cardiovascular-agents and Arterial-Occlusive-Diseases

Treatment of superficial femoral artery (SFA) lesions remains challenging. We conducted a network meta-analysis of randomized controlled trials aiming to explore the efficacy of treatment modalities for SFA "de novo" lesions.. Eleven treatments for SFA occlusive disease were recognized. We used primary patency and binary restenosis at 12-month follow-up as proxies of efficacy for the treatment of SFA lesions.. A total of 33 studies (66 study arms; 4659 patients) were deemed eligible. In terms of primary patency, odds ratios (ORs) with 95% confidence intervals (CIs) were statistically significantly higher in drug-eluting stent (DES; OR, 10.05; 95% CI, 3.22-31.39), femoropopliteal bypass surgery (BPS; OR, 7.15; 95% CI, 2.27-22.51), covered stent (CS; OR, 3.56; 95% CI, 1.33-9.53), and nitinol stent (NS; OR, 2.83; 95% CI, 1.42-5.51) compared with balloon angioplasty (BA). The rank order from higher to lower primary patency in the multidimensional scaling was DES, BPS, NS, CS, drug-coated balloon, percutaneous transluminal angioplasty with brachytherapy, stainless steel stent, cryoplasty (CR), and BA. Combination therapy of NS with CR and drug-coated balloon were the two most effective treatments, followed by NS, CS, percutaneous transluminal angioplasty with brachytherapy, cutting balloon, stainless steel stent, BA, and CR in terms of multidimensional scaling values for binary restenosis.. DES has shown encouraging results in terms of primary patency for SFA lesions, whereas BPS still maintains its role as a principal intervention. On the contrary, BA and CR appear to be less effective treatment options.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Brachytherapy; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Cryotherapy; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Humans; Network Meta-Analysis; Odds Ratio; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency; Vascular Surgical Procedures

Fibrinogen is cleaved by thrombin to fibrin, which provides the blood clot with its essential structural backbone. As an acute phase protein, the plasma levels of fibrinogen are increased in response to inflammatory conditions. In addition to fibrinogen levels, fibrin clot structure is altered by a number of factors. These include thrombin levels, treatment with common cardiovascular medications, such as aspirin, anticoagulants, statins and fibrates, as well as metabolic disease states such as diabetes mellitus and hyperhomocysteinaemia. In vitro studies of fibrin clot structure can provide information regarding fibre density, clot porosity, the mechanical strength of fibres and fibrinolysis. A change in fibrin clot structure, to a denser clot with smaller pores which is more resistant to lysis, is strongly associated with cardiovascular disease. This pathological change is present in patients with arterial as well as venous diseases, and is also found in a moderate form in relatives of patients with cardiovascular disease. Pharmacological therapies, aimed at both the treatment and prophylaxis of cardiovascular disease, appear to result in positive changes to the fibrin clot structure. As such, therapies aimed at 'normalising' fibrin clot structure may be of benefit in the prevention and treatment of cardiovascular disease.

Topics: Arterial Occlusive Diseases; Blood Coagulation; Cardiovascular Agents; Cardiovascular Diseases; Fibrin; Fibrinogen; Fibrinolysin; Fibrinolysis; Humans; Porosity; Venous Thrombosis

Critical limb ischemia refers to the clinical state of advanced arterial occlusive disease, placing an extremity at risk for gangrene and limb loss. Critical limb ischemia has 2 broad clinical subcategories that are vital to differentiate: acute limb ischemia and chronic arterial occlusive disease. This article reviews the etiologies, diagnosis, and treatment of critical limb ischemia.

Topics: Acute Disease; Arterial Occlusive Diseases; Cardiovascular Agents; Chronic Disease; Compartment Syndromes; Endarterectomy; Equipment Design; Humans; Ischemia; Lower Extremity; Magnetic Resonance Angiography; Reperfusion; Rhabdomyolysis; Thrombectomy; Thrombolytic Therapy; Tomography, X-Ray Computed; Upper Extremity

The aim of this article was to review the available literature on the use of drug-coated balloons (DCB) for endovascular treatment of femoropopliteal arterial stenosis.. Manual searches of articles, presentations, and clinical trials were performed. Selected references were reviewed and summarized.. Due to the high morbidity associated with femoropopliteal bypass, endovascular approaches, such as balloon angioplasty and stent placement, have become the first line of therapy for isolated, de novo femoral atherosclerosis. However, percutaneous interventions have been limited by restenosis. In an effort to overcome this obstacle, the use of antiproproliferative drugs to inhibit hyperplasia has been attempted. The success of drug-eluting stents (DES) in the coronary circulation has not been reproduced in the femoropopliteal segment. Animal and human experiments have shown prolonged inhibition of intimal hyperplasia with single delivery of large doses of paclitaxel during balloon angioplasty. Recent randomized trials have shown significant advantages at 12 and 24 month angiographic follow-up with the use of DCB when compared to standard balloon angioplasty.. Several clinical trials have demonstrated promising early results with the use of DCB in treating femoropopliteal stenosis. However, long term results, exact indications, and optimal applications are yet to be determined.

Topics: Angioplasty, Balloon; Animals; Arterial Occlusive Diseases; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug-Eluting Stents; Femoral Artery; Humans; Paclitaxel; Popliteal Artery; Treatment Outcome

The concept of using a balloon catheter to directly deliver an antiproliferative drug at the site of injury has become one of the most interesting technological developments in endovascular therapy. There have been important advances in knowledge concerning balloon-based drug delivery technologies during the last years, and different methods have been developed by different companies to coat the balloon with the antiproliferative agent. Currently there is a rapidly increasing clinical study program using drug coated balloons (DCB) in different locations and indications. There are four already finished randomized studies in patients with superficial femoral artery lesions investigating the efficacy of paclitaxel release by DCB, and all demonstrated significantly improved patency rates compared to balloon angioplasty with non coated balloons. DCB offer several advantages compared to drug eluting stents, since any stentless technology for improvement of longterm patency is preferable to overcome the drawbacks of stenting. This technology has demonstrated the capacity to have a significant impact on the practice of percutaneous cardiovascular interventions in the future.

Topics: Angioplasty, Balloon; Animals; Arterial Occlusive Diseases; Cardiovascular Agents; Catheters; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Radiography; Recurrence; Treatment Outcome; Vascular Patency

Magnetic guidance is a physical targeting strategy with the potential to improve the safety and efficacy of a variety of therapeutic agents--including small-molecule pharmaceuticals, proteins, gene vectors, and cells--by enabling their site-specific delivery. The application of magnetic targeting for in-stent restenosis can address the need for safer and more efficient treatment strategies. However, its translation to humans may not be possible without revising the traditional magnetic targeting scheme, which is limited by its inability to selectively guide therapeutic agents to deep localized targets. An alternative two-source strategy can be realized through the use of uniform, deep-penetrating magnetic fields in conjunction with vascular stents included as part of the magnetic setup and the platform for targeted delivery to injured arteries. Studies showing the feasibility of this novel targeting strategy in in-stent restenosis models and considerations in the design of carrier formulations for magnetically guided antirestenotic therapy are discussed in this review.

Topics: Angioplasty; Animals; Arterial Occlusive Diseases; Cardiovascular Agents; Constriction, Pathologic; Coronary Restenosis; Drug Delivery Systems; Humans; Magnetics; Prosthesis Design; Recurrence; Stents

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

Many patients with severe intermittent claudication (IC) or critical limb ischemia (CLI) have chronic total occlusions (CTO) in their lower extremity vascular bed. The successful treatment of these lesions is becoming increasingly more important as the population ages and the prevalence of diseases such as diabetes mellitus and its consequences increases. Many of these patients have significant comorbidities and may benefit from less invasive treatment options. Several endovascular techniques have now become well established in the treatment of these lesions. Additionally, several new adjunctive tools have been developed to enhance the technical success of CTO revascularization. These tools and techniques offer a minimally invasive alternative for limb salvage in this compromised patient population and have become an established practice in many centers. Although some concerns about procedure durability and lower rates of primary patency exist, particularly when compared to surgical bypass, the limb salvage and amputation-free survival rates are much more encouraging. Advantages of these techniques compared to surgical bypass are reduced morbidity and mortality, reduced anesthesia requirements, and potential reductions in length of hospital stay and cost. In addition, bypass options are typically preserved after endovascular treatment. The more conventional and some newer endovascular treatment approaches, some of the adjunctive tools and techniques used in CTO revascularization as well as their clinical results will be discussed in this review.

Topics: Adult; Aged; Amputation, Surgical; Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Chronic Disease; Constriction, Pathologic; Disease Progression; Equipment Design; Female; Humans; Intermittent Claudication; Ischemia; Limb Salvage; Male; Middle Aged; Radiography, Interventional; Stents; Treatment Outcome; Ultrasonography, Interventional; Vascular Surgical Procedures

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

In the last years the development of new techniques and technologies for the endovascular treatment of peripheral arterial occlusive disease has allowed to treat a vast array of lesions with high technical success and low complications. Despite these advances, restenosis, and in particular in-stent restenosis, is a problem that significantly affects middle and long-term results and remains to be solved. Drug-eluting balloons (DEB) have shown good results in the treatment of coronary in-stent restenosis in experimental and clinical trials, but only few experimental and clinical trials focus on the peripheral district. This review summarizes the available experimental and clinical data in support of DEB in the treatment of ISR in the peripheral district. Larger clinical trials focused on paclitaxel-coated balloon in the treatment of ISR in the peripheral arteries will be necessary to provide definitive evidence of clinical benefit.

Topics: Angioplasty, Balloon; Animals; Arterial Occlusive Diseases; Cardiovascular Agents; Constriction, Pathologic; Drug-Eluting Stents; Evidence-Based Medicine; Humans; Lower Extremity; Paclitaxel; Prosthesis Design; Secondary Prevention; Treatment Outcome

The incidence of restenosis after percutaneous peripheral interventions (PPI) varies considerably depending upon the vascular bed but appears to be highest in the femoropopliteal and tibioperoneal arteries. The restenosis process in the periphery does not appear to stop at the 6-month mark, as seen with bare metal stents in the coronary arteries, but continues for a longer time, possibly years, after the intervention. This review evaluates the incidence of restenosis following lower extremity arterial interventions and potential drugs or devices that could alter this process, including nonpharmacological (stents, cryoplasty, Cutting Balloon angioplasty, atherectomy, brachytherapy, and photodynamic therapy) and pharmacological (systemic and direct drug delivery) approaches. A global strategy to achieve optimal outcome with PPI is offered: (1) obtain excellent acute angiographic results with less dissection and recoil, (2) protect the distal tibial vascular bed, and (3) reduce smooth muscle cell proliferation with pharmacological intervention.

Topics: Angioplasty, Balloon; Arterial Occlusive Diseases; Atherectomy; Brachytherapy; Cardiovascular Agents; Cell Proliferation; Constriction, Pathologic; Cryotherapy; Humans; Hyperplasia; Lower Extremity; Muscle, Smooth, Vascular; Photochemotherapy; Practice Guidelines as Topic; Secondary Prevention; Stents; 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

Endovascular interventions focused on the treatment of superficial femoral artery occlusive disease have increased exponentially as technologic advances have provided the practitioner with a wide array of treatment options. Unfortunately, there is a lack of comparative trials available to guide the practitioner in determining when these devices are best utilized. In the current report, the available comparative data, single-arm trials, and registry data are reviewed and device recommendations are proposed based on TASC II classification, lesion morphology, and indication.

Topics: Angioplasty, Balloon; Arterial Occlusive Diseases; Atherectomy; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Embolism; Femoral Artery; Humans; Laser Therapy; Patient Selection; Practice Guidelines as Topic; Prosthesis Design; Radiography; Stents; Treatment Outcome; Vascular Surgical Procedures

Regardless of the type of arterial reconstruction, luminal narrowing (stenosis or restenosis) develops in approximately one third of the vessels. In the past, the focus of research has been on the mechanisms of stenosis (intimal hyperplasia, pathologic remodeling) and pharmacologic approaches to prevention. An alternative approach is to induce intimal atrophy after luminal narrowing has developed, thus limiting treatment to only those patients that develop a problem. This approach to treat established disease by reducing wall mass through induction of cell death and extracellular matrix removal would be particularly useful for treating stenosis in synthetic bypass grafts or stented vessels, in which intimal hyperplasia is the primary mechanism of stenosis. This approach may be applicable as well to other vascular proliferative disorders, such as pulmonary hypertension and chronic transplant arteriopathy. Proof of principle has been shown in experiments with antibodies to platelet-derived growth factor (PDGF) receptors that cause neointimal regression in baboon polytetrafluoroethylene (PTFE) grafts and with angiotensin-converting enzyme inhibitors that induce medial atrophy in hypertensive arteries. Possible molecular targets could include PDGF receptors, A20, and BMP4. Further studies are needed to determine the utility of such a therapeutic approach to vascular disease.

Topics: Animals; Arterial Occlusive Diseases; Atrophy; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Blood Vessels; Cardiovascular Agents; Cell Death; Cell Proliferation; Constriction, Pathologic; Coronary Disease; Disease Models, Animal; Heart Transplantation; Humans; Hyperplasia; Hypertension; Hypertrophy; Recurrence; Remission Induction; Signal Transduction; Stents

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

To prove the efficacy of the treatment of atherosclerotic stable peripheral arterial occlusive disease with drugs certain criteria are to be considered in the context of the design and performance of clinical trials. These criteria refer to the design of the study, randomisation, blinding, inclusion and exclusion criteria, definition of outcomes, methods of examination, sample size estimation, and evaluation of the results. If these criteria and conditions are not taken into consideration, false positive and negative results can arise. In the present study, the criteria to prove the efficacy of vasoactive substances in the treatment of atherosclerotic peripheral occlusive arterial diseases are presented.

Topics: Arterial Occlusive Diseases; Cardiovascular Agents; Clinical Trials as Topic; Double-Blind Method; Humans; Random Allocation; Research Design; Treatment Outcome

High restenosis rate is still the major limitation of peripheral arterial interventions. Within the last years, drug-eluting stents have gained wide acceptance in the coronary arteries, however, these devices are not currently available for arteries outside the coronary vasculature. This article summarizes the special role of the superficial femoral artery in restenosis, with efforts being made to reduce the restenosis rate in this artery, focusing on stents and drug-eluting stents.

Topics: Arterial Occlusive Diseases; Cardiovascular Agents; Drug Delivery Systems; Femoral Artery; Humans; Paclitaxel; Secondary Prevention; Sirolimus; Stents

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

Topics: Arterial Occlusive Diseases; Cardiovascular Agents; Combined Modality Therapy; Exercise; Humans

Although our understanding of the pathophysiology of atherosclerosis and peripheral vascular disease continues to grow, we have yet to discover a medication that can safely and efficaciously be given to most claudicants that will alleviate their symptoms to prevent disease progression. Many patients with intermittent claudication improve or remain stable without therapy if they attempt to alter their risk factors (e.g., control of diabetes, smoking cessation, lowering of cholesterol levels). However, many require concomitant drug therapy to alleviate symptoms of PVD, and some require surgical intervention. Even with the recent advances in therapeutic development and the promise of agents currently in clinical trials, the questions of who to treat, when treatment should begin, and which agent to use remain uncertain.

Topics: Angiotensin-Converting Enzyme Inhibitors; Arterial Occlusive Diseases; Cardiovascular Agents; Cyclooxygenase Inhibitors; Humans; Ischemia; Leg; Pentoxifylline; Platelet Aggregation Inhibitors; Prostaglandins, Synthetic; Vasodilator Agents

Topics: Arterial Occlusive Diseases; Arteriosclerosis; Cardiovascular Agents; Cerebral Infarction; Fibrinolytic Agents; Humans; Myocardial Infarction; Recurrence

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

Three consecutive periods in the natural history of atherosclerosis are amenable to medical treatment. Plaque development is the main target of prevention, which also aims at slowing the progression of already existing plaques. The control of several established risk factors (high blood cholesterol, high blood pressure, diabetes mellitus, tobacco smoking) has already yielded encouraging benefits, especially in the field of secondary prevention. More efficient prophylaxis is to be expected, either from the further improved control of these classic risk factors with earlier, stronger, and longer interventions or from the correction of newly established causal determinants of atherosclerosis. A plaque manifests itself clinically through progressive or abrupt obstruction of the arterial lumen, which can be avoided or retarded by interventions aimed at reducing thrombosis, at controlling plaque instability (the major cause of thrombosis), and at enhancing arterial remodeling (which allows compensatory enlargement of the arterial lumen). When ischemia has occurred, a third wave of palliative treatments aims at improving energy supply to the organ with compromised vascularization. Classic treatments reduce oxygen consumption or improve oxygen extraction by ischemic tissues. In addition, the design of drugs to enhance the development of collateral channels appears to be promising therapeutic approach.

Topics: Animals; Arterial Occlusive Diseases; Arteriosclerosis; Cardiovascular Agents; Humans; Ischemia

In Raynaud's phenomenon few new medical treatment options have become available in recent years, but the merits and demerits of drugs already longer available have been established more firmly. Calcium antagonists remain the treatment of first choice even despite their frequent side effects. Prostacyclin analogues are effective but oral formulations are still eagerly awaited. In PAOD attention is shifting from the often disappointing medical treatment of symptoms to possible secondary prevention. Except for the effects of some prostanoids little clinical benefit is obtained from vasodilators and rheologically active drugs. Attempts to influence skeletal muscle metabolism with carnitine-analogues like 1-carnitine are interesting but clinical benefit has not yet been proven. In the next few years results of trials with lipid-lowering drugs to stop progression of atherosclerotic lesions will become available.

Topics: Arterial Occlusive Diseases; Arteriosclerosis; Cardiovascular Agents; Humans; Raynaud Disease; Vasodilator Agents

Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow(®) paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm.. A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5-15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera(®) stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention.. The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting.. ISRCTN47846578.

Topics: Alloys; Amputation, Surgical; Angiography, Digital Subtraction; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Cardiovascular Agents; Clinical Protocols; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Equipment Failure; Femoral Artery; Hemodynamics; Humans; Hyperplasia; Limb Salvage; Neointima; Netherlands; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Prosthesis Failure; Recurrence; Research Design; Resins, Plant; Single-Blind Method; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices

Critical limb ischemia, the most severe form of peripheral arterial disease, results in extremity amputation if left untreated. Endovascular recanalization of stenotic or occluded infrapopliteal arteries has recently emerged as an effective form of therapy, although the duration of patency is typically limited by restenosis. Recently, it has been suggested that drug-eluting stents originally developed for the coronary arteries might also be effective in preventing restenosis in the infrapopliteal arteries. This prospective, randomized, controlled clinical trial tested the hypothesis that treatment of infrapopliteal arterial occlusive lesions with an everolimus-eluting stent (Xience V) would provide superior patency to treatment with a bare-metal stent (Multi-Link Vision).. A sample size of 140 patients was planned to be enrolled at five European investigative sites. The primary end point was arterial patency at 12 months, defined as the absence of ≥50% restenosis based on quantitative analysis of contrast angiography.. Between March of 2008 and September of 2009, 74 patients were treated with Xience V and 66 patients were treated with Vision. After 12 months, the primary patency rate after treatment with Xience V was 85% compared with 54% after treatment with Vision (P = .0001). Treatment with Xience V significantly reduced mean in-stent diameter stenosis (21% ± 21% vs 47% ± 27%; P < .0001) and mean in-stent late lumen loss (0.78 ± 0.63 vs 1.41 ± 0.89 mm; P = .001). There were no differences in the percentage of patients receiving a designation of Rutherford class 0 or 1 at the 12-month follow-up visit (56% for Vision, vs 60% for Xience V; P = .68). Major extremity amputations were rare in both groups (two for Vision and one for Xience V). The use of the Xience V stent significantly reduced the need for repeat intervention: freedom from target lesion revascularization was 91% for Xience V vs 66% for Vision (P = .001).. Treatment of the infrapopliteal occlusive lesions of critical limb ischemia with everolimus-eluting stents reduces restenosis and the need for reintervention compared with bare metal stents.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty; Arterial Occlusive Diseases; Cardiovascular Agents; Constriction, Pathologic; Critical Illness; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Metals; Middle Aged; Popliteal Artery; Prospective Studies; Prosthesis Design; Radiography; Recurrence; Risk Assessment; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome; Vascular Patency

To report 6-month results of the DEBELLUM (Drug-Eluting Balloon Evaluation for Lower Limb MUltilevel TreatMent) randomized trial to evaluate the efficacy of a drug-eluting balloon (DEB) to reduce restenosis after treatment of multilevel lower limb occlusive disease vs. a conventional angioplasty balloon (AB).. Between September 2010 and March 2011, 50 consecutive patients (37 men; mean age 66±4 years) with 122 lesions (96 stenoses and 26 occlusions) of the femoropopliteal (92, 75.4%) or below-the-knee (BTK) arteries (30, 24.6%) were enrolled and randomly assigned to the DEB (25 patients with 57 lesions) or AB (25 patients with 65 lesions) group. Twenty patients presented multilevel lesions. Mean lesion length was 7.5±3.5 cm. Thirty-one (62%) of the patients were Fontaine stage IIb, while 19 (38%) were stage III or IV. DEBs or ABs were used for dilation of de novo lesions or for postdilation after primary stenting (superficial femoral artery only). Patients requiring provisional stenting after angioplasty secondary to flow-limiting dissection or residual stenosis >50% were ineligible. Primary endpoint was late lumen loss at 6 months. Secondary endpoints were target lesion revascularization (TLR), amputation, and thrombosis.. Late lumen loss was lower in the DEB group (0.5±1.4 vs. 1.6±1.7 mm, p<0.01). TLR was necessary in 6.1% of the DEB group vs. 23.6% of the AB group (p=0.02). Comparing the DEB to AB groups, the thrombosis rates were 3.0% vs. 5.2% (p=0.6), and the amputation rates were 3.0% vs. 7.9% (p=0.36). The binary restenosis rates were 9.1% (3/33 limbs) in the DEB group vs. 28.9% (11/38 limbs) in the control group (p=0.03). The ankle-brachial index improved to a greater degree in the DEB group: 0.87±0.22 vs. 0.70±0.13 (p<0.05). The Fontaine stage improved in both groups but more so in patients treated with DEBs (p=0.04).. The DEBELLUM trial confirmed the ability of paclitaxel-eluting balloons to reduce restenosis vs. conventional balloons at 6 months after treatment of multilevel (femoropopliteal and BTK) arterial disease in patients affected by claudication and CLI. A lower TLR rate and better clinical outcomes appear to be associated with the use of DEBs regardless of stent placement.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Constriction, Pathologic; Drug Carriers; Equipment Design; Female; Femoral Artery; Humans; Limb Salvage; Lower Extremity; Male; Middle Aged; Paclitaxel; Popliteal Artery; Prospective Studies; Radiography; Recurrence; Rome; Severity of Illness Index; Stents; Thrombosis; Time Factors; Treatment Outcome; Vascular Access Devices

Peripheral percutaneous transluminal angioplasty is fraught with a substantial risk of restenosis and reintervention. A drug-eluting balloon (DEB) based on a novel coating was compared with uncoated balloons in patients undergoing femoro-popliteal percutaneous transluminal angioplasty.. Patients with symptomatic femoro-popliteal atherosclerotic disease undergoing percutaneous transluminal angioplasty were randomized to paclitaxel-coated IN.PACT Pacific or uncoated Pacific balloons. The primary end point was late lumen loss at 6 months assessed by blinded angiographic corelab quantitative analyses. Secondary end points were binary restenosis and Rutherford class change at 6 months, and target lesion revascularization plus major adverse clinical events (major adverse events=death, target limb amputation, or target lesion revascularization) at 6 and 12 months. Eighty-five patients (91 cases=interventional procedures) were randomized in 3 hospitals (44 to DEB and 47 to uncoated balloons). Average lesion length was 7.0 ± 5.3 and 6.6 ± 5.5 cm for DEB and control arm, respectively. Procedural success was obtained in all cases. Six-month quantitative angiography showed that DEB were associated with significantly lower late lumen loss (-0.01 mm [95% CI, -0.29; 0.26] versus 0.65 mm [0.37; 0.93], P=0.001) and fewer binary restenoses (3 [8.6%] versus 11 [32.4%], P=0.01). This translated into a clinically relevant benefit with significantly fewer major adverse events for DEB versus uncoated balloons up to 12 months (3 [7.1%] versus 15 [34.9%], P<0.01) as well as target lesion revascularizations (3 [7.1%] versus 12 [27.9%], P=0.02).. Use of IN.PACT Pacific DEB is associated with significant reductions in late lumen loss and restenoses at 6 months, and reinterventions after femoro-popliteal percutaneous transluminal angioplasty up to 1 year of follow-up.. URL http://www.clinicaltrials.gov. Unique identifier: NCT01083030.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Constriction, Pathologic; Drug Carriers; Equipment Design; Female; Femoral Artery; Germany; Humans; Kaplan-Meier Estimate; Likelihood Functions; Linear Models; Male; Middle Aged; Paclitaxel; Popliteal Artery; Proportional Hazards Models; Radiography; Secondary Prevention; Time Factors; Treatment Outcome; Vascular Access Devices

The study tested the feasibility of using a new portable mechanical compression device for the treatment of claudication. The device applies intermittent non-pneumatic mechanical compression (IMC) to the calf. It was hypothesized that it can offer a low-cost convenient option for patients and achieve good compliance and improved clinical outcomes.. Thirty patients were enrolled in a randomized controlled single blind study. Fourteen patients were assigned to active IMC. Sixteen control patients continued with medical treatment alone. Outcomes were recorded at baseline, after one month, three months, and six months. The study examined changes in exercise tolerance using Initial Claudiacation Distance (ICD) and Absolute Claudiaction Distance (ACD) as well as ankle-brachial index at rest (ABI-r) and post-exercise (ABI-pe). All patients had stable claudication due to peripheral arterial disease (PAD) and were already under best medical treatment (BMT). To be eligible for inclusion, patients had to be between the ages of 50 and 75 years, had to have stable claudication with an absolute claudication distance >40 meters but <300 meters on a standardized treadmill stress test (3.8 km/h at a 10% grade), have a resting ABI in the affected limb <0.8 with a drop of at least 0.15 following exercise, in whom surgical intervention was not expected for at least three months. Fourteen patients were assigned to active IMC consisting of compressions 65 mm Hg in amplitude, applied for three 3-second compressions/minute, two hours/day for three months. Sixteen control patients continued with BMT alone.. One month after treatment, ICD increased by 66% (P = .001), ACD increased by 51.75% (P = .005), and ABI-pe increased by 42% (P = .01). Treatment effects were maintained or further improved after three months. ABI-r did not increase at any time. Compliance exceeded 80%. Three months following cessation of therapy, claudication distances and ABI-pe did not decrease significantly.. We concluded that the use of IMC of the calf for three months increased claudication distances and led to objective improvements in ABI-pe. Intermittent mechanical compression may be a useful approach to patients with continued claudication despite standard medical treatment.

Topics: Ankle; Arterial Occlusive Diseases; Blood Pressure; Brachial Artery; Cardiovascular Agents; Combined Modality Therapy; Equipment Design; Exercise Test; Exercise Tolerance; Female; Humans; Intermittent Claudication; Leg; Male; Middle Aged; Patient Compliance; Pressure; Prospective Studies; Recovery of Function; Single-Blind Method; Time Factors; Treatment Outcome

In a (negative) multicenter randomized trial on management for inoperable critical lower limb ischemia, comparing spinal cord stimulation and best medical treatment, a number of pre-defined factors were analyzed for prognostic value. We included a radiological arterial disease score, modified from the SVS/ISCVS runoff score. The purpose of this analysis was to evaluate clinical factors and commonly used circulatory measurements for prognostic modeling in patients with critical lower limb ischemia. We determined the incidence of amputation and its relation to various pre-defined risk factors. A total of 120 patients with critical limb ischemia were included in the study. The integrity of circulation in the affected limb was evaluated on five levels: suprainguinal, infrainguinal, popliteal, infrapopliteal and pedal. A total radiological arterial disease score was calculated from 1 (full integrity of circulation) to 20 (maximally compromised state). We used Cox regression analysis to quantify prognostic effects and differential treatment (predictive) effects. Major amputation occurred in 33% of the patients at 6 months and in 51% at 2 years. The presence of ischemic skin lesions and the radiological arterial disease score were independent prognostic factors for amputation. Patients with ulcerations or gangrene had a higher amputation risk (hazard ratio 2.38, p = 0.018 and 2.30, p = 0.036 respectively) as well as patients with a higher radiological arterial disease score (hazard ratio 1.17 per increment, p = 0.003). We did not observe significant interactions between prognostic factors and the effect of spinal cord stimulation. In conclusion, in patients with critical lower limb ischemia, the presence of ischemic skin lesions and the described radiological arterial disease score can be used to estimate amputation risk.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Arterial Occlusive Diseases; Cardiovascular Agents; Constriction, Pathologic; Critical Illness; Electric Stimulation Therapy; Female; Humans; Ischemia; Kaplan-Meier Estimate; Leg Ulcer; Lower Extremity; Male; Middle Aged; Netherlands; Proportional Hazards Models; Radiography; Risk Assessment; Risk Factors; Severity of Illness Index; Spinal Nerves; Time Factors; Treatment Failure

The Percutaneous transluminal Angioplasty and Drug eluting stents for Infrapopliteal lesions in critical limb ischemia (PADI) trial is a prospective, multicenter, randomized, controlled, double-arm study investigating the safety and efficacy of primary paclitaxel-eluting stent implantation vs primary percutaneous transluminal angioplasty (PTA) in infrapopliteal lesions in critical limb ischemia (CLI). PTA with provisional "bailout" stent implantation is currently an accepted treatment for arterial obstructions in CLI, including those in below-the-knee arteries. A drawback compared to open bypass surgery is the relatively high restenosis rate. One proposed method to reduce restenosis is the use of drug-eluting stents (DES), as these have shown good results in the coronary bed. Primary DES implantation for focal obstructions in infrapopliteal arteries in CLI potentially reduces restenosis compared to PTA alone and may subsequently prolong effect of treatment, allowing for better wound healing, and preventing recurrence of symptoms. In this article, we report on rationale, design, and progress of the PADI trial, which investigates the safety and efficacy of a paclitaxel-eluting stent system compared to PTA with provisional bare metal stent implantation.

Topics: Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Constriction, Pathologic; Critical Illness; Drug-Eluting Stents; Humans; Ischemia; Lower Extremity; Metals; Netherlands; Paclitaxel; Popliteal Artery; Prospective Studies; Prosthesis Design; Research Design; Secondary Prevention; Stents; Treatment Outcome

To evaluate the safety and effectiveness of the Zilver vascular stent in the treatment of de novo or restenotic lesions in the external and common iliac arteries.. Regardless of the results of an initial percutaneous transluminal angioplasty (PTA), 151 consecutive patients were implanted with Zilver vascular stents (Cook, Bloomington, Ind) in up to two stenotic (< or =10 cm) or occluded (< or =5 cm) atherosclerotic lesions of the external or common iliac arteries. The primary endpoint was the rate of major adverse events within 9 months after the procedure. Major adverse events were defined as death, myocardial infarction, target lesion revascularization, and limb loss. Secondary endpoints included acute procedural success, 30-day clinical success, 9-month patency rate, 9-month functional status (on the basis of the validated Walking Impairment Questionnaire), and ankle-brachial index (ABI).. of 1-, 6-, and 9-month follow-up are reported. Results The 9-month device and/or procedural-related major adverse event rate (adjudicated by an independent clinical events committee) was 2.7%. The all-cause major adverse event rate was 7.5%. Both rates were substantially below the prespecified objective performance criterion of 16%. The acute procedure success rate and 30-day clinical success rate were 98.0% and 94.0%, respectively. The 9-month patency rate, measured with duplex ultrasonography, was 92.9%. Significant improvement in the ABI and walking distance and walking speed scores, relative to preprocedural values, was seen at 1 month and was maintained through 9-month follow-up.. The Zilver vascular stent is safe and effective as an adjunct to PTA in the treatment of symptomatic disease of the iliac arteries.

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Ankle; Arterial Occlusive Diseases; Atherosclerosis; Blood Pressure; Brachial Artery; Cardiovascular Agents; Female; Humans; Iliac Artery; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Radiography; Recovery of Function; Recurrence; Risk Assessment; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; United States; Vascular Patency; Walking

The effectiveness of propionyl-L-carnitine (PLC) monotherapy regimen alone or in association with pulsed muscular compression was compared to the physical therapy by itself against obliterant arteriopathy Leriche Fontaine stage II. PLC is involved in cellular metabolism and is transformed into two active substances, free L-carnitine and propionyl-coenzyme A in the mitochondria, which take part in fatty acid transfer and in the citric acid cycle, respectively.. Forty-two patients with arterial disease were selected (22 males and 20 females; mean age: 62+/-8 years; 21 type 2 diabetic [DB] and 21 non-DB [NDB]). At enrollment all patients completed a symptoms questionnaire enabling both clinical and social evaluation of the impact of the arteriopathy on the quality of life. Then, patients had: routine blood samples, echo duplex scan; evaluation of the ankle/arm (Winsor) index; impedance plethysmography (Rheoscreen) to measure the crest time (CT), index of the pathological changes due to the sclerosis on the vascular wall, and measurement of walking distance by means of treadmill test. Patients were randomized in three groups, each of them composed by 14 patients (7 DB and 7 NDB): the first group was submitted to infusional PLC therapy at a dosage of 4 fl (total: 1,200 mg PLC) in 250 cc of physiological solution for 5 days a week for 4 weeks; the second group was treated with PLC in association with pulsed muscular compression therapy by Vascupump (5 sessions a week for 4 weeks); the third group was submitted only to Vascupump.. The efficacy of both PLC and Vascupump in the treatment of the peripheral vasculopathies was confirmed. From a subjective point of view, patients referred benefits both in clinical terms, i.e. increased walking distance (average increaseaegroup I: DB 102%, NDB 118%; group II: DB 94%, NDB 193%; group III: DB 33%, NDB 67%) and of decreased intensity of the calf pain from the quality of life questionnaire (21.5 to 10.7). The instrumental parameters showed a trend towards normality, i.e decrease in CT and an increase of the Winsor index, indicators of increased peripheral blood circulation.. Combined pharmaco- and physical therapy was most efficient treatment regime and best results were seen in NDB compared to the DB patients.

Topics: Aged; Arterial Occlusive Diseases; Cardiovascular Agents; Carnitine; Combined Modality Therapy; Diabetes Mellitus, Type 2; Female; Humans; Infusions, Intravenous; Intermittent Claudication; Intermittent Pneumatic Compression Devices; Male; Middle Aged; Quality of Life; Recovery of Function; Severity of Illness Index; Time Factors; Treatment Outcome; Walking

In a double blind pilot study, we examined the effects of the stable prostacyclin derivate taprostene compared to a combination of aspirin and dipyridamole on platelet uptake and clinical outcome after peripheral percutaneous angioplasty. Taprostene was administered to 19 patients as a continuous intravenous infusion from 2 hours before until 8 (n = 6) or 24 (n = 6) hours after angioplasty; 7 control patients were given a combination of 330 mg aspirin and 75 mg dipyridamole. Uptake of 111-indium labelled platelets at the site of the PTA was measured 3 hours before and 4 and 24 hours after angioplasty. Clinical parameters were obtained one day before PTA, on the following day and 3 months after the procedure. There was a tendency for slightly higher platelet uptake ratios in the taprostene groups as compared to the control group especially in patients requiring technically difficult procedures. There were no differences between the 3 groups with regard to primary success or periinterventional complications. In the taprostene patients, 3 early reocclusions were found up to 72 hours after the procedure and 1 late reocclusion within 3 months. In the control group, no reocclusion was apparent in the observation time. No advantages were found when taprostene was administered during angioplasty as compared to conventional treatment with aspirine and dipyridamole.

Topics: Administration, Oral; Adult; Aged; Angioplasty, Balloon; Arterial Occlusive Diseases; Aspirin; Cardiovascular Agents; Dipyridamole; Drug Therapy, Combination; Epoprostenol; Female; Humans; Infusions, Intravenous; Male; Middle Aged; Pilot Projects; Platelet Activation; Recurrence; Treatment Outcome

Iloprost, a stable carbaprostacyclin analog, was infused (up to 2-4 ng/kg/min) for 12 h daily on 5 consecutive days into the forearm vein of 13 patients with peripheral arterial occlusive disease (PAOD) of legs (stages IIb-III). All vasodilatory and antiplatelet drugs were stopped three weeks earlier. For comparison, dextran was infused in a randomized, crossover, double-blind manner with an average interval of 3 months. Iloprost increased significantly ankle systolic pressure and ankle/arm pressure ratio for the follow-up period of one month. Foot skin temperature increased insignificantly. Pain-free walking distance was prolonged up to 1.51 times by iloprost and 1.14 times by dextran (p less than 0.05). Venous occlusion plethysmography showed no improvement in the blood flow of legs. Eight patients experienced a subjective improvement in their clinical status with iloprost. Ten patients suffered from mild to severe headache, nausea, transient rest pain of legs, and hypotension. One patient with gastric ulcer history was withdrawn because of mild hematemesis, not definitely drug-related. No significant changes occurred in standard laboratory safety control or in hemostasis. The results suggest that a 5-day iloprost infusion exerts a mild favourable effect on patients with PAOD.

Topics: Aged; Ankle; Arterial Occlusive Diseases; Blood Pressure; Cardiovascular Agents; Dextrans; Double-Blind Method; Epoprostenol; Female; Humans; Iloprost; Infusions, Intravenous; Leg; Male; Middle Aged; Random Allocation; Time Factors

The effectiveness of iloprost, a prostacyclin derivative, was assessed in a placebo-controlled multicentre trial on 101 patients with chronic arterial disease, stage IV. All patients were on a basic local treatment, 53 randomly being assigned to the iloprost group, 48 to the placebo one. Both groups received identical saline infusions, one with the other without iloprost. Infusions were given on 28 consecutive days, iloprost being added at a dose of up to 2 ng/kg.min over six hours. At the end of the treatment period, 32 of 52 patients (61.5%) of the iloprost group and eight of the 47 in the placebo group (17%) had partial or complete healing of ulcers (P less than 0.05), the treatment effect persisting in both groups for a mean duration of at least one year. Iloprost was well tolerated, once individual dosages had been appropriately adjusted. Facial flushes, headache and nausea were the most common side effects. Heart rate and blood-pressure variations did not differ between the two groups.

Topics: Adult; Aged; Aged, 80 and over; Arterial Occlusive Diseases; Cardiovascular Agents; Chronic Disease; Clinical Trials as Topic; Epoprostenol; Female; Follow-Up Studies; Humans; Iloprost; Male; Middle Aged; Multicenter Studies as Topic; Placebos; Random Allocation; Time Factors

Topics: Arterial Occlusive Diseases; Cardiovascular Agents; Clinical Trials as Topic; Diabetic Angiopathies; Epoprostenol; Humans; Iloprost; Multicenter Studies as Topic; Random Allocation

Topics: Arterial Occlusive Diseases; Blood Pressure; Cardiovascular Agents; Clinical Trials as Topic; Epoprostenol; Female; Flushing; Humans; Infusions, Intravenous; Male; Platelet Aggregation; Prostaglandins, Synthetic

The dose-dependent inhibition of platelet aggregation by the chemically stable, prostacyclin-mimetic, iloprost, was studied in patients suffering from stage II-III peripheral arterial obliterative disease (PAOD). The study was designed as a randomized placebo-controlled cross-over trial. Iloprost was administered i.v. to six patients at doses of 0.5, 1.0, 2.0 or 3.0 ng/kg X min for 4 h, with an interval of 2-3 days between the infusions. During iloprost infusion, systolic and diastolic arterial blood pressure, heart rate and blood flow in the affected limb remained unchanged. In contrast, there was a considerable, dose-dependent inhibition of ADP- and thrombin-induced platelet aggregation and secretion ex vivo at doses of 0.5-2.0 ng/kg X min iloprost, indicating that iloprost reduced platelet stimulation by 50%-70%. The antiplatelet action of iloprost remained unchanged during infusion but ceased with 2 h after administration had ended. The agent was tolerated by the patients without unacceptable side-effects at doses up to 2 ng/kg X min. It is concluded that iloprost administered i.v. at doses of 1-2 ng/kg X min in patients with stage II-III PAOD does not involve haemodynamic side-effects and might be considered an effective antiplatelet agent.

Topics: Adult; Aged; Arterial Occlusive Diseases; Cardiovascular Agents; Dose-Response Relationship, Drug; Drug Evaluation; Epoprostenol; Female; Hemodynamics; Humans; Iloprost; Male; Middle Aged; Platelet Aggregation; Random Allocation; Time Factors

Topics: Arterial Occlusive Diseases; Cardiovascular Agents; Cinnarizine; Clinical Trials as Topic; Dihydroergotamine; Dihydroergotoxine; Drug Combinations; Exercise Test; Flunarizine; Humans; Intermittent Claudication; Nafronyl; Pentoxifylline; Placebos; Pyrrolidines; Secologanin Tryptamine Alkaloids; Yohimbine

Several multicenter industry-sponsored clinical trials reported satisfactory results in the use of drug-coated balloons (DCBs) for treatment of femoropopliteal occlusive disease. However, few single-center studies have been published to verify the outcome from real-world experience.. In this study, 228 patients treated with DCB angioplasty (Lutonix 0.35; Bard, Tempe, Arizona) were analyzed. Perioperative major adverse events (death, amputation, target lesion thrombosis or reintervention) were calculated. Kaplan-Meier analysis was used to estimate primary patency rates (based on duplex ultrasound with or without ankle-brachial index) and limb salvage rates.. Lesions treated were primarily TransAtlantic Inter-Society Consensus (TASC) type C and D lesions. Indications included claudication (Rutherford classes 2 and 3) in 40% and critical limb ischemia (CLI; Rutherford classes 4 and 5) in 60%. Lesions treated included 61% in the superficial femoral artery, 15% in the popliteal artery, and 24% in both superficial femoral artery and popliteal artery. Mean follow-up was 12.2 months (range, 1-42 months). Overall perioperative morbidity and mortality rates were 13% and 1%. The perioperative major adverse event rate was 3%. Symptom relief (improvement of one Rutherford category or more) was obtained in 64%. Primary patency rates were 56% and 39% at 1 year and 2 years, respectively. Limb salvage rates were 92% and 83% at 1 year and 2 years. Patients with claudication had a lower rate of early perioperative complications (4% vs 19%; P = .001). Symptom improvement was 76% for claudication vs 49% for CLI (P < .001). Overall, major amputation rate was 0% for claudication vs 13% for CLI (P < .001). The primary patency rates at 1 year and 2 years were 59% and 41% for claudication vs 54% and 37% for CLI (P = .307). The assisted primary patency rates at 1 year and 2 years were 72% and 52% for claudication vs 64% and 46% for CLI (P = .223). Primary patency rates at 1 year and 2 years were 82% and 71% for TASC A to C lesions vs 29% and 14% for TASC D lesions (P < .001). Limb salvage rates at 1 year and 2 years were 100% and 100% for claudication vs 85% and 74% for CLI (P < .001).. Clinical outcomes after DCB angioplasty in femoropopliteal lesions were inferior to what has been reported in previous studies, particularly for TASC D lesions. Further investigation from real-world experience with long-term follow-up is needed to confirm these results.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Vascular Access Devices; Vascular Patency

The aim of this study was to evaluate the performance and predictors of stent failure of paclitaxel drug-eluting stents for the treatment of femoropopliteal disease.. A retrospective review of clinical and angiographic data was performed for patients treated for femoropopliteal disease with the Zilver PTX (Cook Medical, Bloomington, IN) stent by a single operator between 2012 and 2015 at a tertiary referral center. Clinical grading was determined by both Rutherford classification and the Society for Vascular Surgery's Wound, Ischemia, and Foot Infection (WIFi) scoring system, and lesions were classified anatomically by the TransAtlantic Intersociety Consensus (TASC) II criteria. Treated lesions included those with prior in-stent restenosis and long-segment disease. Primary clinical end points were stent failure, need for reintervention, and major adverse limb events (MALE). Kaplan-Meier methods and Cox proportional hazard models were used to evaluate factors affecting outcomes.. Zilver PTX stents were placed in 52 limbs among 46 patients (71.1% male, mean age 72.6 years) with a median follow-up of 11.1 (range 1-26) months. Limbs were treated for life-disabling claudication in 76.9% and critical limb ischemia in 23.1%. Disease severity was highly variable, with 21 (40.4%) limbs with TASC C or D lesions and 16 (30.7%) treated for restenosis after prior endovascular treatment. During follow-up, 6 (12.7%) limbs experienced loss of stent patency (5 occlusions, one >50% restenosis). Four limbs underwent target lesion revascularization, 2 required open bypass, 2 underwent thrombolysis, and no patients required major amputation. Primary patency was 88.9%, 81.6%, and 81.6% at 6, 12, and 18 months, respectively. Treated lesion length (hazard ratio [HR] 4.99, 95% confidence interval [CI] 1.14-21.75) was the only independent predictor of patency loss. Freedom from target lesion revascularization at 6, 12, and 18 months was 94.2%, 87.8%, and 87.8%, respectively. Freedom from MALE (composite of thrombolysis, major amputation, and bypass operation) was 97.5%, 90.9%, and 79.6% at 6, 12, and 18 months, respectively. Chronic renal insufficiency was the only factor that trended toward increased risk of MALE (HR 9.92, 95% CI 0.86-113.35) within a multivariate model.. Our real-world experience supports the continued use of the Zilver PTX for the treatment of both de novo lesions and lesions with prior endovascular revascularization in the femoropopliteal segment. Routine follow-up between 6 and 12 months postoperatively is essential for detecting early restenosis and guiding reintervention. Careful attention when treating complex lesions and long-segment disease remains important for selecting the optimal revascularization strategy for individual patients and optimizing stent patency.

Topics: Adult; Aged; Aged, 80 and over; Arterial Occlusive Diseases; Cardiovascular Agents; Constriction, Pathologic; Critical Illness; Disease-Free Survival; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Metals; Middle Aged; Multivariate Analysis; Paclitaxel; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Prosthesis Failure; Recurrence; Retreatment; Retrospective Studies; Risk Factors; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency

Critical limb ischemia (CLI), a frequently encountered disorder, is associated with a high rate of limb amputation and mortality. To identify patients at high risk for CLI, we developed a simple risk score for peripheral arterial occlusive disease (PAOD).In our cross-sectional study, we first evaluated 1000 consecutive PAOD patients treated at our institution from 2005 to 2007, documenting clinical symptoms, comorbidities, and concomitant medication. We calculated odds ratios (OR) in a binary logistic regression model to find possible risk factors for CLI. We then verified the score in a second step that included the 1124 PAOD patients we treated between 2007 and 2011.In the first patient group, the greatest risk factors for CLI were age ≥75 years (OR 2.0), type 2 diabetes (OR 3.1), prior myocardial infarction (OR 2.5), and therapy with low molecular weight heparins (2.8). We scored 1 point for each of those conditions. One point was given for age between 65 and 75 years (OR 1.6) as well as for therapy with cardiac glycosides (OR 1.9) or loop diuretic therapy (OR 1.5). As statin therapy was protective for CLI with an OR of 0.5, we subtracted 1 point for those patients.In the second group, we could prove that frequency of CLI was significantly higher in patients with a high CLI score. The score correlated well with inflammatory parameters (c-reactive protein and fibrinogen). We were also able to define 3 different risk groups for low (score -1 to 1), intermediate (score 2-4), and high CLI risk (score >4).We developed a simple risk stratification scheme that is based on conditions that can be easily assessed from the medical history, without any laboratory parameters. This score should help to identify PAOD patients at high risk for CLI.

Topics: Age Factors; Aged; Aged, 80 and over; Arterial Occlusive Diseases; Cardiovascular Agents; Comorbidity; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Extremities; Female; Humans; Hypoglycemic Agents; Ischemia; Male; Microcirculation; Middle Aged; Myocardial Infarction; Odds Ratio; Peripheral Arterial Disease; Risk Assessment; Risk Factors

Topics: Aged; Angiography; Arterial Occlusive Diseases; Cardiovascular Agents; Delayed Diagnosis; Diagnosis, Differential; Female; Heart Failure; Hemodiafiltration; Humans; Hypertension; Hypertension, Renovascular; Iliac Artery; Kidney Transplantation; Postoperative Complications; Renal Artery Obstruction; Reoperation; Stents; Ultrasonography, Doppler

Topics: Adult; Aorta, Abdominal; Aortic Diseases; Aortography; Arterial Occlusive Diseases; Cardiovascular Agents; Chronic Disease; Collateral Circulation; Female; Humans; Middle Aged; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Walking

Basilar artery occlusion (BAO) causes mortality up to 90%.. A total of 99 patients with BAO received either endovascular (endovascular mechanical recanalization and/or intra-arterial with optional intravenous thrombolysis [IVT] as bridging concept) or conservative medical treatment (IVT and/or medical oral therapy). Outcome parameters were measured in accordance with the thrombolysis in cerebral infarction (TICI), National Institutes of Health Stroke Scale (NIHSS), and modified Rankin Scale (mRS) scores.. In all, 78% underwent endovascular and 22% conservative medical treatment. The NIHSS at admission was 20 in both the groups. Postprocedurally, 36% (95% confidence interval: 26%-48%) of the endovascular group and 9% (21%-64%) of the conservative group reached TICI 3 (P = .017). In all, 30% of the endovascular group and 9% of the conservative group were documented with TICI 2b (P = .057). At 90 days follow-up, 45% (31%-60%) of the endovascular-treated patientsand no patient (0%-25%) of the conservative-treated group reached mRS ≤2 (P = .012).. Endovascular treatment of BAO provides a better chance to survive this severe condition with good clinical outcome.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Analysis of Variance; Angiography, Digital Subtraction; Arterial Occlusive Diseases; Cardiovascular Agents; Cerebral Angiography; Disability Evaluation; Endovascular Procedures; Female; Humans; Magnetic Resonance Angiography; Male; Middle Aged; Registries; Risk Factors; Thrombolytic Therapy; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Vertebrobasilar Insufficiency

This study sought to evaluate vascular drug uptake, distribution and response of second-generation paclitaxel coated balloon (PCB) (Cotavance, MEDRAD Interventional, Indianola, Pennsylvania) and compare it with first-generation technology, containing identical excipient and drug concentration.. Original PCB technologies displayed a heterogeneous deposition of crystalline paclitaxel-iopromide inside the balloon folds, whereas second-generation PCBs consisted of more homogeneous, circumferential coatings.. Paclitaxel tissue uptake was assessed in 20 iliofemoral arteries of a domestic swine. Vascular healing response was assessed in the familial hypercholesterolemic model of iliofemoral in-stent restenosis. Three weeks after bare-metal stent implantation, vascular segments were randomly revascularized with first-generation PCBs (n = 6), second-generation PCBs (n = 6), or plain balloon angioplasty (PBA) (n = 6). At 28 days, angiographic and histological evaluation was performed in all treated segments.. One-hour paclitaxel tissue uptake was 42% higher in the second-generation PCBs (p = 0.03) and resulted in more homogeneous segment-to-segment distribution compared with first-generation PCBs. Both angiography (percentage of diameter stenosis: second-generation 11.5 ± 11% vs. first-generation 21.9 ± 11% vs. PBA 46.5 ± 10%; p < 0.01) and histology (percentage of area stenosis: second-generation 50.5 ± 7% vs. first-generation 54.8 ± 18% vs. PBA 78.2 ± 9%; p < 0.01) showed a decrease in neointimal proliferation in both PCB groups. Histological variance of the percentage of area stenosis was lower in second-generation compared with first-generation PCBs (51.7 vs. 328.3; p = 0.05). The presence of peristrut fibrin deposits (0.5 vs. 2.4; p < 0.01) and medial smooth muscle cell loss (0 vs. 1.7; p < 0.01) were lower in the second-generation compared with first-generation PCBs.. In the experimental setting, second-generation PCB showed a comparable efficacy profile and more favorable vascular healing response when compared to first-generation PCB. The clinical implications of these findings require further investigation.

Topics: Angioplasty, Balloon; Animals; Arterial Occlusive Diseases; Cardiovascular Agents; Cell Proliferation; Coated Materials, Biocompatible; Constriction, Pathologic; Contrast Media; Disease Models, Animal; Equipment Design; Femoral Artery; Fibrosis; Hyperlipoproteinemia Type II; Iliac Artery; Iohexol; Neointima; Paclitaxel; Radiography; Sus scrofa; Tissue Distribution; Vascular Access Devices; Wound Healing

Topics: Angiography; Anti-Inflammatory Agents; Arterial Occlusive Diseases; Cardiovascular Agents; Cryoglobulinemia; Cryoglobulins; Diabetes Mellitus, Type 2; Diagnostic Imaging; Drug Therapy, Combination; Female; Fibrinogens, Abnormal; Fingers; Humans; Hypertension; Ischemia; Ischemic Attack, Transient; Middle Aged

Topics: Angioplasty; Arterial Occlusive Diseases; Cardiovascular Agents; Drug-Eluting Stents; Everolimus; Female; Humans; Ischemia; Male; Metals; Popliteal Artery; Sirolimus; Stents

Topics: Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Catheters; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Male; Paclitaxel; Popliteal Artery

This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease.. Conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis. Twelve-month outcomes following PEB use with provisional stenting are described.. This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤ 15 cm. Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed.. The registry enrolled 105 patients. Baseline ankle-brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions. The device was successfully used in all patients and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up.. PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization.

Topics: Aged; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Cardiovascular Agents; Catheters; Chi-Square Distribution; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Humans; Italy; Kaplan-Meier Estimate; Linear Models; Male; Middle Aged; Paclitaxel; Popliteal Artery; Prospective Studies; Quality of Life; Recovery of Function; Recurrence; Registries; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency; Walking

Topics: Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Drug Carriers; Female; Femoral Artery; Humans; Lower Extremity; Male; Paclitaxel; Popliteal Artery; Vascular Access Devices

Topics: Animals; Arterial Occlusive Diseases; Cardiovascular Agents; Cell Movement; Cell Proliferation; Constriction, Pathologic; Humans; Hyperplasia; Kv1.3 Potassium Channel; Mice; Muscle, Smooth, Vascular; Myocytes, Smooth Muscle; Potassium Channel Blockers; Recurrence; Tunica Intima

To report the long-term outcomes of a single-center prospective study investigating primary placement of everolimus-eluting metal stents for recanalization of long infrapopliteal lesions compared to a matched historical control group treated with plain balloon angioplasty and provisional placement of bare metal stents in a bailout manner.. The study included 81 patients (63 men; mean age 71 years, range 45-85) suffering from critical limb ischemia (CLI) and angiographically proven long-segment (at least 1 lesion >4.5 cm) de novo infrapopliteal artery disease who underwent below-the-knee revascularization with either primary placement of everolimus-eluting stents (n = 47, 51 limbs, 102 lesions) or angioplasty and bailout bare metal stenting (n = 34, 36 limbs, 72 lesions). Clinical and angiographic follow-up was collected at regular time intervals. Primary clinical and angiographic endpoints included patient survival, major amputation-free survival, angiographic primary patency, angiographic binary restenosis (>50%), and overall event-free survival. Results were stratified according to endovascular treatment received. Multivariable Cox proportional hazards regression analysis was applied to adjust for confounding factors of heterogeneity.. Baseline demographics were well matched. No significant differences were identified between the 2 groups with regard to overall 3-year patient survival (82.2% versus 65.7%; p = 0.90) and amputation-free survival (77.1% versus 86.9%; p = 0.20). Up to 3 years, lesions fully covered with everolimus-eluting stents were associated with significantly higher primary patency [hazard ratio (HR) 7.98, 95% CI 3.69 to 17.25, p < 0.0001], reduced binary restenosis (HR 2.94, 95% CI 1.74 to 4.99, p < 0.0001), and improved overall event-free survival (HR 2.19, 95% CI 1.16 to 4.13, p = 0.015) versus the matched historical control group.. Primary infrapopliteal everolimus-eluting stenting for CLI treatment significantly inhibits restenosis and improves long-term angiographic patency and overall patient event-free survival compared to balloon angioplasty and bailout bare metal stenting.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Constriction, Pathologic; Critical Illness; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Female; Greece; Humans; Ischemia; Kaplan-Meier Estimate; Lower Extremity; Male; Metals; Middle Aged; Popliteal Artery; Proportional Hazards Models; Prospective Studies; Radiography; Risk Assessment; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome; Vascular Patency

To determine the efficacy of sirolimus-eluting bioabsorbable magnesium alloy stents (SEBMAS) in restenosis prevention.. A balloon-expandable bioabsorbable magnesium alloy stent (BMAS) was created and coated with biodegradable poly(lactic acid-co-trimethylene carbonate) that contained the antiproliferative drug sirolimus (140 ± 40 µg/cm²). Both the uncoated BMAS and the coated SEBMAS were deployed 2 cm apart in balloon-injured infrarenal abdominal aortas of 20 New Zealand white rabbits. The stented aortic segments were removed at 30, 60, 90, and 120 days (5 rabbits per interval) after implantation. The average stent strut sectional area of each group was measured to evaluate the degree of magnesium corrosion and to forecast the biodegradation time profile of the magnesium stent. Histology and histopathology of the sectioned stented aortic segments were performed to evaluate neointima formation, endothelialization, and inflammation.. The SEBMAS degraded gradually after being implanted into the rabbit aorta, and total biocorrosion occurred after ~120 days. In all groups, the lumen area was significantly greater, but the neointimal area was significantly smaller in SEBMAS segments compared with the uncoated BMAS segments (p < 0.05) at all time points. There was no significant difference in the injury or inflammation scores between the groups. Endothelialization was delayed at 30 days in the SEBMAS segments vs. the uncoated BMAS segments.. SEBMAS further reduces intimal hyperplasia and improves the lumen area when compared to uncoated BMAS; however, it delays vascular healing and endothelialization.

Topics: Alloys; Angioplasty; Animals; Aorta, Abdominal; Aortic Diseases; Arterial Occlusive Diseases; Cardiovascular Agents; Cell Proliferation; Coated Materials, Biocompatible; Constriction, Pathologic; Dioxanes; Disease Models, Animal; Drug-Eluting Stents; Endothelial Cells; Hyperplasia; Lactic Acid; Magnesium; Male; Polyesters; Polymers; Prosthesis Design; Rabbits; Secondary Prevention; Sirolimus; Time Factors; Wound Healing

Topics: Alloys; Angioplasty; Animals; Aorta, Abdominal; Aortic Diseases; Arterial Occlusive Diseases; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Magnesium; Male; Sirolimus

To report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov ).. The Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2-6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6±9.5 years) were enrolled at 30 international sites.. Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5±82.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. There were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%. The ankle-brachial index, Rutherford score, and walking distance/speed scores significantly improved (p<0.001) from baseline to 12 months.. These results indicate that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Canada; Cardiovascular Agents; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Popliteal Artery; Prospective Studies; Prosthesis Design; Recovery of Function; Recurrence; Republic of Korea; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency

To evaluate safety and results of the Freepac drug-eluting balloon (DEB) technology for the treatment of chronic femoropopliteal steno-occlusions.. In a multicentre registry we enrolled 66 patients with symptomatic femoropopliteal stenosis and/or occlusion <15 cm (Rutherford stages 2 to 4). Patients were treated first with an undersized uncoated balloon and then with an appropriate sized DEB. In case of unsatisfactory results, nitinol stents were implanted. Clinical evaluations and echo-duplex were performed at baseline, at discharge, and at three months after intervention. Procedural success was 100%. Stents were implanted in 10.8% of the patients. At three months follow-up, the mean ankle-brachial index (ABI) significantly improved from 0.58 ± 0.13 to 0.82 ± 0.25, thus resulting in a Rutherford class improvement (p <0.01) and amelioration of the claudication distance (102 ± 87 vs. 403 ± 160 meters) (p<0.001). No serious adverse events occurred during the follow-up.. The results of this registry demonstrate the safety of mediated paclitaxel elution for the prevention of restenosis in the superficial femoral and popliteal arteries after angioplasty. This technique was associated with encouraging results in terms of clinical improvement as well as a lack of adverse events, including target lesion revascularisation, at three months.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug Delivery Systems; Equipment Design; Female; Femoral Artery; Humans; Italy; Male; Middle Aged; Paclitaxel; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Registries; Stents; Time Factors; Treatment Outcome

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

Patients with peripheral arterial occlusive disease (PAD) experience deteriorating ambulatory function and consequently impaired quality of life (QOL). QOL in patients receiving prostaglandin E(1) in lipid microspheres (lipo-PGE(1); Liple) for the treatment of PAD has not been evaluated using the Japanese version of the Walking Impairment Questionnaire (WIQ).. Data from 169 patients (98 men, 71 women; mean [median] age, 74+/-10 [74] years) with an ankle-brachial pressure index <0.9 were analyzed. WIQ scores and symptom scores significantly improved after lipo-PGE(1) treatment (P<0.01). Physicians' assessments of global improvement significantly correlated with all 4 WIQ subscales (R< or =0.31).. WIQ is a valid tool for evaluating therapeutic response in patients with PAD. Lipo-PGE(1) improves QOL as evaluated by patients themselves.

Topics: Aged; Aged, 80 and over; Alprostadil; Arterial Occlusive Diseases; Cardiovascular Agents; Disability Evaluation; Female; Humans; Intermittent Claudication; Japan; Male; Middle Aged; Predictive Value of Tests; Quality of Life; Recovery of Function; Reproducibility of Results; Severity of Illness Index; Surveys and Questionnaires; Treatment Outcome; Walking

Midterm technical and clinical evaluation of stent angioplasty with drug-eluting stents in infrapopliteal lesions in patients with critical limb ischemia (CLI).. Percutaneous stent angioplasty was performed in 128 limbs in 114 patients presenting with 320 vascular lesions. Lesions with up to 6 cm in length and at least one patent vessel below the obstruction were treated; 341 drug-eluting Cypher(R) stents (diameter of 2.5-3.5 mm; length of 18-33 mm) were implanted. Follow-up examinations were performed up to 18 months postinterventionally using clinical examination, ankle-brachial index (ABI) calculation, and color coded Duplex sonography. Patency rates were calculated on the basis of the Kaplan-Meier life-table analysis.. Technical success was achieved in 99.06%. Minor complications (hematoma, distal emboli, and vessel dissection) were documented in 8.77% of the patients. The 6, 12, and 18 months primary patency rate as controlled by Duplex sonography was 89.8, 84.2 and 83.3%, respectively; 77.6% of the lesions healed postinterventionally. The cumulative limb salvage rate was 95.6%.. Drug-eluting stent (DES) angioplasty in infrapopliteal arteries is a safe and effective technique for the treatment of patients with CLI. The use of a DES results in favorable technical and clinical outcome in the midterm follow-up.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Cardiovascular Agents; Critical Illness; Drug-Eluting Stents; Female; Germany; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Male; Middle Aged; Prospective Studies; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency

To report 12-month outcomes following application of sirolimus-eluting stents (SES) in infrapopliteal arteries in patients with chronic limb ischemia.. A prospective single-center study was conducted involving 146 consecutive patients (102 men; mean age 73+/-9 years) with Rutherford-Becker categories 2 to 5 lower limb ischemia who underwent SES placement. The average degree of stenosis at baseline was 86%+/-5%; there were 44 (30%) occlusions. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent restenosis (luminal narrowing > or =70%) detected with angiography or, if appropriate, with duplex ultrasound. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, ankle-brachial index (ABI), and changes in the Rutherford-Becker classification.. Fifteen (10%) patients were lost to follow-up, and 27 (18%) patients died during the follow-up period, leaving 104 patients undergoing the 6- and 12-month follow-up examinations. After 6 months and 1 year, the primary patency rates were 88.5% and 83.7%, respectively. The mean ABI increased from 0.6+/-0.4 at baseline to 0.8+/-0.2 after 6 months and remained significantly improved during 1-year follow-up (p<0.0001). The mean Rutherford-Becker classification decreased from 3.3+/-0.8 at baseline to 0.9+/-1.1 (p<0.0001) after 1 year.. Treatment of infrapopliteal arteries with SES yields encouraging long-term results that compare favorably with previously published data on bare metal stents or plain balloon angioplasty.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Cardiovascular Agents; Chronic Disease; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Female; Germany; Humans; Ischemia; Kaplan-Meier Estimate; Logistic Models; Lower Extremity; Male; Middle Aged; Odds Ratio; Popliteal Artery; Prospective Studies; Prosthesis Design; Radiography; Recurrence; Registries; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Topics: Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Chronic Disease; Constriction, Pathologic; Drug-Eluting Stents; Humans; Ischemia; Limb Salvage; Lower Extremity; Popliteal Artery; Prosthesis Design; Recurrence; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome; Vascular Patency

Endovascular management of limb-threatening ischemia often requires treatment of tibial occlusive disease. This study was preformed to examine the patency of drug-eluting tibial stents.. The medical records of all patients undergoing drug-eluting tibial stent placement for limb-threatening ischemia from June 2004 to June 2008 were retrospectively reviewed. Postprocedural antiplatelet therapy included clopidogrel and aspirin. Patients were followed with serial arterial duplex ultrasonography and had selective subsequent angiographic evaluation based on noninvasive findings. Primary patency of the target lesion, limb salvage, and survival rates were reported.. A total of 240 patients underwent 283 tibial angioplasty procedures to treat limb-threatening ischemia during the 4-year period. Fifty-two patients (22%) had a suboptimal balloon result and were treated with a drug-eluting tibial stent. Balloon-expandable paclitaxel-eluting stents were used in all patients (1.2 stents per patient; range, 1-3; median diameter, 2.75 mm; range, 2.5-3.5 mm; median length, 24 mm; range, 20-32 mm). Forty-eight of those 52 patients (92%) had simultaneous endovascular treatment of proximal lesions. Mean follow-up was 14.3 months (range, 1-48 months). Target lesion patency of the drug-eluting tibial stent was 73% at 24 months (SE < 10%). Limb salvage rate in patients treated with drug-eluting tibial stents was 86% at 26 months (SE < 10%), and the survival rate was 65% at 24 months (SE < 10%).. Drug-eluting tibial stents are a viable option for the endovascular management of limb-threatening ischemia and have acceptable patency rates. The majority of patients require multilevel endovascular treatment, and close surveillance is required for limb salvage.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Constriction, Pathologic; Drug-Eluting Stents; Female; Humans; Ischemia; Life Tables; Limb Salvage; Male; Middle Aged; Minnesota; Paclitaxel; Platelet Aggregation Inhibitors; Prosthesis Design; Radiography; Recurrence; Reoperation; Retrospective Studies; Severity of Illness Index; Tibial Arteries; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

To evaluate the efficacy of the curcumin-coating stent (CCS) on the inhibition of restenosis in a rabbit iliac artery stent model.. Curcumin, pigment naturally acquired from the rhizome of the plant curcuma longa, is known to have antiproliferative, antimigratory, and anti-inflammatory effects. However, it is still unclear that curcumin can inhibit neointimal proliferation of the injured vessel.. Dose-dependent inhibition of cell growth was observed over a dose range from 10 nM to 10 microM. CCS was prepared by a dip-coating method (high-dose: HD, low-dose: LD). The release profile of the HD CCS showed that drug release persisted until day 21. Scanning electron microscopy of the CCS showed an intact surface of the stent even after expansion. To test the efficacy of CCS in vivo, LD CCS, HD CCS, and bare metal stents (BMS) were implanted in random order in one iliac artery (N = 30 arteries) of male New Zealand White rabbits (N = 15).. After 28 days, the LD and HD CCS groups had a 43% and 55% reduction in the neointimal area, compared with the BMS group (BMS 3.3 +/- 1.0 mm(2), LD 1.9 +/- 0.8 mm(2), and HD 0.9 +/- 0.5 mm(2), P < 0.05). There appeared to be no cytotoxicity related to curcumin at the indicated doses.. Curcumin, a natural compound in the human diet, seems to be a safe and effective candidate drug for use in a drug-eluting stent for the prevention of stent restenosis following angioplasty.

Topics: Angioplasty, Balloon; Animals; Arterial Occlusive Diseases; Becaplermin; Cardiovascular Agents; Cell Movement; Cell Proliferation; Cells, Cultured; Coated Materials, Biocompatible; Constriction, Pathologic; Curcumin; Disease Models, Animal; Dose-Response Relationship, Drug; Drug-Eluting Stents; Hypercholesterolemia; Iliac Artery; Male; Muscle, Smooth, Vascular; Myocytes, Smooth Muscle; Platelet-Derived Growth Factor; Prosthesis Design; Proto-Oncogene Proteins c-sis; Rabbits; Rats; Rats, Sprague-Dawley; Surface Properties; Time Factors

Topics: Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Constriction, Pathologic; Critical Illness; Drug-Eluting Stents; Humans; Ischemia; Lower Extremity; Metals; Paclitaxel; Popliteal Artery; Prospective Studies; Prosthesis Design; Secondary Prevention; Stents; Treatment Outcome

Takayasu arteritis is a chronic, progressive, autoimmune, idiopathic, large-vessel vasculitis that usually affects young adults. The disease has been reported to occur in all races and ethnicities. The diffuse nature of this vasculitis can affect multiple-organ systems to varying degrees. Herein, we report the case of a young woman whose exertional angina and claudication were the initial presentation of active Takayasu arteritis. During more than 4 years of ongoing treatment, therapy, and follow-up, she has displayed differing disease symptoms of varying intensity. We discuss the challenges of managing Takayasu arteritis in our patient and describe different treatments for this rare vasculitic disorder.

Topics: Adult; Angina Pectoris; Aortography; Arterial Occlusive Diseases; Cardiovascular Agents; Combined Modality Therapy; Coronary Angiography; Coronary Artery Bypass; Coronary Stenosis; Exercise Test; Female; Humans; Immunosuppressive Agents; Intermittent Claudication; Magnetic Resonance Angiography; Severity of Illness Index; Takayasu Arteritis; Treatment Outcome

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

Topics: Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Cilostazol; Constriction, Pathologic; Female; Femoral Artery; Humans; Male; Popliteal Artery; Research Design; Secondary Prevention; Tetrazoles; Treatment Outcome; Vascular Patency

Stent implantation is an alternative, safe, and reliable strategy for the treatment of chronic mesenteric ischemia, especially for patients at high surgical risk. However, in-stent restenosis (the Achille's hill of bare metal stent) may occur in up to 20% of cases at 6 months and 53% at 1 year. We describe a case of celiac trunk stenosis treated by bare metal stent complicated by recalcitrant in-stent restenosis and treated by paclitaxel-eluting stent implantation.

Topics: Aged; Angioplasty, Balloon; Arterial Occlusive Diseases; Cardiovascular Agents; Celiac Artery; Chronic Disease; Constriction, Pathologic; Drug-Eluting Stents; Female; Humans; Ischemia; Magnetic Resonance Angiography; Mesenteric Vascular Occlusion; Metals; Paclitaxel; Prosthesis Design; Recurrence; Stents; Tomography, X-Ray Computed; Treatment Outcome

Topics: Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Catheterization; Coated Materials, Biocompatible; Femoral Artery; Humans; Ischemia; Leg; Popliteal Artery; Radiography; Stents; Tibial Arteries; Treatment Outcome

Topics: Arterial Occlusive Diseases; Cardiovascular Agents; Catheterization; Exercise; Humans; Ischemia; Leg; Stents; Treatment Outcome

Topics: Arterial Occlusive Diseases; Cardiovascular Agents; Connective Tissue Diseases; Dyspnea; Hemangioma; HIV Infections; Humans; Hypertension, Pulmonary; Risk Factors

Topics: Arterial Occlusive Diseases; Cardiovascular Agents; Cost Control; Drug Approval; Germany; Health Services Accessibility; Humans; Insurance, Pharmaceutical Services; National Health Programs

Topics: Aged; Arterial Occlusive Diseases; Cardiovascular Agents; Combined Modality Therapy; Diagnosis, Differential; Female; Humans; Male; Middle Aged; Practice Guidelines as Topic

Topics: Arterial Occlusive Diseases; Arteriosclerosis Obliterans; Cardiovascular Agents; Humans; Ischemic Attack, Transient; Raynaud Disease

Topics: Adenosine Diphosphate; Arterial Occlusive Diseases; Blood Platelets; Cardiovascular Agents; Collagen; Epoprostenol; Fingers; Humans; Iloprost; Ischemia; Male; Middle Aged; Platelet Aggregation; Scleroderma, Systemic; Time Factors

Topics: Arterial Occlusive Diseases; Arteriosclerosis Obliterans; Cardiovascular Agents; Drug Evaluation; Drug Therapy, Combination; Endarteritis; Humans; Infusions, Intra-Arterial; Leg; Middle Aged

Topics: Arterial Occlusive Diseases; Cardiovascular Agents; Endarteritis; Ergot Alkaloids; Oxytocics; Plants; Thromboangiitis Obliterans