cardiovascular-agents and Peripheral-Vascular-Diseases

Despite significant advances in vascular biology, bioengineering, and pharmacology, restenosis remains a limitation to the overall efficacy of vascular reconstructions, both percutaneous and open. Although the pathophysiology of intimal hyperplasia is complex, a number of drugs and molecular tools have been identified that can prevent restenosis. Moreover, the focal nature of this process lends itself to treatment with local drug administration. This article provides a broad overview of current and future techniques for local drug delivery that have been developed to prevent restenosis after vascular interventions.. A systematic electronic literature search using PubMed was performed for all accessible published articles through September 2012. In an effort to remain current, additional searches were performed for abstracts presented at relevant societal meetings, filed patents, clinical trials, and funded National Institutes of Health awards.. The efficacy of local drug delivery has been demonstrated in the coronary circulation with the current clinical use of drug-eluting stents. Until recently, however, drug-eluting stents were not found to be efficacious in the peripheral circulation. Further pursuit of intraluminal devices has led to the development of balloon-based technologies, with a recent surge in trials involving drug-eluting balloons. Early data appear encouraging, particularly for treatment of superficial femoral artery lesions, and several devices have recently received the Conformité Européene mark in Europe. Investigators have also explored the periadventitial application of biomaterials containing antirestenotic drugs, an approach that could be particularly useful for surgical bypass or endarterectomy. In the past, systemic drug delivery has been unsuccessful; however, there has been recent exploration of intravenous delivery of drugs designed specifically to target injured or reconstructed arteries. Our review revealed a multitude of additional interesting strategies, including >65 new patents issued during the past 2 years for approaches to local drug delivery focused on preventing restenosis.. Restenosis after intraluminal or open vascular reconstruction remains an important clinical problem. Success in the coronary circulation has not translated into solutions for the peripheral arteries. However, our literature review reveals a number of promising approaches, including drug-eluting balloons, periadventitial drug delivery, and targeted systemic therapies. These and other innovations suggest that the future is bright and that a solution for preventing restenosis in peripheral vessels will soon be at hand.

Topics: Animals; Cardiac Catheters; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug Carriers; Drug-Eluting Stents; Endovascular Procedures; Equipment Design; Humans; Hyperplasia; Neointima; Percutaneous Coronary Intervention; Peripheral Vascular Diseases; Secondary Prevention; Treatment Outcome; Vascular Access Devices

Since patients with peripheral arterial occlusive disease (PAOD) are at high-risk for cardiovascular morbidity and mortality, preventive measures aimed to reduce cardiovascular adverse events are advocated in the current guidelines. We conducted a systematic review to assess the implementation of secondary prevention (SP) measures in PAOD patients.. PubMed, Cochrane Library, EMBASE and Web of Science databases were searched to perform a systematic review of the literature from 1999 till June 2008 on SP for PAOD patients. Assessment of study quality was done following the Cochrane Library review system. The record outcomes were antiplatelet agents, heart rate lowering agents, blood pressure lowering agents, lipid lowering agents, glucose lowering agents, smoking cessation and walking exercise.. From a total of 2137 identified studies, 83 observational studies met the inclusion criteria, of which 24 were included in the systematic review comprising 34 157 patients. These patients suffered from coronary artery disease (n=3516, 41%), myocardial infraction (n=2647, 38%), angina pectoris (n=1790, 31%), congestive heart failure (n=2052, 14%), diabetes mellitus (n=10 690, 31%),hypertension (n=20 823, 73%) and hyperlipidaemia (n=15 067, 64%). Contrary to what the guidelines prescribe, antiplatelet agents, heart rate lowering agents, blood pressure lowering agents and lipid lowering agents were prescribed in 63%, 34%, 46% and 45% of the patients, respectively. Glucose lowering agents were prescribed in 81% and smoking cessation in 39% of the patients.. The majority of patients suffering from PAOD do not receive the entire approach of SP measures as suggested by the current guidelines. To our knowledge, the cause of this undertreatment is multifactorial: patient, physician or health-care-related.

Topics: Aged; Arterial Occlusive Diseases; Cardiovascular Agents; Cardiovascular Diseases; Evidence-Based Medicine; Exercise; Female; Guideline Adherence; Humans; Male; Middle Aged; Peripheral Vascular Diseases; Practice Guidelines as Topic; Risk Assessment; Risk Factors; Risk Reduction Behavior; Secondary Prevention; Smoking Cessation; Walking

Ever since the first percutaneous transluminal angioplasty (PTA) was carried out in Switzerland in 1977, restenosis remains a major drawback of this minimally invasive treatment intervention. Numerous attempts to increase vessel patency after PTA have included systemic medications and endovascular brachytherapy, but these techniques have not met our expectations in preventing restenosis. Nitinol stents have been shown to reduce rates of restenosis and target lesion revascularization in patients undergoing endovascular treatment of long femoropopliteal obstructions. Despite further technical refinements in nitinol stent technology, restenosis occurs in approximately every third patient undergoing femoropopliteal stenting. Similarly, initial clinical trials with drug-eluting stents have failed to indicate restenosis inhibition in femoropopliteal segment. Unfortunately, restenosis rates after below-the-knee PTA and stenting have been reported to be even higher than those following femoropopliteal revascularization. Current concepts for the prevention and treatment of restenosis after PTA or stenting include the sustained release of antiproliferative paclitaxel into the vessel wall. Drug eluting balloons are a promising, novel technology aimed at inhibiting restenosis after PTA. Its clinical efficacy in reducing restenosis has already been proven for coronary arteries as well as for the femoropopliteal segment. The purpose of this article is to review the clinical utility of drug-eluting balloons for lower limb endovascular interventions.

Topics: Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Constriction, Pathologic; Drug-Eluting Stents; Humans; Lower Extremity; Peripheral Vascular Diseases; Prosthesis Design; Radiography; Secondary Prevention; Treatment Outcome; Vascular Patency

A total of 12,000 infrainguinal bypass grafts are performed annually in the United Kingdom, with outcomes suboptimal: 20% of above-knee vein grafts require intervention by 3 years. Transatlantic Inter-Society Consensus (TASC) guidelines exist on pharmacological management of peripheral vascular disease patients, however, little is recommended regarding optimum pharmacological management following revascularization to improve graft patency. The current recommendation is that all patients are on an antiplatelet agent following bypass grafting, the only intervention with significant evidence supporting use. This article will review pharmacological strategies aimed at improving the survival of infrainguinal vein grafts and the current evidence base for their use.

Topics: Cardiovascular Agents; Combined Modality Therapy; Evidence-Based Medicine; Humans; Lower Extremity; Peripheral Vascular Diseases; Practice Guidelines as Topic; Time Factors; Treatment Outcome; Vascular Patency; Vascular Surgical Procedures; Veins

The incidence of peripheral arterial disease (PAD) is on the increase and is associated with a major health concern in current practical care. The most common disease process underlying PAD is atherosclerosis. Atherosclerosis is a complex generalized disease affecting several arterial beds, including the peripheral and coronary circulation. Especially in patients with PAD, high incidences of coronary artery disease (CAD) have been observed, which may be asymptomatic or symptomatic. The prognosis of patients with PAD is related to the presence and extent of underlying CAD. In patients with PAD undergoing major vascular surgery, cardiac complications are the major cause of perioperative morbidity and mortality and indicate a high-risk for adverse long-term cardiac outcome. In order to improve outcome for PAD patients, assessment and aggressive therapy of atherosclerotic risk factors and usage of cardio-protective medications is recommended. Unfortunately, substantial differences in risk factor management and treatment and long-term outcome have been reported between PAD and CAD patients.

Topics: Cardiovascular Agents; Cardiovascular Diseases; Coronary Artery Disease; Humans; Peripheral Vascular Diseases; Predictive Value of Tests; Risk Assessment; Risk Factors; Risk Reduction Behavior; Treatment Outcome; Vascular Surgical Procedures

To ascertain the effectiveness of medical therapy for reducing risk in peripheral artery disease (PAD) and to model the potential impact of combining multiple efficacious approaches.. 17 electronic databases, reference lists of primary studies, clinical practice guidelines, review articles, trial registries and conference proceedings from cardiology, vascular surgery and atherosclerosis meetings were screened. Eligible studies were randomized trials or meta-analyses of randomized trials of medical therapy for PAD which reported major cardiovascular events (myocardial infarction, stroke and cardiovascular death). Baseline event rates for modelling analyses were derived from published natural history cohorts. Overall, three strategies had persuasive evidence for reducing risk in PAD: antiplatelet agents (pooled RRR 26%, 95% CI 10 to 42), statins (pooled RRR 26%, 95% CI 18 to 33) and angiotensin-converting enzyme inhibitors (individual trial RRR 25%, 95% CI 8 to 39). The estimated cumulative relative risk reduction for all three strategies was 59% (CI 32 to 76). Given a 5-year major cardiovascular event rate of 25%, the corresponding absolute risk reduction and number needed to treat to prevent one event were 15% (CI 8 to 19) and 7 (CI 5 to 12), respectively. Population level analyses suggest that increased uptake of these modalities could prevent more than 200 000 events in patients with PAD each year.. The use of multiple efficacious strategies has the potential to substantially reduce the cardiovascular burden of PAD. However, these data should be regarded as hypothetical, since they are based on mathematical modelling rather than factorial randomized trials.

Topics: Cardiovascular Agents; Cardiovascular Diseases; Drug Therapy, Combination; Evidence-Based Medicine; Humans; Models, Statistical; Peripheral Vascular Diseases; Sensitivity and Specificity

Cerebrovascular disease is one of the leading causes of morbidity and mortality in developed countries. The identification of at-risk individuals is a high priority so that efficacious preventive measures can be implemented. Subjects with the highest risk of cerebrovascular diseases are those who already have had a stroke or a transient ischemic attack, and those with vascular disease in other territories, either in coronary or peripheral arteries. Other subjects at risk are those with cardiac disease, such as atrial fibrillation, those with hypertension, diabetes and smoking habit, as well as individuals with subclinical vascular disease. Although there is considerable evidence for the efficacy of preventive treatment in this population, the percentage of patients receiving optimum treatment is far from ideal. There is a need to implement strategies in the population directed towards increasing awareness of the need to establish healthy habits and adequate preventive pharmacological treatment that could reduce the incidence of this debilitating disease.

Topics: Arteriosclerosis; Cardiovascular Agents; Cerebrovascular Disorders; Coronary Disease; Evidence-Based Medicine; Health Knowledge, Attitudes, Practice; Humans; Patient Education as Topic; Patient Selection; Peripheral Vascular Diseases; Practice Guidelines as Topic; Recurrence; Registries; Risk Assessment; Risk Factors; Risk Reduction Behavior

To evaluate the efficacy of pharmacological interventions in improving walking capacity and health-related quality of life for people with intermittent claudication. DATASOURCES: We searched Medline, EMBASE, Cochrane library and relevant websites for studies published from the start of the databases to February 2009. In addition, reference lists were manually searched.. Based upon a power calculation, only robust (n>56), peer-reviewed, double-blinded, randomised and placebo-controlled trials were included. The main outcomes evaluated were maximal walking distance (MWD) and pain-free walking distance on a treadmill. Random models were used in the statistical analysis, and chi-square test were used to test for heterogeneity.. Among 220 trials, only 43 trials fulfilled the quality criteria. Treatment periods, follow-up and treadmill protocols varied substantially. Vasodilator agents and phosphodiesterase inhibitors show robust significant results compared to placebo, but the improvements in MWD are modest. The highest benefit was caused by lipid-lowering agents, which in mean gained above 160 m in MWD, while the other agents only improved MWD about 50 m.. Several drugs have shown to improve MWD, but with limited benefits. Statins seem to be the most efficient drug at the moment.

Topics: Cardiovascular Agents; Double-Blind Method; Exercise Test; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Intermittent Claudication; Peripheral Vascular Diseases; Phosphodiesterase Inhibitors; Platelet Aggregation Inhibitors; Quality of Life; Randomized Controlled Trials as Topic; Recovery of Function; Treatment Outcome; Vasodilator Agents; Walking

Critical limb ischemia (CLI) is the term used to designate the condition in which peripheral artery disease has resulted in resting leg or foot pain or in a breakdown of the skin of the leg or foot, causing ulcers or tissue loss. If not revascularized, CLI patients are at risk for limb loss and for potentially fatal complications from the progression of gangrene and the development of sepsis. The management of CLI requires a multidisciplinary team of experts in different areas of vascular disease, from atherosclerotic risk factor management to imaging, from intervention to wound care and physical therapy. In the past decade, the most significant change in the treatment of CLI has been the increasing tendency to shift from bypass surgery to less invasive endovascular procedures as first-choice revascularization techniques, with bypass surgery then reserved as backup if appropriate. The goals of intervention for CLI include the restoration of pulsatile, inline flow to the foot to assist wound healing, the relief of rest pain, the avoidance of major amputation, preservation of mobility, and improvement of patient function and quality of life. The evaluating physician should be fully aware of all revascularization options in order to select the most appropriate intervention or combination of interventions, while taking into consideration the goals of therapy, risk-benefit ratios, patient comorbidities, and life expectancy. We discuss the incidence, risk factors, and prognosis of CLI and the clinical presentation, diagnosis, available imaging modalities, and medical management (including pain and ulcer care, pharmaceutical options, and molecular therapies targeting angiogenesis). The endovascular approaches that we review include percutaneous transluminal angioplasty (with or without adjunctive stenting); subintimal angioplasty; primary femoropopliteal and infrapopliteal deployment of bare nitinol, covered, drug-eluting, or bioabsorbable stents; cryoplasty; excimer laser-assisted angioplasty; excisional atherectomy; and cutting balloon angioplasty.

Topics: Amputation, Surgical; Cardiovascular Agents; Combined Modality Therapy; Critical Illness; Extremities; Humans; Incidence; Intermittent Claudication; Ischemia; Limb Salvage; Minimally Invasive Surgical Procedures; Patient Care Team; Peripheral Vascular Diseases; Practice Guidelines as Topic; Risk Factors; Time Factors; Treatment Outcome; Vascular Surgical Procedures

Peripheral arterial disease is a major cause of morbidity and mortality in Americans. Without aggressive management of the disease as well as comorbidities and risk factors, peripheral arterial disease may progress and place patients at risk for amputation of the affected limb. In addition, patients affected by peripheral arterial disease are at increased risk for death from both cardiovascular and noncardiovascular causes. Although traditionally felt to be a disease of Caucasian men, women compose a significant portion of patients with peripheral arterial disease, especially among the elderly. Increased prevalence of asymptomatic disease in women can lead to delayed diagnosis and treatment. Without the appropriate medical and or surgical intervention, women are at risk of poor procedural outcomes and increased mortality. This review will focus on the differences in peripheral arterial disease based on gender and how these differences can affect the presentation, diagnosis and treatment of peripheral arterial disease in women.

Topics: Age Factors; Angiotensin-Converting Enzyme Inhibitors; Aspirin; Biomarkers; C-Reactive Protein; Cardiovascular Agents; Comorbidity; Estrogen Replacement Therapy; Exercise; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Peripheral Vascular Diseases; Postmenopause; Prevalence; Risk Factors; Sex Factors; Smoking; Women's Health

Topics: Angioplasty, Balloon; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug Carriers; Equipment Design; Evidence-Based Medicine; Humans; Peripheral Vascular Diseases; Treatment Outcome

Giant cell arteritis (GCA) is increasingly being recognized as a systemic vascular disease, not confined to the cranial arteries. Epidemiological studies have shown that almost one-third of the patients with GCA develop serious peripheral vascular complications during long-term follow up, and there is growing evidence that unrecognized extracranial involvement may be even more common. GCA of large- and medium-sized peripheral arteries typically leads to long tapering and occlusion of the arterial lumen due to concentric intimal thickening, sometimes accompanied by spontaneous dissection. Depending on the extent of the arterial obliteration and on the anatomy of the involved arterial segment, this may result in severe ischemia of the limbs during the acute phase of the disease. GCA of the aorta usually remains asymptomatic for many years, and leads to a markedly increased risk of aneurysms and dissections, particularly of the thoracic aorta. Evolving vascular imaging techniques such as duplex ultrasound, computer tomography (CT), magnetic resonance imaging (MRI), and fluorine-18-desoxyglucose positron emission tomography (18F-FDG-PET) have greatly improved our ability to detect and study arterial changes in large-artery vasculitis. Boosted by these advances in vascular imaging, vascular specialists are increasingly involved in the early diagnosis, follow-up and treatment of patients with large-vessel vasculitis.

Topics: Angiography, Digital Subtraction; Arterial Occlusive Diseases; Biomarkers; Cardiovascular Agents; Fluorodeoxyglucose F18; Giant Cell Arteritis; Glucocorticoids; Humans; Inflammation Mediators; Magnetic Resonance Angiography; Peripheral Vascular Diseases; Physical Examination; Positron-Emission Tomography; Radiopharmaceuticals; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Surgical Procedures

Atherosclerosis can affect nearly any part of the arterial system. Therefore, it is considered as a generalized disease. As most probably similar or identical etiopathogenetic mechanisms are involved in different atherosclerotic diseases, a different effect of treatment of risk factors on atherosclerotic lesions in different parts of the vascular system is expected. Until now, great emphasis has been placed on the aggressive pharmacological management of coronary artery disease, less attention has been devoted to the management of cerebrovascular and much less to peripheral arterial disease, despite their significant morbidity and mortality. The data from recent trials have indicated that treatment of patients with antiplatelet drugs, statins, antihypertensive and antidiabetic drugs prevents the progression of coronary atherosclerosis, reduces cardiovascular events and improves prognosis of coronary patients. Subgroup analyses from large studies have also shown that treatment of risk factors for atherosclerosis with drugs reduces cardiovascular events and improves prognosis of cerebrovascular and peripheral arterial occlusive disease. Although some studies indicate that the effects of distinct preventive procedures are to some extent dependent on the locations of atherosclerotic disease, it seems that the success of preventive measures is mostly related to the progression of the disease or the risk of treated population and not on the treated vascular bed.

Topics: Angiotensin-Converting Enzyme Inhibitors; Arterial Occlusive Diseases; Atherosclerosis; Cardiovascular Agents; Cardiovascular Diseases; Cerebrovascular Disorders; Coronary Artery Disease; Disease Progression; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypoglycemic Agents; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Treatment Outcome

Subjects with peripheral arterial disease (PAD) of the lower limbs are at high risk for cardiovascular and cerebrovascular events and the prevalence of coronary artery disease in such patients is elevated. Recent studies have shown that regular use of cardiovascular medications, such as therapeutic and preventive agents for PAD patients, seems to be promising in reducing long-term mortality and morbidity. The angiotensin-converting-enzyme (ACE) system plays an important role in the pathogenesis and progression of atherosclerosis, and ACE-inhibitors (ACE-I) seem to have vasculoprotective and antiproliferative effects as well as a direct anti-atherogenic effect. ACE-I also promote the degradation of bradykinin and the release of nitric oxide, a potent vasodilator; further, they have shown important implications for vascular oxidative stress. Other studies have suggested that ACE-I may also improve endothelial dysfunction. ACE-I are useful for reducing the risk of cardiovascular events in clinical and subclinical PAD. Particularly, one agent of the class (ie, ramipril) has shown in many studies to able to significantly reduce cardiovascular morbidity and mortality in patients with PAD.

Topics: Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Cardiovascular Diseases; Cell Proliferation; Endothelium, Vascular; Fibrinolysis; Humans; Lower Extremity; Oxidative Stress; Peripheral Vascular Diseases; Treatment Outcome

Peripheral arterial disease (PAD) is a major health problem affecting millions of patients worldwide. Many will suffer from intermittent claudication (IC), which leads to marked impairment of quality of life (QoL). Besides surgical and endovascular interventions to improve limb-specific outcomes, pharmacotherapy is an effective tool in the treatment of IC. Cilostazol, a Federal Drug Administration-approved medication for the treatment of IC, has demonstrated consistent efficacy in improving exercise capacity and overall health-related QoL. This manuscript will review the pharmacokinetics, safety, and efficacy of cilostazol in the treatment of patients with IC as well as compare this agent with other proven non-invasive therapies for PAD.

Topics: Cardiovascular Agents; Cilostazol; Exercise Tolerance; Humans; Intermittent Claudication; Peripheral Vascular Diseases; Quality of Life; Tetrazoles; Treatment Outcome

Peripheral arterial occlusive disease (PAD) is a highly prevalent atherosclerotic syndrome associated with significant morbidity and mortality. It is defined by atherosclerotic obstruction of the abdominal aorta and arteries to the legs that reduces arterial flow during exercise and/or at rest, and is a common manifestation of systemic atherosclerosis. PAD represents a marker for premature cardiovascular events, and in patients with PAD, even in the absence of a history of myocardial infarction (MI) or ischemic stroke, they have approximately the same relative risk of death from cardiovascular causes as do patients with a history of coronary or cerebrovascular disease. In addition, their death rate from all causes is approximately equal in men and women and is elevated even in asymptomatic patients. The major risk factors for PAD are the well defined atherosclerotic risks such as diabetes mellitus, cigarette smoking, advanced age, hyperlipidemia, and hypertension. Due to the presence of these risk factors, the systemic nature of atherosclerosis, and the high risk of ischemic events, patients with PAD should be candidates for aggressive secondary prevention strategies including aggressive risk factor modification, antiplatelet therapy, lipid lowering therapy and antihypertensive treatment. This article reviews the current medical treatment and risk factor modification of patients with PAD.

Topics: Age Factors; Atherosclerosis; Cardiovascular Agents; Cardiovascular Diseases; Diabetes Complications; Disease Progression; Drugs, Investigational; Exercise Therapy; Female; Humans; Hyperhomocysteinemia; Hyperlipidemias; Hypertension; Inflammation; Intermittent Claudication; Male; Peripheral Vascular Diseases; Renal Insufficiency, Chronic; Risk Factors; Smoking; Smoking Cessation; Treatment Outcome

Peripheral arterial disease (PAD) is strongly associated with atherosclerosis in the coronary and carotid arteries, leading to a highly increased incidence of myocardial infarction, ischaemic stroke and cardiovascular death. Fortunately, pharmacological interventions in large clinical trials have been as effective in subgroups of patients with PAD as in subjects with other atherosclerotic disease. Antiplatelet treatment is indicated in virtually all patients with PAD. Aspirin 75-325 mg day(-1) is considered as first-line treatment, and clopidogrel 75 mg day(-1) is an effective alternative. Statin therapy is indicated to achieve a target low-density lipoprotein cholesterol level of < or = 2.5 mmol L(-1) in patients with PAD and there is emerging evidence that even lower levels are beneficial. Lowering of plasma homocysteine by supplementing folic acid, vitamin B(12) and vitamin B(6) is not recommended in patients with mild to moderate hyperhomocysteinaemia in the 12-25 micromol L(-1) range, since it does not reduce the incidence of cardiovascular events. Antihypertensive treatment is indicated to achieve a goal blood pressure of < or = 140/90 mmHg or < or = 130/80 mmHg in the presence of diabetes or chronic kidney disease. All classes of antihypertensive drugs are acceptable for treatment of hypertension in patients with PAD, but angiotensin-converting enzyme inhibitors ramipril or perindopril are especially appropriate because they reduce the incidence of cardiovascular events beyond their blood pressure-lowering effects. Beta-blockers should not be used as first-line antihypertensive treatment. Diabetic patients with PAD should reduce their glycosylated haemoglobin to < or = 7%. In conclusion, pharmacological secondary prevention of cardiovascular morbidity and mortality in patients with PAD should be as comprehensive as that in patients with established coronary or cerebrovascular disease.

Topics: Antihypertensive Agents; Aspirin; Cardiovascular Agents; Diabetic Angiopathies; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypercholesterolemia; Hyperhomocysteinemia; Hypertension; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Risk Factors; Thrombosis

Infrainguinal peripheral arterial disease is increasingly treatable by endovascular techniques. Bare-metal, drug-eluting, and covered stents (stent-grafts) are increasingly important adjuncts to percutaneous transluminal angioplasty in the treatment of occlusive and aneurysmal disease. Preliminary data suggest bioabsorbable stents may also have a significant clinical impact as well. In this article, we describe the available evidence supporting use of stents in the femoropopliteal and tibial arteries, as well as some of their limitations and complications.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Constriction, Pathologic; Femoral Artery; Humans; Patient Selection; Peripheral Vascular Diseases; Popliteal Artery; Prosthesis Design; Recurrence; Stents; Tibial Arteries; Treatment Outcome

Medical therapy to improve symptoms, stabilise the underlying vascular disease and improve lower limb outcomes is an important and effective adjunct to lifestyle modification and surgical or endovascular interventions in patients with IC. Randomised placebo controlled trials have shown that the phosphodiesterase III inhibitor cilostazol 100mg bid improves pain-free and maximum walking distance, as well as quality of life, in a range of patients with intermittent claudication in whom there is no evidence of tissue necrosis or rest pain. This review summarises the evidence from 8 pivotal trials of cilostazol involving over 2000 patients with intermittent claudication treated for up to 6 months. There is comparatively less evidence to support the use of other treatment modalities for relief of symptoms in intermittent claudication, but there is considerable interest in therapeutic angiogenesis to promote new vessel formation and enhance collateralisation of the lower limb using recombinant growth factor proteins or gene transfer strategies. The rationale for therapeutic angiogenesis is discussed, together with the most recent results from randomised trials in patients with peripheral arterial disease.

Topics: Aged; Angiogenic Proteins; Animals; Cardiovascular Agents; Cilostazol; Collateral Circulation; Female; Genetic Therapy; Humans; Intermittent Claudication; Lower Extremity; Male; Neovascularization, Physiologic; Peripheral Vascular Diseases; Phosphodiesterase Inhibitors; Regional Blood Flow; Stem Cell Transplantation; Tetrazoles; Treatment Outcome

Peripheral arterial disease (PAD) encompasses the vascular diseases caused primarily by atherosclerosis and thromboembolic pathophysiological processes that alter the normal structure and function of the aorta, its visceral arterial branches and the arteries of the upper and lower extremities. PAD is associated with an increased risk for cardiovascular morbidity and mortality. The goals for pharmacological therapy in PAD should focus on reducing cardiovascular risk, improving walking distance and preventing critical limb ischaemia. Exercise training plays a key role in the therapeutic assessment, as well stopping smoking. Antiplatelet therapy (aspirin) should be given to every PAD patient if there are no contraindications. Neither their combination nor anticoagulant therapy has shown additional benefit in PAD patients. Several pharmacological agents have been developed to improve the functional state of the claudicant and to relieve the symptoms. Many studied drugs have shown either no, a small or a potential benefit. With future development of new drugs for PAD, there is an absolute need for very strict well-designed protocols in order to evaluate the claudication distance, the progression of the disease and the reduction in cardiovascular morbidity and mortality. New developments should focus on improvement of endothelial function, vascular repair and enhancement of collateral circulation.

Topics: Antihypertensive Agents; Cardiovascular Agents; Cardiovascular Diseases; Exercise Therapy; Fibrinolytic Agents; Humans; Hypolipidemic Agents; Intermittent Claudication; Life Style; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Risk Factors; Smoking Cessation; Treatment Outcome

Arterial disease in women will become a major issue in the near future.. A systemic review of existing literature was retrospectively conducted to collect information on the three most common entities of vascular disease: carotid atherosclerotic, abdominal aortic aneurismal, and lower extremity arterial occlusive disease.. Vascular disease is either underdiagnosed or undertreated in women. Whether regarding cerebrovascular disease, aortic aneurysmal disease, or atherosclerosis affecting the lower extremities, natural history, clinical and physiologic patterns are different in women vs men. Current biomedical devices create challenges in endovascular procedures performed in women. Furthermore, indications for treatment of vascular disease are derived from large studies where women are often underrepresented; and, thus, may not be applicable in female vascular patients.. Better understanding of the gender differences in vascular disease with focused randomized trials, biomedical research, and identification of gender specific medical and social risk factors will improve the clinical outcomes in female patients.

Topics: Aortic Aneurysm; Arterial Occlusive Diseases; Cardiovascular Agents; Carotid Stenosis; Estrogen Replacement Therapy; Female; Healthcare Disparities; Humans; Lower Extremity; Peripheral Vascular Diseases; Sex Factors; Vascular Surgical Procedures; Women's Health

Smoking should be stopped and hypertension, diabetes mellitus, dyslipidemia, and hypothyroidism treated in patients with peripheral arterial disease (PAD) of the lower extremities. Statins decrease the incidence of intermittent claudication and improve exercise duration until the onset of intermittent claudication in persons with PAD and hypercholesterolemia. Antiplatelet drugs such as aspirin or clopidogrel, especially clopidogrel, angiotensin-converting enzyme inhibitors, and statins should be given to all persons with PAD. Beta blockers should be given if coronary artery disease is present. Exercise rehabilitation programs and cilostazol increase exercise time until intermittent claudication develops. Chelation therapy should be avoided. Indications for lower extremity percutaneous transluminal angioplasty or bypass surgery are (1) incapacitating claudication in persons interfering with work or lifestyle, (2) limb salvage in persons with limb-threatening ischemia as manifested by rest pain, nonhealing ulcers, and/or infection or gangrene, and (3) vasculogenic impotence.

Topics: Angioplasty, Balloon; Atherosclerosis; Cardiovascular Agents; Exercise; Humans; Intermittent Claudication; Lower Extremity; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Prevalence; Risk Factors; Smoking Cessation; Stents; Vascular Surgical Procedures

Cardiovascular diseases, the clinical paradigm of atherosclerosis, are the primary cause of mortality in developed countries. The origin of the atheromatous lesion is multifactorial, as it is the therapeutic approach to its prevention and clinical complications. The initial symptoms of ischemia in a vascular bed are usually evident when the atherosclerotic process is very advanced, being indicative of a diffuse disease and of an elevated future risk for ischemic events in other vascular territories. We perform this review in this clinical scenario, highlighting the preventive and therapeutic aspects of demonstrated clinical efficacy, with no detail of those treatments with benefit insufficiently proven.

Topics: Angina Pectoris; Anticoagulants; Atherosclerosis; Brain Ischemia; Cardiovascular Agents; Combined Modality Therapy; Heart Failure; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Myocardial Infarction; Myocardial Ischemia; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Risk Factors

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Algorithms; Aneurysm; Aorta, Abdominal; Aortic Aneurysm, Abdominal; Aortic Rupture; Atherosclerosis; Cardiovascular Agents; Combined Modality Therapy; Comorbidity; Diagnostic Imaging; Evidence-Based Medicine; Female; Femoral Artery; Humans; Iliac Artery; Intestines; Ischemia; Leg; Male; Mesenteric Arteries; Middle Aged; Peripheral Vascular Diseases; Popliteal Artery; Prevalence; Randomized Controlled Trials as Topic; Renal Artery; Risk Factors; Risk Reduction Behavior; Treatment Outcome; Vascular Surgical Procedures

Pharmacological and non-pharmacological interventions to improve function and quality of life in patients with claudication are being evaluated in clinical research trials. An important component of clinical development programs is assessing the safety of the intervention and monitoring for adverse impact of the therapy on research participants. The conduct of both of these safety assessments is facilitated by the ability to estimate the anticipated rates of cardiovascular events and death in the target population. To obtain estimates of these rates, data were abstracted from randomized, double-blind, placebo-controlled trials performed in patients with claudication and designed to show functional improvement, and which have been published since 1990. Patient-year exposures and the number of deaths, serious adverse events and cardiovascular serious adverse events in the placebo arms of these trials were tabulated, and summed event rates calculated. The mortality rate was 1.9 deaths per hundred patient-years (27 deaths observed in 1446 patient-years). The mortality rate in claudication trials is lower than that reported in natural history studies. Cardiovascular serious adverse events in claudication trials were observed at a rate of 8.5 per hundred patient-years (65 events in 762 patient-years). Thus, cardiovascular morbidity and mortality should be expected in clinical trials enrolling claudicants. The current analyses provide benchmark data for ensuring that development programs are large enough to allow meaningful safety conclusions, and to assist in data and safety monitoring of these trials.

Topics: Adverse Drug Reaction Reporting Systems; Cardiovascular Agents; Cardiovascular Diseases; Humans; Intermittent Claudication; Linear Models; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Research Design; Risk Factors

Topics: Arterial Occlusive Diseases; Cardiovascular Agents; Drug Therapy, Combination; Fibrinolytic Agents; Humans; Hypolipidemic Agents; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Vasodilator Agents

United Therapeutics Corp (UTC) is developing treprostinil sodium (Remodulin, UT-15), a stable structural analog of prostacyclin, for the potential treatment of primary pulmonary (arterial) hypertension (PAH), peripheral vascular disease (PVD) and other cardiovascular conditions [327593], including critical limb ischemia (CLI) [412483]. In August 2000, UTC submitted the initial, non-clinical sections of an NDA for the treatment of pulmonary hypertension [378906]. Treprostinil, which had previously been designated as an Orphan Drug, was also awarded Priority Review status by the US FDA in October 2000 [385864], [386271]. In December 2000, UTC agreed with the FDA that the NDA for treprostinil did not need to be presented to the Cardiovascular and Renal Drugs Advisory Committee, which was expected to allow UTC and the FDA to work towards the 6-month Priority Review timeline [393888]. On August 9, 2001, the advisory committee recommended approval of treprostinil and UTC refiled the NDA on the same day [418682]. In February 2002, the FDA issued an approvable letter for treprostinil injection for the treatment of PAH. The FDA proposed drug labeling for PAH consistent with the treatment of both primary and secondary pulmonary hypertension in patients with New York Heart Association (NYHA) Class II-IV symptoms. The approvable letter also stated that the FDA intended to approve treprostinil with a requirement that UTC subsequently conduct a post-marketing controlled clinical trial to verify and further describe the drug's clinical benefit [439278]. In February 2001, UTC submitted a marketing authorization application (MAA) in France for approval of treprostinil for the treatment of PAH. Upon approval of the MAA, UTC planned to file for Mutual Recognition in other European countries and was also preparing similar submissions to non-European countries [391986], [397958]. By early 2001, phase II trials of treprostinil for the treatment of CLI were underway [412483]. In March 2001, the company was planning a phase III pivotal study in late-stage PVD by the end of 2001 [424180]. In April 2000, UTC was issued US-06054486 for the method of treating PVD with treprostinil [364130]. In February 2000, UTC entered into an agreement with Paladin Labs for the exclusive Canadian distribution of treprostinil for the remainder of clinical trials and after regulatory approvals [357302]. In November 2000, UTC and Antigen Pharmaceuticals entered into a strategic alliance for the distr

Topics: Cardiovascular Agents; Clinical Trials as Topic; Epoprostenol; Extremities; Humans; Hypertension, Pulmonary; Ischemia; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors

Peripheral occlusive arterial disease (POAD) is a disease with a progressive course in about half of the patients affected. The Fontaine stage II and III have been treated not always successfully in the last decades with physical exercise, vasoactive substances (pentoxifyllin, naftidrofuryl, buflomedil) and with alprostadil. Recently methods of vascular surgery such as PTA, stent implantation and bypass operations are introduced in the treatment of Fontaine POAD stages III and IV, but these procedures are not recommended in patients younger than 50 years in order to delay amputation of a limb. The vasoactive substances are seen in a new light, because they improve processes of the microcirculation such as decreasing plasma viscosity, the raised plasma fibrinogen level and increasing the deformability of red blood cells and inhibiting platelet aggregation. According to a number of studies pentoxifylline and naftidrofuryl may delay the progression of arteriosclerosis. Therefore, a new concept of the treatment of POAD must be evaluated (1) resulting in a combination of vascular surgery and intermittent drug therapy with vasoactive agents, (2) leading to a decrease in the risk of amputation frequency and (3) reducing the treatment costs in spite of a higher frequency of the disease and a longer average life expectancy.

Topics: Amputation, Surgical; Arterial Occlusive Diseases; Cardiovascular Agents; Humans; Life Style; Peripheral Vascular Diseases; Risk Factors

Iliac vein stenting has emerged as the procedure of choice in the treatment of iliac vein obstruction (IVO). However, clinical outcomes have never been studied by a randomized clinical trial. Our purpose was to compare medical and endovascular treatment results in symptomatic chronic venous disease (CVD) patients with significant IVO documented by intravascular ultrasound (IVUS).. Patients with Clinical, Etiology, Anatomy, and Pathophysiology clinical class C3 to C6 and a visual analog scale for pain (VAS pain) score >3 were considered eligible. We randomly assigned limbs with ≥50% IVO on IVUS to undergo medical treatment alone or medical treatment plus iliac vein stenting. The patient and clinical physician were blinded. Primary outcomes included change from baseline in VAS pain score, Venous Clinical Severity Score, and 36-Item Short Form Health Survey quality of life questionnaire. Secondary outcomes included stent integrity, migration, and patency rates at 6 months.. Of 207 CVD patients, 58 (28%) were eligible and eight (14%) were excluded; 51 of 85 class C3 to C6 limbs (60%) had ≥50% IVO by IVUS. Iliac vein stenting, in randomized patients, was 100% technically successful. At 6 months' follow-up, the mean VAS pain score declined from a median of 8 to 2.5 in patients receiving stents and from 8 to 7 in patients receiving only medical treatment (P < .001). The Venous Clinical Severity Score dropped from a median of 18.5 to 11 after stenting and from 15 to 14 with medical treatment (P < .001). The 36-Item Short Form Health Survey (0-100) improved from a total median score of 53.9 to 85.0 with stenting and 48.3 to 59.8 after medical treatment (P < .001). There was no stent fracture or migration, and the primary, assisted primary, and secondary patency rates were 92%, 96%, and 100%, respectively (median, 11.8; range, 6-18 months).. Endovascular treatment of IVO with stenting is safe and promotes effective relief of symptoms and improvement in quality of life compared with medical treatment alone in symptomatic CVD patients. Our results echo those achieved in numerous previously published nonrandomized clinical series.

Topics: Adult; Aged; Angioplasty, Balloon; Cardiovascular Agents; Chronic Disease; Computed Tomography Angiography; Constriction, Pathologic; Double-Blind Method; Female; Humans; Iliac Vein; Male; Middle Aged; Multidetector Computed Tomography; Pain Measurement; Peripheral Vascular Diseases; Phlebography; Prospective Studies; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler; Ultrasonography, Interventional; Vascular Patency; Venous Insufficiency

The development of microvascular complications in diabetes is a complex process in which endothelial dysfunction is important. Emerging evidence suggests that arginase is a key mediator of endothelial dysfunction in type 2 diabetes mellitus by reciprocally regulating nitric oxide bioavailability. The aim of this prospective intervention study was to test the hypothesis that arginase activity is increased and that arginase inhibition improves microvascular endothelial function in patients with type 2 diabetes and microvascular dysfunction.. Microvascular endothelium-dependent and -independent dilatation was determined in patients with type 2 diabetes (n = 12) and healthy age-matched control subjects (n = 12) with laser Doppler flowmetry during iontophoretic application of acetylcholine and sodium nitroprusside, respectively, before and after administration of the arginase inhibitor N. Arginase inhibition improves microvascular endothelial function in patients with type 2 diabetes and microvascular dysfunction. Arginase inhibition may represent a novel therapeutic strategy to improve microvascular endothelial function in patients with type 2 diabetes.

Topics: Acetylcholine; Aged; Arginase; Arginine; Cardiovascular Agents; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Endothelium, Vascular; Enzyme Inhibitors; Female; Humans; Laser-Doppler Flowmetry; Male; Microvessels; Middle Aged; Nitroprusside; Ornithine; Peripheral Vascular Diseases; Severity of Illness Index; Vascular Resistance; Vasodilation; Vasodilator Agents

Cilostazol improves walking distance and quality of life in patients with peripheral arterial disease (PAD). This study assessed the vascular and biochemical effects of cilostazol therapy in PAD patients.. PAD patients were prospectively recruited to a randomized, double-blinded, placebo-controlled trial. Baseline clinical data were recorded. Clinical assessment included measurement of arterial compliance, transcutaneous oxygenation, ankle-brachial index (ABI), and treadmill walking distance. Blood analyses included a full blood panel, coagulation screen, urea and electrolytes, liver function tests, estimated glomerular filtration rate, and lipid profiles. Quality of life indices were recorded using validated generic and walking-specific questionnaires. All tests were performed at baseline, 6, and 24 weeks.. Eighty patients (53 men) were recruited from December 2004 to January 2006. The cilostazol group had a significant reduction in the augmentation index compared with the placebo group at 6 weeks (19.7% vs 26.7%, P = .001) and at 24 weeks (19.7% vs 27.7%, P = .005). A paradoxic reduction in transcutaneous oxygenation levels was identified in the cilostazol group for the left foot at 6 weeks and for the right foot at both 6 and 24 weeks. The ABIs were not significantly different between treatment groups at baseline, 6 weeks, or 24 weeks for the left and right lower limbs. The mean percentage change in walking distance from baseline improved more markedly in the cilostazol compared with the placebo group for absolute claudication distance at 6 (78.6% vs 26.4%, P = .20) and 24 weeks (173.1% vs 92.1%, P = .27); however, these failed to reach significance. Significant improvements in lipid profiles were demonstrated with cilostazol therapy at 6 weeks (triglycerides, high-density lipoprotein [HDL]) and at 24 weeks (cholesterol, triglycerides, HDL, and low-density lipoprotein). The cilostazol treatment group demonstrated significant improvements in the Short Form-36 (physical functioning, physical component score), Walking Impairment (distance and speed), and Vascular Quality of Life (pain) indices at 6 and 24 weeks. Although cilostazol was associated with side effects in approximately one-third of patients, most settled within 6 weeks, facilitating the continuation of therapy in >89%.. Cilostazol is a well-tolerated, safe, and efficacious treatment for PAD patients. It not only improves patients' symptomatology and quality of life but also appears to have beneficial effects on arterial compliance, possibly through its lipid-lowering property.

Topics: Adult; Aged; Aged, 80 and over; Ankle; Aorta; Biomarkers; Blood Pressure; Brachial Artery; Cardiovascular Agents; Cilostazol; Compliance; Double-Blind Method; Female; Humans; Lipids; Male; Middle Aged; Oxygen; Peripheral Vascular Diseases; Prospective Studies; Quality of Life; Recovery of Function; Surveys and Questionnaires; Tetrazoles; Time Factors; Treatment Outcome; Walking

To compare the safety and efficacy of a bioresorbable paclitaxel-eluting wrap implanted with a synthetic vascular graft (treatment) versus the graft implanted alone (control).. Prospective, randomized, controlled, multicentre, 2-year clinical study conducted in adults scheduled to undergo femoropopliteal peripheral bypass surgery with a polytetrafluoroethylene (PTFE) graft.. Hundred and nine subjects were randomized 2:1 to treatment or control. All subjects were implanted with a 6mm expanded PTFE vascular graft; in addition, treated subjects had a 2.5 cm x 4 cm paclitaxel-eluting wrap (1.6 microg/mm(2)) placed around the distal graft anastomosis.. The overall incidence of adverse events was similar in both groups. Treated subjects required fewer limb amputations than controls (15.5% vs 18.4%) and time to amputation for those that required amputation was twice as long (153 days vs 76 days). Among diabetics, this effect was pronounced with 13.8% of treated subjects requiring limb amputations compared with 23.5% of controls. Over the course of study, the diameter at the distal graft anastomosis was greater in treated subjects than in controls (difference of 2.1mm at 2 yr, p=0.03).. The paclitaxel-eluting wrap maintained graft patency at the distal anastomosis and was safe to use in patients who had received a peripheral bypass PTFE graft.

Topics: Amputation, Surgical; Anastomosis, Surgical; Bandages; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Europe; Female; Femoral Artery; Humans; Male; Middle Aged; Netherlands Antilles; Paclitaxel; Peripheral Vascular Diseases; Polytetrafluoroethylene; Popliteal Artery; Prospective Studies; Prosthesis Design; Reoperation; Time Factors; Treatment Outcome; Vascular Patency

Intermittent claudication is the primary symptom of peripheral arterial disease, affecting between 1 and 3 million Americans. Symptomatic improvement can be achieved by endovascular revascularization, but such procedures are invasive, expensive, and may be associated with procedural adverse events. Medical treatment options, including claudication medications and supervised exercise training, are also known to be effective, albeit also with associated limitations. The CLEVER (Claudication: Exercise Vs. Endoluminal Revascularization) study, funded by the Heart, Lung, and Blood Institute of the National Institutes of Health, is a prospective, multicenter, randomized, controlled clinical trial evaluating the relative efficacy, safety, and health economic impact of four treatment strategies for people with aortoiliac peripheral arterial disease and claudication. The treatment arms are: (1) optimal medical care (claudication pharmacotherapy); (2) primary stent placement; (3) supervised exercise rehabilitation; and (4) combined stenting with supervised exercise rehabilitation. The CLEVER study is a 5-year randomized, controlled clinical trial to be conducted at approximately 25 centers in the United States that will monitor 252 patients and their responses to treatment during an 18-month follow-up period. The primary end point is change in maximum walking duration on a graded treadmill test. Secondary end points include the change at 18 months in maximum walking duration from baseline, comparisons of free-living daily activity levels assessed by pedometer, health-related quality of life, and cost-effectiveness. Other analyses include the effect of these treatment strategies on anthropomorphic and physiologic variables, including body mass index, waist circumference, blood pressure, pulse pressure, and resting pulse as well as biochemical markers of cardiovascular health, including fasting lipids, fibrinogen, C-reactive protein, and hemoglobin A 1c values.

Topics: Activities of Daily Living; Biomarkers; Cardiovascular Agents; Cost-Benefit Analysis; Exercise Therapy; Humans; Intermittent Claudication; Patient Selection; Peripheral Vascular Diseases; Prospective Studies; Quality of Life; Recovery of Function; Research Design; Stents; Time Factors; Treatment Outcome; United States; Vascular Surgical Procedures; Walking

Several case reports have implicated Ginkgo biloba in clinically adverse bleeding disorders. Ginkgo biloba has been reported to increase pain-free walking distance among patients with peripheral artery disease (PAD). Standard PAD therapy includes 325 mg/day aspirin. The objective of this study was to examine potential adverse effects of concomitant aspirin and Ginkgo biloba on platelet function. Ginkgo biloba (EGb 761, 300 mg/day) was compared with placebo for effects on measures of platelet aggregation among adults consuming 325 mg/day aspirin in a randomized, double-blind, placebo-controlled, parallel design trial of 4-week duration. Participants were adults, age 69 +/- 10 years, with PAD or risk factors for cardiovascular disease. Outcome measures included platelet function analysis (PFA-100 analyzer) using ADP as an agonist (n = 26 placebo; n = 29 ginkgo), and platelet aggregation using ADP, epinephrine, collagen and ristocetin as agonists (n = 21 placebo; n = 23 ginkgo). Participants kept daily logs of bleeding or bruising episodes. There were no clinically or statistically significant differences between treatment groups for any agonists, for either PFA-100 analysis or platelet aggregation. Reports of bleeding or bruising were infrequent and similar for both study groups. In conclusion, in older adults with PAD or cardiovascular disease risk, a relatively high dose of Ginkgo biloba combined with 325 mg/day daily aspirin did not have a clinically or statistically detectable impact on indices of coagulation examined over 4 weeks, compared with the effect of aspirin alone. No adverse bleeding events were observed, although the trial was limited to a small sample size.

Topics: Aged; Aspirin; Blood Platelets; Cardiovascular Agents; Double-Blind Method; Drug Therapy, Combination; Female; Ginkgo biloba; Humans; Male; Middle Aged; Peripheral Vascular Diseases; Plant Extracts; Platelet Aggregation; Platelet Aggregation Inhibitors; Platelet Function Tests

The influence of optimal medical treatment (OMT) with or without additional percutaneous transluminal angioplasty (PTA) on vascular inflammation in peripheral arterial occlusive disease (PAD) patients was investigated. Patients with intermittent claudication (IC) and angiographically verified PAD were randomized to OMT (n = 28) or OMT + PTA (n = 28) and followed for 12 months. Ankle-brachial index (ABI), treadmill walking distances (WD), visual analogue scale (VAS), and blood sampling for the determination of selected soluble biomarkers were undertaken at baseline and after 3 and 12 months. After both 3 and 12 months, ABI, WD and VAS were highly significantly improved in favour of OMT + PTA (p < 0.05 for all). Significant improvements were recorded in both groups in serum lipids (p < 0.01 for all), except for triglycerides, and in the inflammatory markers P-selectin, interleukin-6, interleukin-10, monocyte chemoattractant protein-1 and fibrinogen (p < 0.05 for all). There were, however, no differences in the changes from baseline between the groups in any variable. Intervention with OMT alone or in combination with PTA did not differ with regard to the effects on serum lipids and markers of inflammation in our population of PAD patients. The combined treatment was, however, better for the treadmill walking distance.

Topics: Aged; Angioplasty, Balloon; Ankle; Atherosclerosis; Biomarkers; Blood Pressure; Brachial Artery; Cardiovascular Agents; Combined Modality Therapy; Female; Finland; Humans; Inflammation; Intermittent Claudication; Male; Middle Aged; Pain Measurement; Peripheral Vascular Diseases; Prospective Studies; Recovery of Function; Severity of Illness Index; Time Factors; Treatment Outcome; Walking

To examine the degree of success at maintaining patients randomized to epidural or general anesthesia for peripheral vascular surgery within predetermined blood pressure (BP) and heart rate (HR) limits. To investigate associations between such hemodynamic control and intraoperative myocardial ischemia and postoperative major cardiac morbidity.. Prospective randomized clinical trial.. University-affiliated hospital.. 100 patients undergoing elective lower extremity revascularization for atherosclerotic peripheral vascular disease.. Patients were randomized to receive either epidural anesthesia or general anesthesia. Blood pressure and HR limits were determined prior to randomization. Hemodynamic monitoring and management of anesthesia was standardized. Myocardial ischemia and major cardiac morbidity were diagnosed by a blinded cardiologist, based on continuous ambulatory ECG monitoring, cardiac enzymes, and 12 lead ECGs. Intraoperative BP and HR date were analyzed by investigators masked to the type of anesthesia given.. A greater percentage of patients randomized to general anesthesia had intraoperative BPs more above their limit (95% vs 72%, p = 0.002) and/or more rapid changes in HR (75% vs 48%, p = 0.008) or BP (100% vs 93%, p = 0.04) than those randomized to epidural anesthesia. Intraoperative ischemia and major cardiac morbidity were similar in the two anesthesia groups. Patients experiencing intraoperative ischemia, regardless of anesthetic type, more frequently had BPs greater than 10% above their upper limit (90% vs 60% p = 0.04) and/or more rapid HR changes (90% vs 58%, p = 0.03) compared with patients without ischemia. These vital sign abnormalities, however, were not necessarily temporally related to the ischemic episodes. Patients experiencing subsequent major cardiac morbidity were not different from other patients with respect to excursions out of BP on HR limits.. Prevention of elevated intraoperative BP and/on rapid changes in BP or HR may be more successful with epidural than with general anesthesia. Such vital sign abnormalities may occur more frequently in patients who have had intraoperative ischemia or are at risk for having it later in the procedure.

Topics: Aged; Anesthesia, Epidural; Anesthesia, General; Arteriosclerosis; Blood Pressure; Cardiovascular Agents; Elective Surgical Procedures; Electrocardiography, Ambulatory; Female; Heart Diseases; Heart Rate; Humans; Intraoperative Complications; Leg; Male; Middle Aged; Monitoring, Intraoperative; Myocardial Ischemia; Myocardium; Peripheral Vascular Diseases; Postoperative Complications; Prospective Studies; Risk Factors; Single-Blind Method

Critical limb ischaemia (CLI) is a serious clinical condition that often immediately precedes limb loss. The Consensus Documents of 1989 and 1991 attempted to define CLI and give direction to its investigation and management. Whilst the need for such a consensus was clear and should be supported we believe the definition of CLI as documented in the Consensus Documents I and II recommendation number I is wrong. We present evidence from 140 patients with severe limb ischaemia taken from the PARTNER Group studies to support our request for an amendment to the ankle pressure recommendation from < or = 50 mmHg to >50 mmHg and big toe pressure from < or = 30 mmHg to >30 mmHg for the purpose of conducting clinical trials and to include Doppler index and tcPO2 as additional parameters. We also believe that the current document may be actually excluding the only group of patients likely to benefit from drug treatment or other interventions and that the above amendment should be prioritized.

Topics: Amputation, Surgical; Blood Pressure; Cardiovascular Agents; Combined Modality Therapy; Consensus Development Conferences as Topic; Epoprostenol; Europe; Follow-Up Studies; Humans; Ischemia; Leg; Peripheral Vascular Diseases; Prostaglandins, Synthetic; Retrospective Studies; Survival Rate; Treatment Outcome; Vascular Surgical Procedures

Topics: Aortic Diseases; Cardiovascular Agents; Carotid Artery Diseases; Humans; Leg; Peripheral Vascular Diseases; Randomized Controlled Trials as Topic; Stents; Venous Thromboembolism

To assess the level of secondary prevention and the outcome of coronary artery disease (CAD) in patients who have a history of non-coronary vascular intervention.. Patients with polyvascular disease have been reported to receive less evidence-based medications, with worse risk factor control and to be at higher risk than patients with single-bed disease. It is unknown whether these findings remain valid in the modern era of secondary prevention.. We included 4184 patients with stable CAD. Two groups were formed according to the absence (n = 3704) or presence (n = 480) of a history of non-coronary vascular intervention. Treatments and risk factor control were recorded at inclusion. Follow-up was performed after 2 years.. Antiplatelets, angiotensin system antagonists, beta-blockers and statins were widely prescribed in both groups. The number of antihypertensive drugs was higher in patients with non-coronary vascular intervention. Except for slight increases in the rate of current smokers and in systolic blood pressure, risk factor control was similar between groups. All-cause and cardiovascular mortality rates were higher in patients with non-coronary intervention with adjusted HR of 1.55 (1.13-2.13) (p = 0.007), and 1.98 (1.24-3.15) (p = 0.004), respectively.. In modern practice and real life conditions, the higher risk of CAD patients with a history of non-coronary vascular intervention is taken into account, with more intense secondary prevention and similar risk factor control than patients without such history. In spite of the level of secondary prevention, patients with a history of non-coronary vascular intervention remain at high risk of cardiovascular events. This should be an incentive to discuss more stringent objectives for secondary prevention in patients with polyvascular disease.

Topics: Cardiovascular Agents; Cause of Death; Comorbidity; Coronary Artery Disease; France; Humans; Kaplan-Meier Estimate; Peripheral Vascular Diseases; Proportional Hazards Models; Risk Assessment; Risk Factors; Risk Reduction Behavior; Secondary Prevention; Time Factors; Treatment Outcome

The ratio of revascularization to medical therapy (referred to herein as the revascularization ratio) for the initial treatment of stable ischemic heart disease varies considerably across hospitals. We conducted a comprehensive study to identify patient, physician and hospital factors associated with variations in the revascularization ratio across 18 cardiac centres in the province of Ontario. We also explored whether clinical outcomes differed between hospitals with high, medium and low ratios.. We identified all patients in Ontario who had stable ischemic heart disease documented by index angiography performed between Oct. 1, 2008, and Sept. 30, 2011, at any of the 18 cardiac centres in the province. We classified patients by initial treatment strategy (medical therapy or revascularization). Hospitals were classified into equal tertiles based on their revascularization ratio. The primary outcome was all-cause mortality. Patient follow-up was until Dec. 31, 2012. Hierarchical logistic regression models identified predictors of revascularization. Multivariable Cox proportional hazards models, with a time-varying covariate for actual treatment received, were used to evaluate the impact of the revascularization ratio on clinical outcomes.. Variation in revascularization ratios was twofold across the hospitals. Patient factors accounted for 67.4% of the variation in revascularization ratios. Physician and hospital factors were not significantly associated with the variation. Significant patient-level predictors of revascularization were history of smoking, multivessel disease, high-risk findings on noninvasive stress testing and more severe symptoms of angina (v. no symptoms). Treatment at hospitals with a high revascularization ratio was associated with increased mortality compared with treatment at hospitals with a low ratio (hazard ratio 1.12, 95% confidence interval 1.03-1.21).. Most of the variation in revascularization ratios across hospitals was warranted, in that it was driven by patient factors. Nonetheless, the variation was associated with potentially important differences in mortality.

Topics: Age Factors; Aged; Angina, Stable; Cardiovascular Agents; Cohort Studies; Comorbidity; Coronary Angiography; Coronary Artery Bypass; Databases, Factual; Diabetes Mellitus; Exercise Test; Female; Hospitals; Humans; Hyperlipidemias; Hypertension; Income; Logistic Models; Male; Middle Aged; Myocardial Ischemia; Myocardial Revascularization; Ontario; Percutaneous Coronary Intervention; Peripheral Vascular Diseases; Practice Patterns, Physicians'; Proportional Hazards Models; Pulmonary Disease, Chronic Obstructive; Severity of Illness Index; Smoking

Topics: Cardiology; Cardiovascular Agents; Elective Surgical Procedures; Europe; Heart Diseases; Heart Function Tests; Humans; Perioperative Care; Peripheral Vascular Diseases; Practice Guidelines as Topic; Risk Assessment; Societies, Medical; Vascular Surgical Procedures

Topics: Arterial Occlusive Diseases; Cardiovascular Agents; Cardiovascular Diseases; Exercise; Guideline Adherence; Humans; Peripheral Vascular Diseases; Practice Guidelines as Topic; Risk Assessment; Risk Factors; Risk Reduction Behavior; Secondary Prevention; Smoking Cessation

Peripheral vascular disease (PVD) is associated with a high risk of cardiovascular events after an acute coronary syndrome (ACS). The impact of suboptimal risk-factor control and drug prescription on morbidity and mortality rates in patients with PVD following an ACS remains to be established.. To assess whether a global atherosclerosis management programme and optimal secondary prevention could benefit high-risk PVD patients after an ACS.. A total of 851 ACS patients underwent an intensified intervention focusing on evaluating risk factors and atherosclerosis lesions, and on optimizing treatment and education. We compared its impact on long-term risk factors, medication observance and cardiovascular outcomes in patients with coronary artery disease (CAD) alone (n=715, 84.0%) and with both CAD and PVD (n=136).. At a median follow-up of 18.6months, both groups reached recommended secondary prevention goals and showed no significant differences in rates of drug prescription. PVD was not associated with minor cardiovascular events (hazard ratio [HR] 1.32, 95% confidence interval [CI] 0.57-3.02) but remained independently associated with major (HR 2.15, 95% CI 1.12-4.13) and total (HR 1.76, 95% CI 1.05-2.93) cardiovascular events. Compared to patients with CAD alone, this risk was significantly higher in CAD patients with both PVD and diabetes (HR 2.87, 95% CI 1.52-5.43), but not in PVD patients without diabetes (HR 1.35, 95% CI 0.71-2.56) or diabetic patients without PVD (HR 1.11, 95% CI 0.68-1.81).. Despite optimization of risk-factor control and drug prescription after ACS, patients with both PVD and diabetes carry a 2.9-fold higher risk of cardiovascular events at 18-month follow-up versus patients with CAD alone. This excess risk was not significant in PVD patients without diabetes or in diabetic patients without PVD.

Topics: Acute Coronary Syndrome; Aged; Cardiovascular Agents; Chi-Square Distribution; Diabetes Complications; Drug Prescriptions; Female; Health Knowledge, Attitudes, Practice; Heart Diseases; Humans; Male; Medication Adherence; Middle Aged; Patient Education as Topic; Peripheral Vascular Diseases; Proportional Hazards Models; Risk Assessment; Risk Factors; Secondary Prevention; Time Factors; Treatment Outcome

To assess the current 'real-world' management of hospitalised patients with lower-extremity peripheral artery disease (LE-PAD) and to assess the 1-year outcome.. The prospective and multicentre registry COhorte des Patients ARTériopathes (COPART) recruited consecutive patients from the departments of vascular medicine of three academic hospitals in Southwestern France.. Among the 940 patients, 27.4% had intermittent claudication (IC), 9.3% ischaemic rest pain, 54.3% ulceration or gangrene and 9.3% acute limb ischaemia (ALI). Patients with IC were younger and more likely to be men, with a history of smoking (89.5%) and chronic obstructive pulmonary disease (17%). Among those with IC, 8.9% had bypass surgery and 41.5% were treated with percutaneous angioplasty. Those with tissue loss had higher rates of cardiovascular disease (CVD) risk factors and co-morbidities. At entry to the study, the level of control of the CVD risk factors was poor. The 1-year mortality rate was of 5.7% in patients with IC, 23.1% in patients with ischaemic rest pain, 28.7% in patients with tissue loss and 23% in those with ALI. Compliance with evidence-based medicine and pharmacological treatment was sub-optimal.. This registry underscores the differences in patient profiles in the daily clinical setting, compared to those enrolled in several trials.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Cardiovascular Diseases; Chi-Square Distribution; Evidence-Based Medicine; Female; France; Gangrene; Guideline Adherence; Hospital Mortality; Hospitalization; Hospitals, University; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Leg Ulcer; Length of Stay; Lower Extremity; Male; Middle Aged; Outcome and Process Assessment, Health Care; Peripheral Vascular Diseases; Practice Guidelines as Topic; Proportional Hazards Models; Prospective Studies; Registries; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Surgical Procedures

Topics: Ankle Brachial Index; Cardiovascular Agents; Humans; Peripheral Vascular Diseases; Practice Guidelines as Topic; Quality of Life; Severity of Illness Index; Treatment Outcome

To investigate the current status of peripheral arterial disease (PAD) drug treatment in Japan, and the effects of drug treatment, risk factors, and complications on disease progress and onset of cardiovascular events in PAD patients.. In this prospective observational cohort study, 557 PAD patients were followed up for 3 years, and the current status of PAD treatment, risk factors, and cardiovascular events were monitored.. Three drugs, i.e., beraprost sodium, cilostazol, and aspirin, were most frequently used. The patients who had undergone vascular reconstruction of the lower limbs before enrollment showed significant improvement in ABI. Among the patients who had not undergone vascular reconstruction before enrollment, there was a significant improvement in ABI after treatment with beraprost. During the observation period, cardiovascular deaths occurred in 35 patients (6.3%), heart diseases in 63 (11.3%), brain diseases in 39 (7.0%), and events in the lower limbs in 94 (16.9%). The factors affecting the increase of the cardiovascular events were explored by multivariate analysis (Cox regression analysis). As a result, age (75 years or older), ischemic heart disease and increase in severity on the Fontaine classification were identified as significant factors for cardiovascular deaths, whereas kidney disorders and increase in severity on the Fontaine classification were identified for heart diseases, the number of oral drugs for treating PAD was identified for brain diseases, and age (younger than 75 years), dialysis, ABI (less than 0.7) and aspirin were identified for the events in the lower limbs.. As a result of the three-year follow-up on the Japanese PAD cohort, the current status of PAD treatment, risk factors, and cardiovascular events could be identified.

Topics: Adult; Aged; Aged, 80 and over; Ankle Brachial Index; Aspirin; Cardiovascular Agents; Cardiovascular Diseases; Cilostazol; Disease Progression; Epoprostenol; Female; Follow-Up Studies; Humans; Japan; Male; Middle Aged; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Quality of Life; Risk Assessment; Risk Factors; Severity of Illness Index; Societies, Medical; Tetrazoles; Time Factors; Treatment Outcome; Vascular Surgical Procedures; Vasodilator Agents

Atrial fibrillation (AF) is a significant risk factor for cardiovascular (CV) mortality. This study aims to evaluate the prognostic implication of AF in patients with peripheral arterial disease (PAD).. The International Reduction of Atherothrombosis for Continued Health (REACH) Registry included 23,542 outpatients in Europe with established coronary artery disease, cerebrovascular disease (CVD), PAD and/or > or =3 risk factors. Of these, 3753 patients had symptomatic PAD. CV risk factors were determined at baseline. Study end point was a combination of cardiac death, non-fatal myocardial infarction (MI) and stroke (CV events) during 2 years of follow-up. Cox regression analysis adjusted for age, gender and other risk factors (i.e., congestive heart failure, coronary artery re-vascularisation, coronary artery bypass grafting (CABG), MI, hypertension, stroke, current smoking and diabetes) was used.. Of 3753 PAD patients, 392 (10%) were known to have AF. Patients with AF were older and had a higher prevalence of CVD, diabetes and hypertension. Long-term CV mortality occurred in 5.6% of patients with AF and in 1.6% of those without AF (p<0.001). Multivariable analyses showed that AF was an independent predictor of late CV events (hazard ratio (HR): 1.5; 95% confidence interval (CI): 1.09-2.0).. AF is common in European patients with symptomatic PAD and is independently associated with a worse 2-year CV outcome.

Topics: Aged; Aged, 80 and over; Atrial Fibrillation; Cardiovascular Agents; Cardiovascular Diseases; Chi-Square Distribution; Europe; Female; Humans; Male; Middle Aged; Myocardial Infarction; Outpatients; Peripheral Vascular Diseases; Prevalence; Prognosis; Proportional Hazards Models; Prospective Studies; Registries; Risk Assessment; Risk Factors; Stroke; Time Factors

We compared medical secondary prevention in patients with peripheral arterial disease stage II (Fontaine) located in the femoro-popliteal artery managed by vascular surgeons and medical doctors / angiologists in our multidisciplinary vascular center.. We retrospectively analyzed demission protocols of in-hospital treatments between 01.01.2007 and 20.06.2008.. We surveyed 264 patients (54.2 % women; mean age 67.52 +/- 8.98 yrs), 179 (67.8 %) primarily treated by medical doctors / angiologists and 85 (32.2 %) primarily managed by vascular surgeons. Medical doctors / angiologists treated more women (n = 109) than men (n = 34), (p = 0.002) and documented smoking and diabetes mellitus more often (p < 0.001) than vascular surgeons. Besides, patients had similar cardiovascular risk profiles and concomitant diseases, vascular surgeons prescribed 5.47 +/- 2.26 drugs, medical doctors / angiologists 6.37 +/- 2.67 (p = 0.005). Overall, 239 (90.5 %) patients were on aspirin, 180 (68.2 %) on clopidogrel, and 18 (6.9 %) on oral anticoagulants. Significantly more patients treated by medical doctors / angiologists received clopidogrel (169 versus 11; p < 0.001), significantly more surgical patients received oral anticoagulants (11 versus 7; p = 0.016). The number of patients without prescriptions for any antithrombotic therapy was 6 (6.9 %) in patients treated by vascular surgeons and 0 (0 %) in patients managed by medical doctors / angiologists (p = 0.001). Prescription-rates of beta-blockers, ACE-inhibitors, Angiotensin II-antangonists, calcium channel blockers, and diuretics were statistically not different between the two disciplines, but statins were prescribed significantly more often by medical doctors / angiologists (139 versus 49; p < 0001). With the exceptions of Clopidogrel (women > men) and diuretics (men > women) we observed no gender-specific prescriptions.. We observed high prescriptions rates of secondary medical prevention in patients primarily treated by medical doctors / angiologists and vascular surgeons. We believe that this result is highly influenced by our multidisciplinary approach. Nevertheless, efforts have to be made to raise vascular surgeons awareness of statin use and complete prescription of antithrombotic and antiplatelet drugs.

Topics: Aged; Aged, 80 and over; Attitude of Health Personnel; Cardiovascular Agents; Cooperative Behavior; Critical Pathways; Drug Prescriptions; Evidence-Based Medicine; Female; Femoral Artery; Germany; Guideline Adherence; Health Care Surveys; Health Knowledge, Attitudes, Practice; Hospitalization; Humans; Interdisciplinary Communication; Male; Patient Care Team; Peripheral Vascular Diseases; Popliteal Artery; Practice Guidelines as Topic; Practice Patterns, Physicians'; Retrospective Studies; Secondary Prevention; Treatment Outcome; Vascular Surgical Procedures

Pharmacological treatment has been advocated as a first line therapy for Peripheral Arterial Disease (PAD) patients suffering from intermittent claudication. Previous studies document the ability of pharmacological treatment to increase walking distances. However, the effect of pharmacological treatment on gait biomechanics in PAD patients has not been objectively evaluated as is common with other gait abnormalities.. Sixteen patients were prescribed an FDA approved drug (Pentoxifylline or Cilostazol) for the treatment of symptomatic PAD. Patients underwent baseline gait testing prior to medication use which consisted of acquisition of ground reaction forces and kinematics while walking in a pain free state. After three months of treatment, patients underwent repeat gait testing.. Patients with symptomatic PAD had significant gait abnormalities at baseline during pain free walking as compared to healthy controls. However, pharmacological treatment did not produce any identifiable alterations on the biomechanics of gait of the PAD patients as revealed by the statistical comparisons performed between pre and post-treatment and between post-treatment and the healthy controls.. Pharmacological treatment did not result in statistically significant improvements in the gait biomechanics of patients with symptomatic PAD. Future studies will need to further explore different cohorts of patients that have shown to improve significantly their claudication distances and/or their muscle fiber morphology with the use of pharmacological treatment and determine if this is associated with an improvement in gait biomechanics. Using these methods we may distinguish the patients who benefit from pharmacotherapy and those who do not.

Topics: Aged; Biomechanical Phenomena; Cardiovascular Agents; Case-Control Studies; Cilostazol; Dyskinesias; Female; Gait; Humans; Leg; Male; Middle Aged; Pentoxifylline; Peripheral Vascular Diseases; Range of Motion, Articular; Tetrazoles; Time Factors; Treatment Outcome; Walking

This paper summarizes the highlights of the 15th International Workshop of Endovascular Surgery, held in Ajaccio in June 2008. This is an annual event that attracts leading endovascular therapists from both sides of the Atlantic Ocean as well as a contingency from down-under. The layout of this meeting followed the previous events with sessions on carotid artery disease and abdominal and thoracic aortic aneurysms topped up with clinical cases, lower limb ischemia and venous disease. Generally the session takes off by summarising new evidence, followed by questions and discussion. This workshops gives the participants an excellent opportunity to get an updated perspective within these fast developing areas.

Topics: Adult; Aged, 80 and over; Aortic Aneurysm; Aortic Dissection; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Cardiovascular Diseases; Carotid Artery Diseases; Female; Humans; Male; Minimally Invasive Surgical Procedures; Peripheral Vascular Diseases; Renal Artery; Treatment Outcome; Vascular Surgical Procedures; Veins

Patients with peripheral arterial disease constitute a high-risk population. Guideline-recommended medical therapy use is therefore of utmost importance. The aims of our study were to establish the patterns of guideline-recommended medication use in patients with PAD at the time of vascular surgery and after 3 years of follow up, and to evaluate the effect of these therapies on long-term mortality in this patient group.. Data on 711 consecutive patients with peripheral arterial disease undergoing vascular surgery were collected from 11 hospitals in the Netherlands (enrollment between May and December 2004). After 3.1+/-0.1 years of follow-up, information on medication use was obtained by a questionnaire (n=465; 84% response rate among survivors). Guideline-recommended medical therapy use for the combination of aspirin and statins in all patients and beta-blockers in patients with ischemic heart disease was 41% in the perioperative period. The use of perioperative evidence-based medication was associated with a reduction of 3-year mortality after adjustment for clinical characteristics (hazard ratio, 0.65; 95% CI, 0.45 to 0.94). After 3 years of follow-up, aspirin was used in 74%, statins in 69%, and beta-blockers in 54% of the patients respectively. Guideline-recommended medical therapy use for the combination of aspirin, statins, and beta-blockers was 50%.. The use of guideline recommended therapies in the perioperative period was associated with reduction in long-term mortality in patients with peripheral arterial disease. However, the proportion of patients receiving these evidence-based treatments-both at baseline and 3 years after vascular surgery-was lower than expected based on the current guidelines. These data highlight a clear opportunity to improve the quality of care in this high-risk group of patients.

Topics: Adrenergic beta-Antagonists; Aged; Aspirin; Cardiovascular Agents; Drug Therapy, Combination; Evidence-Based Medicine; Female; Follow-Up Studies; Guideline Adherence; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Middle Aged; Myocardial Ischemia; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Prognosis; Registries; Risk Factors

No data are currently available on the role of oral sirolimus in the prevention of recurrent stenosis in the periphery. We report the effects of oral sirolimus in the prevention of recurrent infrainguinal obstructions in patients with complex peripheral arterial disease. Three patients with ischemic rest pain of the lower limbs and repeated short-term need for surgical and/or endovascular revascularization: 9 times within 12 months, 7 times within 15 months, 11 times within 26 months, respectively. Oral sirolimus on a case by case basis, resulted in less frequent restenosis and longer intervention-free intervals: three re-interventions within 37 months in the first patient, one balloon angioplasty within 17 months in the second, and three re-interventions within 21 months in the third patient, respectively. Side effects, in particular dyspepsia and diarrhoea, were mild and tolerable. To our knowledge, this is the first report to show that oral sirolimus was successfully administered in patients with recurrent excessive neointimal proliferation after revascularization of peripheral arterial lesions lowering the necessity of re-intervention and hence prolonging intervention-free intervals.

Topics: Administration, Oral; Aged; Angioplasty, Balloon; Cardiovascular Agents; Constriction, Pathologic; Female; Humans; Ischemia; Lower Extremity; Male; Middle Aged; Peripheral Vascular Diseases; Reoperation; Saphenous Vein; Secondary Prevention; Sirolimus; Thrombectomy; Treatment Failure; Vascular Surgical Procedures

This study investigated whether polydeoxyribonucleotide (PDRN) may be efficacious in the treatment of peripheral artery occlusive diseases, which are a major cause of morbidity in Western countries and still lack standardized treatment.. We investigated the effects of PDRN, a mixture of deoxyribonucleotides, in an experimental model of hind limb ischemia (HLI) in rats to stimulate vascular endothelial growth factor (VEGF)-A production and to avoid critical ischemia. The femoral artery was excised to induce HLI. Sham-operated on rats (sham HLI) were used as controls. Animals were treated daily with intraperitoneal PDRN (8 mg/kg) or its vehicle. Animals were euthanized at day 7, 14, and 21 after the evaluation of blood flow by laser Doppler. Dissected muscles were used to measure VEGF-A messenger RNA (mRNA) and protein expression, to evaluate edema, and to assess histologic damage.. Administration of PDRN dramatically increased VEGF mRNA throughout the study (day 14: HLI, 7 +/- 2.2 n-fold/beta-actin; HLI + PDRN, 13.3 +/- 3.8 n-fold/beta-actin; P < .0001) and protein expression (HLI, 11 +/- 3.4 integrated intensity; HLI + PDRN, 16 +/- 3.8 integrated intensity; P < .0001). The compound stimulated revascularization, as confirmed by blood flow restoration (P < .005 vs HLI + vehicle), and blunted the histologic damage and the degree of edema. PDRN did not modify VEGF-A expression and blood flow in sham HLI animals. Furthermore, the concomitant administration of 3,7-dimethyl-1-propargilxanthine (DMPX), a selective adenosine A(2A) receptor antagonist, abolished the positive effects of PDRN, confirming that PDRN acts through this receptor.. These results led us to hypothesize a role for PDRN in treating peripheral artery occlusive diseases.

Topics: Adenosine A2 Receptor Agonists; Angiogenesis Inducing Agents; Animals; Arterial Occlusive Diseases; Cardiovascular Agents; Disease Models, Animal; Edema; Hindlimb; Ischemia; Laser-Doppler Flowmetry; Male; Muscle, Skeletal; Neovascularization, Physiologic; Oxidative Stress; Peripheral Vascular Diseases; Polydeoxyribonucleotides; Rats; Rats, Sprague-Dawley; Receptors, Adenosine A2; Regional Blood Flow; RNA, Messenger; Time Factors; Up-Regulation; Vascular Endothelial Growth Factor A

Variations in the resources, stability and priorities of health care systems conceivably affect their capacity to implement health care reform and ensure an evidence based approach to health care. Such variation may partially account for differences in cardiovascular mortality rates between former communist states in Central Europe and Western European countries, but specific data on this subject is sparse. The aim of this study was to compare the presentation of stable angina to cardiology services in Poland vs. the United Kingdom, the management of the condition in relation to existing European guidelines and clinical outcome.. Data was collected as part of a prospective observational cohort study of stable angina in Europe. Information was recorded on referral patterns, clinical presentation and the use of pharmacological therapies, investigations, revascularisation and cardiovascular events during 1 year of follow up. A total of 571 patients with stable angina were enrolled in Poland and 319 in the UK. Patients presenting to cardiology services in Poland were less likely to be referred by a primary care physician, younger, and had more adverse clinical risk predictors at presentation. Non-invasive investigation and coronary angiography were performed less frequently in Poland, but waiting times for invasive assessment were shorter. European guidelines with regard to the use of evidence based secondary preventative medical therapy were applied widely by cardiologists in both countries. No differences were observed in rates of cardiovascular events.. The use of evidence based pharmacological therapy was equally high in both countries, but guidelines regarding investigation were less completely adhered to in Poland, where invasive assessment and subsequent management was prompt but only performed in a highly selected proportion of the population with stable angina.

Topics: Age Distribution; Aged; Angina Pectoris; Cardiovascular Agents; Coronary Angiography; Coronary Circulation; Drug Utilization; Electrocardiography; Exercise Test; Female; Follow-Up Studies; Guideline Adherence; Heart Failure; Humans; Hyperlipidemias; Hypertension; Male; Middle Aged; Myocardial Revascularization; Peripheral Vascular Diseases; Poland; Practice Guidelines as Topic; Primary Health Care; Prospective Studies; Referral and Consultation; Sex Distribution; United Kingdom

Topics: Adrenergic beta-Antagonists; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents; Cardiovascular Agents; Cardiovascular Diseases; Drug Prescriptions; Guideline Adherence; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Lower Extremity; Myocardial Infarction; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Practice Patterns, Physicians'; Risk Assessment; Risk Factors; Time Factors

We compared the use of secondary prevention among patients with a first-time hospitalisation for peripheral arterial disease (PAD) of the lower limb with that among patients with a first-time hospitalisation for myocardial infarction (MI).. Population-based follow-up study between 1997 and 2003 using registry data from the counties of Northern Jutland, Aarhus and Viborg, Denmark.. Between 1997 and 2003, within 180 days after hospital discharge, 26% of patients with lower limb PAD (n=3,424) used antiplatelet drugs, 10% statins, 22% ACE-inhibitors/AT-II receptor antagonists and 13% betablockers compared with 55%, 46%, 42% and 78% respectively among patients with MI (n=11,927). Patients with PAD were substantially less likely than patients with MI to use antiplatelet drugs [adjusted relative risk (RR)=0.39 (95% confidence interval (CI): 0.36-0.41)], statins [adjusted RR=0.21 (95% CI: 0.19-0.23)], ACE-inhibitors/AT-II receptor antagonists [adjusted RR=0.43 (95% CI: 0.40-0.47)] and beta-blockers [adjusted RR=0.10 (95% CI: 0.09-0.11). Between 1997 and 2003 secondary prevention increased considerably in both patient groups, but the disparity in treatment persisted.. Efforts to further increase secondary prevention among patients with PAD are needed urgently.

Topics: Adrenergic beta-Antagonists; Aged; Aged, 80 and over; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Cardiovascular Diseases; Denmark; Drug Prescriptions; Female; Follow-Up Studies; Hospitalization; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Lower Extremity; Male; Middle Aged; Myocardial Infarction; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Population Surveillance; Practice Patterns, Physicians'; Proportional Hazards Models; Prospective Studies; Registries; Risk Assessment; Risk Factors; Time Factors

Our objective was to examine the effect of concomitant lower extremity peripheral arterial disease (PAD) on long-term prognosis and pharmacotherapy in patients with coronary artery disease (CAD).. Prospective cohort study enrolling all patients with angiographically proven CAD between April 1, 2000, and December 31, 2004, in Alberta, Canada.. Of 28,649 patients (mean age 64 years) with CAD, 2509 (9%) had a physician-assigned diagnosis of lower extremity PAD. Mortality was higher in the patients with CAD and PAD over a mean follow-up of 3.1 years, even after adjusting for the fact that patients with PAD had more severe CAD and more comorbidities (adjusted hazard ratio [HR] 1.41, 95% CI 1.28-1.55). Fewer patients with CAD and PAD received antiplatelet agents (83% vs 86%, odds ratio 0.86, 95% CI 0.77-0.97) or beta-blockers (63% vs 67%, odds ratio 0.89, 95% CI 0.82-0.98), but users of these agents exhibited lower mortality (adjusted HR 0.68, 95% CI 0.60-0.77, for antiplatelet agents and adjusted HR 0.72, 95% CI 0.64-0.80, for beta-blockers). Approximately half of these patients were prescribed statins or angiotensin-converting enzyme inhibitors, and 27% were using all 3 evidence-based anti-atherosclerotic therapies (antiplatelets, statin, and angiotensin-converting enzyme inhibitor).. In patients with CAD, lower extremity PAD is independently associated with poorer outcomes. Although all evidence-based therapies are underused in patients with CAD, patients with concomitant PAD are less likely to be prescribed antiplatelet agents or beta-blockers--both agents are associated with improved survival in patients with CAD and PAD.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Female; Humans; Lower Extremity; Male; Middle Aged; Peripheral Vascular Diseases; Prognosis; Prospective Studies

The pharmacologic treatment of the cardiovascular comorbidities in patients with peripheral arterial disease (PAD) can have a profound effect on the outcomes of these patients. Guidelines for the treatment of hypertension, hyperlipidemia, diabetes, and tobacco use have been published by the American Heart Association and American College of Cardiology (AHA/ACC). Patients with PAD are often under-treated for these conditions. We sought to evaluate the adherence to these established guidelines in all new patients presenting with PAD to a vascular surgery clinic and delineate the opportunity for vascular surgeon involvement in these treatments. Consecutive new patients with symptomatic, objectively proven PAD (ankle-brachial index < 0.9) were evaluated in a vascular surgery clinic by a staff vascular surgeon. PAD risk factors, pre-visit medications, and prior cardiovascular interventions were recorded. Patients were stratified whether they were receiving appropriate preventive pharmacotherapy and whether they were meeting AHA/ACC goals. In patients without prior cardiovascular history, screening for these conditions was performed. One hundred sixty-seven new patients were evaluated over a 1-year period. Objectively diagnosed PAD included intermittent claudication in 115 (69%) and critical limb ischemia in 52 (31%) patients. Average age was 67.8 years, and 73 patients (44%) were current smokers. At initial evaluation, only 115 (69%) patients reported antiplatelet use. Patients with a recorded diagnosis of hypertension met clinical guidelines in 39 instances (71%). Eighteen patients (20%) with diabetes mellitus had poor glycemic control (Hgb-A1C > 7.0%). Seventeen (19%) of 88 patients with a history of hyperlipidemia were not adequately treated. Vascular surgeon medical interventions resulted in 31% of patients being started on antiplatelet therapy, 29% of hypertension therapies were modified, 19% of established lipid therapy was modified, and lipid therapy was initiated in 20%. A new diagnosis of hypertension was made in 10 cases (6%) and hyperlipidemia in 13 cases (7%). Despite clear guidelines for the medical community regarding cardiovascular prevention, a large percentage of patients with symptomatic PAD presenting to the vascular surgery clinic are not receiving appropriate therapy for their comorbidities or are not meeting the established goals. Vascular surgeons have an important role in promoting vascular health through the systemic prevention of isch

Topics: Aged; Aged, 80 and over; Antihypertensive Agents; Atherosclerosis; California; Cardiovascular Agents; Drug Utilization; Female; Guideline Adherence; Humans; Hypoglycemic Agents; Hypolipidemic Agents; Male; Patient Compliance; Peripheral Vascular Diseases; Physician's Role; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Practice Patterns, Physicians'; Registries; Retrospective Studies; Risk Factors; Smoking; Smoking Cessation; Specialties, Surgical; Vascular Surgical Procedures

To assess the safety and efficacy of sirolimus-eluting stents (SESs) in the treatment of severe intermittent claudication and critical limb ischaemia with "below-the-knee" lesions, unsuitable for surgery.. Limited published evidence suggests that drug-eluting stents may offer significant improvements in the treatment of infrapopliteal lesions.. Thirty consecutive patients with either severe intermittent claudication or critical limb ischemia (CLI), category 3-6 of Rutherford classification, and multivessel disease of infrapopliteal arteries (> or = 2 vessels) were treated with SES. Sixty-two arteries were treated with 106 SES. Mean age was 73.9 years, 77% of patients were male and 36% diabetic. The primary endpoint was clinical improvement and healing of ulcers at short term (1 month) and mid term (7.7 months). The secondary endpoint was primary vessel patency rate (angiographic or duplex assessment). All patients received clopidogrel (75 mg daily) or ticlopidine (150 mg daily) for 2 months or longer.. Angiographic and procedural success was achieved in all patients. At 7 months (7.7 +/- 5.8), it was necessary to amputate 1 toe in one patient and 1 mid-foot in another. Limb salvage was obtained in 100% of patients. Other events were: two cardiac deaths unrelated to CLI, one stroke with hemiparesia, one initial reperfusion syndrome, one contralateral CLI, and three recurrent homolateral claudication cases. All surviving patients had a mid-term clinical improvement with 97% of primary patency (56 patent arteries on 58 arteries).. Treatment of "below-the-knee" lesions with SES may provide an alternative treatment for patients with CLI.

Topics: Adult; Aged; Aged, 80 and over; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Safety; Female; Follow-Up Studies; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Leg; Male; Middle Aged; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors; Popliteal Artery; Prospective Studies; Research Design; Severity of Illness Index; Sirolimus; Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Cardiovascular Agents; Cause of Death; Coronary Disease; Humans; Peripheral Vascular Diseases

Atherothrombosis is a systemic disease affecting coronary, cerebral, and lower limb arteries, and requiring secondary prevention measures.. Data from three observational studies carried out in 1999-2000 (ECLAT1, APRES, PRISMA) were pooled to describe the prevalence of cardiovascular risk factors and the patterns of drug use in atherothrombotic patients.. General practitioners and cardiologists engaged in a private practice and evenly distributed in France recruited consecutive patients who had a history of at least one atherothrombotic event: myocardial infarction (MI), ischaemic stroke, and/or peripheral arterial disease (PAD).. The sample was composed of 14 544 patients (men: 75.0%, age 75 or older: 31.0%). At least one of the four major risk factors (smoking, hypertension, hypercholesterolaemia, diabetes) was present in 94.3% of the sample. Prevalence of drug use was: 78.8% (antiplatelet agents), 48.5% (statins), 36.7% (beta-blockers), and 33.4% [angiotensin-converting enzyme (ACE) inhibitors]. After adjustment for confounders, statins were taken in a significantly larger extent in patients with a history of isolated MI than in those with a previous ischaemic stroke or PAD, or in patients who suffered from both MI and ischaemic stroke. Isolated MI (as compared with ischaemic stroke and PAD) was significantly and independently associated with a higher probability to take antiplatelet agents, beta-blockers or ACE inhibitors.. At least one conventional risk factor was observed in almost all atherothrombotic patients. Use of preventive drugs was lower in patients with a history of ischaemic stroke or PAD, and should increase, accordingly to the results of recent randomized controlled trials.

Topics: Adult; Aged; Brain Ischemia; Cardiovascular Agents; Diabetes Mellitus, Type 2; Female; France; Humans; Hypercholesterolemia; Hypertension; Life Style; Male; Middle Aged; Myocardial Infarction; Peripheral Vascular Diseases; Prevalence; Risk Factors; Smoking; Stroke

Topics: Cardiovascular Agents; Contraindications; Humans; Peripheral Vascular Diseases

Topics: Arteriosclerosis; Cardiovascular Agents; Humans; Muscle Relaxants, Central; Peripheral Arterial Disease; Peripheral Vascular Diseases; Propiophenones; Tolperisone

Topics: Albumins; Cardiovascular Agents; Iodine; Peripheral Vascular Diseases; Serum Albumin; Vascular Diseases; Vasodilator Agents

Topics: Cardiovascular Agents; Humans; Muscle Cramp; Muscle Relaxants, Central; Peripheral Vascular Diseases; Sleep-Wake Transition Disorders; Vascular Diseases

Topics: Arteriosclerosis; Cardiovascular Agents; Muscle Relaxants, Central; Peripheral Vascular Diseases; Scleroderma, Systemic; Vascular Diseases; Vasodilator Agents

Topics: Cardiovascular Agents; Cyclandelate; Muscle Relaxants, Central; Peripheral Vascular Diseases; Vascular Diseases; Vasodilator Agents

Topics: Cardiovascular Agents; Isoxsuprine; Muscle Relaxants, Central; Peripheral Vascular Diseases; Vascular Diseases

Topics: Cardiovascular Agents; Ergot Alkaloids; Peripheral Vascular Diseases; Vascular Diseases; Vasodilator Agents

Topics: Cardiovascular Agents; Muscle Relaxants, Central; Peripheral Vascular Diseases; Vascular Diseases

Topics: Cardiovascular Agents; Cyclandelate; Muscle Relaxants, Central; Peripheral Vascular Diseases; Vascular Diseases

Topics: Cardiovascular Agents; Ergoloid Mesylates; Ergot Alkaloids; Leg; Oxytocics; Peripheral Vascular Diseases; Vascular Diseases

Topics: Cardiovascular Agents; Enzyme Therapy; Enzymes; Humans; Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Vasodilator Agents

Topics: Cardiovascular Agents; Isoxsuprine; Muscle Relaxants, Central; Parasympatholytics; Peripheral Vascular Diseases; Vascular Diseases; Vasodilation; Vasodilator Agents

Topics: Cardiovascular Agents; Ergoloid Mesylates; Ergot Alkaloids; Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases

Topics: Cardiovascular Agents; Ergoloid Mesylates; Ergot Alkaloids; Heparin; Histamine H1 Antagonists; Humans; Hydrocortisone; Penicillins; Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases

Topics: Animals; Behavior, Animal; Cardiovascular Agents; Ergot Alkaloids; Gout; Peripheral Vascular Diseases; Social Behavior; Vascular Diseases

Topics: Cardiovascular Agents; Ergoloid Mesylates; Ergot Alkaloids; Oxytocics; Peripheral Vascular Diseases; Vascular Diseases

Topics: Cardiovascular Agents; Ergoloid Mesylates; Ergot Alkaloids; Oxytocics; Peripheral Vascular Diseases; Vascular Diseases

Topics: Cardiovascular Agents; Cyclandelate; Muscle Relaxants, Central; Peripheral Vascular Diseases; Vascular Diseases

Topics: Cardiovascular Agents; Ergoloid Mesylates; Ergot Alkaloids; Humans; Peripheral Vascular Diseases; Vascular Diseases

Topics: Cardiovascular Agents; Ergoloid Mesylates; Ergot Alkaloids; Peripheral Vascular Diseases; Vascular Diseases

Topics: Alkaloids; Cardiovascular Agents; Ergoloid Mesylates; Ergot Alkaloids; Peripheral Vascular Diseases; Vascular Diseases

Topics: Cardiovascular Agents; Cyclandelate; Muscle Relaxants, Central; Peripheral Vascular Diseases; Vascular Diseases

Topics: Cardiovascular Agents; Ergot Alkaloids; Oxytocics; Peripheral Vascular Diseases; Vascular Diseases

Topics: Cardiovascular Agents; Ergoloid Mesylates; Ergot Alkaloids; Oxytocics; Peripheral Vascular Diseases

Topics: Cardanolides; Cardiovascular Agents; Coronary Disease; Ergoloid Mesylates; Ergot Alkaloids; Peripheral Vascular Diseases

Topics: Cardiovascular Agents; Ergot Alkaloids; Oxytocics; Peripheral Vascular Diseases; Sympathectomy; Sympatholytics

Topics: Cardiovascular Agents; Cardiovascular Diseases; Ergot Alkaloids; Oxytocics; Peripheral Vascular Diseases

Topics: Cardiovascular Agents; Ergot Alkaloids; Oxytocics; Peripheral Vascular Diseases

Topics: Cardiovascular Agents; Ergot Alkaloids; Oxytocics; Peripheral Vascular Diseases

Topics: Alkaloids; Cardiovascular Agents; Ergot Alkaloids; Peripheral Vascular Diseases; Treatment Outcome; Vascular Diseases

Topics: Cardiovascular Agents; Ergot Alkaloids; Oxytocics; Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases

Topics: Cardiovascular Agents; Ergot Alkaloids; Peripheral Vascular Diseases; Vascular Diseases

Topics: Cardiovascular Agents; Cardiovascular Diseases; Dihydroergotoxine; Ergot Alkaloids; Peripheral Vascular Diseases; Vascular Diseases