It has been nearly 2 decades since the first guidelines for the diagnosis and management of cholesterol disorders were published.1 During that time, several prospective, randomized, high-quality clinical trials have definitively shown that lowering low-density lipoprotein (LDL) cholesterol levels is associated with reductions in first and recurrent cardiac events. These guidelines have formed the basis for progressively more aggressive and more evidence-based guidelines for the evaluation and management of patients with dyslipidemia.2-4 Despite these guidelines and overwhelming data, there still remains a large treatment gap that is especially prominent among individuals at highest risk of coronary events: patients with established coronary artery disease or with coronary artery disease risk equivalent conditions.3,5,6 A recent report from the 1999-2002 National Health and Nutrition Examination Survey of 3,281 US adults showed that of patients at high risk, only 22.3% had an LDL cholesterol level less than 100 mg/dL and nearly 65% were more than 11% above their LDL cholesterol goal.5 These findings are concordant with those from the Multi-Ethnic Study of Atherosclerosis, of 6,814 adults, in which approximately 25% of high-risk participants had an LDL cholesterol level less than 100 mg/dL.6

The treatment gap is a particularly vexing problem with many causes. Several barriers to treatment have been identified at the patient level, including adherence to therapy, cost of therapy, beliefs and attitudes about dietary and pharmacological interventions, and health habits.7 Furthermore, physician factors, such as lack of knowledge, disagreement with guidelines, or lack of time or interest in risk factor reduction, and system factors, including but not limited to insurance and doctor-patient communications, represent formidable barriers.7 It is likely that addressing barriers at each of these levels will be needed to make a significant dent in the treatment gap. It is interesting that in a recent survey, family physicians reported that patient factors accounted for 74% of the total barriers to treatment; system factors, 23% of total barriers; and physician factors, only 3% of barriers.7 These findings are similar to those of another recent survey, where nearly 60% of physicians believed that patients were concerned about side effects from prescription drugs, could not afford them, and did not comply with their prescriptions, whereas only one third of patients reported that they feared the side effects of medications, felt that the medications cost too much, and did not like taking their medication. Clearly, there is room for improvement in all factors that represent barriers to treatment.

Simple interventions to improve physician awareness of patients not achieving lipid goals, such as chart prompts, are effective.8 In a study of 145 consecutive patients with coronary disease presenting to a cardiology clinic, simply flagging the charts of patients not being managed to guidelines increased the frequency of physicians ordering lipid panels, prescribing lipid-lowering therapy, and increased compliance with guidelines by approximately 3-fold. We had a similar experience at the University of Wisconsin Hospital and Clinics. In 1996, only 31% of the patients presenting to our outpatient cardiac rehabilitation program were on lipid-lowering therapy. A routine inpatient cardiac rehabilitation consultation that included placement of National Education Program Adult Treatment Panel II targets for lipid levels was placed on the front of the inpatient chart of all patients who had experienced myocardial infarction.2 At discharge, 78% of the patients were on therapy. When cholesterol therapy was added to our standardized discharge orders, more than 90% of patients were sent home on cholesterol medication.

The report by Meis et al in this issue of the Journal of Cardiopulmonary Rehabilitation continues with the theme of simple interventions directed at physicians can lead to clinically relevant prescribing practices with subsequent reductions in total and LDL cholesterol levels. The report is important because it shows how effective a cardiac rehabilitation setting can be for implementing these changes. This was a retrospective cohort study where a control group of 178 patients from January 2000 to October 2002 were compared with an intervention cohort of 67 patients who were enrolled from October 2003 to January 2005. The intervention was straightforward. If a patient had an LDL cholesterol level of greater than 100 mg/dL, the medical director of a cardiac rehabilitation program sent a letter detailing the patient's lipid goals and therapeutic options to the patient's cardiologist and primary care physician. In addition, a fax to the primary care physician was sent after 30 and 60 days, documenting progress and further recommendations for goals and therapy. These also were discussed with the patient. Patients in the intervention group had significantly greater reductions in total cholesterol and LDL cholesterol levels compared with the control group and were more likely to have a lipid medication change. At the end of cardiac rehabilitation, 67% of patients in the intervention group had achieved their LDL cholesterol goal compared with a historical average of 43%. The authors emphasized that the cardiac rehabilitation setting represents an ideal time to evaluate and reinforce lipid goals and that these programs can help coordinate care among the patient, the cardiologist, and the primary care physician. We concur with these observations. The post-myocardial infarction period represents a powerful teachable moment for patients and their physician. Patients frequently develop strong emotional attachments to cardiac rehabilitation staff because of the intense and frequent interaction with exercise physiologists, medical directors, and the rest of the interdisciplinary team, each of which facilitates education and compliance.

There were some limitations to the study, most notably the use of historical controls. The time period between the end of the control cohort and the end of the intervention cohort coincided with a rapid increase in knowledge about the importance of aggressive lipid-lowering therapy after acute coronary syndromes.4 These studies increased general awareness of the importance of aggressively lowering LDL cholesterol and led to an optional LDL cholesterol target of less than 70 mg/dL for patients with coronary artery disease, a target that was specifically recommended for patients with a recent acute coronary syndrome. This was clearly seen in the study of Meis et al, where 41.5% of patients in the control cohort had an LDL cholesterol greater than 100 mg/dL, but only 26.4% of patients in the more recent intervention cohort had an LDL cholesterol greater than 100 mg/dL. Similarly, patients in the intervention cohort also were more likely to be taking lipid-lowering agents, [beta]-blockers, aspirin, and clopidogrel, indicating generally more aggressive care during the time of the intervention. It is likely that this accounts for part of the improvement in the number of patients at target in the intervention cohort, rather than the intervention itself. It is unlikely that the absolute increase of 24% is solely caused by temporal trends; however, this could have been investigated more vigorously using a multivariate analysis with adjustments for markers that serve as proxies for aggressive care. A multivariate analysis would also have been useful given baseline differences between the control and intervention group in the sex distribution and the incidence of hypertension. Alternatively, a propensity analysis would have strengthened the conclusions.

We disagree that a prospective randomized study would not be possible. Indeed, the recently published Extensive Lifestyle Management Intervention after cardiac rehabilitation study was a 4-year randomized controlled trial of risk factor and lifestyle management after cardiac rehabilitation, which included 302 subjects.9 The Extensive Lifestyle Management Intervention showed that a risk factor and lifestyle management intervention (exercise sessions, telephone follow-ups, counseling sessions, and reports to the patient's primary care physician) resulted in improvements in lipids, blood pressure, and the Framingham risk score and that being in the intervention group independently predicted improvement in Framingham risk. Prospective randomized clinical trials are the mainstay of evidence-based medicine and are going to be critical to convincing payers of the value of extended and more intensive interventions for cardiovascular risk reduction after myocardial infarction.

Unfortunately, programs directed only at physician behavior are unlikely to completely close the gap because physicians do not always believe that they are contributing to the problem, and because there are major barriers at the system and patient levels. A recent trial of improving blood pressure control through provider education, provider alerts, and patient education demonstrated that patient education is a critical factor and that adding patient education to provider education and alerts improved blood pressure control.10

In summary, closing the treatment gap is critical. The multidisciplinary care provided by a comprehensive cardiac rehabilitation program provides a powerful opportunity to influence short- and long-term compliance with cardiovascular risk reduction guidelines. Simple interventions, as outlined in the article by Meis et al, are important, but only go part way. Physician barriers, patient barriers, and system barriers all need to be addressed using both simple and more complicated tools. Quality improvement and disease management strategies are necessary to achieve optimal treatment targets for high-risk patients. The cardiac rehabilitation program is a vital part of achieving quality standards.

References