General introduction. Chapter 1

Size: px

Start display at page:

Download "General introduction. Chapter 1"

Mark Lyons
5 years ago
Views:

1 Chapter 1

3 Despite a better understanding of the aetiology and pathophysiology of atherothrombotic vascular disease, and the availability of effective treatment modalities, the burden of vascular disease is likely to increase rather than decrease in the next 20 years (1). The life expectancy of men and women is increasing and will contribute to a higher prevalence of chronic diseases. The global burden of coronary heart disease, cerebrovascular disease, peripheral arterial disease, and abdominal aortic aneurysm is not only increasing, but also shifting from developed to developing countries as a result of increased life expectancy and lifestyle changes in these regions (2). Abnormal lipid profiles, smoking, hypertension, abdominal obesity, psychosocial factors, diminished consumption of fresh fruit and vegetables, excessive alcohol use, and less physical activity are the major risk factors for vascular disease worldwide in both sexes and at all ages (3). Historically, intervention thresholds for the treatment of these vascular risk factors have been based on variable and arbitrary cut-off points for individual risk factors. Indeed, international and national guidelines were often developed for the diagnosis and treatment of a single risk factor (4-6). However, because patients seldom have only one risk factor (7) and multiple risk factors have a multiplicative effect on cardiovascular risk (8), most international guidelines for vascular disease prevention now use an absolute risk approach, taking all major risk factors into account (9-11). Absolute risk is the probability of developing a vascular event in a finite period, e.g. within the next 10 years. For most countries, the threshold for aggressive medical treatment in the general population is a 20% risk of developing a myocardial infarction, ischemic stroke, or vascular death in the coming 10 years. Patients with clinically manifest arterial disease are already at high risk of future vascular events in the same or different arterial bed (12). In these patients intensive risk factor management is needed to reduce the vascular risk. There are two main approaches to reduce the risk of vascular events. The first is to focus interventions on patients likely to benefit the most, the so-called individual highrisk approach. This approach should be integrated in everyday clinical practice. The second is to aim to reduce risk in the entire population regardless of each individual s level of risk and potential benefits. This approach focuses on diet, transport, employment, education, health, and other policies at international, national, regional, and local levels (13). 11

4 12 Chapter 1 It is well established that the occurrence of vascular disease is strongly associated with lifestyle and modifiable factors. Despite the fact that guidelines and recommendations exist for the treatment of the several forms of vascular disease and their associated risk factors, many patients with peripheral arterial disease (14;15), coronary heart disease (16-18), cerebrovascular disease (19), abdominal aortic aneurysm (20;21), and vascular disease in general (22) do not reach treatment goals. Incomplete implementation of appropriate therapy may be one cause of this failure. Three groups of barriers to the implementation of evidence-based guidelines have been suggested: physician-related, patient-related, and healthcare-related (23). Physician-related barriers include lack of knowledge of the best current evidence, lack of agreement with specific guidelines, or insufficient belief that an intervention will lead to an improved outcome (24). Patient-related barriers include poor compliance with prescribed drugs, time, financial constraints, and lack of motivation to make lifestyle changes (quit smoking, increase physical activity, adopt a healthy diet) that are crucial for vascular risk reduction. In a study examining the patterns and predictors of compliance with concomitant antihypertensive and lipid-lowering agents, only 1 in 3 patients in a group of 8406 patients were compliant with both medications at 6 months (25). Patients were more likely to be compliant if antihypertensive and lipid-lowering agents were initiated simultaneously, if they had a higher absolute cardiovascular risk, or if they took fewer other medications. Lastly, healthcare-related barriers include the lack of systematic approaches to the care of chronic illnesses. With the shift from short-stay acute tertiary hospital care to patient-centred, home-based, and team-driven care, new skills, multidisciplinary collaboration, and continuity of care (follow-up arrangements) are required (26). Objectives The objective of the studies described in this thesis is twofold. To examine additional interventions aimed at reducing the vascular risk of patients with clinical manifestations of arterial disease, and to distinguish high-risk from low-risk patients by predicting the risk of a recurrent vascular event at the same or at another site of the vascular tree. The study population consisted of participants of the Second Manifestations of ARTerial disease (SMART) study, an ongoing single-centre prospective cohort study of the University Medical Center Utrecht. The aim of the SMART study is to investigate the prevalence and incidence of additional vascular diseases in patients who already have a

5 Suspect of vascular disease or poorly controlled risk factors Vascular Surgeon Internist Carotid artery stenose Peripheral arterial disease Abdominal aortic aneurysm Hypertension Hyperlipidemia Diabetes mellitus 13 Cardiologist Neurologist Myocardial infarction Transient ischemic attack Angina pectoris Ischemic stroke Figure 1. Disease categories of the SMART study clinical manifestation of arterial disease or who are otherwise at high risk (type 1 or 2 diabetes mellitus, hypertension, hyperlipidemia) of developing symptomatic arterial disease (27). Patients were referred by general practitioners or by medical specialists from other hospitals. All referral diagnoses were confirmed by vascular specialists at the outpatient clinics. Patients were classified into disease categories on the basis of their referral diagnosis and vascular history. The different disease categories are represented in Figure 1. Parallel to the medical treatment or intervention given by the treating

6 Treating vascular specialist General practitioner 14 Diagnosis Inclusion SMART Chapter 1 Diagnostic work up Treatment Vascular screening - blood + urine analysis - ankle brachial pressure index - duplex scan carotid arteries - ultrasonography abdomen - electrocardiogram - health questionnaire Evaluation Results and treatment recommendations Follow-up Biannual follow-up - vascular hospitalization - outpatient clinic visit Figure 2. Workflow of vascular screening vascular specialist, patients included in the SMART study underwent a standardized noninvasive vascular screening program. The results of the screening program and treatment recommendations were discussed at weekly meetings of a multidisciplinary team and were reported in writing to the treating specialist and the general practitioner, with further action being left to their discretion (Figure 2). Patients included in the SMART study were asked to complete a questionnaire on hospitalizations and outpatient clinic visits biannually, in order to detect non-fatal and fatal vascular events.

7 Outline of this thesis The outline of this thesis is as follows. The review, described in chapter 2, outlines the consequences of important vascular risk factors and the impact of various manifestations of arterial disease on life expectancy. The prevalence of risk factors and the additional benefit of non-invasive screening to detect asymptomatic arterial disease in patients at low risk or high risk of experiencing (new) vascular events, according to the European Guidelines of Cardiovascular Disease Prevention, are discussed in chapter 3. In the study reported in chapter 4, the relationship between asymptomatic carotid artery stenosis and the risk of new vascular events was established. In chapter 5 the performance of Framingham, PROCAM, and Systematic COronary Risk Evaluation (SCORE) prediction models in the SMART population is discussed, and the development of a new risk model for the prediction of recurrent vascular events in patients with manifest arterial disease is described. In chapter 6, a longitudinal study, also called second vascular screening, to establish the relationship between baseline variables and subsequent vascular events in patients with symptomatic peripheral arterial disease is described. Thereafter, the changes and the amount of vascular risk factors were studied between baseline and 5.5 years follow-up. The study described in chapter 7 investigated whether the recommendations given to the treating vascular specialist and the general practitioner by a multidisciplinary team of vascular specialists regarding the medical treatment of risk factors (based on international guidelines) led to changes in medication use in a high-risk population. The randomized controlled trial Vascular prevention by NUrses Study (VENUS) is presented in chapter 8. This study investigated whether the extra care of a nurse practitioner plus usual care compared to usual care alone was beneficial for the cardiovascular risk profile of patients with clinical manifestations of arterial disease. Chapter 9 presents the rationale and design of a feasibility study, the Self-management of vascular Patients Activated by the Internet and Nurses study (SPAIN). The aim of this study was to develop and test a safe patient-specific website to provide patients with clinical manifestations of arterial disease additional treatment and individual coaching by a nurse practitioner regarding several vascular risk factors. In the general discussion, chapter 10, the main findings of the different chapters are presented and discussed. Finally, a summary of the results presented in this thesis is given in chapter 11. Figure 3 gives an overview of the different study samples that were used for the different studies described in this thesis. 15

8 Second Manifestations ARTerial disease (SMART) study Clinical manifestations of arterial disease Vascular risk factors 16 Chapter 1 Coronary heart disease (CHD) Cerebrovascular disease (stroke / TIA) Peripheral arterial disease (PAD) Abdominal aortic aneurysm (AAA) Diabetes mellitus (DM) Hypertension Hyperlipidemia Chapter 3 Inclusion: Sep March patients with all inclusion diagnosis Chapter 4 Inclusion: Sep March patients with CHD, AAA, PAD, DM and without a history of stroke / TIA Chapter 5 Inclusion: Sep March patients with CHD, stroke / TIA, PAD, or AAA Chapter 6 Inclusion: Sep Dec patients with symptomatic PAD Sub-study Second vascular screening Chapter 7 Inclusion: Jan Aug patients with CHD, stroke / TIA, PAD, or AAA Chapter 8 Inclusion: Jan March patients with stroke / TIA or PAD and at least 2 modifiable risk factors Sub-study VENUS Chapter 9 Inclusion: Nov July patients with CHD, stroke / TIA, PAD, or AAA Sub-study SPAIN Figure 3. Overview of the different study samples

9 Reference List 1. Murray CJ, Lopez AD. Alternative projections of mortality and disability by cause : Global Burden of Disease Study. Lancet 1997; 349: Murray CJ, Lopez AD. Mortality by cause for eight regions of the world: Global Burden of Disease Study. Lancet 1997; 349: Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet 2004; 364: Standards of medical care for patients with diabetes mellitus. American Diabetes Association. Diabetes Care 1994; 17: The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med 1993; 153: National Cholesterol Education Program. Second Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). Circulation 1994; 89: Zanchetti A. The hypertensive patient with multiple risk factors: is treatment really so difficult? Am J Hypertens 1997; 10:223S-229S. 8. Kannel WB, D Agostino RB, Sullivan L, Wilson PW. Concept and usefulness of cardiovascular risk profiles. Am Heart J 2004; 148: European Society of Hypertension-European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertens 2003; 21: De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J et al. European guidelines on cardiovascular disease prevention in clinical practice. Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Eur Heart J 2003; 24: Pearson TA, Blair SN, Daniels SR, Eckel RH, Fair JM, Fortmann SP et al. AHA Guidelines for Primary Prevention of Cardiovascular Disease and Stroke: 2002 Update: Consensus Panel Guide to Comprehensive Risk Reduction for Adult Patients Without Coronary or Other Atherosclerotic Vascular Diseases. American Heart Association Science Advisory and Coordinating Committee. Circulation 2002; 106: Drouet L. Atherothrombosis as a systemic disease. Cerebrovasc Dis 2002; 13 Suppl 1: World Health Organization: The World Health Report 2003: shaping the future. 14. Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW et al. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA 2001; 286: Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, Circulation 2004; 110:

10 18 Chapter EUROASPIRE. A European Society of Cardiology survey of secondary prevention of coronary heart disease: principal results. EUROASPIRE Study Group. European Action on Secondary Prevention through Intervention to Reduce Events. Eur Heart J 1997; 18: Lifestyle and risk factor management and use of drug therapies in coronary patients from 15 countries; principal results from EUROASPIRE II Euro Heart Survey Programme. Eur Heart J 2001; 22: Clinical reality of coronary prevention guidelines: a comparison of EUROASPIRE I and II in nine countries. EUROASPIRE I and II Group. European Action on Secondary Prevention by Intervention to Reduce Events. Lancet 2001; 357: Puranen J, Laakso M, Riekkinen P, Sr., Sivenius J. Risk factors and antiplatelet therapy in TIA and stroke patients. J Neurol Sci 1998; 154: Shteinberg D, Halak M, Shapiro S, Kinarty A, Sobol E, Lahat N et al. Abdominal aortic aneurysm and aortic occlusive disease: a comparison of risk factors and inflammatory response. Eur J Vasc Endovasc Surg 2000; 20: Lloyd GM, Newton JD, Norwood MG, Franks SC, Bown MJ, Sayers RD. Patients with abdominal aortic aneurysm: are we missing the opportunity for cardiovascular risk reduction? J Vasc Surg 2004; 40: Bhatt DL, Steg PG, Ohman EM, Hirsch AT, Ikeda Y, Mas JL et al. International prevalence, recognition, and treatment of cardiovascular risk factors in outpatients with atherothrombosis. JAMA 2006; 295: Rich MW. From clinical trials to clinical practice: bridging the GAP. JAMA 2002; 287: Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA et al. Why don t physicians follow clinical practice guidelines? A framework for improvement. JAMA 1999; 282: Chapman RH, Benner JS, Petrilla AA, Tierce JC, Collins SR, Battleman DS et al. Predictors of adherence with antihypertensive and lipid-lowering therapy. Arch Intern Med 2005; 165: Dancy M. Bridging the treatment gap: the secondary care perspective. Heart 2005; 91 Suppl 2:ii Simons PC, Algra A, van de Laak MF, Grobbee DE, van der Graaf Y. Second Manifestations of ARTerial disease (SMART) study: rationale and design. Eur J Epidemiol 1999; 15:

Abstract. Objective. Chapter 3

Abstract. Objective. Chapter 3 Screening for asymptomatic cardiovascular disease with non-invasive imaging in patients at high risk and low risk according to the European Guidelines on Cardiovascular Disease Prevention. The SMART study