Seth Bilazarian, MD

Disclosures

November 13, 2013

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Hi. Seth Bilazarian on theheart.org and Practitioner's Corner on Medscape. Today there's a release of guidelines[1] which are new and long awaited. "Guidelines Update 'ATP-4' -- Finally!" is the title of this blog.

The ACC (American College of Cardiology) and AHA (American Heart Association) in combination with NHLBI (National Heart, Lung, and Blood Institute) have released 4 new guidelines: the cholesterol management guidelines, a risk assessment guideline, obesity, and lifestyle recommendations. ACC and AHA have been collaborating for a long time on guidelines. I learned that they started collaborating in 1980 with the first guideline, a pacemaker guideline released in 1984. So they've been at this for a very long time, almost 30 years.

We've been waiting for ATP-4 since ATP-3 was released in 2001. It's an incredibly long time. A lot of time has elapsed. Over 12 years have we been waiting for it. Just to remind you, in 2001, President George Bush II was president. We had the 9/11 attack. The United States began its invasion of Afghanistan. Wikipedia came online. Napster closed down. The first iPod was released in 2001. So we've come a really long way since 2001 in many ways, but unfortunately the guidelines were not advanced.

Of course, in the lipid field there have been multiple statin trials since 2001: HPS, PROVE-IT, ASCOT, PROSPER, ALLHAT, TNT, IDEAL. There have been several nonstatin trials: 2 large niacin trials and 2 fibrate trials. We're still waiting for an ezetimibe trial, so a lot of things have happened in the lipid field while we've been waiting for these guidelines. Community-based clinicians like myself, trying to make best decisions for our patients, have been sort of stuck in the middle trying to interpret the data and waiting for some kind of consensus guideline, which can be frustrating.

There are several persistent questions I've been waiting for answers to, and these guidelines answer some but leave me short in some areas. One question that has been brought up many times by many lipidologists is that the Framingham risk score, which ATP-3 recommends we use, underestimates risk for women and for young patients. Is that something that I should continue to use? Of course, many people have used inflammatory markers, particularly C-reactive protein (CRP), to help evaluate intermediate risk patients. What is its role? Others are enthusiastic about imaging and use calcium scores or carotid intima medial thickness or the ankle brachial index (ABI). At the heart meetings and the exhibition hall, I always see vascular tonometry exhibits. How should I use these or should I use them at all? What role does patient preference play as we move more towards being patient-centric in a patient who has a Framingham risk score in the intermediate-risk range of 10%-20%? Is it completely up to them or should we use some other strategies?

In regard to secondary prevention, what's the story with residual risk? This is a topic that's promoted by people who are motivated to sell nonstatin therapies. Is that a legitimate thing to consider or should that just be ignored? What role, if any, should drugs like niacin and fibrates and ezetimibe and bile acid sequestrants have? These are questions that I've tried to make sense of in my own mind and was hoping we would get some answers to -- and we have some in these new guidelines.

Then, of course, other issues that come up are the best approach for women, patients with diabetes, or those with the metabolic syndrome. I think everyone is aware that there are poor data for statin benefit in chronic kidney disease. We have little data for transplant patients or HIV patients. What do we do with all those patients? What do we do with these 2 new therapies for familial hypercholesterolemia (FH)? I was hoping to get some guidance on that.

So we've been waiting since 2001 for NHLBI. Earlier this year, in June 2013, Medscape editor Shelley Wood had a report that said that the NHLBI (or National Institutes of Health [NIH] specifically) had turned over the guideline writing to the ACC and AHA after 11 years. From June until now is only 6 months and we now have guidelines, which is actually a great turnaround and a credit to the ACC and AHA. As a taxpayer, I'm dissatisfied with how long it took NIH to move to that more effective strategy. We were supposed to get JNC 8 as well, according to the reports in June, but we don't have JNC 8 with this announcement today.

Ultimately, where are we and what's been changed? The guidelines were written a little bit differently, as has been reported. ACC/AHA are now using a different style. It's not an extensive compendium, but they're focusing on specific questions which should, of course, be better for clinicians in practice. They're trying to choose only the best trials. They're leaving a lot of questions unanswered, and it retains the same kind of reasoning with I, IIa, IIb, and III in terms of the strength of their recommendations.

There are 4 guidelines. Briefly, the obesity guidelines answer 5 questions. What's the health risk associated with obesity and how do you calculate that based on using BMI and weight circumference? How much weight loss is beneficial? Some questions are answered; the best diets and the role of bariatric surgery are addressed in the obesity guidelines.

The cholesterol treatment guidelines are the ones I'm most interested in, and I'll spend a few minutes talking about them. They basically promote some new approaches, which I think will change a lot of the way primary care doctors and cardiologists practice. They've tried to identify 4 groups for statin therapy. Number one is the patient with a history of heart disease or stroke. This is secondary prevention. That's not a change.

The second is the patient with an LDL-C over 190 mg/dL. Do they have FH? That's a new concept for this update. Then 2 other groups: the patient age 40-75 years with diabetes with an LDL of 70-189 mg/dL. Then a fourth group is the patient with a global 10-year risk of 7.5% based on a new calculator that they are releasing today. That's another statin group.

They also have promoted this new concept of high-intensity, moderate-intensity, and low-intensity statin therapy. They recommend high-intensity and moderate-intensity statins for some of these groups. Of the 4 groups I just mentioned, the first one being secondary prevention and LDL-C over 190 mg/dL, they're recommending high-intensity statins. They recommend moderate-intensity statins for diabetic patients and for those who are primary prevention age 40-75 years with a risk above 7.5% in 10 years.

The definition of high intensity that was used is the dose that lowers LDL-C by more than 50%. That's easy to remember: It's the 2 most potent statins, atorvastatin and rosuvastatin, at the top 2 doses for those 2 drugs. Moderate-intensity statins are pretty much all the other statins except for the older statins at their lowest dose. So, atorvastatin 10 or 20 mg is considered to be moderate; rosuvastatin 5 or 10 mg is considered to be moderate; simvastatin 20-40 mg, pravastatin 40-80 mg, and lovastatin 40 mg are examples of moderate-intensity statins.

The second thing that they've developed is a new calculator that's available at americanheart.org and at the CardioSource Website from ACC. We'll be able to go to these Websites and either download the calculator as an Excel spreadsheet or, presumably, these people will quickly create smartphone apps so that we can enter these data. Hopefully, they'll be integrated into the electronic medical records. They promoted this idea that they really don't have a quantitative risk, so you'll be able to tell your patient, "Your number is 7.8%." They are attempting to endorse the concept that was promoted at ATP-3 to match the therapy to the patient's absolute risk.

There are a variety of other changes, and a summary of the Class I, IIa, or IIb recommendations is that they're promoting race- and sex-specific equations. It's not clear from my reading of the document how we interpret the race issue for patients who may be of mixed race.

The sex-specific component, I think, is already available for us in the Framingham risk score. They have given us some leeway. If a patient after quantitative risk assessment still is uncertain in terms of the value of using statin therapy, they've cleared the path for some other strategies like family history, CRP, calcium score, or ankle brachial index (ABI). The greatest endorsement is for calcium score. They also say it's reasonable for us to assess patients for primary prevention every 4-6 years when they're age 20-79. So, those are the highlights of the cholesterol treatment issues.

The cut points for those intermediate-risk tiebreakers are family history, males less than 55 years of age for first-degree relatives or females less than 65 years, so that's a little bit different from what we've had in the past. The CRP cut point is 2 mg/L. The calcium score cut point is 300 Agatston units and the ABI is 0.9. They recommend against carotid intima-medial thickness, so that's out for the time being in regard to these new guidelines.

The major recommendations for statin therapy were secondary prevention for LDL-C greater than 190 mg/dL, high intensity, unless they're over 75 years old. So if a patient is a secondary prevention patient or has an LDL-C over 190 mg/dL, they get high-intensity statin therapy -- unless they're over 75 years, and then they get moderate-intensity statin. That's different from what I'm practicing. For diabetics they're recommending not to assume it's equivalent to secondary prevention and just use secondary prevention guidelines, but that we actually use a risk calculator, and if they have over 7.5% then use a high-intensity statin. Otherwise, diabetics should get a moderate-intensity statin. Then for primary prevention in patients age 40-75 years, use a moderate- or high-intensity statin if they're greater than 7.5%.

This whole moderate-to-high-intensity-statin approach is another area that we're going to have to change. We're not treating to target LDLs anymore, according to their recommendations; we just give one of these therapies. I don't know what will happen. Do we even check LDL or do we just leave it alone? They also omitted -- or have specifically not made a recommendation for -- systolic heart failure patients or hemodialysis patients. Again, they're not saying they're not recommending it; they're just not making any recommendation.

There is another document for lifestyle recommendations, which I won't talk about because of time.

But on this first blush, the biggest changes to my practice with these cholesterol guidelines are that we'll now need to evaluate diabetics and not equate them with secondary prevention goals. It was very easy previously if you had any atherosclerosis that was identified or you were a diabetic: You qualified for secondary prevention. This will change that, so that complicates things a little bit. We're no longer treating to goals, so this implies that secondary prevention patients who have a very low LDL-C probably should not have their high-intensity statin reduced. That's not my current practice. If it's a patient who is several years out and has an LDL-C in the 40-50 mg/dL range on atorvastatin 80 mg, my approach has been to reduce the statin in order to reduce the risk for potential hazard. This seems to imply that I shouldn't do that.

There will also be issues for those of us in practice who are on the pay-for-performance guidelines. The performance goal for secondary prevention is an LDL-C less than 100 mg/dL; that is part of the pay-for-performance guideline that I live under. So these are already antiquated. If a patient is on a high-intensity statin, theoretically that would be the best approach based on these new guidelines. Another thing will be, how fast can these calculators be integrated into our practice? They are electronic medical records. That will be some kind of cost and some kind of hassle that will have to be undertaken. In our practice we don't use a lot of calcium scores, so since this seems to be the highest recommendation for intermediate-risk patients to be risk stratified, we may have to reconsider that approach.

There's an evidence statement in the appendix about heart failure. They're saying statins should not be used because of a lack of evidence, and because heart failure patients were excluded from the trials. So should I discontinue statin therapy in a patient who has had a prior myocardial infarction who is a secondary-prevention patient but has congestive heart failure? That has not been my approach. I'm not sure what to do about that. On the other hand, these guidelines bolster my approach, which has been to not use fibrates, niacin, or fish oil for the past several years due to the lack of effectiveness. This document seems to bolster that position.

So, some new guidelines. It's going to take some time to digest these and make sense of them, but there are some different approaches and I think the high intensity/low intensity and not paying attention to the LDL as a treatment goal are really going to be something that's going to take some time for me to get my head around.

Seth Bilazarian of theheart.org. Thanks until next time. Post a comment and tell me what you think about these. Have a good day.

To download the slides used in Dr. Bilazarian's presentation, click here.

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