP guideline endorsed by the cardiology professional societies.
This new guideline concerns the most prevalent modifiable risk factor for most CVD and — for women — for mortality in general. Thus, for the majority of our American population (women), the new guideline addresses their most prevalent modifiable risk factor. This is exciting and could finally place BP management in its proper place for medical care, rather than something taken for granted. That clearly has not worked out very well in terms of hypertension recognition and management.
The authors of the new hypertension guideline essentially took a group of people with BPs that are clearly acknowledged to place them into higher risk categories and codified this status by calling it hypertension. It could be argued extensively as to whether that’s a good thing or a bad thing. But I believe that getting rid of the “prehypertension” label at the end of the day will turn out to be a good thing because it will make people more aware that they have a problem that places them at risk. Furthermore, that the problem can be modified with lifestyle changes — which the authors emphasize dramatically — at a time in their life when the prevailing practice is for providers to tap them on the shoulder and say “your BP is fine” or “it’s just a touch high, don’t worry about it.” Now, I believe that message is loud and clear and they’ll be concerned about it. This could motivate people to implement changes that would produce a good result in their lives.
Putting the guideline into practice will be challenging, especially where BP measurement is concerned. I still believe there is question about how to best measure BP. The BPs obtained in SPRINT were to be “unattended.” Although there are some data to the contrary, I’m still a believer that an unattended BP can be more valuable in the clinic environment.
It is also unfortunate that hypertension management is not really embraced by some cardiologists, and I hope the new guideline will change that. Some cardiologists say hypertension management is for general practice, general internal medicine, family practice or other non-specialist providers. It is perceived by some cardiologists that it is really not their field of interest. Which is a shame, because we know these patients aren’t cared for well. Half of patients with hypertension are not near controlled. In my view, this is an opportunity missed.
Exciting research
Also of interest from CANTOS, canakinumab was associated with reduced risk for incident lung cancer and lung cancer mortality. As we learn more about these effects of inflammation and its modification, it should be an exciting time for research in CV medicine, oncology and other disciplines.
One example of where research is heading is a paper published in The New England Journal of Medicine in June. It found that clonal hematopoiesis of indeterminate potential confers increased risk for CHD. A previous paper on age-related clonal hematopoiesis showed there is a pool of cells that have mutations, which increases exponentially with aging. Those mutations are known to be associated with cancer. In the June 2017 paper, we learned that they are also associated with CHD. This suggests one potential mechanism why CVD and cancer increase with aging and offers one potential mechanism why CVD can be linked with cancer.
Interest in intervention
While our Top 10 list has little related to interventional cardiology, 2017 brought some significant developments to that field.
There was much excitement around the first fully bioresorbable scaffold (Absorb, Abbott Vascular), which was approved by the FDA in 2016, but slow sales and discouraging data prompted the company to withdraw it from the market in September. It will be very interesting to see if development of the technology continues; the potential is there to improve long-term results of PCI.
Also of note is that in 2017, we saw both existing transcatheter aortic valve replacement platforms, the balloon-expandable valves (Sapien family of products, Edwards Lifesciences) and the self-expanding valves (CoreValve family of products, Medtronic) become approved for use in patients with severe aortic stenosis at intermediate risk for surgery. As the valves get smaller and perform better, TAVR becomes a much less risky procedure, and one day we could see it overtake surgical AVR as the default procedure for these patients.
The ORBITA trial presented at TCT caused great controversy. It suggested that PCI had no benefit vs. a sham procedure for exercise and other outcomes at 6 weeks in patients with single-vessel, clinically stable CAD. The results have spurred a vigorous debate about the appropriate patient population for PCI. We will deal with this topic in more depth in future issues.
While 2017 was not a year that brought much definitive good news, it spawned discussions about many issues that should continue well into the future.
Disclosure: Pepine reports serving as a reviewer for the 2017 ACC/AHA hypertension guideline.