New York, NY - What made headlines in 2011? Everything from novel oral anticoagulants, blockbuster trials stopped early, and a new scrutiny on procedure appropriateness. heartwire reporters called up cardiologists across 11 different subspecialties to ask them what they thought the biggest news was in their field this past year.
Acute coronary syndromes
heartwire : What was the biggest advance in ACS care in 2011?
Dr Anthony Gershlick (University of Leicester, UK): For me, the biggest advance in 2011 was the RIFLE study showing a large reduction in bleeding and mortality with the radial approach vs the femoral approach to PCI in STEMI patients.
I believe bleeding is an important cause of morbidity and mortality, and we have had many studies showing a reduction in non-access-site bleeding with bivalirudin vs heparin. But this year we saw the first real hard data on reducing non-access-site bleeding with the radial approach. We saw some evidence of this in the RIVAL trial in both STEMI and non-STEMI ACS, with the suggestion of a better effect in STEMI. Then the RIFLE trial, presented at TCT , conducted just in STEMI patients, gave confirmation, with a 47% reduction in bleeding and a 4% absolute reduction in mortality.
h eart wire : How will this affect your practice?
Gershlick: While the size of the mortality reduction may appear rather too good to be true, and I would like to examine the published data to verify that, the RIFLE results have encouraged me to use the radial site for PCI in ACS patients, particularly STEMI patients.
Anticoagulation and atrial fibrillation
Dr Alexander Turpie (McMaster University, Hamilton, ON): This has been a banner year for new oral anticoagulants, particularly the factor Xa inhibitors, with great data from ROCKET (rivaroxaban) and ARISTOTLE (apixaban) in atrial fibrillation [AF] and from ATLAS (rivaroxaban) in ACS. These agents, like dabigatran, will replace warfarin in AF patients. They are much easier to use and have a lower rate of intracranial hemorrhage. They represent the most important change I have ever seen in the anticoagulant/AF field.
heart wire : A re you concerned about recent reports of bleeding surfacing with dabigatran?
Turpie: This is bound to happen when new agents are introduced. It is very difficult to interpret without knowing how many people are taking the drug, but I suspect the bleeding is only what is to be expected and is probably less than the bleeding we see with warfarin, which is taken for granted. However, doctors do need to be aware that these new drugs are excreted in the kidney, and therefore caution is needed in patients with renal dysfunction and the elderly. A lot of education is needed. But I believe these drugs will bring about a big reduction in stroke rates, given that one-fifth of all strokes are in AF patients, and many more AF patients will now receive effective anticoagulation.
Dr Gregory Lip (University of Birmingham, UK): In addition to the new anticoagulants, we have also achieved a better understanding of stroke risk scores in 2011, which is bringing about a sea change in how we identify patients suitable for anticoagulation.
Data finalized this year have shown that just one stroke risk factor now makes an AF patient eligible for anticoagulation. So we are moving away from just trying to identify the high-risk AF patients and putting them on warfarin toward now trying to identify the low-risk patients without any other risk factors who don't need anticoagulation and putting everyone else on an anticoagulant.
h eart wire : Will the new oral anticoagulants help?
Lip: They will help enormously. When we had only warfarin, we would make excuses not to use it and there was a misconception that aspirin was a reasonable alternative. New data show that there is no role at all for aspirin in AF, and there is more evidence in favor of anticoagulation in the medium-risk patient. So now it is "anticoagulants for all except those at the lowest stroke risk." This has been evolving for some time but has come to a head this year.
Dr Eric Topol (Scripps Clinical Research Institute, La Jolla, CA): There is one discovery that changed my practice, and that is this demonstration about aortic aneurysm and bicuspid valves being the same fibrilin-1 gene as Marfan's syndrome. This has enormous practical importance; it's something that everybody was thinking might be the case, but to demonstrate that was a really big deal because this has immediate implications for therapy—the use of losartan in Marfan's syndrome, for example—and there is the potential for genomics screening.
heartwire: What would you say about the field of genomics overall?
Topol: Much of the recent genomics research, as highlighted in a [recent] New England Journal of Medicine review by O'Donnell and Nabel, has been academic, it doesn't have clinical relevance yet. . . . I don't think we are a whole lot further along than we were. [For example,] the use of genotyping for clopidogrel response is still far from being routine for people who get stents.
heart wire : W hat was the biggest HF advance this year?
Dr John R Teerlink (San Francisco Veterans Affairs Medical Center, CA): In terms of what was the biggest advance this year, I would go with the fact that there was no one big story, but very important incremental gains in a number of areas. The RAFT trial provided additional support for targeted use of cardiac resynchronization therapy in patients with chronic heart failure. In acute heart failure, two major issues were addressed with the publication of ASCEND-HF (nesiritide) and DOSE (diuretic regimens), and intriguing future therapies emerged, such as omecamtiv mecarbil. In patient monitoring, the positive results of CHAMPION , a much less invasive approach to implantable hemodynamic monitoring, are refined by the findings of TARGET, where a patient notification algorithm was not found to be beneficial. The advent of the newer anticoagulant agents (dabigatran and rivaroxaban) provides the basis for future investigation of the role of these agents in heart failure, especially if the WARCEF results are supportive. Cardiac support devices have been greatly advanced by the multiple of studies and results emerging from the INTERMACS registry and the newer devices, such as HeartMate 2.
heart wire : What was the most important study in therapeutics?
Teerlink: We have all the substudies of EMPHASIS-HF [eplerenone in patients with mild systolic heart failure] that came out this year. It's a crucial trial that fills in the gap between RALES [NYHA class 3-4 heart failure] and EPHESUS [post-MI LV dysfunction] regarding the use of aldosterone antagonists in LV dysfunction and heart failure. In EMPHASIS-HF, treatment with eplerenone reduced the risk of cardiovascular death or heart-failure hospitalization by 37%. Its substudies showed that in the trial, eplerenone significantly benefited a range of high-risk patient subgroups, including diabetics, the very elderly, and those with LVEF <30% or renal dysfunction; and they showed that the drug suppressed development of new atrial fibrillation.
Dr Alan H Gradman (Temple University School of Medicine, Philadelphia, PA): We're seeing a lot more use of combination therapy and initial combination therapy in hypertension, and this is an ongoing trend that I think has accelerated [this year].
The emphasis now is on putting the results of clinical trials into clinical practice, so it's increasing the BP regulation of the entire population rather than proving a scientific point. In that sense, combination therapy and initial combination therapy are very important because they give more BP reduction and get [people] to goal faster, and it's also resource sparing, in the sense that it reduces the number of office visits, and things like that."
heart wire : And what else is important in the field of hypertension going forward?
Gradman: The biggest issue today, certainly in the academic community, is the BP targets: where are we going with these? The whole discussion that was accentuated by the ACCORD trial with regard to results in diabetes and, of course, the delay in JNC 8 has just exacerbated that, it's been such a critical issue. Of course, they [the JNC 8 committee] are working very hard to statistically try to get a handle on things.
heart wire : How does that play into combination therapy?
Gradman: They do sit together—the lower the targets, the more combinations you need. It makes a big difference in terms of how many people need treatment at all and how much treatment people need. That's the largest factor in terms of its future implications.
Dr James Min (Cedars Sinai Medical Center, Los Angeles, CA): I say all of this with my own biases, but [our group's] DISCOVER FLOW study was the biggest thing this year for imaging. It was the first of its kind to apply computational fluid dynamics to coronary artery images, and for the first time we could computationally simulate physiology, pressure, and flow. That's a game changer. . . . It had never been done before.
The EUROCMR registry has done something really special for MR. . . . T2-weighted magnetic resonance imaging for detecting of intermyocardial hemorrhage after [ST-elevation MI] is a big one, I think, because it potentially changes practice. If we can figure out, after a heart attack, people who are having big bleeds in their heart vs not bleeding, it makes a difference in therapies like dual antiplatelet therapies and things like that.
Implantable cardiac devices
h eart wire : What was the most important advance this year in device-based rhythm management?
Dr Brian Olshansky (University of Iowa Hospitals, Iowa City): I'd say data logging with transtelephonic monitoring, and its utility in helping to make clinical decisions, is right up there. Several studies on it were presented or published in the past year, looking at the "burden" of atrial fibrillation, which is often silent, and outcomes. And there does appear to be, at least based on monitoring data, a reasonably strong relationship between the presence of AF and its burden and thromboembolic events, heart-failure events, and total mortality in patients with pacemakers, [implantable cardioverter defibrillators] ICDs, and in particular cardiac resynchronization therapy [CRT].
In ALTITUDE , in which patients were followed by the [Boston Scientific] LATITUDE monitoring system, the risk of poor outcomes was greater in CRT patients with AF than in those without AF. Part of the reason for this may be related to the percent biventricular pacing, which is likely less in patients with episodic or long-standing AF. In fact, in those with or without AF, there was a direct relationship between more or less than 98.5% biventricular pacing and survival.
There's also the TRENDS study, which included patients with an implantable device that can detect the burden of atrial fibrillation. While a relationship exists between that burden and thromboembolic events, a substudy showed that it isn't necessarily a temporal relationship, which means the mechanism behind those events isn't completely understood.
heart wire : H ow do those trials influence your practice?
Olshansky: Some of these data are really important to how we decide to manage our patients. We can use remote monitoring for determining the need for anticoagulation or for ablation of the [atrioventricular] AV node or to adjust the device's programming, and by doing so we hope to lower the risk of hospitalization and heart failure. Telemonitoring of CRT and other devices is now done routinely, and some people would say it's revolutionizing the practice of electrophysiology.
heart wire : What developments in this area do you see coming up?
Olshansky: The development of silent AF is actually becoming a hot issue in patients who had ablation for elimination of AF and a challenging issue for people who do monitoring. What does it mean? What do you do about it?
heart wire : What were the top stories in interventional cardiology in 2011?
Dr Christopher White (Ochsner Medical Center, New Orleans, LA): Clearly the percutaneous approach to valve therapy made huge strides this year. The second big deal was a document that resulted from the carotid stenting trial, CREST . Fourteen medical societies, including the surgeons and the neurologists and the cardiologists, all got together holding hands around the table and sang "Kumbaya" and made carotid stenting for average-risk patients a level 1 indication. Many of us thought that would never happen.
h eart wire : What about the debate over procedure appropriateness and doctors found to have implanted unnecessary stents?
White: There's a few rotten apples in every barrel, and of course we acknowledge there's no defending any of these guys. But the point is, we would love to clean our own house. . . . If every hospital in the US participated in the Accreditation for Cardiovascular Excellence (ACE), we'd find our own bad guys—we'd flush them all out like rats, and it would be very hard for them to nest ever again.
h eart wire : And what will be the next big thing, in 2012?
White: The SYMPLICITY renal-nerve ablation stuff is preliminary, but it looks really good. . . . Can you imagine what the world would look like if the population of essential-hypertension patients didn't have to consume billions of dollars in drugs that they don't want to take? If I can treat a 40-year-old and stop them from needing 40 years of medication, we're talking about a sea change.
Dr Sekar Kathiresan (Massachusetts General Hospital, Boston): In my mind, the biggest study was AIM-HIGH [showing no benefit of niacin on top of statin therapy in patients with a history of CVD].
The reason I think it's an important advance is because we have medicines that improve laboratory tests, and many medicines are used based on the fact that they improve the numbers, but this doesn't necessarily mean there will be a reduction in the risk for disease.
In this case, niacin has been around for a very long time, but the clinical data suggesting that giving niacin does anything more than improving the lab tests are quite minimal. We have this drug around, with not a lot of clinical evidence, and at the same time it's heavily marketed and widely used because it does a lot of favorable things. It makes the numbers look better: it lowers triglycerides, lowers LDL, and raises HDL cholesterol.
h eart wire : Will this have an impact on your practice?
Kathiresan: My approach has always been, in patients with established coronary artery disease, the secondary-prevention patients, I get them on a statin. If their LDL is at goal, but their HDL cholesterol is low and the triglycerides are a little high, my approach right now, in general, is to leave those patients alone. There are a lot of physicians out there, despite the lack of evidence, who would reach for something like a fibrate or niacin, but I personally don't subscribe to that practice.
heart wire : What was the biggest advance in this field in 2011?
Dr Brendan Everett (Brigham and Women's Hospital, Boston, MA): There was the usual drumbeat of good epidemiological studies showing that eating well and exercising reduces your risk of cardiovascular disease. These studies aren't emblazoned with really catchy monikers, so they get missed, but I think in the long term, on a population level, changing behavior, eating habits, and the way we get patients to engage in physical activity is probably one of the most important things that we as cardiologists need to do from a public-health standpoint.
Another public-health message is that we actually have a large number of very effective therapies for primary and secondary prevention that are just underutilized. I think Dr Salim Yusuf's (McMaster University, Hamilton, ON) Prospective Urban Rural Epidemiology (PURE) study is a really good example of this. Even in wealthy countries, statin prescriptions, which you would think should be close to 100% in people who have had a stroke or heart attack, the number is just 66.5%. That's just astonishing to me. And of course, the numbers were even lower in less wealthy countries.
h eart wire : You also singled out the Post-Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) trial led by Dr Niteesh Choudhry (Harvard University, Boston, MA), showing that if insurance makes secondary-prevention medications free for patients, these data show there is some improvement in adherence and a reduction in outcomes.
Everett: Even still, the evidence shows that the use of these lifesaving medications is not nearly what it should be.
Dr Grayson Wheatley (Arizona Heart Institute, Phoenix): From a surgical standpoint, the approval of the percutaneous heart valve in the US and the release of a lot of study data, including the PARTNER trial, I think was really a sentinel event. For surgeons in the US, it represents a paradigm shift in how patients with heart-valve disease will be taken care of. . . . It will have a huge impact on the surgical field. Many patients who might be getting surgery aren't going to get surgery. They'll get the catheter-based approach. It's really a challenge for surgeons to get involved with minimally invasive catheter-based therapies that they haven't traditionally embraced in the past. It will be a stimulus for us to evolve into a more diversified skill set.
Aortic surgery has seen a significant deflection on the meter this year, with a lot of interest relative to the aortic arch in an innovative fashion, and there's a lot of work being done with hybrid therapies where you use a stent graft combined with surgical repair. That's a very hot and growing topic.
Dr Timothy Gardner (Christiana Care's Center for Heart & Vascular Health, Wilmington, DE): [Another story] is the continued reports from the SYNTAX trial. They reported the four-year outcomes and from the surgeon's perspective it's increasingly clear that there's a category of patients with coronary artery disease who clearly do better with surgery..
|Gradman disclosed being an investigator for Novartis and a consultant and speaker for Daiic hi, Novartis, Forest , and Takeda. Olshanky discloses consulting for Boston Scientific, Medtronic, Amarin, Biocontrol, Boehringer Ingelheim , and Executive Health Resources and being on data safety monitoring boards for trials sponsored by Boston Scientific, Amarin, and Sanofi- Aventis. Teerlink has disclosed receiving research grants from Amgen, Corthera, Cytokinetics, Merck, Novartis, and Scios and consulting fees from Bayer, Corthera, Cytokinetics, Merck, Nile Therapeutics, and Novartis. White disclosed having previously served as a princip a l investigator for a carotid stenting trial and as the current president of the Society for Cardiac Angiography and Interventions . Lip has received consultancy or speaker ' s fees and/or research grants from Boehringer Ingelheim , S anofi- A ventis , Bayer, Merck , Astellas Pharma, Portola, B iotronik, AstraZeneca , Bristol-Myers Squibb , and Pfizer. Turpie h as s erved as an advisor or consultant for Astellas Pharma , Bayer , Johnson & Johnson , Portola , and Takeda a nd has served as a speaker or a member of a speaker ' s bureau for Boehringer Ingelheim , GlaxoSmithKline , and Pfizer. Gershlick h as received fees for consultancy or speaker ' s fees and/or research g rants from Abbott Laboratories, Boston Scientific , Cordis , Medtronic , and Sanofi-Aventis.|
Heartwire from Medscape © 2011
Cite this: Biggest cardiology stories of 2011 - Medscape - Dec 21, 2011.