Risk factor modification in intermittent claudication: effect on life expectancy and walking capacity

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1 European Heart Journal Supplements (2002) 4 (Supplement B), B50 B54 Risk factor modification in intermittent claudication: effect on life expectancy and walking capacity Section of Vascular Medicine, Divisions of Geriatrics and Cardiology, Department of Medicine, University of Colorado Health Sciences Center, Denver, Colorado, U.S.A. Peripheral arterial disease (PAD) is among the common manifestations of systemic atherosclerosis. In the U.S.A. it is estimated that this disorder affects 8 10 million adults, with resultant increased risk for cardiovascular morbidity and mortality. Thus, 50% of patients with PAD will have a fatal or non-fatal cardiovascular event within 5 years. The initial treatment goal in patients with PAD is to identify their risk factors for atherosclerosis and then to initiate risk factor modification. These patients should all be placed on antiplatelet therapy as well. However, these interventions typically do not result in an immediate change in the symptoms of PAD, mainly intermittent claudication, and additional interventions are necessary to treat this disabling symptom. These include a formal exercise programme; with regard to pharmacological therapies cilostizol is available in the U.S.A., and several medications that are effective including propionyl-l-carnitine are available in Europe. (Eur Heart J Supplements 2002; 4 (Suppl B): B50 B54) 2002 The European Society of Cardiology Key Words: Intermittent claudication, peripheral arterial disease. Introduction Peripheral arterial disease (PAD) involves atherosclerotic occlusion of the arterial circulation to the legs. The typical patient with PAD presents with intermittent claudication that results in a profound limitation in exercise capacity and quality of life. In addition to affecting the legs, PAD is a manifestation of systemic atherosclerosis that involves other major circulations, such as the cerebral and coronary arteries. Thus, all patients with PAD are at increased risk for cardiovascular morbidity and mortality. The treatment goals are directed at providing symptom relief and at reducing the risk for systemic cardiovascular morbidity and mortality. An overall approach to the treatment of PAD is presented in Fig. 1 [1]. Risk factor modification The risk factors for PAD are similar to those for coronary artery disease. The most potent risk factors for PAD are age, Correspondence: William R. Hiatt, MD, Novartis Professor of Cardiovascular Research, University of Colorado Health Sciences Center, Colorado Prevention Center, 789 Sherman St., Suite 200, Denver, CO 80203, U.S.A X/02/0B $35.00/0 diabetes mellitus and cigarette smoking. In addition, hyperlipidaemia, hypertension and elevations in plasma homocysteine levels play important roles in promoting peripheral atherosclerosis. The primary initial goals of medical therapy in patients with PAD are to treat the systemic atherosclerosis by risk factor modification and antiplatelet drugs in an attempt to reduce cardiovascular morbidity and mortality. Once that has been accomplished, the physician can then address symptom relief and limb preservation. Age PAD is particularly prevalent in the elderly. In several studies, the risk of PAD increased approximately twofold for every 10-year increase in age [2]. Diabetes mellitus Diabetes is a major risk factor for PAD, raising the risk fourfold to fivefold as compared with non-diabetic persons [2]. It appears that the association of smoking, hypertension and hyperlipidaemia contribute more to atherosclerosis than does the degree of glycaemic control [3] The European Society of Cardiology

2 Risk factor modification in intermittent claudication B51 Figure 1 Evaluation and treatment of patients with proven peripheral arterial disease. All patients with peripheral arterial disease, regardless of symptom severity, should undergo risk factor modification to achieve the listed treatment goals and receive antiplatelet drug therapy with aspirin, but clopidogrel is an acceptable alternative drug. Angiotensin-converting enzyme (ACE) inhibitors should be considered because of their potential to prevent ischaemic events, which is independent of blood pressure (BP) lowering. A treadmill test to define the absolute claudication distance (ACD) and the initial claudication distance (ICD) can provide an objective assessment of the severity of claudication and response to therapy. The functional limitations of claudication and response to therapy can also be quantified by the physical function scales of the non-disease-specific Medical Outcomes Short Form 36 questionnaire (SF-36) and the disease-specific Walking Impairment Questionnaire (WIQ). Treatment of claudication should begin with exercise therapy or drugs such as cilostazol. Patients who do not improve and remain disabled, or who have worsening symptoms, should have additional localization of the occlusive lesions to plan endovascular or surgical intervention. Non-invasive disease localization can be done with haemodynamic tests such as segmental limb pressures and/or pulse volume recordings. In addition, duplex ultrasound and magnetic resonance angiography both have a high sensitivity and specificity for localization of lesions, but conventional angiography is still required in most patients before a surgical or angioplasty procedure. Patients with critical leg ischaemia typically have an ankle brachial index below 0 40 and should initially be considered for localization of their occlusive disease in anticipation of the need for revascularization. (Reprinted with permission from the New England Journal of Medicine [1].) Patients with diabetes should first undergo intensive blood glucose control to achieve a haemoglobin A1c of below 7 0%. Attaining this goal may have favourable effects on risk for cardiovascular events in both type 1 and type 2 diabetes [4,5]. However, intensive glycaemic control had no effect on the risk of amputation from PAD in one study. [5] In addition to intensive blood sugar control, patients with atherosclerosis and diabetes also require aggressive risk factor modification. This may be particularly true in the treatment of hypertension, in which an angiotensinconverting enzyme (ACE) inhibitor may be the preferable agent [6]. Given the lack of specific trials, drug therapy for patients with diabetes and PAD should follow general published recommendations [7]. Cigarette smoking Cigarette smoking is associated with an approximate threeto fourfold increase in risk for peripheral atherosclerosis [8]. In addition, disease progression from intermittent claudication to ischaemic rest pain to amputation occurs significantly more frequently in patients who continue to smoke than in those who stop [9,10]. Several studies [9,11] have suggested that smoking cessation will decrease the risk for critical leg ischaemia, and may even reduce mortality in patients with PAD. However, a recent meta-analysis [12] suggested that smoking cessation results in a modest, nonsignificant increase in walking capacity. All patients with PAD should be referred to a smoking cessation programme,

3 B52 and prescribed nicotine replacement and antidepressants when additional pharmacological treatment is needed to assist in the cessation effort. Hyperlipidaemia Independent risk factors for PAD include a reduced highdensity lipoprotein (HDL)-cholesterol level, and elevations in total cholesterol, low-density lipoprotein (LDL)- cholesterol, triglycerides and lipoprotein(a) [2,8]. Several effective therapies have been developed to treat patients with hyperlipidaemia. The statin drugs are very effective at reducing LDL-cholesterol levels. In addition, fibrates modestly lower LDL-cholesterol concentration, but are more effective in increasing in HDL-cholesterol concentrations. Additional means to modify HDL-cholesterol concentration is with the use of niacin, which in a recent study [13] was found to be safe in patients with PAD and diabetes. In patients with PAD, a meta-analysis of lipid-lowering studies [14] showed a non-significant reduction in mortality (odds ratio 0 21, 95% confidence interval ), because of the relatively small sample size. That analysis also concluded that lipid reduction therapies favourably altered angiographic disease progression and symptoms of claudication. In addition, treatment with statins has been shown to reduce the risk for developing claudication [15] and to improve endothelial function in PAD patients with hypercholesterolaemia [16]. Unfortunately, there have been no large clinical trials in patients with PAD that directly assessed the benefits of lipid-lowering therapy to prevent ischaemic events. Despite this limitation, the National Cholesterol Education Program III guidelines [17] include patients with PAD as a population that is at high risk for future coronary heart disease events and is therefore in need of aggressive secondary prevention therapies. The current recommendation for lipid-lowering therapy in the PAD population is to achieve an LDL-cholesterol level below 100 mg. dl 1 and a triglyceride level below 150 mg. dl 1[18]. The LDL-cholesterol goals will often require the use of a statin, and achieving the HDL-cholesterol goals will often require the use of niacin. Hypertension The presence of hypertension increases risk for PAD approximately twofold to threefold [2,8]. According to the Joint National Committee VI guidelines [19], all patients with PAD and hypertension should receive aggressive treatment to lower their blood pressure. All classes of antihypertensive agents can be used in patients with PAD; this includes beta-adrenergic blockers, which, contrary to the general notion that they may deteriorate leg symptomalogy, are safe in patients with claudication [20]. In addition, beta-adrenergic blockers are routinely used in the perioperative setting to decrease the risks for vascular surgery [21]. Another class of drugs, the ACE inhibitors, may be protective against cardiovascular events in PAD patients. In the Heart Outcomes Prevention Evaluation study, 44% of the population had evidence of PAD [22]. That study demonstrated that ramipril was associated with a 20% reduced risk for vascular death, non-fatal myocardial infarction or stroke in patients with PAD, and suggests that ACE inhibitors may be important agents in reducing the risk for ischaemic events in the PAD population. Antiplatelet therapy In addition to risk factor modification, other therapies have been employed to slow the progression of peripheral atherosclerosis as well as to decrease the risk for cardiovascular morbidity and mortality. The role of platelets in thrombus formation has led to many studies of the effectiveness of various antiplatelet agents, particularly aspirin, in the prevention of ischaemic events. A meta-analysis by the Antiplatelet Trialists Collaboration [23] concluded that, in patients with a history of myocardial infarction or stroke, antiplatelet therapy reduced the risk for ischemic events by approximately 25%. In patients with PAD treated with bypass surgery, the Antiplatelet Trialists Collaboration also found that antiplatelet therapy significantly promoted graft patency following vascular surgery [24]. Furthermore, in a primary prevention trial [25] aspirin reduced the subsequent need for peripheral arterial surgery. Thus, it would appear prudent to treat patients with PAD with low-dose aspirin. In patients with PAD, ticlopidine has been shown to be more effective than placebo in reducing the need for vascular surgery [26] and risk for fatal and non-fatal myocardial infarction and stroke [27,28]. This observation led to the development of other drugs, including clopidogrel, which lacks many of the side effects of ticlopidine. The Clopidogrel versus Aspirin for the Prevention of Ischaemic Events (CAPRIE) trial [29] demonstrated that PAD patients exhibited a 24% reduction in risk for ischaemic events with clopidogrel as compared with aspirin. Exercise training A programme of supervised exercise has demonstrated efficacy in improving exercise performance, quality of life and functional capacity [30]. The typical benefits include a % improvement in peak exercise performance on the treadmill and significant improvements in functional status [31]. However, the effects of exercise on cardiovascular risk factors are less well studied, but exercise training may induce modest improvements in glucose resistance, lipids and blood pressure. Conclusion PAD is a prevalent manifestation of atherosclerosis that is associated with significant risk for morbidity and mortality,

4 Risk factor modification in intermittent claudication B53 Table 1 Clinical benefits of risk factor modification, drug therapy and exercise training in patients with intermittent claudication Treatment MI/stroke/death Leg events Symptoms Risk modification Smoking cessation Possible Risk amputation No benefit Diabetes Possible benefit No benefit Not known Dyslipidaemia* Possible Progression Possible benefit Hypertension* Possible Not known No benefit ACE inhibition Risk Not known Not known Antiplatelet drugs Aspirin Possible Improved graft patency No benefit Ticlopidine Risk Improved graft patency Possible benefit Clopidogrel Risk Not known Not known *The benefits of treating hypertension and hyperlipidaemia have been well established in other populations. ACE=angiotensin-converting enzyme; MI=myocardial infarction. and with marked reduction in ambulatory capacity and quality of life. Patients with PAD should be considered candidates for secondary disease prevention strategies. Target goals for the management of atherosclerotic risk factors should be achieved in all PAD patients. The use of ACE inhibitors may confer additional benefits in terms of reduction in risk for fatal and non-fatal ischaemic events. Study data provide compelling support for the use of antiplatelet therapies to prevent ischaemic events in PAD. Aspirin should be considered in all PAD patients, with clopidogrel an alternate (and potentially more effective) agent. Importantly, none of these therapies has been shown to result in symptom relief. Medical therapies to treat the symptoms of claudication and limited mobility are now well established. A supervised walking exercise programme should first be considered in all patients, given the low risk and marked improvements seen in functional capacity. Pharmacological therapies are also available that offer meaningful improvements in functional status. However, treatments directed at relieving the symptoms of claudication do not necessarily reduce the risk for ischaemic events. Thus, a broad approach is required in the treatment of PAD, recognizing that therapies to prevent mortality do not necessarily treat the symptoms. Table 1 contrasts these various approaches. References [1] Hiatt WR. Medical treatment of peripheral arterial disease and claudication. N Engl J Med 2001; 344: [2] Hiatt WR, Hoag S, Hamman RF. Effect of diagnostic criteria on the prevalence of peripheral arterial disease. The San Luis Valley diabetes study. Circulation 1995; 91: [3] Beach KW, Strandness DE. Arteriosclerosis obliterans and associated risk factors in insulin-dependent and non-insulindependent diabetes. Diabetes 1980; 29: [4] Anonymous. Effect of intensive diabetes management on macrovascular events and risk factors in the Diabetes Control and Complications Trial. Am J Cardiol 1995; 75: [5] Anonymous. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998; 352: [6] Estacio RO, Jeffers BW, Hiatt WR et al. The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension. N Engl J Med 1998; 338: [7] DeFronzo RA. Pharmacologic therapy for type 2 diabetes mellitus. Ann Intern Med 1999; 131: [8] Murabito JM, D Agostino RB, Silbershatz H, Wilson WF. Intermittent claudication. A risk profile from The Framingham Heart Study. Circulation 1997; 96: [9] Quick CRG, Cotton LT. The measured effect of stopping smoking on intermittent claudication. Br J Surg 1982; 69(suppl): S24 6. [10] Stewart CP. The influence of smoking on the level of lower limb amputation. Prosthet Orthot Int 1987; 11: [11] Jonason T, Bergstrom R. Cessation of smoking in patients with intermittent claudication. Acta Med Scand 1987; 221: [12] Girolami B, Bernardi F, Prins MH et al. Treatment of intermittent claudication with physical training smoking cassation, pentoxfylline, or nafronyl: a meta-analysis. Arch Intern Med 1999; 159: [13] Elam MB, Hunninghake DB, Davis KB et al. Effect of niacin on lipid and lipoprotein levels and glycemic control in patients with diabetes and peripheral arterial disease: the ADMIT study: a randomized trial. Arterial Disease Multiple Intervention Trial. JAMA 2000; 284: [14] Leng GC, Price JF, Jepson RG. Lipid-lowering for lower limb atherosclerosis (Cochrane Review). In: The Cochrane Library. Oxford, Update Software, [15] Pedersen TR, Kjekshus J, Pyorala K et al. Effect of simvastatin on ischemic signs and symptoms in the Scandinavian simvastatin survival study (4S). Am J Cardiol 1998; 81: [16] Kahn F, Litchfield SJ, Belch JJ. Cutaneous microvascular responses are improved after cholesterol-lowering in patients with peripheral arterial disease. Adv Exp Med Biol 1997; 428: [17] Anonymous. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA 2001; 285: [18] Ansell BJ, Watson KE, Fogelman AM. An evidence-based assessment of NCEP Adult Treatment Panel II guidelines. National Cholesterol Education Program. JAMA 1999; 282: [19] Anonymous. The sixth report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. Arch Intern Med 1997; 157: [20] Radack K, Deck C. Beta-adrenergic blocker therapy does not worsen intermittent claudication in subjects with peripheral arterial disease. A meta-analysis of randomized controlled trials. Arch Intern Med 1991; 151: [21] Poldermans D, Boersma E, Bax JJ et al. The effect of bisoprolol on perioperative mortality and myocardial infarction in high-risk patients undergoing vascular surgery. N Engl J Med 1999; 341:

5 B54 [22] The Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med 2000; 342: [23] Anonymous. Collaborative overview of randomised trials of antiplatelet therapy. I: prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Antiplatelet Trialists Collaboration. BMJ 1994; 308: [24] Anonymous. Collaborative overview of randomised trials of antiplatelet therapy. II: maintenance of vascular graft or arterial patency by antiplatelet therapy. Antiplatelet Trialists Collaboration. BMJ 1994; 308: [25] Goldhabez SZ, Manson JE, Stampfer MJ et al. Low-dose aspirin and subsequent arterial surgery in the Physician Health Study. Lancet 1992; 340: [26] Berqvist D, Almgren B, Dickinson JP. Reduction of requirement for leg vascular surgery during long-term treatment of claudicant patients with ticlopidine: results from the Swedish Ticlopidine Multicentre Study (STIMS). Eur J Vasc Endovasc Surg 1995; 10: [27] Bokissel JP, Peyrieux JC, Destors JM. Is it possible to reduce the risk of cardiovascular events in subjects suffering from intermittent claudication of the lower limbs? Thromb Haemost 1996; 62: [28] Arcan JC, Blanchard J, Boissel JP, Destors JM, Panak E. Multicenter double-blind study of ticlopidine in the treatment of intermittent claudication and the prevention of its complications. Angiology 1988; 39: [29] CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet 1996; 348: [30] Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA 1995; 274: [31] Regensteiner JG, Steiner JF, Hiatt WR. Exercise training improves functional status in patients with peripheral arterial disease. J Vasc Surg 1996; 23:

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