New Guidelines Focus on Treating the Whole Patient Not Just a Number
While the press attention on the new guidelines has focused on the issue of how many more people will be given statin therapy, and whether we may be over-identifying them based on the new risk assessment equations, there has been a failure to adequately communicate the ultimate goal of the guidelines, that is, to optimize our efforts to prevent cardiovascular disease. In particular, the risk assessment, lifestyle, and obesity management guideline statements, published concurrently with the cholesterol guideline show the importance the American College of Cardiology and American Heart Association places on these issues as integral to prevention of cardiovascular and related conditions. Lifestyle management is a crucial initial step in maintaining healthy levels of lipids (and is in fact mentioned at the top of the cholesterol management algorithm) and other cardiovascular risk factors. The guidelines together encourage a patient-centered care approach.
An important forward-thinking aspect of the cholesterol management guidelines is the greater focus on treating a patient's cardiovascular risk rather than just a cholesterol number. Statins reduce cardiovascular disease risk and are not just cholesterol-lowering medications. The recommendation to use risk assessment (in the current guideline the Pooled Cohort Equations) is not new; ATP III in 2001 recommended we calculate the 10-year risk of coronary heart disease based on the Framingham risk scores and went on to recommend therapy according to a combination of risk level and LDL-cholesterol. While no risk score is perfect and is often based on a limited set of risk factors available in the cohorts they were designed from, the new equations are an improvement in that they encompass prediction of both coronary heart disease and stroke, both of which risk is reduced from statin therapy. Moreover, they allow for accurate prediction in African-Americans, which was not the case in the earlier risk scores. A 7.5% risk in 10 years as a cutpoint to recommend statin therapy should be considered a starting point to further evaluate the patient’s suitability for statin therapy. It should be noted that only non-fatal myocardial infarction, CHD death, or nonfatal or nonfatal stroke are included in this estimate, so the risk of total cardiovascular disease would actually be higher (over 10% and perhaps closer to 15%) should other outcomes such as PCI, CABG, unstable angina requiring hospitalization, peripheral arterial disease, heart failure and other forms of cardiovascular disease be included. It should also be an opportunity to educate the patient about his/her risks and how to reduce them thorough lifestyle management. Lifestyle adjustment is the cornerstone for maintaining not only healthy levels of lipids, but other risk factors as well. This cutpoint is based on where there is reasonable net clinical benefit for preventing cardiovascular events based on the expected 20-25% relative risk reduction for cardiovascular events from statin therapy seen across much of the spectrum of baseline risk. Ultimately capturing the greater segment of the population who would derive benefit from statin treatment (and the lifestyle counseling that should go along with it) will save more lives from cardiovascular disease and be an important means to helping us achieve.
The basis for treatment according to level of risk derives from large meta-analyses that have shown us that the benefit of statins for prevention of cardiovascular events is quite consistent regardless of risk group studied. Even those as low as 5% 10-year risk of cardiovascular disease show relative benefit similar to that in higher risk groups. There are clearly individuals who were at increased risk of cardiovascular disease who were not indicated for treatment in past guidelines but who would be included in the current guidelines and would benefit in terms of cardiovascular risk reduction. This should ultimately help prevent more heart attacks and strokes annually than would have been the case under earlier guidelines.
The new guidelines also recommend that when the treatment decision is uncertain other measures be considered, such as whether the person has an elevated hs-C-reactive protein, family history, increased coronary calcium score, or abnormal ankle brachial index. These measures may better help to inform the healthcare provider as to the patient's risk and appropriateness for beginning or intensifying therapy. These measures, if elevated or abnormal, have been shown to provide added clinical utility for identification of persons at highest risk of CVD events.
While some agree there has been too much emphasis in the past on a particular LDL-cholesterol goals, which were in fact quite arbitrary and not well-supported by the data, the guidelines do recommend checking LDL-cholesterol to ensure adherence and response to statins. This can also help identify non-responders, which may warrant the clinician to consider additional or alternative therapies to achieve lower LDL-C levels. It is important to point out, however, that we are still awaiting clinical trials to demonstrate whether additional therapies added to statins will provide definitive evidence of cardiovascular outcomes benefit. But clinicians will want to continue checking LDL-C for adherence and response to therapy and should not be discouraged from doing so. The guidelines should not be interpreted as recommending against checking LDL-C for these reasons.
Also, the new guidelines were based on strict clinical trial evidence in those subgroups studied so recommendations were based on those groups; they should not be interpreted to imply that other groups not studied (such as persons older than 75 or less than 40) would not benefit and the clinician should always consider other factors where judgment may warrant treatment.
The clinician should take into account the whole patient and their other risks to make the best judgment regarding treatment. Importantly, as few physicians currently do quantitative risk assessment, we recognize it will be a challenge to get appropriate risk assessment as recommended adequately implemented. Widespread incorporation into electronic medical record systems will be an essential component of such implementation.
The new guidelines have both strengths and limitations, but represent an important opportunity for the ACC and AHA in partnership with other prevention-minded societies to help healthcare providers interpret how they can be best used and implemented to optimize cardiovascular disease prevention efforts. They further encourage a “risk discussion” be done with the patient to make the best decisions together for prevention – a crucial feature of patient-centered care. It is crucial that clinicians continue to use the best judgment based on all available evidence, while using the principles of the guidelines to inform, but not to replace their judgment.
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