CHICAGO – Cardiologists certainly have their work cut out in order to bring their patients into concordance with the 2013 American College of Cardiology/American Heart Association cholesterol guidelines, according to Dr. Thomas M. Maddox.
An analysis of nearly 1.2 million patients in U.S. outpatient cardiology practices showed that one in three who appeared to have an indication for statin therapy under the latest guidelines weren’t on a statin as of 2012. That constitutes a sizable “statin gap” that cardiologists need to address, he said at the American Heart Association scientific sessions.
Dr. Thomas M. Maddox
Dr. Maddox presented an analysis of 1,174,535 adult patients under cardiologists’ care during 2008-2012 in more than 100 U.S. outpatient cardiology practices participating in the voluntary National Cardiovascular Data Registry’s Practice Innovation and Clinical Excellence Registry (NCDR PINNACLE). Under this national office-based quality improvement program sponsored by the ACC, patient electronic medical record (EMR) data gets uploaded to the registry nightly.
The 2013 ACC/AHA cholesterol guidelines in some ways greatly simplified patient management. The guidelines redefined the risk groups warranting treatment: basically, patients with known atherosclerotic cardiovascular disease (ASCVD), diabetes, an off-treatment LDL of 190 mg/dL or more, or a 10-year ASCVD risk of 7.5% or greater using the risk calculator incorporated in the guidelines (Circulation 2014; 129:S1-45). Also, physicians were advised to use fixed-dose statins and no longer to treat to an LDL target, thereby making repeated LDL testing unnecessary.
The purposes of this new NCDR PINNACLE study were to evaluate the potential impact of the new guidelines on current cardiology practice through an assessment of current treatment and testing patterns, and to make a determination of the scope of changes necessary under the 2013 guidelines, explained Dr. Maddox, a cardiologist at the Veterans Affairs Eastern Colorado Health Care System and the University of Colorado at Denver.
Under the new guidelines, 1,129,205 adult cardiology patients, or 96% of the study population, appeared to be candidates for statin therapy, most often because they had known ASCVD, as was the case in 88%, or diabetes without known ASCVD, accounting for another 6%.
Among the statin-eligible patients, 29% were not on any lipid-lowering therapy, and another 3% were on nonstatin lipid-lowering agents only, which is not recommended in the guidelines. Thus, 32% of the cardiologists’ patients for whom statin therapy appeared to be indicated under the 2013 guidelines weren’t on it.
In addition, 29% of statin-eligible patients were on combined lipid-lowering therapy with a statin plus a nonstatin, such as niacin, a fibrate, or ezetimibe. The guidelines don’t recommend the use of nonstatins because of the lack of evidence of clinical benefit, so cardiologists will want to reconsider their use of combination therapy in this sizable group. The major caveat here is that the guidelines are likely to be revised to embrace the selective use of a moderate-intensity statin plus ezetimibe on the basis of the positive findings of the IMPROVE-IT trial, also presented at the AHA meeting, Dr. Maddox noted.
The registry analysis also pointed to a need to reduce repeated LDL testing, which the guidelines characterize as costly, inconvenient, and unnecessary. Nearly 21% of subjects had at least two LDL assessments during the 4-year period, and 7% had more than four. And those figures probably underestimate the true rate of LDL testing, since many patients may have also had LDL measurements taken in primary care settings.
Several audience members rose to decry the one-in-three-patient statin gap as evidence of widespread substandard care by cardiologists, especially given that 28% of the patients with known ASCVD and 36% with diabetes were not receiving any lipid-lowering therapy, contrary to recommendations both in the current ACC/AHA guidelines and the guidelines in place in 2012. There is good evidence to show that putting such patients on statin therapy would result in roughly a 25% reduction in cardiovascular events.
But Dr. Maddox took a more sanguine view of the statin gap. Although it’s likely there is some heterogeneity in clinical practice that needs to be corrected, he cautioned that the limitations of an analysis based upon EMR data must be borne in mind. Some cardiologists probably didn’t record the use of statins at every visit, and they may not have always reliably documented patients’ intolerance of statins in the EMR.
The NCDR PINNACLE Registry is supported by the American College of Cardiology Foundation. Dr. Maddox reported having no relevant financial conflicts of interest.