Are we treating to target?

Are we treating to target?

Atherosclerosis Supplements 1 (2000) 9 – 14 www.elsevier.com/locate/atherosclerosis Are we treating to target? L. Erhardt* Department of Cardiology, ...

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Atherosclerosis Supplements 1 (2000) 9 – 14 www.elsevier.com/locate/atherosclerosis

Are we treating to target? L. Erhardt* Department of Cardiology, Malmo¨ Uni6ersity Hospital, 205 02 Malmo¨, Sweden

Abstract The identification of a number of independent risk factors for coronary heart disease (CHD) led to the development of guidelines for the prevention of CHD in an attempt to target these risk factors and reduce the rates of CHD-related morbidity and mortality. Surveys conducted of physician’s clinical practice patterns indicate, however, that the recommendations made in the guidelines are often not implemented and the predefined goals of therapy for patients are not achieved. Possible reasons for this apparent shortfall in preventive care include a lack of physician awareness of evidenced-based guidelines, an insufficient focus towards preventive care in health care systems, and patient non-compliance with lifestyle changes and medication. To ensure an optimal outcome, specialists, primary care physicians and the patient need to provide an integrated approach to the management of CHD. The first step is to achieve universal understanding and implementation of the guidelines. Not only do guidelines promote interventions of proven benefit, but when followed they also improve consistency of care. Nurse-led shared-care programs, which individualize care based on a comprehensive assessment of CHD risk factors, are of proven benefit and offer continuity between the hospital and a patients return to the community. Patients themselves also have a role to play in the management of their disease by adhering to lifestyle changes and medication. © 2000 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Secondary prevention; Coronary heart disease; Guidelines; Treat-to-target

Evidence from clinical and epidemiological research continues to improve our understanding of the pathogenesis of coronary heart disease (CHD). We know that multiple risk factors contribute to the development and progression of CHD and that the risk of CHD can be significantly reduced through reduction of modifiable risk factors [1–4]. To help physicians assess a patients coronary risk, guidelines such as those recently published by the Second Joint Task Force of the European Society of Cardiology, European Atherosclerosis Society and European Society of Hypertension, have been developed to identify priorities for prevention [5]. The guidelines are based on the results of major clinical trials for CHD prevention. However, despite their comprehensive nature and wide dissemination, a number of studies documented that patients are not being treated to target for cardiovascular risk factors, especially hyperlipidemia.

* Tel.: +46-40-331941; fax: + 46-40-337329. E-mail address: [email protected] (L. Erhardt).

1. Surveys of CHD prevention practices In 1997, the European Action of Secondary Prevention through Intervention to Reduce Events (EUROASPIRE), a large survey of patients with CHD living in several European countries, was conducted by the European Society of Cardiology [6]. The objectives of the survey were: (i) to determine if physicians recorded major risk factors for CHD in patient’s medical records; (ii) to estimate the prevalence of CHD risk factors that could be modified by drug therapy or lifestyle changes and evaluate the management of CHD in patients who had been previously hospitalized; and (iii) to evaluate the prevalence of screening for CHD risk factors among close relatives of patients who were at high risk of CHD. Data for the survey were collected in nine countries by medical record review and from patient interviews that took place at least 6 months after patients were hospitalized for a CHD event. In total, 4863 medical records were reviewed and 3569 patients were interviewed. Data analysis revealed that there were large areas of improvement needed. Upon admission for a

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cardiovascular event, 34% of patients reported that they were currently smoking and 58% had elevated blood pressure levels of \140/90 mmHg. In addition, a significant proportion of CHD patients had total cholesterol levels above recommended targets (Fig. 1). These percentages were only slightly improved among patients interviewed after their hospitalization for a cardiac event. Among patients on pharmacologic therapy to lower either their blood pressure to B 140 mmHg, or their total cholesterol levels to B5.5 mmol/l (210 mg/ dl), approximately half were not adequately controlled. The authors concluded that the results indicated significant improvements could be made to reduce risk factors and, consequently, reduce the amount of CHD mortality and morbidity in Europe. A more recent study in the UK evaluating secondary prevention of CHD in general physician offices also revealed that improvements were needed in the treatment of CHD risk factors and in modifying patients’ lifestyles [7]. In this study of 1921 patients, only 51% of the participants exercised regularly, 18% were currently

smoking, 64% were overweight, and 52% consumed more dietary fat than recommended by the European Joint Societies on CHD prevention. Physician prescribing practices were also not consistent with the recommendations of the Second Joint Task Force of European and other Societies on coronary prevention. Only 17% of patients were prescribed drugs to control their elevated lipid levels, only 32% of patients with a history of a myocardial infarction were prescribed betablockers, and only 40% with documented coronary heart failure were prescribed angiotensin-converting enzyme inhibitors to control their disease [7]. In the USA, the Lipid Treatment Assessment Project (L-TAP) assessed the prevalence of CHD risk factors and treatment of patients with CHD in primary care practices [8]. L-TAP evaluated 4888 patients with elevated lipids who were under the care of physicians known to routinely prescribe lipid-lowering drugs for patients with dyslipidemia. The study patients were grouped according to their level of risk for CHD as defined by the US National Cholesterol Education Pro-

Fig. 1. Prevalence of elevated plasma cholesterol in patients with CHD [6,19].

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Fig. 2. Percent of patients achieving LDL-cholesterol target by risk group. Target LDL-cholesterol levels were B4.1 mmol/l (160 mg/dl) in the low-risk group, B3.4 mmol/l (130 mg/dl) in the high-risk group, and 5 2.6 mmol/l (100 mg/dl) in the CHD group [8]. Table 1 Potential reasons for the gap between guideline recommendations and what is seen in clinical practice Too many guidelines are currently available and new versions are produced too soon and too often to allow uptake in the ‘real world’ The dissemination of guidelines is generally very poor Guidelines say very little about their own implementation Guidelines are generally not particularly useful. To be practical they need to be simple, consider local requirements, incorporate local expertise, opinion and circumstances Local implementation of national guidelines requires enormous effort which must include educational activities, constant repetition and reminders Implementation of guidelines requires consensus, effort and interaction. It is hard work and it costs money

gram (NCEP) [9]. Twenty-three percent were at low risk ( Btwo risk factors and no evidence of CHD), 47% were at high risk ( ]two risk factors and no evidence of CHD), and 30% had documented CHD. One objective of the study was to estimate the percentage of patients who achieved NCEP goals for lipid therapy. The results of the study showed that even though approximately 95% of the physicians were aware of the NCEP guidelines, only 38% of all patients achieved their NCEP-specified goal for low-density lipoprotein (LDL) cholesterol. The percentage of patients who achieved their goals varied by their level of risk. Only 37% of patients in the high-risk group and 18% of patients with CHD managed to achieve their goals of therapy (Fig. 2). These percentages suggest that the majority of patients on lipid-lowering therapy for dyslipidemia who are at high risk for CHD, or have CHD, are not being treated aggressively enough to reach NCEP goals [8]. Another smaller study from the USA indicated that the percentage of patients in treatment for CHD, but not achieving their goals, does not appear to change if the patient is seen in a clinic or in private practice [10]. After reviewing the medical records of 270 patients with CHD from both private practice and cardiac clinics, only 43% of patients had documentation that they had their lipids tested and only 29% were on lipid-lowering

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therapy. The percentage of patients achieving goal was also poor — only 22% had LDL-cholesterol levels 5 2.6 mmol/l (100 mg/dl) and only 54% had LDLcholesterol levels 53.4 mmol/l (130 mg/dl). While no significant differences in treatment were noted between private practice or the clinics, large differences were noted among individual physicians in their practice patterns. Depending on the physician evaluated, the percentage of patients who had cholesterol levels measured and documented in their records ranged from 0 to 83%. Prescribing patterns also varied widely between physicians such that the proportion of patients on lipid-lowering therapy ranged from 10 to 88% of patients. The authors concluded that individual physician’s beliefs and practices can be an important determinant in treating patients to goal and that the actual clinical setting has little impact [10].

2. Potential obstacles to optimal preventive care

2.1. Guidelines There are numerous potential reasons for the gap between guideline recommendations and what is seen in clinical practice (Table 1). Physician confusion concerning optimal management strategies for CHD prevention may result from conflicting reports in the literature. Physicians, unfamiliar with the Joint Task Force guidelines, may not be aware that they have been developed based on evidence from clinical trial data and may, therefore, feel that the guidelines do not warrant close scrutiny. In the past, numerous sets of guidelines have been developed by various organizations in different countries. These have not always been consistent in their recommendations for the management of patients with CHD, for example in terms of the goals set for lipid-lowering. The application of different cholesterol guidelines leads to considerable variations in decisions to screen and to treat when applied to a representative population [11]. Physicians may also be overwhelmed by the amount of literature they receive. A recent survey of 22 general practices in the UK found 855 different guidelines — a pile 68 cm high and weighing 28 kg [12]. This mass of paper represents a large amount of information, but is in an unmanageable form that does little to aid decision making.

2.2. Healthcare deli6ery systems Many patients with or at risk of CHD have more than one cardiovascular risk factor. However, physicians unfamiliar with the literature may adopt a more focused view, and only treat the particular risk factor relevant to their speciality, instead of screening for and treating all modifiable risk factors present. Low aware-

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ness of the benefits of achieving low cholesterol, specifically LDL-cholesterol, may stem from the fact that cholesterol is not viewed as ‘serious’ compared with other cardiovascular risk factors, potentially due to the fact that it is perceived as a ‘diet’ problem. Healthcare delivery systems and physicians are often focused on acute care and not on the long-term management and secondary prevention of CHD in patients. Once patients with CHD are discharged from hospital, they are no longer routinely managed by the cardiologist or hospital specialist who was responsible for their in-hospital care [13]. Instead, they return to the care of their family physician, who may not be as familiar with the benefits of lowering LDL-cholesterol levels or the recommended Joint Task Force guidelines for the treatment of CHD. Cardiovascular disease is the leading cause of mortality in developed countries and consequently is one of the largest markets for pharmaceutical intervention. The array of preventive drugs available for the management of CHD may therefore be daunting to some physicians. Adding to the confusion are differences in licensing agreements for these drugs worldwide, which may mean that recommended drugs are available in some countries but not others. Variations between countries in a physician’s ability to access adequate laboratory facilities for screening patients may also act as a barrier to determine which patients are priorities for prevention. Assessment of the economic impact of a drug is complex, involving the consideration of many factors, including drug, hospital and indirect costs associated with the disease, its treatment and consequences. There is currently a lack of national evidence-based guidelines in which recommendations are linked with evidence on benefits and costs. Information on the cost:benefit ratio for a treatment is required by physicians for a full understanding of the benefits that can be gained from secondary prevention of CHD.

2.3. Patient Lack of patient awareness of CHD and patient noncompliance also play a role in the less-than-optimal number of patients achieving the predefined goals for therapy. Results from an unpublished survey conducted in Sweden of 1000 patients with CHD revealed that 80% of the patients who reported that they were ‘not feeling well’ at the time of the survey, did not know their cholesterol values, and 60% did not know that lipid-lowering drugs could reduce the risk of future cardiac events. Interestingly, of those that said that they ‘felt better,’ more reported that they were aware of their cholesterol levels and the benefits of lipid-lowering therapy.

A survey of CHD patients from five European countries, which evaluated the response of patients and their families to suggested lifestyle changes, found that only about half actually implemented the changes [14]. The study evaluated 1256 patients after a diagnosis of myocardial infarction. Only one patient in four or five attempted to reduce their cholesterol levels by changing their diet. Only 50% either stopped or reduced smoking and only 30% increased their physical exercise [14].

3. How can we improve preventive care?

3.1. Uni6ersal understanding and implementation of guidelines Guidelines have been shown to change clinical practice and improve patient outcome [15]. The implementation of guidelines and uniform improvement in the quality of screening and treatment of patients with CHD can be achieved, but several conditions must be met in order for this to happen. Physicians in general practice manage a large proportion of presenting problems without referral elsewhere. They require information to help manage difficult or complex decisions, but the information must not be hidden in a mass of paper but should be readily accessible and easy to use. Guidelines need to be presented in a form directly relevant to individual patient care. Wherever possible, treatment decisions should be guided by the absolute risks and benefits of treatment and clearly present goals for therapy and specific targets for intervention. To be accepted, guidelines must be based upon current findings from scientific studies. Once succinct and scientifically valid guidelines have been developed, the responsibility for their implementation to persuade physicians in both hospital and primary care that prevention of CHD should be a primary part of their daily work lies with the local health authority. Using the European Joint Societies recommendations as a benchmark, local authorities should be encouraged to produce their own set of guidelines. These guidelines need to include information on the cost-effectiveness of the recommended treatments to support their application in health care systems with a finite amount of resources. The process should involve multidisciplinary groups of specialists and primary care physicians, and the end-product should be authored by physicians well-known in their geographical area. Physicians are more likely to accept and use guidelines developed with their involvement and by those known to them.

3.2. Care programs A patient recovering from a coronary event or cardiovascular procedure provides an opportunity for ini-

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tiation of risk-reduction strategies. However, barriers to effective management occur at numerous levels of interaction between the patient, general practitioner, specialist and healthcare organization. Therefore, in order to be successful, strategies for secondary prevention of CHD must involve all health care providers treating the patient. These providers must reach a consensus on the care to be provided to a patient with CHD and maintain consistency of care in both the in-patient and out-patient setting. One such example of this kind of consensus-building is shared-care programs. These allow general practitioners, nurses and specialists to become partners in long-term patient management. In successful shared-care programs responsibilities between providers are defined and the patient can benefit from the shared expertise of all involved. Nurse-led shared-care programs have been shown to be successful in providing the additional support and health promotion needed for secondary prevention. In the USA, the work of nurse case managers has evolved to include the care of patients in the out-patient setting. Their role includes: helping to overcome treatment barriers by bridging in-patient/out-patient care; securing long-term patient compliance and follow-up; developing clinic policy and computerized patient databases; and implementing management according to established CHD guidelines[16]. Similar programs have also been adopted in other countries. In the UK, a randomized study has compared intensive management by nurses versus routine follow-up in general practice for patients with CHD. Those patients under intensive care by a nurse reported improvements in their health, functional status, and in the likelihood of hospitalization within the first year of care [17].

3.3. Patient cooperation It is imperative to involve the patient in developing a long-term plan for the management of their disease. Lack of patient compliance includes both changes in lifestyle and the use of drugs. In order to encourage patient compliance in patients with hypercholesterolemia, emphasis must be placed on the notion that guidelines are focused on the prevention of CHD as a whole and that lipid-lowering therapy is just one part of the process. Management of this kind cannot be the responsibility of the physician alone; the patient must also play a role. A program to address this problem has been implemented in Sweden and has now been running since 1997 [18]. The aim of the program is to assess and control the quality of secondary prevention in order to improve the treatment and long-term follow-up of patients with CHD. A ‘patient manual’ is given to all patients during their hospital stay following an acute myocardial infarction or revascularization procedure.

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At discharge, after 3 and 6 months and then each year for 5 years, the patient will fill in a form containing information about risk factors, medical treatment, changes in lifestyle and self-rated health. In addition, all patients healthcare contacts are recorded, regardless of where they take place. It is hoped that this will give the patient increased responsibility in following his/her risk factors over time with the aim of improving compliance. The Swedish program combines shared-care with increased responsibility for the patients. By following changes in lifestyle, risk factors and their treatment over an extended period, it will provide valuable information on whether the goals set by current guidelines are being met, which will enable us to find ways of improving their implementation for the future.

4. Conclusion There is much evidence that pharmacologic therapy and interventions to modify patients’ lifestyles can reduce the risk of future ischemic events in patients at risk for CHD. Many sets of guidelines have been developed that provide targets for secondary prevention of CHD and goals for therapy. Results of surveys evaluating physician’s practice patterns indicate, however, that improvements could be made in the actual implementation of the guidelines into a physician’s routine provision of care. The potential to further reduce the risk of cardiovascular events in patients with established CHD can be achieved with an integrated approach to the management of CHD by specialists, primary-care physicians, health care workers and the patients themselves. To help them in this task succinct and scientifically-valid guidelines are required, such as those produced by the European Joint Societies on CHD prevention.

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