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13 Cardiac Rehabilitation: Statins and the Rationale for Implementation of Lipid-Lowering Therapy

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13 Cardiac Rehabilitation: Statins and the Rationale for Implementation of Lipid-Lowering Therapy 13 Cardiac Rehabilitation: Statins and the Rationale for Implementation of Lipid-Lowering Therapy Ryan Neal and Christie Ballantyne CONTENTS Coronary Heart Disease and Secondary Prevention 142 Secondary Prevention and the Treatment Gap 142 Cardiac Rehabilitation 143 Risk Factor Modification in Cardiac Rehabilitation 143 Dyslipidemia and the Risk of CHD 143 Observational Data for Cholesterol and the Risk of CHD 144 Cholesterol Metabolism and Statins 144 Evidence-Based Data for Statin Therapy 144 Recent Clinical Trials and the Adult Treatment Panel III Guidelines: New Recommendations and Treating to Goal 145 The Implications of New Clinical Trials 145 Newer Statin Trials Establish that Lower LDL-C Levels are Associated with Lower CHD Risk in High-Risk Patients 146 The “Optimal” Versus “Optional” LDL-C Level 147 The Ability to Achieve New LDL-C Goals 148 Treatment Options 149 CHD and the Treatment of Dyslipidemia 151 Lipid-Lowering Therapy in Cardiac Rehabilitation 152 References 152 From: Contemporary Cardiology: Cardiac Rehabilitation Edited by: W. E. Kraus and S. J. Keteyian © Humana Press Inc., Totowa, NJ 141 142 R. Neal and C. Ballantyne CORONARY HEART DISEASE AND SECONDARY PREVENTION Coronary heart disease (CHD) remains the leading cause of death in the United States. Although there has been an overall decline in mortality from acute coronary events, the prevalence of CHD continues to rise, largely due to the aging population and improved survival after myocardial infarction (post-MI). This increase has led to more patients at risk for recurrent ischemic events and subsequent death. According to the American Heart Association (1), within 1 year of an MI, 25% of men and 38% of women will die of heart disease. Within the following 6 years of such an event, 18–34% of patients will suffer another MI, approximately 6% will have sudden death, 22–46% will develop congestive heart failure, and 8–11% will have a stroke (1). The total economic burden of cardiovascular disease will exceeds $300 billion in the United States annually this year alone (1). Although there is a growing body of evidence that lifestyle modification and pharmacological therapies can reduce recurrent events, numerous studies have carefully documented that clinicians are not following the available guidelines for secondary prevention to achieve appropriate outcomes. Current evidence clearly indicates that both secondary prevention and cardiac rehabilitation programs are effective systems for improving risk reduction (2). When combined, these two systems can offer the synergistic effect of achieving multiple goals for risk factor modification. SECONDARY PREVENTION AND THE TREATMENT GAP Secondary prevention is defined as an intervention or treatment that reduces the risk of recurrence, progression, or mortality in a person known to have cardiovascular disease. Multiple studies have documented the benefit of secondary prevention of CHD with lipid-lowering therapy (LLT) (3), hypertension control (4), smoking cessation (5), physical exercise (6), weight management (6), antiplatelet therapy (5), beta-blocker therapy (5), and angiotensin-converting enzyme (ACE)-inhibitor therapy (6) as single interventions as well as combined or comprehensive interventions. The implementation of LLT alone has the ability to reduce coronary events such as recurrent MI, angina pectoris, and coronary mortality by 25–42% (7). In addition, medical compliance with aspirin therapy has been shown to have a risk reduction benefit of 20–30%, beta-blocker therapy 20–35%, and ACE-inhibitor therapy 22–25% (5). Despite these well-defined benefits in risk reduction, the data from the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Associ- ation Guidelines (CRUSADE) Quality Improvement Initiative trial found only 58% of patients admitted with acute coronary syndrome (ACS) had their low-density lipoprotein cholesterol (LDL-C) tested, and of those tested and appropriate for LLT, more than 30% were not treated with LLT (8). The definition of the treatment gap is the difference in the percent of patients eligible for a specific treatment and the percent of patients actually receiving that treatment. The estimated treatment gap for CHD patients, according to National Registry of Myocardial Infarction (9) and the Quality Assurance Program (10) data, is 66% for outpatient office practices and 68–80% for hospital discharges. Barriers to implementing risk factor modification guidelines for patients with CHD are several: (i) problem-focused physician visits, (ii) lack of Chapter 13 / Treating to Goal: Lipids 143 systems to implement protocols or guidelines, (iii) time constraints and lack of incen- tives (including reimbursement), (iv) lack of knowledge and training on the benefits, and (v) lack of specialist–generalist communication. As a result, a large percentage of the patients with CHD are therefore undertreated and are at unnecessary risk for preventable cardiovascular events. CARDIAC REHABILITATION As outlined elsewhere in this volume, cardiac rehabilitation combines supervised prescriptive exercise training with CHD risk factor modification principles in patients with established CHD. Patients with the diagnosis of CHD, post-MI, coronary artery bypass surgery, post-percutaneous angioplasty, and other past cardiovascular surgeries including valve surgery and cardiac transplantation are eligible for referral to cardiac rehabilitation programs. The American Heart Association Medical/Scientific Position Statement on Cardiac Rehabilitation Programs (11) states that cardiac rehabilitation efforts targeted at exercise, lipid management, hypertension control, and smoking cessation can reduce cardiovascular mortality (12), improve functional capacity (13), attenuate myocardial ischemia (14), retard the progression of atherosclerosis (15), and reduce the risk for further coronary events (16). Therefore, cardiac rehabilitation is the standard of care and should be integrated into the overall treatment plan of patients with CHD. RISK FACTOR MODIFICATION IN CARDIAC REHABILITATION The concept of combining comprehensive risk factor modification with cardiac rehabilitation has been assessed in previous trials such as the Stanford Coronary Risk Intervention Project (SCRIP) (6). In this study, researchers evaluated the effects of intensive multiple risk factor reduction on coronary atherosclerosis over a 4-year period and found significant improvements in lipid profiles, body weight, and dietary compliance as well as decreased progression of coronary atherosclerosis. This study revealed that combining comprehensive secondary prevention guidelines with a standardized approach to cardiac rehabilitation could improve the effectiveness of implementing evidence-based risk factor modification standards. DYSLIPIDEMIA AND THE RISK OF CHD Dyslipidemia remains one of the major risk factors for CHD. The origin of the lipid hypothesis began with Virchow (17), who along with other scientists of his time observed the deposition of cholesterol within atherosclerotic plaques. Much later, the development of fractional assays allowed clinicians to identify and measure plasma cholesterol in humans. This discovery sparked desire to determine whether there was a link between plasma cholesterol in humans and the development of atherosclerotic plaques. Basic science researchers first established this relationship between cholesterol and atherosclerosis in animal models (18,19). This finding then led to a great interest in determining the role of cholesterol in humans, which led to the delineation of the cholesterol pathway, mechanisms involved in lipid deposition, and the discovery of the LDL receptor pathway (20). These discoveries and others opened the door to the practice of treating dyslipidemia and reducing CHD risk. 144 R. Neal and C. Ballantyne OBSERVATIONAL DATA FOR CHOLESTEROL AND THE RISK OF CHD Multiple observational studies, such as The Framingham Heart Study (21) and the Multiple Risk Factor Intervention Trial (MRFIT) screenees (22), began to solidify a direct relationship between patients with elevated cholesterol levels and the devel- opment of CHD. Moreover, these trials established a directly proportional relationship between total cholesterol (TC) and LDL-C to CHD. These observational studies led to the development of randomized clinical trials (RCTs) to test the reverse hypothesis of whether lowering cholesterol in patients with elevated cholesterol levels reduces the risk of CHD. The earliest trials involved lifestyle modifications, such as diet, exercise, and weight loss, directed at lowering cholesterol and reducing the risk of CHD (23). Soon thereafter, RCTs with pharmacologic LLTs began to confirm the hypothesis that lowering TC and LDL-C lowered the risk of cardiovascular morbidity and mortality (24). As the wealth of clinical evidence mounted in support of lowering cholesterol to reduce the risk of cardiovascular disease, and as basic science evidence grew surrounding the understanding of LDL as the principal lipoprotein involved in the development of atherosclerosis, LDL-C emerged as the primary target for cholesterol lowering. CHOLESTEROL METABOLISM AND STATINS The world of treating dyslipidemia was revolutionized when a better understanding of cholesterol metabolism was established surrounding the role of HMG-CoA reductase and the LDL receptor pathway. Statins were developed as competitive inhibitors
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