cardiovascular-agents and Peripheral-Arterial-Disease

Wearable devices, such as smartwatches and activity trackers, are commonly used by patients in their everyday lives to manage their health and well-being. These devices collect and analyze long-term continuous data on measures of behavioral or physiologic function, which may provide clinicians with a more comprehensive view of a patients' health compared with the traditional sporadic measures captured by office visits and hospitalizations. Wearable devices have a wide range of potential clinical applications ranging from arrhythmia screening of high-risk individuals to remote management of chronic conditions such as heart failure or peripheral artery disease. As the use of wearable devices continues to grow, we must adopt a multifaceted approach with collaboration among all key stakeholders to effectively and safely integrate these technologies into routine clinical practice. In this Review, we summarize the features of wearable devices and associated machine learning techniques. We describe key research studies that illustrate the role of wearable devices in the screening and management of cardiovascular conditions and identify directions for future research. Last, we highlight the challenges that are currently hindering the widespread use of wearable devices in cardiovascular medicine and provide short- and long-term solutions to promote increased use of wearable devices in clinical care.

Topics: Cardiovascular Agents; Heart Failure; Hospitalization; Humans; Peripheral Arterial Disease; Wearable Electronic Devices

Paclitaxel drug-coated balloons (DCBs) have been shown to improve patency and lower revascularization rates compared with plain old balloon angioplasty. DCBs continue to evolve by improving balloon-coating techniques that minimize the quantity of particles washed off into the bloodstream while maximizing drug retention and vascular-healing profile. Against this backdrop, it is clear that the future of antiproliferatives for the superficial femoral artery will focus on enhancements in device coating materials that will improve the efficiency of drug delivery. The Ranger DCB system recently gained US FDA approval for use. This review discusses the background of DCBs and how the Ranger DCB builds on these previous platforms based on experimental and clinical data.. Drug-coated balloons are medical devices used to open blocked arteries (a procedure called angioplasty) in patients who have atherosclerotic disease. The drug coating is provided to help keep the arteries open after treatment with the balloon. This is thought to occur through several mechanisms. In this review, we discuss recent advances in technology related to drug-coated balloons focusing on the recently introduced Ranger drug-coated Balloon.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Peripheral Arterial Disease; Pharmaceutical Preparations; Popliteal Artery; Technology; Time Factors; Treatment Outcome; Vascular Patency

Numerous randomised clinical trials and real-world studies have supported the safety of paclitaxel-coated devices for the treatment of femoropopliteal occlusive disease. However, a 2018 summary-level meta-analysis suggested an increased mortality risk for paclitaxel-coated devices compared with uncoated control devices. This study presents an updated analysis of deaths using the most complete and current data available from pivotal trials of paclitaxel-coated versus control devices.. Ten trials comparing paclitaxel-coated versus control devices were included in a patient-level pooled analysis. Cox regression models were used to evaluate the effect of paclitaxel exposure on risk of death in both intention-to-treat (ITT; primary analysis) and three as-treated analysis sets accounting for treatment group crossover at the index procedure and over time. The effect of paclitaxel dose and baseline covariates were also evaluated.. A total of 2666 participants were included with a median follow-up of 4·9 years. No significant increase in deaths was observed for patients treated with paclitaxel-coated devices. This was true in the ITT analysis (hazard ratio [HR] 1·14, 95% CI 0·93-1·40), the as-treated analysis (HR 1·13, 95% CI 0·92-1·39), and in two crossover analyses: 1·07 (0·87-1·31) when late crossovers were censored and 1·04 (0·84-1·28) when crossovers were analysed from the date of paclitaxel exposure. There was no significant effect of paclitaxel dose on mortality risk.. This meta-analysis found no association between paclitaxel-coated device exposure and risk of death, providing reassurance to patients, physicians, and regulators on the safety of paclitaxel-coated devices.. Becton Dickinson, Boston Scientific, Cook, Medtronic, Philips, Surmodics, and TriReme Medical.

Topics: Boston; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome

Topics: Amputation, Surgical; Angioplasty, Balloon; Arteries; Cardiovascular Agents; Coated Materials, Biocompatible; Humans; Lower Extremity; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Treatment Outcome

Clinical benefit of paclitaxel-coated devices for patients with peripheral arterial disease has been confirmed in randomized controlled trials (RCTs). A meta-analysis published in 2018 identified late mortality risk over a long follow-up period due to use of paclitaxel-coated devices in the femoropopliteal arteries, which caused enormous controversy and debates globally. This study aims to further evaluate the safety of paclitaxel-coated devices by incorporating the most recently published data.. We searched for candidate studies in PubMed (MEDLINE), Scopus, EMBASE (Ovid) online databases, government web archives and international cardiovascular conferences. Safety endpoints of interest included all-cause mortality rates at one, two and five years and the risk ratio (RR) was used as the summary measure. The primary analysis was performed using random-effects models to account for potential clinical heterogeneity.. Thirty-nine RCTs including 9164 patients were identified. At one year, the random-effects model yielded a pooled RR of 1.06 (95% CI [0.87, 1.29]) indicating no difference in short-term all-cause deaths between the paclitaxel and control groups (crude mortality, 4.3%, 214/5025 versus 4.5%, 177/3965). Two-year mortality was reported in 26 RCTs with 382 deaths out of 3788 patients (10.1%) in the paclitaxel arm and 299 out of 2955 patients (10.1%) in the control arm and no association was found between increased risk of death and usage of paclitaxel-coated devices (RR 1.08, 95% CI [0.93, 1.25]). Eight RCTs recorded all-cause deaths up to five years and a pooled RR of 1.18 (95% CI [0.92, 1.51]) demonstrated no late mortality risk due to use of paclitaxel-coated devices (crude mortality, paclitaxel 18.2%, 247/1360 versus control 15.2%, 122/805).. We found no significant difference in either short- or long-term all-cause mortalities between patients receiving paclitaxel-coated and uncoated devices. Further research on the longer-term safety of paclitaxel usage (e.g., 8- or 10-year) is warranted.. PROSPERO, CRD42021246291.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Risk Factors; Treatment Outcome

Endovascular intervention is one of the main methods of treatment in atherosclerotic lesions of the infrainguinal segment in patients with chronic lower limb ischaemia. Recent years have witnessed active use of drug-eluting techniques, significantly improving the long-term outcomes of peripheral reconstructions. This article is a review of publications on the results of using modern drug-eluting balloon catheters and stents in the femoropopliteoltibial position. The accumulated data will help solve the main problems of the classic balloon angioplasty, reducing the incidence of restenosis, improving primary patency, and decreasing the need for repeat interventions in the remote period of follow-up.. Эндоваскулярные вмешательства являются одним из основных методов лечения при атеросклеротическом поражении инфраингвинального сегмента у пациентов с хронической ишемией нижних конечностей. В последние годы отмечается активное применение технологий с лекарственным покрытием, которые значительно улучшили отдаленные результаты периферических реконструкций. В статье представлен обзор публикаций по результатам использования современных баллонных катетеров и стентов с лекарственным покрытием в бедренно-подколенно-берцовой позиции. Накопленные данные помогут решить основные проблемы классической баллонной ангиопластики: снизить частоту рестенозов, улучшить первичную проходимость, уменьшить необходимость повторных вмешательств в отдаленном периоде наблюдений.

Topics: Angioplasty, Balloon; Arteries; Cardiovascular Agents; Coated Materials, Biocompatible; Humans; Paclitaxel; Peripheral Arterial Disease; Pharmaceutical Preparations; Stents; Treatment Outcome; Vascular Patency

Infrapopliteal atherosclerotic disease continues to present the greatest conundrum for effective endovascular therapies. To date, conventional angioplasty has been fraught with early restenosis and recoil in these complex, long, calcified, and occlusive lesions. The success of metallic drug-eluting stents in coronary arteries has not carried over to below-the-knee arteries. Initial promise in paclitaxel-coated balloons has not been demonstrated in large randomized clinical trials. Furthermore, the potential association between paclitaxel and mortality continues to generate tremendous controversy. The goal of this review article is to discuss the evolution and challenges of drug-coated balloon (DCB) science, present the clinical results of currently available tibial DCBs, and introduce new horizons in DCB technology.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Humans; Peripheral Arterial Disease; Pharmaceutical Preparations; Popliteal Artery; Treatment Outcome; Vascular Patency

This study sought to determine the safety and efficacy of paclitaxel (PTX) devices in the treatment of peripheral artery disease involving the femoropopliteal artery.. A meta-analysis of PTX devices for the treatment of femoropopliteal artery disease reported a mortality signal.. This was a multicenter cohort study using an integrated clinical data surveillance system to conduct a prospective, propensity score-matched survival analysis of 2,456 patients in the Society for Vascular Surgery Vascular Quality Initiative from January 2017 to May 2020. The study compared PTX drug-coated balloon angioplasty versus percutaneous transluminal balloon angioplasty, PTX drug-eluting stents versus bare-metal stents, and any PTX device versus any non-PTX device. The primary outcome was 2-year survival. Secondary endpoints were successful ambulation and interventional success.. Treatment with any PTX device versus any non-PTX device was associated with increased 2-year survival (89.5% vs 86.7%; HR: 0.79; 95% CI: 0.72-0.87; P = 0.004), improved interventional success (81.6% vs 77.6%; HR: 0.82; 95% CI: 0.74-0.91; P < 0.001), and higher rates of independent ambulation at 1 year (86.0% vs 83.4%; HR: 0.85; 95% CI: 0.79-0.91; P = 0.008). Treatment with PTX drug-coated balloon angioplasty was associated with improved survival at 2 years (88.9% vs 85.7%; HR: 0.77; 95% CI: 0.70-0.86; P = 0.005), while PTX drug-eluting stent therapy was associated with similar survival compared with bare-metal stent therapy (91.3% vs 89.6%; HR: 0.84; 95% CI: 0.70-1.01; P = 0.36).. In this prospective, active surveillance of a national clinical registry, PTX-containing devices were associated with increased survival at 2 years and improved clinical outcomes at 1 year. (VQI DELTA Paclitaxel Device Safety Analysis [VQI-PTX]; NCT04110288).

Topics: Angioplasty, Balloon; Cardiovascular Agents; Cohort Studies; Drug-Eluting Stents; Femoral Artery; Humans; Multicenter Studies as Topic; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Treatment Outcome; Vascular Patency

The aim of this review is to summarize and update current research concerning the safety of drug-coated balloons (DCBs) and drug-eluting stents (DESs) with paclitaxel (PTX) in peripheral arteries. The data from the large randomized controlled trials showed evidence of the superiority of DCBs over plain balloon angioplasty concerning efficacy. Also, the safety parameters between the two groups did not differ. However, two meta-analyses identifying an increased late mortality risk after using PTX technologies were published only a short time ago. In contradiction, a lot of following studies (meta-analyses, real-world analysis, retrospective review) published in 2019 and 2020, did not confirm any significant difference in all-cause death between PTX and no-PTX cohorts. The safety of PTX technologies still represents the most serious and controversial issue in peripheral interventions. Until it is definitively solved further research must continue. In daily practice, recommendations for the use of PTX products include the treatment of restenosis after percutaneous transluminal angioplasty (PTA) (not of de novo lesions), the maintenance of patency of bypasses, and angioplasty for limb salvage. In heavily calcified lesions, a prior debulking with atherectomy is suitable. Generally, the risks and benefits of the application of PTX devices should be considered in every single patient.

Topics: Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Stents; Treatment Outcome; Urinary Catheters; Vascular Patency

Diabetes mellitus (DM) is also a cause of cardiovascular (CV) disease (CVD). Addressing the atherosclerotic CVD (ASCVD) burden in DM should reduce premature death and improve quality of life. Diabetes mellitus-associated ASCVD can lead to complications in all vascular beds (carotids as well as coronary, lower extremity, and renal arteries). This narrative review considers the diagnosis and pharmacological treatment of noncardiac atherosclerotic vascular disease (mainly in patients with DM). Based on current knowledge and the fact that modern DM treatment guidelines are based on CV outcome trials, it should be noted that patients with noncardiac CVD may not have the same benefits from certain drugs compared with patients who predominantly have cardiac complications. This leads to the conclusion that in the future, consideration should be given to conducting well-designed trials that will answer which pharmacological treatment modalities will be of greatest benefit to patients with noncardiac ASCVD.

Topics: Animals; Aortic Aneurysm; Cardiovascular Agents; Diabetes Mellitus; Humans; Hypoglycemic Agents; Peripheral Arterial Disease; Renal Artery Obstruction; Risk Assessment; Risk Factors; Stroke; Treatment Outcome

To systematically evaluate the therapeutic effects of commonly used drugs for the treatment of intermittent claudication in patients with peripheral arterial diseases.. We systematically searched bibliographic databases for randomized clinical trials published between 2000 and 2020, through the China National Knowledge Infrastructure, WanFang Data, PubMed, MEDLINE, Embase, and Cochrane library. Included studies focused on therapeutic effects of beraprost, clopidogrel, aspirin, sarpogrelate and cilostazol on treating intermittent claudication. The outcome measures were maximum walking distance, pain-free walking distance, ankle-brachial index, and severe adverse events. The quality of included trials was evaluated by using the bias risk assessment tool recommended by the Cochrane, after extracting data from the literatures. Stata was used to conduct the network meta-analysis.. There were 27 randomized control trials included in the study, covering in total 9491 patients. The network meta-analysis results showed that for maximum walking distance, better therapeutic effect was noted in using beraprost, sarpogrelate, and cilostazol. Beraprost, beraprost combined with aspirin, and sarpogrelate were better in improving pain-free walking distance than other drugs. For the ankle-brachial index, cilostazol combined with clopidogrel, sarpogrelate, and beraprost had better therapeutic effects than others. The use of sarpogrelate, beraprost, and aspirin was associated with a lower ratio of severe adverse events than the use of cilostazol and placebo.. Among the commonly used drugs for the treatment of intermittent claudication, beraprost and sarpogrelate may have better efficacy in improving the walking distance and ankle-brachial index, with a beneficial effect on cardiovascular and cerebrovascular comorbidities.

Topics: Ankle Brachial Index; Cardiovascular Agents; Exercise Tolerance; Humans; Intermittent Claudication; Network Meta-Analysis; Peripheral Arterial Disease; Randomized Controlled Trials as Topic; Recovery of Function; Time Factors; Treatment Outcome; Walk Test

Several international guidelines concerning lower extremity arterial disease (LEAD) have been published recently, in particular, by the American Heart Association the European Society of Cardiology/European Society for Vascular Surgery, the European Society for Vascular Medicine and the Society for Vascular Surgery. These guidelines differ in some respects and certain issues are not addressed. The objective of this consensus driven by the French Societies of vascular Medicine and surgery was to analyze the disparities between the different guidelines, as well as certain issues not covered, and develop proposals with regard to these points. The following fields of LEAD have been explored: 1) classifications, 2) clinical evaluation, 3) diagnostic criteria, 4) quantification of arterial stenosis using duplex ultrasound, 5) detection of asymptomatic multisite lesions, 6) screening for LEAD in the context of cardiac disease, 7) medical treatment, 8) supervised exercise therapy, 9) revascularization and revascularization of the internal artery stenosis, 10) management of chronic limb ischemia, 11) longitudinal follow-up, and 12) diet.

Topics: Cardiovascular Agents; Consensus; Delphi Technique; Diet, Healthy; Endovascular Procedures; Evidence-Based Medicine; Exercise Therapy; Healthcare Disparities; Humans; Lower Extremity; Peripheral Arterial Disease; Risk Reduction Behavior; Societies, Medical; Treatment Outcome; Vascular Surgical Procedures

There have been concerns about the long-term risk of all-cause death with the use of paclitaxel-coated devices in the lower limbs. Results from a 2018 meta-analysis were corroborated by the US Food and Drug Administration and later confirmed by an individual patient data meta-analysis. However, population-based observational studies have produced contradictory results and often claimed a survival benefit with the use of paclitaxel. The recently published Swedish drug-elution trial in peripheral arterial disease did not confirm a significant mortality risk. In this review, the authors discuss the key elements of the identified mortality signal and stress important facts and figures that remain underrecognized and elusive. They also highlight the important types of epidemiological bias that pertain to the ongoing debate on paclitaxel.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Evidence-Based Medicine; Humans; Lower Extremity; Paclitaxel; Patient Safety; Peripheral Arterial Disease; Prosthesis Design; Risk Assessment; Risk Factors; Treatment Outcome; Vascular Access Devices

Drug delivery is central to modern cardiovascular care, where drug-eluting stents, bioresorbable scaffolds, and drug-coated balloons all aim to restore perfusion while inhibiting exuberant healing. The promise and enthusiasm of these devices has in some cases exceeded demonstration of efficacy and even understanding of driving mechanisms. The authors review the means of drug delivery in each device, outlining how the technologies affect vascular behavior. They focus on how drug retention and response are governed by lesion morphology: lipid displacing drug-specific binding sites, calcium inhibiting diffusion, blocking thrombi or promoting luminal washout, and vascular healing steering hyperplastic developments. In this regard, the authors outline the fundamental impact of vascular structure on drug delivery and review the development of contemporary and future devices for coronary and peripheral intervention. They look toward a future where incorporating information on lesion distribution is central to therapeutic success and envision a transition toward lesion-specific treatment for improved interventional outcomes.

Topics: Absorbable Implants; Cardiovascular Agents; Drug Delivery Systems; Drug-Eluting Stents; Humans; Peripheral Arterial Disease; Prosthesis Design; Vascular Surgical Procedures

Peripheral artery disease is an atherosclerotic disease of the lower extremities associated with high cardiovascular mortality. Management of this condition may include lifestyle modifications, medical management, endovascular repair, or surgery. The medical approach to peripheral artery disease is multifaceted and includes cholesterol reduction, antiplatelet therapy, anticoagulation, peripheral vasodilators, blood pressure management, exercise therapy, and smoking cessation. Adherence to this regimen can reduce limb-related complications like critical limb ischemia and amputation, as well as systemic complications of atherosclerosis like stroke and myocardial infarction. Relative to coronary artery disease, peripheral artery disease is an undertreated condition. In this article, we explore the evidence behind medical therapies for the management of peripheral artery disease.

Topics: Amputation, Surgical; Cardiovascular Agents; Evidence-Based Medicine; Hemodynamics; Humans; Limb Salvage; Peripheral Arterial Disease; Risk Factors; Risk Reduction Behavior; Treatment Outcome; Vascular Surgical Procedures

To report the risk of all-cause mortality after treatment with paclitaxel-coated devices vs uncoated controls in patients with chronic limb-threatening ischemia (CLTI).. A search of the PubMed, Embase, Cochrane, CINAHL, DARE, and PROSPERO databases was made on 5 November 2019 to identify randomized controlled trials (RCT) using intention-to-treat analysis to compare a paclitaxel-coated device to an uncoated device in PAD patients having clinical follow-up of at least 6 months. Half of the study population had to have CLTI or extractable data on the CLTI subgroup if <50%. The search identified 11 trials having 1450 patients randomized to a paclitaxel-coated device (n=866) or an uncoated control (n=584). There were 1367 (94.3%) patients with CLTI (range 10-429). The single endpoint was all-cause mortality, which was analyzed by pooling the mortality data in a DerSimonian and Laird random effects model. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI).. The mean follow-up was 25.6 months (range 6-60); 10 of 11 studies reported a minimum 12-month follow-up. There were 161 (18.6%) deaths among 866 subjects in the paclitaxel device group and 116 deaths among 584 (19.9%) subjects in the non-coated control group (RR 0.93, 95% CI 0.78 to 1.12, p=0.45).. There was no observed difference in short- to midterm mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Cause of Death; Chronic Disease; Coated Materials, Biocompatible; Drug-Eluting Stents; Female; Humans; Ischemia; Male; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices

Peripheral artery disease of the lower limbs is a chronically progressive disorder characterised by the presence of occlusive lesions in the medium and large arteries that result in symptoms secondary to insufficient blood flow to the lower extremities. It is both a manifestation of systemic atherosclerosis and a marker of increased cardiovascular morbidity and mortality. Because of its highly heterogenous clinical picture, a detailed history and physical assessment, a high degree of suspicion for peripheral artery disease and the use of the ankle-brachial pressure index is essential to identify patients with peripheral artery disease. This will allow early administration of basic pharmacotherapy and lifestyle changes to reduce cardiovascular events, minimise claudication symptoms and enable optimal revascularisation to prevent loss of limb function.

Topics: Age Factors; Ankle Brachial Index; Cardiovascular Agents; Diagnostic Imaging; Health Behavior; Humans; Life Style; Lower Extremity; Peripheral Arterial Disease; Physical Examination; Risk Factors; Severity of Illness Index; Sex Factors

Restenosis remains a significant problem in endovascular therapy for hemodialysis vascular access. Drug-coated balloon (DCB) angioplasty decreases restenosis in peripheral and coronary artery diseases. The aim of this systematic review and meta-analysis is to assess the patency outcomes following DCB angioplasty, as compared to conventional balloon (CB) angioplasty for the stenosis of hemodialysis vascular access.. A comprehensive search in the MEDLINE, EMBASE, and CENTRAL databases was conducted in order to identify eligible randomized controlled trials evaluating DCB angioplasty for hemodialysis vascular access dysfunction. The primary endpoint was the 6-month target lesion primary patency and the secondary endpoints were 12-month target lesion primary patency and procedure-related complications. Risk ratios (RR) were pooled and relevant subgroups were analyzed separately.. Eleven randomized controlled trials comprised of 487 patients treated with DCB angioplasty and 489 patients treated with CB angioplasty were included. There were no significant differences in the target lesion primary patency at 6 months [RR, 0.75; 95% confidence interval (CI), 0.56, 1.01; p = 0.06] and at 12 months (RR 0.89; 95% CI, 0.79, 1.00; p = 0.06). The absence of benefit for the DCB group remained, even in the arteriovenous fistula subgroup or the subgroup of studies excluding central vein stenosis. The risk of procedure-related complication did not differ between the two groups (RR 1.00; 95% CI 0.98, 1.02; p = 0.95).. DCB angioplasty did not demonstrate significant patency benefit for the treatment of hemodialysis vascular access dysfunction. Wide variations in patency outcomes across studies were noted. Further studies focusing on specific types of access or lesions are warranted to clarify the value of DCB for hemodialysis vascular access. (PROSPERO Number CRD42019119938).

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Fistula; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Renal Dialysis; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The advancement of drug-coated balloons (DCB) presents an alternative nonstent method in the percutaneous treatment of atherosclerotic lesions. While the current generation of drug-eluting stents (DES) are the device of choice, especially in coronary artery disease (CAD), DCB has potential applications in the treatment of de novo lesions, in-stent restenosis (ISR), bifurcations, and in peripheral artery disease (PAD). In terms of coronary clinical experience, DCB is used most in ISR scenarios and more data are collected to support the use of DCB in de novo lesions compared to best-in-class DES. The use of DCB in bifurcation side branch treatment has demonstrated safety, and with good angiographic and clinical outcomes, but more data from randomized trials will be required to assess its clinical value. For PAD, the clinical outcomes of DCB with and without debulking devices in diseased femoropopliteal arteries and treatment of below-the-knee (BTK) vessels with DCB are discussed. Current data demonstrated conflicting long-term safety outcomes in the use of paclitaxel devices in the femoral and/or popliteal arteries, while the role of DCB in BTK disease remains uncertain due to a lack of randomized controlled trial data. In summary, this review provides an overall view of current DCB technologies and progress, followed by an update on DCB clinical data in the treatment of CAD and PAD.

Topics: Angioplasty, Balloon; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Equipment Design; Humans; Peripheral Arterial Disease; Treatment Outcome; Vascular Access Devices

We aimed to evaluate whether paclitaxel eluting devices increased the risk of death in patients undergoing revascularization for infrainguinal peripheral artery disease using network meta-analyses.. PUBMED and EMBASE were searched through April 2020 for randomized trials in patients with infrainguinal peripheral artery disease who underwent revascularization with or without a paclitaxel eluting device (balloon/stent). Short-term mortality defined as death at 6-12 months, and long-term mortality defined as death at >12 months after revascularization.. Our search identified 57 eligible randomized controlled studies enrolling a total of 9,362 patients comparing seven revascularization strategies (balloon angioplasty vs. bare metal stent vs. covered stent vs. paclitaxel eluting stent vs. other drug eluting stent vs. paclitaxel-coated balloon vs. bypass surgery). Overall, paclitaxel eluting stent and paclitaxel-coated balloons did not increase short-term mortality (eg, vs. balloon angioplasty: paclitaxel-coated balloon OR [95% CI] 1.21 [0.88-1.66], p = .24; paclitaxel eluting stent OR [95%CI] 1.01 [0.63-1.63], p = .97, respectively). In addition, paclitaxel eluting stent did not show significant increase in long-term mortality (eg, vs. balloon angioplasty: OR [95%CI] 1.06 [0.70-1.59], p = .79). However, paclitaxel-coated balloon showed significant increase in long-term mortality compared to balloon angioplasty and bypass (vs. balloon angioplasty: OR [95% CI] 1.48 [1.06-2.07], p = .021; vs. bypass: OR [95%CI] 1.73 [1.05-2.84], p = .031, respectively).. In this meta-analysis of randomized trials, there was no significant increase in mortality with paclitaxel eluting stent, but there was increased risk of long-term mortality in paclitaxel-coated balloon for the treatment of infrainguinal peripheral artery disease.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Endovascular Procedures; Female; Humans; Male; Middle Aged; Network Meta-Analysis; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices

Restenosis by myointimal hyperplasia after peripheral arterial angioplasty or stenting often limits long term patency. Drug-eluting balloons (DEBs) which inhibit the proliferation of neo-intimal growth of vascular smooth muscle cells may prevent restenosis. The aim of this paper was to examine the evidence in published literature on the use of DEBs in the treatment of peripheral arterial in-stent restenosis (ISR).. A systematic literature review was undertaken of all published literature on the treatment of peripheral ISR with drug eluting balloon using Medline and cross-referenced. All published papers on the use of DEBs in peripheral arterial disease (PAD) were used. Cochrane Central Register of Controlled Trials and electronic databases were also searched for on-going studies.. There were no level 1 or 2 evidence published on this subject. The number of high-quality publications is few, and consequently a sufficient analysis is not possible. Recently data from non-randomized cohort studies showed encouraging results with DEB as treatment modality for ISR, whether used alone or as combined strategies.. Evidence from the published literature suggests that DEBs are safe in preventing peripheral ISR. Despite strong corporate pressure for the use of DEBs, there is only circumstantial evidence that this is a useful modality for ISR. Results from on-going studies may allow further meta-analysis for efficiency and cost-effectiveness.

Topics: Angioplasty, Balloon; Animals; Cardiovascular Agents; Humans; Hyperplasia; Lower Extremity; Neointima; Peripheral Arterial Disease; Recurrence; Retreatment; Stents; Treatment Outcome; Vascular Access Devices; Vascular Patency

Systematic literature searches using Embase, PubMed, and Cochrane Library for directional atherectomy with antirestenotic therapy (DAART) in femoropopliteal artery disease (FPAD) from January 2003 to February 2018 were conducted to evaluate clinical safety and effectiveness. A meta-analysis was conducted using Stata software for the event rate of technical success, bailout stent placement, primary patency, and target lesion revascularization (TLR) at 12 months. Five studies with 189 patients who received DAART were included in the meta-analysis. Pooled rates of technical success and bailout stent placement were 90.4% (95% confidence interval [CI] 86.3%-94.6%) and 4.8% (95% CI 0.7%-8.9%), respectively. Primary patency and TLR at 12 months were 85.3% (95% CI 79.6%-91.1%) and 5.5% (95% CI 1.9%-9.1%), respectively. Meta-analysis of 3 comparative studies demonstrated that DAART was not superior in performance in clinical endpoints, including technical success, bailout stent placement, primary patency, and TLR at 12 months (relative risk [RR] 1.111, 95% CI 0.896-1.377, P = .337; RR 0.400, 95% CI 0.120-1.332, P = .135; RR 1.136, 95% CI 0.841-1.535, P = .405; and RR 0.722, 95% CI 0.291-1.789, P = .482). The data did not suggest that DAART was an improvement over paclitaxel-coated balloon angioplasty for FPAD. The theoretical advantages of DAART still require further confirmation.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Drug-coated balloons (DEB) and drug-eluting stents (DES) emerged as a tool to aid in lowering the rates of neointimal hyperplasia and target lesion restenosis following endovascular peripheral arterial disease (PAD) interventions.. Although the initial trials comparing these devices with non-drug balloons and stents showed favorable results, more recent data raised concerns regarding the mid to long-term safety of these devices. In this review, we will discuss the evolution of endovascular therapy for PAD, with highlights regarding the recent debates on the long-term safety of the drug-coated devices for treatment of PAD.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Treatment Outcome

The aim of this article is to systematically review the literature on medical adjunctive therapy for patients with chronic limb-threatening ischemia (CLTI).. MEDLINE, Embase, and Cochrane Database of Systematic Reviews were searched for studies published between January 1st, 2009, and June 1st, 2019. Articles that studied medical treatment of CLTI patients and reported clinical outcomes were eligible. Main exclusion criteria were case reports <20 patients, incorrect publication type, and CLTI caused by Buerger disease. The primary end point was major amputation (above the ankle) in studies with a follow-up of ≥6 months. Secondary end points were other clinical end points such as death and wound healing. Study quality was assessed according to the Downs and Black checklist.. Included were 42 articles: four focused on antiplatelet therapy, five on antihypertensive medication, 6 on lipid-lowering therapy, 16 on stem cell therapy, three on growth factors, five on prostanoids, and one study each on cilostazol, glucose-lowering therapy, spinal cord stimulation, sulodexide, and hemodilution. Calcium channel blockers, iloprost, cilostazol, and hemodilution showed significant improvement of limb salvage, but data are limited. Stem cell therapy showed no significant improvement of limb salvage but could potentially improve wound healing. Antiplatelets, antihypertensives, and statins showed significantly lower cardiovascular events rates but not evident lower major amputation rates. The quality of the studies was fair to good.. Certain medical therapies serve to improve limb salvage next to revascularization in CLTI patients, whereas others are important in secondary prevention. Because high quality evidence is limited, further research is needed.

Topics: Amputation, Surgical; Cardiovascular Agents; Critical Illness; Humans; Ischemia; Peripheral Arterial Disease; Risk Factors; Treatment Outcome

Peripheral artery disease (PAD) is often diagnosed in an advanced stage. Accordingly, revascularization is also performed late.. In this paper, the authors describe the progression to critical limb ischemia and cardiovascular risk. Revascularization for secondary prevention is explained. Revascularization strategies according to lesion location and complexity of the stenosis or occlusion are discussed.. The current guidelines and randomized controlled studies and meta-analyses are analyzed.. PAD is associated with a considerable level of suffering and a high cardiovascular risk. Up to 20% of patients with claudicants will progress to critical limb ischemia. Progression and risk of mortality increase during the course of the disease. Improvement of walking ability by revascularization is a major goal of secondary prevention. In the femoropopliteal segment, drug-coated balloon (DCB) angioplasty and bare-metal stent (BMS) implantation are the methods of choice. In long lesions, spot-stenting should be preferred. For treatment of in-stent restenosis, DCB have proven their effectiveness. In severely calcified or dissected lesions, BMS are well suited. Infrapopliteal lesions should be revascularized to provide in-line flow to the foot through the target arterial path. According to current evidence, DCB or drug-eluting stents are more effective than plain old balloon angioplasty or BMS.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Drug-Eluting Stents; Humans; Lower Extremity; Peripheral Arterial Disease; Practice Guidelines as Topic; Randomized Controlled Trials as Topic; Stents; Treatment Outcome; Vascular Patency

The aim of the present study was to quantify the probability of increased mortality with paclitaxel compared with control in a dataset of 28 randomized controlled trials.. Analysis of data from 28 randomized controlled trials using conventional null-hypothesis statistical testing has produced the unexpected finding of a 68% increase in mortality at 2 years and a 93% increase at 3 to 5 years after using paclitaxel-eluting balloons and stents to treat femoropopliteal arterial disease, but no biologic explanation for increased mortality has been identified.. A Bayesian sequential model was developed to quantify the probability of increased mortality 1, 2, and 3 to 5 years after treatment, and p values were replaced with meta-analytic Bayes factors (BFs), which provide decisive evidence at values >100 and very strong evidence at values of 32 to 100.. The evidence for increased mortality at 1 year (BF = 0.02), 2 years (BF = 8.5), and 3 to 5 years (BF = 14.6) was less than conclusive. All-cause mortality at 1 year was similar between the paclitaxel and control arms at 1 year (odds ratio: 0.92; 95% Bayesian credible interval: 0.53 to 1.53) and 2 years (odds ratio: 1.23; 95% Bayesian credible interval: 0.84 to 1.71) but was increased at 3 to 5 years (odds ratio: 1.43; 95% Bayesian credible interval: 1.01 to 1.90).. This study finds some support for increased mortality after using paclitaxel-eluting devices in femoropopliteal arterial disease, but the evidence is not unequivocal and may not sway skeptical investigators concerned about causation, unreported studies, or the post hoc analysis of trials underpowered for mortality.

Topics: Angioplasty, Balloon; Bayes Theorem; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Humans; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices

Peripheral artery disease (PAD) is highly prevalent but is often underdiagnosed and undertreated. Lower extremity PAD can often be life style limiting. Revascularization in carefully selected lower extremity PAD patients improves symptoms and functional status. Surgical revascularization used to be the only available strategy, but in the recent years, endovascular strategies have gained popularity due to faster recovery times with low morbidity and mortality rates. Endovascular procedures have increased significantly in the United States in the past few years. That being said, higher restenosis rates and low long-term patency rates have been the limiting factors for this strategy. Drug eluting stents have been introduced to help with lowering restenosis, however lower extremity PAD involves long segment where the outcomes of stents are suboptimal. Also, the disease often crosses joint line that makes it less ideal for the stents. Drug-coated balloons (DCB) have been introduced to improve patency rates following endovascular intervention for lower extremity PAD. They have gained popularity among endovascular specialists due to its ease of use and the concept of "leave nothing behind". This is a review of scientific evidence supporting DCB use in PAD.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Humans; Peripheral Arterial Disease; Recurrence; Risk Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Topics: Angioplasty, Balloon; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Treatment Outcome; Vascular Patency

Within the last years, many new endovascular treatment modalities have been invented for treatment of peripheral arterial disease. To leave nothing behind and to keep options for future treatment are key issues of these new revascularization procedures. Drug coated balloon technology (DCB) is one key element in this strategy but there are still limitations for this revascularization technology. Especially calcium rich lesions and long lesions are still challenging in terms of treatment success and long-term patency. Treatment of both calcified and long lesions continues to be a clinical challenge for every interventionalists. Therefore, a treatment combination of debulking procedure using atherectomy plus antirestenotic therapy using DCB seems to be promising to treat complex lesions.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Recurrence; Risk Factors; Treatment Outcome; Vascular Access Devices; Vascular Calcification; Vascular Patency

Endovascular treatment for peripheral artery occlusive disease carries unresolved problem of restenosis. Treatment modalities in areas of high mechanical stress like popliteal artery and common femoral artery remains challenging. New-generation devices improved the results of stent therapy in this anatomical territory, but could impact on future surgical options if they are needed. Vessel preparation prior to drug (paclitaxel)-coated balloons (DCB) angioplasty leads to better paclitaxel penetration into the arterial wall and improved drug uptake. The "leave nothing behind" strategies, DCB angioplasty and combined directional atherectomy (DA) and antirestenotic therapy (DAART), can theoretically overcome the problems caused by the mobility of the knee joint. However, calcified and longer lesions remain a challenging subset that is less responsive to DCBs, resulting in higher provisional stent rates. For the treatment of long and calcified femoropopliteal lesions, vessel preparation with DA before DCB angioplasty seems to be safe in mid-term follow-up and might have benefits in more challenging lesion subsets that are at higher risk for acute and chronic technical treatment failure of percutaneous transluminal angioplasty, including DCB angioplasty, such as severely calcified lesions. Treatment with DA+DCB resulted in both increased technical success and fewer flow-limiting dissections compared with treatment with DCB alone. In concept of "leave nothing behind" therapies for isolated popliteal artery lesions, DAART was associated with a higher primary patency rate than DCB angioplasty alone.

Topics: Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Humans; Paclitaxel; Peripheral Arterial Disease; Recurrence; Risk Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Critical limb ischemia (CLI) is a highly morbid disease with many patients considered poor surgical candidates. The lack of treatment options for CLI has driven interest in developing molecular therapies within recent years. Through these translational medicine studies in CLI, much has been learned about the pathophysiology of the disease. Here, we present an overview of the macrovascular and microvascular changes that lead to the development of CLI, including impairment of angiogenesis, vasculogenesis, and arteriogenesis. We summarize the randomized clinical controlled trials that have used molecular therapies in CLI, and discuss the novel imaging modalities being developed to assess the efficacy of these therapies.

Topics: Angiogenesis Inducing Agents; Cardiovascular Agents; Critical Illness; Genetic Therapy; Humans; Ischemia; Microcirculation; Neovascularization, Physiologic; Peripheral Arterial Disease; Regional Blood Flow; Treatment Outcome

Drug-coated balloon (DCB) angioplasty has emerged as a mainstay of therapy for the treatment of peripheral arterial disease (PAD) involving the superficial femoral and popliteal arteries. We performed a meta-analysis including all available randomized controlled trials (RCTs) to date which compare DCB to plain balloon angioplasty (POBA) in femoropopliteal disease (FPD).. Five databases were analyzed including EMBASE, PubMed, Cochrane, Scopus, and Web-of-Science from January 2000 to September 2018 for RCTs comparing DCB to POBA in patients with FPD. Heterogeneity was determined using Cochrane's Q-statistics. Random effects model was used.. Twenty-two RCTs, including five trials of in-stent restenosis (ISR) intervention, with 3,217 patients were included in the analysis. Mean follow-up was approximately 21.6 ± 14.4 months. Overall, DCB use was associated with a 51% reduction in target vessel revascularization (TLR) when compared to POBA at follow-up (relative risk [RR]: 0.49, 95% confidence interval [CI]: 0.40-0.61, P < 0.0001). Rates of TLR were 45% lower in the DCB group when compared to POBA in patients with ISR (RR: 0.55, 95% CI: 0.37-0.81, P = 0.002). DCB was associated with lower rates of binary stenosis, late lumen loss and higher primary safety endpoints. Major amputation and mortality were not different between DCB and POBA.. Use of DCBs is associated with improved vessel patency and a lower risk of TLR when compared to POBA in patients with FPD, especially in the setting of ISR. There was no difference in mortality between DCB and POBA in our meta-analysis. Extended follow-up of the available RCT data will be essential to analyze long-term device-related mortality.

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Femoral Artery; Humans; Limb Salvage; Male; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Risk Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The role of cilostazol after endovascular therapy (EVT) of peripheral artery disease (PAD) remains unclear. We conducted a meta-analysis for all studies reporting the outcomes of cilostazol after EVT of PAD from January 2000 through November 2018 with the outcomes of interest including primary patency, major adverse limb events (MALE), target lesion revascularization (TLR), and major amputation. We included eight studies (three randomized controlled trials (RCTs) and five observational studies) with a total of 3846 patients (4713 lesions). During a mean follow-up duration of 12.5 ± 5 months, the use of cilostazol was associated with higher primary patency (OR 2.28, 95% CI (1.77, 2.94),

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Cardiovascular Agents; Cilostazol; Endovascular Procedures; Female; Humans; Limb Salvage; Male; Middle Aged; Observational Studies as Topic; Peripheral Arterial Disease; Protective Factors; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

The aim of this study was to perform a comprehensive meta-analysis comparing all therapeutic modalities for intermittent claudication (IC), including best medical therapy (BMT) alone, percutaneous angioplasty (PTA), supervised exercise therapy (SET), and PTA combined with SET, to establish the optimal first-line treatment for IC.. IC is a common health problem that limits physical activity, results in decreased quality of life (QoL) and is associated with poor cardiovascular outcomes. Previous meta-analyses have attempted to combine data from randomized trials; however, none have combined data from all possible treatment combinations or synthesized QoL outcomes.. Following a systematic review of the published research (conducted in December 2018) that identified 37 published randomized trials, a network meta-analysis was performed combining all possible IC treatment strategies.. Overall, 2,983 patients with IC were included (mean weighted age 68 years, 54.5% men). Comparisons were performed between BMT (n = 688, 28 arms) versus SET (n = 1,189, 35 arms) versus PTA (n = 511, 12 arms) versus PTA plus SET (n = 395, 8 arms). Mean weighted follow-up was 12 months (95% confidence interval: 9 to 23 months). Compared with BMT alone, PTA plus SET outperformed other treatment strategies, with a maximum walking distance gain of 290 m (95% credible interval: 180 to 390 m; p < 0.001). A variety of QoL assessments using validated tools were reported in 15 trials; PTA plus SET was superior to other treatments (Cohen's D = 1.8; 95% credible interval: 0.21 to 3.4).. In addition to BMT, PTA combined with SET seems to be the optimal first-line treatment strategy for IC in terms of maximum walking distance and QoL improvement.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty; Cardiovascular Agents; Combined Modality Therapy; Exercise Therapy; Exercise Tolerance; Female; Humans; Intermittent Claudication; Male; Middle Aged; Network Meta-Analysis; Peripheral Arterial Disease; Quality of Life; Randomized Controlled Trials as Topic; Recovery of Function; Time Factors; Treatment Outcome; Walking

A recent meta-analysis identified increased 2- to 5-year mortality associated with paclitaxel-eluting balloons and stents when they are used to treat peripheral artery disease. The history of the development of paclitaxel, its mechanism of action, and its use in the coronary and peripheral circulation are reviewed in this special communication. In addition, inferences are made to place these findings in perspective and to explain them in light of presently available information, and proposals regarding end points and open access to data are put forth to minimize risk of such developments in the future.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Evidence-Based Medicine; Humans; Paclitaxel; Patient Safety; Peripheral Arterial Disease; Prosthesis Design; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices

The standard of care for treating symptomatic peripheral arterial disease has been percutaneous transluminal angioplasty with or without stenting over the last couple of years. This endovascular treatment of claudicants or patients with critical limb ischemia has increased in numbers and has even surpassed open surgery. Our daily practice has evolved to an endovascular-first approach, especially in the femoropopliteal region, being the most frequently treated vessel. However, neointimal hyperplasia and elastic recoil leading to target lesion restenosis or occlusion after initial successful treatment is not uncommon. In recent years, drug-eluting technologies on balloons or stents have been investigated as a potential solution for this problem with excellent results compared to plain-old balloon angioplasty. Nonetheless in the majority of those trials, the bailout stenting rate increased with lesion complexity, albeit it in long or heavily calcified lesions due to flow-limiting dissections, elastic recoil or the calcium barrier preventing adequate drug uptake. There is a need for vessel preparation in order to ameliorate drug delivery, especially in complex lesions. Multiple devices are available to prepare even the most challenging lesions for drug uptake or stenting, by achieving maximal luminal gain and by minimizing dissections. This review aims to give an overview of the most common modalities for vessel preparation in the superficial femoral artery beside plain old balloon angioplasty together with an overview of the current literature of each device in the superficial femoral artery.

Topics: Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Drug-Eluting Stents; Femoral Artery; Humans; Lithotripsy; Peripheral Arterial Disease; Prosthesis Design; Risk Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Despite the progress in endovascular treatment of patients with peripheral arterial disease, restenosis remains the major drawback, especially in patients with femoropopliteal lesions. To reduce neointimal proliferation and subsequent restenosis the use of antiproliferative drug eluting devices was implemented in the endovascular treatment of femoropopliteal disease. Aiming to use the favorable effects of these antiproliferative agents and to reduce foreign body exposure in affected arteries, drug coated balloons (DCB) have been developed. Up to now, several randomized controlled trials have consistently demonstrated the superiority of DCB over uncoated balloon angioplasty in the treatment of femoropopliteal lesions. Similarly, DCB appear to have favorable effects on vessel patency in the treatment of femoropopliteal in-stent restenosis. However, there still is a need for further studies, especially addressing different lesion characteristics as well as the combinations of particular treatment modalities.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Femoral Artery; Humans; Peripheral Arterial Disease; Vascular Access Devices; Vascular Patency

Drug-coated balloons (DCBs) may increase durability of endovascular treatment of superficial femoral artery (SFA) disease while avoiding stent-related risks. The purpose of this study was to use meta-analytic data of DCB studies to compare the cost-effectiveness of potential SFA treatments: DCB, drug-eluting stent (DES), plain old balloon angioplasty (POBA), or bare-metal stent (BMS).. A search for randomized controlled trials comparing DCB with POBA for treatment of SFA disease was performed. Hazard ratios were extracted to account for the time-to-event primary outcome of target lesion revascularization. Odds ratios were calculated for the secondary outcomes of primary patency (PP) and major amputation. Incorporating pooled data from the meta-analysis, cost-effectiveness analysis, assuming a payer perspective, used a decision model to simulate patency at 1 year and 2 years for each index treatment modality: POBA, BMS, DCB, or DES. Costs were based on current Medicare outpatient reimbursement rates.. Eight studies (1352 patients) met inclusion criteria for meta-analysis. DCB outperformed POBA with respect to target lesion revascularization over time (pooled hazard ratio, 0.41; P < .001). Risk of major amputation at 12 months was not significantly different between groups. There was significantly improved 1-year PP in the DCB group compared with POBA (pooled odds ratio, 3.30; P < .001). In the decision model, the highest PP at 1 year was seen in the DES index therapy strategy (79%), followed by DCB (74%), BMS (71%), and POBA (64%). With a baseline cost of $9259.39 per patent limb at 1 year in the POBA-first group, the incremental cost per patent limb for each other strategy compared with POBA was calculated: $14,136.10/additional patent limb for DCB, $38,549.80/limb for DES, and $59,748,85/limb for BMS. The primary BMS option is dominated by being more expensive and less effective than DCB. Compared directly with DCB, DES costs $87,377.20 per additional patent limb at 1 year. Based on the projected PP at 1 year in the decision model, the number needed to treat for DES compared with DCB is 20. At current reimbursement, the use of more than two DCBs per procedure would no longer be cost-effective compared with DES. At 2 years, DCB emerges as the most cost-effective index strategy with the lowest overall cost and highest patency rates over that time horizon.. Current data and reimbursements support the use of DCB as a cost-effective strategy for endovascular intervention in the SFA; any additional effectiveness of DES comes at a high price. Use of more than one DCB per intervention significantly decreases cost-effectiveness.

Topics: Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Cost-Benefit Analysis; Drug-Eluting Stents; Femoral Artery; Health Expenditures; Humans; Insurance, Health, Reimbursement; Peripheral Arterial Disease; Randomized Controlled Trials as Topic; Treatment Outcome; Vascular Patency

This paper will discuss the results from the most recent randomized trials and large registries for DCB's and atherectomy, and the drawbacks of these two therapeutic options. It will also discuss the results of combination therapy in complex femoropopliteal lesions. Several studies indicate that combining atherectomy and DCB yields better outcomes in complex calcified lesions, but the only randomized pilot study could not demonstrate a benefit of combination therapy in the mid-term follow-up. Larger, randomized studies are needed to define the role of atherectomy followed by DCB angioplasty further.

Topics: Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Combined Modality Therapy; Drug-Eluting Stents; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery

Drug coated balloons (DCBs) are new on stented-based anti-proliferative drug delivery systems, recently introduced in interventional cardiology. Their primary aim is to transfer an anti-proliferative drug to reduce the subsequent neo-intima hyperplasia and to maintain the normal vessel diameter and function.. A review of the most recent influential studies about DCBs in all the fields of interventional cardiology has been performed.. As demonstrated by different studies, DCBs have different theoretical advantages over Drug Eluting Stents (DESs), especially for the treatment of some endovascular lesions, as In-Stent Restenosis (ISR), coronary bifurcations, small vessels disease and peripheral artery disease at femoropopliteal and below the knee sites.. Despite the need of further studies are needed to elucidate the optimal use of DCBs their current use in interventional cardiology appears promising.

Topics: Cardiovascular Agents; Drug-Eluting Stents; Humans; Peripheral Arterial Disease

Health status outcomes, including symptoms, functional status, and quality of life, are critically important outcomes from patients' perspectives. The PORTRAIT study (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) was designed to prospectively define health status outcomes and examine associations between patients' characteristics and care to these outcomes among those presenting with new-onset or worsened claudication.. PORTRAIT screened 3637 patients with an abnormal ankle-brachial index and new, or worsened, claudication symptoms from 16 peripheral arterial disease (PAD) specialty clinics in the United States, the Netherlands, and Australia between June 2, 2011, and December 3, 2015. Of the 1608 eligible patients, 1275 (79%) were enrolled. Before treatment, patients were interviewed to obtain their demographics, PAD symptoms and health status, psychosocial characteristics, preferences for shared decision-making, socioeconomic, and cardiovascular risk factors. Patients' medical history, comorbidities, and PAD diagnostic information were abstracted from patients' medical records. Serial information about patients' health status, psychosocial, and lifestyle factors was collected at 3, 6, and 12 months by a core laboratory. Follow-up rates ranged from 84.2% to 91%. Clinical follow-up for PAD-related hospitalizations and major cardiovascular events is ongoing.. PORTRAIT systematically collected serial PAD-specific health status data as a foundation for risk stratification, comparative effectiveness studies, and clinicians' adherence to quality-based performance measures.. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01419080.

Topics: Aged; Australia; Cardiovascular Agents; Exercise Therapy; Female; Health Status; Health Status Indicators; Healthcare Disparities; Humans; Intermittent Claudication; Life Style; Male; Middle Aged; Multicenter Studies as Topic; Netherlands; Patient Outcome Assessment; Peripheral Arterial Disease; Prospective Studies; Quality of Life; Registries; Research Design; Risk Factors; Surveys and Questionnaires; Time Factors; Treatment Outcome; United States; Vascular Surgical Procedures

Peripheral artery disease (PAD) of the lower extremities is a common manifestation of atherosclerosis that is increasing in global prevalence and in the associated public health costs. Ageing of the general population, combined with the pandemics of diabetes mellitus, metabolic syndrome, and tobacco use, is a major underlying factor. A broad range of care providers are involved in the management of patients with PAD, and all health-care professionals require familiarity with the risk factors, diagnosis, and treatment options for this common disease. Although medical therapies are the cornerstone of secondary prevention in atherosclerotic disease, they have limited direct limb-related benefits in advanced PAD. Despite a major evolution in technologies for limb revascularization, the increasing array of treatment options has not been accompanied by adequate evidence of their comparative effectiveness, which is needed to guide treatment decisions. This Review provides a framework for examining the current status of interventions for PAD, including an overview of disease staging, treatment goals, and the key factors associated with outcomes in defined subgroups. The status of evolving approaches to PAD, such as cell-based and gene-based therapies, and persistent unmet therapeutic needs in this field are also discussed.

Topics: Animals; Cardiovascular Agents; Cell- and Tissue-Based Therapy; Endovascular Procedures; Exercise Therapy; Genetic Therapy; Humans; Lower Extremity; Peripheral Arterial Disease; Recovery of Function; Risk Factors; Severity of Illness Index; Treatment Outcome; Vascular Surgical Procedures

Background Several randomized controlled trials ( RCT s) have already shown that paclitaxel-coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascularization after lower extremity interventions. Methods and Results A systematic review and meta-analysis of RCT s investigating paclitaxel-coated devices in the femoral and/or popliteal arteries was performed. The primary safety measure was all-cause patient death. Risk ratios and risk differences were pooled with a random effects model. In all, 28 RCT s with 4663 patients (89% intermittent claudication) were analyzed. All-cause patient death at 1 year (28 RCT s with 4432 cases) was similar between paclitaxel-coated devices and control arms (2.3% versus 2.3% crude risk of death; risk ratio, 1.08; 95% CI, 0.72-1.61). All-cause death at 2 years (12 RCT s with 2316 cases) was significantly increased in the case of paclitaxel versus control (7.2% versus 3.8% crude risk of death; risk ratio, 1.68; 95% CI, 1.15-2.47; -number-needed-to-harm, 29 patients [95% CI , 19-59]). All-cause death up to 5 years (3 RCT s with 863 cases) increased further in the case of paclitaxel (14.7% versus 8.1% crude risk of death; risk ratio, 1.93; 95% CI , 1.27-2.93; -number-needed-to-harm, 14 patients [95% CI , 9-32]). Meta-regression showed a significant relationship between exposure to paclitaxel (dose-time product) and absolute risk of death (0.4±0.1% excess risk of death per paclitaxel mg-year; P<0.001). Trial sequential analysis excluded false-positive findings with 99% certainty (2-sided α, 1.0%). Conclusions There is increased risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the lower limbs. Further investigations are urgently warranted. Clinical Trial Registration URL : www.crd.york.ac.uk/PROSPERO . Unique identifier: CRD 42018099447.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Female; Femoral Artery; Humans; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices

The use of drug-eluting stents and of drug-coated balloons have mitigated the prevalence of in-stent restenosis, however in-stent remains a problem that continues to affect the long-term outcomes of femoro-popliteal endovascular therapy. This paper will provide an overview on the latest data with regard to the treatment of femoro-popliteal in-stent restenosis.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Femoral Artery; Humans; Lower Extremity; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Retreatment; Risk Factors; Stents; Treatment Outcome; Vascular Access Devices; Vascular Patency

Despite a constantly expanding spectrum of therapeutic options for lower limb artery disease, there is not yet a well-defined consensus on the specific type of endovascular treatment that is best suited. Clinical data on patients with femoropopliteal disease treated with drug-coated balloons have not been elaborated sufficiently, especially in the case of in-stent restenosis. For this review a systematic research of the medical databases (Pubmed) has been conducted. Keywords such as "drug-coated balloons" (DCB), "drug-eluting balloons," "in-stent restenosis", "de novo stenosis", "angioplasty", "superficial femoral artery," "popliteal artery," "above the knee," "below the knee," "peripheral artery disease" (PAD) have been used. Furthermore, data from reviews, original contributions regarding randomized controlled studies, observational studies, registries and single center experiences have been included. Many trials have shown superiority for DCB- over percutaneous transluminal angioplasty-treatment alone in TASC IIA and TASC IIB femoropopliteal lesions. However, the currently available DCB systems are different in terms of efficacy and long-term outcomes depending on their mechanical and pharmacological features. Moreover, angiographic characteristics of femoropopliteal lesions classified by Tosaka seem to influence subsequent outcomes of DCB treatment. Lastly, there is still lack of reliable prospective long-term data regarding DCB technology.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Humans; Lower Extremity; Peripheral Arterial Disease; Prosthesis Design; Recurrence; Retreatment; Stents; Treatment Outcome; Vascular Access Devices; Vascular Patency

Approximately 27 million people in Europe and North America currently have peripheral arterial disease (PAD). The endovascular treatment of stenosis or blocked peripheral arteries in PAD include percutaneous transluminal angioplasty with or without a drug coated balloon (DCB), atherectomy (rotational, directional, orbital or laser), and stenting. The development of next generation peripheral stents and drug-coated stents have led to the improved treatment of complex superficial femoral artery (SFA) lesions, and consequently increased their usage. Additionally, the technologies developed for PAD intervention have further improved the overall adoption of endovascular procedures leading to increased utilization of stents to address procedural dissections (bailout stenting), as support scaffolding for complex lesions, and to prevent preventing elastic recoil post balloon angioplasty. For example, bail-out stenting after DCB angioplasty has been reported to be as high as 40% in long lesions and as high as 46% in chronic total occlusions lesions. In total, approximately 200,000 stents are placed annually in the femoral and popliteal arteries in PAD patients in the USA, with 30% to 40% of these stents expected to develop in-stent restenosis within 2-3 years of implantation. Accordingly, the treatment of in-stent restenosis (ISR) remains a substantial healthcare burden. Few technologies reported on improved ISR patency rates as compared to PTA treatment alone, including drug-eluting stents and balloons, laser atherectomy or covered stents. However, the reported longer-term patency for ISR remains suboptimal creating a cyclical treatment pattern that burdens patients and providers. In this review, we present the rational and clinical evidence for utilizing OCT-guided therapies for the treatment of ISR for PAD.

Topics: Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Female; Humans; Lower Extremity; Male; Peripheral Arterial Disease; Predictive Value of Tests; Recurrence; Retreatment; Risk Factors; Stents; Tomography, Optical Coherence; Treatment Outcome; Vascular Access Devices; Vascular Patency

The management of complex, lower-extremity peripheral artery disease remains a difficult challenge, with ample room for improvement in the results seen with current generation devices. Therapies which use a combination of multiple devices for their mechanical and anti-restenotic properties may be advantageous, and offer an opportunity to improve the durability of revascularization through optimizing and individualizing care. Combination therapy typically utilizes drug delivery devices in addition to stents and atherectomy to achieve improved results. However, there is a paucity of high-level evidence with which to direct treatment, with many different forms of combination therapy under investigation and little clinical research coordination. Herein we seek to describe and evaluate the growing number of options for combination treatment in this challenging disease.

Topics: Cardiovascular Agents; Coated Materials, Biocompatible; Combined Modality Therapy; Drug-Eluting Stents; Endovascular Procedures; Humans; Lower Extremity; Peripheral Arterial Disease; Prosthesis Design; Recurrence; Treatment Outcome; Vascular Access Devices; Vascular Patency

In the current era, endovascular treatment of long femoropopliteal lesions (>15 cm) is becoming more feasible and favorable, with patency rates that rival surgical outcomes. Drug-coated balloons offer promising results at least to one year follow-up although randomized, controlled trials to evaluate its efficacy compared to other treatment modalities (surgical and endovascular alike) is lacking at this time.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Humans; Lower Extremity; Peripheral Arterial Disease; Treatment Outcome; Vascular Access Devices; Vascular Patency

Peripheral artery disease (PAD) is common and associated with significant morbidity and mortality. Optimal medical management of PAD is required for each patient, irrespective of the decision regarding lower extremity revascularization. The goals include reducing cardiovascular morbidity and mortality and improving quality of life. The approach should consist of aggressive and individualized risk factor modification including smoking cessation, antiplatelet therapy, a statin, and an angiotensin-converting enzyme inhibitor. Exercise is critical for cardiovascular health and highly effective for improving claudication symptoms. Cilostazol may be considered for symptomatic treatment in certain patients.

Topics: Cardiovascular Agents; Comorbidity; Drug Therapy, Combination; Humans; Intermittent Claudication; Life Style; Lower Extremity; Peripheral Arterial Disease; Quality of Life; Risk Factors; Risk Reduction Behavior; Treatment Outcome

Critical limb ischemia (CLI) is a prevalent condition associated with cardiovascular mortality and limb loss. Areas covered: This review discusses the epidemiology of CLI, revascularization options, and drug-elution therapies. Expert commentary: Drug-eluting stents (DES) and drug-coated balloons (DCB) improve patency rates in the femoropopliteal segment, and are generally used as first-line therapies. For below-knee disease, angioplasty is the default strategy unless lesions are focal whereby DES can be used to reduce restenosis risk.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Drug-Eluting Stents; Humans; Lower Extremity; Paclitaxel; Peripheral Arterial Disease; Treatment Outcome

Endovascular management of peripheral artery disease was until recently limited to percutaneous balloon angioplasty, atherectomy, stent grafts, and bare-metal stents. These therapies have been valuable, but plagued by high restenosis and revascularization rates. Important progress has been made with the introduction of combination devices, including drug-eluting stents and drug-coated balloons (DCB), designed to combat restenosis by locally delivering anti-proliferative drugs. In particular, promising clinical performance has been seen with the Medtronic IN.PACT™ Admiral™ DCB, with durable, consistent and safe results. Rigorous, randomized controlled trials have directly compared this and other drug-delivering devices to their non-drug-coated counterparts with data available through two years. Additionally, trials are ongoing to assess use of drug-coated technologies in combination with traditional therapies in hope of synergistic effects. This review gathers data from currently published clinical trials with the IN.PACT Admiral DCB for the treatment of femoropopliteal peripheral artery disease and explores the possible impact on continuing clinical practice.

Topics: Angioplasty, Balloon; Animals; Cardiovascular Agents; Clinical Trials as Topic; Coated Materials, Biocompatible; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome; Vascular Access Devices

Peripheral arterial disease (PAD) is a highly prevalent condition that contributes significantly to the morbidity and mortality of affected patients. PAD creates a significant economic burden on health care systems around the world. We reviewed all available literature to provide a meta-analysis assessing the outcome of patients treated with drug-eluting balloons (DEBs) compared with percutaneous transluminal balloon angioplasty (PTA) through measuring the rate of target lesion revascularization (TLR).. An electronic search of the MEDLINE, Scopus, Embase, Web of Science, and Cochrane Library databases was performed. Articles reporting randomized controlled trials that compared treatment with DEBs vs PTA were selected for inclusion. A meta-analysis was performed by pooling data on rates of TLR, binary restenosis (BR), and late lumen loss (LLL).. The 10 included articles comprised a sample size of 1292 patients. Meta-analysis demonstrated the rate of TLR in DEB-treated patients was significantly lower compared with patients treated with PTA at 6 months (odds ratio [OR], 0.24; 95% confidence interval [CI], 0.11-0.53; P = .0004), 12 months (OR, 0.28; 95% CI, 0.13-0.62; P = .002), and 24 months (OR, 0.25; 95% CI, 0.10-0.61; P = .002). Decreased LLL and BR was demonstrated at 6 months in patients treated with DEBs compared with patients treated with PTA (mean difference, -0.74; 95% CI, -0.97 to -0.51; P = .00001; OR, 0.34; 95% CI, 0.23-0.49; P = .00001).. This meta-analysis demonstrates that treatment with DEBs compared with PTA results in reduced rates of reintervention in patients with PAD. Comparison of DEBs to other emerging treatments to determine which method results in the lowest reintervention rates and in the greatest improvement in quality of life should be the focus of future trials.

Topics: Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Humans; Limb Salvage; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Retreatment; Risk Factors; Treatment Outcome; Vascular Access Devices

The prevalence of peripheral artery disease (PAD) is increasing worldwide and is strongly age-related, affecting about 20 % of Germans over 70 years of age. Recent advances in endovascular and surgical techniques as well as clinical study results on comparative treatment methods strengthened the need for a comprehensive review of the published evidence for diagnosis, management, and prevention of PAD. The interdisciplinary guideline exclusively covers distal aorta and atherosclerotic lower extremity artery disease. A systematic literature review and formal consensus finding process, including delegated members of 22 medical societies and two patient self-support organisations were conducted and supervised by the Association of Scientific Medical Societies in Germany, AWMF. Three levels of recommendation were defined, A = "is recommended/indicated", B = "should be considered", C = "may be considered", means agreement of expert opinions due to lack of evidence. Altogether 294 articles, including 34 systematic reviews and 98 RCTs have been analysed. The key diagnostic tools and treatment basics have been defined. In patients with intermittent claudication endovascular and/or surgical techniques are treatment options depending on appropriate individual morphology and patient preference. In critical limb ischaemia, revascularisation without delay by means of the most appropriate technique is key. If possible and reasonable, endovascular procedures should be applied first. The TASC classification is no longer recommended as the base of therapeutic decision process due to advances in endovascular techniques and new crural therapeutic options. Limited new data on rehabilitation and follow-up therapies have been integrated. The article summarises major new aspects of PAD treatment from the updated German Guidelines for Diagnosis and Treatment of PAD. Limited scientific evidence still calls for randomised clinical trials to close the present gap of evidence.

Topics: Aged; Cardiovascular Agents; Consensus; Critical Illness; Endovascular Procedures; Evidence-Based Medicine; Female; Germany; Humans; Intermittent Claudication; Ischemia; Male; Peripheral Arterial Disease; Risk Reduction Behavior; Vascular Surgical Procedures

Percutaneous transluminal angioplasty is an established form of therapy for femoropopliteal artery disease. Currently, percutaneous transluminal angioplasty (PTA) is carried out using standard balloon with or without deployment of a stent but is associated with a high rate of restenosis and stent-related complications. Treatment options for restenosis, especially in-stent restenosis, are limited. Drug-coated balloons promise to reduce the rates of restenosis by effective delivery of antiproliferative agent (paclitaxel) directly to vessel wall without the need for a permanent implant. In this review, we look at the technology and rationale behind drug-coated balloons and examine the evidence available so far.. Recently, several studies tested the effectiveness of paclitaxel-coated balloon angioplasty compared to that of standard PTA in both de novo lesions and in-stent restenosis of femoropopliteal artery. Paclitaxel-coated balloon use resulted in reduced rates of restenosis and favourable clinical outcomes in both these lesion groups. However, in complex lesions, there is still lack of data to support the use of these balloons. Paclitaxel-coated balloon is a safe and effective therapeutic option in patients with both de novo lesions and in-stent restenosis involving femoropopliteal artery. In light of the new evidence, it is time to consider incorporation of this effective therapeutic option into clinical practice. However, further research is needed for the use of paclitaxel-coated balloons in complex femoropopliteal lesions like calcified lesions especially as adjuncts to cutting balloons and debulking strategies.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Treatment Outcome; Vascular Patency

Restenosis is one of the main complications in patients undergoing coronary or peripheral revascularization procedures and is the leading cause for their long-term failures. Cilostazol is the only pharmacotherapy that showed an adequate efficacy for preventing restenosis in randomized, controlled studies after coronary or peripheral revascularization procedures. The present review sums up the main clinical evidence supporting the use of cilostazol after revascularization interventions, focusing on all its benefits, warnings, and administration schedules.

Topics: Cardiovascular Agents; Cilostazol; Coronary Artery Disease; Coronary Restenosis; Endovascular Procedures; Humans; Peripheral Arterial Disease; Recurrence; Risk Factors; Tetrazoles; Treatment Outcome

Delivery of drugs onto arterial targets via endovascular devices commands several principles: dissolution, diffusion, convection, drug binding, barriers to absorption, and interaction between the drug, delivery vehicle, and accepting arterial wall. The understanding of drug delivery in the coronary vasculature is vast; there is ongoing work needed in the peripheral arteries. There are differences that account for some failures of application of coronary technology into the peripheral vascular space. Breakthroughs in peripheral vascular interventional techniques building on current technologies require investigators willing to acknowledge the similarities and differences between these different vascular territories, while developing technologies adapted for peripheral arteries.

Topics: Arteries; Cardiovascular Agents; Drug Delivery Systems; Drug-Eluting Stents; Humans; Peripheral Arterial Disease

Severe peripheral artery disease requires revascularization to relieve life-limiting ischemic symptoms. Postrevascularization in-stent restenosis continues to be a problem after femoropopliteal procedures. Our aim was to evaluate the use of cilostazol to prevent in-stent restenosis among patients with lower extremity arterial stenting. We performed a MEDLINE and EMBASE search and reviewed the abstracts and manuscripts following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The primary efficacy outcome was patency rate after stenting. The odds ratio estimates were pooled using the Mantel-Haenszel random-effects method. We identified 524 studies, and 20 articles were fully abstracted and 4 were included in the meta-analysis. The total number of patients included was 2434. Patients in the cilostazol group had better primary patency rates after endovascular stenting than those not taking cilostazol (odds ratio: 0.55; 95% confidence interval: 0.43-0.71). The use of cilostazol appears to prevent in-stent restenosis of high-risk patients.

Topics: Cardiovascular Agents; Cilostazol; Endovascular Procedures; Femoral Artery; Humans; Odds Ratio; Peripheral Arterial Disease; Popliteal Artery; Protective Factors; Recurrence; Risk Factors; Stents; Tetrazoles; Time Factors; Treatment Outcome; Vascular Patency

Polypharmacy is common among patients with peripheral arterial disease (PAD) with a combination of medications used for risk-factor modification and medical management of the disease itself. Interaction between commonly prescribed medications and nutritional status has not previously been well described. This review aims to critically appraise evidence exploring associations between medications commonly prescribed to patients with PAD and nutritional status and provide recommendations for practice.. A comprehensive literature search was conducted to locate studies relating to nutrient interactions among lipid-lowering, antihypertensive, antiplatelet, and oral hypoglycemic drug classes. Quality of the evidence was rated on the basis of recommendations by the National Health and Medical Research Council.. A total of 25 articles were identified as suitable and included in the review. No studies were specific to patients with PAD, and hence findings highlighting risk of ubiquinone (coenzyme Q10 [CoQ10]) depletion with lipid-lowering medications, zinc depletion with antihypertensive medications, and vitamin B12 depletion with oral hypoglycemic medications are extrapolated from heterogeneous groups of patients and healthy adults. The body of evidence ranged in quality from satisfactory to poor.. High-quality research is required to confirm the interactions suggested by the included studies in patients with PAD specifically. It is, however, recommended that patients with PAD that are long-term consumers of the selected medications are monitored for CoQ10, zinc, and vitamin B12 to facilitate early identification of deficiencies and initiation of treatment. Treatment may involve dietary intervention and/or supplementation.

Topics: Biomarkers; Cardiovascular Agents; Deficiency Diseases; Humans; Hypoglycemic Agents; Hypolipidemic Agents; Nutritional Status; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Polypharmacy; Risk Factors

To provide a qualitative analysis and quantitative synthesis of randomized controlled trials (RCTs) investigating paclitaxel-coated balloons (PCBs) in the femoropopliteal artery.. PubMed, EMBASE, AMED, Scopus, CENTRAL, online content, and abstracts from international meetings were last screened in April 2015 for eligible RCTs using the PRISMA selection process. Risk of bias was assessed using the Cochrane Collaboration's tool, and quality of evidence was evaluated with the GRADE system. Outcome measures included late lumen loss (LLL) at 6 months and event rates of major limb amputations, binary lesion restenosis, and target lesion revascularization (TLR). Pooled treatment effects were analyzed in a random effects model to account for clinical heterogeneity; the outcomes are presented as the rate ratios (RRs) and their 95% confidence intervals (CIs). Extensive meta-regression was performed to analyze potential confounders. The review was registered in the PROSPERO database (CRD42015023938; www.crd.york.ac.uk/PROSPERO).. Eleven RCTs with 1609 subjects (1403 claudicants and 206 patients with critical limb ischemia) with medium-length femoropopliteal lesions (mean range 5.1-11.9 cm) were included. There was consistently high-quality evidence supporting the clear superiority of PCBs in terms of reduced LLL (mean difference -0.89 mm, 95% CI -1.14 to -0.64, p<0.001), less binary restenosis (RR 0.47, 95% CI 0.37 to 0.61, p<0.001), and fewer TLR events (RR 0.33, 95% CI 0.22 to 0.49, p<0.001). Major amputations were rare in both active and control arms (pooled event rate: 0.7%, 95% CI 0.3% to 1.2%). Results were stable across all potential risk modifiers and in the presence of stents as well. There was high-quality evidence that the dose of paclitaxel was related to the magnitude of the treatment effect; standard dose (3.0-μg and 3.5-μg) PCBs were significantly more effective compared with low-dose 2-μg PCB in reducing both restenosis (RR 2.1, 95% CI 1.2 to 3.4, p<0.001) and TLR (RR 2.5, 95% CI 1.9 to 3.8, p<0.001).. PCBs reduce by more than half the rates of restenosis and TLR in the femoropopliteal artery regardless of stent placement. Biologic effect size may vary according to paclitaxel bioavailability.

Topics: Amputation, Surgical; Angioplasty, Balloon; Biological Availability; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Femoral Artery; Humans; Limb Salvage; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Topics: Cardiovascular Agents; Critical Illness; Diffusion of Innovation; Endovascular Procedures; Forecasting; Humans; Ischemia; Limb Salvage; Peripheral Arterial Disease; Secondary Prevention; Time Factors; Treatment Outcome; Vascular Surgical Procedures

The prevalence of peripheral artery disease (PAD) continues to increase worldwide. It is important to identify patients with PAD because of the increased risk of myocardial infarction, stroke, and cardiovascular death and impaired quality of life because of a profound limitation in exercise performance and the potential to develop critical limb ischemia. Despite effective therapies to lower the cardiovascular risk and prevent progression to critical limb ischemia, patients with PAD continue to be under-recognized and undertreated. The management of PAD patients should include an exercise program, guideline-based medical therapy to lower the cardiovascular risk, and, when revascularization is indicated, an "endovascular first" approach. The indications and strategic choices for endovascular revascularization will vary depending on the clinical severity of the PAD and the anatomic distribution of the disease. In this review, we discuss an evidence-based approach to the management of patients with PAD.

Topics: Cardiovascular Agents; Endovascular Procedures; Exercise Therapy; Humans; Peripheral Arterial Disease; Treatment Outcome

Clinical practice guidelines (CPGs) provide recommendations to assist health professionals and patients in the process of making decisions for specific clinical conditions to improve the quality of the patient care. However, there are concerns about the quality of some CPGs. The aim of this study was to review the quality of CPGs in pharmacologic management of peripheral artery disease (PAD).. A systematic review of CPGs for the pharmacologic treatment of PAD was performed. CPGs published between 2003 and January 2015 in English, Spanish, or French were retrieved using PubMed, Cochrane, and TRIP databases; guideline developer organization Web sites, and European and American scientific societies related to PAD Web sites. One reviewer performed the search and guideline selection, which was validated by a second reviewer. Three appraisers independently assessed the quality of CPGs using the Appraisal of Guidelines, REsearch and Evaluation II (AGREE II) instrument.. A total of seven CPGs, published between 2006 and 2012, were included. All except one were written in English. Average AGREE II guidelines scores varied from 45% to 72%. There was considerable variation in the quality of the CPGs across the AGREE II domain scores (ranging from 4% to 85%). The highest scored domains were 'clarity of presentation' and 'editorial independence' and the lowest scored domain was 'applicability.' The reviewers consider that six CPGs could be recommended with modifications for use and one without modification.. There is great variability in the quality of the CPGs on pharmacologic treatment in PAD. All of the assessed guidelines could be recommended; however, there is considerable scope to improve their quality by highlighting aspects of applicability, the involvement of the stakeholder, as well as the rigor of development.

Topics: Cardiovascular Agents; Guideline Adherence; Humans; Peripheral Arterial Disease; Practice Guidelines as Topic; Practice Patterns, Physicians'; Quality Improvement; Quality Indicators, Health Care; Treatment Outcome

Currently, endovascular therapy is the standard of care for peripheral artery disease. The main issue of these techniques is restenosis which is a complex mechanism associating elastic recoil, constrictive remodelling and intimal hyperplasia. More and more evidence show that drug-coating balloon (DCB) is a promising device to prevent and to treat restenosis. Herein we have reviewed the role for DCB's in the treatment of in-stent restenosis (ISR).. Currently, few studies are available regarding DCB use for femoropopliteal (FP) ISR treatment. In different studies evaluating DCB for treatment of FP ISR the freedom from target lesion revascularization rate at one year are range from 87% to 92.1%. In comparison to other devices used for treatment of FP ISR such as atherectomy, cutting balloon, standard angioplasty, DCB seems to show better results in terms of freedom from TLR and primary patency. Other devices such as drug-eluting stent, brachytherapy, covered stent show also good results for FP ISR.. Majority of assessed data on FP ISR treated with DCB derived from uncontrolled study or historical comparisons. Only one randomized, controlled study compared DCB versus standard angioplasty. The FAIR trial showed better results in favour of DCB in terms of freedom from TLR at 12 months (90.8%).. Drug coating balloon could be the first choice of devices for the treatment of FP ISR, because of its efficacy, its ease of use in comparison with more complex and less efficient devices.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Endovascular Procedures; Femoral Artery; Humans; Hyperplasia; Neointima; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Retreatment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices

Amassed evidence from several randomized controlled trials and high quality meta-analyses clearly support the primary use of paclitaxel-coated balloons (PCB) in the superficial femoral artery over traditional plain balloon angioplasty or primary bare nitinol stenting with significantly lower vascular restenosis, less need for repeat procedures, improved quality of life and potential cost savings for the healthcare system. Stents may be reserved for bail-out in case of a suboptimal dilatation result, and for selected more complex lesions, or in case of critical limb ischemia in order to eliminate vessel recoil and maximize immediate hemodynamic gain. Debulking atherectomy remains unproven, but holds a lot of promise in particular in combination with PCBs, in order to improve compliance of the vessel wall by plaque removal, allow for a better angioplasty result and optimize drug transfer and bioavailability. The present overview summarizes and discusses current evidence about femoropopliteal PCB angioplasty compared to the historical standard of plain old balloon angioplasty and bare nitinol stents. Available evidence is appraised in the context of clinically meaningful results, relevant unresolved issues are highlighted, and future trends are discussed.

Topics: Alloys; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Cost-Benefit Analysis; Female; Femoral Artery; Health Care Costs; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Stents; Treatment Outcome; Vascular Access Devices

The aim of this study was to perform a meta-analysis of randomized trials investigating the outcomes of patients undergoing percutaneous revascularization with drug-coated balloons (DCBs) for atherosclerotic disease of the infrapopliteal arteries.. The role of DCBs as revascularization therapy for infrapopliteal arteries represents a matter of ongoing controversy.. Scientific databases were searched for randomized trials of DCB therapy for atherosclerotic disease of the infrapopliteal arteries. The primary efficacy and safety outcomes were target lesion revascularization and amputation, respectively. Secondary outcomes were death, major adverse events, Rutherford class 5 or 6, and late lumen loss.. A total of 641 patients enrolled in 5 trials received DCBs (n = 378) or control therapy (uncoated balloons or drug-eluting stents; n = 263). Median follow-up duration was 12 months. Patients treated with DCBs had risk for target lesion revascularization (risk ratio: 0.71; 95% confidence interval [CI]: 0.47 to 1.09; p = 0.12), amputation (risk ratio: 1.01; 95% CI: 0.65 to 1.58; p = 0.95), death (risk ratio: 1.14; 95% CI: 0.71 to 1.82; p = 0.59), major adverse events (risk ratio: 0.92; 95% CI: 0.59 to 1.43; p = 0.70), and Rutherford class 5 or 6 (risk ratio: 0.87; 95% CI: 0.46 to 1.62; p = 0.65) comparable with that of patients treated with control therapy. Lesions treated with DCBs showed lower late lumen loss (weighted mean difference -0.41; 95% CI: -0.79 to -0.03; p = 0.04) compared with those treated with control therapy.. In comparison with uncoated balloons or drug-eluting stents, the treatment of infrapopliteal arteries with DCBs is associated with similar clinical outcomes and favorable angiographic efficacy at 1-year follow-up. Further studies in larger numbers of patients are still needed to definitively address the role of DCB technology in this setting. (Drug-coated balloon for revascularization of tibialpedal arteries: a meta-analysis of randomized trials; CRD42015029283).

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Drug-Eluting Stents; Evidence-Based Medicine; Female; Humans; Limb Salvage; Male; Odds Ratio; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Peripheral artery disease (PAD) includes atherosclerosis of the aorta and lower extremities. Affecting a large segment of the population, PAD is associated with impaired functional capacity and reduced quality of life as well as an increased risk of stroke, myocardial infarction and cardiovascular death. The evaluation of PAD begins with the physical examination, incorporating non-invasive testing such as ankle-brachial indices to confirm the diagnosis. Therapeutic interventions are aimed at alleviating symptoms while preserving limb integrity and reducing overall cardiovascular risk. With this in mind, risk factor modification with exercise and medical therapy are the mainstays of treatment for many patients with PAD. Persistent symptoms or non-healing wounds should prompt more aggressive therapies with endovascular or surgical revascularisation. The following manuscript provides a comprehensive review on the contemporary evaluation and management of PAD.

Topics: Amputation, Surgical; Cardiovascular Agents; Diet, Healthy; Endovascular Procedures; Exercise; Humans; Limb Salvage; Lower Extremity; Peripheral Arterial Disease; Predictive Value of Tests; Risk Factors; Risk Reduction Behavior; Smoking Cessation; Treatment Outcome; Vascular Patency; Vascular Surgical Procedures

A significant proportion of patients with severe lower limb peripheral arterial disease require revascularization. Over the past decade, an endovascular-first approach even for complex disease has gained widespread use among vascular specialists. An important limitation of percutaneous transluminal balloon angioplasty or stenting remains the occurrence of restenosis. Drug-coated balloons have emerged as an exciting technology developed to overcome the limitations of standard balloon angioplasty and stenting. Drug-eluting devices inhibit neointimal growth of vascular smooth muscle cells with the potential of preventing restenosis. This review provides a synopsis of the up-to-date evidence on the role of drug-coated balloons in the treatment of lower limb peripheral arterial disease. Bibliographic searches were conducted using MEDLINE, EMBASE, and the Cochrane Library electronic database. Eleven randomized clinical trials, two systematic reviews, and a published registry providing the best available evidence were identified. Current evidence suggests that angioplasty with drug-coated balloon is reliable, safe, and efficient in increasing patency rates and reducing target lesion revascularization and restenosis. However, it remains unknown whether these improved results can translate into beneficial clinical outcomes, as current randomized clinical trials have failed to demonstrate a significant benefit in limb salvage and mortality. Further randomized trials focusing on clinical and functional outcomes of drug-eluting balloons and on cost versus clinical benefit are required.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Lower Extremity; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Risk Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Peripheral arterial disease (PAD) is a chronic condition; an increasing number of patients affected. Infrapopliteal disease is related to critical limb ischemia (CLI). Amputation-free survival in these situations is the goal to achieve; it is well-known that life expectancy and quality of live are reduced by this condition. PAD is rarely isolated in one anatomical region when a CLI condition exists. The endovascular approach to lower limb infrapopliteal disease (BTK) has been constantly increasing in the last years trying to prevent a potential amputation. Even with the current endovascular armamentarium, BTK disease remains challenging, long and even midterm results remain uncertain. The rationale behind using drug-eluting stent (DES) at BTK is similar to other regions; deal with elastic recoil, treat potential dissections, deliver drug to the intima to prevent restenosis and reduce late lumen loss. Current evidence comprehensive review of the latest published results has been performed as well a comparison with other available reviews and meta-analyses. There is an increasing evidence for the use of DES in BTK disease, multiple platforms with different drugs had been evaluated and some good initial results had been published and presented recently. The safety of DES used in BTK occlusive has been clearly proven over the different studies performed in the last years. Good primary patency has been reported for balloon expandable DES but available studies focused on short/focal lesions. Current results support the use of DES in BTK region when a stent is necessary (bail-out) or the total lesion length is short. There is a clear benefit for primary patency, potential clinical benefits and, under these conditions, DES treatment seems to be cost-effective. Further investigation and technology improvement is required to apply these good results to longer and more diffuse lesions.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Constriction, Pathologic; Drug-Eluting Stents; Humans; Leg; Limb Salvage; Peripheral Arterial Disease; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

Restenosis or re-occlusion after femoropopliteal angioplasty or stent implantation is the main limitation of endovascular treatment strategies for peripheral artery disease. Within the last years, balloon catheters with anti-proliferative drug coating on the balloon surface have shown to be associated with higher patency rates compared to plain balloon angioplasty. Thus, drug-coated balloons were gradually adopted in many interventional centres for the treatment of femoropopliteal obstructions. The current review summarises the existing evidence for drug-coated balloons in the infrainguinal vessels and their indication in special lesion cohorts.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Cost-Benefit Analysis; Drug Costs; Equipment Design; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Risk Factors; Stents; Treatment Outcome; Vascular Access Devices

In order to assess the role of drug-coated balloons (DCB) in below-the-knee (BTK) artery interventions, we analyzed randomized trials which compare coated to non-coated balloons and additionally a direct comparison of drug-eluting stents (DES) with DCB. As angioplasty with non-coated balloons is per guideline-recommendation still standard of care for below-the-knee artery endovascular treatment, we focused on the direct comparison of efficacy and clinical outcome data of both treatment modalities. Data from peer reviewed and published trials were consulted. For each single study, primary and secondary endpoints were reported and compared. Three single-center, non-core lab adjudicated trials showed encouraging data which suggests that DCB in BTK arteries effectively inhibit the risk of early restenosis, but the pivotal, prospectively randomized, multicenter, core lab adjudicated trials failed to match with these result. Limitations of DEB treatment and trials in BTK arteries had been reported, hence a technical evaluation of possible side effects of DCB treatment and of trial design was taken into account. On the basis of the results available, the distinguishing findings of drug eluting effects in the femoropopliteal region cannot be transferred to BTK arteries. Refinement of the existing DCB technology and of future trial design should be considered. To adjudicate on DCB technology applied for BTK treatment is premature and it is mandatory to be kept under evaluation, because the potential benefit, with respect to the compelling results in the femoropoliteal arteries, could be huge to improve endovascular BTK and especially CLI treatment.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Humans; Peripheral Arterial Disease; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Tibial Arteries; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The optimal percutaneous treatment for femoropopliteal arterial occlusive disease has yet to be assessed. This systematic review and meta-analysis assessed the efficacy of drug-eluting balloons (DEBs) compared with uncoated balloons (UCBs) for the treatment of femoropopliteal arterial occlusive disease.. We used Preferred Reporting Items for Systematic Reviews and Meta-Analysis Statement (PRISMA) standards to systematically search the electronic databases of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) for trials comparing DEBs vs UCBs in the femoropopliteal arteries. All articles were critically assessed for relevance, validity, and availability of data regarding patient and lesion characteristics and outcomes. All data were systematically pooled, and meta-analysis was performed on binary restenosis, late lumen loss (LLL), target lesion revascularization (TLR), major amputation, mortality, and changes in the ankle-brachial index and the Rutherford-Baker classification.. From 364 screened articles, we included nine trials, all of which had a low risk of bias. We found a significant reduction of binary restenosis at 6 months (14.3% vs 40.1%; P < .0001), binary restenosis at 1 year (26.6% vs 47.4%; P = .008), LLL at 6 months (-0.80 mm; P < .00001), TLR at 1 year (10.4% vs 26.9; P = .0008), and TLR at 2 years (13.8% vs 40.7%; P = .0003) after DEB angioplasty compared with UCB angioplasty. The difference in amputation rate and mortality was not significant. Definitions on changes in ankle-brachial index and Rutherford classifications were heterogeneous and, therefore, could not be pooled in sufficient numbers.. Compared with UCB angioplasty, the use of DEBs increases the durability of the treatment effect in femoropopliteal arterial disease, expressed by a significant decrease of binary restenosis, LLL, and TLR at short-term and midterm follow-up.

Topics: Amputation, Surgical; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Constriction, Pathologic; Femoral Artery; Humans; Limb Salvage; Odds Ratio; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Risk Factors; Treatment Outcome; Vascular Access Devices

This study sought to assess the risk of target lesion revascularization (TLR) and all-cause death at 12 months and at the maximum available follow-up. Secondary objectives included the identification of factors which could have influenced general findings.. Recently several randomized trials comparing drug-coated balloon (DCB) with conventional plain balloon (PB) for the treatment of femoropopliteal artery disease have been reported, but no updated meta-analyses are available and questions remain surrounding the long-term antirestenotic effectiveness of the 2 therapies.. We searched main electronic databases for randomized trials comparing DCB and PB for femoropopliteal artery disease. Random effects models were used to estimate the risk of TLR and all-cause death at 12 months, whereas long-term TLR and death risk were assessed by mixed effects Poisson regression models and incident rates of each outcome per patient-year. Main analyses were supplemented by sensitivity analyses, Bayesian estimates, and trial sequential analysis.. A total of 8 eligible trials were identified. DCB was associated with a marked 12-month TLR risk reduction as compared with PB (risk ratio: 0.33; 95% confidence interval [CI]: 0.19 to 0.57). The risk of death was similar between groups (risk ratio: 0.96; 95% CI: 0.47 to 1.95). Long-term outcomes assessment showed a reduced incidence of TLR with DCB (0.35; 95% CI: 0.24 to 0.51) and a similar incidence of all-cause death (incidence rate ratio: 1.13; 95% CI: 0.60 to 2.15). Similar findings were observed in Bayesian analyses. Significant heterogeneity was present with evidence of differential efficacy across devices. Trial sequential analysis indicated that available evidence is sufficient to prove superior antirestenotic efficacy of DCB over PB.. DCB significantly reduces the risk of TLR as compared with PB without any effect on all-cause death. Evidence exists for differential efficacy according to the type of device used. Future trials investigating DCB angioplasty should include potentially more effective comparator therapies.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Femoral Artery; Humans; Odds Ratio; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Peripheral arterial disease, particularly critical limb ischemia, is an area with urgent need for optimized therapies because, to date, vascular interventions often have limited life spans. In spite of initial encouraging technical success after femoropopliteal percutaneous transluminal angioplasty or stenting, postprocedural restenosis remains the major problem. The challenging idea behind the drug-coated balloon (DCB) concept is the biological modification of the injury response after balloon dilatation. Antiproliferative drugs administered via DCBs or drug-eluting stents are able to suppress neointimal hyperplasia, the main cause of restenosis. This article reviews the results of DCB treatments of femoropopliteal and infrapopliteal lesions in comparison to standard angioplasty with uncoated balloons. A systematic literature search was performed in 1) medical journals (ie, MEDLINE), 2) international registers for clinical studies (ie, www.clinicaltrials.gov), and 3) abstracts of scientific sessions. Several controlled randomized trials with follow-up periods of up to 5 years demonstrated the efficacy of paclitaxel -DCB technology. However, calcified lesions seem to affect the efficacy of DCB. Combinations of preconditioning methods with DCBs showed promising results. Although the mechanical abrasion of calcium via atherectomy or laser ablation showed favorable periprocedural results, the long-term impact on restenosis and clinical outcome has to be demonstrated. Major advantages of the DCBs are the rapid delivery of drug at uniform concentrations with a single dose, their efficacy in areas wherein stents have been contraindicated until now (ie, bifurcation, ostial lesions), and in leaving no stent scaffold behind. Reinterventions are easier to perform because DCBs leave no metal behind. Various combinations of DCBs with other treatment modalities may prove to be viable options in future. The follow-up results of clinical studies will evaluate the long-term impact of DCBs.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Critical Illness; Equipment Design; Femoral Artery; Humans; Ischemia; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome; Vascular Access Devices; Vascular Patency

Endovascular techniques have improved markedly over the past several decades. Plain old balloon angioplasty can only reach patencies around 40% after 1 year. Scaffolding stents have resulted in improved short-term results but encountered limitations for longer-term durability. With the introduction of drug-eluting technologies the process of intimal hyperplasia might be slowed, resulting in improved long-term patency results. At first, limus-eluting technologies were not able to transfer the enthusiasm from the coronaries to the infrainguinal vascular bed. However, the newer generation paclitaxel-eluting technologies perform significantly better in femoropopliteal arteries than their non-eluting or non-coated counterparts. The results of a prospective randomized trial comparing DES versus DCB is eagerly awaited. For the moment there seems, based on the meta-analysis, no difference between the two treatment modalities. Although, we need to keep in mind that DCB perform worse in long calcified lesions.

Topics: Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Humans; Peripheral Arterial Disease; Prosthesis Design; Risk Factors; Standard of Care; Treatment Outcome; Vascular Access Devices; Vascular Patency

The endovascular treatment of atherosclerotic disease of the infra-inguinal arteries has changed significantly since the introduction of drug-eluting balloon technology. The role of angioplasty using drug-eluting balloons for lesions of the superficial femoral and popliteal artery is now well established. The positive results of the use of drug-eluting balloons in the above knee segment could not be achieved in the below-the-knee segment. This paper will give an overview of the current status of drug-eluting balloon angioplasty for below-the-knee lesions, and will present a review of 2 single center registry, 5 randomized trials and a meta-analysis.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Humans; Leg; Peripheral Arterial Disease; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To report a Bayesian network meta-analysis of randomized controlled trials (RCTs) comparing bare metal stents (BMS), paclitaxel-coated balloons (PCBs), and drug-eluting stents (DES) with balloon angioplasty (BA) or with each other in the infrapopliteal arteries.. Sixteen RCTs comprising 1805 patients with 1-year median follow-up were analyzed. Bayesian random effects binomial models were employed (WinBUGS). Relative treatment effects were expressed as odds ratios (ORs) with 95% credible intervals (CrI), and the cumulative rank probabilities were calculated to provide hierarchies of competing treatments. Quality of evidence (QoE) was assessed with the GRADE (grading of recommendations assessment, development, and evaluation) system. Sensitivity, heterogeneity, and consistency analyses were performed.. There was high QoE that infrapopliteal DES significantly reduced restenosis compared with BMS (OR 0.26, 95% CrI 0.12 to 0.51) and BA (OR 0.22, 95% CrI 0.11 to 0.45). Likewise, DES significantly reduced target lesion revascularization (TLR) compared with BA (OR 0.41, 95% CrI 0.22 to 0.75) and BMS (OR 0.26, 95% CrI 0.15 to 0.45). Paclitaxel-coated balloons also reduced TLR compared with BA (OR 0.55, 95% CrI 0.34 to 0.90) and BMS (OR 0.35, 95% CrI 0.18 to 0.67), but QoE was low to moderate. BA had lower TLR than BMS (OR 0.63, 95% CrI 0.40 to 0.99) with high QoE. DES was the only treatment that significantly reduced limb amputations compared with BA (OR 0.58, 95% CrI 0.35 to 0.96), PCB (OR 0.51, 95% CrI 0.26 to 0.98), or BMS (OR 0.38, 95% CrI 0.19 to 0.72) with moderate to high QoE. DES also significantly improved wound healing compared with BA (OR 2.02, 95% CrI 1.01 to 4.07) or BMS (OR 3.45, 95% CrI 1.41 to 8.73) with high QoE. Results were stable on sensitivity and meta-regression analyses without any significant publication bias or inconsistency.. Infrapopliteal DES were associated with significantly lower rates of restenosis, TLR, and amputations and improved wound healing compared to BA and BMS. DES also significantly reduced amputations compared with PCB.

Topics: Amputation, Surgical; Angioplasty, Balloon; Bayes Theorem; Cardiovascular Agents; Coated Materials, Biocompatible; Comparative Effectiveness Research; Constriction, Pathologic; Drug-Eluting Stents; Humans; Limb Salvage; Markov Chains; Metals; Network Meta-Analysis; Odds Ratio; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency; Wound Healing

Peripheral arterial disease (PAD) is one of the most frequent manifestations of atherosclerosis and is associated with atherosclerosis in the coronary and carotid arteries, leading to a highly increased incidence of cardiovascular events. Major risk factors of PAD are similar to those that lead to atherosclerosis in other vascular beds. However, there are differences in the power of individual risk factors in the different vascular territories. Cigarette smoking and diabetes mellitus represent the greatest risks of PAD. For prevention of the progression of PAD and accompanying cardiovascular events similar preventative measures are used as in coronary artery disease (CAD). However, recent data indicate that there are some differences in the efficacy of drugs used in the prevention of atherothrombotic events in PAD. Antiplatelet treatment is indicated in virtually all patients with PAD. In spite of the absence of hard evidence- based data on the long term efficacy of aspirin, it is still considered as a first line treatment and clopidogrel as an effective alternative. The new antiplatelet drugs ticagrelol and prasugrel also represent promising options for treatment of PAD. Statin therapy is indicated to achieve the target low density lipoprotein cholesterol level of ≤2.5 mmol/L (100 mg/dL) and there is emerging evidence that lower levels are more effective. Statins may also improve walking capacity. Antihypertensive treatment is indicated to achieve the goal blood pressure (<140/90 mmHg). All classes of antihypertensive drugs including beta-blockers are acceptable for treatment of hypertension in patients with PAD. Diabetic patients with PAD should reduce their glycosylated haemoglobin to ≤7%. As PAD patients represent the group with the highest risk of atherothrombotic events, these patients need the most intensive treatment and elimination of risk factors of atherosclerosis. These measures should be as comprehensive as those in patients with established coronary and cerebrovascular disease.

Topics: Aged; Cardiovascular Agents; Disease Progression; Female; Humans; Male; Middle Aged; Peripheral Arterial Disease; Predictive Value of Tests; Risk Assessment; Risk Factors; Risk Reduction Behavior; Treatment Outcome

Peripheral arterial disease has become more and more present in daily practice, mostly due to the increase of cardiovascular risk factors, especially in below the knee (BTK) area in diabetic patients. Critical limb ischemia (CLI) is the most usual clinical presentation with a major amputation rate of 30%, mortality rate of 25%, and chronic pain of 20% at one year. Nowadays, endovascular treatment is usually the first choice, given the high comorbidity of those patients. Angioplasty and stenting in BTK lesions have already proven their efficacy in CLI treatment. However, BTK revascularization remains highly controversial in the treatment of intermittent claudication in TASC 2 recommendations. Restenosis being the major pitfall in BTK procedures, the use of drug-coated devices is one of the actual answers. We performed an extensive review of the literature over the last 15 years on the use of drug-eluting stents (DES) in BTK revascularization. DES has been compared to balloon angioplasty, in the ACHILLES trial, bare metal stents (BMS), in the DESTINY and YUKON trials, drug eluting balloons, in a trial guided by Siablis, and paclitaxel has even been compared to sirolimus in the PARADISE trial. In conclusion, DES is one of the solutions to the increase of BTK arteriopathy in CLI patients. Angiographic results are better, compared to BMS, in terms of primary patency, restenosis and TLR rates. However clinical results are missing. Treated lesions in the literature are short lesions. And DES is a metal balloon expandable stent with greater risks of compressions and stent fractures than nitinol self expandable stents, and such complications are known to increase post operative restenosis rates. Further reports are still needed on this matter.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Drug-Eluting Stents; Humans; Leg; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Risk Factors; Treatment Outcome; Vascular Patency

Peripheral arterial disease is common and is associated with significant morbidity and mortality.. We conducted a systematic review to identify randomized trials and systematic reviews of patients with intermittent claudication to evaluate surgery, endovascular therapy, and exercise therapy. Outcomes of interest were death, amputation, walking distance, quality of life, measures of blood flow, and cost.. We included eight systematic reviews and 12 trials enrolling 1548 patients. Data on mortality and amputation and on cost-effectiveness were sparse. Compared with medical management, each of the three treatments (surgery, endovascular therapy, and exercise therapy) was associated with improved walking distance, claudication symptoms, and quality of life (high-quality evidence). Evidence supporting superiority of one of the three approaches was limited. However, blood flow parameters improved faster and better with both forms of revascularization compared with exercise or medical management (low- to moderate-quality evidence). Compared with endovascular therapy, open surgery may be associated with longer length of hospital stay and higher complication rate but resulted in more durable patency (moderate-quality evidence).. In patients with claudication, open surgery, endovascular therapy, and exercise therapy were superior to medical management in terms of walking distance and claudication. Choice of therapy should rely on patients' values and preferences, clinical context, and availability of operative expertise.

Topics: Amputation, Surgical; Cardiovascular Agents; Combined Modality Therapy; Cost-Benefit Analysis; Endovascular Procedures; Exercise Therapy; Exercise Tolerance; Health Care Costs; Humans; Intermittent Claudication; Length of Stay; Limb Salvage; Lower Extremity; Peripheral Arterial Disease; Quality of Life; Recovery of Function; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency; Vascular Surgical Procedures; Walking

Critical limb ischemia (CLI) encompasses the most extreme end of the peripheral artery disease (PAD) spectrum leading to significant morbidity and mortality. CLI is defined as greater than 2 weeks of extremity rest pain, ulcers or extremity gangrene, secondary to objectively proven peripheral artery disease. Corresponding to Fontaine Stages III/IV and Rutherford category IV through VI, CLI is a complex disease comprising of both macrovascular and microvascular systems with inconsistent historical data on optimal treatment. CLI is distinct from intermittent claudication with different goals of treatment, however in both groups risk factor modification is of the utmost importance involving tobacco cessation, and treatment of underlying conditions like diabetes mellitus, hyperlipidemia and hypertension. In CLI, medical therapy involves wound care and also consists of antiplatelet therapy, anti-inflammatory therapy including statin use or ACE inhibitors. Surgical therapies include distal bypass surgery, thromboendartectomy and amputation. Endovascular techniques include percutaneous transluminal angioplasty, bare metal stents, atherectomy, drug-coated balloon and drug-eluting stents. CLI is considered the end-stage of PAD, requiring a thoughtful and multidisciplinary approach, risk-benefit analysis and treatment of comorbid conditions. Conservative and surgical treatments, along with endovascular techniques, have allowed excellent opportunities for treating complicated patients for wound healing and limb salvage.

Topics: Amputation, Surgical; Cardiovascular Agents; Critical Illness; Endovascular Procedures; Humans; Ischemia; Limb Salvage; Peripheral Arterial Disease; Risk Factors; Risk Reduction Behavior; Treatment Outcome; Vascular Surgical Procedures; Wound Healing

Endovascular management of superficial femoral artery disease has historically been limited to percutaneous balloon angioplasty, atherectomy, and bare-metal stents. However, these therapies have been plagued by high restenosis and target lesion revascularization rates. More recent technologies such as drug-coated stents and balloons are designed to combat restenosis by locally delivering antiproliferative drugs. Several randomized controlled trials have directly compared these antiproliferative drug-delivering devices to their non-drug-coated counterparts. Additionally, trials are currently ongoing to compare use of drug-coated technologies in combination with traditional therapies in hope of synergistic effects. This review gathers data from currently published clinical trials, provides an overview of upcoming clinical studies utilizing drug-coated technology, and explores the possible impact these devices may have on clinical practice.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Drug-Eluting Stents; Femoral Artery; Humans; Lower Extremity; Peripheral Arterial Disease; Randomized Controlled Trials as Topic

Introducing anti-restenotic drug-based treatment modalities in femoropopliteal interventions is the potential revolutionizing reperfusion treatment of peripheral artery disease. Durability of recanalization procedures using drug-coated balloons (DCB) and drug-eluting stents (DES) yields in excellent mid-term and long-term technical and clinical outcomes and may be cost saving on the long term as compared to traditional treatment modalities such as plain old balloon angioplasty (POBA) and bare metal nitinol stent implantation. Drug-eluting bioresorbable scaffolds are another drug-based promising treatment option but are still investigational. In particular, DCB provide a novel method to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system or even if those devices will be indicated, they can be delivered focally. Following the first positive pilot studies, two large pivotal trials have confirmed superiority of DCB over plain old balloon angioplasty (POBA) in the treatment of TASC II A and B femoropopliteal lesions. Even for more complex femoropopliteal lesions such as long lesions and instent restenosis, single center studies and small randomized studies have shown promising mid-term technical and clinical results. For DES, follow-up data for the only commercially available device are now presented up to 5 years with excellent clinical outcome regarding freedom from target lesion revascularization and improvement of walking capacity. This review article summarizes the current knowledge and perspectives of drug-based endovascular treatment modalities in femoropopliteal interventions and discusses still unresolved needs.

Topics: Absorbable Implants; Angioplasty, Balloon; Blood Flow Velocity; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Vascular Patency

Several randomized controlled trials (RCTs) have shown the superiority of some of these technologies over balloon angioplasty, but direct comparisons between these treatment options are lacking. The authors conducted a network meta-analysis of RCTs comparing bare nitinol stents, covered nitinol stents, paclitaxel- or sirolimus-eluting stents (PES or SES), and paclitaxel-coated balloons (PCB) with plain balloon angioplasty or with each other in the femoropopliteal artery (PROSPERO registry: CRD42013004845).. Sixteen RCTs comprising 2532 patients with 4227 person-years of follow-up were analyzed on an intention-to-treat basis. Bayesian random effects Poisson and binomial models were used for mixed treatment comparisons (WinBUGS). Clinical heterogeneity was accounted for by incorporating a meta-regression model on trial-specific baseline risk. End points included technical success, vascular restenosis, target lesion revascularization, and major amputations. Pairwise odds ratios and rate ratios (ORs and RRs) of absolute treatment effects were calculated, and the probabilities of each treatment being best are reported. Summary estimates are reported as the posterior median and associated credible intervals (CrIs) that serve the same purpose as confidence intervals in the context of the Bayesian framework. Extensive sensitivity, meta-regression, and network consistency analyses were performed to evaluate heterogeneity.. Technical success was highest with covered stents (pooled OR, 13.6; 95% CrI, 3.3-31.1, probability best 82%) followed by uncovered stents (pooled OR, 7.0; 95% CrI, 2.6-129, probability best 18%) when compared with balloon angioplasty (reference treatment). Vascular restenosis was lowest with PES (RR, 0.43; 95% CrI, 0.16-1.18, probability best 45%) followed by PCB (RR, 0.43; 95% CrI, 0.26-0.67, probability best 42%). Target lesion revascularization was lowest with PCB (RR, 0.36; 95% CrI, 0.23-0.55, probability best 56%) followed by PES (RR, 0.42; 95% CrI, 0.16-1.06, probability best 33%). Major amputations were rare in all treatment and control groups (pooled amputation rate of 0.7 events per 100 person-years).. Immediate technical success is better with the use of covered stents, whereas paclitaxel-eluting stents and paclitaxel-coated balloons offer the best long-term results in the femoropopliteal artery.

Topics: Alloys; Amputation, Surgical; Angioplasty, Balloon; Bayes Theorem; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug-Eluting Stents; Equipment Design; Femoral Artery; Humans; Limb Salvage; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Sirolimus; Stents; Treatment Outcome; Vascular Access Devices

Endovascular approach to superficial femoral artery (SFA) disease, the most common cause of symptomatic peripheral arterial disease, remains fraught with high failure rates. Newer devices including second-generation nitinol stents, drug-coated stents, drug-coated balloons, covered stents, cryo-therapy, LASER, and directional atherectomy have shown promising results. Clinical equipoise still persists regarding the optimal selection of devices, largely attributable to the different inclusion criteria, study population, length of lesions treated, definition of "patency" and "restenosis," and follow-up methods in the pivotal trials.. A prospective protocol was developed. We performed a literature search using PubMed from January 2006 to November 2013. Published articles including endovascular interventions in SFA or popliteal arteries with reported 12-month "primary patency" or "binary restenosis" rates as endpoints were included.. We identified 6,024 patients in 61 trials reporting 12-month primary patency rates in patients with femoropoliteal disease. Primary patency rates were (weighted average) 77.2% for nitinol stents, 68.8% for covered stents, 84% for drug eluting stents, 78.2% for drug eluting/coated balloon, 60.7% for cryoballoon, 51.1% for LASER atherectomy, 63.5% for directional atherectomy and 70.2% with a combination of endovascular devices.. The most frequently used endovascular devices yielded various 12-month primary patency rates ranging from 51% to 85%. The increased variation in inclusion criteria, length, and complexity of lesions between studies does not allow direct comparison between them. Larger randomized trials in specific patient populations comparing those modalities is needed before we can make safe recommendation of the superiority of one device over the other.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The treatment of in-stent restenosis (ISR) in the femoro-popliteal artery (FPA) is one of the major challenges of endovascular therapy, occurring in up to 40% of femoro-popliteal lesions treated with bare-metal stents within 1 year of treatment. Drug-eluting technologies, involving local delivery of paclitaxel, are providing a new paradigm for the treatment of ISR. Preliminary experience shows promising results compared to other techniques such as cutting balloon angioplasty and debulking strategies. Based on available data, drug-eluting balloons (DEBs) seem sufficient as stand-alone treatment of FPA-ISR. However, larger evidence from randomized studies is warranted to identify the clinical and/or anatomical setting in which they could fail.

Topics: Angioplasty, Balloon; Animals; Cardiovascular Agents; Constriction, Pathologic; Drug-Eluting Stents; Femoral Artery; Humans; Neointima; Peripheral Arterial Disease; Plaque, Atherosclerotic; Popliteal Artery; Prosthesis Design; Radiography; Recurrence; Retreatment; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To study the economic impact on payers and providers of the four main endovascular strategies for the treatment of infrainguinal peripheral artery disease.. Bare metal stents (BMS), drug-eluting stents (DES), and drug-coated balloons (DCB) are associated with lower target lesion revascularization (TLR) probabilities than percutaneous transluminal angioplasty (PTA), but the economic impact is unknown.. In December 2012, PubMed and Embase were systematically searched for studies with TLR as an endpoint. The 24-month probability of TLR for each treatment was weighted by sample size. A decision-analytic Markov model was used to assess the budget impact from payers' and facility-providers' perspectives of the four index procedure strategies (BMS, DES, DCB, and PTA). Base cases were developed for U.S. Medicare and the German statutory sickness fund perspectives using current 2013 reimbursement rates.. Thirteen studies with 2,406 subjects were included. The reported probability of TLR in the identified studies varied widely, particularly following treatment with PTA or BMS. The pooled 24-month probabilities were 14.3%, 19.3%, 28.1%, and 40.3% for DCB, DES, BMS, and PTA, respectively. The drug-eluting strategies had a lower projected budget impact over 24 months compared to BMS and PTA in both the U.S. Medicare (DCB: $10,214; DES: $12,904; uncoated balloons $13,114; BMS $13,802) and German public health care systems (DCB €3,619; DES €3,632; BMS €4,026; PTA €4,290).. DCB and DES, compared to BMS and PTA, are associated with lower probabilities of target lesion revascularization and cost savings for U.S. and German payers.

Topics: Angioplasty, Balloon; Budgets; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Cost Savings; Cost-Benefit Analysis; Decision Support Techniques; Drug Costs; Drug-Eluting Stents; Femoral Artery; Germany; Health Care Costs; Humans; Insurance, Health, Reimbursement; Markov Chains; Medicare; Metals; Models, Economic; Outcome and Process Assessment, Health Care; Peripheral Arterial Disease; Popliteal Artery; Stents; Treatment Outcome; United States; Vascular Access Devices

Trimetazidine is a cytoprotective drug whose cardiovascular effectiveness, especially in patients with stable ischemic heart disease, has been the source of much controversy in recent years; some have gone so far as to treat the medication as a 'placebo drug' whose new side effects, such as Parkinsonian symptoms, outweigh its benefits. This article is an attempt to present the recent key studies, including meta-analyses, on the use of trimetazidine in chronic heart failure, also in patients with diabetes mellitus and arrhythmia, as well as in peripheral artery disease. This paper also includes the most recent European Society of Cardiology guidelines, including those of 2013, on the use of trimetazidine in cardiovascular disease.

Topics: Cardiovascular Agents; Cardiovascular Diseases; Heart Failure; Humans; Peripheral Arterial Disease; Trimetazidine

Peripheral arterial disease most commonly affects the femoropopliteal segment. Despite enormous improvements in device and treatment technology the long-term patency rate and clinical benefit of endovascular treatment in the respective vascular bed is not satisfying. Drug coated balloon technology as a treatment option in femoropopliteal disease has shown encouraging results in first-in-man trials, which have now been proven in large randomized controlled trials.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Femoral Artery; Health Care Costs; Humans; Peripheral Arterial Disease; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Stents have been created to prevent vessel recoil after percutaneous transluminal angioplasty (PTA). Despite the evolution in stent design, intimal hyperplasia and stent fractures and the resulting in-stent restenosis (ISR) still occur. Different strategies to treat ISR have been described with variable results in patency rates in the short and the long-term. PTA only in the treatment of ISR showed high procedural success, but the mid and long-term patency rates were very disappointing. Atherectomy devices have showed same insufficient results. If stent fracture is the cause of the ISR, the fracture has to be overstent. The best two options are covered stents and drug eluting stents (DES). Drug eluting devices like DES and drug eluting balloons (DEBs) showed promising results, with patency rates up to over 90% after one year. DEBs have the advantage of leaving nothing behind. Combined treatment of ISR with atherectomy and DEB has a similar good result. Endovascular brachytherapy showed high patency rates after one year but this technique is limited due to the time-consuming nature of the procedure, complex radiation safety measurements, and staffing requirements. Overall drug-eluting devices are emerging as the best treatment of SFA ISR with patency rates over 90% after 2 years.

Topics: Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug-Eluting Stents; Femoral Artery; Humans; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

This paper is the review of the Consensus Document on Intermittent Claudication of the Central European Vascular Forum (CEVF), published in 2008, and and shared with the North Africa and Middle East Chapter of International Union of Angiology and the Mediterranean League of Angiology and Vascular Surgery. The Document presents suggestions for general practitioners and vascular specialists for more precise and appropriate management of PAD, particularly of intermittent claudication, and underlines the investigations that should be required by GPs and what the GP should expect from the vascular specialist (angiologist, vascular surgeon). The idea of the Faculty is to produce a short document, which is an easy reference in daily clinical practice, both for the GPs and vascular specialists.

Topics: Asymptomatic Diseases; Cardiovascular Agents; Consensus; Critical Illness; General Practice; Humans; Intermittent Claudication; Ischemia; Peripheral Arterial Disease; Referral and Consultation; Risk Factors; Risk Reduction Behavior; Severity of Illness Index; Treatment Outcome; Vascular Surgical Procedures

Peripheral artery disease affects over eight million Americans and is associated with an increased risk of mortality, cardiovascular disease, functional limitation, and limb loss. In its most severe form, critical limb ischemia, patients are often treated with lower extremity (LE) amputation (LEA), although the overall incidence of LEA is declining. In the US, there is significant geographic variation in the performing of major LEA. The rate of death after major LEA in the US is approximately 48% at 1 year and 71% at 3 years. Despite this significant morbidity and mortality, the use of diagnostic testing (both noninvasive and invasive testing) in the year prior to LEA is low and varies based on patient, provider, and regional factors. In this review we discuss the significance of LEA and methods to reduce its occurrence. These methods include improved recognition of the risk factors for LEA by clinicians and patients, strong advocacy for noninvasive and/or invasive imaging prior to LEA, improved endovascular revascularization techniques, and novel therapies.

Topics: Amputation, Surgical; Cardiovascular Agents; Diagnostic Imaging; Early Diagnosis; Endovascular Procedures; Humans; Limb Salvage; Lower Extremity; Peripheral Arterial Disease; Predictive Value of Tests; Risk Assessment; Risk Factors; Risk Reduction Behavior; Treatment Outcome

Endovascular intervention has become a well-recognized treatment modality for peripheral artery disease; however, mid- and long-term outcomes have been plagued by limited durability. Plain balloon angioplasty and bare-metal stents have historically suffered from high restenosis rates leading to the need for frequent repeat revascularization procedures. The innovation of locally administered, drug-delivering balloons and stents has been a direct result of technological innovations directed toward prevention and treatment of this limitation. Over the last 5 years, numerous clinical trials investigating the use of drug-coated stents and drug-coated balloons indicate a significant improvement in endovascular treatment durability and outcomes. This review provides an up-to-date assessment of the current evidence for the use of drug-coated stents and drug-coated balloons in the treatment of femoropopliteal and infrapopliteal peripheral artery disease. Additionally, it provides an overview of the development of this technology, highlights landmark ongoing and completed clinical trials, examines evidence to support the use of drug-coated technologies in combination with other modalities, and examines promising new technological developments. Last, it summarizes the challenges and safety concerns that have delayed U.S. Food and Drug Administration approval of these devices.

Topics: Absorbable Implants; Animals; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug Carriers; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Risk Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Peripheral arterial occlusive disease is becoming a major health problem in Western societies as the population continues to age. In addition to risk of limb loss, the complexity of the disease is magnified by its intimate association with medical comorbidity, especially cardiovascular and cerebrovascular disease. Risk factor modification and antiplatelet therapy are essential to improve long-term survival. Surgical intervention is indicated for intermittent claudication when a patient's quality of life remains unacceptable after a trial of conservative therapy. Open reconstruction and endovascular revascularization are cornerstone for limb salvage in patients with critical limb ischemia. Recent advances in catheter-based technology have made endovascular intervention the preferred treatment approach for infrainguinal disease in many cases. Nevertheless, lower extremity bypass remains an important treatment strategy, especially for reasonable risk patients with a suitable bypass conduit. In this review, we present a summary of current knowledge about peripheral arterial disease followed by a review of current, evidence-based medical and surgical therapy for infrainguinal arterial occlusive disease.

Topics: Amputation, Surgical; Cardiovascular Agents; Critical Illness; Endovascular Procedures; Evidence-Based Medicine; Humans; Intermittent Claudication; Ischemia; Limb Salvage; Lower Extremity; Peripheral Arterial Disease; Risk Factors; Treatment Outcome; Vascular Surgical Procedures

Diabetic foot ulceration (DFU) is associated with high morbidity and mortality, and represents the leading cause of hospitalization in patients with diabetes. Peripheral arterial disease (PAD), present in half of patients with DFU, is an independent predictor of limb loss and can be difficult to diagnose in a diabetic population. This review focuses on the evidence for therapeutic strategies in the management of patients with DFU. We highlight the importance of timely referral of patients presenting with a new foot ulcer to a multidisciplinary team, which includes vascular surgeons and interventional radiologists.

Topics: Anti-Bacterial Agents; Cardiovascular Agents; Combined Modality Therapy; Diabetic Foot; Endovascular Procedures; Evidence-Based Medicine; Humans; Hypoglycemic Agents; Patient Care Team; Peripheral Arterial Disease; Referral and Consultation; Risk Factors; Treatment Outcome; Vascular Surgical Procedures

Peripheral arterial disease (PAD) is a manifestation of systemic atherosclerosis. It affects 10-15% of the general population, and is often asymptomatic; leading to under-diagnosis and under-treatment. Atherosclerotic risk factors are often not intensively managed in PAD patients.. To summarise the information around the diagnosis and management of PAD in the general practice setting.. Careful history, clinical examination, and measurement of ankle-brachial index remain the initial means of diagnosing PAD. More detailed anatomic information from duplex imaging, computed tomography angiography and magnetic resonance angiography, is usually unnecessary unless endovascular or surgical intervention is being considered, or if abdominal aortic aneurysm or popliteal aneurysm need to be excluded. Management is focused on lifestyle modification, including smoking cessation and exercise; medical management of atherosclerotic risk factors, including antiplatelet agents, statins, antihypertensive therapy; and agents to improve walking distance, such as cilostazol and ramipril. Endovascular or surgical interventions are usually considered for lifestyle limiting intermittent claudication not responding to conservative therapies, and for critical limb ischaemia.

Topics: Ankle Brachial Index; Australia; Cardiovascular Agents; Combined Modality Therapy; Diet Therapy; Exercise Therapy; General Practice; Humans; Magnetic Resonance Angiography; Medical History Taking; Peripheral Arterial Disease; Physical Examination; Risk Factors; Tomography, X-Ray Computed; Vascular Surgical Procedures

The complex pathophysiology response to injury of the lower-extremity arteries has prompted the development of several unique balloon technologies to overcome initial technical failures and short-term intimal hyperplasia. Cryoplasty alters the cellular and mechanical properties of the vessel wall during angioplasty. Cutting balloons incise the wall, preventing elastic recoil and allowing expansion of the lumen at a lower pressure, thus limiting barotrauma. Drug-eluting balloons actively transfer inhibitory compounds to the wall during the initial therapy, while brachytherapy balloons allow for localized delivery of radiation to inhibit the proliferative response seen after angioplasty. These platforms provide unique means to enhance immediate and short-term results and also reduce stent usage in the lower extremity.

Topics: Angioplasty, Balloon; Brachytherapy; Cardiovascular Agents; Cryotherapy; Drug Carriers; Equipment Design; Hemodynamics; Humans; Lower Extremity; Peripheral Arterial Disease; Regional Blood Flow; Treatment Outcome; Vascular Access Devices

The prevalence of peripheral arterial occlusive disease (PAD) in women and men is equal. Studies to date present conflicting data of gender effects on the risk factors, clinical presentation, and treatment outcomes. Clinical trials have often failed to analyze results by gender or to recruit sufficient women to enable such an analysis. This review summarizes the management and outcome of limb salvage therapy with a particular focus in women.

Topics: Cardiovascular Agents; Endovascular Procedures; Female; Health Status; Healthcare Disparities; Hemodynamics; Humans; Limb Salvage; Middle Aged; Peripheral Arterial Disease; Regional Blood Flow; Risk Factors; Risk Reduction Behavior; Sex Factors; Treatment Outcome

The prevalence of peripheral arterial disease and both traditional and nontraditional vascular risk factors are more common in patients with end-stage renal disease who are undergoing hemodialysis than the general population. Patients undergoing hemodialysis may also be at risk for peripheral arterial disease via nonvascular risk factors and the hemodialysis treatment itself. Unfortunately, because peripheral arterial disease and its risk factors in hemodialysis patients have not been thoroughly ascertained, evaluation of potential treatments has been limited. Given the high potential of morbidity and impaired quality-of-life related to peripheral arterial disease in patients with end-stage renal disease, additional studies are needed to evaluate both quality of life and potential screening for peripheral arterial disease, its risk factors, and treatments to identify areas for improvement in this vulnerable population.

Topics: Adult; Cardiovascular Agents; Endovascular Procedures; Female; Humans; Kidney Failure, Chronic; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Renal Dialysis; Risk Factors; Treatment Outcome; Vascular Surgical Procedures

Topics: Aortic Aneurysm; Cardiovascular Agents; Endovascular Procedures; Evidence-Based Medicine; Humans; Lower Extremity; Peripheral Arterial Disease; Risk Factors; Risk Reduction Behavior; Treatment Outcome; Vascular Surgical Procedures

Restenosis remains a major problem after angioplasty in peripheral artery disease despite stenting. It occurs in 30 - 50% / year depending on lesion localization and characteristics. One main reason for restenosis is neointimal hyperplasia, which can be suppressed by the topical administration of antiproliferative drugs. In percutaneous coronary intervention the concept of "local drug delivery" has been used for almost a decade with great success. In recent years, drug-eluting stents and drug coated balloons have also been increasingly used in the treatment of peripheral arterial disease as a consequence of positive results of clinical trails. The following article is an overview of the currently available data of completed trials, ongoing and planned studies. Evidence suggests that "drug-coating technology" is reliable, safe and efficient in reducing the target lesion revascularization and binary restenosis rate significantly. With regard to limb salvage and mortality in critical limb ischemia, there is no benefit shown in current published studies.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Catheters; Coated Materials, Biocompatible; Drug-Eluting Stents; Equipment Design; Evidence-Based Medicine; Humans; Limb Salvage; Peripheral Arterial Disease; Prosthesis Design; Risk Assessment; Risk Factors; Secondary Prevention; Time Factors; Treatment Outcome

This paper provides an update on the mechanisms of vascular impairment associated with insulin resistance and the pathogenesis of diabetic nephropathy and peripheral artery disease (PAD). It also considers the optimal treatment strategies for systemic vascular protection in light of recent findings. This area is of major clinical importance given the ongoing global epidemic of type 2 diabetes and the pivotal role played by insulin resistance in the mechanism of vascular impairment that manifests as macroangiopathy and microangiopathy. Timely diagnosis and intervention is critical in patients with systemic arteriosclerotic disease. Therefore, treatment strategies are aimed not only at targeting the presenting pathology, but also at reducing the risk of cardiovascular events. These efforts can help reduce the risk of both cardiovascular events and mortality. Treatment for PAD includes pharmacotherapy, endovascular treatment, and vascular reconstruction, along with exercise therapy. Because PAD can cause ischemia in the lower extremities, typical drug approaches include use of vasodilators and antiplatelet agents. Beraprost sodium and cilostazol are common choices in Japan, and their risks and benefits are discussed. Of note, beraprost has several therapeutic properties, including vascular endothelial protection, and antiplatelet and anti-inflammatory effects, in addition to vasodilatory activity. In patients with PAD, these activities improve the pathological process in the lower extremities and reduce the incidence of systemic vascular events. Recent preclinical findings indicate that beraprost improves not only ischemic extremities through its vasodilatory properties, but also reduces the insulin resistance which affects vascular endothelium. In this way, beraprost may contribute to an overall systemic vascular protective action. The use of agents, such as beraprost, which are capable of improving insulin resistance and resulting vascular endothelial function at an earlier disease stage, may ultimately contribute to increasing the life expectancy of patients with PAD.

Topics: Animals; Cardiovascular Agents; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Endovascular Procedures; Exercise Therapy; Humans; Hypoglycemic Agents; Insulin Resistance; Peripheral Arterial Disease; Treatment Outcome

Among patients with atherothrombosis, including coronary artery disease (CAD), cerebrovascular disease (CVD), and peripheral arterial disease (PAD), patients with PAD generally have the worse prognosis. The Reduction of Atherothrombosis for Continued Health (REACH) Registry characterized the atherothrombotic risk factor profile, and evaluated treatment intensity and cardiovascular events among different atherothrombotic patient populations worldwide. Two thirds of PAD patients had polyvascular disease, defined as symptomatic involvement of more than one vascular bed. The risk factor profile in patients with CAD, CVD and PAD was very much similar. However, optimal risk factor control by medical treatment and lifestyle interventions was least accomplished in PAD patients. Furthermore, PAD patients and patients with polyvascular disease showed the highest cardiovascular event rates. Of note, therapeutic strategies are similar for all atherothrombotic disease categories, irrespective of the presence of polyvascular disease. Therefore, it is of the utmost importance to achieve optimal risk factor control, particularly for PAD patients and for those with polyvascular disease, in order to prevent future cardiovascular events.

Topics: Aged; Cardiovascular Agents; Cerebrovascular Disorders; Coronary Artery Disease; Europe; Female; Humans; Male; Peripheral Arterial Disease; Practice Guidelines as Topic; Prognosis; Registries; Risk Assessment; Risk Factors; Risk Reduction Behavior

Local drug delivery (LDD), the direct application of a therapeutic agent to a focal location, has been used in cardiovascular interventions to prophylactically reduce neointimal hyperplasia and relieve clot burden. LDD allows targeted use of drugs whose toxicities inhibit their systemic use while stent delivery allows for consistent and prolonged delivery. Stents eluting limus family drugs or paclitaxel inhibit vascular smooth muscle cell hyperplasia and migration and clinical use of such stents have reduced restenosis rates after percutaneous coronary procedures. However, associated with the increased efficacy is an increased rate of late stent thrombosis associated with death and myocardial infarction. Recent innovations, including bioabsorbable polymers and completely bioabsorbable stents may expand the use of drug-eluting stents. In this review, we discuss the development, the clinical use, and the effects of LDD from balloon and stent-based platforms in the treatment of restenosis and thrombus.

Topics: Absorbable Implants; Angioplasty, Balloon; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Catheters; Coated Materials, Biocompatible; Coronary Artery Disease; Drug Delivery Systems; Drug-Eluting Stents; Equipment Design; Humans; Peripheral Arterial Disease; Prosthesis Design; Treatment Outcome

Even if recently the first positive results were presented for a paclitaxel releasing drug eluting stent there are still concerns about stent implantation in the femoro-popliteal artery. This makes any stentless technology attractive that achieves at least as good acute and longer term results in this vessel area. Three randomized studies investigating the value of short time paclitaxel release using a drug coated balloon gave promising results with significantly improved patency rates compared to plain balloon angioplasty in femoro-popliteal lesions and at least as good patency results as for the majority of bare metal nitinol stents (THUNDER, FEMPAC, LEVANT 1). Below-the-knee this promising concept is still under evaluation (PICCOLO study) whereas the first positive results for drug eluting stents in shorter lesions had been recently presented (YUKON BTK, DESTINY). This article gives an overview upon already published and presented data and still ongoing trials on drug releasing balloons in the peripheral arteries.

Topics: Angioplasty, Balloon; Animals; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Evidence-Based Medicine; Humans; Lower Extremity; Peripheral Arterial Disease; Time Factors; Treatment Outcome; Vascular Patency

The treatment of peripheral artery disease (PAD) focuses on risk factor modification, cardiovascular event reduction, limb viability, and symptom improvement. Hypertension, hyperlipidemia, and diabetes mellitus should all be controlled to recommended target levels, and smoking cessation is vital. Antiplatelet therapies, such as aspirin or clopidogrel, should be administered in all patients unless contraindicated. Whenever possible, patients who present with claudication should be offered a regimen comprised of both medical and exercise therapy, which often results in substantial improvement in symptoms. For patients presenting with more-advanced disease, such as acute limb ischemia, critical limb ischemia, and severely-limiting symptoms of PAD, revascularization is often necessary. As a result of the rapid evolution in endovascular revascularization technology and expertise, many patients with PAD can be treated percutaneously. Therefore, in this Review, we will focus on medical therapy and endovascular revascularization of patients with PAD, with reference to surgical bypass in specific clinical scenarios.

Topics: Cardiovascular Agents; Endovascular Procedures; Exercise Therapy; Humans; Peripheral Arterial Disease; Preventive Health Services; Risk Assessment; Risk Factors; Smoking Cessation; Treatment Outcome

Peripheral artery disease (PAD) results from progressive narrowing of arteries secondary to atherosclerosis and is defined as an Ankle Brachial Index of <0.9. PAD is highly prevalent and is an increasing burden on both the economy and the patient, especially given the rapid shift in demographics in the United States. Despite its prevalence and association with cardiovascular disease, PAD is still underdiagnosed and undertreated. This may, in part, be related to lack of recognition from the physician's side or paucity of evidence from clinical trials. It has been shown that medical therapy approved for cardiovascular disease is effective in the treatment of PAD and decreases cardiovascular events. Various revascularization strategies are also available for improving symptoms and quality of life in these patients, yet they are underutilized. In an attempt to increase its recognition, PAD has been considered a coronary artery disease equivalent. This article reviews the diagnosis and management of PAD. © 2011 Wiley Periodicals, Inc. The authors have no funding, financial relationships, or conflicts of interest to disclose.

Topics: Cardiovascular Agents; Diagnostic Techniques, Cardiovascular; Endovascular Procedures; Humans; Peripheral Arterial Disease; Predictive Value of Tests; Risk Assessment; Risk Factors; Risk Reduction Behavior; Treatment Outcome; Vascular Surgical Procedures

Topics: American Heart Association; Cardiovascular Agents; Endovascular Procedures; Humans; Patient Selection; Peripheral Arterial Disease; Radiography, Interventional; Risk Reduction Behavior; Smoking Cessation; Societies, Medical; Treatment Outcome; United States; Vascular Surgical Procedures

Intermittent claudication is a common symptom of peripheral arterial disease. Currently, there is a lack of consensus on the most effective therapies for this problem. We conducted a meta-analysis of randomized trials assessing the efficacy of endovascular therapy (EVT) compared with noninvasive therapies for the treatment of intermittent claudication.. Randomized trials comparing the efficacy of EVT and noninvasive therapies, such as medical therapy (MT) and supervised exercise (SVE) in patients with intermittent claudication were identified by a systematic search. Data were pooled, and combined overall effect sizes (standardized differences of mean values) were calculated for a random effect model in terms of ankle-brachial index (ABI) and treadmill walking for initial claudication distance (ICD) and maximum walking distance (MWD). Nine eligible trials (873 participants) were included: two compared EVT and MT alone, four compared EVT and SVE, and three trials compared EVT plus SVE vs SVE alone.. Heterogeneity between studies was marked. Quantitative data analysis suggested that EVT improved outcomes over MT alone at early follow-up evaluations. Outcomes of EVT plus SVE were better than those of SVE alone in terms of both ABI and treadmill walking at immediate, early, and intermediate follow-up. No substantial differences in outcomes of EVT alone compared with SVE alone were found.. In patients with intermittent claudication, current evidence supports improved ABI and treadmill walking when EVT is added to MT or SVE during early and intermediate follow-up. There is no evidence that EVT alone provides improved outcome over SVE alone. There is low confidence in these findings for a number of reasons, including the small number of trials, the small size of these studies, the heterogeneity in study design, and the limited use of quality of life tools in assessing outcomes. More consistent data from larger, more homogenous studies, including longer follow-up, are required.

Topics: Ankle Brachial Index; Cardiovascular Agents; Endovascular Procedures; Evidence-Based Medicine; Exercise Test; Exercise Therapy; Exercise Tolerance; Humans; Intermittent Claudication; Peripheral Arterial Disease; Quality of Life; Randomized Controlled Trials as Topic; Recovery of Function; Time Factors; Treatment Outcome; Walking

There is a lack of adjudicated and prospectively randomized published outcomes on the use of drug-coated balloons (DCB) to treat dysfunctional arteriovenous fistula in Asian patients. This post hoc subgroup analysis of 112 Japanese participants from the global IN.PACT AV Access trial reports outcomes through 12 months.. Participants were treated with DCB (n = 58) or standard non-coated percutaneous transluminal angioplasty (PTA) balloons (n = 54). Outcomes included target lesion primary patency (TLPP), access circuit primary patency, and safety.. Through 6 months, TLPP was 86.0% (49/57) in the DCB group and 49.1% (26/53) in the PTA group (p < 0.001). Through 12 months, TLPP was 67.3% (37/55) in the DCB group and 43.4% (23/53) in the PTA group (p = 0.013).. In this post hoc analysis of Japanese participants from the IN.PACT AV Access trial, participants treated with DCB had higher TLPP through 6 and 12 months compared with PTA.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Humans; Japan; Peripheral Arterial Disease; Prospective Studies; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

We designed a retrospective study to evaluate the performance and outcomes of a novel iopromide-based paclitaxel-coated balloon for the treatment of chronic total occlusion of femoropopliteal arteries.. Patients with femoropopliteal chronic total occlusion (<100 mm) on angiogram were screened from hospital management system and were included in the study. The width and length of the drug-eluting peripheral balloon was chosen to ensure a vessel/balloon ratio of 1: 1 and exceed the lesion by 10 mm on both ends (based on visual estimation).. The proportion of patients with ankle-brachial index improvement was 89.8% (106 of 118). The mean ankle-brachial index was 0.5 (0.4-0.7) at baseline and 0.8 (0.7-0.9) at 12 months (P < 0.001). Changes in the Rutherford category between baseline and 12 months were statistically significant (P < 0.001), with the majority of patients (77.9%, 92/118) having ≥1 level improvement. The rate of clinically driven target lesion revasculariza-tion at 12 months was 13.5%(16/118). Overall, the 1-year primary patency rate was 86.4% (102 of 118). The major adverse limb event rate was 9.8% (16/162). Acute limb ischemia was detected in 14 patients, and amputation was performed in 2 patients.. Our study is a non-randomized clinical study focusing on the use of drug-eluting balloon as a single treatment strategy. There was significant clinical benefit to patients, as clearly demonstrated by the improvement in ankle-brachial index and the reduction in Rutherford class in the short term, and these results may offer clear insights on the revascularization strategy outlook of interventionalists.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Treatment Outcome

Paclitaxel-coated balloons have shown safety and efficacy in the short- to intermediate-term; however, long-term data remain limited.. To report late safety and efficacy outcomes for a low-dose paclitaxel drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA) in femoropopliteal lesions from a large randomized controlled trial (RCT).. ILLUMENATE Pivotal is a multicenter, single-blind RCT conducted across 43 US and EU centers to examine the safety and efficacy of the Stellarex DCB for the treatment of femoropopliteal disease. Assessments were recorded for all active patients at 36 and 48 months. Vital status of patients formally exited from the study was also collected.. Primary patency through 36 months for patients treated with DCB was significantly higher compared with PTA (p=0.016). The primary safety endpoint through 36 months was 77.4% and 72.4%, respectively (p=0.377). Kaplan-Meier analysis indicated that a higher proportion of DCB subjects were event-free compared with PTA at all study visits. The rate of major adverse event (MAE) through 48 months was 32.9% in the DCB group and 37.9% in the PTA group (p=0.428). No differences in the rate of mortality were evident through 48 months of follow-up with 15.6% in the DCB group and 15.2% in the PTA group (p=0.929).. Stellarex DCB was associated with significantly higher patency compared with PTA through 3 years with no mortality difference detected through 4 years. The data from the ILLUMENATE Pivotal RCT support the long-term safety and efficacy of the low-dose Stellarex DCB.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Time Factors; Treatment Outcome; Vascular Patency

There appears to be an association between paclitaxel-coated devices and increased 5-year all-cause mortality.. We are conducting a prospective, randomized, controlled, single-center, noninferiority study. All consecutive patients with femoropopliteal arterial disease who fulfilled the inclusion/exclusion criteria are sequentially and consecutively assigned to either paclitaxel (Ranger, Boston Scientific) or sirolimus (MagicTouch, Concept Medical) coated balloon angioplasty treatment. The primary outcome are procedural success and primary vessel patency at index procedure. The secondary outcomes are 30-day and 12-month freedom from MAEs (amputation, death, TLR/TVR, MI, distal embolization that requires a separate intervention or hospitalization), procedural success (≤30% residual diameter stenosis or occlusion after the procedure), Rutherford category improvement (reduction ≤1 category) and ABI improvement (increase ≥0.10 from baseline).. A total of six patients have been enrolled in the present study up to now. The mean age was 72.6 years old and five were male. All patients had angiographic evidence of isolated occlusion in the transition segment of the distal femoral superficial artery in the popliteal artery. The mean length was 109 mm. Three patients were treated by sirolimus-coated (group A) and three by paclitaxel coated balloon angioplasty (group B). The primary patency and procedural success was in two of three and three of three patients, for group A and B, respectively.. Preliminary results show safety and feasibility of the Sirolimus-coated balloon angioplasty. Further investigation and increase of sample size will allow for more sustained conclusions regarding patency and procedural success of this type of balloons for the endovascular treatment of peripheral arterial disease.

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Limb Salvage; Male; Paclitaxel; Peripheral Arterial Disease; Plaque, Atherosclerotic; Popliteal Artery; Progression-Free Survival; Sirolimus; Time Factors; Vascular Patency

To study, from a U.S. payer's perspective, the economic consequences of drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) use for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulae.. Cost differences between DCBs and PTA at year 1 and beyond were calculated via 2 methods. The first approach used the mean absolute number of trial-observed access circuit reinterventions through 12 months (0.65 ± 1.05 vs 1.05 ± 1.18 events per patient for DCBs and PTA, respectively) and projected treatment outcomes to 3 years. The second approach was based on the trial-observed access circuit primary patency rates at 12 months (53.8% vs 32.4%) and calculated the cost difference on the basis of previously published Medicare cost for patients who maintained or did not maintain primary patency. Assumptions regarding DCB device prices were tested in sensitivity analyses, and the numbers needed to treat were calculated.. Using the absolute number of access circuit reinterventions approach, the DCB strategy resulted in an estimated per-patient savings of $1,632 at 1 year and $4,263 at 3 years before considering the DCB device cost. The access circuit primary patency approach was associated with a per-patient cost savings of $2,152 at 1 year and $3,894 at 2.5 years of follow-up. At the theoretical DCB device reimbursement of $1,800, savings were $1,680 and $2,049 at 2.5 and 3 years, respectively. The one-year NNT of DCB compared to PTA was 2.48.. Endovascular therapy for arteriovenous access stenosis with the IN.PACT AV DCB can be expected to be cost-saving if longer follow-up data confirm its clinical effectiveness.

Topics: Aged; Angioplasty, Balloon; Arteriovenous Fistula; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Cost-Benefit Analysis; Femoral Artery; Humans; Medicare; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Time Factors; Treatment Outcome; United States; Vascular Patency

So far only 1-year data have been reported for direct comparisons of paclitaxel-coated balloons (PCBs) using different coating technologies.. The aim of this study was to report the 24-month results on the efficacy and safety of low-dose vs high-dose PCBs with nominal paclitaxel densities of 2.0 and 3.5 μg/mm. Within a prospective, multicenter, clinical trial, 414 patients with symptomatic femoropopliteal lesions (Rutherford categories 2-4, maximum lesion length 30 cm) were randomly assigned in a 1:1 ratio to endovascular treatment with either a low-dose (Ranger) or a high-dose (IN.PACT) PCB after stratification for lesion length. Two-year follow-up included assessment of primary patency (defined as absence of CD TLR or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, and functional and clinical outcomes.. At 2 years, the Kaplan-Meier estimates of primary patency were 70.6% and 71.4% for the low-dose and high-dose PCBs (log-rank P = 0.96), respectively. One major amputation occurred in the high-dose group, and rates of all-cause mortality (3.6% vs 2.2%; P = 0.55) and CD TLR (17.3% vs 13.0%; P = 0.31) were similar between the groups. Among a total of 57 CD TLRs, 44.6% were performed for reocclusion and 28.1% for in-stent restenosis. Functional and clinical benefits over baseline were sustained in both groups.. The 2-year results of the COMPARE trial demonstrate a sustained treatment benefit of both low-dose and high-dose PCBs for femoropopliteal interventions including a wide range of lesion lengths. (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease; NCT02701543).

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Pilot Projects; Polychlorinated Biphenyls; Popliteal Artery; Prospective Studies; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Femoropopliteal chronic total occlusions are challenging to treat, and evidence of the effectiveness of drug-coated balloon angioplasty for long femoropopliteal chronic total occlusion lesions is limited. We compared the midterm outcomes of drug-coated balloon angioplasty versus plain old balloon angioplasty (POBA) for femoropopliteal chronic total occlusions.. In total, 95 patients from the AcoArt I trial (ClinicalTrials.gov identifier NCT01850056) with ≥5-cm femoropopliteal chronic total occlusion lesions were enrolled in this post-hoc subset analysis (drug-coated balloon,. Demographic, clinical, and lesion characteristics were matched (mean lesion length, 20 cm). The six-month late-lumen loss rate was lower in the drug-coated balloon than POBA group (0.18 ± 0.81 vs. 1.34 ± 0.94 mm, respectively;. The paclitaxel drug-coated balloon shows better primary patency and freedom from target lesion revascularization than POBA at 24month after treatment of femoropopliteal chronic total occlusions (≥5 cm) lesion.

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; China; Chronic Disease; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

We evaluated the long-term safety and efficacy of treatment using drug-coated balloons (DCBs) in Chinese patients with severe femoropopliteal artery (FPA) disease (FPAD).. In this prospective, multicenter, randomized controlled trial, 200 Chinese patients with FPAD were prospectively randomized to undergo percutaneous transluminal angioplasty with a DCB or an uncoated balloon (UCB). The clinical endpoints were all-cause mortality, clinically driven target lesion revascularization, and major amputation of the treated leg within 5 years after treatment.. During the 5-year follow-up period, freedom from all-cause mortality was 82.7% in the DCB group compared with 73.2% in the UCB group (log-rank P = .262). Freedom from clinically driven target lesion revascularization was 77.5% in the DCB group vs 59.1% in the UCB group (log-rank P < .001). No device- or procedure-related deaths occurred in either group. Cox regression analysis revealed that coronary heart disease and provisional FPA lesion stenting were associated with an increased mortality risk and the nominal paclitaxel dose was not associated with mortality during the 5-year follow-up period.. We found no significant differences in 5-year mortality between patients with FPAD treated with DCBs vs UCBs. The clinical benefit of DCBs vs UCBs in terms of clinically driven target lesion revascularization persisted for the 5-year period.

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; China; Coated Materials, Biocompatible; Equipment Design; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Time Factors; Treatment Outcome; Vascular Access Devices

The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm;

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Treatment Outcome; Vascular Patency

Luminor is a new drug-coated angioplasty balloon, which is approved by the European Conformity market. The aim of the present study is to analyze the 1-year results, in terms of effectiveness and safety, of the Luminor® 14/14M and 35 drug-coated balloons (iVascular, Sant Vicenç dels Horts, Barcelona, Spain) in a special cohort of critical limb ischemia (CLI) of the Luminor registry.. Luminor is phase IV, nonrandomized, prospective, observational, and multicenter clinical study. The present study includes patients with CLI to analyze the effectiveness, in terms of primary patency, and the safety defined by the major adverse effects: any cause mortality, major amputation, and/or clinically driven target lesion revascularization (TLR). Both femoropopliteal and below-the-knee infrapopliteal lesions were treated. All the end points were assessed after the procedure, at 30 days, 6 and 12 months thereafter.. About 148 patients (101 males; mean age, 73.2 ± 11.4 years) with CLI were included. About 83.3% were classified as Rutherford's class 5. Diabetes mellitus was diagnosed in 71.6%; hypertension, hyperlipidemia, renal insufficiency, and coronary disease were present in 87.2%, 57.4%, 29.7%, and 39.2% of the sample, respectively. The average follow-up was 11.2 ± 3.27 months. The primary patency and the freedom of clinically driven TLR, at 1 year, were 87.7% and 92.1%, respectively. Survival and freedom from major amputations were 85.1% and 84.7%, respectively.. Even with a very sick population, the results at 12 months are highly satisfactory with reference to survival, freedom from amputation, patency, and the absence of reintervention.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Critical Illness; Equipment Design; Female; Femoral Artery; Humans; Ischemia; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Progression-Free Survival; Prospective Studies; Risk Factors; Spain; Time Factors; Vascular Access Devices; Vascular Patency

The long-term benefit of revascularization for intermittent claudication is poorly understood. The aim of this study was to investigate the long-term effectiveness and cost-effectiveness compared with a noninvasive approach.. The IRONIC trial (Invasive Revascularization or Not in Intermittent Claudication) randomized patients with mild-to-severe intermittent claudication to either revascularization + best medical therapy + structured exercise therapy (the revascularization group) or best medical therapy + structured exercise therapy (the nonrevascularization group). The health-related quality of life short form 36 questionnaire was primary outcome and disease-specific health-related quality of life (vascular quality of life questionnaire) and treadmill walking distances were secondary end points. Health-related quality of life has previously been reported superior in the revascularization group at 1- and 2-year follow-up. In this study, the 5-year results were determined. The cost-effectiveness of the treatment options was analyzed from a payer/healthcare standpoint.. After 5 years of follow-up, a revascularization strategy had lost its early benefit and did not result in any long-term improvement in health-related quality of life or walking capacity compared to a noninvasive treatment strategy. Revascularization was not a cost-effective treatment option from a payer/healthcare point of view.. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01219842.

Topics: Aged; Cardiovascular Agents; Combined Modality Therapy; Cost-Benefit Analysis; Exercise Therapy; Exercise Tolerance; Female; Health Care Costs; Health Status; Humans; Intermittent Claudication; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Quality of Life; Quality-Adjusted Life Years; Recovery of Function; Sweden; Time Factors; Treatment Outcome; Vascular Surgical Procedures; Walking

Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact™) vs. low-dose (Ranger™) DCB with nominal paclitaxel densities of 3.5 vs. 2.0 μg/mm2.. Within a prospective, multicentre, non-inferiority, clinical trial 414 patients with symptomatic femoropopliteal lesions (Rutherford classification 2-4) were randomly assigned in a 1:1 ratio to endovascular treatment with either high- or low-dose DCB after stratification for lesion length. Primary efficacy and safety endpoints comprised primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1 month, major amputations, and clinically driven target lesion revascularization through 12 months). We set a non-inferiority margin of -10% at 12 months. Total occlusions were observed frequently (>40%) and provisional stenting was performed in every fourth intervention. Non-inferiority was determined for both primary efficacy and safety endpoints at 12 months. Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group {difference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) -5.2%]; Pnon-inferiority < 0.01}. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference -1.6% (lower bound of the 90% two-sided CI -6.5%); Pnon-inferiority < 0.01]. Overall death rate was low (2.0%) and no major amputation occurred.. Two DCBs with different coating characteristics exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions including a wide range of lesion lengths.. The trial is registered with ClinicalTrials.gov (NCT02701543).

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Pharmaceutical Preparations; Popliteal Artery; Prospective Studies; Time Factors; Treatment Outcome; Vascular Patency

Topics: Aged; Amputation, Surgical; Cardiovascular Agents; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Japan; Limb Salvage; Male; Middle Aged; New Zealand; Paclitaxel; Patient Safety; Peripheral Arterial Disease; Progression-Free Survival; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Time Factors; United States; Vascular Calcification; Vascular Patency

Topics: Aged; Aged, 80 and over; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Brazil; Cardiovascular Agents; Drug-Eluting Stents; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Length of Stay; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

The performance of drug-coated balloons (DCBs) in femoropopliteal interventions has been proven through randomized trials in short lesions and lesions with relatively low proportion of occlusions. There is limited evidence of DCBs in long or occlusive lesions. This study is to investigate the efficacy of the paclitaxel-coated balloon for treatment of long and occlusive femoropopliteal arterial lesions.. A single-arm trial including 44 femoropopliteal lesions (chronic total occlusion (CTO) plus > 10 cm) treated with DCBs was performed to collect data of average 1-year follow-up. Endpoints contain primary patency, target lesion revascularization (TLR), amelioration of the Rutherford classification, change of ankle brachial index (ABI) and major adverse events.. Technical success is 97.7% while device success is 100%. Mean lesion length was 186 ± 86.3 cm. Stent implantation was performed in 13.6%. Cumulative probability of primary patency was 78.8% ± 6.8% at 1 year while that of freedom from TLR was 91.4% ± 4.9%. Rutherford classification improved from average 3.3 ± 1.0 to 2.1 ± 1.4 (p < 0.001) at follow-up with a 72.7% amelioration rate. Ankle-branchial index changed from 0.33 ± 0.40 to 0.67 ± 0.37 (p = 0.002). No major adverse event was observed.. These results suggest that it is safe and effective to treat long and totally occlusive femoropopliteal artery disease with DCBs. Further studies are demanded to confirm these results.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Beijing; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Time Factors; Treatment Outcome; Vascular Patency

The goal of this study was to evaluate the 5-year follow-up data of the IN.PACT DEEP (Randomized IN.PACT Amphirion Drug-Coated Balloon [DCB] vs. Standard Percutaneous Transluminal Angioplasty [PTA] for the Treatment of Below-the-Knee Critical Limb Ischemia [CLI]) trial.. Initial studies from randomized controlled trials have shown comparable short-term outcomes of DCB angioplasty versus PTA in patients with CLI with infrapopliteal disease. However, the long-term safety and effectiveness of DCB angioplasty remain unknown in this patient population.. IN.PACT DEEP was an independently adjudicated prospective, multicenter, randomized controlled trial that enrolled 358 subjects with CLI. Subjects were randomized 2:1 to DCB angioplasty or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, amputation, and all-cause death. Additional assessments were conducted to identify risk factors for death and major amputation, including paclitaxel dose tercile.. Freedom from clinically driven target lesion revascularization through 5 years was 70.9% and 76.0% (log-rank p = 0.406), and the incidence of the safety composite endpoint was 59.8% and 57.5% (log-rank p = 0.309) in the DCB angioplasty and PTA groups, respectively. The rate of major amputation was 15.4% for DCB angioplasty compared with 10.6% for PTA (log-rank p = 0.108). Given the recent concern regarding a late mortality signal in patients treated with paclitaxel-coated devices, additional analyses from this study showed no increase in all-cause mortality with DCB angioplasty (39.4%) compared with PTA (44.9%) (log-rank p = 0.727). Predictors of mortality included age, Rutherford category >4, and previous revascularization but not paclitaxel by dose tercile.. Tibial artery revascularization in patients with CLI using DCB angioplasty resulted in comparable long-term safety and effectiveness as PTA. Paclitaxel exposure was not related to increased risk for amputation or all-cause mortality at 5-year follow-up. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733).

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Critical Illness; Equipment Design; Europe; Female; Humans; Ischemia; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Recurrence; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

The primary objective of the BATTLE (Bare Metal Stent vs. Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate-Length Femoropopliteal Lesions) trial is to demonstrate the clinical superiority of the Zilver PTX stent over the Misago stent in the treatment of femoropopliteal lesions.. No randomized studies have compared self-expanding paclitaxel-eluting stents with bare-metal stents in the treatment of femoropopliteal lesions.. BATTLE is a multicenter randomized controlled trial in patients with symptomatic (Rutherford category 2 to 5) de novo lesions of the superficial femoral or proximal popliteal artery. The primary endpoint is freedom from in-stent restenosis (ISR) at 1 year, with restenosis defined as a peak systolic velocity index >2.4 at the target lesion. The Kaplan-Meier method was used to evaluate time-to-event data for freedom from ISR over the 2-year follow-up period.. Between March 2014 and August 2016, 186 patients were enrolled; 91 were assigned to the Misago arm and 90 to the Zilver PTX arm. Kaplan-Meier 1-year estimates of freedom from ISR were 88.6% for Misago and 91% for Zilver PTX (hazard ratio [HR]: 1.2; 95% confidence interval [CI]: 0.6 to 2.4; p = 0.64). Comparing Misago with Zilver PTX, 2-year estimates were 6.4% and 1.2% (HR: 7.3; 95% CI: 0.9 to 59.3; p = 0.0632) for mortality, 74.6% and 78.8% (HR: 1.2; 95% CI: 0.6 to 2.1; p = 0.62) for patency, and 14.4% and 12.4% (HR: 1.2; 95% CI: 0.5 to 2.8; p = 0.69) for target lesion revascularization.. In the treatment of symptomatic femoropopliteal lesions, the Zilver PTX stent failed to show superiority over the Misago stent in freedom from ISR at 1 year.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; France; Humans; Male; Metals; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Cardiovascular Agents; Coronary Stenosis; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Humans; Japan; Neointima; Paclitaxel; Peripheral Arterial Disease; Polymers; Popliteal Artery; Predictive Value of Tests; Prospective Studies; Risk Factors; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

A total of 1446 participants, 65- to 74-year-old men diagnosed with abdominal aortic aneurysm (AAA), peripheral arterial disease (PAD) or high blood pressure (HB) in the Viborg Vascular (VIVA) screening trial, were consecutively included and randomised to a telephone counselling (TC) or no TC 3 months after being screened positive. Data from VIVA were linked to data from Danish registers from 2007 to 2016. The primary outcome was a composite outcome of proportion of days covered by statin, antithrombotic drugs and antihypertensive agents and for each specific drug class at 6-month follow-up. The same outcomes were assessed at 12 and 60 months and considered secondary outcomes. Outcome measures are reported as risk differences (RD). There were no differences between the groups in relation to the composite of all three drug classes over 6 months of follow-up, RD = 4.1 (95% CI: -1.0; 9.1). A significant increase in redeemed statin prescriptions was observed in the intervention group at 6 months, RD = 9.8% (CI 95%: 0.5; 19.0). There was no intervention effect observed after 12 and 60 months. TC 3 months after screening improved adherence to statin at 6-month follow-up, but had no effect on the composite treatment, statins, antithrombotic or antihypertensive treatment over 60 months of follow-up.

Topics: Aged; Antihypertensive Agents; Aortic Aneurysm, Abdominal; Cardiovascular Agents; Counseling; Denmark; Diagnostic Screening Programs; Drug Prescriptions; Fibrinolytic Agents; Health Knowledge, Attitudes, Practice; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypertension; Male; Medication Adherence; Peripheral Arterial Disease; Telephone; Time Factors; Treatment Outcome

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Delayed-Action Preparations; Female; Femoral Artery; Germany; Humans; Ischemia; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Recovery of Function; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome; Vascular Patency

To evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA).. A post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2-4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]).. In the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes.. In both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men.

Topics: Age Factors; Aged; Angioplasty, Balloon; Cardiovascular Agents; Disease Progression; Female; Femoral Artery; Health Status Disparities; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Risk Factors; Sex Factors; Single-Blind Method; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The goal of this study is to evaluate the efficacy of a smoking cessation intervention performed by a vascular surgery provider compared with current smoking cessation practices.. Patients with peripheral arterial and aneurysmal disease who presented to the vascular surgery service at a tertiary care center over a 9-month period were randomized to either control or intervention group. Both control and intervention groups received 2 weeks of free nicotine patches and referral to an outpatient smoking-cessation program. The intervention group additionally received a brief presentation by a vascular surgeon regarding the benefits of smoking cessation, with a focus on vascular complications. At enrollment and at follow-up, patients underwent carbon monoxide breath testing and completed a survey. The primary outcome was smoking cessation or reduction among control and intervention groups in patients who underwent medical management, endovascular procedures, or open surgical procedures. Fisher's exact test was used to assess the primary outcome among groups.. Fifty-nine patients were enrolled in the trial initially, but 55 had 1-month follow-up (control n = 28, intervention n = 27) and 52 had long-term follow-up (control n = 28, intervention n = 24). By long-term follow-up, 40 patients (77%) had reduced smoking by at least 50% and 16 patients (31%) had quit completely. At long-term follow-up, 88% of patients in the intervention group and 68% of patients in the control group reduced smoking (P = 0.1).. A large proportion of vascular patients who received 2 weeks of nicotine replacement with or without the addition of brief smoking cessation counseling delivered by a vascular surgery provider were able to reduce smoking and maintain reduction after 6 months. Delivery of a brief standardized smoking cessation counseling session by a vascular surgery provider is safe and feasible. Additional randomized controlled trials with large enrollment periods and long follow-up are needed to determine the efficacy of this intervention in comparison to standard care.

Topics: Aneurysm; Cardiovascular Agents; Cholinergic Agents; Connecticut; Endovascular Procedures; Female; Humans; Male; Middle Aged; Nicotine; Patient Education as Topic; Peripheral Arterial Disease; Pilot Projects; Risk Factors; Risk Reduction Behavior; Smokers; Smoking; Smoking Cessation; Time Factors; Tobacco Use Cessation Devices; Transdermal Patch; Treatment Outcome; Vascular Surgical Procedures

Endovascular treatment of occlusive disease of the superficial femoral artery (SFA) has evolved from plain old balloon angioplasty (POBA) through primary stenting strategy to drug eluting technology-based approach. The RAPID Trial investigates the added value of drug coated balloons (DCB, Legflow) in a primary stenting strategy (Supera stent) for intermediate (5-15 cm) and long segment (>15 cm) SFA lesions.. In this multicenter, patient-blinded trial, 160 patients with intermittent claudication, ischemic rest pain, or tissue loss due to intermediate or long SFA lesions were randomized (1:1) between Supera + DCB and Supera. Primary endpoint was primary patency at 2 years, defined as freedom from restenosis on duplex ultrasound (peak systolic velocity ratio <2.4).. At 2 years, primary patency was 55.1% (95% CI: 43.1-67.1%) in the Supera + DCB group versus 48.3% (95% CI: 35.6-61.0%) in the Supera group (P=0.957). Per protocol analysis showed a primary patency rate of 60.9% (95% CI: 48.6-73.2%) in the Supera + DCB group versus 49.8% (95% CI: 36.9-62.7%) in the Supera group (P=0.469). The overall mortality rate was 5% in both groups (P=0.975). Sustained functional improvement was similar in both groups.. The 2-year results in the current trial of a primary Supera stenting strategy are consistent with other trials reporting on treatment of intermediate and long SFA lesions. A DCB supported Supera stent strategy did not improve patency rate compared to a Supera stent only strategy.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Stenosis is a known complication in bypass vein grafts for peripheral arterial disease. The aim of this study was to evaluate the effect of drug-coated balloons (DCBs) in the treatment of vein graft stenoses. DCBs may prevent restenosis in arterial lesions. One small prospective and larger retrospective and registry studies have failed to show benefit from DCBs in vein grafts. Prospective data are scarce.. Sixty patients treated for primary or recurrent stenosis in venous bypass grafts were randomized to DCB (n = 30) or standard balloon angioplasty (BA) (n = 30). Follow-up was 1 year. The primary outcome measure was target lesion revascularization (TLR). Secondary outcome measures were assisted primary patency and secondary patency and graft occlusion.. Fifty-seven patients were analyzed. Three patients were excluded due to primary technical failure (2 DCB, 1 BA). Overall TLR rate was 34.5% and 46.4% in the DCB and BA groups, respectively (P = 0.33). Five (8.8%) grafts occluded during follow-up (1 DCB, 4 BA). Assisted primary patency was 93.1% (DCB) versus 85.7% (BA) (P = 0.362) and secondary patency was 100% (DCB) versus 89.3% (BA) (P = 0.076). Subgroup analysis showed a significant benefit from DCB in the treatment of primary stenosis (TLR rate 15.0% vs. 18.9%, P = 0.03).. There was no significant benefit from DCBs for treatment of vein graft stenosis compared to BA, although a trend in favor of DCBs could be seen.. ClinicalTrials.govNCT03023098.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Finland; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Peripheral Arterial Disease; Saphenous Vein; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Grafting; Vascular Patency

To assess the longer-term safety and efficacy of the IN.PACT Admiral (MDT-2113) drug-coated balloon (DCB) for the treatment of de novo and non-stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PTA) in a Japanese cohort.. Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains a paucity of results in non-Caucasian populations.. IN.PACT SFA Japan is an independently-adjudicated, prospective, multicenter, randomized, single-blinded trial. Endpoints through 2 years included primary patency and a composite safety endpoint of freedom from device- and procedure-related death through 30 days, freedom from target limb major amputation and freedom from clinically-driven target vessel revascularization at 24 months.. One hundred patients were assigned by 2:1 randomization to treatment with the IN.PACT Admiral DCB (n = 68) or PTA (n = 32). The groups were well-matched at baseline. Mean lesion length for the DCB and PTA groups were 9.15 ± 5.85 and 8.89 ± 6.01 cm (P = 0.838), respectively. Patients treated with DCB exhibited superior 24-month primary patency compared to PTA (79.8% vs. 46.9%; log rank P < 0.001). The 24-month clinically driven target lesion revascularization rate was 9.1% for DCB versus 20.7% for PTA (P = 0.177). There were no device- or procedure-related deaths, major amputations, or thromboses in either group.. Two-year results from IN.PACT SFA Japan demonstrated persistently superior patency and low CD-TLR rates through 2 years when compared to uncoated PTA in Japanese patients. These data are consistent with other IN.PACT DCB trials.

Topics: Adult; Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Femoral Artery; Humans; Japan; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Progression-Free Survival; Prospective Studies; Risk Factors; Single-Blind Method; Time Factors; Vascular Access Devices; Vascular Patency; Young Adult

This study evaluated the 12-month safety and effectiveness of a paclitaxel drug-coated balloon for treatment of intermittent claudication or rest pain in subjects with femoropopliteal chronic total occlusions (CTO).. CTOs are difficult to treat, and the optimal intervention remains to be determined.. The IN.PACT Global Study is an international single-arm study that enrolled 1,535 patients with symptomatic femoropopliteal artery disease. The study contains prospectively defined cohorts with prospectively planned imaging analyses, including a CTO (≥5 cm) cohort in which subjects underwent duplex ultrasonography analyzed by an independent core laboratory. The primary safety endpoint was a composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and target vessel revascularization through 12 months. An independent Clinical Events Committee adjudicated all adverse events. The primary effectiveness endpoint was primary patency at 12 months, defined as freedom from clinically driven target lesion revascularization and freedom from restenosis.. The CTO imaging cohort had 126 subjects with 127 lesions (mean lesion length 22.83 ± 9.76 cm). Primary patency by Kaplan-Meier estimate was 85.3% through 12 months. Provisional stenting was performed in 46.8% of lesions. The primary safety composite endpoint was achieved by 88.7% of subjects. There were no device- or procedure-related deaths through 30 days or major target limb amputations through 12 months.. The paclitaxel drug-coated balloon was safe and highly effective at 12 months after treatment of subjects with CTO ≥5 cm in the femoropopliteal arteries. (IN.PACT Global Clinical Study; NCT01609296).

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Chronic Disease; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Progression-Free Survival; Prospective Studies; Recurrence; Risk Assessment; Risk Factors; Time Factors; Vascular Access Devices; Vascular Patency

Background While randomized trials have demonstrated the superiority of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal peripheral artery disease, the long-term durability of DCB angioplasty remains uncertain. Methods and Results IN.PACT SFA is a prospective, multicenter, randomized single-blinded trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 subjects with symptomatic (Rutherford 2-4) femoropopliteal lesions. Subjects were randomly assigned 2:1 to the IN.PACT Admiral DCB or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the primary safety end point, and major adverse events. Through 5 years, patients treated with the IN.PACT Admiral DCB demonstrated a sustained treatment effect with superior freedom from clinically driven target lesion revascularization when compared with PTA (Kaplan-Meier estimate of 74.5% versus 65.3%; log-rank P=0.020). The primary safety composite was achieved in 70.7% of subjects in the DCB and 59.6% in the PTA groups ( P=0.068). The major adverse event rate was 42.9% for DCB and 48.1% for PTA ( P=0.459). There were no device- or procedure-related deaths in either group as adjudicated by an independent and blinded Clinical Events Committee. Conclusions The IN.PACT SFA randomized trial demonstrates that the IN.PACT Admiral DCB continues to perform better than PTA through 5 years with higher freedom from clinically driven target lesion revascularization. The sustained safety and effectiveness profile of this DCB supports its use as a preferred treatment choice compared with PTA for femoropopliteal lesions. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT01175850 (IN.PACT SFA phase I) and NCT01566461 (IN.PACT SFA phase II).

Topics: Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Limb Salvage; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Progression-Free Survival; Prospective Studies; Risk Factors; Single-Blind Method; Time Factors; Vascular Access Devices; Vascular Patency

The purpose of this study was to assess the safety and performance of Stellarex Drug-coated balloon (DCB).. DCB coatings differ in excipients, paclitaxel dose, and coating morphologies. Due to these differences, a class effect with DCBs has not been demonstrated. Consequently, each DCB needs to be evaluated independently based on its own clinical study results.. The ILLUMENATE Global Study is a prospective, multicenter, single-arm study. Patients with intermittent claudication or ischemic rest pain due to superficial femoral artery (SFA) and/or popliteal peripheral artery disease (PAD) were treated with the Stellarex DCB. The primary efficacy endpoint was primary patency, defined as freedom from restenosis with peak systolic velocity ratio ≤2.5 or clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety endpoint was freedom from device and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and CD-TLR through 12 months.. In total, 417 lesions were treated in 371 patients. The mean lesion length was 7.5 ± 5.3 cm, 40.8% of lesions were severely calcified per core laboratory fluoroscopy criteria and 31.3% were total occlusions. Primary patency by independent duplex core lab evaluation was 81.4% and the freedom from CD-TLR was 94.8% day 365 per Kaplan-Meier estimate. The majority of patients experienced improvements in their Rutherford classification (90.3%) and walking impairment questionnaire score (83.6%) at 12 months compared to baseline.. This study validated previous positive findings and confirms the strong safety profile and effectiveness outcomes.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recovery of Function; Regional Blood Flow; Time Factors; Treatment Outcome; Vascular Access Devices

Randomized controlled trials have reported favorable 1-year outcomes with drug-coated balloons (DCBs) for the treatment of symptomatic peripheral arterial disease when compared with standard percutaneous transluminal angioplasty (PTA). Evidence remains limited on the durability of the treatment effect with DCBs in the longer term.. IN.PACT SFA is a single-blind, randomized trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 patients with symptomatic (Rutherford 2-4) femoropopliteal lesions up to 18 cm in length. Patients were randomized 2:1 to receive treatment with DCB or PTA. The 36-month assessments included primary patency, freedom from clinically driven target lesion revascularization, major adverse events, and functional outcomes. At 36 months, primary patency remained significantly higher among patients treated with DCB compared with PTA (69.5% versus 45.1%; log rank. Three-year results demonstrate a durable and superior treatment effect among patients treated with DCB versus standard PTA, with significantly higher primary patency and lower clinically driven target lesion revascularization, resulting in similar functional improvements with reduced need for repeat interventions.. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01175850 for IN.PACT SFA phase I in the European Union and NCT01566461 for IN.PACT SFA phase II in the United States.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Europe; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Single-Blind Method; Time Factors; Treatment Outcome; United States; Vascular Access Devices; Vascular Patency

To investigate the midterm safety and effectiveness of cilostazol treatment in claudicant patients undergoing endovascular therapy.. The Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) study ( ClinicalTrials.gov identifier NCT00912756; University Hospital Medical Information Network identifier UMIN000002091) enrolled 200 patients (mean age 73 years; 131 men) treated for femoropopliteal disease from March 2009 to April 2011 at 13 cardiovascular centers in Japan. The participants were randomized 1:1 to receive oral aspirin with or without cilostazol. Of the 100 patients assigned to the 2 treatment groups, 7 patients in the cilostazol group and 2 patients in the no-cilostazol group were withdrawn from the study without undergoing endovascular treatment, leaving 93 patients in the cilostazol group and 98 patients in the no-cilostazol group for follow-up analysis. The primary outcome measure was primary patency; secondary outcome measures were freedom from clinically-driven target lesion revascularization (CD-TLR) and overall survival. Outcomes were analyzed on an intention-to-treat basis using the Kaplan-Meier method; estimates were compared with the log-rank test.. The median follow-up was 38.1 months (interquartile range 25.1, 47.7). Among the 93 subjects in the cilostazol group, 7 died and 26 withdrew from administration 1 year after the endovascular procedure. Discontinuation of cilostazol was not a significant factor for restenosis. Primary patency was significantly higher in the cilostazol group than in the no-cilostazol group (69% vs 54%, p=0.026) at 3 years. The cilostazol group also had better 3-year freedom from CD-TLR (78% vs 63%, p=0.014), although overall survival estimates did not differ significantly (p=0.95).. These results suggest that the safety and effectiveness of cilostazol treatment were sustained in patients with femoropopliteal disease undergoing endovascular treatment.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Cilostazol; Female; Femoral Artery; Humans; Intermittent Claudication; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

The authors sought to evaluate the performance of the Ranger paclitaxel-coated balloon versus uncoated balloon angioplasty for femoropopliteal lesions at 12 months.. Drug-coated balloons (DCBs) are a promising endovascular treatment option for peripheral artery disease of the femoropopliteal segment, and each unique device requires dedicated clinical study.. The prospective, randomized RANGER SFA (Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries) study (NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2 to 4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68 ± 8 years, n = 53 men) were enrolled in the Ranger DCB arm, and 34 patients (mean age 67 ± 9 years, n = 23 men) were assigned to the control group. Twelve-month analysis included patency, safety, and clinical outcomes and quality-of-life assessments.. The DCB group had a greater primary patency rate at 12 months (Kaplan-Meier estimate 86.4% vs. 56.5%), with a significantly longer time to patency failure (log-rank p < 0.001). The estimated freedom from target lesion revascularization rate was 91.2% in the DCB group and 69.9% in the control group at 12 months, with a significantly longer time to reintervention (p = 0.010). No target limb amputations or device-related deaths occurred in either group.. Twelve-month results show that patency was maintained longer after Ranger DCB treatment than after conventional balloon angioplasty, and this result was associated with a low revascularization rate and good clinical outcomes.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Europe; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Recurrence; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Background The IN.PACT Global Study was an international prospective single-arm clinical trial to evaluate the safety and effectiveness of a drug-coated balloon in the treatment of atherosclerotic disease of the superficial femoral and/or popliteal arteries (P1-P3) in subjects with intermittent claudication and/or rest pain. Prespecified subjects were selected for core-laboratory-adjudicated duplex ultrasound imaging, including a subcohort with long lesions (≥15 cm). Methods and Results Subjects were followed for 12 months. The primary safety end point was a composite of freedom from device- and procedure-related mortality through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 12 months. An independent Clinical Events Committee adjudicated all adverse events. The primary effectiveness end point was primary patency at 12 months (by duplex ultrasound). The long lesion imaging cohort had 157 subjects (164 lesions). Mean lesion length was 26.40±8.61 cm. Provisional stents were implanted in 39.4% (63/160) of lesions. Primary patency by Kaplan-Meier estimate was 91.1%, and freedom from clinically-driven target lesion revascularization was 94.2% at 12 months. The primary safety composite end point was achieved by 94.0% (126/134) of subjects. There were no device- or procedure-related deaths or major target limb amputations. Conclusions The IN.PACT Admiral drug-coated balloon was safe and highly effective at 12 months after treatment in a rigorous independently adjudicated analysis of real-world subjects with lesions ≥15 cm in the superficial femoral and/or popliteal arteries (P1-P3). CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov . Unique identifier: NCT01609296.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices

New-generation bare-metal nitinol (BNS) and drug-eluting stents have improved long-term outcomes in patients undergoing endovascular therapy for femoropopliteal lesions. Furthermore, cilostazol reduces in-stent restenosis (ISR) after first-generation BNS implantation for femoropopliteal lesions.. We studied 255 patients with femoropopliteal lesions treated at 25 cardiovascular centers. Patients were randomly assigned to the BNS group (Misago stent implantation without cilostazol), BNS with cilostazol group (Misago stent implantation with cilostazol), or drug-eluting stents group (Zilver PTX stent implantation without cilostazol). Primary end point was 1-year restenosis noted using duplex ultrasound (peak systolic velocity ratio, >2.0). Secondary end point was major adverse limb events (limb-related death, target lesion revascularization, major amputation, and major bleeding). During the 1-year follow-up, 12 patients (4.7%) died and 237 (92.9%) had relevant ultrasound findings. The 1-year ISR rate did not differ significantly among the BNS, BNS with cilostazol, and drug-eluting stents groups (28.4% versus 12.2% versus 21.0%; P=0.052). Although the 1-year ISR rate was significantly lower in the BNS with cilostazol group than in the BNS group, it was similar to that in the drug-eluting stents group ( P=0.16). Major adverse limb event was significantly higher in the BNS group (16.9% versus 6.5% versus 6.3%; P=0.034); however, target lesion revascularization and major bleeding were similar (9.7% versus 5.1% versus 3.6%; P=0.25, 4.8% versus 1.2% versus 2.4%; P=0.37, respectively).. Misago stent implantation with cilostazol showed a comparable 1-year ISR rate with Zilver PTX. Cilostazol reduced the 1-year ISR rate after endovascular therapy when used with new-generation BNS.. URL: http://www.umin.ac.jp/ctr/ . Unique identifier: UMIN 000010071.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Cardiovascular Agents; Cilostazol; Double-Blind Method; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Limb Salvage; Male; Metals; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

The authors sought to investigate the midterm efficacy and safety of drug-coated balloon (DCB) in the treatment of severe femoropopliteal artery disease (FPAD).. The midterm outcome of DCB versus uncoated balloon percutaneous transluminal angioplasty (PTA) for FPAD are still debated.. A total of 200 Chinese patients with FPAD were prospectively randomized into treatment with DCB or with PTA. The primary efficacy endpoints were primary patency of the target lesion, freedom from clinically driven target lesion revascularization, improved ankle-brachial index, and improved Rutherford class at 24 months. The primary safety endpoint was the rate of major adverse events.. The DCB group and PTA group were comparable in demographic characteristics and clinical severity at baseline. At 24-month follow-up, primary patency was better in the DCB group versus PTA group (64.6% vs. 31.4%; p < 0.001). The DCB group had a higher rate of freedom from clinically driven target lesion revascularization than the PTA group (86.5% vs. 58.9%; p < 0.001). Rutherford class and ankle-brachial index also confirmed more improvements in the DCB group (p < 0.01 and p < 0.05, respectively). There was no significant difference in major adverse events.. The superiority of DCB versus PTA in the efficacy of FPAD treatment persists at 24-month follow-up and the safety of DCB is equivalent to that of PTA.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; China; Coated Materials, Biocompatible; Equipment Design; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Risk Factors; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The aim of this study was to assess the safety and effectiveness of a next-generation low-dose drug-coated balloon (DCB) designed to optimize the amount of drug transferred into the vessel wall and to maximize the amount of time the drug resides in the vessel wall.. Several randomized controlled studies evaluating various DCBs have demonstrated a significantly higher patency rate compared with noncoated percutaneous transluminal angioplasty balloons at 1 year. However, the data are limited and vary by DCB at longer follow-up time points. An earlier generation low-dose DCB failed to demonstrate significant treatment effect at 2 years, raising questions regarding the durability of low-dose DCBs.. In this prospective, multicenter trial, 294 patients were randomized (3:1) to treatment with a DCB or an uncoated percutaneous transluminal angioplasty balloon. Assessments at 2 years included primary patency with duplex ultrasonography, clinically driven target lesion revascularization, and functional outcomes.. Primary patency at 2 years was significantly higher in the DCB cohort (75.9% vs. 61.0%; p = 0.025), and the rate of clinically driven target lesion revascularization was significantly lower (12.1% vs. 30.5%; p < 0.001). There were no major limb amputations in either group. The rates of all-cause (6.5% vs. 5.1%; p = 1.00) and cardiovascular-related (1.6% vs. 1.7%; p = 1.00) mortality were similar between groups. Functional improvements over baseline were sustained in both groups, with 60% fewer reinterventions in the DCB group.. A sustained treatment effect is achievable with a low-dose DCB with an optimized coating formulation. This trial demonstrated for the first time a statistically significantly higher primary patency rate for a low-dose DCB versus PTA at 2 years. (CVI Drug Coated Balloon European Randomized Clinical Trial; NCT01858363).

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Europe; Female; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Recurrence; Risk Factors; Single-Blind Method; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Poland; Popliteal Artery; Prospective Studies; Single-Blind Method; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long.. The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0-58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI).. Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months.. In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.

Topics: Aged; Aged, 80 and over; Alloys; Angiography; Belgium; Cardiovascular Agents; Constriction, Pathologic; Critical Illness; Drug-Eluting Stents; Endovascular Procedures; Female; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

Clinical outcomes reported after treatment of infrapopliteal lesions with drug-eluting stents (DESs) have been more favorable compared with percutaneous transluminal angioplasty with a bailout bare metal stent (PTA-BMS) through midterm follow-up in patients with critical limb ischemia. In the present study, long-term results of treatment of infrapopliteal lesions with DESs are presented.. Adults with critical limb ischemia (Rutherford category ≥4) and infrapopliteal lesions were randomized to receive PTA-BMS or DESs with paclitaxel. Long-term follow-up consisted of annual assessments up to 5 years after treatment or until a clinical end point was reached. Clinical end points were major amputation (above ankle level), infrapopliteal surgical or endovascular reintervention, and death. Preserved primary patency (≤50% restenosis) of treated lesions was an additional morphological end point, assessed by duplex sonography. In total, 74 limbs (73 patients) were treated with DESs and 66 limbs (64 patients) were treated with PTA-BMS. The estimated 5-year major amputation rate was lower in the DES arm (19.3% versus 34.0% for PTA-BMS;. Both clinical and morphological long-term results after treatment of infrapopliteal lesions in patients with critical limb ischemia are improved with DES compared with PTA-BMS.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00471289.

Topics: Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Critical Illness; Disease-Free Survival; Drug-Eluting Stents; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Netherlands; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

Severe limb ischaemia (SLI) is defined as the presence of rest pain and/or tissue loss secondary to lower extremity atherosclerotic peripheral arterial disease. The superficial femoral and popliteal arteries are the most commonly diseased vessels in such patients and are being increasingly treated using endovascular revascularisation techniques. However, it is currently unknown whether drug-eluting stents and drug-coated balloons confer additional clinical benefits over more established techniques using plain balloons and bare metal stents, or whether they represent a cost-effective use of NHS resources.. The BASIL-3 trial is a UK National Institute for Health Research, Health Technology Assessment Programme-funded, multicentre, randomised controlled trial (RCT) comparing the clinical and cost-effectiveness of plain balloon angioplasty with or without bail-out bare metal stenting, drug-coated balloon angioplasty with or without bail-out bare metal stenting, and primary stenting with drug-eluting stents for SLI secondary to femoro-popliteal disease. Patients with 'multilevel' disease may receive aorto-iliac and/or infrapopliteal treatments concurrently with their randomised femoro-popliteal intervention. The primary clinical outcome is amputation-free survival defined as the time to major (above the ankle) amputation of the index limb or death from any cause. The primary outcome for the economic analysis is cost per quality-adjusted life year. Secondary outcome measures include overall survival, major adverse limb events, major adverse cardiac events, relief of ischaemic pain, healing of tissue loss, and quality of life. The required sample size has been calculated at 861 participants (287 on each arm). These patients will be recruited over 3 years and followed-up for between 2 and 5 years.. BASIL-3 is a pragmatic RCT designed to reflect current UK clinical practice. The results will inform decision-making regarding the appropriateness of funding the use of drug-coated balloons and drug-eluting stents, by the NHS, for the management of SLI due to femoro-popliteal disease.. ISRCTN Registry, identifier: ISRCTN14469736 . Registered on 22 October 2015.

Topics: Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Clinical Protocols; Coated Materials, Biocompatible; Cost-Benefit Analysis; Disease-Free Survival; Drug-Eluting Stents; Health Care Costs; Humans; Ischemia; Limb Salvage; Lower Extremity; Metals; Peripheral Arterial Disease; Prosthesis Design; Quality-Adjusted Life Years; Regional Blood Flow; Sample Size; Severity of Illness Index; State Medicine; Stents; Time Factors; Treatment Outcome; United Kingdom; Vascular Access Devices; Vascular Patency

To evaluate the performance of the Ranger paclitaxel-coated balloon vs uncoated balloon angioplasty for femoropopliteal lesions.. Between January 2014 and October 2015, the prospective, randomized RANGER SFA study ( ClinicalTrials.gov identifier NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2-4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68±8 years; 53 men) were enrolled in the Ranger drug-coated balloon (DCB) arm and 34 patients (mean age 67±9 years; 23 men) were assigned to the control group. Six-month analysis included angiographic late lumen loss and safety and clinical outcomes assessments.. Baseline characteristics of the DCB and control groups were similar, as were lesion lengths (68±46 vs 60±48 mm; p=0.731), severity of calcification (p=0.236), and the prevalence of occlusions (34% vs 34%; p>0.999). At 6 months, late lumen loss was significantly less for the DCB group vs controls (-0.16±0.99 vs 0.76±1.4; p=0.002). The DCB group had significantly greater freedom from binary restenosis (92% vs 64%; p=0.005) and primary patency rates (87% vs 60%; p=0.014). Target lesion revascularization rates were 5.6% in the DCB group and 12% in the control group (p=0.475). No target limb amputations or device-related deaths occurred in either group.. Six-month results suggest that Ranger DCB treatment effectively inhibited restenosis in symptomatic femoropopliteal disease, resulting in improved vessel patency and a low revascularization rate in the short term compared with uncoated balloon angioplasty.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Europe; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Recurrence; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Optimal medical therapy after endovascular therapy in patients with critical limb ischemia (CLI) remains unclear. Therefore, we investigated whether cilostazol reduce restenosis after balloon angioplasty for infrapopliteal lesions in CLI patients.. This study was performed as a multicenter, prospective, randomized, open-label, blinded-end point study with independent angiographic core laboratory adjudication. Sixty patients were eligible and 53 patients were enrolled and allocated. The primary end point was 3-month angiographic restenosis. The main secondary end points included major adverse limb event (MALE defined as requirement of any reintervention or major amputation), perioperative complications, major amputation, all-cause death, and hemorrhagic events.. A total of 53 patients were randomized and all received their allocated intervention. Two patients in the cilostazol plus aspirin group and 1 in the aspirin group did not undergo any angioplasty for infrapopliteal stenotic lesions, and therefore were excluded from analysis. Finally, 38 vessels in 25 patients in the cilostazol plus aspirin group and as many cases in the aspirin group were included in the analysis. There were no significant differences in baseline characteristics between the 2 groups. The 3-month restenosis rate was 82% in the cilostazol + aspirin group and 81% in the aspirin group, with no significant difference (P = 0.91). The MALE rate was 11% in the cilostazol plus aspirin group and 8% in the aspirin group (P = 0.73). In addition, no significant difference was observed in any secondary points.. Cilostazol did not reduce 3-month angiographic restenosis after balloon angioplasty for below-the-knee lesion in CLI patients.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angiography; Angioplasty, Balloon; Cardiovascular Agents; Cilostazol; Female; Humans; Ischemia; Japan; Leg; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Recurrence; Severity of Illness Index; Tetrazoles; Time Factors; Treatment Outcome

Drug-coated balloons (DCBs) are a predominant revascularization therapy for symptomatic femoropopliteal artery disease. Because of the differences in excipients, paclitaxel dose, and coating morphologies, varying clinical outcomes have been observed with different DCBs. We report the results of 2 studies investigating the pharmacokinetic and clinical outcomes of a new DCB to treat femoropopliteal disease.. In the ILLUMENATE Pivotal Study (Prospective, Randomized, Single-Blind, U.S. Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions With A Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon), 300 symptomatic patients (Rutherford class 2-4) were randomly assigned to DCB (n=200) or standard angioplasty (percutaneous transluminal angioplasty [PTA]) (n=100). The primary safety end point was freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months. The primary effectiveness end point was primary patency through 12 months. In the ILLUMENATE PK study (Pharmacokinetic Study of the Stellarex Drug-Coated Angioplasty Balloon), paclitaxel plasma concentrations were measured after last DCB deployment and at prespecified times (at 1, 4, 24 hours and at 7 and 14 days postprocedure) until no longer detectable.. The data demonstrate superior safety and effectiveness of the Stellarex DCB in comparison with PTA, and plasma levels of paclitaxel fall to low levels within 1 hour.. URL: http://clinicaltrials.gov. Unique identifiers: NCT01858428 and NCT01912937.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Half-Life; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Severity of Illness Index; Single-Blind Method; Time Factors; Treatment Outcome; Vascular Patency

Paclitaxel-eluting balloon (PEB) angioplasty has superior efficacy compared with conventional balloon angioplasty (BA) for de novo lesions of superficial femoral artery (SFA). Studies investigating the angiographic and clinical performance of PEB angioplasty versus BA for in-stent restenosis of SFA are limited. We performed a randomized trial to investigate angiographic and clinical performance of PEB versus BA for in-stent restenosis of SFA.. Patients with symptomatic in-stent restenosis of SFA were randomly assigned to either PEB or BA at 2 centers in Munich, Germany. The primary end point was the percentage diameter stenosis at 6- to 8-month follow-up angiography. Secondary end points were the rate of binary restenosis at follow-up angiography and target lesion revascularization, target vessel thrombosis, ipsilateral amputation, bypass surgery of the affected limb, and all-cause mortality at 24-month follow-up. Seventy patients were assigned to PEB (n=36) or BA (n=34). Mean lesion length was 139±67 mm, and roughly one third of lesions were completely occluded at the time of the index procedure. At control angiography, the percentage diameter stenosis (44±33% versus 65±33%,. In patients with in-stent restenosis of SFA, a percutaneous therapy with PEB compared with BA has superior angiographic performance at 6 to 8 months and improved clinical efficacy up to 24-month follow-up.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01083394.

Topics: Aged; Aged, 80 and over; Angiography; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Disease-Free Survival; Endovascular Procedures; Equipment Design; Female; Femoral Artery; Germany; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Recurrence; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To report a randomized trial comparing the Legflow paclitaxel-eluting balloon (PEB) + Supera stenting to Supera stenting alone in patients with intermediate to long superficial femoral artery (SFA) lesions.. The multicenter RAPID trial ( controlled-trials.com ; identifier ISRCTN47846578) randomized (1:1) 160 patients (mean age 67 years; 102 men) with Rutherford category 2-6 ischemia to treatment with Legflow PEB + Supera stent or Supera stent alone in intermediate to long SFA lesions (mean lesion length 15.8±7.4 vs 15.8±7.6 cm, respectively). The efficacy outcome was primary patency, defined as freedom from restenosis on duplex ultrasound or angiography.. Baseline characteristics including the percentage of occlusions were similar between groups. In the intention-to-treat analysis, the estimated primary patency at 1 year was 68.3% (95% CI 56.7% to 79.9%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the Supera group (p=0.900). Per-protocol analysis showed a 12-month primary patency estimate of 74.7% (95% CI 63.1% to 86.3%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the control group (p=0.273). Secondary patency estimates at 12 months (per-protocol analysis) were 89.0% (95% CI 80.6% to 97.4%) vs 98.0% (95% CI 94.1% to 100%; p=0.484); the estimates for freedom from clinically driven target lesion revascularization (CD-TLR) were 83.0% (95% CI 72.8% to 93.2%) and 77.8% (95% CI 66.6% to 89.0%; p=0.277), respectively.. The short-term results from the multicenter RAPID randomized controlled trial indicate that the Legflow PEB is safe and feasible for the treatment of intermediate to long SFA lesions. In this trial, at least 70% of the patients suffered an occlusion. The PEB group had higher rates of primary patency and freedom from CD-TLR, although there were no statistically significant differences vs controls.

Topics: Aged; Alloys; Angiography; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Femoral Artery; Germany; Humans; Male; Middle Aged; Netherlands; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices; Vascular Patency

The optimal endovascular treatment for femoropopliteal arterial occlusive disease has yet to be assessed. Patency rates after uncoated balloon angioplasty are disappointing. Although stents have better outcomes, they also have limitations. Intra-arterial stenting may lead to stent thrombosis and flow pattern disruption, which may result in stent fracture or in-stent restenosis. In the past decade, drug-eluting balloons (DEBs) and drug-eluting stents (DESs) have been introduced, and both have been proven to possess antirestenotic features compared with conventional techniques. The objective of this study is to perform a noninferiority analysis of DEBs with provisional bare-metal stenting and primary stenting with DESs in the treatment of femoropopliteal arterial occlusive disease. If DEB with provisional bare-metal stenting proves to be noninferior to primary stenting with DESs, DEBs may be the favorable technique because the postoperative long-term limitations of stents will be restricted. This is a prospective, randomized, controlled, single-blind, multicenter trial. The study population consists of volunteers aged ≥18 years, with chronic, symptomatic peripheral arterial occlusive disease (Rutherford-Baker classification 2 to 5) caused by de novo stenotic or occlusive atherosclerotic lesions of the superficial femoral artery or of the popliteal artery (only segment P1). Subjects will be treated with a DEB and provisional bare-metal stenting (if a stenosis >30% or a flow-limiting dissection persists after prolonged inflation with an uncoated balloon) or with primary stenting with a DES. The study will include 254 patients (ratio 1:1). The primary end point is 2-year freedom from binary restenosis, defined as a lumen diameter reduction of <50% assessed by duplex ultrasound imaging (peak systolic velocity ratio <2.5). Secondary end points are technical success, target lesion revascularization, target vessel revascularization, improvement in ankle-brachial index, improvement in Rutherford classification, amputation rate, and mortality rate.

Topics: Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Clinical Protocols; Coated Materials, Biocompatible; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Femoral Artery; Humans; Peripheral Arterial Disease; Prosthesis Design; Recovery of Function; Recurrence; Research Design; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices

Studies assessing drug-coated balloons (DCB) for the treatment of femoropopliteal artery disease are encouraging. However, challenging lesions, such as severely calcified, remain difficult to treat with DCB alone. Vessel preparation with directional atherectomy (DA) potentially improves outcomes of DCB.. DA+DCB treatment was effective and safe, but the study was not powered to show significant differences between the 2 methods of revascularization in 1-year follow-up. An adequately powered randomized trial is warranted.. http://www.clinicaltrials.gov. Unique Identifier: NCT01366482.

Topics: Aged; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Europe; Female; Humans; Intermittent Claudication; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Pilot Projects; Prospective Studies; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Calcification; Vascular Patency

The superiority of drug eluting stents versus bare metal stents or balloon angioplasty in the treatment of patients with critical limb ischemia and infrapopliteal lesions has been established. However, only shorter lesions were evaluated. This study was designed to evaluate the immediate and long-term (up to 12 months) outcome of the Xience Prime™ Everolimus-Eluting Coronary Stent System (Abbott Vascular) in a controlled, prospective, multi-center investigation for long lesions up to 10 cm.. All patients with critical limb ischemia and long infrapopliteal lesions between 30 and 100 mm, who met the inclusion criteria, were included in this study. The primary endpoint was primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion based on quantitative analysis of contrast angiography.. Between August 2011 and October 2013, 60 patients were enrolled in this study with a mean lesion length of 47.40±25.06 mm (range 2-100 mm). The primary patency rate at 12 months was 75.4%. Freedom from target lesion revascularization was 84.9%. The amputation rate was rare (94.4% freedom from amputation). At the 12-month follow-up time point, a total of 36 out of 42 (85.7%) patients improved in their Rutherford classification by at least 1 class.. The use of everolimus-eluting stents in longer infrapopliteal lesions in the treatment of critical limb ischemia is safe and effective with a comparable primary patency, freedom from target lesion revascularization and amputation free survival as in short lesions.

Topics: Adult; Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty; Australia; Belgium; Cardiovascular Agents; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Germany; Humans; Ischemia; Kaplan-Meier Estimate; Leg; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency; Young Adult

Several trials have shown that drug coated balloon (DCB) angioplasty reduce the rates of restenosis in the femoropopliteal artery. This controlled, prospective, multicenter study was designed to demonstrate the efficacy of DCB to inhibit restenosis of the infrainguinal arteries in an exclusive diabetic population.. Between 2012 and 2014, 106 diabetic patients with symptomatic peripheral arterial disease (PAD) were enrolled at 11 sites in Belgium, 54 treated with DCB angioplasty and 52 treated with plain old balloon angioplasty (POBA). The primary endpoint of the study are the primary patency, mean diameter restenosis and binary restenosis of the treated sites at 6 months without re-intervention in the interim.. The 6-month mean diameter restenosis was significantly lower in the DCB arm than in the POBA group (29±36% vs. 46±35%, P=0.032) and the binary (≥50% diameter stenosis) restenosis rate was signicantly lower in DCB patients compared with the POBA's (27% vs. 49%, P=0.03). The primary patency was significantly better in the paclitaxel coated balloon group (73% vs. 51%, P=0.03). The 6-month adverse effects rates were 5.5% in the POBA and 5.7% in the DCB arm.. The treatment of diabetic PAD of the infra-inguinal arteries with the DCB provides a bettter primary patency rate compared with the plain old balloon angioplasty. The use of DCB did not increase the number of major adverse clinical events when compared with those seen with the use of the uncoated balloons.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Belgium; Cardiovascular Agents; Coated Materials, Biocompatible; Diabetic Angiopathies; Equipment Design; Female; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Recurrence; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Cilostazol improves clinical endovascular therapy outcomes for femoropopliteal (FP) lesions in patients with symptomatic peripheral arterial disease, but whether it also has clinical benefits for patients after drug-eluting stent implantation remains unclear.. This study is a subanalysis of the ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy (ZEPHYR) study, a prospective multicenter study investigating FP lesions treated with the Zilver (Cook Medical, Bloomington, Ind) paclitaxel-eluting stent. The present study analyzed 475 lesions in 459 limbs of 399 patients who maintained therapy with aspirin and thienopyridine, with or without cilostazol, during the 1-year follow-up period.. Restenosis rates at 1 year were assessed with duplex ultrasound imaging (peak systolic velocity ratio >2.4) or angiography (≥50% diameter stenosis) and compared in the groups with and without cilostazol. Propensity score matching was performed to minimize intergroup differences in baseline characteristics. The present study included 93 cilostazol-treated and 382 cilostazol-free cases. Among the patients, 71% had diabetes mellitus and 31% were on dialysis. Critical limb ischemia accounted for 29% of cases. The prevalence of de novo lesions was 76%, and in-stent restenosis was present in 15%. Propensity score matching was performed in 91 pairs. The 1-year restenosis rate was 33% (95% confidence interval [CI], 23%-43%) in the cilostazol-treated group and 51% (95% CI, 41%-62%) in the cilostazol-free group (P = .008). The odds ratio was 0.5 (95% CI, 0.3-0.8).. The propensity score-matching analysis demonstrated that additional cilostazol administration was associated with a significantly lower restenosis incidence 1 year after drug-eluting stent implantation for FP lesions.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Cilostazol; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Logistic Models; Male; Middle Aged; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Popliteal Artery; Propensity Score; Prospective Studies; Prosthesis Design; Recurrence; Registries; Risk Factors; Tetrazoles; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

To examine the effects of physical therapy (kinesitherapy and electrotherapeutic procedures) on the course of peripheral arterial occlusive disease by monitoring the changes in values of claudication distance and ankle-brachial indexes.. Prospective randomized study included 47 patients with peripheral arterial occlusive disease manifested by intermittent claudications associated with ankle-brachial indexes values ranging from 0.5 to 0.9. Patients from the first group (25 pts) were treated with medicamentous therapy, walking exercises beyond the pain threshold, dynamic low-burden kinesi exercises and electrotherapeutic ageneses (interference therapy, diadynamic therapy, and electromagnetic field), while the second group of patients (22 pts) was treated with "conventional" non-operative treatment - medicamentous therapy and walking exercises. The values of newly established absolute claudication distance and ankle-brachial indexes were measured.. Significant increase of absolute claudication distance in both groups of patients was registered, independently of therapeutic protocol applied (p < 0.001), as well as the increase in the claudication distance interval in the physical therapy group. There was no significant increase in ankle-brachial indexes values in both groups of patients.. Methods of physical therapy presented valuable supplement in non-operative treatment of peripheral arterial occlusive disease patients, improving their functional ability and thus postponing surgical treatment. However, further investigations including larger number of patients are needed.

Topics: Aged; Ankle Brachial Index; Cardiovascular Agents; Electric Stimulation Therapy; Exercise Therapy; Exercise Tolerance; Female; Humans; Intermittent Claudication; Magnetic Field Therapy; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Recovery of Function; Serbia; Time Factors; Treatment Outcome; Walking

Topics: Cardiovascular Agents; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Humans; Neointima; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

To report a subanalysis of the German centers enrolling patients in the prospective, global, multicenter, randomized LEVANT 2 pivotal trial (ClinicalTrials.gov identifier NCT01412541) of the Lutonix drug-coated balloon (DCB) for the treatment of femoropopliteal occlusive disease.. Among the 476 patients in LEVANT 2, 126 patients (mean age 67.1±9.6 years; 79 men) were enrolled at the 8 participating German sites between August 2011 and July 2012 and were randomized 2:1 to treatment with the Lutonix DCB (n=83) vs an uncoated balloon during percutaneous transluminal angioplasty (PTA, n=43). All patients had intermittent claudication or rest pain (Rutherford categories 2-4). Average lesion length was 58 mm and average treated length was 100 mm. Severe calcification was present in 11% of lesions, and 23% were total occlusions. The efficacy outcome was primary patency at 12 months, and the safety outcome was 12-month freedom from a composite of perioperative death, index limb-related death, amputation (below or above the ankle), and index limb revascularization. Secondary endpoints included target lesion revascularization (TLR), major adverse events, and functional outcomes.. Demographic, clinical, and lesion characteristics were matched between Lutonix DCB and PTA groups, as were the final percent diameter stenosis (19%) and procedure success (91%). By Kaplan-Meier analysis, the 12-month primary patency rate was 80% vs 58% (p=0.015) and the composite safety endpoint rate was 94% vs 72% (p=0.001), respectively. Freedom from TLR was higher for DCBs (96%) vs PTA (82%, p=0.012). Major adverse events were similar for both groups. The benefit favoring DCB over PTA was observed in German men and women. Compared to the non-German LEVANT 2 cohort, there was a shorter time between insertion and inflation of treatment balloons (21.8 vs 39.5 seconds, p<0.001) in the German cohort. Balloons were inflated to higher pressures (9.0 vs 7.7 atm, p<0.001) but for a shorter period of time (130 vs 167 seconds, p<0.001), and although treated lesions in the German cohort had a higher baseline stenosis, final postprocedure diameter stenosis was lower (19% vs 22%, p=0.04) than in the non-German patients.. Superiority of DCB over PTA in the German cohort of LEVANT 2 was demonstrated for primary patency, composite safety, and freedom from TLR. The benefit of DCB was also consistent for both genders. Geographic or regional differences in procedural variables may account for the different outcomes between the German and non-German cohorts.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Germany; Humans; Intermittent Claudication; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Recurrence; Single-Blind Method; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To report the 12-month results of the MAJESTIC clinical study of the self-expanding Eluvia paclitaxel-eluting stent in the treatment of femoropopliteal lesions.. The prospective, single-arm, multicenter trial (clinicaltrials.gov identifier NCT01820637) enrolled 57 patients (mean age 69±9 years; 47 men) with chronic lower limb ischemia referable to de novo or restenotic lesions in the native superficial femoral and/or proximal popliteal arteries. A third of the patients had diabetes. Mean lesion length was 70.8±28.1 mm, and diameter stenosis was 86.3%±16.2%; 26 (46%) lesions were occluded. Primary patency was defined as duplex ultrasound peak systolic velocity ratio ≤2.5 and the absence of target lesion revascularization (TLR) or bypass. Major adverse events (MAEs) included all-cause death through 1 month and target limb major amputation and TLR through 12 months.. All 57 patients had a single Eluvia stent implanted, employing pre- and postdilation in 93% (53/57) and 95% (54/57) of cases, respectively. Technical success was 97% (55/57; 2 failures due to residual stenosis >30%). At 12 months, primary patency was 96% (49/51) and the MAE rate was 4% (2/53); both MAEs were TLRs. No stent fractures were identified. There were no major amputations. One death occurred 368 days postprocedure, unrelated to the device or procedure. Improvements in the Rutherford category were sustained through 1 year, with 81% (43/53) exhibiting no symptoms (category 0) and 13% (7/53) presenting with mild claudication (category 1). Mean ABI improved from 0.73±0.22 at baseline to 1.02±0.20 at 12 months.. MAJESTIC results showed that patients whose femoropopliteal arteries were treated with the Eluvia drug-eluting stent sustained high patency and low MAE rates through 12 months.

Topics: Aged; Alloys; Ankle Brachial Index; Australia; Blood Flow Velocity; Cardiovascular Agents; Chronic Disease; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; New Zealand; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Regional Blood Flow; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

This is the first-in-human study of a drug-eluting bioresorbable vascular scaffold (BVS) for treatment of peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA).. Drug-eluting BVS has shown promise in coronary arteries.. The ESPRIT BVS system is a device-drug combination consisting of an everolimus-eluting poly-l-lactide scaffold. Safety and performance were evaluated in 35 subjects with symptomatic claudication.. Lesions were located in the SFA (88.6%) and EIA (11.4%). Mean lesion length was 35.7 ± 16.0 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in 3 patients (groin hematoma, dissection). Within 2 years there was 1 unrelated death, but no patients in this cohort had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively, and target lesion revascularization was performed in 3 of 34 patients (8.8%) and 4 of 32 patients (11.8%), respectively. The ankle brachial index 0.75 ± 0.14 improved from pre-procedure to 0.96 ± 0.16 at 2 years' follow-up. At 2 years, 71.0% of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet.. The safety of the ESPRIT BVS was demonstrated with no procedure or device-related deaths or amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 2-years. (A Clinical Evaluation of the Abbott Vascular ESPRIT BVS [Bioresorbable Vascular Scaffold] System [ESPRIT I]; NCT01468974).

Topics: Absorbable Implants; Aged; Angiography; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Coated Materials, Biocompatible; Everolimus; Exercise Tolerance; Feasibility Studies; Female; Femoral Artery; Humans; Iliac Artery; Intermittent Claudication; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Recovery of Function; Recurrence; Retreatment; Risk Factors; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

The hypothesis that paclitaxel-eluting balloon angioplasty provides higher 1-year patency rates in femoropopliteal artery in-stent restenosis compared with standard percutaneous transluminal angioplasty (PTA) was tested.. Several trials have demonstrated that paclitaxel-eluting balloon angioplasty reduces late luminal loss in comparison with PTA.. In a prospective, randomized, single-blind, dual-center study, 74 patients with symptomatic peripheral artery disease due to in-stent restenosis were treated with either paclitaxel-based drug-eluting balloon (DEB) angioplasty (n = 35) or standard PTA (n = 39). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months.. The mean lesion length was 17.3 ± 11.3 cm in the DEB group and 18.4 ± 8.8 cm in the PTA group. A single major complication (bleeding) was observed once (1.4%). The mean ankle-brachial index before endovascular treatment was 0.65 ± 0.16 in both groups and 0.79 ± 0.2 versus 0.84 ± 0.3 (p = 0.70, Student t test) in the DEB versus PTA group at 12 months. The 12-month primary patency rates were 40.7% (95% confidence interval [CI]: 0.26 to 0.64) versus 13.4% (95% CI: 0.05 to 0.36) (log-rank p = 0.02) in the DEB versus PTA group. The odds ratio for PTA over DEB angioplasty for experiencing an event was estimated at 2.8 (95% CI: 1.2 to 6.6). Freedom from clinically driven target lesion revascularization was 49.0% (95% CI: 0.32 to 0.75) versus 22.1% (95% CI: 0.10 to 0.48) (log-rank p = 0.11) in the DEB versus PTA group. Clinical improvement by ≥1 Rutherford-Becker category was 68.8% versus 54.5% (p = 0.87) in the DEB versus PTA group at 12 months.. When treating peripheral artery disease in patients with in-stent restenosis in the femoropopliteal artery, paclitaxel-eluting balloon angioplasty provides significantly higher patency rates than standard PTA. (Paclitaxel Balloon Versus Standard Balloon in In-Stent Restenoses of the Superficial Femoral Artery [PACUBA I Trial] [PACUBA 1]; NCT01247402).

Topics: Aged; Angioplasty, Balloon; Ankle Brachial Index; Austria; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Recurrence; Retreatment; Risk Factors; Single-Blind Method; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The aim of this study was to investigate the efficacy and safety of a new paclitaxel-coated balloon catheter in the treatment of stenotic or occluded femoropopliteal arteries.. The incidence of restenosis can be reduced by the use of drug-coated balloons. However, dose, coating composition, and technology are decisive for efficacy.. Two hundred Chinese patients with peripheral arterial occlusive disease were prospectively randomized to treatment with new paclitaxel-coated or standard uncoated balloon catheters. The primary endpoint was angiographic late lumen loss at 6 months, measured by a blinded core laboratory. Secondary angiographic endpoints (6 months) and specific clinical endpoints (1 year) were binary restenosis, ankle-brachial index, Rutherford stage, clinically driven target lesion revascularization, and amputation.. Patients' mean age was 66 years, 74% were men, 31% were smokers, and 55% had diabetes. Patients were in Rutherford stages 2 through 5, with a mean lesion length of 150 mm; 25% had in-stent restenosis, 55% had occlusion or partial occlusion, and 20% underwent provisional stenting. Late lumen loss at 6 months was available for 89%, and clinical follow-up was available for >95% per group. Mean late lumen loss was 0.05 ± 0.73 mm with coated balloons and 1.15 ± 0.89 mm with uncoated balloons (p < 0.001). Correspondingly, the rates of restenosis were 22.5% and 70.8% (p < 0.001). After 1 year, the rates of target lesion revascularization were 7.2% and 39.6% (p < 0.001), and Rutherford class and ankle-brachial index improved more markedly in the coated group (p < 0.046 and p = 0.023, respectively). One major amputation was recorded in the control group. No coating-related adverse events were observed for doses of up to 43 mg paclitaxel per patient.. In this medium-sized trial with long superficial femoral artery lesions, the use of paclitaxel-coated balloon catheters markedly improved angiographic and clinical outcomes of interventions despite advanced disease in the majority of patients.

Topics: Aged; Amputation, Surgical; Angiography; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; China; Coated Materials, Biocompatible; Equipment Design; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Recurrence; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The aim of this study was to evaluate the safety and efficacy of percutaneous catheter-delivered ultrasound energy to improve local paclitaxel delivery effects in patients with critical limb ischemia (CLI) treated for femoral-popliteal arterial disease.. Treatment of patients with CLI continues to be the greatest challenge in peripheral artery disease; in particular, treatment of femoral-popliteal chronic total occlusion is characterized by poor primary patency.. This single-center, single-blind, randomized trial included 56 patients with CLI randomly assigned to treatment in 2 groups: 28 patients (the control group) were treated with drug-eluting balloons, and 28 patients (the study group) were treated with intravascular ultrasound using the CardioProlific Genesis System followed by local administration of a liquid mixture of iopromide 370 and paclitaxel 1.0 μg/mm. No adverse procedural events were observed; all 56 patients tolerated the procedure well. At 6-month follow-up, no myocardial infarction, deaths, or amputations were observed in either group. In the study group, the rate of restenosis at 6 months was 3.6% (1 of 28), and the rate of target lesion revascularization (TLR) was 0% (0 of 28); at 12 months, the rate of TLR was 3.8% (1 of 26), and the rate of amputation was 0% (0 of 26). In the control group, the rate of restenosis at 6 months was 21.4% (6 of 28), and the rate of TLR was 10.7% (3 of 28); at 12 months, the rate of TLR was 36% (9 of 25), and the rate of amputation was 16% (4 of 25).. This study demonstrates encouraging results at 6- and 12-month follow-up in patients treated with ultrasound and paclitaxel compared with drug-eluting balloons. Larger multicenter studies are required to validate this approach.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Catheterization, Peripheral; Coated Materials, Biocompatible; Constriction, Pathologic; Critical Illness; Equipment Design; Female; Femoral Artery; Humans; Ischemia; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Single-Blind Method; Time Factors; Treatment Outcome; Ultrasonic Therapy; Ultrasonography, Interventional; Vascular Access Devices; Vascular Patency

The aim of this investigator-initiated trial is to evaluate the safety and efficacy of the novel Luminor® paclitaxel-coated drug-eluting balloon (DEB) catheter (iVascular, S.L.U., Barcelona, Spain) in inhibiting restenosis and in ensuring long-term vascular patency.. This is a multicenter randomized controlled trial to evaluate the Luminor® paclitaxel-coated DEB catheter for stenotic or occlusive lesions (length ≤15 cm) in the superficial femoral artery (SFA) and the popliteal artery (PA) up to the P1 segment compared to the noncoated, plain old balloon angioplasty (POBA) catheter. In total 172 subjects will be treated with either the DEB catheter or the POBA catheter in 11 German study centers in a 1:1 randomization study design. The primary endpoint is late lumen loss (LLL) at 6 months. Secondary endpoints are patency rate, target lesion/vessel revascularization, quality of life (assessed with the Walking Impairment Questionnaire (WIQ) and the EQ-5D), change of Rutherford stage and ankle-brachial index, major and minor amputation rate at the index limb, number of dropouts and all-cause mortality.. EffPac represents a randomized controlled trial that will provide evidence on the effectiveness of the Luminor® paclitaxel-coated DEB catheter for the reduction of restenosis compared to the POBA catheter for the SFA and the PA. The results of EffPac will allow direct comparison to other already-completed RCTs applying paclitaxel-coated DEBs from different manufacturers with different coating technologies in the same target vessel.. ClinicalTrials.gov Identifier: NCT02540018 , registered on 17 August 2015. Protocol version: CIP Version Final04, 11 February 2016. EUDAMED No: CIV-15-03-013204.

Topics: Angiography, Digital Subtraction; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Clinical Protocols; Coated Materials, Biocompatible; Computed Tomography Angiography; Constriction, Pathologic; Exercise Tolerance; Female; Femoral Artery; Germany; Humans; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Quality of Life; Recovery of Function; Recurrence; Research Design; Risk Factors; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices; Vascular Patency; Walking

The aim of this study was to evaluate the cost-effectiveness of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA).. Recent trials have reported lower rates of target lesion revascularization with DCB angioplasty versus standard PTA. However, the cost-effectiveness of DCB angioplasty is unknown.. A prospective economic study was performed alongside the IN.PACT SFA II (IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA]) trial, which randomized 181 patients with femoropopliteal disease to the IN.PACT DCB versus standard PTA. Resource use data were collected over 2-year follow-up, and costs were assigned using resource-based accounting and billing data. Health utilities were assessed using the EuroQol 5-dimensions questionnaire. Cost-effectiveness was assessed as cost per quality-adjusted life-year (QALY) gained using a decision-analytic model on the basis of empirical data from the trial assuming identical long-term mortality.. Initial costs were $1,129 per patient higher with DCB angioplasty than standard PTA, driven by higher costs for the DCB itself. Between discharge and 24 months, target limb-related costs were $1,212 per patient lower with DCB angioplasty such that discounted 2-year costs were similar for the 2 groups ($11,277 vs. $11,359, p = 0.97), whereas QALYs tended to be greater among patients treated with DCBs (1.53 ± 0.44 vs. 1.47 ± 0.42, p = 0.40). The probability that DCB angioplasty is cost-effective compared with standard PTA was 70% using a threshold of $50,000 per QALY gained and 79% at a threshold of $150,000 per QALY gained.. For patients with femoropopliteal disease, DCB angioplasty is associated with better 2-year outcomes and similar target limb-related costs compared with standard PTA. Formal cost-effectiveness analysis on the basis of these results suggests that use of the DCB angioplasty is likely to be economically attractive.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Cost Savings; Cost-Benefit Analysis; Decision Support Techniques; Drug Costs; Equipment Design; Female; Femoral Artery; Health Care Costs; Humans; Male; Middle Aged; Models, Economic; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Quality-Adjusted Life Years; Time Factors; Treatment Outcome; United States; Vascular Access Devices

The purpose of this study was to evaluate the 5-year follow-up (FU) data of the THUNDER (Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries).. The THUNDER trial was the first study to investigate the treatment of femoropopliteal arteries with a paclitaxel-coated balloon (PCB).. In 154 patients, femoropopliteal arteries were treated with PCB, with angioplasty with paclitaxel in contrast medium, or no paclitaxel (control). The primary endpoint was 6-month late lumen loss (LLL). Secondary endpoints included freedom from target lesion revascularization (TLR), binary restenosis rate, and amputation. The 5-year FU compares outcomes in patients treated with PCB and control subjects. Additionally, LLL at 6 months and TLR up to 5-year FU were analyzed in terms of sex and lesion length.. Over the 5-year period, the cumulative number of patients with TLR remained significantly lower in the PCB group (21%) than in the control group (56%, p = 0.0005). In the small group of patients with angiographic and duplex sonographic follow-up, PCB was associated with a lower rate of binary restenosis (17% vs. 54%; p = 0.04). No signs of aneurysm formation or constrictive fibrosis were detected. Whereas LLL at 6-month FU did not differ between men and women in the PCB group, the TLR rate was lower in men than in women at 5-year FU. A benefit of PCB treatment in terms of LLL and TLR was seen independent of lesion length.. The reduced TLR rate following PCB treatment was maintained over the 5-year FU period. No signs of drug-related local vessel abnormalities were detected. (Thunder Trial-Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries [THUNDER]; NCT00156624).

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Radiography; Recurrence; Risk Factors; Sex Factors; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices

To assess the safety and effectiveness of the Stellarex™ drug-coated angioplasty balloon (DCB) to inhibit restenosis in the superficial femoral and/or popliteal artery.. Treatment of peripheral arterial disease is challenged by restenosis, requiring revascularization procedures to maintain patency. DCBs are designed to deliver an anti-proliferative drug to the vessel wall to diminish smooth muscle cell proliferation and maintain patency.. This prospective, single-arm, multicenter study enrolled 50 patients with 58 lesions in the first cohort that required pre-dilatation with an uncoated angioplasty balloon prior to inflation of the DCB. The primary effectiveness endpoint was 6-month late lumen loss (LLL). The major secondary endpoint was major adverse event (MAE) rate at 6 months, defined as cardiovascular death, amputation, and/or ischemia-driven target lesion revascularization.. The mean lesion length was 7.2 cm and baseline stenosis was 75.1%. Calcification was present in 62.1% of lesions and 12.1% were occluded. Both endpoints met their prespecified performance goals; at 6 months, the MAE rate was 4% and the mean LLL was 0.54 mm. The primary patency rate was 89.5% at 12 months and 80.3% at 24 months. The freedom from clinically-driven target lesion revascularization rate, per Kaplan-Meier estimate, was 90.0% at 12 months and 85.8% at 24 months. Additionally, there were no amputations or cardiovascular deaths reported through 24 months.. The Stellarex DCB provides safe and durable clinical outcomes for treatment of femoropopliteal artery disease through 24 months.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Disease-Free Survival; Female; Femoral Artery; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Radiography; Recurrence; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To evaluate the safety and efficacy of the novel Passeo-18 Lux paclitaxel-coated balloon compared with the Passeo-18 uncoated balloon in patients with symptomatic de novo or restenotic femoropopliteal lesions.. Sixty patients (34 men; mean age 70.7 ± 10.1 years) in 5 European centers were enrolled in the BIOLUX P-I trial (ClinicalTrials.gov identifier NCT01056120) and randomized 1:1 to either the paclitaxel-coated balloon or the uncoated balloon. The primary endpoint was late lumen loss at 6 months. Secondary endpoints were binary restenosis at 6 months, clinically driven target lesion revascularization (TLR), change in ankle-brachial index and Rutherford classification, and major adverse events at 6 and 12 months.. At 6 months, patients treated with paclitaxel-coated balloons had a significantly lower late lumen loss (0.51 ± 0.72 vs. 1.04 ± 1.00 mm, p = 0.033) and binary restenosis (11.5% vs. 34.6%, p = 0.048) than the control group. Correspondingly, clinically driven TLR was lower in the paclitaxel-coated balloon group at 12 months [15.4% vs. 41.7% (p = 0.064) for the intention-to-treat population and 16.0% vs. 52.9%, (p = 0.020) for the as-treated population]. No death and one minor amputation were observed compared with two deaths and two minor amputations in the control group. No major amputations or thrombosis were reported.. The Passeo-18 Lux paclitaxel-coated balloon has been proven to be safe and effective in patients with femoropopliteal lesions, with superior performance outcomes compared with treatment with an uncoated balloon.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Ankle Brachial Index; Austria; Butyrates; Cardiovascular Agents; Coated Materials, Biocompatible; Excipients; Female; Femoral Artery; Follow-Up Studies; Germany; Humans; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Radiography; Treatment Outcome

The aim of BIOLUX P-II (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries) trial was to compare the safety and efficacy of a novel paclitaxel-coated drug-eluting balloon (DEB) versus an uncoated balloon (percutaneous transluminal angioplasty [PTA]) in de novo or native restenotic lesions of the infrapopliteal arteries in patients with claudication and critical limb ischemia.. DEB have shown promising results in femoropopliteal lesions, but data for infrapopliteal lesions are scarce.. In this prospective, multicenter, randomized first-in-man study, 72 patients were randomized 1:1 to either a Passeo-18 Lux DEB (Biotronik AG, Buelach, Switzerland) (n = 36) or Passeo-18 PTA (n = 36). Follow-up assessments were scheduled at 1, 6, and 12 months, with angiographic assessment at 6 months. Adverse events were adjudicated by an independent clinical events committee, and angiographic parameters were assessed by an independent core laboratory.. The primary safety endpoint (a composite of all-cause mortality, target extremity major amputation, target lesion thrombosis, and target vessel revascularization at 30 days) was 0% in the DEB group versus 8.3% in the PTA group (p = 0.239). The primary performance endpoint (patency loss at 6 months) was 17.1% in the DEB group versus 26.1% in the PTA group (p = 0.298), and major amputations of the target extremity occurred in 3.3% versus 5.6% of the patients at 12 months, respectively.. The Passeo-18 Lux DEB has been proven to be safe and effective in infrapopliteal lesions with comparable outcomes to PTA.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Critical Illness; Equipment Design; Female; Humans; Intermittent Claudication; Ischemia; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Radiography; Recurrence; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency; Young Adult

This study sought to evaluate the safety and efficacy of the Lutonix drug-coated balloon (DCB) coated with 2 μg/mm(2)paclitaxel and a polysorbate/sorbitol carrier for treatment of femoropopliteal lesions.. Percutaneous treatment of peripheral vascular disease is associated with a high recurrence. Paclitaxel-coated balloons at 3 μg/mm(2) formulated differently have shown promising results with reduced restenosis. Methods Subjects at 9 centers with Rutherford class 2 to 5 femoropopliteal lesions were randomized between June 2009 and December 2009 to treatment with Lutonix DCB (n = 49) versus uncoated balloons (control group [n = 52]), stratified by whether balloon-only treatment (n = 75) or stenting (n = 26) was intended. The primary endpoint was angiographic late lumen loss at 6 months. Secondary outcomes included adjudicated major adverse events (death, amputation, target lesion thrombosis, reintervention), functional outcomes, and pharmacokinetics.. Demographic, peripheral vascular disease, and lesion characteristics were matched, with mean lesion length of 8.1 3.8 cm and 42% total occlusions. At 6 months, late lumen loss was 58% lower for the Lutonix DCB group (0.46 1.13 mm) than for the control group (1.09 1.07 mm; p = 0.016). Composite 24-month major adverse events were 39% for the DCB group, including 15 target lesion revascularizations, 1 amputation, and 4 deaths versus 46% for uncoated balloon group, with 20 target lesion revascularizations, 1 thrombosis, and 5 deaths. Pharmacokinetics showed biexponential decay with peak concentration (Cmax) of 59 ng/ml and total observed exposure (AUC(all)) of 73 ng h/ml. For successful DCB deployment excluding 8 malfunctions, 6-month late lumen loss was 0.39 mm and the 24-month target lesion revascularization rate was 24%.. Treatment of femoropopliteal lesions with the low-dose Lutonix DCB reduced late lumen loss with safety comparable to that of control angioplasty. (LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis; NCT00930813)

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug Carriers; Equipment Design; Europe; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Polysorbates; Popliteal Artery; Radiography; Secondary Prevention; Sorbitol; Time Factors; Treatment Outcome; Vascular Access Devices

The aim of the present paper was to make a report of the 12-month clinical outcomes of the DEBELLUM (Drug-Eluting-Balloon-Evaluation-for-Lower-Limb- mUltilevel-treatMent) randomized trial.. From September 2010 to March 2011, 50 patients were randomized between drug eluting balloon (DEB, N.=25) and conventional angioplasty balloon (PTA, N.=25). Patients were symptomatic for claudication and critical limb ischemia, with de novo stenosis or occlusion in the femoropopliteal (SFA) and infrapopliteal (BTK) region. Only in the SFA primary stenting was allowed and postdilatation performed with DEB or PTA depending on the assigned group.. One hundred and twenty-two lesions were treated: 92 (75.4%) SFA, 30 (24.6%) BTK. Twenty (40%) patients presented multilevel concomitant femoropopliteal and infra-popliteal lesions. Late lumen loss (LLL) was 0.64±0.9 mm in DEB group vs. 1.81±0.1 mm in the control group (P=0.01). In non-stented segment LLL was 0.63±0.9 mm (DEB) vs. 1.70±0.6 mm (PTA), P<0.01. In the stent subgroup was LLL 0.65±0.2 mm (DEB) vs. 1.91±0.3 mm (PTA), P<0.01. In the femoropopliteal region the overall LLL was 0.61±0.8 mm for DEB vs. 1.84±0.3 mm for PTA (P=0.02). BTK the overall LLL was 0.66±0.9 mm (DEB) vs. 1.69±0.5 mm (PTA) (P=0.03). The overall TLR was 12.2% for DEB and 35.3% for PTA (P<0.05). Amputation rate was 4% (DEB) vs. 12% (PTA), P=0.36. Thrombosis was 4% (DEB) vs. 8% (PTA), P≥0.05. Major adverse events 24% (DEB) vs. 60% (PTA), P<0.05. ABI improved more in the DEB group: 0.81±0.3 vs. 0.68±0.13 (P=0.02). Fontaine stage increased (from II b to I) 80% DEB vs. 56% PTA (P<0.05).. Results confirm and reinforce initial 6-month outcomes. In.Pact DEB balloons can be considered efficient to reduce restenosis rate.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Critical Illness; Drug Carriers; Equipment Design; Female; Femoral Artery; Hemodynamics; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Risk Factors; Rome; Thrombosis; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Ischaemia in different arterial territories before acute myocardial infarction (AMI) may influence post-AMI outcomes. No studies have evaluated prospectively collected information on ischaemia and its effect on short- and long-term coronary mortality. The objective of this study was to compare patients with and without prospectively measured ischaemic presentations before AMI in terms of infarct characteristics and coronary mortality.. As part of the CALIBER programme, we linked data from primary care, hospital admissions, the national acute coronary syndrome registry and cause-specific mortality to identify patients with first AMI (n = 16,439). We analysed time from AMI to coronary mortality (n = 5283 deaths) using Cox regression (median 2.6 years follow-up), comparing patients with and without recent ischaemic presentations. Patients with ischaemic presentations in the 90 days before AMI experienced lower coronary mortality in the first 7 days after AMI compared with those with no prior ischaemic presentations, after adjusting for age, sex, smoking, diabetes, blood pressure and cardiovascular medications [HR: 0.64 (95% CI: 0.57-0.73) P < 0.001], but subsequent mortality was higher [HR: 1.42 (1.13-1.77) P = 0.001]. Patients with ischaemic presentations closer in time to AMI had the lowest seven day mortality (P-trend = 0.001).. In the first large prospective study of ischaemic presentations prior to AMI, we have shown that those occurring closest to AMI are associated with lower short-term coronary mortality following AMI, which could represent a natural ischaemic preconditioning effect, observed in a clinical setting.. Clinicaltrials.gov identifier NCT01604486.

Topics: Aged; Aged, 80 and over; Angina Pectoris; Atherosclerosis; Cardiovascular Agents; Cerebrovascular Disorders; Electronic Health Records; Female; Follow-Up Studies; Humans; Ischemia; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Peripheral Arterial Disease; Prognosis; Prospective Studies; Risk Factors

The study objective was to identify the predictors of outcomes in a contemporary cohort of patients from the Reduction in cardiovascular Events by acaDesine in patients undergoing CABG (RED-CABG) trial. Despite the increasing risk profile of patients who undergo coronary artery bypass grafting, morbidity and mortality have remained low, and identification of the current predictors of adverse outcomes may permit new treatments to further improve outcomes.. The RED-CABG trial was a multicenter, randomized, double-blind, placebo-controlled study that determined that acadesine did not reduce adverse events in moderately high-risk patients undergoing nonemergency coronary artery bypass grafting. The primary efficacy end point was a composite of all-cause death, nonfatal stroke, or the need for mechanical support for severe left ventricular dysfunction through postoperative day 28. Logistic regression modeling with stepwise variable selection identified which prespecified baseline characteristics were associated with the primary outcome. A second logistic model included intraoperative variables as potential covariates.. The 4 independent preoperative risk factors predictive of the composite end point were (1) a history of heart failure (odds ratio, 2.9); (2) increasing age (odds ratio, 1.033 per decade); (3) a history of peripheral vascular disease (odds ratio, 1.6); and (4) receiving aspirin before coronary artery bypass grafting (odds ratio, 0.5), which was protective. The duration of the cardiopulmonary bypass (odds ratio, 1.8) was the only intraoperative variable that contributed to adverse outcomes.. Patients who had heart failure and preserved systolic function had a similar high risk of adverse outcomes as those with low ejection fractions, and new approaches may mitigate this risk. Recognition of patients with excessive atherosclerotic burden may permit perioperative interventions to improve their outcomes. The contemporary risks of coronary artery bypass grafting have changed, and their identification may permit new methods to improve outcomes.

Topics: Age Factors; Aminoimidazole Carboxamide; Aspirin; Cardiopulmonary Bypass; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Bypass; Double-Blind Method; Heart Failure; Humans; Logistic Models; Multivariate Analysis; Odds Ratio; Patient Selection; Peripheral Arterial Disease; Protective Factors; Ribonucleosides; Risk Assessment; Risk Factors; Stroke; Stroke Volume; Time Factors; Treatment Outcome; Ventricular Dysfunction, Left; Ventricular Function, Left

This study sought to report the results of a prospective randomized controlled trial comparing paclitaxel-coated balloons (PCB) versus drug-eluting stents (DES) in long infrapopliteal lesions.. DES have an established role in the treatment of short infrapopliteal lesions, whereas there is increasing evidence for the use of PCB in longer below-the-knee lesions.. Inclusion criteria were patients with Rutherford classes 3 to 6 and angiographically documented infrapopliteal disease with a minimum lesion length of 70 mm. The primary endpoint was target lesion restenosis >50% assessed by digital angiography at 6 months. Secondary endpoints included immediate post-procedure stenosis and target lesion revascularization.. Fifty patients were randomized to undergo infrapopliteal PCB angioplasty (25 arteries in 25 limbs; PCB group) or primary DES placement (30 arteries in 27 limbs; DES group). Immediate residual post-procedure stenosis was significantly lower in DES (9.6 ± 2.2% vs. 24.8 ± 3.5% in PCB; p < 0.0001). At 6 months, 5 patients died (2 in PCB vs. 3 in DES; p = 1.00) and 3 suffered a major amputation (1 in PCB vs. 2 in DES; p = 1.00). In total, 44 angiograms were evaluable with quantitative vessel analysis. Binary (>50%) angiographic restenosis rate was significantly lower in DES (7 of 25 [28%] vs. 11 of 19 [57.9%] in PCB; p = 0.0457). There were no significant differences with regard to target lesion revascularization (2 of 26 [7.7%] in DES vs. 3 of 22 [13.6%] in PCB; p = 0.65). Positive vessel wall remodeling was observed in 3 cases in the PCB arm (3 of 19 [(15.8%)] vs. 0 of 19 [0%] in DES; p = 0.07).. Compared with PCB in long infrapopliteal lesions, DES are related with significantly lower residual immediate post-procedure stenosis and have shown significantly reduced vessel restenosis at 6 months. PCB may produce positive vessel remodeling. (Infrapopliteal Drug-Eluting Angioplasty Versus Stenting [IDEAS-I]; NCT01517997).

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angiography, Digital Subtraction; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug-Eluting Stents; Female; Greece; Humans; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency; Vascular Remodeling

To report a subgroup analysis comparing safety and effectiveness outcomes in Japanese and non-Japanese patients as part of a prospective, multinational, randomized controlled trial (ClinicalTrials.gov identifier NCT00120406) evaluating a paclitaxel-coated drug-eluting stent (DES) compared to percutaneous transluminal angioplasty (PTA) for treating peripheral artery disease.. Patients were randomly assigned to primary DES or PTA. In the Japanese cohort, 27 patients (21 men; mean age 71.2±9.6 years) were randomized to PTA and 25 patients (19 men; mean age 69.8±10.2 years) to primary DES. In the non-Japanese cohort, 211 patients (131 men; mean age 67.3±10.6 years) were randomized to PTA and 211 patients (136 men; mean age 67.6±9.5 years) to primary DES. Outcome measures included event-free survival (EFS), freedom from target lesion revascularization (TLR), patency, stent fracture, and sustained clinical benefit through 2 years.. Safety and effectiveness outcomes were similar in the Japanese and non-Japanese cohorts, although the outcomes in the Japanese cohort treated with primary DES were numerically better. In the DES group, the 2-year EFS was 92.0% vs. 85.0% (p=0.61), freedom from TLR was 96.0% vs. 85.5% (p=0.55), primary patency was 80.0% vs. 74.3% (p=0.61), and clinical benefit was sustained in 88.5% vs. 80.5% of patients (p=0.31) in the Japanese and non-Japanese cohorts, respectively. Stent fractures were seen in 4 of 457 stents at 12 months: 3 in the Japanese cohort and 1 in the non-Japanese cohort.. The subgroup analysis comparing Japanese and non-Japanese patients supports the safety and effectiveness of the paclitaxel-coated DES in Japanese patients with stenotic lesions in the femoropopliteal arteries. The lack of major differences associated with ethnicity in these 2-year outcomes supports the validity and value of multinational clinical trials.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Female; Femoral Artery; Germany; Humans; Japan; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Prosthesis Failure; Reproducibility of Results; Research Design; Time Factors; Treatment Outcome; United States; Vascular Patency

Currently, endovascular treatment is indicated to treat femoropopliteal lesions ≤15 cm. However, the Achilles' heel of femoropopliteal endovascular repair remains restenosis. Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty. A recently released prospective registry using a newer generation of self-expandable nitinol stents (Misago®; Terumo Corp., Tokyo, Japan) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions. To date, no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions. The BATTLE trial was designed to compare paclitaxel eluting stents (Zilver® PTX®) and a last generation bare self-expandable nitinol stents (Misago® RX, Terumo Corp., Tokyo, Japan) in the treatment of intermediate length femoropopliteal lesions (≤14 cm).. A prospective, randomized (1:1), controlled, multicentric and international study has been designed. One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions ≤14 cm in symptomatic patients (Rutherford 2 to 5): bare stent group and paclitaxel eluting stent group. The primary endpoint is freedom from in-stent restenosis at 1 year defined by a peak systolic velocity index >2.4 (restenosis of >50%) at the target lesion and assessed by duplex scan. Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver® PTX® stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease.. This is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions. It may clarify the indication of stent choice for femoropopliteal lesions of intermediate length.. Clinicaltrials.gov identifier: NCT02004951. 3 December 2013.

Topics: Cardiovascular Agents; Clinical Protocols; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; France; Humans; Metals; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Research Design; Stents; Switzerland; Time Factors; Treatment Outcome

Both supervised exercise (SE) and stenting (ST) improve functional status, symptoms, and quality of life compared with optimal medical care (OMC) in patients with claudication. The relative cost-effectiveness of these strategies is not well defined.. The Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) study randomized patients with claudication due to aortoiliac stenosis to a 6-month SE program, to ST, or to OMC. Participants who completed 6-month follow-up (n=98) were included in a health economic analysis through 18 months. Costs were assessed using resource-based methods and hospital billing data. Quality-adjusted life-years were estimated using the EQ-5D. Markov modeling based on the in-trial results was used to explore the impact of assumptions about the longer term durability of observed differences in quality of life. Through 18 months, mean healthcare costs were $5178, $9804, and $14 590 per patient for OMC, SE, and ST, respectively. Measured quality-adjusted life-years through 18 months were 1.04, 1.16, and 1.20. In our base case analysis, which assumed that observed differences in quality of life would dissipate after 5 years, the incremental cost-effectiveness ratios were $24 070 per quality-adjusted life-year gained for SE versus OMC, $41 376 for ST versus OMC, and $122 600 for ST versus SE. If the treatment effect of ST was assumed to be more durable than that of SE, the incremental cost-effectiveness ratio for ST versus SE became more favorable.. Both SE and ST are economically attractive by US standards relative to OMC for the treatment of claudication in patients with aortoiliac disease. ST is more expensive than SE, with uncertain incremental benefit.. www.clinicaltrials.gov, Unique identifier: NCT00132743.

Topics: Ambulatory Care; Aortic Diseases; Cardiovascular Agents; Constriction, Pathologic; Cost-Benefit Analysis; Drug Costs; Endovascular Procedures; Exercise Therapy; Health Care Costs; Hospital Costs; Humans; Iliac Artery; Intermittent Claudication; Life Expectancy; Models, Economic; Peripheral Arterial Disease; Quality of Life; Quality-Adjusted Life Years; Stents; Time Factors; Treatment Outcome; United States; Vascular Patency

This study sought to evaluate the outcomes of drug-eluting stent treatment for femoropopliteal in-stent restenosis (ISR).. ISR after femoropopliteal interventions is an increasing problem. Although the role of drug-eluting stents in the treatment of coronary ISR is well defined, no published studies have examined drug-eluting stents in the treatment of femoropopliteal ISR.. This study examines 108 patients with 119 ISR lesions who were enrolled in the ZILVER-PTX single-arm study, a prospective, multicenter clinical trial of 787 patients. All patients were treated with paclitaxel-eluting nitinol stents.. Mean patient age was 68.3 ± 9.4 years; 61.1% of patients were men. Mean lesion length was 133.0 ± 91.7 mm; 33.6% of lesions were >150 mm long and 31.1% of lesions were totally occluded. Procedural success was achieved in 98.2% of lesions with 2.1 ± 1.2 stents placed per lesion. Primary patency was 95.7% at 6 months and 78.8% at 1 year. Freedom from target lesion revascularization was 96.2% at 6 months, 81.0% at 1 year, and 60.8% at 2 years. Forty patients experienced major adverse events, exclusively target lesion revascularization. Before treatment, 81.1% of patients had Rutherford scores ≥3; at 2 years, 60.9% of patients had Rutherford scores ≤1. Both ankle brachial index and walking impairment questionnaire scores significantly improved following treatment. The 1-year fracture rate of stents used in ISR lesions was 1.2%. No significant risk factors associated with loss of patency were identified.. Treatment of femoropopliteal ISR with paclitaxel-eluting stents results in favorable acute, midterm, and long-term outcomes. (Zilver PTX Global Registry [ZILVER-PTX]; NCT01094678).

Topics: Aged; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Canada; Cardiovascular Agents; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Europe; Exercise Test; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Prosthesis Failure; Recurrence; Registries; Republic of Korea; Risk Factors; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vascular Patency

This study sought to compare paclitaxel-eluting balloon (PEB) with conventional percutaneous transluminal angioplasty (PTA), followed by systematic implantation of a self-expanding nitinol bare-metal stent (BMS) in patients at risk for restenosis.. PTA is an effective strategy for treating atherosclerosis of the femoropopliteal axis (FPA). Whereas PEB have shown advantage over uncoated balloons in the treatment of simple lesions, it is unknown whether these results are applicable to complex degrees of FPA atheroma.. A total of 104 patients (110 FPA lesions in 110 limbs) were randomly assigned to either PEB + BMS or PTA + BMS. The primary endpoint was 12-month binary restenosis. Secondary endpoints were freedom from target lesion revascularization and major amputation. Post hoc subanalyses were performed for the comparison of long (≥100 mm) versus short lesions and true lumen versus subintimal approach.. Mean lesion length was 94 ± 60 versus 96 ± 69 mm in the PEB + BMS and PTA + BMS groups (p = 0.8), respectively. The primary endpoint occurred in 9 (17%) versus 26 (47.3%) of lesions in the PEB + BMS and PTA + BMS groups (p = 0.008), respectively. A near-significant (p = 0.07) 1-year freedom from target lesion revascularization advantage was observed in the PEB + BMS group. No major amputation occurred. No significant difference was observed according to lesion characteristics or technical approach.. Pre-dilation with PEB angioplasty prior to BMS implantation, as compared to PTA + BMS in complex FPA lesions, reduces restenosis and target lesion revascularization at 12-month follow-up. Restenosis reduction is maintained irrespective of lesion length and recanalization technique. (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery [DEBATE-SFA]; NCT01556542).

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Disease-Free Survival; Equipment Design; Female; Femoral Artery; Humans; Italy; Kaplan-Meier Estimate; Limb Salvage; Male; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Radiography; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To investigate the impact of using paclitaxel-coated balloons (PCB) on outcome after post-angioplasty dissection in femoropopliteal arteries.. The angiograms obtained in the THUNDER study (ClinicalTrials.gov identifier NCT00156624) were analyzed to compare degrees of dissection and angiographic parameters between the control (uncoated balloons, n=43) and treatment (PCBs, n=43) groups before and after the intervention and at 6-month follow-up. Furthermore, target lesion revascularizations (TLR) were documented up to 2 years.. In each group, 24 (56%) patients had a dissection after the intervention. At the 6-month follow-up, patients with dissection of any grade after treatment with PCBs had significantly less late lumen loss (0.4 mm) than patients with dissection after treatment with uncoated balloons (1.9 mm, p=0.001) and a lower degree of stenosis (20% vs. 51%, respectively; p=0.003). Patients with severe dissection (grades C, D, or E) especially seemed to benefit from the PCBs, with late lumen loss of 0.4 mm vs. 2.4 mm for controls (p=0.05). The binary restenosis rate was also markedly lower in the PCB group (20%) than in the uncoated group (55%, p=0.02). In the 2-year follow-up, TLR was performed in 56% of patients in the control group compared to 10% of patients in the PCB group (p=0.002).. The results of this subgroup analysis suggest that patients with dissection following treatment with a paclitaxel-coated balloon have a very acceptable outcome and stent implantation is not necessary as long as the dissection does not result in acute flow limitation.

Topics: Aged; Angioplasty, Balloon; Aortic Dissection; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Double-Blind Method; Equipment Design; Female; Femoral Artery; Germany; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Radiography; Recurrence; Regional Blood Flow; Retreatment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices

A novel self-expanding drug-eluting stent was designed to release everolimus 225 μg/cm(2) to prevent restenosis following peripheral arterial intervention. The purpose of this study was to measure the pharmacokinetic profile of everolimus following stent implantation.. One hundred four patients with symptomatic peripheral arterial disease underwent implantation of everolimus-eluting stents in the femoropopliteal arteries. In a prespecified subset of 26 patients, blood samples for assay of everolimus content were collected prior to stent implantation, at 1, 4, and 8 hours postprocedure, prior to discharge, and at 1 month postprocedure.. A total of 39 stents, ranging from 28 mm to 100 mm in length, were implanted in 26 patients, resulting in a total delivered everolimus dose range of 3.0 to 7.6 mg. Following the procedure, the maximum observed everolimus blood concentrations (C(max)) varied from 1.83 ± 0.05 ng/mL after implantation of a single 80-mm stent to 4.66 ± 1.78 ng/mL after implantation of two 100-mm stents. The mean time to peak concentration (T(max)) varied from 6.8 hours to 35 hours. The pharmacokinetics of everolimus were dose-proportional in that dose-normalized C(max) and area under the curve values were constant over the studied dose range.. After implantation of everolimus-eluting self-expanding stents in the femoropopliteal arteries, systemic blood concentrations of everolimus are predictable and considerably lower than blood concentrations observed following safe oral administration of everolimus.

Topics: Aged; Cardiovascular Agents; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Europe; Everolimus; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Sirolimus; Treatment Outcome

A novel self-expanding drug-eluting stent was designed to slowly release everolimus to prevent restenosis following peripheral arterial intervention. The purpose of the first-in-human Superficial Femoral Artery Treatment with Drug-Eluting Stents (STRIDES) trial was to evaluate the safety and efficacy of this device for the treatment of symptomatic superficial femoral and proximal popliteal arterial occlusive disease.. One hundred four patients were enrolled at 11 European investigative centers in a prospective, nonrandomized, single-arm trial. The patients had severe symptomatic vascular disease, including a significant proportion of patients with critical limb ischemia (17%), diabetes (39%), and single-vessel outflow (26%). The mean lesion length was 9.0 ± 4.3 cm. Ninety-nine percent of patients were available for 12-month follow-up, including duplex imaging in 90% and arteriography in 83%. Clinical improvement, defined as a sustained decrease in Rutherford-Becker clinical category, was achieved in 80% of patients. Primary patency (freedom from ≥50% in-stent restenosis) was 94 ± 2.3% and 68 ± 4.6% at 6 and 12 months, respectively. Plain radiographic examination of 122 implanted devices at 12 months revealed no evidence for stent fracture.. The everolimus-eluting self-expanding nitinol stent can be successfully implanted in patients with severe peripheral arterial disease with favorable outcomes and clinical improvements observed in the majority of patients.

Topics: Aged; Angioplasty; Ankle Brachial Index; Cardiovascular Agents; Constriction, Pathologic; Drug-Eluting Stents; Europe; Everolimus; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Radiography; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

To examine the influence of peripheral arterial disease (PAD) on heart rate variability (HRV) in patients, and to examine the influence of an intense long-term (12 months) exercise program on HRV in PAD patients.. This study involved ambulatory patients attending a local hospital and university center. Participants were twenty-five patients with diagnosed PAD and intermittent claudication and 24 healthy, age-matched adults. Interventions involved random allocation of PAD patients to 12 months of conservative medical treatment (Conservative) or medical treatment with supervised treadmill walking (Exercise). The main outcome measures were time- and frequency-domain, nonlinear HRV measures during supine rest, and maximal walking capacity prior to and following the intervention.. Despite significantly worse walking capacity (285 ± 190 m vs 941 ± 336 m; P < .05), PAD patients exhibited similar resting HRV to healthy adults. At the 12-month follow-up, Exercise patients exhibited a significantly greater improvement in walking capacity (183% ± 185% vs 57% ± 135%; P = .03) with similar small nonsignificant changes in HRV compared with Conservative patients.. The current study demonstrated that PAD patients exhibited similar resting HRV to healthy adults with 12 months of intense supervised walking producing similar HRV changes to that of conservative medical treatment. The greater walking capacity of healthy adults and PAD patients following supervised exercise does not appear to be associated with enhanced HRV.

Topics: Aged; Ankle Brachial Index; Cardiovascular Agents; Combined Modality Therapy; Exercise Test; Exercise Therapy; Exercise Tolerance; Female; Heart Rate; Humans; Intermittent Claudication; Male; Middle Aged; Peripheral Arterial Disease; Queensland; Time Factors; Treatment Outcome; Walking

Although various devices and strategies were introduced into endovascular therapy, factors associated with chronic outcomes remain unclear. Therefore, this study aimed to build preliminary data of Japanese femoropopliteal lesions in a period of transition from non-drug to drug technology. This research was a multicenter, prospective, and observational study. A total of 1003 consecutive patients with a mean age of 73.6 ± 8.3 years from 67 institutes were registered from February 2017 to June 2018 in Japan. In addition to the baseline data, angiographic findings affecting primary patency were studied. Lesion length was 16.4 ± 9.6 cm, and chronic total occlusion was found in 42%. Calcified lesions were found in 75% of patients. The 1-year and 2-year freedom from target lesion revascularization were 81% and 75%, respectively, and maximum walking distance showed improvement over the two years (pre; 234 m ± 211 m, 1-year; 402 m ± 241 m, 2-year; 428 m ± 231 m). The independent predictors for primary patency were pre-procedure ankle-brachial index, history of minor amputation, ostium lesion, and drug-coated balloon use. Angiographic analysis revealed that only lesion length and full cover stent were related to primary patency. Two-year freedom from target vessel revascularization was 75% in the Japanese transitional period of drug-eluting devices. Maximum walking distance was improved and well maintained for up to 2-year.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Endovascular Procedures; Femoral Artery; Humans; Japan; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Time Factors; Treatment Outcome; Vascular Patency

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome

There is a little datum about the impact of paclitaxel dosage in patients undergoing drug-coated balloons (DCB) in endovascular therapy (EVT) for femoropopliteal lesions. In the current study, the authors sought to compare the clinical outcomes of low-dose (LD) and high-dose (HD) paclitaxel DCBs for patients undergoing EVT for femoropopliteal lesions in a real-world setting.. The study population was derived from a multicenter registry named "Evaluation of clinical outcome after endovascular therapy for femoropopliteal artery disease in Kanagawa" (LANDMARK registry). This registry consists of patients from 5 hospitals in Kanagawa, Japan. Overall, 1,378 patients with 1,777 lesions received treatment between July 2017 and June 2020. Among these, DCB angioplasty was performed in 477 patients (516 lesions). Propensity score matching analysis was performed to compare the clinical outcomes of LD-DCB (Lutonix; Becton Dickinson and Company, Franklin Lakes, New Jersey) and HD-DCB (IN.PACT Admiral; Medtronic Vascular, Santa Clara, CA, USA).. A total of 160 matched pairs of lesions were analyzed. Primary patency and freedom from target lesion revascularization at 2 years were similar between the two groups (LD-DCB vs. HD-DCB: 72% vs. 70%, p = 0.53; and 75% vs. 73%, p = 0.59, respectively).. No significant differences were found in the clinical outcomes between LD-DCB and HD-DCB angioplasty for femoropopliteal lesions.. Level 3.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Time Factors; Treatment Outcome; Vascular Patency

Background Although clinical trials have reported favorable outcomes after drug-coated balloon (DCB) therapy for femoropopliteal lesions, their real-world performance and predictors have not been well evaluated. This study aimed to elucidate 1-year freedom from restenosis and to explore the associated factors after a DCB for femoropopliteal lesions in clinical settings. Methods and Results This multicenter, prospective cohort registered 3165 de novo or restenotic femoropopliteallesions (mean lesion length, 13.5±9.3 cm; chronic total occlusion, 25.9%; severe calcification, 14.6%) that underwent successful DCB (Lutonix [24.2%] and IN.PACT Admiral [75.8%]) treatment between March 2018 and December 2019. Patency was assessed at 12±2 months. The primary outcome measure was 1-year freedom from restenosis and its associated factors. Bailout stenting was performed in 3.5% of patients. The postprocedural slow flow phenomenon was observed in 3.9% of patients. During a median follow-up of 14.2 months, 811 patients experienced restenosis. The Kaplan-Meier estimate of freedom from restenosis was 84.5% at 12 months (79.7% at 14 months). Focal, tandem, diffuse, and occlusive restenosis accounted for 37.4%, 9.8%, 18.9%, and 33.9%, respectively. Freedom from target lesion revascularization was 91.5% at 12 months. Risk factors independently associated with 1-year restenosis were a history of revascularization, smaller distal reference vessel diameter, severe calcification, chronic total occlusion, low-dose DCB, and residual stenosis. Conclusions The 1-year clinical outcomes after DCB use for femoropopliteal lesions in real-world practice was favorable. The additive risk factors were associated with a lower rate of freedom from restenosis.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Treatment Outcome; Vascular Patency

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome; Vascular Patency

To investigate the real-world safety of paclitaxel (PTX)-coated devices for treating lower extremity peripheral artery disease using a commercial claims database.. Data from FAIR Health, the largest commercial claims data warehouse in the United States, were used for this study. The study consisted of patients who underwent femoropopliteal revascularization procedures between January 1, 2015, and December 31, 2019, with PTX and non-PTX devices. The primary outcome was 4-year survival following treatment. The secondary outcomes included 2-year survival, 2- and 4-year freedom from amputation, and repeat revascularization. Propensity score matching was used to minimize confounding, and the Kaplan-Meier methods were used to estimate survival.. A total of 10,832 procedures were included in the analysis, including 4,962 involving PTX devices and 5,870 involving non-PTX devices. PTX devices were associated with a reduced hazard of death following treatment at 2 and 4 years (hazard ratio [HR], 0.74 [95% confidence interval {CI}, 0.69-0.79]; P <.05, and HR, 0.89 [95% CI, 0.77-1.02]; log-rank P =.018, respectively). The risk of amputation was also lower following treatment with PTX devices than with non-PTX devices at 2 and 4 years (HR, 0.82 [95% CI, 0.76-0.87]; P =.02, and HR, 0.77 [95% CI, 0.67-0.89]; log-rank P =.01, respectively). In addition, the odds of repeat revascularization were similar with PTX and non-PTX devices at 2 and 4 years.. In the real-world commercial claims database, no short- or long-term signal for increased mortality or amputations was observed following treatment with PTX devices.

Topics: Cardiovascular Agents; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome; Vascular Patency

To evaluate the incidence of distal embolism and local vascular responses after treatment with the Kanshas drug-coated balloon (DCB) in a preclinical model.. A total of 90 femoral arteries from 35 healthy swine were treated with a single-dose (×1) or triple-dose (×3) Kanshas DCB that applies the Unicoat technology with 3.2 μg/mm. Arteries treated with the Kanshas DCB showed mild proteoglycan deposition accompanied by the loss of smooth muscle cells (SMCs). These changes increased in a dose-dependent manner (medial SMC loss at 28 days in the ×1 vs ×3 groups, in depth, 1 (0.75-1.38) vs 2 (1.63-2.44); P = .0008; in circumference, 0.83 (0.67-1) vs 1.5 (1.19-1.81); P = .0071). No evidence of distal embolization in skeletal muscles (0 of 210 histological sections) and nontarget organs (0 of 345 sections) was observed. The pharmacokinetic evaluation showed high paclitaxel concentration in the treated artery (912 ng/mg, peaking at 3 minutes), which remained detectable at up to 180 days (0.04 ng/mg).. The Kanshas DCB showed a local drug effect in treated arteries up to 180 days with a high concentration of paclitaxel and no histological evidence of distal embolization.

Topics: Angioplasty, Balloon; Animals; Cardiovascular Agents; Femoral Artery; Paclitaxel; Peripheral Arterial Disease; Swine

Cardiovascular disease guidelines recommend that patients with established peripheral artery disease (PAD) are prescribed antihypertensive, lipid-lowering, and antiplatelet medication to reduce cardiovascular ischaemic events. However, the prescribing of these medications for patients with PAD within New Zealand (NZ) remains undefined.. This was a retrospective observational cohort study of patients in the Midland region of NZ, that underwent PAD-related percutaneous and surgical intervention between 1st January 2010 and 31st December 2021. Patient level data was collected. The primary outcome was prescribing of cardioprotective medications either before or within 1 year of incident procedure. Secondary outcome was overall survival.. There were 2547 patients included. Antihypertensive prescription occurred in 80.7%, lipid-lowering in 77.4% and antithrombotic in 89.9%. Concomitant ischaemic heart disease increased prescription of cardioprotective medications. Women were prescribed less lipid-lowering medication compared to men. Māori men were prescribed less antiplatelet medication compared to non-Māori men. On univariate analysis lipid-lowering and antiplatelet medication showed survival advantage, while antihypertensive and anticoagulation did not. After adjustment for age, sex, end stage renal failure and presence of chronic limb-threatening ischaemia, best medical therapy was associated with better survival (HR 0.88, 95% CI 0.79-0.98, P = 0.02).. This study highlights areas of deficiency in prescribing of cardioprotective medication in this high-risk group. These could be targets for national quality improvement initiatives.

Topics: Antihypertensive Agents; Australasian People; Cardiovascular Agents; Cardiovascular Diseases; Cohort Studies; Female; Humans; Hypolipidemic Agents; Ischemia; Lipids; Male; Maori People; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Protective Agents; Retrospective Studies; Risk Factors; Treatment Outcome

To investigate the clinical performance and safety of the Passeo-18 Lux drug-coated balloon (DCB) in complex femoropopliteal Trans-Atlantic Inter-Society Consensus (TASC) C and D lesions in an all-comers patient population.. Data from BIOLUX P-III SPAIN, a prospective, national, multicenter, postmarket all-comers registry conducted from 2017 to 2019, and a matching long lesion subgroup from the BIOLUX P-III All-Comers global registry conducted from 2014 to 2018 were pooled for analysis. The primary safety end point was freedom from major adverse events (MAEs) at 6 months, and the primary performance end point was freedom from clinically driven target lesion revascularization (fCD-TLR) at 12 months, both adjudicated by an independent clinical events committee.. A total of 159 patients, of whom 32.7% had critical limb ischemia, were included in the Passeo-18 Lux long lesion cohort. The mean lesion length was 248.5 mm ± 71.6, and the majority were occluded (54.1%), calcified (87.4%), and of type TASC C (49.1%) or TASC D (50.9%). Freedom from MAEs was 90.6% (95% CI, 84.6-94.3) at 6 months and 83.9% (95% CI, 76.7-89.0) at 12 months. fCD-TLR was 84.4% (95% CI, 77.3-89.5) at 12 months. Freedom from target limb major amputation was 98.6% (95% CI, 94.6-99.7), and all-cause mortality was 5.3% (95% CI, 2.7-10.4) at 12 months. There were no device- or procedure-related deaths or amputations up to the 12-month follow-up.. Passeo-18 Lux DCB is safe and effective for the treatment of long femoropopliteal lesions in a real-word setting.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Limb Salvage; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Registries; Spain; Treatment Outcome; Vascular Patency

Topics: Calcium; Cardiovascular Agents; Drug-Eluting Stents; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Stents; Tomography, Optical Coherence; Treatment Outcome

Drug-coated balloon therapy is a minimally invasive endovascular approach to treat obstructive arterial disease, with increasing utilization in the peripheral circulation due to improved outcomes as compared to alternative interventional modalities. Broader clinical use of drug-coated balloons is limited by an incomplete understanding of device- and patient-specific determinants of treatment efficacy, including late outcomes that are mediated by postinterventional maladaptive inward arterial remodeling. To address this knowledge gap, we propose a predictive mathematical model of pressure-mediated femoral artery remodeling following drug-coated balloon deployment, with account of drug-based modulation of resident vascular cell phenotype and common patient comorbidities, namely, hypertension and endothelial cell dysfunction. Our results elucidate how postinterventional arterial remodeling outcomes are altered by the delivery of a traditional anti-proliferative drug, as well as by codelivery with an anti-contractile drug. Our findings suggest that codelivery of anti-proliferative and anti-contractile drugs could improve patient outcomes following drug-coated balloon therapy, motivating further consideration of novel payloads in next-generation devices.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome; Vascular Patency

Topics: Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome; Vascular Diseases

Several trials have shown that paclitaxel drug-coated balloons (DCBs) significantly reduce restenosis rates. However, some reports have shown distal embolisms occurring after DCBs. No study has analyzed the clinical outcomes of patients with DCB-induced distal embolism. This study aimed to investigate the clinical outcomes of DCB-induced distal embolism in patients with femoropopliteal artery disease. Between February 2018 and April 2019, consecutive patients (n = 32) who presented with de novo femoropopliteal artery disease and underwent endovascular therapy using DCB were retrospectively reviewed in a single-center study. Patients were divided into two groups based on whether distal embolism was detected using laser doppler flowmetry (DEL group) or not (non-DEL group). Baseline characteristics and 1-year clinical outcomes were compared between the groups. DEL was found in 44% of limbs (DEL group: n = 15, non-DEL group: n = 19). Below-the-knee arterial runoff ≤ 1 (p = 0.033), popliteal lesion (p = 0.044), ambulation difficulty (p = 0.021), and previous history of coronary artery disease (p = 0.013) were identified as predictive factors of DEL. Procedural factors, reference vessel diameter, lesion length, and total drug amount were not predictive of DEL. The overall target lesion restenosis (TLR) rate was 17.4% (n = 5). The TLR rate was not significantly different between the DEL and non-DEL groups (13.3% vs. 15.8%, p = 0.55). Severe calcification was the only significant factor for TLR (4.2% vs. 40.0%, p = 0.02). Among patients with femoropopliteal disease, there was no difference in 1-year clinical outcome between patients who underwent DEL and those who did not.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Embolism; Femoral Artery; Humans; Laser-Doppler Flowmetry; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Time Factors; Treatment Outcome; Vascular Patency

Drug-coated balloons (DCBs) for femoropopliteal peripheral artery disease have been shown to be clinically superior and cost-effective compared to conventional percutaneous transluminal angioplasty (PTA). However, few studies enrolled patients with chronic limb-threatening ischemia (CLTI). Our objective was to study the cost-effectiveness of endovascular treatment with versus without DCB in CLTI patient populations in the Netherlands and Germany.. Target lesion revascularization (TLR) and major amputation rates were obtained from the CLTI subgroup of the IN.PACT Global study. Rates for "status quo" treatment involving PTA with primary or bailout stenting were derived from systematic literature search. Costs and cost-effectiveness were calculated using a decision-analytic Markov model considering, in the base case, a 2-year horizon, and strategy-specific quality-adjusted life year (QALY) gains calculated from survival and health state-specific utilities. A willingness-to-pay threshold of €50,000/QALY was assumed, and extensive sensitivity analyses were performed.. Model-projected 24-month probabilities of TLR were 26.2% and 32.8% for treatment with and without DCB, and probabilities for amputation were 2.8% and 11.9%, respectively. DCB added 0.017 QALYs while saving €1,030 in the Dutch setting and €513 in the German setting, respectively. DCB was found dominant or cost-effective across a wide range of assumptions.. Urea excipient drug-coated balloon therapy for treating CLTI from femoropopliteal artery disease is associated with improved patient outcomes and expected overall cost savings to payers in the Dutch and German healthcare systems, rendering it a cost-effective and likely dominant treatment strategy.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Chronic Limb-Threatening Ischemia; Coated Materials, Biocompatible; Cost-Benefit Analysis; Excipients; Femoral Artery; Germany; Humans; Netherlands; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome; Urea; Vascular Patency

Topics: Cardiovascular Agents; Drug-Eluting Stents; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome

The use of drug-coated devices (DCD) in peripheral arterial disease (PAD) intervention continues to remain controversial after a recent meta-analysis raised concerns of higher late mortality outcome with the use of these devices. Given this, there is need for more data with regards to the late mortality outcome with DCD use. We sought to assess the 2-year mortality outcome in patients with PAD treated with DCD in an inner-city public hospital that mainly serves patients of lower socio-economic status.. This was an observational study of consecutive patients with femoropopliteal arterial disease who had revascularization procedures from 2014 to 2018 at Jacobi Medical Center and were followed for 2 years. Patients were classified into DCD and non-drug-coated (nDCD) groups based on the device used at the index procedure. The primary endpoint was 2-year mortality. Propensity cohort matching was applied. A multivariate Cox regression model was used to identify baseline variables associated with 2-year mortality.. 152 patients were included in this analysis (DCD group = 83, nDCD group =69). No significant difference in mortality between the two groups was identified at 2 years after propensity score matching with replacement (DCD: HR 0.72; 95% CI 0.30-1.71; p = 0.457). Patients that had revascularization because of intermittent claudication had lower mortality at 2 years compared to patients with critical limb ischemia as procedure indication (HR 0.18; 95% CI 0.04-0.82; p = 0.026).. This propensity score matched study revealed no difference in 2-year mortality between patients treated with DCD compared to patients treated with nDCD.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; New York; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Treatment Outcome

The aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics.. DES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating.. Within a multicenter, first-in-man, single-arm study, 100 patients with symptomatic femoropopliteal disease (Rutherford category 2-4, mean lesion length 5.8 ± 3.9 cm, 35.0% total occlusions) were treated with the NiTiDES stent (Alvimedica). Two-year follow-up included assessment of primary patency (defined as absence of clinically driven target lesion revascularization or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, functional, and clinical outcomes.. At 24 months, Kaplan-Meier estimates of primary patency and freedom from clinically driven target lesion revascularization were 83.4% (95% CI: 73.9%-89.6%) and 93.1% (95% CI: 85.3%-96.9%), respectively. Over the study period, 3 deaths were reported with no major limb amputation. Functional and clinical benefits were sustained, as 82.1% of patients fell into Rutherford category 0 or 1 at 24 months, which was associated with preserved improvements in all walking disability questionnaire scores.. The 2-year results of the ILLUMINA (Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy) study demonstrate a sustained treatment benefit with a novel sirolimus-eluting stent that also compares favorably to other femoropopliteal intervention trials. Head-to-head comparisons of NiTiDES with a paclitaxel-based DES are warranted. (The ILLUMINA Study [ILLUMINA]; NCT03510676).

Topics: Cardiovascular Agents; Drug-Eluting Stents; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Sirolimus; Stents; Treatment Outcome; Vascular Patency

To evaluate the use of drug-coated balloons in a real-world patient population with peripheral arterial disease and analyse the impact of sex on mid-term outcomes following their utilisation.. The BIOLUX P-III is a prospective, international, multi-centre, registry of patients with infra-inguinal lesions treated using the Passeo-18 Lux, a drug-coated balloon. Our study is a 24-month subgroup analysis of these patients; primary endpoints were freedom from major adverse events and clinically driven target lesion re-vascularisation within 12 months post-intervention.. Of the 877 patients in the registry, 561 (64.0%) were male and 316 (36.0%) were female. Chronic limb threatening ischaemia (Rutherford class ≥ 4) occurred in 35.7% of males and 40.6% of females. Rates of freedom from major adverse events and clinically driven target lesion re-vascularisation at 12 months were 87.3% (95% confidence interval [CI] 84.2-89.9) and 90.4% (95% CI 86.5-93.3), and 92.3% (95% CI 89.9-94.1) and 92.9% (95% CI 89.7-95.1) in males and females, respectively. All-cause mortality at 24 months was 12.0% (95% CI 9.4-15.3) in males and 11.9% (95% CI 8.6-16.5) in females. The major target limb amputation rate at 24 months was 9.1% (95% CI 6.9-11.9) in males and 4.0% (95% CI 2.3-7.0) in females.. Treatment with the Passeo-18 Lux DCB demonstrated high efficacy and low complication rates. Despite the greater proportion of chronic limb threatening ischaemia observed in females, males were at a greater risk of ipsilateral major limb amputation and major adverse events following drug-coated balloon utilisation.. NCT02276313.. Level 4.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Limb Salvage; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Registries; Treatment Outcome; Vascular Patency

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Medicare; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome; United States

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Diabetes Mellitus; Femoral Artery; Humans; Ischemia; Limb Salvage; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Time Factors; Treatment Outcome; Vascular Patency

To investigate mortality and causes of death associated with the use of paclitaxel-coated balloon (PCB) compared with plain balloon (PB) angioplasty in the treatment of femoropopliteal artery lesions in real-world clinical setting.. This retrospective, single-center study included patients who underwent percutaneous femoropopliteal artery angioplasty without stenting between years 2014 and 2020. Patients were stratified into PCB and PB groups according to the index procedure. Those who had undergone any prior or subsequent intervention using drug-eluting technology were excluded from the PB group. Long-term survival was estimated up to 5 years using the Kaplan-Meier method, and risk factors for all-cause mortality were assessed in a multivariable analysis. Causes of death were retrieved from a national registry.. The study included 139 patients treated with PB and 190 with PCB. Patients treated with PCB had a higher prevalence of chronic pulmonary disease (27% vs 17%; P = .02) and were less often on anticoagulant therapy (34% vs 48%; P = .01) compared with patients in the PB group. Those treated with PB were more likely to have chronic limb-threatening ischemia (CLTI; 82% vs 72%; P = .04). Ipsilateral perioperative amputation rate was significantly higher in the PB group (7% vs 1%; P = .01). There were no major differences in other 30-day outcomes between the groups and no differences in the rates of reinterventions and ipsilateral amputations during a mean follow-up time of 2.7 ± 1.9 years. Survival at 1 year in the PCB group was 83% ± 3% compared with 73% ± 4% in the PB group (P = .0001). The 5-year survival estimates were 56% ± 5% and 37% ± 5%, respectively. PCB use was independently associated with decreased risk of mortality (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.50-0.97). Independent risk factors for increased mortality were age (HR, 1.04 per year; 95% CI, 1.02-1.06), cardiac insufficiency (HR, 1.60; 95% CI, 1.12-2.27), chronic renal insufficiency (HR, 2.04; 95% CI, 1.47-2.85), anticoagulation therapy (HR, 1.65, 95% CI, 1.16-2.34), and CLTI (HR, 2.85; 95% CI, 1.51-5.39). In the PCB group, 63% of deaths were due to cardiovascular causes compared with 42% in the PB group (P < .01).. The use of PCB is safe, and there is no concern of increased mortality after the procedure based on the 5-year survival estimates.

Topics: Angioplasty, Balloon; Anticoagulants; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Treatment Outcome

Data on the long-term safety and effectiveness of drug-coated balloons (DCBs) for the treatment of long femoropopliteal atherosclerotic lesions in the real-world setting are rare. This study reports 3 year and 5 year outcomes of the pre-specified 150 mm balloon sub-cohort of the IN.PACT Global Study.. The IN.PACT Global Study was a prospective, multicentre, international, single-arm study evaluating the performance of the IN.PACT Admiral DCB in real-world patients with femoropopliteal atherosclerotic disease. This pre-specified 150 mm DCB cohort analysis comprised 107 participants (111 lesions) with all target lesions treated with at least one 150 mm DCB.. Mean lesion length was 20.3 ± 9.2 cm; 18.0% had in-stent restenosis, 58.6% were totally occluded, and 17.1% were severely calcified. Through 60 months, the Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization (CD-TLR) was 72.7% [95% confidence interval (CI):62.4%-80.5%]. The safety composite endpoint (freedom from device/procedure-related death through 30 days; freedom from target limb major amputation and clinically driven target vessel revascularization through 5 years) was 70.5%. The cumulative incidence of major amputation was 1.0% and all-cause mortality was 18.4% through 60 months. Freedom from CD-TLR rates in the provisional stented and non-stented subgroups through 36 months were 64.0% [95% CI: 46.1%-77.3%] and 81.9% [95% CI: 69.7%-89.6%] (log-rank p = 0.074), respectively.. The results demonstrate sustained long-term safety of the 150 mm IN.PACT Admiral DCB for long femoropopliteal atherosclerotic lesions in real-world patients. In particular, the results show that DCB angioplasty is an effective revascularization modality in long complex lesions.. gov identifier: NCT01609296.. Level 3, Cohort Study.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Cohort Studies; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Time Factors; Vascular Access Devices; Vascular Patency

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome; Vascular Patency

Topics: Cardiovascular Agents; Humans; Peripheral Arterial Disease; Telmisartan; Walking

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome

The long-term data on the use of drug-coated balloons (DCBs) for femoropopliteal atherosclerotic lesions in the real-world setting are limited, even more so for racially and geographically distinct populations. The present analysis reports the 5-year safety and effectiveness outcomes of a DCB in the Asian subset of the prospective, real-world IN.PACT Global Study.. The IN.PACT Global Study was a prospective, multicenter, international, single-arm study designed to assess the long-term safety and effectiveness of the IN.PACT Admiral DCB in real-world participants with femoropopliteal artery disease. The present analysis included 114 Asian participants (138 lesions) treated in South Korea and Singapore. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the safety endpoint (a composite of freedom from device- and procedure-related mortality through 30 days; and freedom from major target limb amputation and clinically driven target vessel revascularization within 60 months after the index procedure) and major adverse events.. In this prespecified Asian subset, there was a high incidence of diabetes mellitus (54.4%), hypertension (78.1%), coronary artery disease (43.9%), and concomitant below-the-knee vascular disease of target leg (39.5%). Mean lesion length was 17.4 ± 12.4 cm; 26.8% were in-stent restenosis, and more than half of the lesions were totally occluded (51.4%) and calcified (54.3%). The 5-year Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization was 77.1% (95% confidence interval: 67.0%-84.5%). The safety composite endpoint was 76.0%; the cumulative incidence of all-cause mortality was 19.9%, and no major target limb amputations were reported through 5 years.. This subset analysis of Asian participants from the IN.PACT Global Study demonstrated consistent results with the previously reported data of the IN.PACT Admiral DCB. The data confirm the durable clinical effectiveness and safety profile of the DCB through 5 years for femoropopliteal atherosclerotic disease in this real-world population.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Meta-analyses of randomized controlled trials have suggested an increased long-term mortality risk following femoropopliteal and infrapopliteal angioplasty using paclitaxel-coated devices. This study was conducted to evaluate long-term mortality after paclitaxel drug-coated balloon (DCB) and plain old balloon angioplasty (POBA) of infrapopliteal lesions in real-world practice.. A retrospective mortality analysis of patients with at least 3 years of follow-up who underwent balloon-based endovascular therapy of infrapopliteal lesions was performed.. Overall, 2,424 patients with infrapopliteal lesions were treated within the study period. Five hundred seventy-six patients fulfilled the study criteria. Of those, 269 patients were treated with uncoated devices without crossover to a paclitaxel-coated device during follow-up and 307 patients with DCB angioplasty. Mean (SD) follow-up was 46.48 (32.77) months. The mortality rate was 66.9% after POBA and 46.9% after DCB (P < .001). In the matched-pair cohort, 164 patients died after uncoated treatment (66.7%), and 119 in the DCB group died (48.4%; P < .001). There was no correlation between DCB length and mortality rate (P = .357). For the entire cohort, multivariate logistic regression analysis showed type of treatment (uncoated device vs DCB; P = .002), age (P < .001), stroke (P = .005), renal insufficiency (P = .014), and critical limb ischemia (P = .001) to be independent predictors of all-cause mortality. There was no significant difference in mortality among the paclitaxel exposure groups.. In this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of infrapopliteal lesions.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Time Factors; Treatment Outcome; Vascular Patency

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome; Vascular Patency

To evaluate the all-cause mortality after treatment with paclitaxel-coated devices depending on paclitaxel exposure in real-world practice.. A retrospective analysis of mortality of patients with at least a 3-year follow-up was performed. Patients were categorized into terciles according to the paclitaxel dosage received during the index procedure and every subsequent intervention. The incidence of mortality of these patients was compared with that of a paclitaxel-naïve control group.. In total, 2,376 patients were treated with drug-coated devices and 980 patients with uncoated devices. The overall all-cause mortality rate at a mean follow-up of 46.27 months ± 24.71 was 29.2% (n = 696) for the paclitaxel group and 49.4% (n = 484) for the paclitaxel-naive control group. The mortality rate between the groups according to the initial paclitaxel exposure was not significantly different (P = .205). In comparison to the group of surviving patients, the total lifetime paclitaxel dosage was lower in the group of patients who died (P < .001).. In this real-world retrospective analysis, long-term mortality was not correlated with the paclitaxel exposure during the index procedure. Regarding the total paclitaxel exposure, lower mortality was observed in the highest tercile of paclitaxel exposure.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Treatment Outcome

To confirm the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) based on the indication approved by the Pharmaceuticals and Medical Devices Agency Japan in real-world patients with femoropopliteal artery disease.Methods and Results:IN.PACT PMS Japan was a prospective, multicenter, single-arm, post-market surveillance (PMS) study conducted in Japan that enrolled 304 participants (mean age 75.3±7.9 years). The primary endpoint was primary patency at 6 months following the index procedure, defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤2.4 (assessed by the independent DUS core laboratory). Secondary endpoints included acute outcomes, primary patency at 12 months post-index procedure, freedom from CD-TLR, and major adverse events at 12 months. The mean lesion length was 97.81±58.97 mm. The primary endpoint, 6-month primary patency, was 91.3% (240/263). Kaplan-Meier estimates of primary patency and freedom from CD-TLR through 12 months were 91.5% and 94.1%, respectively. The CD-TLR rate was 5.8% (14/240) with low rates of thrombosis (0.8%) and target limb amputation (0.4%) at 12 months.. The results of this real-world PMS study were consistent with outcomes from previous IN.PACT DCB studies, confirming the safety and efficacy of the IN.PACT Admiral DCB for broader use in patients seen in everyday practice.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Japan; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Treatment Outcome; Vascular Access Devices; Vascular Patency

Drug coated balloons (DCB) with paclitaxel (Ptx) dose of 2-3.5 μg/mm2 balloon surface inhibit restenosis with different effectiveness and duration of success. A clinical dose finding study is not known for any of the currently marketed products. The aim of the present preclinical trial was to investigate a novel DCB coated with 6 μg Ptx/mm2 in a porcine model.. The current study investigated a DCB with a novel, modified iopromide based matrix with 6 μg Ptx/mm2. Drug transfer to the vessel wall of peripheral arteries was compared with a dose of 3 μg Ptx/mm2 and two fully overlapping DCB with 3 μg Ptx/mm2, each. Ptx concentration in the vessel wall after drug transfer was about twice as high for balloons with 6 μg/mm2 (1957±1472 μg/g) and two overlapping DCB with 3 μg Ptx/mm2, each (1287±619 μg/g) compared to a single balloon with 3 μg Ptx/mm2, (787±738 μg/g), with statistical significant differences for 1x6 μg/mm2 vs. 1x3 μg/mm2 (p = 0.017) but not for 2x3 μg/mm2 vs. 1x3 μg/mm2 (p = 0.184) and 1x6 μg/mm2 vs. 2x3 μg/mm2 (p = 0.178). The proportion of residual Ptx on balloon after treatment was similar for all groups between 6±1% and 10±3% of dose on balloon.. The dose of 6 μg Ptx/mm2 was successfully as well as reproducibly coated on conventional balloon catheters. Increased Ptx on balloons resulted in increased drug concentration in the vessel wall. A single balloon with 6 μg Ptx/mm2 seems to provide double dose compared to 3 μg Ptx/mm2, facilitates the procedure, and may reduce medico-economic cost compared to the use of two standard DCB.

Topics: Angioplasty, Balloon; Animals; Cardiovascular Agents; Coated Materials, Biocompatible; Paclitaxel; Peripheral Arterial Disease; Swine; Vascular Access Devices

Endovascular stenting has become the first-line treatment of symptomatic peripheral artery disease of the femoropopliteal axis (FPA). Several randomized clinical trials have reported that paclitaxel-eluting stents (PESs) significantly reduce the rates of restenosis. However, a meta-analysis investigating paclitaxel-coated devices in the FPA showed a significant increase in all-cause mortality after the use of PES. The aim of this study was to compare the long-term, real-world outcomes of bare-metal stents (BMSs) and PESs for treating FPA occlusive disease.. A retrospective review of the medical records of 296 patients who underwent FPA stenting between January 2011 and December 2017 was performed. Patients were grouped into BMS and PES groups. The primary end point was all-cause mortality. Secondary end points included limb salvage, primary patency, primary assisted patency, and secondary patency. A comparison between the two groups within TransAtlantic Inter-Society Consensus (TASC) II subgroups was also performed.. Of the study cohort, 101 patients (34%) received PES, whereas 195 patients (66%) underwent BMS placement. Median follow-up time was 23 months (interquartile range, 7-40 months). The 2-year all-cause mortality estimates were 12% for the PES group compared with 11.4% for the BMS group (P = .26). There were no differences in the 2-year limb salvage (90.7% vs 92%; P = .4), primary patency (78.8% vs 81.1%; P = .62), primary assisted patency (100% vs 96.5%; P = .4), and secondary patency (100% vs 98.6%; P = .26) between the PES and the BMS groups, respectively (all P > .05). These findings persisted when patients were stratified by TASC II lesions. Among patients with TASC C and D lesions, the use of PES was associated with significantly higher 2-year all-cause mortality (23.9% vs 5.1%; P = .05). After adjustment for age and other potential confounders, PES use was associated with significant increase in all-cause mortality (adjusted hazard ratio, 2.3; 95% confidence interval, 1.31-27 P = .02) in TASC C and D patients.. Consistent with the meta-analysis of several randomized clinical trials, the use of PES in a real-world setting was associated with a twofold increase in the risk of death. However, these findings were seen only among patients with TASC C and D lesions, who required multiple longer stents and potentially larger paclitaxel dose. There was no advantage in terms of patency in PES vs BMS in this population with extensive disease. Further studies of larger populations are required.

Topics: Aged; Cardiovascular Agents; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retreatment; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Ischemia; Peripheral Arterial Disease; Sirolimus; Treatment Outcome; Vascular Access Devices

Paclitaxel-coated devices have been shown to decrease restenosis when used in the femoropopliteal artery. Recent reports have suggested a possible risk of increased late mortality in patients treated with paclitaxel. It has been suggested that younger patients and those with limited comorbidities may be at higher risk. Our objective was to analyze long-term mortality based on patient age comparing treatment with paclitaxel to uncoated devices.. We performed a retrospective review of 1,170 consecutive patients who underwent femoropopliteal percutaneous intervention by angioplasty, atherectomy, stent placement, or combination between 2011 and 2018. Patients were grouped by age at the time of procedure: <60 years old (n = 244, 20.9%), 60-80 years old (n = 635, 54.3%), and >80 years old (n = 291, 24.9%). Within each group, patients were further divided by use of paclitaxel. The primary outcome measure was survival assessed by Kaplan-Meier analysis. Differences between the groups were analyzed with analysis of variance. Multivariable analysis was performed using Cox proportional hazard models.. Of the 1,170 patients who underwent femoropopliteal percutaneous intervention, 654 (55.9%) received a paclitaxel-coated device during treatment and 516 (44.1%) did not. Mean age of the overall patient cohort was 70.4 ± 12.6 years and 663 (56.7%) were male. When comparing the groups by age we found an increase in age but a decrease in the proportion of patients who smoke. The use of paclitaxel-coated devices was similar across the groups (<60 years old, 56.2%; 60-80 years old, 57.0%; >80 years old, 52.6%; P = 0.45). Demographics and comorbidities were similar between the patients treated with and without paclitaxel within each age group except more males in the <60-year-old group treated without paclitaxel and more patients with chronic limb threatening ischemia in the >80-year-old group treated with paclitaxel. In patients <60 and 60-80 years old paclitaxel use was associated with increased survival at 4 years: <60 (80.7% vs. 64.4%; P = 0.04); 60-80 (63.2% vs. 55.1%; P = 0.04). Survival was similar in the >80-year-old group (46.6% vs. 32.8%; P = 0.65).. Our data suggest that the use of paclitaxel-coated arterial devices is not associated with increased mortality. On the contrary, our data show that younger patients treated with paclitaxel show improved survival compared with those treated without paclitaxel. Paclitaxel-coated devices may be used with continued caution especially in patients at high risk for restenosis.

Topics: Age Factors; Aged; Aged, 80 and over; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Drug-Eluting Stents; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

To compare drug (paclitaxel)-coated balloon angioplasty with femoropopliteal bypass surgery in the treatment of femoropopliteal lesions.. A retrospective study was performed between January 2015 and January 2019, covering a four-year period. All subjects who underwent femoropopliteal bypass surgery and drug-coated balloon angioplasty over a four-year period were evaluated. The subjects' demographic characteristics, lesion characteristics, treatment outcomes and disease-free survival were collected. Subjects were divided into the femoropopliteal bypass group (Group A) and the drug-coated balloon angioplasty (Group B) group.. In total, 220 subjects were enrolled. Both Group A and Group B consisted of 110 subjects. The proportion of patients with a claudication distance between 0 and 50 m was significantly higher in Group A, and the proportion of patients with a claudication distance between 50 and 100 m was significantly higher in Group B (. Femoropopliteal bypass resulted in better disease-free survival rates than drug-coated balloon angioplasty and serves as an effective modality for the treatment of femoropopliteal lesions.

Topics: Aged; Angioplasty, Balloon; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Disease-Free Survival; Equipment Design; Female; Femoral Artery; Humans; Intermittent Claudication; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Time Factors; Vascular Access Devices; Vascular Patency

Concern has been raised over potential paclitaxel-related increase in mortality following treatment with drug-coated balloons. We report mid-term and long-term patient-level mortality in three trials from our institution.. Patient data from the DRECOREST I and II trials, as well as the FINNPTX-trial, were included for analysis. The DRECOREST I involved patients with stenosis in a bypass vein graft, and the DRECOREST II included patients with stenosis in a dialysis fistula. The FINNPTX-trial randomized patients to either a prosthetic bypass or drug-eluting stent for long femoropopliteal lesions. Since the present retrospective study addressed mortality related to intravascular paclitaxel exposure and population data in Finland are comprehensive, we were able to include all patients exposed to paclitaxel in the three trials. Mortality data were extracted from the population registry, as well as patient records. Survival rates were analyzed for all trials pooled and separately. Late mortality was retrospectively analyzed and cross-referenced with national registry data.. A total of 142 patients were included, 76 treated with paclitaxel-eluting device, and 66 without. The mean follow-up time for survivors was 3.9 years. Overall all-cause mortality was 31.7% during follow-up. In the DRECOREST I-trial, 35.5% of patients died in the paclitaxel group and 37.9% in the control group (P = 0.84). In the DRECOREST II, overall mortality was 55.6% in the paclitaxel group and 44.4% in the control group (P = 0.51). In the FINNPTX-trial 22.2% died in the paclitaxel group and 10.5% in the control group during follow-up (P = 0.30). No single cause of death was overrepresented. The most common causes of death in both groups were cardiovascular death, 59.3% in the paclitaxel group and 52.4% in the control group (P = 0.733), followed by malignancy (14.8% vs. 14.3% in the groups respectively).. No significant difference was seen in the overall analysis between the paclitaxel and the control group. A statistically nonsignificant elevated late mortality in the FINNPTX-trial after paclitaxel exposure was observed. However, the numbers in the individual trials are small and should be interpreted in the context of future patient-level meta-analysis.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Finland; Humans; Paclitaxel; Peripheral Arterial Disease; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices

The treatment of femoropopliteal peripheral artery disease (PAD) using paclitaxel-coated devices (PCDs) has been shown to improve patency in several randomized trials. However, a recent meta-analysis of trial data suggested an increased risk of mortality with PCD usage. Although subsequent studies have found no association with mortality, the subject has remained controversial. Thus, the aim of the present study was to further investigate the outcomes and causes of mortality for patients treated with PCDs.. Patients who had undergone endovascular interventions for PAD from 2013 to 2016 at a single institution were reviewed. The patients were stratified by the use of PCDs, which included drug-coated balloons and drug-eluting stents. The cumulative dose of paclitaxel was calculated for the patients who had received multiple interventions. The causes of mortality were identified and compared between the two groups.. Of the 366 included patients, 138 (38%) had received a PCD and 228 (62%) had received a non-drug-coated (NDC) device. Patients treated with PCDs were less likely to have undergone open surgery compared with patients treated with NDC devices. No differences were found in the indications or 30-day outcomes between the two groups. After a mean follow-up of 3.1 ± 1.8 years, no differences were found in the primary patency, reintervention rate, mean number of reinterventions, major amputation (5% vs 4%; P = .465), or mortality (16% vs 20%; P = .363) between the PCD and NDC groups. Also, no overall difference was found in the cause of mortality with and without PCD use or in the Kaplan-Meier survival curves. Furthermore, PCD use was not associated with an increased risk of mortality in Cox regression analysis. The cumulative dose of paclitaxel in patients treated with PCDs ranged from 383 to 49,259 μg (median, 7561 μg). A comparison of the patients treated with a cumulative dose of paclitaxel in the upper 50th percentile compared with the lower 50th percentile showed no significant differences in mortality (13% vs 19%; P = .333).. PCD use was shown to be safe and not associated with an increased risk of long-term mortality in the present study. Continued monitoring of PCD use is warranted to ensure the safety of this technology.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Endovascular Procedures; Female; Humans; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Retreatment; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

Paclitaxel-eluting stents have demonstrated improved patency over balloon angioplasty and bare metal stenting for endovascular interventions in the femoral-popliteal segment. Recently, concerns have arisen regarding the safety of paclitaxel use and its association with mortality. This study aims to examine real-world, long-term mortality, and patency of patients treated with the Zilver PTX drug-eluting stent.. Patients treated with the PTX stent after FDA approval between 2013 and 2015 were identified from an institutional database. Demographic, procedural, and device information was collected and initial- and lifetime-exposure dose of paclitaxel was calculated. The primary outcome was all-cause mortality and its association with paclitaxel exposure. Long-term patency was also evaluated.. Seventy-nine procedures involving PTX placement were performed on 64 individual patients during the study period, with 15 (23.4%) having bilateral procedures. Average age was 70 years, and 71.9% were male. Forty-five patients (70.3%) were claudicants, and 19 (29.7%) had chronic, limb-threatening ischemia. An average of 2.3 PTX stents, totaling 203 mm in length, were placed per procedure. Paclitaxel exposure was 1.87 mg/procedure initially (range 0.38-4.03 mg), and average lifetime exposure was 4.65 mg/patient (range 0.38-27.91 mg). Average follow-up was 59.6 months. Kaplan-Meier estimated survival was 96.9%, 81.2% and 71.7% at one , three, and five years. On multivariate analysis, no specific factors were associated with overall morality including initial paclitaxel dose (HR 0.99, 95% CI 0.99-1.00) and lifetime paclitaxel exposure (HR 0.98, 95% CI 0.89-1.08). Kaplan-Meier primary patency was 76.2%, 60.1%, and 29.3% at one, two, and five years, respectively. Secondary patency was 92.2%, 85.4%, and 75.2% at the same intervals.. At a mean follow-up of five years, exposure to higher doses of paclitaxel from Zilver PTX does not appear to be associated with increased mortality compared to lower doses in real-world patients. Long-term patency rates confirm the efficacy of Zilver PTX, and further investigation may be warranted before abandoning paclitaxel use altogether.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Databases, Factual; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Progression-Free Survival; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Vascular Patency

Topics: Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Gangrene; Humans; Paclitaxel; Peripheral Arterial Disease; Pharmaceutical Preparations; Popliteal Artery; Retrospective Studies; Treatment Outcome

Aneurysmal degeneration after peripheral angioplasty is a potentially serious complication. In this case, the patient underwent repeated angioplasty of a prior vein bypass graft utilizing a paclitaxel-coated balloon. He subsequently developed a progressive aneurysmal degeneration, threatening his bypass, which ultimately required an urgent exclusion with a covered stent. This case represents a rare complication of peripheral bypass graft related to percutaneous intervention as well as paclitaxel-coated devices and warns other practitioners of the increased scrutiny and caution one should exercise in the use of such interventions.

Topics: Aged; Aneurysm; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Graft Occlusion, Vascular; Humans; Male; Paclitaxel; Peripheral Arterial Disease; Treatment Outcome; Vascular Access Devices; Vascular Grafting

Zilver PTX polymer-free, paclitaxel-coated stents and Viabahn stent grafts are effective for the treatment of femoropopliteal lesions. The aim of this study was to compare clinical outcomes between the two devices in patients with symptomatic peripheral arterial disease in real-world settings.. This multicenter, retrospective study concerned a clinical database of 445 patients with symptomatic peripheral arterial disease (Rutherford categories 1-6) who underwent either Zilver PTX or Viabahn implantation for a femoropopliteal lesion of 10 cm or longer with reference vessel diameters of 4.0 to 7.5 mm between 2012 and 2018 at five hospitals in Japan. Outcome measures were primary patency, freedom from stent thrombosis, freedom from any target lesion reintervention, limb salvage, and overall survival. After propensity score matching, these clinical outcomes were compared between patients treated with the Zilver PTX and those treated with the Viabahn. Also assessed were the interaction effects of baseline characteristics on the association of the Zilver PTX and Viabahn with restenosis and stent thrombosis.. In total, 271 patients were treated with the Zilver PTX, and 174 patients were treated with the Viabahn. Propensity score matching extracted 133 patient pairs with no major intergroup differences in baseline characteristics. The Zilver PTX group had a lower rate of 3-year primary patency (59.5%; [95% confidence interval (CI), 53.0%-66.2%] vs 69.6% [95% CI, 59.3%-79.4%]; P = .005), but a higher rate of 3-year freedom from stent thrombosis (93.6% [95% CI, 90.0%-96.3%] vs 82.4% [95% CI, 74.5%-89.0%], P = .038). There was no significant difference in overall survival, limb salvage, or freedom from reintervention (all P > .05). An interaction analysis showed that the restenosis risk of the Zilver PTX was significantly higher vs the Viabahn in patients with no or one below-the-knee runoff vessel and in those with intravascular ultrasound use than in patients with two or three below-the-knee runoff vessels and in those without intravascular ultrasound use, respectively (P for interaction = .046 and .010, respectively), whereas the stent thrombosis risk of the Zilver PTX was significantly smaller vs the Viabahn in patients not on dialysis than in those on dialysis (P for interaction = .034).. Compared with Viabahn stent grafts, Zilver PTX stents have a lower rate of primary patency but a higher rate of freedom from stent thrombosis.

Topics: Aged, 80 and over; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Databases, Factual; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Japan; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Reoperation; Retrospective Studies; Risk Assessment; Risk Factors; Thrombosis; Time Factors; Treatment Outcome; Vascular Patency

We evaluated the outcomes of revascularization in patients with chronic limb-threatening ischemia (CLTI) treated in real-world settings. This is a prospective multicenter cohort study with 12-month follow-up enrolling patients (n = 287) with CLTI undergoing open, endovascular, or hybrid lower extremity revascularization. The primary end point was amputation-free survival (AFS) at 12 months. Cox proportional analysis was used to determine independent predictors of amputation and restenosis. At 30 days, major adverse cardiovascular and major adverse limb events (MALE) rates were 3.1% and 2.1%, respectively. At 1 year, the overall survival rate was 88.8%, the AFS was 86.6%, and the primary patency was 70.5%. Freedom from MALE was 62.5%. After multivariate analysis, smoking (hazard ratio [HR] = 2.2,

Topics: Aged; Amputation, Surgical; Cardiovascular Agents; Chronic Disease; Endovascular Procedures; Female; Humans; Ischemia; Italy; Limb Salvage; Male; Peripheral Arterial Disease; Prospective Studies; Recurrence; Registries; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Surgical Procedures

To examine nationwide variations in inpatient use of drug-coated balloons (DCBs) for treating femoropopliteal segment occlusive disease and whether DCBs are associated with reduced early out-of-hospital health care utilization.. The study included 24,022 patients who survived hospitalization for femoropopliteal revascularization using DCB angioplasty (n=7850) or uncoated balloon angioplasty (n=16,172) in the 2016-2017 Nationwide Readmissions Database. Differences in patient, hospitalization, and institutional characteristics were compared between treatment strategies. Adjusted logistic regression models were used to examine differences in 6-month rates of readmission, amputation, and repeat intervention. Results are presented as the odds ratio (OR) and 95% confidence interval (CI).. Patients treated with DCBs had a higher prevalence of chronic limb-threatening ischemia, diabetes, hypertension, and tobacco use. Revascularization with a DCB was associated with shorter hospitalizations, lower median hospitalization costs, and fewer inpatient lower extremity amputations. Readmissions at 6 months were decreased in patients treated with DCBs compared with uncoated balloon angioplasty (OR 0.90, 95% CI 0.83 to 0.98, p=0.014). The most common reasons for readmission were complications related to procedures (15.4%) and diabetes (15.4%). Compared to patients treated with DCBs, patients treated with uncoated balloon angioplasty were more often readmitted with early procedure-related complications (13.3% vs 17.5%). There were no between-group differences in readmission for sepsis, myocardial infarction, or congestive heart failure.. DCBs are less often used compared to uncoated balloons during inpatient femoropopliteal procedures. While DCB utilization is associated with more severe comorbidities and advanced peripheral artery disease, readmission rates are decreased through the first 6 months.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Cohort Studies; Femoral Artery; Humans; Inpatients; Paclitaxel; Patient Acceptance of Health Care; Peripheral Arterial Disease; Pharmaceutical Preparations; Popliteal Artery; Prospective Studies; Time Factors; Treatment Outcome; Vascular Patency

Inflammation is a component in the pathogenesis of critical limb ischemia. We aimed to assess how inflammation affects response to treatment in patients treated for critical limb ischemia using neutrophil-to-lymphocyte (NLR) and platelet-to-lymphocytes ratios (PLR) as markers of inflammation.. Patients in a single tertiary cardiovascular center with critical limb ischemia unsuitable for surgical or interventional revascularization were retrospectively identified. Data were collected on medical history for risk factors, previous surgical or endovascular revascularization, and outcome. A standard regimen of low molecular weight heparin, aspirin, statins, iloprost infusions, and a standard pain medication protocol were applied to each patient per hospital protocol. Patients with improvement in ischemic pain and healed ulcers made up the responders group and cases with no worsening pain or ulcer size or progression to minor or major amputations made up the non-responders group. Responders and Non-responders were compared for risk factors including pretreatment NLR and PLR.. 268 included patients who were not candidates for surgical or endovascular revascularization were identified. Responders had significantly lower pretreatment NLR (4.48 vs 8.47, p < 0.001) and PLR (162.19 vs 225.43, p = 0.001) values. After controlling for associated risk factors NLR ≥ 4.63 (p < 0.001) and PLR ≥ 151.24 (p = 0.016) were independently associated with no response to treatment.. Neutrophil-to-lymphocyte ratio and platelet-to-lymphocytes ratio are markers of inflammation that are reduced in patients improving with medical treatment suggesting a decreased state of inflammation before treatment in responding patients.

Topics: Aged; Cardiovascular Agents; Critical Illness; Female; Humans; Iloprost; Ischemia; Lymphocyte Count; Lymphocytes; Male; Middle Aged; Neutrophils; Peripheral Arterial Disease; Predictive Value of Tests; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Wound Healing

Recent evidence from randomized controlled trials has raised concerns about the long-term safety of paclitaxel-coated peripheral devices used for femoropopliteal artery revascularization. In response to a call for more real-world data on the safety of these devices, the SAFE-PAD study (Safety Assessment of Femoropopliteal Endovascular treatment with Paclitaxel-coated Devices) was designed with input from the Food and Drug Administration to provide a long-term, comprehensive evaluation of the mortality risk associated with paclitaxel-coated devices among Medicare beneficiaries.. The SAFE-PAD study will evaluate the long-term safety of drug-coated devices compared with nondrug-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral artery disease.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Humans; Male; Medicare; Peripheral Arterial Disease; Popliteal Artery; Time Factors; Treatment Outcome; United States

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Female; Humans; Ischemia; Lower Extremity; Male; Paclitaxel; Patient Safety; Peripheral Arterial Disease; Randomized Controlled Trials as Topic; Treatment Outcome

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)'s used was 99.6% (1.60 ± 0.79 DCB's/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). The most important predictors for TLR were female gender, in-stent restenosis at baseline and lesion length.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Cause of Death; Coated Materials, Biocompatible; Europe; Female; Femoral Artery; Humans; Malaysia; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Recurrence; Resveratrol; Risk Assessment; Risk Factors; Sex Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Reporting outcomes with a new generation paclitaxel eluting balloon (Luminor®; iVascular, Vascular, S.L.U., Barcelona, Spain) in the popliteal district. Endovascular treatment of popliteal artery atherosclerotic disease is still debated without definitive evidences.. From January to June 2019, patients' data presenting popliteal artery atherosclerotic diseases and treated with the Luminor® (iVascular) drug eluting balloon (DEB) were prospectively collected. Critical limb ischemia (CLI) or severe claudication associated with popliteal artery stenosis >50% were the inclusion criteria. Measured outcomes were technical success, early and late results; including mortality, morbidity, symptoms recurrence, amputation, ankle-brachial index (ABI), survival, primary patency, secondary patency, freedom from restenosis. Median follow-up was 22.43 ± 4 (mean:21.58; IQR:20-24) months.. Of the 33 included patients, 28 (85%) were diagnosed with CLI, with a mean preoperative run-off score of 5.39 (r:0-10; SD:3) and a chronic popliteal occlusion in 21 (64%). Technical success was achieved in all cases. Perioperative mortality was observed in 1 (3%) patient and perioperative complications in 2 (6%). During the follow-up were reported 2 symptoms recurrence; a significant ABI increase (0.57; IQR:0.41-0.47 vs. 0.69; IQR:0.50-0.67; P < 0.01); 1 (3%) major and 2 (6%) minor amputations. Estimated 24 months survival, primary patency, secondary patency, and freedom from restenosis were 97%, 96.9%, 100%, and 93.8% respectively.. In this prospective study, the use of the Luminor® (iVascular) was safe and effective in addressing atherosclerotic popliteal artery lesions. Larger studies with longer term-outcomes are required to assess the durability of this device in the popliteal artery.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Critical Illness; Equipment Design; Female; Humans; Intermittent Claudication; Ischemia; Limb Salvage; Male; Paclitaxel; Peripheral Arterial Disease; Plaque, Atherosclerotic; Popliteal Artery; Prospective Studies; Recurrence; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation.. Assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD.. REALITY (NCT02850107) prospectively enrolled subjects at 13 multinational centers with 8-36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12-month primary patency, and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and a Clinical Events Committee adjudicated events.. A total of 102 subjects were enrolled; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1 cm, 39.0% were chronic total occlusions (mean lesion length 22.6 ± 8.6 cm); 86.2% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 8.8% (9/102) of subjects. Twelve-month primary patency rate was 76.7% (66/86) and freedom from CD-TLR rate was 92.6% (87/94). No device or procedure related deaths and one index-limb major amputation were reported.. Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate.

Topics: Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Time Factors; Treatment Outcome; Vascular Patency

Paclitaxel (PTX)-coated peripheral arterial devices have been shown to decrease femoropopliteal artery restenosis and the need for reintervention compared with non-PTX-coated devices. The data regarding PTX efficacy and safety come from randomized controlled trials that almost exclusively enrolled patients with claudication. The outcomes of PTX treatment in patients who present with chronic limb-threatening ischemia (CLTI) are unknown. This study compares long-term outcomes in patients with CLTI treated with and without PTX.. We retrospectively reviewed 983 patients with CLTI treated with femoropopliteal artery angioplasty, atherectomy, stent, or combination between 2011 and 2019. Procedures were performed with additional proximal or distal tibial interventions as needed. Kaplan-Meier survival analysis and multivariable Cox-regression analysis compared overall survival (OS), amputation-free survival (AFS), freedom from major amputation (ff-MA), and freedom from target vessel revascularization (ff-TVR) between patients treated with and without PTX.. Demographics, comorbidities, and Rutherford class were similar between 574 PTX (58.5%) and 409 non-PTX (41.6%) patients except that non-PTX patients were more likely to be male (56.2% vs 49.7%), dialysis dependent (19.6% vs 14.3%), and have higher average creatinine (2.3 vs 1.8 mg/dL). Through 4-year follow-up, the PTX group demonstrated a significant increase in OS (56.2% vs 43.9%, P = .013), AFS (52.6% vs 36.1%, P < .0001), ff-MA (87.4% vs 78.7%, P = .0007), and ff-TVR (77.6% vs 70.6%, P = .012). Multivariable Cox-regression analysis demonstrated that PTX treatment was associated with improved OS, AFS, ff-MA, and ff-TVR.. In patients with CLTI, treatment with a PTX-coated device is associated with improved OS, AFS, ff-MA, and ff-TVR through 4-year follow-up. PTX-coated devices may be especially beneficial in patients who present with CLTI.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Chronic Disease; Coated Materials, Biocompatible; Equipment Design; Female; Humans; Ischemia; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Progression-Free Survival; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors

We examined the endovascular community response to data demonstrating increased mortality in paclitaxel devices for the treatment of peripheral arterial disease in femoropopliteal lesions.. A retrospective observational study using the Vascular Quality Initiative Peripheral Vascular Intervention registry dataset was performed to examine paclitaxel device use for peripheral arterial disease in femoropopliteal arteries treated from 2017 to 2019. A total of 41,707 patients and 52,208 procedures were analyzed during the study period. A post hoc analysis was performed to examine paclitaxel device use during selected periods in 2019.. The total number of femoropopliteal procedures in 2017, 2018, and 2019 were 17,458, 21,140, and 21,322, respectively. Paclitaxel devices were used for 8852 arteries in 2017, 10,691 in 2018, and 6732 in 2019, which was significantly reduced in 2019 compared with 2017 or 2018 (P < .0001) and 2019 compared with the 2018 and 2017 volumes combined (P < .0001). Post hoc analysis of selected periods in 2019 demonstrated variable use throughout 2019.. After the report of data with concerns of mortality associated with paclitaxel device use in 2018, a rapid reduction in overall paclitaxel device use was observed in 2019.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coated Materials, Biocompatible; Databases, Factual; Drug-Eluting Stents; Endovascular Procedures; Female; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Practice Patterns, Physicians'; Prosthesis Design; Registries; Retrospective Studies; Time Factors; Treatment Outcome

Paclitaxel-eluting devices (PED) reduce restenosis and target lesion revascularization (TLR) in femoropopliteal intervention. Recent data suggest a two-fold increased long-term mortality in patients treated with PED. The aim of our study is to evaluate if endovascular therapy (EVT) with PED increases mortality risk in patients with symptomatic lower limb peripheral artery disease (PAD) compared to non-eluting devices (NED).. The study is a retrospective, single-center registry on patients undergoing EVT for PAD from January 2009 to June 2018. Propensity score analysis on logistic regression model for independent predictors of long-term mortality was used to match PED and NED patients. Mortality was assessed at 2, 5 and 7 years in the entired matched population and in a sub-group of patients ≤75 years.. During the study period, 1294 patients, 718 NED and 576 PED, met the inclusion/exclusion criteria and entered in the study. Propensity score matching analysis identified 854 matched patients, 414 PED and 440 NED. The population was mainly characterized by diabetic patients with CLI (80%) and high prevalence of CAD (30%), heart failure (15%) and renal insufficiency (20%). Mean follow-up length was 58 ± 34 months, (median 52.5). Mortality was 18% in NED vs 12% in PED patients at two years (p = 0.01), 36% vs 30% at 5 years (p = 0.03) and 41% vs 39% at seven years (p = 0.2) respectively. In patients ≤75 years, mortality at 7-year was 28% in PED vs 36% in NED, p = 0.07.. These results suggest a reduced mortality at 2 and 5 years with PED as compare to NED treatment in a real-world CLI scenario. At 7-year follow-up, the advantage was numerically evident only in patients ≤75 years.

Topics: Cardiovascular Agents; Drug-Eluting Stents; Endovascular Procedures; Humans; Lower Extremity; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Factors; Treatment Outcome

This study investigated the 1-year clinical outcomes of directional atherectomy combined with drug-coated balloon (DA + DCB) in femoropopliteal artery disease (FPAD) from real-world experience.. A retrospective study was conducted of patients treated between July 2016 and June 2019 using DA + DCB for FPAD. Patients' demographics, comorbidities, clinical characteristics and outcomes, and angiography and duplex ultrasound findings were analyzed. The 6-month and 1-year primary patency, primary assisted patency, secondary patency, and freedom from clinically-driven target lesion revascularization (CD-TLR) were evaluated. Univariate and multivariate analyses were performed to identify risk factors of primary patency loss or CD-TLR.. Seventy-nine consecutive patients (83 lesions, mean age 70.9 years, 52 men) were included. Twenty-seven limbs had lifestyle-limiting claudication and 56 limbs had critical limb ischemia. There were 73 and 10 limbs with de novo lesion and in-stent restenosis, respectively. The mean lesion length of all the patients was 22.1 cm. The mean length of chronic total occlusions (CTOs) was 8.3 cm. Severe calcification was found in 32.5% cases. The 1-year primary patency rate was 80.8% and freedom from CD-TLR was 92.2%. The bailout stenting rate was 2.4%. Patients with CTO >10 cm had significantly lower 1-year primary patency rate and freedom from CD-TLR than did patients with CTO ≤10 cm. Total length of CTO (stratified as ≤5 cm, 5-10 cm, >10 cm) was identified as an independent risk factor of 1-year primary patency loss and CD-TLR.. DA + DCB appears to be a safe and effective endovascular therapy to treat FPAD in real-world clinical practice, with a promising 1-year patency rate with a low rate of bailout stenting.

Topics: Aged; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Factor Analysis, Statistical; Femoral Artery; Humans; Male; Peripheral Arterial Disease; Pharmaceutical Preparations; Popliteal Artery; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

Zilver PTX nitinol self-expanding drug-eluting stent with paclitaxel coating is effective for treatment of superficial femoral artery (SFA) disease. However, as with any stent, it induces a measure of vascular inflammatory response. The current clinical trial (NCT02734836) aimed to assess vascular patency, remodeling, and inflammatory markers with intravascular optical coherence tomography (OCT) in patients with SFA disease treated with Zilver PTX stents.. Serial OCT examinations were performed in 13 patients at baseline and 12-month follow-up. Variables evaluated included neointimal area, luminal narrowing, thrombus area, stent expansion as well as measures of inflammation including, peri-strut low-intensity area (PLIA), macrophage arc, neovascularization, stent strut apposition and coverage.. Percentage of malapposed struts decreased from 10.3 ± 7.9% post-intervention to 1.1 ± 2.2% at 12-month follow-up, but one patient showed late-acquired stent malapposition (LASM). The percent of uncovered struts at follow-up was 3.0 ± 4.5%. Average expansion of stent cross-sectional area from baseline to follow-up was 35 ± 19%. The average neointimal area was 7.8 ± 3.8 mm. At 12-month follow-up, OCT analysis of Zilver PTX stent shows outward remodeling and minimal neointimal growth, but evidence of inflammation including PLIA, neovessels, thrombus and macrophages.. Thirteen patients with PAD had paclitaxel-coated stents implanted in their SFAs and were then imaged with OCT at baseline and 12-month follow-up. OCT proxy metrics of inflammation were quantified.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Cardiovascular Agents; Drug-Eluting Stents; Female; Femoral Artery; Humans; Inflammation; Male; Middle Aged; Neointima; Paclitaxel; Peripheral Arterial Disease; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Self Expandable Metallic Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Patency; Vascular Remodeling

Peripheral artery disease is the second most common cardiovascular disease. It can often occur in complex form when there is a presence of long, diffuse, and multiple lesions. Current treatments use either single long drug-coated balloons (DCBs) or multiple DCBs; however, treatment success is limited. The purpose of this study was to investigate the preclinical feasibility of our multiple-release Tailored Medical Devices DCB (MR-TMD-DCB) to treat multiple arterial segments using a single DCB.. The MR-TMD-DCBs were developed using a two-layer coating approach. The DCBs were developed in a certified Current Good Manufacturing Practices facility using presterilized materials and reagent and then characterized for coating morphology, thermal and chemical changes, and in vitro particulate shedding. The drug loss, tissue uptake, and undelivered drug amounts were analyzed using an in vitro peripheral artery flow model and explanted pig arteries. Then, an in vivo survival study was performed using a healthy porcine model to measure the short-term drug uptake (seven swine; 14 treatments at day 1) and retention (seven swine; 14 treatments at day 7) in two different arterial segments after treatment with a single MR-TMD-DCB.. The coating on the MR-TMD-DCB was smooth and homogeneous with paclitaxel molecularly dispersed in its amorphous state. A negligible number of particulates were shed from the MR-TMD-DCB coating. A similar amount of drug was accurately delivered into two separate explanted arteries using a single MR-TMD-DCB during the in vitro flow model testing (707 ± 109 ng/mg in the first explanted artery and 783 ± 306 ng/mg in the second explanted artery). The MR-TMD-DCB treatment resulted in equivalent drug amounts in the two arterial segments at day 1 (63 ± 19 ng/mg in the first treatment site and 59 ±19 ng/mg in the second treatment site) and at day 7 (9 ± 6 ng/mg in the first treatment site and 10 ± 6 ng/mg in the second treatment site). In addition, the drug levels at each time point were in the clinically relevant range to prevent neointimal hyperplasia.. The MR-TMD-DCBs provided equivalent and clinically relevant drug retention levels into two different arterial segments. Thus, MR-TMD-DCBs can be used to accurately deliver drug into multiple arterial segments with the use of a single DCB. The clinical outcomes of these findings need further investigation. Future long-term pharmacokinetics and safety studies will be performed to evaluate the safety and efficacy of the MR-TMD-DCB.

Topics: Angioplasty, Balloon; Animals; Cardiovascular Agents; Coated Materials, Biocompatible; Disease Models, Animal; Paclitaxel; Particulate Matter; Peripheral Arterial Disease; Swine; Vascular Patency

Drug-eluting devices (DED) represent a well-established therapy being widely used for endovascular revascularization (EVR) of peripheral vessels. Recent data indicate a two-fold increased long-term mortality in patients treated with paclitaxel-based DED. The subsequent safety concerns affected international regulatory authorities to enunciate several alerts for further application of DED.. In 9.2 million insurants of the German BARMER Health Insurance, data on the application of paclitaxel-based drug-eluting stents (DES) and drug-coated balloons (DCB) were retrieved from their introduction on the market in 2007 until present. All patients with first EVR between 2007 and 2015 were indexed and followed until 31 December 2017. Each subsequently applied DES, DCB, bare-metal stent, and uncoated balloon was included in further analyses. Multivariable Cox regression analysis considered potential non-linear time-dependent hazard ratios (HRs) of DES and DCB over 11 years. We identified 64 771 patients who underwent 107 112 EVR procedures using 23 137 DED. Multivariable Cox regression analysis showed paclitaxel-based DES not to be associated with increased long-term mortality for over 11 years past application (all P > 0.057). DCB was associated with decreased long-term mortality for the first year past application (HR 0.92; P < 0.001), and indifferent correlation in the years thereafter (all P > 0.202).. Our real-world analysis showed no evidence for increased mortality associated with paclitaxel-based DED for over 11 years.

Topics: Cardiovascular Agents; Drug-Eluting Stents; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Stents; Treatment Outcome

To examine the regional variation and temporal change in lumen size along the entire autogenous vein bypass graft used for treating arterial occlusive disease in lower extremity and to explore the factors associated with graft expansive or constrictive remodeling.. Patients were prospectively scanned using contrast-enhanced computed tomography at 1 week and 1, 6, and 12 months postoperatively to obtain lumen cross-sectional areas at 1-mm intervals along the entire grafts. Graft lumen remodeling characteristics and the associated demographic and clinical factors were examined.. Fifty-six patients with at least two consecutive computed tomography scans were analyzed. Patients with a composite or longer graft, or with diabetes, had a larger lumen cross-sectional area variation along the graft. The mean lumen cross-sectional areas of all the grafts demonstrated no significant changes through 12 months. However, individually, graft remodeling was time dependent and there was a more dramatic change in lumen cross-sectional area within the first postoperative month. At 12 months, a near equal distribution between expansive and constrictive grafts existed. A negative relation between the initial lumen diameters and the subsequent lumen diameter changes was observed. Eleven grafts failed within 12 months; failed and patent grafts had similar mean lumen cross-sectional areas at all four time points, but failed grafts had a larger maximal local cross-sectional area reduction from 1 week to 1 month (58.0 ± 6.7% vs 38.1 ± 3.1%, mean ± standard error of the mean, failed vs patent, P = .004). Black patients had a smaller mean lumen cross-sectional area than white patients at all four time points and also had a higher early percent mean area reduction (-20.5 ± 6.3% vs -1.0 ± 3.7%, black vs white, P = .018). Cilostazol use was associated with early expansive graft remodeling.. Vein grafts remodel heterogeneously and dynamically. Remodeling is associated with initial graft lumen size, race, and cilostazol use. It is found that remodeling that produces some critical minimum area or maximal percent reduction during the first postoperative month may predispose to vein graft failure. These findings offer insight into further investigation to examine the underlying mechanisms and opportunities to improve graft remodeling and durability.

Topics: Aged; Cardiovascular Agents; Cilostazol; Computed Tomography Angiography; Female; Humans; Longitudinal Studies; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Phlebography; Prospective Studies; Time Factors; Treatment Outcome; Vascular Grafting; Vascular Remodeling; Veins

Most previous drug-coated balloon (DCB) angioplasty studies used strict inclusion and exclusion criteria and therefore might not be representative for daily practice. This study was performed to evaluate the midterm outcomes of DCB angioplasty in femoropopliteal artery disease and to identify risk factors for restenosis.. All patients treated with DCB angioplasty between January 2015 and September 2016 were included. Provisional stents were placed if indicated. Data were retrospectively collected from digital patient records. No exclusion criteria were applied. The primary end point was primary patency. Secondary end points were primary assisted patency, secondary patency, clinically driven target lesion revascularization (CD-TLR) and major adverse events. All end points were calculated with the Kaplan-Meier analysis. The univariable and multivariable Cox regression analyses were performed to identify risk factors for restenosis.. A total of 109 patients (113 legs) were included (45% male; mean age, 72 ± 10). The rate of critical limb ischemia was 52% and total occlusions were treated in 38%. The mean follow-up was 24 ± 13 months. Primary patency rates were 87%, 79%, and 61% at 1, 2, and 3 years, respectively. Primary assisted patency rates were 95%; 89%, and 79%; secondary patency rates were 99%, 97%, and 91%; and CD-TLR rates were 6.9%, 14.3%, and 20.6% at 1, 2, and 3 years, respectively. Overall mortality and major target limb amputation rates were 18% and 5% at 3 years. Multivariable analysis demonstrated that only Trans-Atlantic Inter-Society Consensus (TASC) D lesions were associated with restenosis (P = 0.008).. DCB angioplasty is an effective and safe treatment option for femoropopliteal lesions in daily practice with excellent 1- and 2-year results. The 3-year results were slightly less favorable, which may be caused by the ongoing vascular disease or a late "catch-up" phenomenon. Only TASC D lesions were associated with loss of primary patency after adjustment for confounders.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Femoropopliteal (FP) artery in-stent restenosis (ISR) is associated with high rates of re-intervention and occlusion. The combined use of laser atherectomy (LA) with balloon angioplasty (BA) is superior to conventional balloon angioplasty (BA). Drug-coated balloons (DCBs) when combined with LA have provided additional efficacy for the treatment of FP-ISR. The aim of this study was to investigate the combination of DCB + LA with the recently approved Turbo-Power™ (Spectranetics Inc., Colorado Springs, CO, USA) LA device.. This was a dual-center retrospective study enrolling 78 consecutive patients with Tosaka type II (n = 18) or III (n = 60) FP-ISR. The lesions were treated with either Turbo-Power™ LA followed by DCB (n = 27) or with other LA devices followed by plain BA (LA + BA; n = 51) from 2015 to 2017. A Cox regression analysis was performed to examine the association between the two groups in terms of target lesion revascularization (TLR) and occlusion rates over a follow up period of 12 months. Kaplan-Meier survival curves were estimated and compared with the log-rank test.. The overall procedural success was 90%. Eight periprocedural complications occurred without any difference between the two groups (Turbo-Power™ + DCB: 7.4% vs LA + BA: 11.8%, p = .7). The 12-month KM estimates for freedom from TLR were 90.9% in the Turbo-Power™ + DCB group vs 55.7% in the LA + BA group (p = .005). Among Toasaka III lesions, the 12 m-KM survival estimates for freedom from TLR were 88.9% in the Turbo-Power™ + DCB group vs 54.2% in the LA + BA group (p = .009). The 12 m-KM estimates for freedom from re-occlusion were 89.0% in the Turbo-Power™ + DCB group vs 58.9% in the LA + BA group (p = .070).. Turbo-Power™ laser atherectomy combined with DCB exerted synergistic mechanism of actions and improved 12-month TLR rates for the treatment of complex FP-ISR lesions.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Atherectomy; California; Cardiovascular Agents; Coated Materials, Biocompatible; Colorado; Constriction, Pathologic; Female; Femoral Artery; Humans; Laser Therapy; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Atherosclerotic disease of the common femoral artery (CFA), commonly associated with multilevel disease affecting the femoropopliteal segment, can cause claudication or contribute to critical limb ischemia. Although endovascular therapy for the management of peripheral arterial disease (PAD) has been increasingly utilized, its role in CFA lesions remains controversial. The aim of this study was to investigate the safety and efficacy of drug (DCB) vs non drug coated balloon angioplasty (BA) at the CFA segment.. In this two-center study, we identified 154 patients treated either with DCB (n = 47) or BA (n = 107) for CFA lesions. Hazard ratios (HR) and the respective 95% confidence interval (CI) were synthesized to examine the association between the two groups in terms of target lesion revascularization (TLR), limb loss, and major adverse limb event (MALE) at 12 and 24 months of follow up.. This real-world population included a high percentage of patients with critical limb ischemia (43%) and moderate to severe lesion calcification (75%). Adjunctive atherectomy was performed in 97.9% of DCB cases (N = 46/47) and 44.7% of BA cases (N = 51/114). The overall procedural success rate was 95% without any differences between the two groups. Post-angioplasty dissections were observed in 15 cases [DCB: 8.5% (N = 4/47) vs BA: 9.7% (N = 11/113); p = .81], while distal embolization occurred in one patient in the DCB group and one in the BA group (p = .52). Provisional stenting was more commonly necessary in BA vs. DCB cases (12.3% vs 2.13%, p = .044). Physiologic assessment during follow up demonstrated a better mean 2-year ABI for the DCB group (mean: 0.9; SD: 0.2) vs BA group (mean: 0.6; SD: 0.4), although statistical significance was not reached (p = .06). No difference between the two groups was detected in terms of freedom from TLR (DCB: 75.5% vs BA: 86.8%; HR: 1.31; 95% CI: 0.46-3.67; p = .61), freedom from limb loss (DCB: 83.8% vs BA: 83.6%; HR: 1.04; 95% CI: 0.36-2.99; p = .94) or freedom from MALE (DCB: 83.5% vs BA: 78%; HR: 0.73; 95% CI: 0.26-1.99; p = .53) at 24 m of follow up. However, at the end of follow up more deaths were observed in patients treated with BA than DCB (DCB: 14.9% vs BA: 31.7%; p = .03). Patients who required provisional stenting were at higher risk for limb loss 2 years after the initial procedure (multivariate: HR: 4.54; 95% CI: 1.09-18.85; p = .04).. Both DCB and non-DCB strategies are effective modalities for revascularization of patients with CFA lesions. Larger prospective studies are necessary to determine the relative benefit, if any, of drug-eluting technologies for the treatment of common femoral artery disease.

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Atherectomy; California; Cardiovascular Agents; Coated Materials, Biocompatible; Colorado; Comparative Effectiveness Research; Critical Illness; Female; Femoral Artery; Humans; Ischemia; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Calcification; Vascular Patency

The aim of this study is to evaluate the performance and predictors of failure of paclitaxel drug-eluting stents and paclitaxel-coated balloons in the treatment of long-segment femoropopliteal disease. We report a retrospective cohort analysis of patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in lesions >100 mm, which were not included in any of the pivotal trials.. Ninety-seven patients with peripheral vascular disease (Rutherford III-VI) underwent long-segment (≥100 mm) femoropopliteal drug-eluting stent (DES) implantation or angioplasty with drug-coated balloons (DCB). Patients were followed after their initial procedure for target lesion restenosis, defined as a reduction in lumen diameter by greater than 50% as measured by duplex ultrasonography (ratio >2).. The median length of the affected arterial segments was 110 mm (interquartile range [IQR] 100-150, absolute range 100-260) using up to 4 overlapping stents. During the median 13-month follow-up (IQR 7-16), no early thrombotic occlusions occurred within 30 days, but 28 (29%) patients developed a target lesion restenosis after 1 year. Cumulative primary patency at 6 and 12 months was 87% and 71% overall, respectively. The cumulative patency during the same follow-up periods varied between patients treated with different paclitaxel modalities with 88% and 80% primary patency in patients treated with DES (n = 63) versus 81% and 49% in patients treated with DCB (n = 21) (adjusted hazard ratio 2.46, P = 0.03). Lesion length, concurrent tibial intervention, and recurrent target lesions were not associated with restenosis.. Short-term outcomes in patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in long lesions, mirror results from the clinical trials. The primary patency observed in patients treated with DES was significantly higher than in patients treated with DCB.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Critical Illness; Databases, Factual; Drug-Eluting Stents; Female; Femoral Artery; Humans; Ischemia; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Time Factors; Treatment Outcome; Vascular Patency

Long-term safety concerns have been raised that the use of paclitaxel-coated balloons and stents is linked to excess mortality. Our objective was to compare outcomes in patients treated with paclitaxel vs uncoated devices and to analyze long-term mortality.. We conducted a retrospective single-institution review of 1170 consecutive patients who underwent femoropopliteal percutaneous revascularization by angioplasty, atherectomy, stent placement, or combination between 2011 and 2018. The primary outcome measure was all-cause mortality. Groups were divided into patients who received paclitaxel (n = 652) and those who did not (n = 518). Categorical variables were assessed using χ. Demographics, risk factors, and Rutherford class were similar between the groups, except that the paclitaxel group was more likely to have diabetes (60.9% vs 55.0%; P = .04), was less likely to be on dialysis (10.7% vs 14.9%; P = .04), and had lower average creatinine concentration (1.6 ± 1.8 mg/dL vs 2.0 ± 2.3 mg/dL; P = .003). There were no differences in all-cause mortality through 2 years between paclitaxel and no-paclitaxel cohorts (25.5% vs 30.3%; log-rank, P = .098). At 3 years and 3.5 years, mortality was significantly lower in the paclitaxel group: year 3, 32.1% vs 39.4% (log-rank, P = .041); year 3.5, 35.2% vs 43.9% (log-rank, P = .027). Survival rates were not significantly different in examining subgroups by diabetes, chronic kidney disease, presence of chronic limb-threatening ischemia, or paclitaxel-coated balloon manufacturer. Multivariable analysis demonstrated that age, dialysis, chronic limb-threatening ischemia, chronic kidney disease, and congestive heart failure were independent risk factors for mortality, whereas paclitaxel use was associated with lower mortality.. The use of paclitaxel-coated balloons and stents does not increase mortality compared with uncoated devices out to 3.5 years. Paclitaxel-coated devices can be used with continued caution, especially in patients at increased risk of restenosis. Further long-term studies are needed to determine the risk of late mortality.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

Inflammatory reaction is an essential factor in the occurrence, development and prognosis of femoropopliteal disease (FPD). The ratio of platelets to lymphocytes (PLR) is a new indicator reflecting platelet aggregation and burden of systemic inflammation. Our study is to explore the association between preoperative platelet-to-lymphocyte ratio (pre-PLR) and 6-month primary patency (PP) after drug-coated balloon (DCB) in FPD.. There were 70 patients who underwent DCB for FPD contained in the study. According to 6-month PP, patients were divided into group A (PP ≥6 months, n = 54) and group B (PP < 6 months, n = 16). Logistic regression analysis was used to identify potential predictors for 6-month PP after DCB in FPD. A receiver operating characteristic (ROC) curve analysis was used to identify the cut-off value of pre-PLR to predict 6-month PP.. Logistic regression analysis showed that pre-PLR (OR: 1.008, 95% CI: 1.001-1.016, P = 0.031) and lesion length > 10 cm (OR: 4.305, 95% CI: 1.061-17.465, P = 0.041) were independently predictive for 6-month PP. The cutoff value of pre-PLR obtained from the ROC analysis was 127.35 to determine 6-month PP with the area of 0.839. Subgroup analysis was conducted based on the cutoff value of pre-PLR. The 6-month PP in the group of pre-PLR < 127.35 was higher than that of pre-PLR ≥ 127.35 group (p < 0.001).. The present study indicated that an elevated pre-PLR was an effective additional indicator for predicting early PP in FPD after DCB.

Topics: Aged; Angioplasty, Balloon; Blood Platelets; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Lymphocyte Count; Lymphocytes; Male; Middle Aged; Peripheral Arterial Disease; Platelet Count; Popliteal Artery; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

The aim of this study was to determine the survival of patients after use of paclitaxel coated devices (PCX), as a recent meta-analysis of randomised trials reported higher mortality in patients treated with PCX balloons and stents METHODS: A retrospective health insurance claims analysis of patients covered by the second largest insurance fund in Germany, BARMER, was used to identify index femoropopliteal arterial interventions between 1 January 2010 and 31 December 2018. To ensure first PCX exposure, patients with prior deployment of PCX were excluded. The study cohort was stratified into patients with chronic limb threatening ischaemia (CLTI) and intermittent claudication (IC), then into balloons vs. stents cohorts. Within each stratum PCX were compared with uncoated devices. Propensity score matching was used to balance the study groups. Survival was evaluated using the Kaplan-Meier method and Cox regression.. There were 37 914 patients (mean age 73.3 years; 48.8% female) included in the study. The annual proportion of PCX use increased from 3% to 39% during the study period for CLTI and from 4% to 48% for IC (both p < .001). Paclitaxel coated balloons and stents were associated with improved overall survival (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.77-0.90), amputation free survival (HR 0.85, 95% CI 0.78-0.91), and freedom from major cardiovascular events (HR 0.82, 95% CI 0.77-0.89) vs. uncoated devices at five years for CLTI. In IC cohort, mortality was significantly lower after using drug coated balloons (DCB) (HR 0.87, 95% CI 0.76-0.99) or combined DCB and drug eluting stents (HR 0.88, 95% CI 0.80-0.98).. In this large health insurance claims analysis, rapid adoption of PCX, higher long term survival, better amputation free survival, and lower rates of major cardiovascular events were seen after their use for the treatment of CLTI.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Constriction, Pathologic; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Retrospective Studies; Vascular Access Devices

Background Underuse of guideline-recommended therapy in peripheral artery disease (PAD) in administrative and procedural databases has been described, but reports on medically managed patients and referral to supervised exercise therapy (SET) in PAD are lacking. We aimed to document the use of PAD guideline-recommended therapy, including SET in patients with PAD symptoms consulting a specialty clinic across 3 countries. Methods and Results The 16-center PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry enrolled 1275 patients with new or an exacerbation of PAD symptoms (2011-2015). We prospectively documented antiplatelet medications, statins, smoking cessation counseling and/or therapy, and referral to SET: "2 quality measures" referred to the use of both statin and antiplatelet medications; "4 quality measures" to receiving all 4 measures. Median odds ratios were calculated to quantify treatment variation across sites. A total of 89% patients were on antiplatelets, 83% on statins, and 23% had been referred to SET. Of 455 current smokers, 342 (72%) patients received smoking cessation therapy/counseling. Overall, 77.2% of patients received "2 quality measures" and 19.7% "4 quality measures." The median odds ratio for 2 quality measures was 2.13 (95% CI, 1.61-3.56;

Topics: Aged; Ambulatory Care Facilities; Australia; Cardiovascular Agents; Exercise Therapy; Female; Guideline Adherence; Healthcare Disparities; Humans; Male; Middle Aged; Netherlands; Peripheral Arterial Disease; Practice Guidelines as Topic; Practice Patterns, Physicians'; Prospective Studies; Quality Indicators, Health Care; Referral and Consultation; Registries; United States

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Asia; Australia; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Europe; Female; Femoral Artery; Humans; Limb Salvage; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Progression-Free Survival; Prospective Studies; Registries; Time Factors; Vascular Access Devices; Vascular Patency

The objective of this study was to investigate the safety and feasibility of treating infrapopliteal lesions using a novel drug delivery catheter locally delivering liquid paclitaxel.. Balloon angioplasty is currently the Gold Standard to treat below-the-knee disease; however, restenosis continues to be a great challenge following these percutaneous revascularization procedures.. The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis (COPPER-A) study-Below-the-Knee Cohort was a prospective, nonrandomized, multicenter, feasibility, and safety study that enrolled 35 patients at 11 participating sites. The safety endpoints at 1, 3, and 6 months were freedom from thrombosis, major amputation in the target limb and target limb related death. The efficacy endpoints were primary patency and freedom from clinically driven target lesion revascularization at 6 months.. All patients tolerated the procedure well with no reports of adverse procedural events. Thirty-five patients were treated with a mean lesion length of 112 ± 81.2 mm with the lesion length range of 20-286 mm. At 6-month follow-up, primary patency was 89.3% and freedom from clinically driven target lesion revascularization was 96.4%. No patients demonstrated thrombosis, major amputation in the target limb and target limb related death at the 1-, 3- and 6-months follow-up intervals.. The results of this multi-center study demonstrated that infrapopliteal arteries can be safely and effectively treated with liquid paclitaxel using the occlusion perfusion catheter.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Drug Delivery Systems; Feasibility Studies; Female; Humans; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Risk Factors; Time Factors; Treatment Outcome; United States; Vascular Access Devices; Vascular Patency

To compare mortality after treatment of superficial femoral-popliteal artery disease with paclitaxel and nonpaclitaxel devices using a multicenter vascular registry.. Patients (N=8376) undergoing endovascular treatment of superficial femoral-popliteal artery disease in the Society for Vascular Surgery Vascular Quality Initiative were studied from October 2016 to December 2017. One-year mortality was compared between 3 groups; plain balloon angioplasty (N=2104) versus paclitaxel-coated balloon angioplasty (N=3543), bare-metal stenting (N= 2045) versus paclitaxel-eluting stents (N=684), and combined paclitaxel versus nonpaclitaxel devices. Mortality rates with hazard ratios (HR) and 95% CI were compared in unadjusted and propensity-matched cohorts and illustrated by Kaplan-Meier analysis with subgroup analysis for intermittent claudication, chronic limb-threatening ischemia, and secondary interventions.. At 1 year, mortality was similar if not lower after treatment of femoral-popliteal occlusive disease with paclitaxel versus nonpaclitaxel devices. This work highlights the potential use of the Society for Vascular Surgery Vascular Quality Initiative for surveillance of the safety of new peripheral arterial devices.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Cause of Death; Coated Materials, Biocompatible; Drug-Eluting Stents; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Quality Indicators, Health Care; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

Drug-coated balloons (DCBs), which deliver anti-proliferative drugs with the aid of excipients, have emerged as a new endovascular therapy for the treatment of peripheral arterial disease. In this study, we evaluated the use of keratose (KOS) as a novel DCB-coating excipient to deliver and retain paclitaxel.. A custom coating method was developed to deposit KOS and paclitaxel on uncoated angioplasty balloons. The retention of the KOS-paclitaxel coating, in comparison to a commercially available DCB, was evaluated using a novel vascular-motion simulating. The KOS coating exhibited greater retention of the paclitaxel at 3 days under pulsatile conditions with vascular motion as compared to the commercially available DCB (14.89 ± 4.12 ng/mg vs. 0.60 ± 0.26 ng/mg,. The ability to enhance drug delivery and retention in targeted arterial segments can ultimately improve clinical peripheral endovascular outcomes.

Topics: Angioplasty, Balloon; Animals; Antineoplastic Agents; Cardiovascular Agents; Coated Materials, Biocompatible; Drug Carriers; Drug Delivery Systems; Drug Evaluation, Preclinical; Immunohistochemistry; Keratosis; Paclitaxel; Peripheral Arterial Disease

Endovascular therapy is often the preferred first treatment option for chronic limb threatening ischemia (CLTI) patients. Drug coated balloons (DCB) reduce restenosis rates compared to percutaneous transluminal angioplasty (PTA), however DCB use has not been studied systematically in patients with CLTI. Thus, the optimal treatment option for these complex lesions remains controversial.. We report on 327 patients with CLTI treated either with DCB (n = 105) or non-DCB (n = 222) for femoropopliteal disease. Data were retrieved from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851). Two DCB types were used at the discretion of the operator: Lutonix® (BARD Peripheral Vascular, Inc., Tempe, AZ, USA) and IN.PACT AdmiralTM (Medtronic, Santa Rosa, CA, USA). Odds ratios and the respective 95% confidence interval were synthesized to examine the association between the two groups in terms of all-cause mortality, target limb repeat endovascular or surgical revascularization, target vessel revascularization (TVR), major and minor amputation at 12 months of follow up.. The mean lesion length was 150.0 mm (SD:123.2) and 151.2 mm (SD:108.3) for the DCB and non-DCB group respectively. No difference between the two groups was detected in terms of all-cause mortality (2.86%vs2.7%,p = .94), target limb repeat endovascular or surgical revascularization (16.19%vs12.61%,p = .25), TVR (16.19%vs.11.71%,p = .26) or minor amputation (15.24%vs10.81%,p = .25) at 12 months of follow up. Although a higher incidence of 12 months major amputation was observed in the DCB group (11%vs.4%,p = .01), after adjusting for several risk factors the odds of major amputation were not statistically different between the DCB and non-DCB groups (OR:1.54;95%CI:0.53-4.51;p = .43).. Both DCB and non-DCB strategies are effective modalities for revascularization of patients with CLTI. No differences were identified between the DCB and non-DCB group in terms of late outcomes during 12 months of follow up.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Ischemia; Limb Salvage; Peripheral Arterial Disease; Pharmaceutical Preparations; Popliteal Artery; Registries; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To assess 24-month outcome differences based on sex in symptomatic femoro-popliteal arterial disease of patients treated with drug-coated balloon (DCB).. Peripheral artery disease affects over 12 million people in the United States. Drug-coated balloons have shown to be effective in treating patients with symptomatic femoropopliteal arterial occlusive disease. Debate remains regarding its safety and efficacy in female gender. We investigated the differential treatment effect between genders.. Patients (93 females and 102 males) with symptomatic femoropopliteal arterial disease treated with DCB from November 2014 to November 2015 were included in this retrospective study. We compared the resting ankle-brachial indices (ABIs) and peak systolic velocities (PSVs) by arterial duplex between the male and female patients at 6, 12, and 24 months postintervention.. Females had significantly smaller vessels (4.70 ± 0.9,. Females treated with DCBs have significantly decreased ABI, PSVs, and an increased rate of TLR than their male counterparts.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Female; Femoral Artery; Health Status Disparities; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Retrospective Studies; Risk Factors; Sex Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Endovascular deployment of drug-coated balloons (DCB) is an emerging strategy for the revascularization of arterial disease. Randomized clinical trials have demonstrated DCB effectiveness, but a recent meta-analysis reported increased mortality risk in humans with use of DCBs containing the common antiproliferative drug paclitaxel. While many factors could have contributed to adverse outcomes, current DCB designs have poor drug delivery efficiency, risk of systemic toxicity, and limited potential to retain therapeutic drug concentrations within the arterial wall following the procedure. Our study focuses on developing a strategy to enhance acute drug transfer from the balloon to the arterial wall over the short procedural window (∼30-120 s). We employed ultraviolet-ozone plasma (UVO) treatment to increase the hydrophilicity of a prototypical balloon material (Nylon-12) and subsequently applied a urea-paclitaxel coating previously shown to undergo favorable adhesive interactions with the arterial wall under simulated ex-vivo deployment. A series of assays were performed to characterize our experimental DCBs in terms of UVO-induced alterations in balloon surface hydrophobicity, formed coating microstructure, coating stability, and acute drug transfer to the arterial wall. Obtained results suggest that the UVO-based surface modification of angioplasty balloons is a promising design strategy and highlights the critical role of coating microstructure in determining the drug transfer efficiency in DCB therapy.

Topics: Cardiovascular Agents; Coated Materials, Biocompatible; Humans; Ozone; Paclitaxel; Peripheral Arterial Disease; Pharmaceutical Preparations; Time Factors; Treatment Outcome

Paclitaxel-coated devices have been increasingly used in endovascular treatment of femoropopliteal disease as they limit recurrence of lesions and improve patient outcomes. However, a recent meta-analysis reported that these devices increase mortality risk at 2 years post-intervention but did not account for confounding variables. Therefore, our goal was to evaluate mortality after paclitaxel treatment of femoropopliteal disease using patient-level data.. We performed a retrospective review of all patients who received endovascular treatment for femoropopliteal lesions at our center between December 2009 and July 2017. There were 388 patients in the paclitaxel group and 314 control patients.. Survival analysis with hazard ratios showed no difference between mortality in the paclitaxel and control groups. Age, renal insufficiency, and chronic limb-threatening ischemia were significant predictors of mortality. We also used logistic regression to evaluate mortality at 1, 2, and 5 years post-intervention and found no difference between the paclitaxel and control groups at any time point, while age, renal insufficiency, and chronic limb-threatening ischemia at the time of intervention were all associated with the risk of death. Finally, we tallied the causes of death in our cohort and found no difference in the distribution of causes between groups.. Our single-center, retrospective study provides no evidence of increased risk of death with paclitaxel treatment in femoropopliteal disease. Contrastingly, age, renal insufficiency, and chronic limb-threatening ischemia were the most important factors contributing to mortality and therefore should be included as potential confounders in future studies assessing mortality in femoropopliteal disease.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Newfoundland and Labrador; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices

Paclitaxel based drug coated balloons (DCBs) and drug eluting stents (DESs) may be associated with increased mortality in patients with peripheral arterial occlusive disease (PAOD), based on a recent meta-analysis. This study, however, had a number of limitations, which have been discussed at great length among the vascular community. The aim of this research was to assess the association between paclitaxel based endovascular treatment (PTX) in the femoropopliteal (F-P) segment and mortality, adjusting for relevant risk factors and including patients with chronic limb threatening ischaemia (CLTI).. This was a retrospective cohort study of a prospectively maintained multicentre (three sites) database of patients with claudication or CLTI. Patients having F-P angioplasty between 1 January 2014 and 30 May 2019 with or without PTX were included. Survival was compared in Cox regression analyses adjusted for parameters of the Charlson comorbidity index. A separate nested case matched (based on each individual's Charlson index) analysis was performed to compare mortality rates between those who received PTX and those who did not.. A total of 2 071 patients were analysed: 966 patients (46.6%) were treated with PTX (952 [46%] had CLTI and 1 119 [54%] severe claudication [Rutherford stage 3]). Over a 24 month median follow up, 456 (22.1%) patients died. Using multivariable Cox regression, PTX was not associated with mortality (HR 0.94, p = .46), even when assessed separately for those with intermittent claudication (HR 1.30, p = .15) or CLTI (HR 0.81, p = .060). In the case matched analysis (885 matched pairs of patients), PTX was not associated with mortality (HR 0.89, p = .17). Paclitaxel dose and use of a DCB or DES were not associated with mortality in any subanalysis.. When relevant risk factors were taken into account, there were no associations between PTX and mid term mortality in patients with PAOD.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Databases, Factual; Drug-Eluting Stents; England; Female; Femoral Artery; Greece; Humans; Intermittent Claudication; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Cardiovascular Agents; Everolimus; Humans; Peripheral Arterial Disease; Registries; Treatment Outcome

Drug-coated balloons are used widely as a form of endovascular treatment for peripheral arterial disease, to improve patency by reducing neointimal hyperplasia and restenosis. We present a rare case of acute coronary syndrome secondary to anaphylaxis after inflation of a paclitaxel-coated balloon used to treat a recurrent superficial femoral artery stenosis.

Topics: Aged; Anaphylaxis; Angioplasty, Balloon; Cardiovascular Agents; Constriction, Pathologic; Drug Hypersensitivity; Female; Femoral Artery; Humans; Kounis Syndrome; Paclitaxel; Peripheral Arterial Disease; Treatment Outcome; Vascular Access Devices

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Recovery of Function; Registries; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency

This study sought to evaluate the long-term mortality after paclitaxel drug-coated balloon (DCB) angioplasty and plain old balloon angioplasty (POBA) of femoropopliteal lesions in real-world practice.. A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel-coated devices.. A retrospective mortality analysis of patients with at least 3-year follow-up who underwent balloon based endovascular therapy of femoropopliteal lesions was performed.. Overall, 7,357 patients with femoropopliteal lesions were treated within the study period receiving either DCB angioplasty or POBA. Of those, 1,579 fulfilled the study criteria. A total of 514 patients were treated with POBA without crossover to a paclitaxel-coated device during follow-up and 1,065 patients were treated with DCB angioplasty. Mortality incidence at mean follow-up of 52.0 ± 20.5 months (median 51 months) was 27.8% after POBA and 16.9% after DCB angioplasty (p < 0.001). Equally, for a cohort excluding patients over 80 years of age, the mortality rate after POBA treatment was significantly higher (23.6% vs. 12.3%; p < 0.001). For the entire cohort, independent predictors for mortality were age (p < 0.001), type of treatment (p = 0.009), hyperlipidemia (p = 0.010), diabetes mellitus (p = 0.010), renal insufficiency (p = 0.007), stroke (p = 0.017), and Rutherford-Becker class 4 (p < 0.001). DCB length was not correlated to mortality rate. After propensity score matching, independent mortality predictors were POBA treatment (p = 0.035), age (p < 0.001), stroke (p = 0.025), and renal insufficiency (p = 0.007).. In this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of femoropopliteal lesions. Known comorbidities, risk factors, and disease severity were identified as mortality predictors but not paclitaxel.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Comorbidity; Equipment Design; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Access Devices

Background Underuse of cardiovascular medications for secondary prevention among individuals with peripheral artery disease (PAD) has been reported. Little is known about PAD treatment status in the Hispanic/Latino population in the United States, who may have limited access to health care and who have worse clinical outcomes than non-Hispanic individuals. Methods and Results We studied the use of cardiovascular therapies in 1244 Hispanic/Latino individuals recruited from 4 sites in the United States, including 826 individuals who reported diagnosis of PAD by physician and 418 individuals with coronary artery disease alone, in the Hispanic Community Health Study/Study of Latinos. We compared the prevalence of using antiplatelet therapy, lipid-lowering therapy and antihypertensive therapy by PAD and coronary artery disease status. Among those with PAD, we studied factors associated with taking cardiovascular medications, including demographic and socioeconomic factors, acculturation, access to health care and comorbidities, using multivariable regression models. The overall prevalence for individuals with PAD taking antiplatelet therapy, lipid-lowering therapy and, among hypertensive individuals, antihypertensive therapy was 31%, 26% and 57%, respectively. Individuals of Mexican background had the lowest use for all classes of cardiovascular medications. Older age, number of doctor visits and existing hypertension and diabetes mellitus were significantly associated with taking cardiovascular therapies in adjusted models. Compared with those with PAD alone, individuals with PAD and concurrent coronary artery disease were 1.52 (95% CI, 1.20-1.93) and 1.74 (1.30-2.32) times more likely to use antiplatelet agents and statins according to multivariable analysis. No significant difference of antihypertensive medication use was found among PAD patients with or without coronary artery disease. Conclusions Hispanic/Latino individuals with known PAD underuse cardiovascular medications recommended in clinical guidelines. More efforts should be directed to improve treatment in this important group.

Topics: Acculturation; Adult; Aged; Antihypertensive Agents; Cardiovascular Agents; Comorbidity; Coronary Artery Disease; Health Services Accessibility; Hispanic or Latino; Humans; Hypolipidemic Agents; Lower Extremity; Middle Aged; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Regression Analysis; Socioeconomic Factors; United States; Young Adult

This retrospective single-center study aimed to analyze immediate and follow-up results of using drug-coated balloons (DCBs) for treating peripheral arterial disease.. In this study, we identified a total of 75 patients who underwent DCB therapy at our institution. The ankle-brachial index (ABI) was measured before and after intervention. Intermittent claudication and whether there was healing of ulcers were determined by telephone.. The cohort consisted of 56 men and 19 women aged 38 to 87 years (68 ± 12 years). Twenty-three patients had Rutherford grade III, 15 had Rutherford grade IV, and 37 had Rutherford grade V. Seventeen patients had stents and 18 had the Rotarex system used. The postoperative ABI was significantly greater than the preoperative ABI (0.911 ± 0.173 vs 0.686 ± 0.249). Good results for treatment were obtained. Intermittent claudication and rest pain did not occur in subjects with Rutherford grades III and IV during follow-up. The amputation rate was 4.1% among all patients using DCB therapy during follow-up.. DCB therapy is safe and effective for treating peripheral arterial disease in real-world patients. Future prospective studies on this issue are recommended.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Pharmaceutical Preparations; Popliteal Artery; Prospective Studies; Retrospective Studies; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent meta-analysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort.. A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the Kaplan-Meier method and Cox regression.. There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p < .001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78-0.91), amputation or death (HR 0.87, 95% CI 0.81-0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80-0.92) were observed.. In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia.

Topics: Administrative Claims, Healthcare; Aged; Aged, 80 and over; Amputation, Surgical; Cardiovascular Agents; Chronic Disease; Coated Materials, Biocompatible; Databases, Factual; Drug-Eluting Stents; Endovascular Procedures; Female; Germany; Humans; Ischemia; Leg; Limb Salvage; Male; Paclitaxel; Peripheral Arterial Disease; Propensity Score; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

Paclitaxel drug-coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow-up have raised uncertainty regarding long-term mortality.. To evaluate the effect of paclitaxel exposure on the long-term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials.. The IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3 years, respectively. To address long-term safety, sites were requested to obtain vital status follow-up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD-TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise.. The rate of long-term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5 years, HR 1.39, log-rank p = .286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p = .381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p < .001). Causes of death did not differ by treatment arm.. In pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Humans; Intermittent Claudication; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices

To evaluate safety and efficacy of percutaneous mechanical thrombectomy using the Rotarex catheter combined with drug-coated balloon (DCB) in treatment of femoropopliteal artery occlusive disease.. Between January 2016 and February 2018, 81 patients with acute or subacute femoropopliteal artery occlusions were treated with the Rotarex catheter combined with DCB. Lesions were classified according to the onset of symptoms as acutely (< 14 d) or subacutely (14 d to 3 mo) occluded. The mean lesion length was 12.1 cm ± 6.7. The primary endpoint was target lesion patency at 1 year as evaluated by duplex ultrasound (peak systolic velocity ratio < 2.4) and freedom from clinically indicated target lesion revascularization. Amputation rate, major adverse events, and ankle-brachial index at 12 months were evaluated.. Technical success rate was 100% (n = 81). Bailout stents were necessary in 14 patients owing to residual stenosis or flow-limiting dissection. Additional thrombolysis was applied in 10 interventions. No major adverse events occurred during hospital stay. There were 9 restenosis cases during the 12-month follow-up period. Primary patency rate was 87.3% (62/71), and freedom from target lesion revascularization rate was 90.1% (64/71). Ankle-brachial index significantly increased from 0.46 ± 0.15 to 0.77 ± 0.14 during follow-up. The amputation rate was 1.4% at 12 months.. These initial data from 2 centers suggest that the combination of the Rotarex catheter and DCB may be safe and effective for treatment of acute or subacute thrombotic femoropopliteal occlusion with superior immediate and midterm results achieved.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Beijing; Cardiovascular Agents; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Retrospective Studies; Risk Factors; Thrombectomy; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The aim of the BIOLUX P-III (A Prospective, International, Multi-Centre, Post-Market All-Comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III) registry was to collect real-world data on the Passeo-18 Lux paclitaxel-coated balloon.. Critical limb ischemia (CLI) is a severe condition associated with high morbidity and mortality. Prospective data are needed to provide further insights on drug-eluting devices.. BIOLUX P-III is a prospective, post-market, all-comers registry assessing the safety and performance of the Passeo-18 Lux. Clinical information was collected at 6, 12, and 24 months. The authors report 24-month outcomes of the CLI subgroup with patients in Rutherford classes 4 to 6.. The CLI subgroup included 328 patients with 422 lesions. Patients were 71.1 ± 10.5 years of age, and 61.0% had diabetes. Femoropopliteal lesions were present in 53.8% (n = 227), below-the-knee lesions were present in 27.0% (n = 114), and lesions were moderate or heavily calcified in 45.0% (n = 190). Major adverse events, defined as 30-day device- or procedure-related mortality, major target limb amputation, and clinically driven target lesion revascularization, occurred in 9.8% of patients through 6 months, in 14.9% through 12 months, and in 19.4% through 24 months. Clinically driven target lesion revascularization occurred in 4.4%, 8.5%, and 12.1%, major amputation in 4.9%, 5.2%, and 6.1%, and mortality in 8.1%, 11.1%, and 20.1%, respectively. Predictors of mortality were age ≥75 years and higher Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease class, and higher Rutherford class was associated with increased mortality and amputation rates.. In a large, multimorbid patient population with complex lesions and CLI, the safety and performance of the Passeo-18 Lux paclitaxel-coated balloon has been confirmed, with low rates of major amputation and target lesion revascularization.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Humans; Ischemia; Limb Salvage; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Time Factors; Treatment Outcome; Vascular Patency

Evidence about sex differences in management and outcomes of critical limb ischemia (CLI) is conflicting.. We identified Fee-For-Service Medicare patients within the 5% enhanced sample file who were diagnosed with new incident CLI between 2015 and 2017. For each beneficiary, we identified all hospital admissions, outpatient encounters and procedures, and pharmacy prescriptions. Outcomes included 90-day mortality and major amputation.. Incidence of CLI declined from 2.80 (95% CI, 2.72-2.88) to 2.47 (95% CI, 2.40-2.54) per 1000 person from 2015 to 2017,. Women with new incident CLI are less likely to receive statin or undergo revascularization at 90 days compared with men. However, the differences were small. There was no difference in risk of 90-day mortality between both sexes. Graphic Abstract: A graphic abstract is available for this article.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Cardiovascular Agents; Critical Illness; Fee-for-Service Plans; Female; Health Status Disparities; Healthcare Disparities; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Incidence; Ischemia; Limb Salvage; Male; Medicare; Peripheral Arterial Disease; Risk Assessment; Risk Factors; Sex Distribution; Sex Factors; Time Factors; Treatment Outcome; United States; Vascular Surgical Procedures

The aim of this study was to evaluate the performance of paclitaxel-eluting stents (PESs) and paclitaxel-coated balloons (PCBs) on amputation-free survival in patients with critical limb ischemia (CLI).. A retrospective review of all patients with Rutherford stage 5 and 6 limb ischemia undergoing endovascular revascularization with paclitaxel-related technology, both PES and PCB, was carried out over a 4-year period. Clinical grading was determined by Rutherford classification and the Society for Vascular Surgery's Wound, Ischemia, and foot Infection (WIfI) scoring system. Clinical and angiographic follow-up was reviewed based on intention-to-treat analysis. The primary endpoint of this study was amputation-free survival at 12 months. Secondary endpoints included wound healing, freedom from target lesion revascularization, and patency of target vessels at 12 months. Follow-up occurred at 3, 6, and 12 months postoperatively. Target lesion patency was defined as <50% stenosis, based on a duplex velocity ratio of less than or equal to 2. Postoperative ankle-brachial index (ABI) and duplex ultrasound were performed to verify successful treatment. Outcomes were evaluated using Kaplan-Meier and Cox proportional-hazards models.. A total of 88 limbs were revascularized in 88 patients. Drug-eluting stent (DES) was used as the sole drug technology in 56 patients (60.7% men, median age 70.5 years) and drug-coated balloon (DCB) was used as the sole drug technology in 32 patients (46.9% men, median age 66 years). Baseline demographics were well matched except for a higher prevalence of occluded target lesions in the DES group (41.1% vs. 12.5%; P = 0.004). Limbs were treated for Rutherford stage 5 CLI in 71.6% and stage 6 CLI in 28.4%. Univariate analysis identified no dependent factors affecting limb salvage, except for the use of DCBs. After 12 months of follow-up, amputation-free survival was significantly higher in the DES group than in the DCB group (88.5% vs. 71.1%; P = 0.0443). Wound healing rates after 1 year were also higher in the DES group (83.9% vs. 59.4%; P = 0.0198). Freedom from target lesion revascularization was no different between patients treated with DESs and patients treated with DCBs (90.6% vs. 85.7%; P = 0.518). Primary patency at 12 months in patients treated with DESs was significantly higher than in patients treated with PCBs (80.4% vs. 58.1%; P = 0.0255).. Overall, drug technology represents a viable option for patients with CLI; a cohort not represented in major randomized trials. In our experience, femoropopliteal lesions treated with DESs have higher primary patency rates than those treated with DCBs. This was found to support higher amputation-free survival rates in patients treated with paclitaxel DESs than those treated with paclitaxel DCB. The use of paclitaxel DESs for CLI was also associated with significantly improved wound healing compared with DCBs. Our data suggest improved outcomes with DESs compared with DCBs; however, these patients represent a nonrandomized, heterogenous group that were treated with the operator's best judgment.

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Clinical Decision-Making; Coated Materials, Biocompatible; Critical Illness; Drug-Eluting Stents; Female; Humans; Ischemia; Limb Salvage; Male; Middle Aged; Paclitaxel; Patient Selection; Peripheral Arterial Disease; Progression-Free Survival; Prosthesis Design; Retrospective Studies; Risk Factors; Time Factors; Vascular Access Devices; Vascular Patency

Topics: Administration, Intravenous; Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Critical Illness; Drug Administration Schedule; Female; Humans; Iloprost; Ischemia; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Retrospective Studies; Time Factors; Treatment Outcome; Vascular Access Devices; Wound Healing

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

To examine if endovascular therapy (EVT) with paclitaxel-coated stents increases the mortality risk in patients with symptomatic lower limb peripheral artery disease (PAD).. A retrospective analysis was conducted of paclitaxel-coated stent use in the femoropopliteal segment of 1535 symptomatic (Rutherford category 2 to 4) patients treated between January 2010 and December 2016 at 4 hospitals in Japan. The risk of all-cause mortality was examined between the 285 patients (mean age 73±8 years; 213 men) treated with a paclitaxel-coated stent (PTX-coated group) and 1250 patients (mean age 73±9 years; 872 men) not exposed to a paclitaxel-coated device (PTX-free group) during EVT. Propensity score matching was employed to balance baseline characteristics. Cox proportional hazards models stratified on the quintiles of the propensity score were used to investigate paclitaxel-coated stent use and mortality risk as well as interactions among baseline variables and the main outcome. Interactions between a PXT-coated stent and subgroups of the PTX-free group (bare stent and angioplasty) were also investigated, as was the impact of paclitaxel dose on mortality risk. The results of regression analysis are reported as the hazard ratio (HR) and 95% confidence interval (CI).. The 3-year overall survival estimates were 86.4% in the PTX-coated group vs 87.7% in the PTX-free group; the corresponding 5-year estimates were 77.5% vs 73.7%, respectively. There was no significant difference in all-cause mortality between the 2 groups (HR 0.89, 95% CI 0.66 to 1.19, p=0.41). The cause of death also showed no remarkable difference between the groups. Chronic renal failure (p=0.044) and arterial calcification (p=0.022) demonstrated a significant interaction effect on the association of the use of a PTX-coated stent with all-cause mortality. No subgroup demonstrated that the use of a paclitaxel-coated stent was associated with an increased risk of all-cause mortality. A dose dependency was not evident.. Mortality risk following application of a PTX-coated stent did not increase over 5 years, irrespective of the dose. A PTX-coated stent for femoropopliteal lesions in PAD patients is a safe treatment option.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

Randomized controlled trials have shown that drug-coated balloons (DCBs) provide superior results compared with percutaneous transluminal angioplasty (PTA) for the treatment of femoropopliteal artery disease. However, these trials have generally included short lesions, few occlusions, and small sample sizes. The present study was an individual-level pooled analysis of duplex ultrasonography (DUS) core laboratory-adjudicated and clinical events committee-adjudicated IN.PACT Admiral DCB subjects across two randomized controlled trials and two single-arm prospective studies to characterize the safety and effectiveness of DCB compared with PTA.. The subjects were treated with DCB (n = 926) or PTA (n = 143). The end points through 12 months included DUS core laboratory-adjudicated primary patency and clinically driven target lesion revascularization (CD-TLR) using Kaplan-Meier estimates and primary safety using proportions. A propensity-matched analysis of DCB (n = 466) to PTA (n = 136) was conducted to address confounders.. At 12 months, DCB compared with PTA had significantly greater primary patency (88.8% vs 53.9%; P < .001), freedom from CD-TLR (94.3% vs 80.2%; P < .001), and better primary safety composite end point (94.1% vs 78.0%; P < .001). After propensity-matched analysis, DCB remained superior to PTA at 12 months for primary patency (90.5% vs 53.8%; P < .001), freedom from CD-TLR (96.9% vs 80.7%; P < .001), and the primary safety composite end point (96.3% vs 78.4%; P < .001). Across multiple prespecified subgroup analyses, including provisional stenting, DCB remained persistently superior to PTA.. In the largest, DUS core laboratory-adjudicated, multiethnic, pooled DCB series to date, the IN.PACT Admiral DCB demonstrated significantly greater primary patency, freedom from CD-TLR, and better composite safety at 12 months compared with PTA.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Peripheral Arterial Disease; Predictive Value of Tests; Propensity Score; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices; Vascular Patency

The aim of this study was to assess safety outcomes of femoropopliteal drug-coated balloon (DCB) angioplasty using patient-level data from the Lutonix clinical program.. A recent systematic review and meta-analysis of heterogenous trials and summary-level data identified increased long-term mortality in patients treated with paclitaxel-coated balloons and stents.. We evaluated DCB angioplasty (n = 1,093) and uncoated balloon angioplasty (percutaneous transluminal angioplasty [PTA]) (n = 250) outcomes in LEVANT 1 (The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis), LEVANT 2 (Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries), and the LEVANT Japan Clinical Trial. Hazard ratios (HRs) were calculated with Cox proportional hazards modeling.. There were no significant differences in mortality rates between DCB angioplasty and PTA. The 5-year HR was 1.01 (95% confidence interval [CI]: 0.68 to 1.52) in the aggregated LEVANT trials. The 2-year HR after DCB angioplasty was 0.99 (95% CI: 0.25 to 3.95) in LEVANT 1, 1.40 (95% CI: 0.62 to 3.14) in LEVANT 2, and 0.32 (95% CI: 0.05 to 1.92) in the LEVANT Japan Clinical Trial. The 5-year HR was 1.60 (95% CI: 0.94 to 2.72) in LEVANT 2. Adverse events and causes of death were balanced, without clustering between DCB angioplasty and PTA. Patients who underwent paclitaxel or nonpaclitaxel reinterventions had higher survival rates than those who did not undergo reinterventions. Baseline covariates predicting mortality included, among others, age (HR: 1.03 per year; p < 0.0001), prior treatment of target lesion (HR: 1.67; p = 0.022), arrhythmia (HR: 1.65; p = 0.031), and diabetes (HR: 1.18; p = 0.047), without differences between the 2 arms. No dose-response relationship was identified when adjusted for key predictors of mortality.. Analyses of patient-level data identified no mortality differences between DCB angioplasty and PTA. Furthermore, the lack of dose-response relationships or clustering of causes of death argues against a causal relationship between paclitaxel and mortality. (LEVANT 1, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis [LEVANT 1], NCT00930813; Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries [LEVANT 2], NCT01412541; LEVANT 2 Continued Access Registry, NCT01628159; LEVANT Japan Clinical Trial, NCT01816412).

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Cause of Death; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

There is a dearth of updated epidemiological data on the prevalence and annual incidence of coronary artery disease (CAD) and lower extremity artery disease (LEAD) in Western countries.. To describe the incidence and prevalence of CAD and LEAD, associated medication patterns and long-term outcomes in France.. This was a retrospective cohort study using French claims data from a representative sample of the French general population. Any hospitalization or long-term disease status for CAD or LEAD between January 2010 and December 2016 was collected to identify incident cases.. Of the 763,338patients screened in the study period, 8559 incident cases of CAD and 4399 of LEAD were identified, with an overall mean follow-up of 2.9±2.0years. The incidence of CAD, LEAD and CAD or LEAD remained stable over the years, and in 2016 were at 33.5 per 10,000person-years, 15.1per 10,000person-years and 42.5 per 10,000person-years, respectively. The prevalence of CAD increased from 3.1% in 2010 to 4.2% in 2016, and LEAD from 1.6% to 2.4%. Most patients received guideline-recommended medication with antithrombotic drugs and lipid-lowering drugs following the index event. However, most of the medications initiated were subsequently discontinued during follow-up. Incident CAD or LEAD was associated with considerable morbidity-particularly an incidence of all-cause hospitalization of 7976.9 per 10,000person-years-and all-cause mortality, with an incidence of 542.8 per 10,000person-years.. In recent years, the prevalence of CAD or LEAD has increased progressively, resulting in considerable morbidity and mortality.

Topics: Administrative Claims, Healthcare; Adolescent; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Cause of Death; Coronary Artery Disease; Databases, Factual; Drug Utilization; Female; France; Hospitalization; Humans; Incidence; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Practice Patterns, Physicians'; Prevalence; Retrospective Studies; Time Factors; Treatment Outcome; Young Adult

Surgical endarterectomy with or without patch angioplasty has been considered the gold standard for treatment of symptomatic common femoral artery (CFA) disease. Surgical risks include wound infection, hematoma and lymph leak in approximately 17% of patients. Endovascular therapy has less procedure-related morbidity and mortality. Endovascular approaches achieve patency rates of 60% to 90% at 1 and 2 years utilizing atherectomy and balloon angioplasty. CFA stenting has been limited due to concerns of stent kinking, thrombosis and restenosis. Combined directional atherectomy with drug-coated balloon to treat CFA disease in patients with Rutherford II/III patients has been studied recently. We sought to study the safety and outcomes of adjunct drug-coated balloon (DCB) therapy in symptomatic CFA disease patients, including critical limb ischemia (Rutherford IV), after achieving procedural success.. To evaluate the additive efficacy of drug coated balloon in treating CFA disease.. Using retrospective single center data, we analyzed the outcomes of patients who underwent CFA interventions. In this non-randomized study, all patients from December 2010 to December 2014 with CFA disease underwent atherectomy (orbital, plaque excision or both) with adjunctive scoring balloon angioplasty (Ath/PTA). After December 2014, patients treated with combination atherectomy and DCB, (Ath/DCB), underwent final drug delivery to the vessel wall with drug-coated balloon. Distal embolic protection devices were used in the majority of patients. Primary efficacy endpoint was 1-year primary patency and freedom from clinically driven target lesion revascularization (CD-TLR). Patency of vessels was assessed at 12-month interval using duplex ultrasound.. Seventy de novo common femoral artery stenotic lesions were treated in both groups. Mean age was 69 in (Ath/PTA) group and 72 in Ath/DCB group. Patients in each group had similar risk factor profiles including diabetes mellitus, hypertension, smoking, coronary artery disease, myocardial infarction, prior coronary revascularization, congestive heart failure, cerebrovascular accidents and chronic kidney disease. The Ath/DCB group had more advanced disease presentation by Rutherford classification (intermittent claudication in 61% and critical limb ischemia in 39% versus intermittent claudication in 76% and chronic limb ischemia in 24%) when compared with the Ath/PTA group. Primary efficacy endpoint was met in 85% and 94% (p = 0.26) in the Ath/PTA and Ath/DCB groups respectively. All patients had run-off angiography at the end of procedure to ensure patency.. Adjunctive drug-coated balloon therapy does not increase the primary patency rate when compared with atherectomy and scoring balloon angioplasty alone at 1-year in common femoral artery disease treatment.

Topics: Aged; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Critical Illness; Embolic Protection Devices; Equipment Design; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Male; Middle Aged; Peripheral Arterial Disease; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

Common femoral artery (CFA) occlusive disease remains a debatable site for endovascular therapy, and the outcome of drug-eluting balloon (DEB) angioplasty in treating CFA occlusive disease is largely unknown. This study compared the efficacy, safety, and short-term patency rate of DEB angioplasty and femoral endarterectomy for treatment of CFA occlusive disease.. From March 2013 to June 2016, there were 100 patients with symptomatic CFA occlusive disease who were retrospectively reviewed. Forty patients were treated with DEB angioplasty and 60 were treated with femoral endarterectomy. Each patient received regular follow-up. Patency rate, ankle-brachial index, target lesion revascularization, and adverse events were assessed.. Technical success was 100% in all patients. The DEB group had a lower 1-year primary patency rate (75.0% vs 96.7%; P = .003), but the secondary patency rate was similar between the two groups (97.5% vs 98.3%; P = 1.000). At 2-year follow-up, the primary patency was lower in the DEB group (57.1%) than in the endarterectomy group (94.1%; P = .001), whereas the secondary patency rate had no significant difference (90.5% vs 97.1%; P = 1.000). Both groups had significant improvement in ankle-brachial index. Freedom from target lesion revascularization was lower in the DEB group both at 1 year (75.0% vs 96.7%; P = .003) and at 2 years (57.1% vs 94.1%; P = .001). There was no significant difference in the incidence of complications and adverse events.. Femoral endarterectomy has a better primary patency rate compared with DEB angioplasty in treating CFA occlusive disease without significant increase in complications. In patients not suitable for endarterectomy, DEB angioplasty provides a similar secondary patency rate and could be considered an alternative treatment.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Coated Materials, Biocompatible; Endarterectomy; Equipment Design; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Postoperative Complications; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Currently, there exist limited data on patient outcomes following the use of drug-coated balloons (DCBs) to treat complex femoropopliteal arterial occlusive lesions. The aim of the this study is to investigate the outcomes of patient treated with DCBs and to identify the predictors of restenosis.. We retrospectively investigated medical records from 120 patients (137 limbs) treated with DCBs for femoropopliteal lesions at a single center between 2013 and 2016. Primary patency, target lesion revascularization (TLR), and risk factors of restenosis were analyzed.. There were 80 de novo and 57 in-stent restenosis lesions. Mean lesion length was 22.2 ± 11.6 cm. The clinical primary patency was 85.2% at 1 year and 65.3% after 2 years. The TLR-free survival rate was 93.0% at 1 year and 87.1% after 2 years. Critical limb ischemia (CLI; hazard ratio [HR] 5.80, 95% confidence interval [CI] 1.26-26.68, P = 0.024) and hypercholesterolemia (HR 4.66, 95% CI 1.30-16.76, P = 0.018) were identified as independent predictors of restenosis. In addition, nonuse of cilostazol and popliteal artery involvement showed trends toward an increased risk of restenosis.. Treatment with DCBs showed excellent primary patency and TLR-free survival at 1 year after the procedure. However, the primary patency continuously deteriorated beyond 1 year, suggesting a late catch-up phenomenon. The risk of restenosis after treatment with DCBs was significantly associated with CLI and hypercholesterolemia.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Critical Illness; Equipment Design; Female; Femoral Artery; Humans; Ischemia; Male; Medical Records; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Progression-Free Survival; Recurrence; Registries; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

We investigated the relationship of postoperative neutrophil-lymphocyte ratio (NLR) with 6-month primary patency of percutaneous transluminal angioplasty (PTA) in femoropopliteal disease using drug-coated balloon (DCB) or uncoated balloon (UCB). This retrospective study included 106 patients who received DCB (n = 44) or UCB (n = 62). The postoperative NLR was lower in the DCB group than that in the UCB group (2.60 vs 3.23;

Topics: Aged; Angioplasty; Angioplasty, Balloon; Cardiovascular Agents; Constriction, Pathologic; Female; Femoral Artery; Humans; Male; Middle Aged; Neutrophils; Peripheral Arterial Disease; Prospective Studies; Time Factors

The use of vascular endothelial growth factor inhibitors such as sorafenib is limited by a risk of severe cardiovascular toxicity. A 28-year-old man with acute myeloid leukemia treated with prednisone, tacrolimus, and sorafenib following stem cell transplantation presented with severe bilateral lower extremity claudication. The patient was discharged against medical advice prior to finalizing a cardiovascular evaluation, but returned 1 week later with signs suggestive of septic shock. Laboratory tests revealed troponin I of 12.63 ng/mL, BNP of 1690 pg/mL, and negative infectious workup. Electrocardiogram showed sinus tachycardia and new pathologic Q waves in the anterior leads. Coronary angiography revealed severe multivessel coronary artery disease. Peripheral angiography revealed severely diseased left anterior and posterior tibial arteries, tibioperoneal trunk, and peroneal artery, and subtotal occlusion of the right posterior tibial artery. Multiple coronary and peripheral drug-eluting stents were implanted. An intra-aortic balloon pump was placed. Cardiac magnetic resonance imaging revealed chronic left ventricular infarction with some viability, 17% ejection fraction, and left ventricular mural thrombi. The patient opted for medical management. Persistent symptoms 9 months later led to repeat angiography, showing total occlusion of the second obtuse marginal artery due to in-stent restenosis with proximal stent fracture, and chronic total occlusion of the right internal iliac artery extending to the pudendal branch. Cardiac positron emission tomography/computed tomography viability study demonstrated viable myocardium, deeming revascularization appropriate. Symptom resolution was obtained with no recurrences. Sorafenib-associated vasculopathy may follow a fulminant course. Multimodality cardiovascular imaging is essential for optimal management.

Topics: Adult; Antineoplastic Agents; Cardiotoxicity; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Defibrillators; Defibrillators, Implantable; Drug-Eluting Stents; Electric Countershock; Endovascular Procedures; Humans; Intra-Aortic Balloon Pumping; Leukemia, Myeloid, Acute; Male; Myocardial Infarction; Peripheral Arterial Disease; Protein Kinase Inhibitors; Sorafenib; Treatment Outcome

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Optical coherence tomography (OCT)-guided directional atherectomy enables a real-time visualization of the arterial wall during plaque debulking and might optimize vessel preparation prior to drug-coated balloon (DCB) angioplasty. Nonetheless there is a paucity of data reporting on the outcomes of OCT-guided directional atherectomy with antirestenotic therapy (DAART). Aim of this study was to evaluate the performance of OCT-guided DAART in the treatment of femoropopliteal atherosclerosis.. Patients treated by OCT-guided DAART for femoropopliteal occlusive disease between January 2015 and December 2016 were included into this retrospective, single-center, single-arm analysis. The primary measure outcome of this study was primary patency rate (PPR). Secondary outcomes were technical success rate (TSR), secondary patency rate (SPR) and freedom from target lesion revascularization (TLR).. Thirty-three patients (N.=33, mean age 67±8 years) and 37 lesions were included into this analysis. The median follow-up time was 15 months (interquartile ratio (IQR): 4-21). The majority of patients presented with lifestyle limiting claudication (N.=25, 75%) and de novo atherosclerotic disease (N.=25, 68%). Median lesion length was 70 mm (IQR: 27-104), while 35% (N.=13) of the lesions were chronic total occlusions. Vessel wall calcification was present in 22% (N.=8) of the treated vessels. The mean luminal gain after atherectomy was 52±17% and the median gain after DAART amounted to 68% (IQR: 58-91). The TSR was 95%. The overall 12 months PPR was 93% whereas the SPR and the freedom from TLR at 12 months were 95% and 100% respectively. A single target vessel perforation (N.=1, 3%) and 2 peripheral embolizations (N.=2, 5%) were observed. The bailout stenting rate was 3% (N.=1) and the final angiography did not reveal any flow limiting dissection. An aneurysmatic degeneration of the target vessel was observed in 2 lesions (5%).. In this study, OCT-guided DAART was associated with sufficient luminal gain, low rates of bailout stenting and perioperative adverse events and led to very promising 12-month outcomes.

Topics: Aged; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Recurrence; Retrospective Studies; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Access Devices; Vascular Patency

To report the 1-year outcomes of the prospective Legflow drug-coated balloon (DCB) registry, which evaluated the safety and 12-month efficacy of the Legflow balloon in the treatment of femoropopliteal disease.. The Legflow is a new generation of DCB that has a homogenous, stable surface coating incorporating 0.1-µm paclitaxel particles. From January 2014 to June 2016, 139 patients (mean age 67.1±10.8 years; 109 men) were enrolled at 4 European institutions. Seventy-nine (56.8%) patients had claudication, while 60 (43.2%) had critical limb ischemia (CLI). Mean lesion length (MLL) was 90.0±41.2 mm. Eighty (57.6%) patients were treated for de novo lesions (MLL 83.2±41.2 mm), 29 (20.9%) for postangioplasty restenosis (MLL 81.2±30.9 mm), and 30 (21.6%) for in-stent restenosis (MLL 117.0±39.5 mm). The primary outcome measure was freedom from binary restenosis as determined by a peak systolic velocity ratio ≥2.4 on duplex or >50% stenosis on digital subtraction angiography at 12 months. The secondary outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months.. Technical success was achieved in all the 139 treated patients. During the hospital stay, 3 CLI patients died of wound-related complications and 3 CLI patients underwent urgent TLR due to early occlusion in 2 and stent thrombosis in 1. At 12 months, 4 additional patients died of cardiac disease unrelated to the procedure. Of the 132 patients available for 1-year follow-up, the primary outcome (freedom from restenosis) was obtained in 107 (81.1%) patients. Freedom from CD-TLR was obtained in 110 (83.3%). Of the 25 late restenoses >50%, only 3 asymptomatic patients did not require TLR. Freedom from CD-TLR was higher in claudicants (87.0%) than in CLI patients (78.2%, p=0.20). In patients treated for in-stent restenosis, freedom from TLR at 1 year was 89.2%.. These data suggest that the use of a new generation paclitaxel-coated balloon represents a safe and effective therapeutic strategy for femoropopliteal obstructions in different clinical and anatomical settings. These data will need to be confirmed with longer-term follow-up and in randomized controlled trials.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Critical Illness; Equipment Design; Europe; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Recurrence; Registries; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study ( ClinicalTrials.gov identifier NCT01609296).. Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI).. Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups.. Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Clinical Trials as Topic; Coated Materials, Biocompatible; Critical Illness; Equipment Design; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Progression-Free Survival; Risk Factors; Time Factors; Vascular Access Devices; Vascular Patency

The aim of this study was to elucidate the vascular responses to paclitaxel-eluting stent (Zilver PTX stent) in superficial femoral artery lesion at different elapsed times using angioscopy. Patients who received Zilver PTX stent implantation from five centers were enrolled. We performed angioscopic examinations at 2, 6, and 12 months after implantation and evaluated neointimal coverage (NIC) grade, intra-stent thrombus (IS-Th) grade, and presence of yellow plaque. NIC grade 0 was defined as stent struts exposed; grade 1, struts transparently visible although covered; grade 2, struts embedded in the neointima, but translucent; and grade 3, struts fully embedded and invisible. IS-Th was graded as follows: grade 0 (none), 1 (focal), and 2 (diffusely spread). Angioscopic follow-up evaluation was performed at 2 months (25 patients, 42 lesions), 6 months (18 patients, 23 stents), and 12 months (14 patients, 24 stents) after stent implantation. Dominant NIC grade significantly increased over time; however, 16.3% of the cases had NIC grade 1 or 2 at 12 months. IS-Th grade decreased; however IS-Th and yellow plaque were persistently observed in 62.5% and 83.3% cases, respectively, at 12 months. An ongoing healing response was observed at 12 months after implantation; however, thrombogenic findings were noted. Prolonged dual antiplatelet therapy could potentially enhance the clinical utility of Zilver PTX.

Topics: Aged; Aged, 80 and over; Alloys; Angioscopy; Cardiovascular Agents; Cell Proliferation; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Male; Middle Aged; Neointima; Paclitaxel; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Wound Healing

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Cardiovascular Agents; Cilostazol; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Limb Salvage; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Progression-Free Survival; Prosthesis Design; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Vascular Calcification; Vascular Patency

This study intended to assess effectiveness and safety of the drug-coated balloon (DCB) angioplasty of infrapopliteal atherosclerotic lesions in patients with critical limb ischaemia (CLI) in a real-world setting.. Consecutive patients with critical limb ischaemia who underwent infrapopliteal drug-coated balloon angioplasty with the ELUTAX SV DCB were enrolled into the prospective, multicentre, single-arm observational registry. Primary outcome was clinical improvement at 6 and 12 months. Secondary outcomes were change in quality of life, primary patency, freedom from repeat revascularisation, and amputation-free survival at 6 and 12 months.. A total of 164 patients (74.7 ± 9.2 years) with CLI were included at nine German sites between November 2015 and September 2017. The majority (79.9%) of patients had diabetes mellitus, 57.3% had renal insufficiency, and 35.3% had coronary artery disease. Mean lesion length was 71.2 ± 76.5 mm. The Rutherford category improved by 3.0 ± 2.0 (p < 0.0001) within 12 months, resulting in a clinical improvement by at least one Rutherford category in 80.2% of the patients. Walking impairment questionnaire score, European Quality of Life index, and patient-reported pain improved significantly from baseline to 6 and 12 months. Primary patency was 68.5%, freedom from target lesion revascularisation 90.6%, and amputation-free survival 83.5% at 12 months.. Infrapopliteal drug-coated balloon angioplasty with the ELUTAX SV DCB in patients with critical limb ischaemia was efficacious and safe over the medium term. The study is registered with Clinical.Trials.gov (Identifier: NCT02539940).

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Germany; Humans; Ischemia; Kaplan-Meier Estimate; Male; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Time Factors; Treatment Outcome; Vascular Patency

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Stents; Treatment Outcome

Purpose The present study aimed to determine the safety and efficacy of a drug-coated balloon inflated within a thin-strut self-expanding bare-metal stent in patients with severe and complex femoropopliteal occlusive disease. Methods This prospective study used the Pulsar-self-expanding stent and Passeo-18 Lux drug-coated balloon in patients with severe and complex femoropopliteal occlusive disease. The primary endpoint was the 12-month primary patency, and the secondary endpoints included 24-month primary patency, assisted primary patency, secondary patency, and clinically associated target lesion revascularisation. Results The study included 44 patients (51 limbs). The mean age of the patients was 67.6 ± 10.2 years, with 73% men. Chronic limb severity was classified as Rutherford Category III in 41% of the patients, stage IV in 31%, and stage V in 27%. Lesions were predominantly Trans-Atlantic Inter-Society Consensus (TASC 2007) D (51%) and C (45%), with 32 (63%) chronic total occlusions. Procedural success was obtained in all cases. The mean lesion length was 200 ± 74.55 mm (95% CI = 167.09-208.01) with a mean number of stents per limb used of 1.57 ± 0.70 (95% CI = 1.37-1.76). Distal embolisation occurred in two patients. The primary patency rates at the 12- and 24-month follow-up were 94% (95% CI = 82.9-98.1) and 88% (95% CI = 75.7-94.5), respectively. The assisted primary was 94% (95% CI = 82.9-98.1) and secondary patency was 96% (95% CI = 85.2-99.0) at 24-month follow-up. The cumulative stent fracture rate at the 24-month follow-up was 10%. Freedom from clinically driven target lesion revascularisation was 94% (95% CI = 83-98%) at 12-month follow-up and 88% (95% CI = 76-94%) at 24-month follow-up, with two patients requiring a bypass graft. Conclusion Our novel approach involving the combination of a thin-strut bare-metal stent and a drug-coated balloon may be safe and effective, with sustainable and promising clinical outcomes up to 24 months after treatment.

Topics: Aged; Alloys; Angioplasty, Balloon; Australia; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Self Expandable Metallic Stents; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency

The objective of this study was to assess the feasibility, safety and initial efficacy of paclitaxel administration using a novel drug delivery catheter for the prevention of restenosis in infrapopliteal de novo and restenotic lesions.. Restenosis continues to be a great challenge after percutaneous revascularization procedures for peripheral arterial disease, particularly for below-the-knee applications.. A prospective, multicenter first-in-human registry of a novel delivery catheter delivering liquid paclitaxel was conducted in 10 patients. The primary efficacy endpoint at 6 months was freedom from clinically driven target lesion revascularization (CD-TLR) and the primary safety endpoint at 1, 3, and 6 months were thrombosis, major amputation in the target limb and target limb related death.. All patients tolerated the procedure well with no reports of adverse procedural events. Twelve (n = 12) lesions in ten patients were treated with a mean lesion length of 83.3 ± 49.2 mm, with the lesion length range of 30mm to 182 mm. At 6-month follow-up, the rate of CD-TLR was 30% (3 of 10 patients). Zero patients (0 out of 10) demonstrated thrombosis, major amputation in the target limb and target limb related death at the 1, 3, and 6 month follow-up intervals.. This first in-human experience obtained in a multicenter study of real-world de novo and restenotic lesions demonstrates a favorable safety and efficacy profile at 6 months. Randomized comparison to current drug coated balloons should be performed to further validate this approach and positive experience.

Topics: Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Catheterization, Peripheral; Constriction, Pathologic; Feasibility Studies; Female; Humans; Limb Salvage; Lower Extremity; Male; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Recurrence; Registries; Risk Factors; Thrombosis; Time Factors; Treatment Outcome; United States; Vascular Access Devices; Vascular Patency

To report an experience using directional atherectomy (DA) with antirestenotic therapy (DAART) in the form of drug-coated balloon (DCB) angioplasty vs DCB angioplasty alone in common femoral artery (CFA) occlusive lesions.. A retrospective review was conducted of 47 consecutive patients (mean age 71 years; 26 men) treated between October 2011 and July 2016 using either DCB angioplasty alone (n=26) or DAART (n=21) for CFA lesions. The majority of patients had lifestyle-limiting claudication (14 DCB and 15 DAART). Mean lesion length (39±14 mm DCB and 34±16 mm DAART) and vessel calcification (17/26 DCB and 11/21 DAART) were comparable between the groups. There were 4 chronic total occlusions, all in the DAART group. The main outcome measure was primary patency. Key secondary outcomes were technical success, secondary patency, and freedom from clinically-driven target lesion revascularization (TLR).. Technical success rates were 89% following DCB angioplasty and 95% for DAART (p=0.41). The 88% 12-month primary patency and 89% freedom from TLR for DAART were higher than the 68% and 75% estimates following DCB angioplasty alone, but neither difference was statistically significant. However, the secondary patency estimate at 12 months was significantly higher in the DAART group (100% vs 81% for DCB, p=0.03). Bailout stenting (1 DCB vs 1 DAART), vessel perforation (1 DCB vs 0 DAART), access site complications (4 DCB vs 3 DAART), and distal embolization (0 DCB vs 1 DAART) were comparable, whereas DCB angioplasty had more non-flow-limiting dissections (8 vs 1 for DAART, p=0.02).. Preparation of the atherosclerotic CFA with directional atherectomy was not associated with statistically significantly higher primary patency or freedom from TLR compared to DCB angioplasty alone at 12 months. Nonetheless, both modalities had promising outcomes in a primarily surgically treated vascular territory.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Plaque, Atherosclerotic; Progression-Free Survival; Recurrence; Retreatment; Retrospective Studies; Risk Factors; Time Factors; Vascular Access Devices; Vascular Patency

Objectives To evaluate 36-month outcomes of drug-eluting balloons in infrapopliteal (=below-the-knee) arterial segments, we made a prospective registry enrolling patients (Rutherford class 2 to 5, ankle-brachial index 0.4-0.7) who were revascularized with drug-eluting balloon from August 2011 to December 2014. Methods Three hundred and seven infrapopliteal arteries were revascularized only with drug-eluting balloon. Endpoints included target lesion revascularization, primary patency rate, and changes in ankle-brachial index and Rutherford class. Results Both ankle-brachial index improvement and Rutherford reduction were statistically significant (p < 0.001). At 36 months control, ankle-brachial index improvement was 59.3% (p = 0.032). The clinically driven target lesion revascularization rate was 28% at 36 months. Limb salvage was accomplished in 73.6% of the critical limb ischemia cases, and complete wound healing was detected in 67.8% of cases with Rutherford category 5. Overall, the 1-year primary patency rate was 32.5%. Conclusions Drug-eluting balloons have shown successful performance in infrapopliteal arteries in mid-term, and evidence regarding clinical effectiveness and safety supports drug-eluting balloon angioplasty as the first line therapy in this segment.

Topics: Aged; Angiography; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Humans; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Angioplasty with drug-coated balloons (DCBs) using excipients as drug carriers is emerging as a potentially viable strategy demonstrating clinical efficacy and proposing additional compliance for the treatment of obstructive vascular diseases. An attempt is made to develop an improved computational model where attention has been paid to the effect of interstitial flow, that is, plasma convection and internalization of bound drug. The present model is capable of capturing the phenomena of the transport of free drug and its retention, and also the internalization of drug in the process of endocytosis to atherosclerotic vessel of heterogeneous tissue composition comprising of healthy tissue, as well as regions of fibrous cap, fibro-fatty, calcified and necrotic core lesions. Image processing based on an unsupervised clustering technique is used for color-based segmentation of a patient-specific longitudinal image of atherosclerotic vessel obtained from intravascular ultrasound derived virtual histology. As the residence time of drug in a stent-based delivery within the arterial tissue is strongly influenced by convective forces, effect of interstitial fluid flow in case of DCB delivery can not be ruled out, and has been investigated by modeling it through unsteady Navier-Stokes equations. Transport of free drug is modeled by considering unsteady advection-reaction-diffusion process, while the bound drug, assuming completely immobilized in the tissue, by unsteady reaction process. The model also takes into account the internalization of drug through the process of endocytosis which gets degraded by the lysosomes and finally recycled into the extracellular fluid. All the governing equations representing the flow of interstitial fluid, the transport of free drug, the metabolization of free drug into bound phase and the process of internalization along with the physiologically realistic boundary and initial conditions are solved numerically using marker and cell method satisfying necessary stability criteria. Simulated results obtained predict that faster drug transfer promotes rapid saturation of binding sites despite perivascular wash out and the concentrations of all drug forms are modulated by the presence of interstitial flow. Such premier attempt of its kind would certainly be of great help in the optimization of therapeutic efficacy of drug.

Topics: Angioplasty, Balloon; Arteries; Blood Flow Velocity; Cardiovascular Agents; Coated Materials, Biocompatible; Computer Simulation; Endocytosis; Equipment Design; Fibrosis; Humans; Models, Cardiovascular; Necrosis; Peripheral Arterial Disease; Plaque, Atherosclerotic; Regional Blood Flow; Tissue Distribution; Vascular Access Devices

To evaluate the 1- and 2-year patency and reintervention rates with the Zilver PTX drug-eluting stent (DES) in long complex femoropopliteal disease.. A retrospective review was conducted of 89 consecutive patients (mean age 68.7±9.8 years; 86 men) with femoropopliteal occlusive disease (Rutherford category 2-6) treated with the Zilver PTX between December 2012 and December 2013. Mean lesion length for the entire cohort was 24.2±11.3 cm (median 24.0, range 4-48). The patient population was dichotomized into a short lesion (≤20 cm) group (n=41; mean lesion length 13.3±5.6 cm) and the full DES jacket (>20 cm) group (n=48; mean lesion length 33.0±6.5 cm). Primary endpoints were duplex-derived restenosis (peak systolic velocity ratio >2.5), clinically driven reintervention, and major amputation.. The incidence of restenosis was lower in the short lesion group at 1 year (19% vs 40% for the longer lesions, p=0.050) and 2 years (39% vs 54%, respectively; p=0.331). The short lesion group had significantly lower rates of reintervention at both 1 year (2% vs 21% in long lesions, p=0.009) and 2 years (12% vs 33%, p=0.019).. Treatment of femoropopliteal lesions >20 cm with the Zilver PTX appears to be a clinically effective therapy for patients with symptomatic peripheral artery disease. However, there is an increase in restenosis and a need for reintervention that continues to progress up to 2 years.

Topics: Aged; Alloys; Angioplasty, Balloon; Cardiovascular Agents; Drug-Eluting Stents; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

Background The aim of our study was to evaluate whether treatments for peripheral artery disease changed in two different cohorts identified in 2002 and 2008, and whether this had an impact on mortality and major clinical outcomes after six years of follow-up. Methods Using administrative health databases of the largest region in Northern Italy, we identified patients admitted to hospital for peripheral artery disease in 2002 and 2008. Both cohorts were followed for six years. All cause death, acute coronary syndrome, stroke and major amputations, cardiovascular prevention drugs and revascularization procedures were collected. Incidence of events was plotted using adjusted cumulative incidence function estimates. The risk, for each outcome, was compared between 2002-2008 and 2008-2014 using a multivariable Fine and Gray's semiparametric proportional subdistribution hazards model. Results In 2002 and 2008, 2885 and 2848 patients were identified. Adjusting for age, sex, Charlson comorbidity index and severity of peripheral artery disease we observed a significant reduction (in 2008 vs. 2002) in the risk of acute coronary syndrome (28%), stroke (27%) and major amputation (17%). No change was observed in the risk of death. The percentages of patients with peripheral artery revascularizations, during the hospital stay, increased: 43.8% in 2002 vs. 49.0% in 2008, p < 0.001. From 2002 to 2008 there was a significant absolute increase in the prescription of lipid-lowering drugs (+18%), antiplatelets (+7.2%) and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (+11.8%), p < 0.001. Conclusions In six years of follow-up we observed a reduction in risk of major cardiovascular events in 2008-2014 in comparison with the 2002-2008 cohort. Increasing use of revascularization interventions and cardiovascular prevention drugs could have contributed to the better prognosis.

Topics: Administrative Claims, Healthcare; Aged; Aged, 80 and over; Amputation, Surgical; Cardiovascular Agents; Databases, Factual; Female; Humans; Incidence; Italy; Limb Salvage; Male; Middle Aged; Outcome and Process Assessment, Health Care; Peripheral Arterial Disease; Practice Patterns, Physicians'; Preventive Health Services; Protective Factors; Registries; Risk Factors; Time Factors; Treatment Outcome; Vascular Surgical Procedures

Cilostazol has been associated with spontaneous reports of cardiovascular adverse events and serious bleeding. The objective of this study is to determine the relative risk of cardiovascular adverse events or haemorrhages in patients with peripheral artery disease treated with cilostazol in comparison to pentoxifylline users.. Population-based cohort study including all individuals older than 40 who initiated cilostazol or pentoxifylline during 2009-2011 in SIDIAP database. The two treatment groups were matched through propensity score (PS).. Nine thousand one hundred twenty-nine patients met inclusion criteria and after PS matching, there were 2905 patients in each group. 76% of patients were men, with similar mean ages in both groups (68.8 for cilostazol and 69.4 for pentoxifylline). There were no differences in bleeding, cerebrovascular and cardiovascular events between both groups.. Patients treated with cilostazol were different from those treated with pentoxifylline at baseline, so they were matched through PS. We did not find differences between treatment groups in the incidence of bleeding or cardiovascular and cerebrovascular events. Cilostazol should be used with precaution in elderly polymedicated patients.

Topics: Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Cerebrovascular Disorders; Cilostazol; Databases, Factual; Drug Interactions; Electronic Health Records; Female; Hemorrhage; Humans; Incidence; Male; Middle Aged; Patient Safety; Pentoxifylline; Peripheral Arterial Disease; Phosphodiesterase 3 Inhibitors; Polypharmacy; Primary Health Care; Retrospective Studies; Risk Assessment; Risk Factors; Spain; Time Factors; Treatment Outcome

All patients with lower extremity peripheral arterial disease (LE-PAD) should benefit from recommended pharmacologic therapies including antiplatelet agents, angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), and HMG-CoA-reductase inhibitors (statins). In the present study, this triple therapy was defined as the best medical treatment. This study was designed to determine the current risk of cardiovascular (CV) events and mortality and also to evaluate the effect of pharmacologic treatment on patient's survival, CV events, and additional vascular surgery in vascularized LE-PAD patients. This observational, cohort study analyzed prospectively collected data of 140 consecutive patients after hospitalization for LE-PAD revascularization in the vascular surgery department of our university hospital, between January 1 and June 30, 2013.. Data from guideline-recommended classes of medications (ACE, ARB, statins, and antiplatelet agents or anticoagulation) were collected at the time of discharge to hospitalization and at the end of the follow-up. Information about mortality, CV events, and additional vascular surgery was collected during follow-up.. The mean follow-up of patients was 41 months. Mortality and CV events concerned 24% and 12% of the patients, respectively, and additional vascular surgery was performed in 33% of the patients. There was no difference in mortality and CV event rates according to pharmacologic treatment. Additional vascular surgery rate of LE-PAD patients with best medical treatment tended to be lower than without (incidence rate ratio = 0.5777; 95% confidence interval, 0.3101-1.06; P = 0.08). Best medical treatment was prescribed in 54% of patients at discharge of hospitalization. This proportion (54%) was statistically unchanged at the end of follow-up.. In this small cohort, we failed to show that best medical treatment decreased mortality or CV event rates, but it tended to be associated with decreased additional vascular surgery rate. Further studies taking into consideration the control of CV risk factors could be interesting to demonstrate better outcome from LE-PAD patients with best medical treatment compared with LE-PAD patients without. There is an urgent need for a more effective implementation of currently recommended medication and a continued search after more effective pharmacologic treatment options in LE-PAD.

Topics: Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Anticoagulants; Cardiovascular Agents; Drug Therapy, Combination; Guideline Adherence; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Lower Extremity; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Practice Patterns, Physicians'; Protective Factors; Retrospective Studies; Risk Assessment; Risk Factors; Secondary Prevention; Time Factors; Treatment Outcome; Vascular Surgical Procedures

The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials.. Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions.. The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months.. Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months.. This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296).

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Recurrence; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The aim of this study was to assess the performance of the fluoropolymer-based paclitaxel-eluting stent (PES) in long femoropopliteal lesions.. The new-generation fluoropolymer-based PES showed promising outcomes in short femoropopliteal lesions. The main feature of the stent is its controlled and sustained paclitaxel release over 12 months. However, the safety and efficacy of this technology in longer femoropopliteal lesions remain unclear.. Between March 2016 and March 2017, 62 patients were included in this analysis. Indications for fluoropolymer-based PES deployment were insufficient luminal gain or flow-limiting dissection after plain old balloon angioplasty in a femoropopliteal lesion. Primary patency, freedom from target lesion revascularization, amputation-free survival, and paclitaxel-related adverse events were retrospectively analyzed for up to 1 year of follow-up.. Lesions were de novo in 84% of patients. Mean lesion length was 20 ± 12 cm, and 79% of the lesions (n = 49) were chronic total occlusions. Moderate or severe calcification was present in 42% of the lesions (n = 26). Stent implantation involved the distal superficial femoral artery and the proximal popliteal artery in 76% (n = 47) and 44% (n = 27) of patients, respectively. The Kaplan-Meier estimate of primary patency and freedom from target lesion revascularization was 87%. Amputation-free survival was 100% for patients with claudication (n = 32 [52%]) and 87% in patients with critical limb ischemia (n = 30 [48%]) (hazard ratio: 6.3; 95% confidence interval: 1.25 to 31.54; p = 0.052). Five aneurysm formations of the treated segments (8%) were thought to be attributable to paclitaxel.. The fluoropolymer-based PES showed promising 1-year clinical and angiographic outcomes in real-world long femoropopliteal lesions. The long-term impact of aneurysm formation remains to be further investigated.

Topics: Aged; Angioplasty; Cardiovascular Agents; Chronic Disease; Constriction, Pathologic; Drug-Eluting Stents; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Time Factors; Treatment Outcome; Vascular Calcification; Vascular Patency

To investigate the midterm performance of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS) for the treatment of symptomatic infrapopliteal atherosclerotic disease.. A single-center study prospectively enrolled 48 symptomatic patients (mean age 82.1±8.0 years; 27 men) between September 2013 and February 2018 to evaluate the Absorb everolimus-eluting BVS system in distal popliteal and tibial lesions. Mean lesion length was 20.1±10.8 mm. Following predilation, up to 2 BVS were implanted in target lesions in 55 limbs. Clinical and duplex ultrasound follow-up was performed at 1, 3, 6, 12, 24, 36, and 48 months to determine 30-day morbidity and midterm Kaplan-Meier estimates of binary restenosis, clinically-driven target lesion revascularization (CD-TLR), amputation, and mortality.. Seventy-one scaffolds were implanted to treat 61 lesions. Technical success was achieved in all patients, with no amputation, death, or target limb bypass surgery within 30 days of the index procedure. There was 1 early thrombotic occlusion of 2 BVS in a previously anticoagulated patient not given antiplatelet medication after the procedure. During a mean follow-up of 24.0±15.3 months, 11 (23%) patients died; the remaining 37 were available for follow-up. Binary restenosis (50%-75%) was detected in 6 (8%) scaffolds. Primary patency estimates at 12, 24, and 36 months were 92.2%, 90.3%, and 81.1%; freedom from CD-TLR estimates were 97.2%, 97.2%, and 87.3% at the same time points. No late scaffold thrombosis has been observed. The majority of the 55 limbs (51, 93%) were clinically improved; 4 (7%) were unchanged. Thirty-six (92%) of 39 limbs treated for tissue loss achieved complete wound healing, with no major amputation (limb salvage 100%).. Midterm follow-up demonstrates excellent safety, patency, and freedom from CD-TLR rates using the Absorb bioresorbable vascular scaffold below the knee.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Everolimus; Female; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Tibial Arteries; Time Factors; Treatment Outcome; Vascular Patency

The long-term outcome of Jetstream atherectomy (JA) with or without adjunctive drug coated balloons (DCB) in a real-world setting remains unknown. We report 16-month target lesion revascularization (TLR) rates on patients treated for femoropopliteal (FP) artery disease with JA in a single center by one operator.. From 1/1/12 to 8/24/16 a total of 311 procedures were performed with atherectomy by a single operator at a single center. Of these procedures, 75 met inclusion and exclusion criteria. This report evaluates the outcomes of these 75 patients treated at index and who were followed up to 16 months. The primary endpoint of the study was clinically driven TLR. Patients were stratified by the use of DCB (vs angioplasty (PTA)) post-JA. TLR was calculated by excluding bailout stenting as TLR. Survival analysis for TLR over time was plotted.. 75 patients (49.3% male, mean age 68.0 years, 54.7% diabetes) with de novo or restenotic FP lesions whose symptoms were classified as Rutherford category I-V were enrolled. Adjunctive PTA was performed on 50 patients (26 de novo, 13 in-stent restenosis, 3 non-stent restenosis, 8 mixed lesions) and adjunctive DCB (LUTONIX® 24, IN.PACT® 1) on 25 patients (21 de novo, 1 in-stent restenosis, 2 non-stent restenosis, 1 mixed lesion) (p = 0.0249). There was no difference in the median treated length between the adjunctive PTA (15 cm) and DCB (10 cm) groups (p = 0.0530). The estimated freedom from TLR (fTLR) was significantly higher with atherectomy and adjunctive DCB compared to atherectomy with adjunctive PTA at 12 months (94.7% vs 68.0%, p = 0.002) and 16 months (94.4% vs 54%; p = 0.002).. In a single center cohort of JA reflecting real-world practice, JA with DCB had a superior TLR rate up to 16-month follow-up when compared to JA with PTA in treating all comers FP arterial disease.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Female; Femoral Artery; Humans; Iowa; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To describe relevant technical details with which to facilitate safe and effective use of the Absorb coronary bioresorbable vascular scaffold (BVS) in lower extremity arteries.. The Absorb BVS is a balloon-expandable, poly-l-lactide structure covered in a poly-d,l-lactide bioresorbable polymer that contains the antiproliferative drug everolimus. As a polymeric structure, it has a number of unique physical, handling, and imaging properties that may differ from metallic stents and pose a challenge to the interventionist. Attention must be paid to lesion selection, preparation, scaffold sizing, deployment, and postdilation to achieve optimal outcomes. A detailed description of these issues and deployment techniques is offered based on experience using this BVS in below-the-knee arteries.. The Absorb BVS may have application in the infrapopliteal circulation; however, its unique properties warrant careful consideration before use in the lower limb.

Topics: Absorbable Implants; Angiography; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Everolimus; Humans; Peripheral Arterial Disease; Polyesters; Popliteal Artery; Prosthesis Design; Time Factors; Treatment Outcome

The aim of this study was to appraise 2-year outcomes after percutaneous transluminal angioplasty of long femoropopliteal artery disease using paclitaxel-coated balloons (PCBs).. Percutaneous transluminal angioplasty with PCBs for TransAtlantic Inter-Society Consensus types C and D femoropopliteal artery disease has provided favorable results ≤12 months but no prospective studies performed longer term follow-up assessment.. Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency (i.e., freedom from the combined endpoint of clinically driven target lesion revascularization and >50% restenosis in the treated lesion as appraised by a duplex ultrasound peak systolic velocity ratio of >2.4) at 24 months. Secondary endpoints included major adverse events (the composite of death, target limb amputation, thrombosis at the target lesion, or clinically driven nontarget lesion revascularization), changes in Rutherford class, and quality of life ≤24 months post-procedure.. A total of 105 patients (age 68 ± 9 years; 81.9% men) successfully treated with PCBs were included (treated lesion length was 251 ± 71 mm; 49.5% total occlusions). The 24-month follow-up data were available in 98 patients; they showed a primary patency rate of 70.4%, with major adverse events occurred in 10 patients (10.2%, 5 non-procedure-related deaths) and persistently significant clinical benefits in Rutherford class (51% of asymptomatic patients at 24 months).. PCBs benefits on primary patency and target vessel revascularization satisfactorily extend over 24 months in patients undergoing percutaneous transluminal angioplasty for symptomatic femoropopliteal disease.

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Italy; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prospective Studies; Quality of Life; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Long-term progression of peripheral arterial disease (PAD) as initial manifestation of atherosclerotic arterial disease is not well described. Cardiovascular (CV) risk was examined in different PAD populations diagnosed in a hospital setting in Sweden.. Data for this retrospective cohort study were retrieved by linking data on morbidity, medication use, and mortality from Swedish national registries. Primary CV outcome was a composite of myocardial infarction, ischemic stroke (IS), and CV death. Kaplan-Meier analysis and Cox proportional hazards modeling was used for describing risk and relative risk.. Of 66,189 patients with an incident PAD diagnosis (2006-2013), 40,136 had primary PAD, 16,786 had PAD + coronary heart disease (CHD), 5803 had PAD + IS, and 3464 had PAD + IS + CHD. One-year cumulative incidence rates of major CV events for the groups were 12%, 21%, 29%, and 34%, respectively. Corresponding numbers for 1-year all-cause death were 16%, 22%, 33%, and 35%. Compared with the primary PAD population, the relative risk increase for CV events was highest in patients with PAD + IS + CHD (hazard ratio [HR], 2.01), followed by PAD + IS (HR, 1.87) and PAD + CHD (HR, 1.42). Despite being younger, the primary PAD population was less intensively treated with secondary preventive drug therapy.. PAD as initial manifestation of atherosclerotic disease diagnosed in a hospital-based setting conferred a high risk: one in eight patients experienced a major CV event and one in six patients died within 1 year. Despite younger age and substantial risk of future major CV events, patients with primary PAD received less intensive secondary preventive drug therapy.

Topics: Age Factors; Aged; Aged, 80 and over; Ambulatory Care; Brain Ischemia; Cardiovascular Agents; Cause of Death; Comorbidity; Disease Progression; Female; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Peripheral Arterial Disease; Prevalence; Prognosis; Proportional Hazards Models; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Secondary Prevention; Stroke; Sweden; Time Factors

Endovascular treatment of below-the-knee region disease is often challenging because of the involvement of arterial bifurcations. Several cases have been reported on the use of coronary stents for the treatment of these patients, but limited evidence is available on the use of dedicated coronary bifurcation devices. We here report the endovascular treatment of a symptomatic bifurcation lesion in below-the-knee region, using a self-expanding Biolimus A9-eluting stent in combination with a "conventional" coronary drug-eluting stent.

Topics: Angiography; Angioplasty, Balloon; Cardiovascular Agents; Drug-Eluting Stents; Humans; Leg; Male; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Radiography, Interventional; Sirolimus; Tibial Arteries; Treatment Outcome

Endovascular treatment of a significant stenosis in an infrainguinal autologous bypass prevents bypass occlusion and improves bypass patency. Drug-eluting balloons (DEBs) have been proven to possess antirestenotic features in the treatment of femoropopliteal stenoses and occlusions. This study evaluated the effects of DEB angioplasty vs uncoated balloon (UCB) angioplasty to rescue infrainguinal autologous bypass grafts at risk (BAR).. The study included all consecutive patients treated endovascularly for BAR from December 1, 2012, to July 31, 2015. As of April 1, 2014, the primary treatment of BAR was changed from UCBs to DEBs. Patients treated with DEBs were prospectively recorded in a database and retrospectively analyzed. Patients treated with UCBs were retrospectively collected from a historical cohort with a similar inclusion period length as the DEB cohort. The follow-up scheme did not differ between the two groups. The primary end point was the combined end point of freedom from recurrent stenosis or bypass occlusion. Secondary end points were primary assisted patency, secondary patency, technical success, major amputation, and mortality.. Twenty-one patients were treated in the DEB group and 18 were treated in the UCB group. The two groups were evenly distributed in demographics, bypass, treatment, and lesion characteristics. No statistically significant differences were found in the combined end point of freedom from recurrent stenosis and the occlusion rate after 1 year between the UCB group (77.8%) and the DEB group (80.0%; P = .76). After 1 year, the primary assisted patency rate was 88.2% in the UCB group vs 95.2% in the DEB group (P = .47), and the secondary patency rate was 94.1% in the UCB group vs 95.2% in the DEB group (P = .91). During follow-up, restenosis developed in four patients (22.2%) in the UCB group and in four patients (19.0%) in the DEB group (P = .80). One bypass (5.6%) in the UCB group and one bypass (4.8%) in the DEB group occluded during follow-up (P = .884).. DEBs and UCBs perform equally in the treatment of significant stenosis in infrainguinal autologous bypasses with regard to freedom from restenosis or bypass occlusion, primary assisted patency, and secondary patency at 1 year. We suggest using a less expensive UCB in the treatment of BAR.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Databases, Factual; Disease-Free Survival; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Recurrence; Retrospective Studies; Risk Factors; Time Factors; Transplantation, Autologous; Treatment Outcome; Vascular Access Devices; Vascular Grafting; Vascular Patency

A polymer-free peripheral paclitaxel-eluting stent (PES, Zilver PTX, Cook, IN) has shown to improve vessel patency after superficial femoral angioplasty. A new-generation fluoropolymer-based PES (FP-PES; Eluvia, Boston Scientific, MA) displaying more controlled and sustained paclitaxel delivery promise to improve the clinical outcomes of first-generation PES. We sought to compare the biological effect of paclitaxel delivered by 2 different stent-coating technologies (fluoropolymer-based versus polymer-free) on neointimal proliferation and healing response in the familial hypercholesterolemic swine model of femoral restenosis.. The biological efficacy of clinically available FP-PES (n=12) and PES (n=12) was compared against a bare metal stent control (n=12; Innova, Boston Scientific, MA) after implantation in the femoral arteries of 18 familial hypercholesterolemic swine. Longitudinal quantitative vascular angiography and optical coherence tomography were performed at baseline and at 30 and 90 days. Histological evaluation was performed at 90 days. Ninety-day quantitative vascular angiography results showed a lower percent diameter stenosis for FP-PES (38.78% [31.27-47.66]) compared with PES (54.16% [42.60-61.97]) and bare metal stent (74.52% [47.23-100.00];. In the familial hypercholesterolemic swine model of femoral restenosis, the implantation of an FP-PES resulted in lower levels of neointimal proliferation and sustained biological effect ≤90 days compared with a polymer-free stent-based approach.

Topics: Angiography; Animals; Cardiovascular Agents; Cell Proliferation; Constriction, Pathologic; Disease Models, Animal; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Hyperlipoproteinemia Type II; Methacrylates; Neointima; Paclitaxel; Peripheral Arterial Disease; Polymers; Polyvinyls; Prosthesis Design; Recurrence; Sus scrofa; Time Factors; Tomography, Optical Coherence; Vascular Patency; Wound Healing

Despite current progress, the prognosis of critical limb ischemia (CLI) remains poor. The ageing of the population, the increasing prevalence of diabetes mellitus, and the stability of tobacco use will increase the prevalence of CLI. CLI patients have risk factors for malnutrition, and the impact of malnutrition on morbidity and mortality has been demonstrated in the general population. However, we have little information on the consequences of undernutrition in the CLI population. The aim of this study is to assess the impact of malnutrition on the early outcomes in CLI patients.. This is a double-center prospective study that included all consecutive hospitalized patients with CLI. All patients were screened for malnutrition and divided into 2 groups: severe malnourished patients (group A) and moderate malnourished and well-nourished (group B). This distribution was based on age-indexed clinical and biological data and the patient's general condition: the Nutritional Risk Index for patients younger than 75 years, the Mini Nutritional Assessment, or the Geriatric Nutritional Risk Index for those older than 75 years. The primary end point was defined as the rate of 30-day death. Outcomes were compared in a univariate analysis. Stepwise logistic regression was used for the multivariate analysis. Variables with a P value <0.2 in the univariate analysis were introduced in the multivariate model.. We included 106 patients. The prevalence of malnutrition was 75.5%, divided into moderate malnutrition (51.9%) and severe malnutrition (23.6%). Six patients (24%) died in group A compared with 8 in group B (4.9%) (P = 0.01). By univariate analysis, severe malnutrition was the only factor associated with death at 30 days. By stepwise logistic regression, severe malnutrition (odds ratio 6.1, 95% confidence interval 1.6-23.7, P = 0.006) was found to be the significant risk factors for death at 30 days.. This study is the first to demonstrate prospectively the major importance of malnutrition in the early prognosis of CLI patients.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Cardiovascular Agents; Chi-Square Distribution; Critical Illness; Endovascular Procedures; Female; France; Geriatric Assessment; Humans; Ischemia; Length of Stay; Limb Salvage; Logistic Models; Male; Malnutrition; Multivariate Analysis; Nutrition Assessment; Nutritional Status; Odds Ratio; Peripheral Arterial Disease; Prevalence; Prospective Studies; Risk Factors; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Grafting

This analysis compared the angiographic outcomes of patients treated with orbital atherectomy for calcified common femoral artery (CFA) and superficial femoral artery (SFA) disease. The ideal revascularization strategy for CFA disease is unknown. Endarterectomy has been considered the standard of care for CFA disease for over 50 years. Endovascular intervention is becoming more commonly used to revascularize the CFA given the advances in technology and the less invasive nature of the procedure. Patient demographics, lesion characteristics, and procedure data for all CONFIRM patients with at least one CFA lesion location ( n=147 patients; n=200 lesions) were compared to patients with at least one SFA lesion location ( n=1508 patients; n=2367 lesions). The primary endpoint was angiographic complication, defined as the composite of dissection, perforation, slow flow, closure, spasm, embolism, or thrombosis. The CFA group had more patients with Rutherford class 4 and shorter lesion length. The CFA group had a higher final residual stenosis, shorter total run time, and shorter total inflation time. The primary endpoint was lower in the CFA group compared with the SFA group (17% vs 24%, p=0.02), driven by a lower dissection rate (10% vs 15%, p=0.04). Plaque modification of the CFA with orbital atherectomy was safe and compared favorably with SFA disease. The need for bail-out stenting was low. A randomized trial is needed to determine the ideal treatment strategy for calcified CFA disease.

Topics: Aged; Aged, 80 and over; Angiography; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Registries; Retrospective Studies; Time Factors; Treatment Outcome; United States; Vascular Access Devices; Vascular Calcification; Vascular Patency

A 59-year-old man with critical claudication underwent left femoro-anterior bypass grafting, which was uneventful. The graft was tunneled medially across the knee, then anterior to the tibia. His symptoms recurred 1 year later and he was found to have critical stenosis of the vein graft just proximal to the anterior tibial arterial anastomosis. This was treated with scaffolded balloon angioplasty and implantation of a coronary, zotarolimus-eluting balloon-expandable stent, which was also uneventful. However, his claudication again recurred 1 year later. Diagnostic angiography revealed crush, deformation and restenosis of the balloon-expandable stent requiring surgical revision of the bypass graft.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Computed Tomography Angiography; Critical Illness; Drug-Eluting Stents; Graft Occlusion, Vascular; Humans; Intermittent Claudication; Male; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Recurrence; Reoperation; Saphenous Vein; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Grafting; Vascular Patency

Sildenafil, a phosphodiesterase-5-inhibitor and Bosentan, an endothelin-1-receptor antagonist combined therapy could have beneficial effect in systemic sclerosis (SSc) patients with peripheral artery disease.. We report a case of a 48-year-old Black woman, who developed severe left limb claudication and walking limitation following a left femoropopliteal bypass occlusion in 2014. She was a heavy smoker and had a history of right middle cerebral artery ischemic stroke and bilateral Raynaud phenomenon.. According to the American College of Rheumatology/European League Against Rheumatism-2013 criteria, diagnosis of limited cutaneous SSc was retained with macrovascular lesions. She was referred for investigation of left limb claudication on treadmill using transcutaneous oxygen pressure measurement during exercise to argue for the vascular origin of the walking impairment. She had a severe left limb ischemia and the maximum walking distance (MWD) she reached was 118 m in March 2015 despite the medical optimal treatment and walking rehabilitation.. Sildenafil, 20 mg tid, was introduced due to active digital ulcers. In July 2015, the MWD increased to 288 m, then to 452 m in December 2015. Adding Bosentan to Sildenafil to prevent recurrent digital ulcers resulted in an MWD of 1576 m.. Recently, the patient is treated with the combined therapy. She has no more pain during walking and his quality of life has improved.. Sildenafil and Bosentan combined therapy was associated in our case with an improvement of MWD without adverse effect. Further clinical trials are necessary to confirm our original observation.

Topics: Bosentan; Cardiovascular Agents; Drug Therapy, Combination; Endothelin Receptor Antagonists; Female; Humans; Middle Aged; Peripheral Arterial Disease; Phosphodiesterase 5 Inhibitors; Scleroderma, Systemic; Sildenafil Citrate; Sulfonamides

To investigate whether administering cilostazol after treatment for femoropopliteal in-stent restenosis (ISR) can have a positive impact on recurrent ISR (Re-ISR).. The database of a multicenter, retrospective, observational registry was interrogated to identify 338 consecutive patients (mean age 72.3±8.8 years; 148 men) who underwent endovascular therapy for femoropopliteal ISR in 379 limbs from January 2010 to December 2014. Ninety-seven patients (103 limbs) who received cilostazol after the initial stent implantation procedure were excluded. This left 24 ISR patients (30 limbs) who received cilostazol initially after ISR treatment for comparison with 217 ISR patients (246 limbs) who did not receive the drug. The primary endpoint was 2-year Re-ISR after treatment. The secondary endpoints were recurrent target lesion revascularization (Re-TLR) and reocclusion at 2 years. Restenosis was determined by a peak systolic velocity ratio >2.4 on a duplex scan or >50% stenosis on angiography.. The mean follow-up was 23.3±15.5 months. At 2 years, freedom from Re-ISR was significantly higher in the cilostazol group than in the no cilostazol group (48.6% vs 32.4%, p=0.047). However, freedom from Re-TLR and reocclusion between the 2 groups did not differ significantly [64.7% vs 53.8% (p=0.15) and 88.3% vs 73.9% (p=0.11), respectively]. After adjusting for prespecified risk factors, cilostazol administration was a negative predictor of Re-ISR.. This small comparative study suggests that administering cilostazol for ISR lesions after femoropopliteal stenting reduces recurrent ISR.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Cilostazol; Databases, Factual; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Registries; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Critical limb ischemia (CLI) is a feared complication of peripheral vascular disease that often requires surgical management and may require amputation of the affected limb. We developed a decision model to inform clinical management for a 63-year-old woman with CLI and multiple medical comorbidities, including advanced heart failure and diabetes.. We developed a Markov decision model to evaluate 4 strategies: amputation, surgical bypass, endovascular therapy (e.g. stent or revascularization), and medical management. We measured the impact of parameter uncertainty using 1-way, 2-way, and multiway sensitivity analyses.. In the base case, endovascular therapy yielded similar discounted quality-adjusted life months (26.50 QALMs) compared with surgical bypass (26.34 QALMs). Both endovascular and surgical therapies were superior to amputation (18.83 QALMs) and medical management (11.08 QALMs). This finding was robust to a wide range of periprocedural mortality weights and was most sensitive to long-term mortality associated with endovascular and surgical therapies. Utility weights were not stratified by patient comorbidities; nonetheless, our conclusion was robust to a range of utility weight values.. For a patient with CLI, endovascular therapy and surgical bypass provided comparable clinical outcomes. However, this finding was sensitive to long-term mortality rates associated with each procedure. Both endovascular and surgical therapies were superior to amputation or medical management in a range of scenarios.

Topics: Amputation, Surgical; Cardiovascular Agents; Clinical Decision-Making; Comorbidity; Computer Simulation; Critical Illness; Decision Support Techniques; Decision Trees; Endovascular Procedures; Female; Humans; Ischemia; Markov Chains; Middle Aged; Peripheral Arterial Disease; Predictive Value of Tests; Quality-Adjusted Life Years; Retreatment; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Grafting

The objective was to compare 2 year outcomes in patients treated with or without predilatation prior to drug coated balloon (DCB) angioplasty for symptomatic femoropopliteal lesions.. This prospective multicentre pilot study was conducted at three sites in Germany. It compared claudicants undergoing predilatation with a bare percutaneous transluminal angioplasty (PTA) balloon before DCB (predilatation group) with patients undergoing direct DCB (direct DCB group). Patients were followed for 2 years. Outcomes included late lumen loss at 6 months, and ankle brachial index (ABI), major adverse events, and primary patency at 2 years. A Clinical Events Committee and core laboratories analysed adverse events and angiographic/duplex images, respectively.. Between December 2011 and November 2012, 50 patients were enrolled to the predilatation group (12% total occlusions) and 28 to the direct DCB group (5% total occlusions). Follow-up compliance at the 2 year visit was 88% (n = 44) and 86% (n = 24), respectively. Late lumen loss at 6 months was lower in the direct DCB group (0.03 ± 0.68 mm vs. 0.54 ± 0.97 mm; p = .01). Major adverse events over 2 years occurred in seven (15%) patients who underwent predilatation and in five (19%) after direct DCB. Mean ABI at 2 years was 0.94 ± 0.15 after predilatation and 1.0 ± 0.12 after direct DCB. Over 2 years, primary patency (80.3% vs. 78.2%; p = .55) was not statistically different between the groups. After propensity score adjustments, 2 year findings remained unchanged.. Paclitaxel coated PTA, with or without bare predilatation, is effective over 2 years in symptomatic patients with femoropopliteal stenotic lesions. Adequately powered randomised controlled comparisons are required to confirm these preliminary results.

Topics: Aged; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Germany; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Pilot Projects; Popliteal Artery; Propensity Score; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The Global SFA Registry sought to assess safety, clinical benefit, and outcomes of the Lutonix 035 drug-coated balloon (DCB) in a heterogeneous, real-world patient population at 12 and 24 months.. Numerous clinical studies have evaluated the use of angioplasty for revascularization of femoropopliteal arteries in peripheral arterial disease with restenosis rates of 40% to 60% at 6 to 12 months. Data from recent studies document decreased restenosis rates and improvement in patency in patients receiving angioplasty of femoropopliteal arteries with DCBs.. The multicenter, prospective study enrolled 691 patients in 38 centers from 10 countries treated with the Lutonix 035 DCB in femoropopliteal lesions. The primary safety endpoint was freedom from a composite of target vessel restenosis, major index limb amputation, and device- or procedure-related death at 30 days. The primary effectiveness endpoint was freedom from target lesion restenosis at 12 months. Secondary endpoints were acute device and procedural success and clinically assessed primary patency.. Freedom at 30 days from the composite safety endpoint was 99.4%. Freedom from target lesion restenosis was 93.4%/89.3% for the overall population, 93.2%/88.2% for long lesions up to 500 mm, and 90.7%/84.6% for in-stent restenosis at 12/24 months. Clinically assessed primary patency by Kaplan-Meier estimates was 85.4%/75.6% at 12/24 months. More than 76% of patients showed improvement of at least 1 Rutherford category.. The Global SFA Registry 24-month outcomes confirm the Lutonix 035 DCB is a safe and effective long-term treatment option in real-world patients with peripheral arterial disease with superficial femoral artery lesions, also in long lesions and in-stent restenosis. (Lutonix Global SFA Registry; NCT01864278).

Topics: Adult; Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Disease-Free Survival; Equipment Design; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Recurrence; Registries; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

To evaluate the safety and efficacy of a one-time infusion of paclitaxel through an Atrium ClearWay balloon in infra inguinal de novo peripheral lesions.. This is a single-center prospective study looking at treatment of 50 limbs. Treatment includes standard infra inguinal endovascular revascularization followed by a pre-prescribed infusion of paclitaxel. Control is standard reintervention without subsequent paclitaxel infusion. Patients were followed at one, four, and 10 months with ankle-brachial index (ABI)s, arterial duplex of the treated limb, and Rutherford classification stage measured before and after procedures and at each follow-up. Freedom from binary restenosis was tracked with duplex ultrasound, and freedom from target lesion revascularization (TLR) was also tracked in the treatment group. Binary restenosis and TLR data was harvested from the patient record for the control group.. Average ABI and Rutherford classification stage improved as expected. The treatment group had a freedom from TLR rate of 86 percent and a freedom from binary restenosis rate of 80 percent at 10 months. Average ABI improved from 0.65 at baseline to 0.94 at 10 months in the treatment group. The control group had a 72 percent freedom from TLR and a 58 percent freedom from binary restenosis at 10 months. Average ABI of the control group improved from 0.67 at baseline to 0.85 at 10 months in the control group. There were no amputations, open bypass revascularizations, or hypersensitivity reactions observed in the treatment group.. Infusion of paclitaxel in de novo lesions appears to be a safe and efficacious treatment in the peripheral vasculature when compared to a historical control group. While it is early, it appears that the patients do receive some benefit from this one time infusion, and this approach should be studied further.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Case-Control Studies; Humans; Lower Extremity; Paclitaxel; Peripheral Arterial Disease; Pilot Projects; Prospective Studies

This study sought to evaluate the safety and effectiveness of a paclitaxel-coated drug-coated balloon (DCB) for the treatment of patients with de novo in-stent restenosis (ISR).. Treatment of patients with ISR remains a challenge. Current strategies are plagued by high rates of recurrent restenosis and need for reintervention. The best intervention for ISR remains to be elucidated.. The IN.PACT Global study is an independently adjudicated multicenter, prospective, single-arm study that enrolled 1,535 subjects with symptomatic atherosclerotic disease of the superficial femoral and/or popliteal arteries, including de novo ISR lesions. Patients enrolled in the pre-specified ISR imaging cohort were evaluated for vessel patency and reintervention within the 12-month follow-up period.. A total of 131 subjects with 149 ISR lesions were included for analysis. The mean age of the cohort was 67.8 years. Mean lesion length was 17.17 ± 10.47 cm, including 34.0% total occlusions and 59.1% calcified lesions. The 12-month Kaplan-Meier estimate of primary patency was 88.7%. The rate of clinically driven target lesion revascularization (CD TLR) at 12 months was 7.3%. The primary safety outcome, a composite of freedom from device- and procedure-related mortality through 30 days and freedom from major target limb amputation and CD TLR within 12 months, was 92.7%. There were no major target limb amputations, no deaths, and a low (0.8%) thrombosis rate.. Results from the ISR imaging cohort demonstrate high patency and a low rate of CD TLR at 12 months. These data confirm the safety and effectiveness of the IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) in complex femoropopliteal lesions, including this challenging subset.

Topics: Aged; Amputation, Surgical; Angiography; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Recurrence; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices; Vascular Patency

Prospective single-arm study, aimed at evaluating safety and effectiveness at 12 and 24 months of the paclitaxel-eluting nitinol stent (Zilver PTX), and focused in particular on the treatment of complex lesions and/or diabetic patients.. Between May 2010 and March 2012, 67 patients (78% males) were treated by Zilver PTX, because of stenosis or occlusions of the superficial femoral artery in one of two centers. The mean age of patients was 70.1±8 years. Thirty-two of 67 (48%) were diabetics, 14 (21%) active smokers and 11 (14.6%) had chronic renal failure (end stage renal disease). The average length of lesions was 104±60 mm. Occlusion was complete in 46.3% of cases, whereas severely calcified lesions were present in 30% of patients (18.8% in diabetics and 31.4% in non-diabetics). Twenty-six patients (39%) had type C or D lesions according to TASC 2.. One hundred-two stents were used (1.7±0.9 per patients); median 1 (range 1-4). All patients had successful stent placement. Primary patency, evaluated by Kaplan-Meier method was 88±0.06% at 12 months, and 68±0.1% at 24 months. In particular, the difference between diabetics (D) and non-diabetics (non-D) was not significant (P=0.07, Log-Rank). Patients turned from 4.2±1.3 to 1.6±1.3 Rutherford class. There were 5 deaths due to systemic comorbidities. There also were 3 major amputations, all of them also in the D group. Among the other patients, differences between D and non-D patients were not significant in terms of wound healing, bipedal stay and spontaneous ambulation. The mean follow-up length was 28±5 months (range 24-36 months). There was only one patient who had fracture and stent migration (1.5%). In 13 diabetic patients, tibial PTA was also associated. Additional treatment was required in 6 D and 1 non-D.. The use of Zilver PTX is safe and effective in the treatment of SFA lesions. In particular, both stent patency and functional results on the basis of both clinical and instrumental tools were similar in D and non-D, suggesting a particularly favorable activity of PTX in a subpopulation of diabetics. Further studies are required to confirm these results, which seem to be particularly promising in diabetic patients.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Cardiovascular Agents; Diabetic Angiopathies; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Italy; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Retreatment; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

Tobacco smoking after lower extremity revascularization for claudication has repeatedly been shown to increase the risk of adverse events, such that many vascular specialists consider that refusal to abstain from smoking constitutes a major contraindication to open surgical bypass or endovascular intervention.. A Markov decision analysis (DA) model was used to compare the options of direct revascularization vs medical therapy only in smokers with claudication. The primary outcome was calculated quality of life (cQoL), determined for each patient at follow-up based on the outcomes of the treatment received. Markov DA software was used to predict the QoL for each treatment option preoperatively based on smoking status.. Among patients referred during a recent 64-month period with vasculogenic claudication, 94 were actively smoking compared with 217 who were not. The DA model predicted that if the patients who smoked were to discontinue smoking, the best therapy would be bypass surgery for 77% and endovascular intervention for 17%. However, despite at least doubling the risks with intervention in the patients who continue to smoke, the DA model still predicted that 78% and 9% would fare better with open surgical or endovascular intervention, respectively. Among actively smoking patients, open surgical (3%) or endovascular (4%) therapies were initially performed in few patients, whereas 93% were offered only medical therapy. Among initial nonsmokers, revascularization was performed by open (27%) or endovascular (42%) means. At 3 years, the median (interquartile range [IQR]) cQoL was lower in initial smokers than in nonsmokers (0.73 [IQR, 0.73-0.77] vs 0.82 [IQR, 0.75-0.86]; P < .0001), primarily because of a lack of revascularization for smokers. Among initial smokers who did undergo revascularization initially, because of progression of symptoms, or after smoking cessation, cQoL was similar to initial nonsmokers (0.77 [IQR, 0.73-0.84] vs 0.73 [IQR, 0.73-0.73]; P = .37). Although 26% of initial smokers had stopped by the time of their last follow-up, 10% of initially nonsmoking patients were smoking at follow-up. However, among all patients undergoing intervention, the cQoL of patients smoking at the time of last their follow-up was similar to nonsmokers (0.82 [IQR, 0.82-0.86] vs 0.83 [IQR, 0.73-0.86]; P = .99).. Patients with claudication who smoke may be denied the symptom improvement associated with revascularization, yet recidivism for smoking also occurs among patients who have stopped smoking in order to receive revascularization. The strategy not to directly revascularize patients with claudication who continue to smoke does not appear to maximize patient midterm QoL.

Topics: Aged; Cardiovascular Agents; Decision Support Techniques; Endovascular Procedures; Female; Humans; Intermittent Claudication; Male; Markov Chains; Middle Aged; Patient Selection; Peripheral Arterial Disease; Quality of Life; Retrospective Studies; Risk Assessment; Risk Factors; Smoking; Smoking Cessation; Smoking Prevention; Time Factors; Treatment Failure; Vascular Surgical Procedures

Intermittent claudication has a major impact on the quality of life and functional ability of the patient. However, when treating these patients, management is largely influenced by vascular surgeons' perceptions of risk. There is little information available regarding the level of risk that patients perceive to be acceptable, when considering complications of treatment. This study investigates patients' acceptance of risk associated with current management options for intermittent claudication and explores factors associated with greater risk acceptance.. Patients with confirmed intermittent claudication presenting to vascular clinic and supervised exercise classes were surveyed in a single-center prospective study. A standard gamble-type method was used to measure patients' acceptance of risk associated with medical treatment, angioplasty, and surgical bypass. Level of risk acceptance was correlated to patient factors.. Fifty patients were surveyed; 74% were male, median age was 68 years (interquartile range [IQR] 59-74), maximal walking distance was 100 m (IQR 70-200), and ankle-brachial pressure index was 0.65 (IQR 0.60-0.78). Median risk acceptance for treatment failure was 70% for medical treatment, 50% for angioplasty, and 40% for surgical bypass. Median risk acceptance for major amputation and death was 0% for all 3 management options. Claudicants with maximal walking distance <100 m accepted higher risk of treatment failure (P = 0.0005 for medical treatment, P = 0.0038 for angioplasty), and death with medical treatment (P = 0.0009). There was no significance between claudication distance and risk acceptance of major amputation with any treatment modality or death with angioplasty or surgical bypass. There was no significant correlation among level of risk acceptance and age, gender, or diabetic status.. Claudicants are prepared to accept significant risk of treatment failure, in order to gain benefit, but regardless of claudication distance, patients have low acceptance of the risk of amputation or death. Patient acceptance of risk should be considered when planning management.

Topics: Aged; Amputation, Surgical; Cardiovascular Agents; Endovascular Procedures; England; Female; Health Knowledge, Attitudes, Practice; Humans; Intermittent Claudication; Limb Salvage; Male; Middle Aged; Patients; Perception; Peripheral Arterial Disease; Pilot Projects; Prospective Studies; Risk Assessment; Risk Factors; Treatment Failure; Vascular Surgical Procedures

All patients with lower extremity peripheral arterial disease (LE-PAD) should benefit from recommended pharmacologic therapies including antiplatelet agents, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers (ARBs), and hydroxy-methyl-glutaryl-coenzyme A reductase inhibitors (statins). In the present study, this triple therapy was defined as the best medical treatment. This study was designed to determine the number of patients who received best medical treatment at admission and at discharge from a vascular surgery department. We also examined the number of patients who received adapted medical treatment and every pharmacologic class separately. Finally, we investigated whether there were differences in prescribing rates according to patient characteristics and cardiovascular history, clinical grade of LE-PAD, and the type of surgery practiced.. This study is a retrospective chart analysis of 140 consecutive patients admitted to the vascular surgery department of our university hospital, between January 1, 2013, and June 30, 2013. To be included, patients required a vascular surgery for peripheral arterial disease with atherosclerosis. Data from guideline-recommended classes of medications (antiplatelet agents, ACE, ARBs, and statins) at the time of admission and discharge were collected and compared.. Best medical treatment was prescribed in 44% patients before hospital admission and in 50% at discharge (P = 0.10). Before hospital admission, 84% of patients had antiplatelet therapy compared with 96% at discharge (P = 0.0004); 73% had a statin, compared with 83% at discharge (P = 0.001); 64% had an ACE inhibitor or ARB, compared with 63% at the time of discharge (P = 1).The proportion of patients receiving best medical treatment at admission and discharge increased in case of coronary artery disease (P = 0.004). There was no difference in prescriptions of best medical treatment and best or adapted treatments at admission and discharge according to the severity of LE-PAD or type of revascularization.. Admission to a vascular department significantly increased the rate of prescription of antiplatelet and statin therapy, but no significant improvement was achieved for the prescription of best medical treatment and best or adapted treatments.

Topics: Aged; Aged, 80 and over; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Delivery of Health Care; Drug Prescriptions; Drug Therapy, Combination; Drug Utilization Review; Female; Hospitals, University; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Lower Extremity; Male; Middle Aged; Patient Admission; Patient Discharge; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Practice Patterns, Physicians'; Quality Improvement; Quality Indicators, Health Care; Retrospective Studies; Severity of Illness Index; Specialization; Surgery Department, Hospital; Treatment Outcome

Peripheral arterial disease (PAD) is highly prevalent in general population. Data on the prevalence of symptomatic PAD in patients with atrial fibrillation (AF) are limited, and the impact of PAD on adverse outcomes in AF patients is controversial. Our aims were: (i) to define the prevalence of symptomatic PAD in European AF patients and describe its associated clinical risk factors and (ii) to establish the relationship of PAD to adverse events in AF, especially all-cause death.. Atrial fibrillation patients enrolled in the EORP-AF Pilot study with data about PAD status were included in this analysis. Event rates were determined at 1-year follow-up. Peripheral arterial disease was recorded in 328 (11%) patients. Age (P < 0.0001), hypertension (P = 0.0059), diabetes mellitus (P = 0.0001), chronic heart failure (P < 0.0001), previous stroke/transient ischaemic attack (P = 0.0060), and antiplatelet drug treatment (P = 0.0001) were associated with the presence of PAD, while female gender was inversely associated (P = 0.0002). Peripheral arterial disease patients had higher absolute rates of both cardiovascular (CV) and all-cause death (both P < 0.0001). On Kaplan-Meier analysis, risk of all-cause death was higher in PAD patients compared with those without PAD (P < 0.0001), but PAD did not emerge as an independent risk factor for mortality on Cox regression analysis. A lower risk of all-cause death was associated with the prescription of statins (P = 0.0019), angiotensin-converting enzyme inhibitors (P = 0.0008), and calcium-channel blockers (P = 0.0071).. Peripheral arterial disease is prevalent in 11% of AF patients and related to various atherosclerotic risk factors. Even if PAD is associated with higher risk of all-cause death on univariate analysis, this risk was significantly lowered and was no longer evident after adjusting for the use of CV prevention drugs.

Topics: Aged; Aged, 80 and over; Atrial Fibrillation; Cardiovascular Agents; Cause of Death; Chi-Square Distribution; Europe; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Peripheral Arterial Disease; Pilot Projects; Prevalence; Prognosis; Proportional Hazards Models; Prospective Studies; Registries; Risk Assessment; Risk Factors; Time Factors

To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery.. Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR).. The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99).. In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively.

Topics: Aged; Aged, 80 and over; Aneurysm; Angiography; Angioplasty, Balloon; Anticoagulants; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Female; Germany; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Popliteal Artery; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

We describe a case of an acute hypersensitivity reaction to a paclitaxel-coated balloon used in the peripheral arterial circulation. Clinicians using these products should be aware of this potential risk.

Topics: Acute Disease; Aged; Amputation, Surgical; Anaphylaxis; Angiography; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug Hypersensitivity; Femoral Artery; Humans; Male; Paclitaxel; Peripheral Arterial Disease; Treatment Outcome; Vascular Access Devices

Critical limb ischemia (CLI), despite revascularization, may result in minor or major amputations with devastating psychological effects and a negative impact on patient survival. Randomized clinical trials demonstrated that drug-eluting stents improve 1-year primary patency and decrease target lesion revascularization, compared to standard angioplasty and bare-metal stents, in patients with short occlusive below-the-knee lesions.. This prospective clinical study was designed to evaluate if one straight-line flow revascularization to the foot, using Xience-Prime Everolimus-Eluting Stent (EES), is an effective treatment of patients in Rutherford-Becker category 4 to 5 with distal popliteal and proximal tibial arteries long occlusive lesions up to 10 cm.. All patients with angiographic documented segment P3 of popliteal artery and proximal tibial arteries stenosis >70%, and lesion length between 20 mm and 100 mm, meeting the inclusion criteria, were included in the Etna Registry. The end points assessed were 1- and 3-year primary patency, major amputation-free survival, target lesion revascularization, and wound healing rates.. Between June 2011 and April 2014, 122 patients were included in the study, with mean lesion length of 52.7 mm (range: 20-100 mm). The 1- and 3-year primary patency rates were 88.9% and 80.1%, respectively. The survival, major amputation-free survival, and target lesion revascularization rates were 88.1%, 93%, and 91.5% at 1-year and 70.4%, 89.3%, and 85.1% at 3-year follow-up, respectively. Primary patency influenced major amputation rate, which was 60% in patients with no target artery patency versus 5.4% in patients with patency ( P = .022). At 1-year follow-up, 78 (88.6%) of 88 patients improved 1 or more of their Rutherford-Becker category, and 48 (80%) of 69 patients had wound healing.. The results of our study suggest that a conservative approach, with EES, seems feasible in selected patients with CLI and infrapopliteal artery occlusive disease.

Topics: Adult; Aged; Aged, 80 and over; Amputation, Surgical; Angiography; Angioplasty, Balloon; Cardiovascular Agents; Constriction, Pathologic; Critical Illness; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Female; Humans; Ischemia; Italy; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Registries; Risk Factors; Tibial Arteries; Time Factors; Treatment Outcome; Vascular Patency; Wound Healing

Drug-eluting stents (DES) are now considered the most promising device to treat peripheral artery disease (PAD) and minimize restenosis. There is uncertainty however on the best antirestenotic drug for such devices. In particular, biolimus (i.e. umirolimus) and everolimus are two of the most promising agents, given the extensive data in support of their coronary safety and efficacy, but their comparative effectiveness for peripheral interventions is not established.. Building upon our extensive experience in the percutaneous treatment of infra-inguinal artery disease with DES, we compared the acute and longterm outlook of patients treated with biolimus-eluting stents (BES) and everolimus-eluting stents (EES). We collected baseline, procedural and outcome details on all patients undergoing infra-inguinal BES or EES implantation. The endpoints of interest were death, amputation, revascularization, their composite, and change in Fontaine class. A total of 80 patients were included (20 treated with BES and 60 with EES). Most features were similar in the two groups, despite longer lesions in the EES group. Unadjusted analysis showed similar results irrespective of the drug used, with composite endpoint occurring, respectively, in 4 (20.0%) and 10 (16.7%) (p=0.741).. However, analysis with inverse probability of treatment weighting showed significant differences in the risk of revascularization (hazard ratio of BES vs EES=9.55 [95% confidence interval 2.16-42.23], p=0.003) and composite endpoint (hazard ratio=5.11 [1.33-19.62], p=0.018). In conclusion, EES appear superior to BES for endovascular therapy of infrainguinal artery disease. Dedicated randomized trials are required to definitely confirm or disprove these findings.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Cardiovascular Agents; Comparative Effectiveness Research; Drug-Eluting Stents; Endovascular Procedures; Everolimus; Female; Humans; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

The study aims to compare outcomes of primary stenting of long femoropopliteal (FP) lesions with bare metal stent (BMS) versus paclitaxel eluting stent (PES).. In a single centre study, we established 2 consecutive and prospective cohorts with TASC C/D FP de novo lesions. The inclusion and exclusion criteria were similar. Bare metal stent (LifeStent. In total, 110 limbs were treated (STELLA: n = 62; STELLA PTX: n = 48). We noted some difference between both cohorts regarding type 2 diabetes (P = 0.05), vitamin K antagonist use (P = 0.05), and angiotensin II receptor blocker use (P = 0.002). More stents were implanted in the STELLA PTX cohort (P < 0.0013). At 12 months, in univariate analysis, freedom from target lesion revascularization (TLR) was higher in the STELLA cohort (P = 0.005). No differences were found between both cohorts in terms of primary sustained clinical improvement (P = 0.25), primary patency (P = 0.07), and survival (P = 0.79). With the propensity score, no difference was observed in terms of primary sustained clinical improvement (P = 0.79), freedom from TLR (P = 0.59), and primary patency (P = 0.69). With Cox logistic regression, the number of implanted stents influenced the primary sustained clinical improvement, the freedom from TLR, and the primary patency.. Paclitaxel-eluting stents do not seem to provide benefits in terms of clinical and morphological outcomes for TASC C/D lesions compared to BMS.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Chi-Square Distribution; Disease-Free Survival; Drug-Eluting Stents; Female; Femoral Artery; France; Humans; Intention to Treat Analysis; Kaplan-Meier Estimate; Logistic Models; Male; Matched-Pair Analysis; Metals; Middle Aged; Multivariate Analysis; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Propensity Score; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

The purpose of this study was to evaluate the efficacy of Zilver PTX, the first drug-eluting stent, in patients with complex femoropopliteal (FP) artery disease. Between July 2012 and March 2013, 60 consecutive patients (39 males; mean age: 72.5 ± 8.6 years) with complex risk factors including TASC II C/D lesions, in-stent restenosis (ISR) and/or on haemodialysis underwent successful Zilver PTX implantation for symptomatic FP artery disease. The primary outcome was primary patency, which was defined as freedom from restenosis at 12 months, as verified by duplex ultrasound. Secondary outcomes included the technical success rate, the freedom from target lesion revascularisation (TLR) rate and the amputation-free survival (AFS) rate. The average follow-up period was 13.2 ± 5.3 months. 62 % of the patients had TASC II C/D lesions, 35.0 % experienced ISR, and 41.6 % were on haemodialysis. The mean lesion length was 188 ± 96 mm. The technical success rate was 98.3 %. The primary patency rate was 50.2 %, the freedom from clinically driven TLR rate was 68.6 %, and the AFS rate was 83.2 % at 12 months. In conclusion, Zilver PTX stent implantation for complex FP artery disease did not affect long-term durability.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Peripheral arterial disease (PAD) and chronic kidney disease (CKD) are associated with increased mortality rates. We assessed long-term outcomes of patients with PAD and CKD. Patients with PAD undergoing invasive angiography and/or endovascular revascularization between 2005 and 2010 were retrospectively classified into 5 CKD stages. A follow-up was performed and 572 patients were included, 116 patients (20%) had normal renal function, 245 were in CKD stage 2 (43%), 156 in CKD stage 3 (27%), and 55 in CKD stages 4 + 5 (10%). Diabetes mellitus, hypertension, and anemia were more frequent in higher CKD stages (P < .03). During follow-up (mean 1135 days; 95% confidence interval 1159-1259), cumulative mortality was 21% and increased with advanced CKD stages (9%, 16%, 29%, and 47%, respectively, P < .001). In multivariate Cox regression models, higher CKD stages were significantly associated with poor survival. Medication adherence for secondary prevention was significantly lower than recommended but irrespective of CKD stages. Kidney function is an independent predictor of worse long-term survival in patients with PAD. While standard medications were used less often than recommended, no differences between CKD stages were noted.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Chi-Square Distribution; Comorbidity; Endovascular Procedures; Female; Glomerular Filtration Rate; Humans; Kidney; Male; Medication Adherence; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Proportional Hazards Models; Renal Insufficiency, Chronic; Retrospective Studies; Risk Factors; Secondary Prevention; Severity of Illness Index; Time Factors; Treatment Outcome

The aim of this study was to assess the long-term, all-cause mortality among PAD patients hospitalized for invasive diagnostics and/or endovascular revascularization (ER) and the applied secondary prevention management.. From 2005 to 2009, at our center 582 consecutive patients underwent invasive peripheral angiography in part in combination with coronary angiography and/or ER. Patients were classified according to their Fontaine stage into 3 subgroups: Fontaine I/IIa, Fontaine IIb, and Fontaine stages III and IV (which were classified as critical limb ischemia, CLI). Demographic and clinical data were retrospectively obtained and patients followed up.. Mean age increased with higher Fontaine stages (P=0.009). The proportion of patients with diabetes and anemia was lowest in Fontaine stage IIb and highest in CLI (each p<0.001). The cumulative all-cause mortality during follow-up was 17% in Fontaine stage I/IIa, 22% in Fontaine stage IIb and 34% in CLI, respectively (P<0.001). In multivariate cox regression models including diabetes mellitus, gender, age, creatinine and baseline hemoglobin, patients with Fontaine stage IIb had a 1.4-fold (95%CI 0.60-3.16) and those with CLI a 2.3-fold (95%CI 1.03-5.08) increased mortality compared to Fontaine stage I/IIa. At baseline, patients with CLI received significantly less beta blocker, statins, ACE or AT1 inhibitors and less anticoagulants; at follow-up only statins were significantly less often prescribed to CLI patients (all p<0.05). Univariate analyses showed that a therapy with statins (HR 0.64; CI 0.43-0.96; P=0.03) and antiplatelet/anticoagulant agents (HR 0.5; CI 0.27-0.94; P=0.03) significantly reduced mortality.. Long-term mortality in CLI patients doubles the rate in patients with Fontaine stage I/IIa. Non-adherence to evidence-based recommendations and guidelines such as inadequate use of cardioprotective drugs might contribute to the observed high mortality rates in patients with CLI.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Critical Illness; Diabetic Angiopathies; Endovascular Procedures; Female; Germany; Guideline Adherence; Humans; Ischemia; Male; Multivariate Analysis; Peripheral Arterial Disease; Practice Guidelines as Topic; Predictive Value of Tests; Proportional Hazards Models; Retrospective Studies; Risk Factors; Secondary Prevention; Time Factors; Treatment Outcome

The aim of this study was to compare the clinical and hemodynamic outcomes of plain vs paclitaxel-coated percutaneous transluminal angioplasty (PTA) in patients with infrainguinal vein bypass stenosis.. A single-center retrospective analysis was conducted of consecutive patients treated by infrainguinal bypass PTA. Primary study end points were primary and assisted primary patency. Secondary end points were clinical and hemodynamic improvement, limb salvage, and survival. Society for Vascular Surgery reporting standards were applied.. From April 2008 to November 2014, 83 infrainguinal vein bypasses were treated for graft stenosis by plain (group A, n = 41) or by paclitaxel-coated PTA (group B, n = 42). The groups did not differ significantly in mean age (71.9 years for both groups; P = .99), hypertension (P = 1.0), hyperlipidemia (P = .5), diabetes (P = .6), coronary artery disease (P = 1.0), smoking (P = 1.0), preoperative ankle-brachial index (P = .08), or bypass characteristics (below-knee, P = .82). Technical success rate was 100% for both groups. Mean follow-up was 2.9 years for group A patients and 2.2 years for group B patients (P = .08). No patient was lost to follow-up. Primary patency rates were 88% vs 87% and 73% vs 75% (P = .19) and assisted primary patency rates were 88% vs 90% and 77% vs 84% (P = .76) for group A and B patients at 1 and 2 years, respectively. Repeat target lesion revascularization rates were 22% vs 14% (P = .17). At the last follow-up, there were eight vs seven bypass occlusions (P = .74) for group A and B patients, respectively. In univariate analysis, proximal in-graft stenosis (Cox F, P = .041), bypass failure <6 months after bypass surgery (Cox F, P = .013), more than one bypass stenosis per graft (Cox F, P = .047), and redo bypass procedure (Cox F, P = .0001) were significantly related to assisted primary bypass patency. Immediate hemodynamic and sustained clinical improvement rates were 88% vs 86% and 70% vs 73% for group A and B patients, respectively. There were three vs one major amputations (P = .36) and eight vs seven deaths (P = .78) in group A and B patients, respectively.. Paclitaxel-coated and plain angioplasty of significant infrainguinal vein bypass stenoses performed equally well in clinical and hemodynamic improvement and in primary and assisted primary bypass patency rates.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Austria; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Proportional Hazards Models; Reoperation; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency; Veins

To report the 3-year safety and effectiveness outcomes from the prospective all-comers DEBATE-ISR study (ClinicalTrials.gov identifier NCT01558531) of symptomatic diabetic patients with femoropopliteal in-stent restenosis (ISR) undergoing treatment with paclitaxel-eluting balloons compared with historical diabetic controls.. From January 2010 to December 2011, 44 consecutive diabetic patients (mean age 74±11 years; 32 men) were treated with drug-eluting balloons (DEBs) and enrolled in the study. The control group comprised 42 consecutive diabetic patients (age 76±7 years; 23 men) treated with conventional balloon angioplasty (BA) from 2008 to 2009.. No significant differences in terms of clinical, angiographic, or procedural characteristics were observed between the study groups. Critical limb ischemia was present in the majority of patients. Tosaka class III ISR was observed in more than half of the patients. Mean lesion length was 132±86 and 137±82 mm in the DEB and BA groups, respectively (p=0.7). At 3-year follow-up, the rate of target lesion revascularization (TLR) was 40% in the DEB group vs 43% in the BA group (p=0.8); Kaplan-Meier analysis showed no significant differences in terms of freedom from TLR. The presence of a Tosaka class III occlusion was associated with a worse outcome in both study groups (odds ratio 3.96, 95% confidence interval 1.55 to 10.1, p=0.004).. Using DEBs for femoropopliteal ISR yielded similar results to BA in terms of TLR at 3-year follow-up. The treatment of more complex ISR lesions was associated with an increased rate of TLR, irrespective of the technology used.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Chi-Square Distribution; Constriction, Pathologic; Critical Illness; Diabetic Angiopathies; Drug-Eluting Stents; Female; Femoral Artery; Historically Controlled Study; Humans; Ischemia; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Registries; Retreatment; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

To evaluate the safety and efficacy of the Igaki-Tamai biodegradable scaffold after drug-eluting balloon (DEB) angioplasty in patients with occlusive superficial femoral artery (SFA) disease.. A prospective, single-center, nonrandomized study enrolled 20 patients (mean age 66.7±11.6 years; 14 men) with symptomatic de novo SFA lesions undergoing angioplasty with the In.Pact Admiral paclitaxel-coated balloon and subsequent implantation of the Igaki-Tamai bioresorbable scaffold. All patients were claudicants. The average diameter stenosis was 89.7%, and the mean length was 43.6 mm. Clinical examinations with duplex sonography were performed after 1, 6, 9, and 12 months. The main study outcomes were technical success, restenosis, target lesion revascularization (TLR), ankle-brachial index (ABI) improvement, and changes in quality of life evaluated with the walking impairment questionnaire. Safety was assessed by monitoring the occurrence of adverse events.. Angioplasty with a paclitaxel-coated balloon was performed in all patients, resulting in an average diameter stenosis of 24%. Subsequent implantation of the Igaki-Tamai scaffold reduced the average diameter stenosis to 3.5%. In the first 6 months, 2 cases of restenosis were reported, with no TLRs within that period. However, by the 12-month follow-up in 19 patients, 11 patients had lost in-stent patency. Among these patients, 8 had TLRs, which were the only adverse events recorded that were referable to the procedure. Quality-of-life assessments showed improvement in the majority of patients.. The GAIA-DEB study shows that DEB treatment of the femoral artery prior to the implantation of the biodegradable Igaki-Tamai scaffold is safe. However, the antiproliferative actions of paclitaxel in the vessel wall were not effective in preventing restenosis. In-stent restenosis occurred predominantly after 6 months.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Germany; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Pilot Projects; Prospective Studies; Recurrence; Retreatment; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices; Vascular Patency

Restenosis remains the primary failure mode after stent placement in the superficial femoral artery (SFA). Drug-eluting technology aims to reduce intimal hyperplasia and subsequent stent failure, improving durability for endovascular management of SFA occlusive disease. We present our early experience with the Cook Zilver PTX stent.. We retrospectively reviewed a prospectively collected database of patients undergoing placement of the Cook Zilver PTX stent for SFA or popliteal disease since its availability to our institution in October 2013. Patients treated with additional non-PTX stents were excluded. Patient demographics, comorbidities, concomitant procedures, TASC classification, procedural details, and follow-up were reviewed.. Thirty-one limbs in 30 patients were treated with Zilver PTX stents, 5 limbs were excluded for concomitant use of non-PTX stents, leaving 26 limbs in 26 patients for analysis. Indications for intervention were claudication in 17 (65.4%), rest pain in 1 (3.8%), and tissue loss in 8 (30.8%). A median of 2 PTX stents per limb was used to treat a mean length of 14.2 ± 11 cm with technical success of 100%. Concomitant inflow (N = 4) or atherectomy (N = 2) interventions were performed in 23%. Sixty-nine percent of lesions were TASC C (N = 7) or D (N = 11) and 42% were total occlusions. Over a mean 20-week follow-up, 2 occlusions were noted (mean 27 weeks), one was treated with surgical bypass and the other with endovascular salvage. Limb salvage in the series was 92.3% with 2 patients requiring major amputations for infected, non-healing wounds, despite patent stents.. On mean 20-week follow-up, we have seen 92.3% primary patency and 96.2% secondary patency. A larger number of patients and longer follow-up will be required to determine the true real-world efficacy of this drug-eluting device, but early experience is encouraging and warrants continued trial.

Topics: Aged; Amputation, Surgical; Cardiovascular Agents; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Recurrence; Registries; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

To identify intravascular ultrasound (IVUS) measurements that can predict angiographic in-stent restenosis (ISR) following nitinol stent implantation in superficial femoral artery (SFA) lesions.. A retrospective review was conducted of 97 patients (mean age 72.9±8.9 years; 63 men) who underwent IVUS examination during endovascular treatment of 112 de novo SFA lesions between July 2012 and December 2014. Self-expanding bare stents were implanted in 46 lesions and paclitaxel-eluting stents in 39 lesions. Six months after stenting, follow-up angiography was conducted to assess stent patency. The primary endpoint was angiographic ISR determined by quantitative vascular angiography analysis at the 6-month follow-up. Variables associated with restenosis were sought in multivariate analysis; the results are presented as the odds ratio (OR) and 95% confidence interval (CI).. At follow-up, 27 (31.8%) angiographic ISR lesions were recorded. The lesions treated with uncoated stents were more prevalent in the ISR group compared with the no restenosis group (74.1% vs 44.8%, p=0.02). Lesion length was longer (154.4±79.5 vs 109.0±89.3 mm, p=0.03) and postprocedure minimum stent area (MSA) measured by IVUS was smaller (13.9±2.8 vs 16.3±1.6 mm(2), p<0.001) in the ISR group. Multivariate analysis revealed that bare stent use (OR 7.11, 95% CI 1.70 to 29.80, p<0.01) and longer lesion length (OR 1.08, 95% CI 1.01 to 1.16, p=0.04) were predictors of ISR, while increasing postprocedure MSA (OR 0.58, 95% CI 0.41 to 0.82, p<0.01) was associated with lower risk of ISR. Receiver operating characteristic analysis identified a MSA of 15.5 mm(2) as the optimal cutpoint below which the incidence of restenosis increased (area under the curve 0.769).. Postprocedure MSA can predict ISR in SFA lesions, which suggests that adequate stent enlargement during angioplasty might be required for superior patency.

Topics: Aged; Aged, 80 and over; Alloys; Angiography; Angioplasty, Balloon; Area Under Curve; Cardiovascular Agents; Chi-Square Distribution; Constriction, Pathologic; Drug-Eluting Stents; Female; Femoral Artery; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Predictive Value of Tests; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; ROC Curve; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

The authors sought to investigate the efficacy of a drug-coated balloon (DCB) for treatment of complex femoropopliteal lesions.. Superiority of DCBs compared with uncoated balloon angioplasty for femoropopliteal interventions has been demonstrated in randomized trials for short lesions. Their performance in complex lesions with higher restenosis rates is unclear.. Patency, target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints of femoropopliteal lesions in 288 limbs (n = 260) treated with the In.Pact Pacific or Admiral DCB (Medtronic, Minneapolis, Minnesota) were retrospectively analyzed for up to 2 years of follow-up. Predictors of restenosis were identified by logistic regression.. Lesions were de novo in 51.7%, restenosis in 11.1%, and in-stent restenosis in 37.2%. Mean lesion length was 24.0 ± 10.2 cm, and 65.3% were occluded. Stent implantation was performed in 23.3%. Kaplan Meier estimates of primary patency were 79.2% and 53.7% for all lesions at 1 and 2 years, respectively, whereas freedom from TLR was 85.4% and 68.6%. Primary patency for in-stent restenosis treatment was 76.6% and 48.6%, and freedom from TLR was 83.0% and 58.7% at 1 and 2 years, respectively. Rutherford category improved from a median 3.3 to 1.2 at 1 year, and to 1.1 at 2 years. Major amputation rate was 2.1% at 2 years. No adverse events were thought to be attributable to the coating of the balloon.. These results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract. Further studies are recommended to confirm these results.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Equipment Design; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Odds Ratio; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Registries; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Topics: Advisory Committees; Aged; Cardiovascular Agents; Centers for Medicare and Medicaid Services, U.S.; Drug Costs; Evidence-Based Medicine; Exercise Therapy; Female; Health Care Costs; Health Policy; Hospital Costs; Humans; Insurance Coverage; Lower Extremity; Male; Medicare; Peripheral Arterial Disease; Policy Making; Practice Guidelines as Topic; Professional Practice Gaps; Treatment Outcome; United States; Vascular Surgical Procedures

To examine patient outcomes following the use of the Lutonix drug-coated balloon (DCB) in patients undergoing endovascular intervention in below-the-knee (BTK) arteries.. A retrospective chart review identified 248 patients who were treated for symptomatic peripheral artery disease with the Lutonix DCB between May 2013 and October 2014. Forty patients were lost to follow-up, leaving 208 patients (mean age 74.1±9.7 years; 138 men) with evaluable data for outcome analysis. The patient cohort suffered from either severe claudication (38.6%) or critical limb ischemia (CLI; 61.4%) in 220 limbs. Almost two-thirds (140, 63.6%) of the 220 target lesions were total occlusions, and 37 (17.8%) of all patients had occlusion of all 3 BTK vessels before intervention.. Over a median 9-month follow-up, target lesion revascularization occurred in 15.9% of patients with an average time to first reintervention of 8 months. In total, 39 amputations were performed in 31 limbs. However, 17 of these amputations were preplanned minor amputations below the ankle; only 9 (4.1%) major amputations occurred corresponding to 6.6% of the CLI cohort. Freedom from the composite of death or major amputation was estimated as 92% and 85% at 6 and 12 months, respectively, by Kaplan-Meier analysis. In the full cohort, improvement of at least 1 Rutherford category was seen in 130 (59.1%) limbs after 1 year or at the last follow-up, with 104 (80.0%) of those limbs showing an improvement of ≥2 categories.. From this single-center experience, the Lutonix DCB shows therapeutic promise in a disease state where new treatment options are needed.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Germany; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Retrospective Studies; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The aim of this study was to appraise 1-year outcomes after percutaneous treatment of long femoropopliteal artery disease using paclitaxel-coated balloons.. Percutaneous transluminal angioplasty with paclitaxel-coated balloons for TransAtlantic Inter-Society Consensus types A and B femoropopliteal artery disease has provided favorable results.. Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long and with 4- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency at 12 months. Secondary endpoints included major adverse events (the composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven non-target lesion target vessel revascularization), changes in Rutherford class, ankle-brachial index, and quality of life up to 24 months post-procedure.. A total of 105 patients (mean age 68 ± 9 years, 81.9% men) treated with paclitaxel-coated balloons and provisional stenting were enrolled, and final procedural success was obtained in all. The mean treated lesion length was 251 ± 71 mm, including 63.4% moderate to severely calcified lesions and 49.5% total occlusions. The bailout stent rate was 10.9%. Follow-up after 12 months was obtained in 101 patients (96.2%), showing that primary patency was maintained in 84 (83.2%), and major adverse events had occurred in 7 (6.2%), with persistently significant clinical benefits in Rutherford class.. Paclitaxel-coated balloons are associated with favorable functional and clinical outcomes at 1 year in patients with long femoropopliteal artery disease requiring percutaneous revascularization. (Drug Eluting Balloon [DEB] and Long Lesions of Superficial Femoral Artery [SFA] Ischemic Vascular Disease [DEB-SFA-LONG]; NCT01658540).

Topics: Aged; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Female; Femoral Artery; Humans; Italy; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Quality of Life; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Calcification; Vascular Patency

Restenosis due to intimal hyperplasia (IH) is a major clinical issue that affects the success of lower limb endovascular surgery. After 1 year, restenosis occurs in 40% to 60% of the treated vessels. The possibility to reduce IH using local antiproliferative drugs, such as taxols, has been the rationale for the clinical applications of drug-eluting stents and drug-eluting balloons (DEBs). The purpose of this study was to evaluate the clinical and instrumental efficacy of DEBs versus simple percutaneous transluminal angioplasty (PTA) in patients affected by chronic limb ischemia (CLI) with tibial artery "de novo" lesions.. A retrospective analysis was performed and included all consecutive patients who underwent endovascular treatment for CLI in our centers between January 2011 and March 2013. Inclusion criteria were (1) "de novo" tibial artery stenosis and (2) Rutherford class >4. Lesions were further divided by TransAtlantic Inter-Societal Consensus (TASC) classification into groups A, B, C, and D.. Between January 2010 and March 2013, a total of 138 patients underwent simple PTA or DEB for CLI, and the groups were clinically and demographically homogenous. We decided to use DEBs in 70 cases. An improvement in the Rutherford Scale in cumulative and single TASC lesions classification was better in the DEB group (74% vs 51%; P = .024) at 24 months than in the PTA group. In the DEB group, the increase in ankle-brachial index was significantly higher than in the PTA group (P = .039).. Our experience in addition to the existing literature supports the use of DEB in patients with CLI Rutherford class >3.

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Europe; Female; Humans; Hyperplasia; Ischemia; Limb Salvage; Lower Extremity; Male; Middle Aged; Neointima; Peripheral Arterial Disease; Recurrence; Retrospective Studies; Tibial Arteries; Time Factors; Treatment Outcome; Vascular Access Devices

Peripheral artery disease (PAD) is common worldwide, and PAD patients are increasingly offered lower limb revascularization procedures. The aim of this population-based study was to describe the current risk for cardiovascular (CV) events and mortality and also to elucidate the current pharmacologic treatment patterns in revascularized lower limb PAD patients.. This observational, retrospective cohort study analyzed prospectively collected linked data retrieved from mandatory Swedish national health care registries. The Swedish National Registry for Vascular Surgery database was used to identify revascularized PAD patients. Current risk for CV events and death was analyzed, as were prescribed drugs aimed for secondary prevention. A Cox proportional hazard regression model was used to explore risk factors for suffering a CV event.. Between May 2008 and December 2013, there were 18,742 revascularized PAD patients identified. Mean age was 70.0 years among patients with intermittent claudication (IC; n = 6959) and 76.8 years among patients with critical limb ischemia (CLI; n = 11,783). Antiplatelet therapy, statins, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and beta-blockers were used by 73%, 60%, 57%, and 49% at admission for revascularization. CV event rate (a composite of myocardial infarction, ischemic stroke, or CV death) at 12, 24, and 36 months was 5.1% (95% confidence interval [CI], 4.5-5.6), 9.5% (95% CI, 8.7-10.3), and 13.8% (95% CI, 12.8-14.8) in patients with IC and 16.8% (95% CI, 16.1-17.6), 25.9% (95% CI, 25.0-26.8), and 34.3% (95% CI, 33.2-35.4) in patients with CLI. Best medical treatment, defined as any antiplatelet or anticoagulant therapy along with statin treatment, was offered to 65% of IC patients and 45% of CLI patients with little change during the study period. Statin therapy was associated with reduced CV events (hazard ratio, 0.76; 95% CI, 0.71-0.81; P < .001), whereas treatment with low-dose aspirin was not.. Revascularized PAD patients are still at a high risk for CV events without a declining time trend. A large proportion of both IC and CLI patients were not offered best medical treatment. The most commonly used agent was aspirin, which was not associated with CV event reduction. This study calls for improved medical management and highlights an important and partly unmet medical need among revascularized PAD patients.

Topics: Aged; Aged, 80 and over; Anticoagulants; Cardiovascular Agents; Cardiovascular Diseases; Critical Illness; Disease-Free Survival; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Lower Extremity; Male; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Proportional Hazards Models; Recurrence; Registries; Retrospective Studies; Risk Factors; Secondary Prevention; Sweden; Time Factors; Treatment Outcome

Topics: Cardiovascular Agents; Critical Illness; Endovascular Procedures; Humans; Ischemia; Lower Extremity; Peripheral Arterial Disease; Treatment Outcome; Vascular Surgical Procedures

Peripheral arterial disease (PAD) affects over 8 million people in the United States alone. Although great strides have been made in reducing the burden of cardiovascular disease the prevalence of PAD is expected to rise with the age of global population. PAD characterized by narrowing of arterial blood can be asymptomatic or cause limb threatening claudication. It has been classically treated with bypass, but these techniques have been supplanted by endovascular therapy. Plain old balloon angioplasty has been successful in helping revascularize lesions, but its effect has not been durable because of restenosis. This prompted the creation of several technologies aimed at reducing restenosis. These advances slowly improved outcomes and the durability of endovascular management. Among the main tools used in current endovascular practice are drug-delivery devices aimed at inhibiting the inflammatory and proliferative pathways that lead to restenosis. This article examines the current drug-delivery technologies used in the superficial femoral artery.

Topics: Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug Compounding; Drug Delivery Systems; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Humans; Peripheral Arterial Disease; Prosthesis Design; Radiography, Interventional; Recurrence; Risk Factors; Treatment Outcome; Vascular Access Devices

Clinical trial data show overall favorable outcomes of paclitaxel-eluting stents for treatment of femoro-popliteal (FP) occlusive disease. However, external validity of trial results may be restricted to less complex FP lesions, and limited data on outcomes of paclitaxel-eluting stents in real world practice have been published.. This is a retrospective analysis of data of all patients who received Zilver® PTX® for FP lesion from February 2013 to October 2014 at our center. The primary endpoint was primary patency, defined as peak systolic velocity ratio <2.0 by Doppler ultrasound, or angiographic diameter stenosis <50%, or freedom from clinically driven target lesion revascularization.. Seventy-eight patients received Zilver® PTX® for FP lesions in the pre-specified time period. Of them, 63 had follow-up data and were included in this study. Mean patient age was 66.3±9.4years, and 57.1% of the patients were men. Participants had a high prevalence of diabetes (49.2%), hypertension (93.7%), hyperlipidemia (93.7%), previous coronary revascularization (52.4%), or previous peripheral arterial disease (77.8%). Critical limb ischemia was present in 25.4% of the patients, Trans-Atlantic Inter-Society Consensus (TASC) class C or D in 76.2%, in-stent restenosis (ISR) in 36.5%, and total occlusion in 69.8%. Mean lesion length was 218.9±128.3mm, mean number of stents was 2.02±1.0, and total stent length was 189.0±128.5mm. Mean follow-up was 270.4±190.3days. Primary patency rate at 1year was 66.7% by Kaplan-Meier survival curve. When compared with patients with primary patency at follow up, those with an adverse outcome had higher prevalence of TASC II class C or D lesions (100% vs. 68.8%, p=0.013), and were more likely to have ISR (66.7% vs. 27.1%, p=0.012), longer lesion (291.3±138.7 vs. 195.7±117.1, p=0.011), and incomplete coverage of the lesion (full coverage of lesions: 40% vs. 77.1%, p=0.011).. Post marketing use of Zilver® PTX® for the treatment of FP lesions is associated with lower patency rates compared with clinical trial data. This may be related to the high prevalence of TASC II class C or D lesions and ISR in real world practice. Future studies should be more representative of contemporary clinical practice.

Topics: Aged; Angiography; Angioplasty, Balloon; Cardiovascular Agents; Constriction, Pathologic; District of Columbia; Drug-Eluting Stents; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Ultrasonography, Doppler; Vascular Patency

To evaluate the safety and efficacy of the drug coated balloon (DCB) with paclitaxel in patients with symptomatic peripheral artery disease (PAD).. The clinical data of 18 patients, who were diagnosed as PAD and treated with DCB from October 2013 to June 2014 in Department of Vascular Surgery, People's Liberation Army General Hospital, were retrospectively analyzed.Thirteen male and 5 female patients were in the series, the mean age of the patients was (65±7) years, and the Rutherford's categories were level 3 to 5. Patients were followed up at 3- and 6-month postoperative. The main efficacy end point were late lumen loss(LLL), rate of restenosis and clinically driven target lesion revascularization (TLR). Meanwhile, the clinical events were recorded.. Mean lesion length, the percentage of total occlusions and the percentage of in-stent restenosis were (138±91) mm, 9/18 and 2/18, respectively. Rate of technical success was 18/18. At 6-month postoperative, LLL, rate of restenosis and TLR were (0.1±0.9) mm, 2/14 and 0, respectively. There was no deaths or no amputations.. DCB with paclitaxel is safe in patients with PAD, and associated with reductions in LLL, restenosis and clinically driven TLR 6-month postoperative.

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Retrospective Studies; Time Factors; Treatment Outcome

The aim of this study was to investigate the midterm performance of an everolimus-eluting, bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, California) for the treatment of focal tibial and distal popliteal lesions.. Drug-eluting stents are used below the knee to improve technical success and durability, but the ongoing presence of a permanent metal scaffold may have deleterious effects on the local vessel.. Tibial and distal popliteal angioplasty with scaffold placement was performed using an everolimus-eluting, bioresorbable scaffold (Absorb). Clinical and ultrasound follow-up was performed at 1, 3, 6, 12, and 24 months to detect binary restenosis and evaluate safety, restenosis, and clinical improvement.. Thirty-eight limbs in 33 patients were treated for critical limb ischemia (68.4%) or severe claudication (31.6%). Fifty scaffolds were used to treat a total of 43 lesions, with a mean length of 19.2 ± 11.6 mm. During a mean follow-up period of 12.0 ± 3.9 months, 5 patients died, and all others were available for follow-up. Among the 38 treated limbs, clinical improvement was present in 30 (79%). Binary restenosis was detected in 3 of 50 scaffolds (6%). Using the Kaplan-Meier method, rates of primary patency were 96% and 84.6% at 12 and 24 months, respectively, and rates of freedom from clinically driven target lesion revascularization were 96% and 96% at 12 and 24 months, respectively. Complete wound healing occurred in 64% of those treated for tissue loss, with no major amputation and a limb-salvage rate of 100%.. Twelve-month follow-up demonstrated excellent safety, patency, and freedom from target lesion revascularization using the Absorb bioresorbable vascular scaffold below the knee.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Angiography; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Critical Illness; Everolimus; Female; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Leg; Limb Salvage; Male; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Tibial Arteries; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency

Although clinical trials demonstrated the superiority of the Zilver (Cook Medical, Bloomington, Ind) paclitaxel-eluting stent (PTX), a recently developed drug-eluting stent (DES), to conventional therapy for femoropopliteal (FP) lesions, the incidence and risk factors of the repetition of reintervention after DES implantation in clinical practice remained unrevealed.. This was a subanalysis of the ZEPHYR (ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy) study, enrolling FP lesions undergoing endovascular therapy (EVT) with DES implantation. The current study analyzed the 2-year database including 583 FP lesions in 495 patients undergoing preoperative intravascular ultrasound imaging before DES implantation. The primary outcome measure was re-re-EVT, defined as undergoing additional EVT more than once during the 2-year follow-up after DES implantation. The secondary outcome measure was re-EVT, defined as undergoing at least one additional EVT during the follow-up.. Critical limb ischemia (CLI) was present in 28% of the study population, 23% had a history of EVT, and 43% had chronic total occlusion. Mean lesion length was 16 ± 10 cm, and intravascular ultrasound imaging-evaluated external elastic membrane area was 28 ± 10 mm. The incidence and risk factors of the repetition of reintervention after DES implantation for FP lesions were revealed. The current findings suggest that DES implantation might be a careful indication in CLI cases especially with a small vessel.

Topics: Aged; Aged, 80 and over; Angiography; Cardiovascular Agents; Critical Illness; Databases, Factual; Disease-Free Survival; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Incidence; Ischemia; Japan; Kaplan-Meier Estimate; Male; Multivariate Analysis; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Recurrence; Retreatment; Risk Factors; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome

The objective of this study was to use instrumental variable (IV) analyses to evaluate the clinical effectiveness of percutaneous stent revascularization versus bypass surgery in the treatment of peripheral artery disease (PAD) among type 2 diabetic patients. Type 2 diabetic patients who received peripheral artery bypass surgery (n = 5,652) or stent revascularization (n = 659) for lower extremity arterial stenosis between 2000 and 2007 were identified from the Taiwan National Health Insurance claims database. Patients were followed from the date of index hospitalization for 2 years for lower-extremity amputation, revascularization, and hospitalization for medical treatment. Analysis using treatment year, patients' monthly income level, and regional difference as IVs were conducted to reduce unobserved treatment selection bias. The crude analysis showed a statistically significant risk reduction in favor of stent placement in lower extremity amputation and in the composite endpoint of amputation, revascularization, or hospitalization for medical treatment. However, peripheral artery stent revascularization and bypass surgery had similar risk of lower limb amputation and composite endpoints in the analyses using calendar year or patients' monthly income level as IVs. These two treatment modalities had similar risk of lower limb amputation among DM patients with PAD.

Topics: Age Distribution; Aged; Amputation, Surgical; Cardiovascular Agents; Comorbidity; Databases, Factual; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Diabetic Nephropathies; Endovascular Procedures; Female; Graft Occlusion, Vascular; Hospitalization; Humans; Hypoglycemic Agents; Leg; Limb Salvage; Lung Diseases; Male; Middle Aged; Minimally Invasive Surgical Procedures; Peripheral Arterial Disease; Risk Reduction Behavior; Stents; Taiwan; Treatment Outcome; Vascular Grafting

To consider the clinical outcomes and restenosis rates of drug-eluting balloons (DEBs) and percutaneous transluminal angioplasty (PTA) in diabetic patients with infrapopliteal (IP) arterial disease.. This retrospective, single-center study included 51 patients (37 males; mean age: 63.43 ± 9.81 years) with diabetes mellitus having IP arterial disease, from October 2012 to September 2014. Twenty-two patients were treated with PTA, and 29 patients were treated with DEBs. After intervention, the patients were evaluated in the first week and every 3 months, clinically and radiologically. Univariate and multivariate analyses were used to evaluate the clinical outcomes of diabetic patients with IP arterial disease who were treated with either DEBs or PTA.. There were no statistically significant differences between the groups in terms of age and gender, risk factors, characteristics of lesions, or the diameters or length of the balloons ( P > .05). Primary patency was higher in the DEB group than in the PTA group (97.8% vs 81.1%, P = .020) in the first 3 months. However, there was no statistically significant difference at 1-year follow-up (68.2% vs 48.5%, P = .131). At the 12-month follow-up, there was no difference in clinical improvement between the groups ( P = .193).. The findings of this study reveal that DEB is a safe alternative treatment method for IP arterial disease in diabetic patients.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Diabetic Angiopathies; Equipment Design; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Turkey; Vascular Access Devices; Vascular Patency

Efficacy of endovascular therapy (EVT) with nitinol stents for femoropopliteal (FP) lesions is limited by restenosis. Oral cilostazol reduces angiographic restenosis rate; however, treatment duration remains unclear. In a retrospective analysis of a multicenter database of 3471 consecutive limbs in 2737 patients (mean age: 72 ± 9 years; 61% diabetic; and 26% on regular dialysis) undergoing EVT for FP lesions between January 2004 and December 2011, we compared Kaplan-Meier estimated primary patency after EVT followed or not by cilostazol treatment. We used Cox hazard regression analysis to assess temporal association between cilostazol treatment and post-EVT restenosis. Five-year primary patency was higher in the cilostazol group than in the noncilostazol group (57% vs 47%, P < .0001). Cilostazol treatment was inversely associated with restenosis for the first 2 years following EVT (P < .05); however, no significant association was observed thereafter. Cilostazol use therefore appears efficacious in preventing restenosis up to 2 years after EVT for FP lesions.

Topics: Administration, Oral; Aged; Aged, 80 and over; Alloys; Cardiovascular Agents; Cilostazol; Databases, Factual; Endovascular Procedures; Female; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Proportional Hazards Models; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Stents; Tetrazoles; Time Factors; Treatment Outcome; Vascular Patency

Although drug-eluting balloons (DEBs) have shown promising results treating de novo (DN) atherosclerotic lesions and appear to have been widely adopted in Europe, their long-term efficacy in the broad spectrum of femoropopliteal restenosis (RE) remains to be proven. The purpose of the study was to assess the efficacy of paclitaxel-DEBs in restenotic (stented and nonstented) vs DN stenotic femoropopliteal arteries.. The study prospectively enrolled 100 patients undergoing femoropopliteal endovascular intervention by DEB for RE or DN stenosis. Patients who received additive atherectomy were excluded. The primary end point was the primary patency (PP) rate at 12 months. Secondary end points were sustained clinical improvement and clinically driven target lesion revascularization.. DEBs were used to treat 105 limbs for intermittent claudication (82 [78%]) or critical limb ischemia (23 [22%]) in 100 patients. Of these, 111 lesions were DN stenosis (46 [41%]) or RE (65 [59%]). The overall PP was 86% at 6 months and 74% at 12 months. PP of DN stenosis was higher at 6 months (93% vs 81%) and was significantly (P = .021) better than RE at 12 months (85% vs 68%). Sustained clinical improvement based on Rutherford classification was significant in both groups (P < .001). Target lesion revascularization was significantly lower in DN stenosis compared with RE at 12 months (15% vs 32%; P = .021).. DEB angioplasty is an effective therapy for DN femoropopliteal lesions. The results of DEB angioplasty for RE are inferior compared with DN stenosis after 12 months. Nevertheless, results of DEB angioplasty for RE seem comparable with technically more demanding literature-derived strategies.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Critical Illness; Equipment Design; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Recurrence; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

The aim of the study was to evaluate the effect of the nutritional supplements Pycnogenol® and total triterpenic fraction of Centella asiatica (TTFCA) on atherosclerosis progression in low-risk asymptomatic subjects with carotid or femoral stenosing plaques.. This was an observational pilot, substudy of the San Valentino epidemiological cardiovascular study. The study included 824 subjects aged 45-60 without any conventional risk factors who had a stenosing atherosclerotic plaque (>50-60%) in at least one carotid or common femoral bifurcation, allocated into 6 groups: Group 1 (Controls): management was based on education, exercise, diet and lifestyle changes. This same management plan was used in all other groups; group 2: Pycnogenol® 50 mg/day; group 3: Pycnogenol® 100 mg/day; group 4: Aspirin® 100 mg/day or ticlopidine 250 mg/day if intolerant to aspirin; group 5: Aspirin® 100 mg/day and Pycnogenol® 100 mg/day; group 6: Pycnogenol® 100 mg/day plus TTFCA 100 mg/day. The follow-up lasted 42 months. Plaque progression was assessed using the ultrasonic arterial score based on the arterial wall morphology and the number of plaques that progressed and on the number of subjects that had cardiovascular events. A secondary endpoint was to evaluate the changes in oxidative stress at baseline and at 42 months.. The ultrasonic score increased significantly in groups 1, 2, and 4 (>1%) but not in groups 3, 5 and 6 (<1%) suggesting a beneficial effect of Pycnogenol® 100 mg. Considering the percent of patients that progressed from class V (asymptomatic) to VI (symptomatic) there was a progression of plaques in 48.09% of controls. In the Pycnogenol® 100 (group 3, 10.4%) and in the Aspirin®+ Pycnogenol® (group 5, 10.68%) progression was half of what observed with antiplatelet agent (group 4, 20.93%); in the TTFCA+ Pycnogenol®group (group 6) progression was 7.4 times lower than in controls; 3.22 times lower than in the antiplatelet agents group (4). Events (hospital admission, specialized care) were observed in 16.03% of controls; there were 8.83% of subjects with events with Pycnogenol® 50 mg and 8% in group 3 (Pycnogenol® 100 mg). In group 4 (antiplatelets), 8.52% of subjects had events; in group 5, 6.87% of subjects had events and in group 6 (TTFCA+ Pycnogenol®) only 4.41% had events (this was the lowest event rate; P<0.05). All treatment groups had a significantly lower event rate (P<0.05) in comparison with controls. Considering treatments groups 2, 3, 5, 6 had a lower number (P<0.05) of subjects in need of cardiovascular management in comparison with controls. The need for risk factor management was higher in controls and lower in group 6 (P<0.05). In groups 2 to 6 the need for risk factor management was lower than in controls (P<0.05). Including all events (hospital admission, need for treatment or for risk management) 51.9% of controls were involved. In the other groups there was a reduction (from a -9.28% reduction in group 2 to a -26% in group 6) (P<0.002). The most important reduction (higher that in all groups; P<0.05) was in group 6. At 42 months, oxidative stress in all the Pycnogenol® groups was less than in the control group. In the combined group of Pycnogenol® and TTFCA the oxidative stress was less than with Pycnogenol® alone (P<0.001).. Pycnogenol® and the combination of Pycnogenol® +TTFCA appear to reduce the progression of subclinical arterial plaques and the progression to clinical stages. The reduction in plaque and clinical progression was associated with a reduction in oxidative stress. The results justify a large, randomized, controlled study to demonstrate the efficacy of the combined Pycnogenol® and TTFCA prophylactic therapy in preclinical atherosclerosis.

Topics: Asymptomatic Diseases; Cardiovascular Agents; Carotid Arteries; Carotid Stenosis; Centella; Combined Modality Therapy; Dietary Supplements; Disease Progression; Drug Therapy, Combination; Female; Femoral Artery; Flavonoids; Humans; Male; Middle Aged; Oxidative Stress; Peripheral Arterial Disease; Pilot Projects; Plant Extracts; Plaque, Atherosclerotic; Platelet Aggregation Inhibitors; Registries; Risk Reduction Behavior; Rupture, Spontaneous; Time Factors; Treatment Outcome; Triterpenes; Ultrasonography

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Vascular Access Devices

To compare the vascular response after paclitaxel-coated nitinol drug-eluting stent (Zilver PTX) implantation for superficial femoral artery lesions after 6 and 12 months using optical coherence tomography (OCT).. Serial OCT examinations were performed in 5 patients (4 men; mean age 78.4 ± 6.8 years) with 9 Zilver PTX stents at 6- and 12-month follow-up. Variables evaluated included neointimal thickness and apposition on each strut, the incidence of extrastent lumen (ESL), peristrut low-intensity area (PLIA), and neovascularization at 1-mm intervals.. A total of 249 matched cross-section images were evaluated and included 4788 and 4826 struts at 6 and 12 months, respectively. Mean neointimal thickness significantly increased from 480 to 540 µm between 6 and 12 months (p < 0.001). The percentage of uncovered struts tended to decrease at 12 months (3% vs. 2.3%, p = 0.054), whereas the percentage of malapposed struts were similar at both examinations (0.2% vs. 0.2%, p > 0.99). Although the incidence of ESL in cross sections was not different (35% vs. 31%, p = 0.29), median ESL area significantly increased from 6 to 12 months [0.12 (0.04-0.36) vs. 0.31 (0.14-0.59) mm(2), p = 0.003)]. The presence of PLIA (29% vs. 44%, p < 0.001) and neovascularization (14% vs. 27%, p < 0.001) increased from 6 to 12 months.. These findings suggest that delayed vascular healing and persistent peristent inflammation may be present even at 12 months after Zilver PTX implantation.

Topics: Aged; Aged, 80 and over; Alloys; Cardiovascular Agents; Drug-Eluting Stents; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Neointima; Paclitaxel; Peripheral Arterial Disease; Predictive Value of Tests; Retrospective Studies; Risk Factors; Sensitivity and Specificity; Tomography, Optical Coherence; Treatment Outcome

To investigate the relationship between postprocedure intravascular ultrasound (IVUS) findings and restenosis after placement of drug-eluting stents (DES) for femoropopliteal lesions.. Between July 2012 and May 2013, DES were placed in 64 patients with 88 de novo femoropopliteal lesions. In 40 patients (mean age 74.2±9.4 years; 27 men), DES were placed in 50 lesions under IVUS guidance, and restenosis was monitored for 1 year. All patients were symptomatic (Rutherford 2-6), and 17 patients (43%) suffered from critical limb ischemia. IVUS findings after stenting were compared for patients with vs without restenosis, which was defined as a peak systolic velocity ratio >2.4 on duplex ultrasonography or >50% diameter stenosis on angiography.. Ten patients (14 lesions) developed restenosis, while 30 patients (36 lesions) did not. There were no significant differences in the frequency of diabetes or dialysis between the 2 groups. Female patients were predominant in the restenosis group (p<0.003). There were no significant differences of the percentage of TransAtlantic Inter-Society Consensus C/D lesions or stent edge dissection. Multivariate analysis indicated that cilostazol use [odds ratio (OR) 0.13; p=0.046], distal lumen cross-sectional area (CSA) (OR 0.86; p=0.035), and axial symmetry index (OR 0.60; p=0.045) were independent predictors of restenosis. Using receiver operator characteristic analysis, the best cutoff values of the distal lumen CSA and axial symmetry index for predicting restenosis were 17.1 cm(2) and 0.6, respectively.. IVUS guidance of DES placement in femoropopliteal lesions can offer useful predictors of restenosis at 1 year. The utility of distal lumen CSA and the axial symmetry index in the prediction of restenosis after femoropopliteal DES placement should be confirmed in a larger cohort.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Area Under Curve; Blood Flow Velocity; Cardiovascular Agents; Constriction, Pathologic; Critical Illness; Drug-Eluting Stents; Female; Femoral Artery; Humans; Ischemia; Japan; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Prosthesis Design; Radiography; Recurrence; Regional Blood Flow; Retrospective Studies; Risk Factors; ROC Curve; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Ultrasonography, Interventional

Topics: Angioplasty, Balloon; Cardiovascular Agents; Drug-Eluting Stents; Female; Femoral Artery; Humans; Ischemia; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Ultrasonography, Interventional

To assess the effectiveness of drug-eluting balloon (DEB) angioplasty for the treatment of iliac artery in-stent restenosis (ISR).. Data from 18 patients (mean age 59.3±9.6 years; 11 men) treated with DEB for iliac ISR between October 2009 and August 2013 were retrospectively evaluated and compared with a control group of 22 patients (mean age 66.7±11.8 years; 16 men) treated with standard balloon angioplasty (BA). Primary endpoint of the study was the primary patency rate at 12 months. Secondary endpoints were 30-day and overall mortality, sustained clinical improvement [ankle-brachial index (ABI) and Rutherford category] and clinically driven target lesion revascularization (TLR). Follow-up examinations were performed by clinical examination, color duplex ultrasound, and ABI measurement at 12 months.. Mean length of the 21 lesions in the DEB group was 27.1±19.2 mm vs 20.0±11.4 mm for the 25 lesions in the BA group (p=0.508), while the grade of restenosis was 70.4%±18.4% and 64.0%±16.1% (p=0.255), respectively. Primary patency rates were 90.5% vs 85.7% at 6 months and 71.4% vs 75.6% at 12 months for DEB and BA, respectively (p=0.784). Five BA patients died during follow-up for reasons unrelated to the procedure, while no patient in the DEB group died (p=0.035). In both groups, Rutherford category and ABI significantly improved compared to pretreatment levels; there were no differences between the groups regarding these variables (p=0.367 and p=0.898, respectively). The TLR rate was 28.6% (6/21) in the DEB group and 20.0% (4/20) in the BA cohort (p=0.434).. Treatment of iliac ISR using DEBs is a safe procedure, with results comparable to BA treatment. Because of the limited number of patients in this study, further investigation of a larger cohort with longer follow-up is needed to define the role of DEBs in the treatment of iliac ISR.

Topics: Aged; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Humans; Iliac Artery; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Radiography; Recurrence; Retreatment; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Access Devices; Vascular Patency

This study sought to assess the rate and predictors of 1-year restenosis after drug-eluting stent implantation for femoropopliteal (FP) lesions in patients with peripheral arterial disease.. Zilver PTX, a paclitaxel-eluting stent for FP lesions, provides superior outcomes to angioplasty and bare-metal stents in clinical trials. However, its real-world outcomes and the associated features remain unclear.. This was a prospective multicenter study enrolling 831 FP lesions (797 limbs, 690 patients) treated by Zilver PTX implantation. The primary endpoint was 1-year restenosis. Secondary endpoints included major adverse limb event and stent thrombosis.. Mean lesion length was 17 ± 10 cm. One-year restenosis, major adverse limb event, and stent thrombosis rates were 37%, 22%, and 2%, respectively. The generalized linear mixed model showed that lesion length ≥16 cm assessed by angiography and distal external elastic membrane area ≤27 mm(2) and minimum stent area ≤12 mm(2) assessed by intravascular ultrasound were independent risk factors for restenosis. One-year restenosis rates were 15% in cases with none of these risk factors and 50% in those with ≥2 risk factors.. The current study demonstrated 1-year real-world outcomes after drug-eluting stent treatment for FP lesions, including challenging ones in clinical practice. Lesion length, external elastic membrane area, and minimum stent area were independent predictors for restenosis. (Zilver PTX for the Femoral Artery and Proximal Popliteal Artery-Prospective Multicenter Registry [ZEPHYR]; UMIN000008433).

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Linear Models; Male; Multivariate Analysis; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Radiography; Recurrence; Risk Factors; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

This study sought to compare the effect of paclitaxel-coated balloon (PCB) concentration on tissue levels and vascular healing using 3 different PCB technologies (In.Pact Pacific = 3 μg/mm(2), Lutonix = 2 μg/mm(2) and Ranger = 2 μg/mm(2)) in the experimental setting.. The optimal therapeutic dose for PCB use has not been determined yet.. Paclitaxel tissue levels were measured up to 60 days following PCB inflation (Ranger and In.Pact Pacific) in the superficial femoral artery of healthy swine (18 swine, 36 vessels). The familial hypercholesterolemic swine model of superficial femoral artery in-stent restenosis (6 swine, 24 vessels) was used in the efficacy study. Two weeks following bare-metal stent implantation, each in-stent restenosis site was randomly treated with a PCB or an uncoated control balloon (Sterling). Quantitative vascular analysis and histology evaluation was performed 28 days following PCB treatment.. All PCB technologies displayed comparable paclitaxel tissue levels 4 h following balloon inflation. At 28 days, all PCB had achieved therapeutic tissue levels; however, the In.Pact PCB resulted in higher tissue concentrations than did the other PCB groups at all time points. Neointimal inhibition by histology was decreased in all PCB groups compared with the control group, with a greater decrease in the In.Pact group. However, the neointima was more mature and contained less peri-strut fibrin deposits in both 2-μg/mm(2) PCB groups.. Compared with the clinically established PCB dose, lower-dose PCB technologies achieve lower long-term tissue levels but comparable degrees of neointimal inhibition and fewer fibrin deposits. The impact of these findings in restenosis reduction and clinical outcomes needs to be further investigated.

Topics: Animals; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Disease Models, Animal; Endovascular Procedures; Femoral Artery; Fibrin; Hyperlipoproteinemia Type II; Metals; Neointima; Paclitaxel; Peripheral Arterial Disease; Radiography; Stents; Swine; Tissue Distribution; Vascular Access Devices; Wound Healing

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

Several balloon catheters coated with paclitaxel have been shown to reduce restenosis rates in the superficial femoral artery (SFA) revealing a relatively wide therapeutic window of effective doses ranging from 2 to 3 µg/mm(2) balloon surface area. Delivering lower antiproliferative drug doses to the vessel wall may not be inferior to higher drug doses provided that effective drug-excipient formulations have been chosen. Leaving non-flow limiting dissection in the SFA non-stented might be an option after use of drug-coated balloons.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Vascular Access Devices

To assess the association of patient, lesion, and procedure variables, including calcification, with late lumen loss (LLL) after use of drug-eluting balloon (DEB) therapy in patients with femoropopliteal arterial disease.. In this retrospective study, 91 patients (mean age 72.0±8.62 years; 50 men) were analyzed at 6 months after DEB treatment. Lesions were located in the superficial femoral artery (SFA, n=68) and popliteal artery (n=23). Lesion calcification was graded by a core laboratory using 2 published scoring indices: the peripheral artery calcification scoring system and a grading system based on circumference (arc) and length of calcium.. The median LLL after 6 months was 0.2 mm (interquartile range -0.5, 1.14) overall and varied significantly across lesions with differing severity of calcification (p=0.042). However, LLL did not differ based on calcium location (intimal, medial, or mixed) or calcium length (p=0.351 and p=0.258, respectively). Additional predictors of LLL after DEB treatment included diabetes (p=0.034), coronary artery disease (p=0.024), and prior intervention (p=0.013). Interestingly, the severity of residual stenosis after the intervention did not have any impact on the LLL during follow-up (Spearman r = -0.238).. Severity of lesion calcification is associated with LLL after treatment with DEB. One possible approach to overcome this limitation might be plaque modification or removal prior to DEB usage. Nevertheless, clinical data that support this hypothesis are currently lacking.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Female; Femoral Artery; Germany; Humans; Male; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Risk Factors; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Calcification

We evaluated the impact of the prescription of evidence-based medical therapy (EBMT) including aspirin (ASA), beta-blockers (BB), ACE-inhibitors or angiotensin receptor blockade (ACE/ARB), and statins prior to discharge after peripheral vascular intervention (PVI) on long-term medication utilization in a large multi-specialty, multicenter quality improvement collaborative. Among patients undergoing coronary revascularization, use of the component medications of EBMT at hospital discharge is a major predictor of long-term utilization. Predictors of EBMT use after PVI are largely unknown. A total of 10,169 patients undergoing PVI between 1 January 2008 and 31 December 2011 were included. Post-PVI discharge and 6-month medication utilization in patients without contra-indications to ASA, BB, ACE/ARB, and statins were compared. ASA was prescribed at discharge to 9345 (92%) patients, BB to 7012 (69%), ACE/ARB to 6424 (63%), and statins to 8342 (82%), and all four component drugs of EBMT in 3953 (39%). Compared with patients not discharged on the appropriate medications, post-procedural use was associated (all p<0.001) with reported 6-month use: ASA (84.5% vs 39.2%), BB (82.5% vs 11.1%), ACE/ARB (78.2% vs 11.8%), statins (84.6% vs 21.8%). Multivariable analysis revealed that prescription of EBMT at the time of discharge remained strongly associated with use at 6 months for each of the individual component drugs as well as for the combination of all four EBMT medications. In conclusion, prescription of the component medications of EBMT at the time of PVI is associated with excellent utilization at 6 months, while failure to prescribe EBMT at discharge is associated with low use of these medications 6 months later. These data suggest that the time of a PVI is a therapeutic window in which to prescribe EBMT in this high-risk cohort and represents an opportunity for quality improvement.

Topics: Cardiovascular Agents; Drug Prescriptions; Drug Utilization Review; Evidence-Based Medicine; Female; Humans; Linear Models; Logistic Models; Male; Multivariate Analysis; Odds Ratio; Patient Discharge; Peripheral Arterial Disease; Practice Patterns, Physicians'; Quality Improvement; Quality Indicators, Health Care; Registries; Time Factors

The cardiovascular burden and consequences of peripheral atherosclerosis appear to differ between men and women. Data regarding long-term outcomes, including the impact of medical prophylactic treatment, are insufficient. This study examined long-term outcomes according to sex following primary vascular surgery, adjusted for multiple variables as well as recommended medical prophylaxis.. All Danish patients who underwent peripheral vascular surgery from January 2000 to December 2007 were stratified into five procedural groups: (a) aorto-iliac bypass or thromboendarterectomy, (b) femoro-femoral crossover, (c) thromboendarterectomy of the femoral arteries, (d) infrainguinal bypass, or (e) axillo- uni-, and bifemoral bypass. Data were analyzed according to sex for differences in myocardial infarction, stroke, and death, individually and combined, after surgery.. A total of 11,234 patients were included: 6,289 males and 4,945 females. The overall adjusted hazard ratio for male patients compared with female patients for death was 1.11 (95% CI 1.06-1.17), for MI was 1.16 (95% CI 1.04-1.29), for stroke was 0.99 (95% CI 0.89-1.11), and for any major adverse cardiovascular event was 1.10 (95% CI 1.05-1.16).. These findings show that, despite indication, severity, and concomitant medical treatment of peripheral artery disease, men have a higher risk of mortality and adverse cardiovascular events following surgery for peripheral arterial disease.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Cause of Death; Comorbidity; Denmark; Female; Health Status Disparities; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Peripheral Arterial Disease; Registries; Retrospective Studies; Risk Factors; Severity of Illness Index; Sex Factors; Stroke; Time Factors; Treatment Outcome; Vascular Surgical Procedures

Topics: Cardiovascular Agents; Female; Health Status Disparities; Humans; Male; Myocardial Infarction; Peripheral Arterial Disease; Stroke; Vascular Surgical Procedures

A delayed availability of clinical evidence in rapidly emerging therapies is considered a major problem. In this study, we examined whether evidence from clinical studies has influenced the therapy of a major disease in industrial countries, peripheral arterial disease (PAD), using novel femoropopliteal stent-angioplasty.. This analysis of retrospective time series data uses multivariate linear regression to investigate associations between published clinical evidence on femoropopliteal stent-angioplasty from Q3/2004 to Q4/2010 and the demand for femoropopliteal stents in Germany, France, Italy and the UK between Q1/2005 and Q4/2010, controlling for the prevalence of PAD risk factors, cardiovascular drug demand, reimbursement of health care providers for stent implantation, stent selling prices of manufacturers and economic indicators.. We did not observe any association of published clinical evidence with femoropopliteal stent demand in Germany, France, Italy and the UK, while we observed such associations for varying control variables at different time lags respectively.. We observed no association between published clinical evidence of femoropopliteal stent-angioplasty and its use in any of the four countries. The country-specific context and practice-related variables at a centre and individual doctor level may have limited the role of published clinical evidence in emerging femoropopliteal stent-angioplasty. More research is needed at this context, centre and individual level.

Topics: Adult; Age Factors; Aged; Angioplasty; Cardiovascular Agents; Comorbidity; Europe; Evidence-Based Medicine; Female; Femoral Artery; Humans; Linear Models; Male; Middle Aged; Models, Econometric; Peripheral Arterial Disease; Retrospective Studies; Socioeconomic Factors; Stents

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Humans; Intermittent Claudication; Ischemia; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Vascular Access Devices

Patients with peripheral artery disease (PAD) less frequently achieve secondary prevention goals compared with patients with coronary artery disease (CAD). We aimed to compare mortality rates in patients with PAD and CAD following first vascular intervention.. Patients 18 years of age or older without a history of cardiovascular disease, who underwent first coronary or lower limb vascular intervention between 2002 and 2010, were included in this study. The primary endpoint was all-cause mortality.. Of the 9950 participants, 8242 (82.8%) underwent first coronary revascularization and 1708 (17.2%) received first peripheral vascular intervention. During a mean follow-up period of 5.6±2.3 years, 1283 (12.9%) participants died. Compared with CAD patients, patients with PAD had significantly worse long-term prognosis with an increased risk for all-cause mortality (hazard ratio=2.95, 95% confidence interval 2.6-3.3, P<0.0001). This association remained statistically significant following a multivariable analysis (hazard ratio=1.86, 95% confidence interval 1.6-2.1, P<0.0001). Furthermore, PAD patients were less frequently treated with cardioprotective medications including statins, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, aspirin, and clopidogrel (P<0.001).. Patients with PAD have worse outcome compared with patients with CAD, even in the specific group of patients following first vascular intervention. These findings demand more effort to improve secondary prevention guidelines in all patients with cardiovascular diseases, but especially in PAD patients.

Topics: Aged; Angioplasty; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Bypass; Coronary Artery Disease; Female; Humans; Kaplan-Meier Estimate; Lower Extremity; Male; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Proportional Hazards Models; Risk Assessment; Risk Factors; Secondary Prevention; Time Factors; Treatment Outcome; Vascular Surgical Procedures

The best treatment strategy for below the knee bifurcation disease is not known. We present first two cases with successful implantation of dedicated coronary bifurcation sirolimus eluting stent BiOSS Lim (Balton, Poland) in complex bifurcation and trifurcation lesions of tibioperoneal trunk. Both implantations were uncomplicated with sustained short-term result at 30-day control Duplex ultrasound and remarkable clinical improvement. Our report demonstrates feasibility and short-term effectiveness of implantation of dedicated coronary bifurcation stent in below-the-knee bi- and tri-furcations.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Drug-Eluting Stents; Humans; Leg; Male; Peripheral Arterial Disease; Prosthesis Design; Sirolimus; Treatment Outcome

Diabetic foot (DF) is a chronic and highly disabling complication of diabetes. The prevalence of peripheral arterial disease (PAD) is high in diabetic patients and, associated or not with peripheral neuropathy (PN), can be found in 50% of cases of DF. It is worth pointing out that the number of major amputations in diabetic patients is still very high. Many PAD diabetic patients are not revascularised due to lack of technical expertise or, even worse, negative beliefs because of poor experience. This despite the progress obtained in the techniques of distal revascularisation that nowadays allow to reopen distal arteries of the leg and foot. Italy has one of the lowest prevalence rates of major amputations in Europe, and has a long tradition in the field of limb salvage by means of an aggressive approach in debridement, antibiotic therapy and distal revascularisation. Therefore, we believe it is appropriate to produce a consensus document concerning the treatment of PAD and limb salvage in diabetic patients, based on the Italian experience in this field, to share with the scientific community.

Topics: Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Consensus; Diabetic Foot; Endovascular Procedures; Humans; Limb Salvage; Peripheral Arterial Disease; Predictive Value of Tests; Prevalence; Risk Factors; Treatment Outcome; Vascular Surgical Procedures

To test the ability of a drug-eluting balloon (DEB) to reduce recurrent in-stent restenosis (ISR) in diabetic patients with femoropopliteal stents.. A prospective all-comers study [Drug-Eluting Balloon in Peripheral Intervention for In-Stent Restenosis (DEBATE-ISR); ClinicalTrials.gov identifier NCT01558531] of symptomatic diabetic patients with femoropopliteal ISR undergoing treatment with paclitaxel-eluting balloons was designed to compare their 12-month recurrent restenosis rate with that of historical diabetic controls. From January 2010 to December 2011, 44 consecutive diabetic patients (32 men; mean age 74±11 years) were treated with DEBs and enrolled in the study. The control group comprised 42 diabetic patients (23 men; mean age 76±7 years) treated with a conventional balloon for femoropopliteal ISR from 2008 to 2009.. No significant differences in terms of clinical, angiographic, or procedural characteristics were observed between the study groups. Lesion length was 132±86 mm in the DEB group vs. 137±82 mm in the BA group. Procedural success, defined as a residual stenosis <30% in the restenotic segment (stent +5 mm at proximal and distal edges), was obtained in all treated lesions. At 1-year follow-up, 6 patients died (3 in each group), and 1 patient in the BA group underwent major amputation. Recurrent restenosis, assessed by angiography (66%) or ultrasound (34%), occurred in 8/41 (19.5%) patients in the DEB group vs. 28/39 (71.8%) in the BA group (p<0.001). Target lesion revascularization for symptomatic recurrent restenosis was performed in 6/44 (13.6%) patients in the DEB vs.13/42 (31.0%) in the BA group (p=0.045).. Using DEB for treating femoropopliteal ISR led to a significant reduction in recurrent restenosis and repeat angioplasty at 1-year follow-up as compared to historical controls.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Diabetic Angiopathies; Equipment Design; Female; Femoral Artery; Humans; Italy; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Radiography; Retreatment; Risk Factors; Secondary Prevention; Time Factors; Treatment Outcome; Ultrasonography; Vascular Access Devices

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Diabetic Angiopathies; Female; Femoral Artery; Humans; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Vascular Access Devices

To evaluate the safety and feasibility of using drug-eluting balloons (DEBs) in the treatment of infrainguinal bypass graft stenoses.. A nonrandomized prospective study evaluated the feasibility of DEB treatment for intragraft/anastomotic stenoses arising >1 month after infrainguinal bypass grafting; stenoses due to graft/technical problems (e.g., vein torsion) were excluded, as were failed grafts that could not be successfully recanalized with catheter-directed thrombolysis. Between February 2010 and February 2012, 41 patients (35 men; mean age 71 years, range 46-87) were treated with DEBs for 63 anastomotic/intragraft stenoses in vein or prosthetic grafts. Follow-up was performed with duplex ultrasonography. The primary endpoint at 12 months was graft occlusion or >50% restenosis at the DEB treatment site.. DEB treatment was technically successful in 61 (96.8%) of the 63 lesions with no complications other than one instance of vasospasm; one totally occluded segment and one restenosis were treated surgically. The mean follow-up was 16.7 months (range 3-24). The estimated cumulative target site primary and secondary patency rates at 6 months were 91% and 96%, respectively, and 70% and 90%, respectively, at both 12 and 18 months (no restenoses after 12 months). The estimated mean durations of primary and secondary treatment site patency were 20.3 and 22.7 months, respectively (p=0.033). At 6 and 12/18 months, the cumulative rates were 96% and 90%, respectively, for graft patency and 98% and 93% for freedom from amputation.. DEBs proved to be a feasible, safe, and effective treatment for vein and prosthetic bypass graft stenoses, with excellent technical success and acceptable short and midterm patency.

Topics: Aged; Aged, 80 and over; Angiography, Digital Subtraction; Angioplasty, Balloon; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Feasibility Studies; Female; Graft Occlusion, Vascular; Humans; Lower Extremity; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Salvage Therapy; Saphenous Vein; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Topics: Angioplasty, Balloon; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Graft Occlusion, Vascular; Humans; Lower Extremity; Male; Paclitaxel; Peripheral Arterial Disease; Salvage Therapy; Saphenous Vein; Vascular Access Devices

Topics: Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Diabetic Foot; Humans; Leg; Limb Salvage; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Risk Assessment; Risk Factors; Treatment Failure; Vascular Access Devices

Acute peripheral arterial thrombosis can be threatening to life and limb. Dissolution of the thrombus local catheter-directed intra-arterial infusion of fibrinolytic agents such as urokinase is the standard therapy for thrombosis; however, this method is time-intensive, and amputation of the affected limb is still needed in 10-30% of cases. Furthermore, thrombolytic therapy carries the risk of bleeding complications. The use of small gas-filled bubbles, or ultrasound contrast agents (UCAs), in combination with ultrasound has been investigated as an improved thrombolytic therapy in acute coronary and cerebral arterial thrombosis. The authors describe a porcine model of acute peripheral arterial occlusion to test contrast-enhanced sonothrombolysis approaches that combine ultrasound, UCAs and fibrinolytic agents and recommend a strategy for preventing severe allergic reactions to UCAs in the pigs.

Topics: Anaphylaxis; Animals; Cardiovascular Agents; Contrast Media; Female; Indomethacin; Lipids; Mechanical Thrombolysis; Microbubbles; Peripheral Arterial Disease; Premedication; Swine; Thrombosis

The aim of this prospective registry was to evaluate the safety and efficacy at 2-year follow-up of the use of drug-eluting balloons (DEBs) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR).. The use of DEBs for the treatment of SFA ISR is associated with a satisfactory primary patency rate at 1 year, but no data are available for longer follow-up. Unfortunately, when DEBs were used to treat SFA de novo lesions, the occurrence of restenosis increased by 50% between the first and the second years of follow-up.. From December 2009 to December 2010, 39 consecutive patients underwent percutaneous transluminal angioplasty of SFA ISR at our institution (Clinica Montevergine, Mercogliano, Italy). All patients underwent conventional SFA percutaneous transluminal angioplasty and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic Inc., Minneapolis, Minnesota). Patients were evaluated for up to 24 months.. During follow-up, 1 patient died of heart failure and another of sudden death, for a 2-years rate of cardiovascular mortality rate of 5.12 %. The primary patency rate at 2 years was 70.3% (11 of 37 patients experienced restenosis recurrence at 2-year follow-up). The treatment of complex ISR lesions (classes II and III) was associated with an increased rate of recurrent restenosis compared with class I (33.3 % and 36.3 % vs. 12.5%; p = 0.05).. The data suggest that adjunctive use of DEBs for the treatment of SFA ISR is a safe and effective therapeutic strategy up to 2 years of follow-up.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Femoral Artery; Follow-Up Studies; Humans; Italy; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Recurrence; Registries; Retreatment; Stents; Time Factors; Treatment Outcome; Vascular Access Devices

Aim of the present study was to report the imaging and clinical outcomes of a prospective single-center study investigating paclitaxel-coated balloons (PCB) for the treatment of failing peripheral bypass grafts (BYPACS study).. In total, 32 patients had their failing peripheral native or synthetic bypass graft treated with PCB angioplasty (Group PCB). Basic inclusion criteria were any significant proximal or distal anastomotic stenosis confirmed by Duplex ultrasound (DUS; PSVR>2.5) associated with significantly reduced in-graft velocities (<45 cm/s) putting the graft at risk of thrombosis. Results were compared with a similar historical control group of 24 patients who had their failing peripheral bypass treated with plain uncoated balloon angioplasty (Group PTA). Primary endpoint was binary lesion restenosis defined as >50% stenosis of the treated lesion on DUS. Secondary endpoints included freedom from target lesion revascularization (TLR) defined as a patent peripheral bypass graft regardless of restenosis but without any repeat intervention (driven by reduced in-graft velocities <45 cm/s), major amputations and graft thrombosis. Multivariable Cox proportional hazards regression analysis was applied to adjust for confounding factors of heterogeneity. Results are reported as Cox-adjusted hazard ratios (HR and 95% CI).. Baseline variables were equally distributed between the two groups. Median follow-up was 7 months in group PCB and 8 months in group PTA. Rates of binary restenosis were similar between the 2 groups (HR=1.08, 95% CI=0.49-2.40; P=0.84). Freedom from TLR was also similar (HR=0.97, 95% CI=0.36-2.66; P=0.88). One amputation occurred in the PCB group and 2 in the PTA (P=0.58). Four events of bypass thrombosis occurred in each group (P=0.71).. PCB does not significantly inhibit restenosis or improve freedom from repeat angioplasty after treatment of failing peripheral arterial vein or synthetic bypass grafts.

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angiography, Digital Subtraction; Angioplasty, Balloon; Blood Flow Velocity; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Constriction, Pathologic; Drug Carriers; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Limb Salvage; London; Male; Middle Aged; Multivariate Analysis; Paclitaxel; Peripheral Arterial Disease; Proportional Hazards Models; Prospective Studies; Prosthesis Failure; Regional Blood Flow; Reoperation; Risk Factors; Time Factors; Treatment Failure; Ultrasonography, Doppler, Duplex; Vascular Access Devices; Veins

The indication for use of drug-eluting stents (DES) in lower limb arteries is still undefined. We report our series of patients treated with Zilver PTS DES, in treating in-stent restenosis (ISR) and Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) C/D femoropopliteal lesions.. The Zilver PTX DES is a self-expanding nitinol stent with a polymer-free Paclitaxel coating. Patients with symptomatic de novo TASC C/D lesions or IRS lesions of femoropopliteal segment were eligible for enrollment. We evaluated patients at one month, six months and one year after treatment. We used clinical evaluation criteria and US Doppler for primary and secondary patency-free rates.. From November 2010 to November 2012, we treated 69 patients with DES Zilver PTX. Indication to treat was given in 36 lesions (52%) by an ISR and in 33 cases (48%) by a TASC C/D lesion. Lesions were staged in the superficial femoral artery (SFA) level in 59 patients (85.6%), in the popliteal artery in 6 patients (8.7%), in a femoropopliteal bypass in 4 patients (5.7%). The mean follow-up was 5.3 months (range 1-24). At 12 months the overall primary patency was 85.5%, secondary patency 89.8% and limb salvage 100%.. Zilver PTX DES seems to be effective in treating TASC C/D lesions and ISR in femoropopliteal lesions at short term. Therefore DES should be recommended when treating those complex lesions.

Topics: Aged; Aged, 80 and over; Alloys; Cardiovascular Agents; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Endovascular Procedures; Female; Humans; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Recurrence; Time Factors; Treatment Outcome; Ultrasonography, Doppler; Vascular Patency

To compare the performance of drug-coated balloons (DCB) and drug-eluting stents (DES) in long femoropopliteal lesions.. A retrospective dual center study included 228 patients (139 men; median age 69 years) with femoropopliteal lesions ≥10 cm suffering from peripheral artery disease (Rutherford categories 1-5) treated either with DCB or DES. Propensity score stratification was used to minimize bias. The 131 DCB patients (77 men; mean age 68.9±10.5 years) had a mean lesion length of 194.4±86.3 mm (range 100-450), while the 97 DES patients (62 men; mean age 68.2±8.0 years) had lesions averaging 195.0±64.5 mm (range 100-350) in length. Restenotic lesions were treated in 68 (51.9%) DCB patients and 43 (44.3%) DES patients; over half the lesions in both groups were total occlusions [DCB: 69 (52.7%), DES: 61 (62.9%)]. Outcome measures were patency (peak systolic velocity ratio <2.4), clinically driven target lesion revascularization (TLR), event-free survival, and freedom from worsening of Rutherford classification by ≥2 categories.. In the DCB cohort, provisional stent placement was performed in 24 (18.3%) lesions for refractory stenosis (5, 3.8%), flow-limiting dissection (13, 9.9%), and other reasons (6, 4.6%). There was no procedure-related mortality in either cohort. The binary restenosis rates were 23.9% (26/109) and 30.4% (24/79, p=0.319) in the DCB and DES cohorts, respectively, and clinically driven TLR rates were 15.6% (17/109) vs. 19.0% (15/79, p=0.543), respectively. Estimates for freedom from clinically driven TLR and event-free survival were not different between the study cohorts nor were outcomes regarding the ankle-brachial index and Rutherford category.. DCB and DES perform equally well in the endovascular treatment of femoropopliteal lesions ≥10 cm and better than traditional endovascular treatment. In a real world setting of TASC C and D lesions, the provisional stent rate in the DCB cohort is low.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Blood Flow Velocity; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Female; Femoral Artery; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Female; Femoral Artery; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Vascular Access Devices

Peripheral arterial disease (PAD) guidelines recommend aggressive risk factor modification to improve cardiovascular outcomes. Recommended pharmacologic therapies include antiplatelets, angiotensin converting enzyme (ACE) inhibitors, and HMG-CoA-reductase inhibitors (statins).. We studied the degree to which patient admission to a vascular surgery service increased the use of these therapies.. The authors conducted a retrospective chart review of 150 patients with PAD admitted to the vascular surgery service at a large Canadian tertiary care hospital. The use of recommended pharmacologic therapies at the time of admission and discharge were compared. A multidisciplinary clinical team established criteria by which patients were deemed ineligible to receive any of the recommended therapies. Angiotensin receptor blockers (ARBs) were considered an alternative to ACE inhibitors.. Prior to hospital admission, 64% of patients were on antiplatelet therapy, 67% were on an ACE inhibitor or ARB, and 71% were on a statin. At the time of discharge, 91% of patients were on an antiplatelet (or not, with an acceptable reason), 77% were on an ACE inhibitor or an ARB (or not, with an acceptable reason), and 85% were on a statin (or not, with an acceptable reason). While new prescriptions were largely responsible for improved guideline adherence with antiplatelets and statins, most of the apparent improvement in ACE inhibitor and ARB use was the result of identifying an acceptable reason for not having them prescribed.. This hypothesis generating pilot study supports the findings of others that there is suboptimal prescription of pharmacologic risk reduction therapies in the PAD population. Admission to a vascular service increases these rates. Nevertheless, some patients are still not receiving evidence-based treatment at discharge even after consideration of acceptable reasons. Strategies are needed to improve PAD guideline adherence in both the community at large and the vascular surgery service.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Drug Prescriptions; Drug Utilization Review; Female; Guideline Adherence; Humans; Lower Extremity; Male; Middle Aged; Ontario; Patient Admission; Patient Discharge; Peripheral Arterial Disease; Pilot Projects; Practice Guidelines as Topic; Practice Patterns, Physicians'; Quality of Health Care; Retrospective Studies; Risk Assessment; Risk Factors; Tertiary Care Centers; Time Factors; Treatment Outcome; Vascular Surgical Procedures

Topics: Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Humans; Peripheral Arterial Disease; Prosthesis Design; Recurrence; Risk Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Vascular Access Devices

This study aimed to appraise 2-year outcomes after percutaneous treatment of femoropopliteal artery disease with paclitaxel-eluting balloons.. Percutaneous transluminal angioplasty with paclitaxel-eluting balloons for femoropopliteal artery disease has provided favorable 1-year results.. Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions ≤15 mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter registry. Endpoints of interest included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularization), changes in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life after ≥24 months.. A total of 105 patients (114 lesions) treated with paclitaxel-eluting balloons and provisional stenting were enrolled, and final procedural success was obtained in all. Follow-up after 27 ± 3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%), and major adverse events had occurred in 17 (17.5%), with persistently significant benefits in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all p < 0.001). Secondary patency rate was achieved in 89 cases (84.7%).. PEBs are associated with favorable functional and clinical outcomes at 2 years in patients with femoropopliteal artery disease requiring percutaneous revascularization.

Topics: Aged; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Exercise Test; Female; Femoral Artery; Humans; Italy; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Quality of Life; Recurrence; Registries; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug-Eluting Stents; Female; Femoral Artery; Humans; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Vascular Access Devices

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Femoral Artery; Humans; Male; Paclitaxel; Peripheral Arterial Disease; Predictive Value of Tests; Recurrence; Stents; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Doppler; Vascular Access Devices

Peripheral artery disease (PAD) is a common vascular disease in women that is underrecognized. It is most strongly associated with smoking and diabetes. Women with PAD are more likely to have atypical or no symptoms compared with men. The classic symptoms of claudication are seen in some, but not all, patients. The most useful initial test for PAD is the ankle-brachial index. The American College of Cardiology Foundation/American Heart Association guideline recommends that it be obtained for all patients with exertional leg symptoms; patients 50 years or older with diabetes; patients 50 years or older who smoke; all patients older than 65 years; and any patient with known coronary artery disease. Other tests, such as Doppler ultrasonography, magnetic resonance angiography, and computed tomography angiography, should be reserved for patients in whom the diagnosis of PAD is unclear. Exercise programs improve symptoms. Aspirin and statins are recommended for all patients with PAD, whereas surgery is reserved for patients who do not benefit from medical therapy.

Topics: Age Factors; Ankle Brachial Index; Cardiovascular Agents; Diagnostic Imaging; Exercise; Female; Humans; Peripheral Arterial Disease; Risk Factors; Women's Health

Aim of the study was to assess the effect of socioeconomic deprivation on prescribing of cardiovascular secondary prevention medications in patients referred with peripheral arterial disease (PAD).. A retrospective review of vascular clinic referrals was performed. All patients referred from primary care with suspected PAD over a two month period were included. The deprivation score, prescription of cardiovascular secondary prevention medications, smoking status and the presence of cardiovascular co-morbidities (coronary artery or cerebrovascular disease--CAD/CVD) were assessed. Comparison was made between socioeconomic groups using the Carstairs Deprivation (DepCat) Score and between patients with and without a history of currently existing cardiovascular co-morbidities.. The study included 391 patients. Almost two thirds of patients (253) were from the most deprived socioeconomic groups and were significantly younger at presentation (median age DepCat 7: 63 yrs, DepCat 1-2: 74.5 yrs, P<0.0001). The majority of patients with a prior history of CAD/CVD were prescribed secondary preventative medications at the time of referral with suspected PAD whereas those with no prior history of CAD/CVD, (212 patients, 54%) were significantly less likely to be prescribed antiplatelets (47% vs. 83%), statins (45% vs. 86%) or ACEi/ARBs (29% vs. 68%) (all P<0.05). Secondary prevention prescribing did not differ between socioeconomic groups.. Secondary prevention prescribing is inadequate in patients with suspected PAD regardless of socioeconomic group and is significantly lower in those without previously diagnosed CAD/CVD. There remains a lack of appreciation of the high cardiovascular risk associated with PAD.

Topics: Aged; Cardiovascular Agents; Comorbidity; Drug Prescriptions; Drug Utilization Review; Female; Humans; Life Style; Male; Middle Aged; Peripheral Arterial Disease; Poverty; Practice Patterns, Physicians'; Referral and Consultation; Retrospective Studies; Risk Factors; Scotland; Secondary Prevention; Smoking; Social Class; Socioeconomic Factors; Treatment Outcome

Topics: Angioplasty, Balloon; Aortic Dissection; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Vascular Access Devices

To explore the cost-effectiveness of using drug-eluting balloon (DEB) angioplasty for the treatment of femoropopliteal arterial lesions, which has been shown to significantly lower the rates of target lesion revascularization (TLR) compared with standard balloon angioplasty (BA).. A simplified decision-analytic model based on TLR rates reported in the literature was applied to baseline and follow-up costs associated with in-hospital patient treatment during 1 year of follow-up. Costs were expressed in Swiss Francs (sFr) and calculated per 100 patients treated. Budgets were analyzed in the context of current SwissDRG reimbursement figures and calculated from two different perspectives: a general budget on total treatment costs (third-party healthcare payer) as well as a budget focusing on the physician/facility provider perspective.. After 1 year, use of DEB was associated with substantially lower total inpatient treatment costs when compared with BA (sFr 861,916 vs. sFr 951,877) despite the need for a greater investment at baseline related to higher prices for DEBs. In the absence of dedicated reimbursement incentives, however, use of DEB was shown to be the financially less favorable treatment approach from the physician/facility provider perspective (12-month total earnings: sFr 179,238 vs. sFr 333,678).. Use of DEBs may be cost-effective through prevention of TLR at 1 year of follow-up. The introduction of dedicated financial incentives aimed at improving DEB reimbursements may help lower total healthcare costs.

Topics: Angioplasty, Balloon; Budgets; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Cost Savings; Cost-Benefit Analysis; Decision Support Techniques; Drug Costs; Equipment Design; Femoral Artery; Health Care Costs; Health Expenditures; Hospital Costs; Humans; Insurance, Health, Reimbursement; Length of Stay; Models, Economic; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome; Vascular Access Devices

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Femoral Artery; Health Care Costs; Humans; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Vascular Access Devices

After an acute coronary syndrome (ACS), optimal medical therapy (OMT) has been shown to be effective in reducing subsequent cardiovascular (CV) events. However, even in populations that reach recommended secondary prevention goals, there is a subset of patients that experience subsequent CV events.. To identify biological or clinical predictors of residual risk of CV events in post-ACS patients receiving OMT.. A total of 990 post-ACS patients benefited from OMT (optimized treatment during the acute and chronic post-ACS phase, along with a therapeutic and dietary education programme). Traditional CV risk factors and atheroma disease markers (intima-media thickness measurement, carotid atheroma, peripheral arterial disease (PAD) measured by ankle brachial index, and the number of coronary arteries with a >50% stenosis) were evaluated at 3 months post ACS. Cardiovascular events were recorded at follow up.. At 20-month follow up, >80% of the patients reached the recommended secondary prevention goals. In this population, diabetes was the only CV risk factor significantly associated with CV events in multivariate analysis including traditional risk factors (HR 1.61, p = 0.017). In multivariate analyses including CV risk factors and atheroma disease markers, only PAD remained significantly associated with CV events (HR 1.83, p = 0.04). The number of vascular beds involved was associated with poorer prognosis (HR for disease in 3-vascular-beds 3.85, p = 0.001, using disease in 1-vascular-bed as a reference group).. In post-ACS patients with OMT, atheroma burden is a powerful prognostic marker of recurrent CV events, while diabetes remains the only independent marker of CV events among traditional CV risk factors.

Topics: Acute Coronary Syndrome; Aged; Ankle Brachial Index; Biomarkers; Cardiovascular Agents; Carotid Artery Diseases; Carotid Intima-Media Thickness; Coronary Angiography; Coronary Stenosis; Diabetes Mellitus; Diet, Reducing; Echocardiography; Exercise; Female; France; Humans; Male; Middle Aged; Multivariate Analysis; Myocardial Perfusion Imaging; Peripheral Arterial Disease; Predictive Value of Tests; Proportional Hazards Models; Risk Assessment; Risk Factors; Risk Reduction Behavior; Secondary Prevention; Time Factors; Treatment Outcome

Lower extremity peripheral artery disease occurs mostly in the elderly and is associated with high mortality. Limited data are available regarding long-term mortality in patients with premature lower extremity atherosclerosis (PLEA). Our objective was to determine the all-cause mortality and its predictors in younger PLEA patients.. We studied patients with severe PLEA who were <55 years of age at diagnosis and treated at a single academic vascular center between 1998 and 2010. Data were collected prospectively at the initial evaluation for vascular care. National Death Index and hospital records were used to determine all-cause mortality. Demographic and clinical characteristics were summarized using count (%), mean (standard deviation), or median (interquartile range), and associations with aspirin use were tested using χ2 test, t-test, or Wilcoxon test. Survival times were estimated using Kaplan-Meier estimates, and associations with covariates were tested using simple and multivariable Cox proportional hazards models.. A total of 564 patients were analyzed (46% female; 20% nonwhite; mean age 49.4 [6.4] years). Ninety-five percent of patients had ≥2 cardiovascular risk factors, 31% had coronary artery disease (CAD), and 10% had a history of cancer. During median follow-up of 5.6 years (interquartile range, 2.3-8.3 years), 108 deaths (19%) were recorded. Two-year estimated mortality (standard error) was 6% (0.01), and 5-year estimated mortality was 16% (0.02). In univariate regression analysis, patient age (P=.04), prior amputation (P<.01), history of cancer (P=.03), and established CAD (P=.04) were associated with increased risk of mortality. Aspirin use and lipid-lowering therapy at the time of first evaluation were associated with improved survival (P<.01 and P=.02, respectively). A multivariable Cox proportional hazards model identified age (hazard ratio [HR] for 5-year increase, 1.17; 95% CI, 1.01-1.36; P=.04), prior amputation (HR, 1.99; 95% CI, 1.18-3.34; P=.01), history of cancer (HR, 2.35; 95% CI, 1.36-4.07; P<.01), and CAD (HR, 1.76; 95% CI, 1.16-2.67; P<.01) as independent predictors of mortality in patients with PLEA. Importantly, history of aspirin use had a significant protective effect (HR, 0.45; 95% CI, 0.30-0.69; P<.01). The impact of lipid-lowering therapy was no longer significant in multivariable modeling.. Patients with PLEA demonstrate high all-cause mortality. No traditional cardiovascular risk factors predicted mortality. Aspirin therapy at the time of first evaluation was a significant and independent predictor of improved survival in patients with PLEA.

Topics: Academic Medical Centers; Adult; Age of Onset; Aspirin; Cardiovascular Agents; Chi-Square Distribution; Comorbidity; Female; Humans; Kaplan-Meier Estimate; Lower Extremity; Male; Middle Aged; Multivariate Analysis; North Carolina; Peripheral Arterial Disease; Prognosis; Proportional Hazards Models; Prospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Time Factors

In United States alone there are more than 12 million people with peripheral artery disease (PAD). Long-term outcomes of plaque excision in high-risk population (patients with diabetes and patients with end stage renal disease on dialysis) are scarce.. Since November 2003, we treated 225 consecutive patients (138 male, mean age: 66.3 ± 12.4, range: 29-93) with SilverHawk(TM) plaque excision for critical limb ischemia or disabling claudication. A total of 367 procedures were performed treating 832 lesions (157 restenotic, 675 de novo). One hundred fifty-five patients (68.9%) were diabetics, 74 (32.9%) were on dialysis. All patients were treated with statins, clopidogrel, aspirin, and aggressive glycemic control. The primary endpoint for our study was target lesion revascularization (TLR), and the secondary endpoint was an assessment of major adverse events (all cause death, amputation, TLR).. The average time of observation was 2.2 ± 1.2 years. Procedural success rate was 99.4% with <30% residual stenosis achieved in 818 (98.9%) lesions. SilverHawk was used alone in 86.7%. No acute limb loss or major perforation occurred. Sixty (26.6%) patients had TLR. Long-term mortality was 16.4%. Seven (3.1%) patients had to undergo major amputations and 7 (3.1%) minor amputations. Seventy (31.1%) patients had a major adverse event. Atorvastatin 80 mg was found to be independent predictor of survival, and major amputation was found to be independent predictor of mortality.. SilverHawk Plaque Excision combined with aggressive pharmacotherapy in this presented high-risk population is associated with promising long-term outcomes that compare favorably with accepted standards of care.

Topics: Adult; Aged; Aged, 80 and over; Amputation, Surgical; Aspirin; Atherectomy; Atorvastatin; Cardiovascular Agents; Clopidogrel; Combined Modality Therapy; Critical Illness; Drug Therapy, Combination; Female; Heptanoic Acids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypoglycemic Agents; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Pyrroles; Recurrence; Registries; Retrospective Studies; Risk Factors; Severity of Illness Index; Ticlopidine; Time Factors; Treatment Outcome

Topics: American Heart Association; Cardiovascular Agents; Endovascular Procedures; Humans; Patient Selection; Peripheral Arterial Disease; Practice Guidelines as Topic; Risk Reduction Behavior; Smoking Cessation; Societies, Medical; Treatment Outcome; United States; Vascular Surgical Procedures

Patients with peripheral artery disease have a high risk of cardiovascular events and death. The rate of prescription of evidence-based cardiovascular therapies and the attainment of therapeutic goals in this population is suboptimal. There are no previous studies evaluating the rate of prescription of these therapies in our country.. PERIFERICA is a cross-sectional study conducted from May to December 2009 in 440 outpatient clinics of general practitioners, internal medicine, cardiology, vascular surgery, endocrinology, and nephrology specialists throughout Spain. Subjects were included if they were aged ≥45 years and had peripheral artery disease and a blood sample obtained during the previous 6 months. Patients were excluded if they had coronary or cerebrovascular diseases. Clinical and anthropometric variables and blood analysis were obtained in all participants.. In total, 4087 patients were included in the study (mean age, 68 years; 74% men). There was a high prevalence of diabetes (50%) and hypertension (90%); 79% of participants received lipid-lowering drugs (76% statins), 85.5% antihypertensive drugs (66% renin-angiotensin blockers) and 83% antithrombotics (75% antiplatelet drugs and 11% anticoagulants). In addition, 30% of subjects had a low-density lipoprotein cholesterol concentration n<100 mg/dL, 29.5% had optimal control of blood pressure, and 74.5% did not smoke. Only 8% had a good control of all of their cardiovascular risk factors.. Although a high percentage of subjects with peripheral artery disease receives adequate treatment with evidence-based preventive therapies, the percentage of subjects with good control of all their risk factors is low.

Topics: Adult; Aged; Blood Pressure; Cardiovascular Agents; Cholesterol; Cross-Sectional Studies; Epidemiologic Studies; Evidence-Based Medicine; Female; Goals; Humans; Male; Middle Aged; Peripheral Arterial Disease; Risk Reduction Behavior; Spain

Atherosclerotic disease (AD) is the leading cause of death worldwide and in Saudi Arabia. Intensive risk reduction therapy plays a major role in reducing adverse cardiovascular outcomes in patients with AD. The level of awareness of this important fact amongst physicians (family physicians, general internists, cardiologists and vascular surgeons) in managing these patients in Saudi Arabia is not currently known. This study was conducted to examine the perceptions and knowledge of risk reduction therapy in patients with AD amongst physicians in Saudi Arabia in two clinical presentations; coronary artery disease (CAD) and peripheral artery disease (PAD).. We conducted a cross-sectional self-administered survey of 897 physicians at different hospitals in four provinces in Saudi Arabia.. The recommended targets of low density lipoprotein-cholesterol (LDL-C), blood glucose, and blood pressure in patients with CAD and PAD were known as 40% and 36%; 70% and 66%; and 32% and 28% of physicians, respectively. The initiation of antiplatelet medications, angiotensin converting enzyme (ACE) inhibitors, statins, and nicotine replacement therapy for smokers in patients with CAD and PAD were recommended by 98% and 97%; 52% and 34%; 61% and 56%; and 50% and 43% of physicians, respectively. Compared to other specialties, cardiologists had the lowest threshold for initiating risk reduction therapy, whereas vascular surgeons had the highest threshold.. The level of physician awareness of atherosclerosis risk reduction therapy across Saudi Arabia has revealed knowledge and action gaps. A call to action to implement effective strategies to encourage health professionals to use risk reduction therapy and increase public awareness is needed.

Topics: Adult; Angiotensin-Converting Enzyme Inhibitors; Attitude of Health Personnel; Awareness; Biomarkers; Blood Glucose; Blood Pressure; Body Mass Index; Cardiovascular Agents; Cardiovascular Diseases; Chi-Square Distribution; Cholesterol, LDL; Clinical Competence; Coronary Artery Disease; Cross-Sectional Studies; Female; Guideline Adherence; Health Knowledge, Attitudes, Practice; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Middle Aged; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Practice Patterns, Physicians'; Risk Assessment; Risk Factors; Risk Reduction Behavior; Saudi Arabia; Smoking; Smoking Cessation; Surveys and Questionnaires

Topics: Aftercare; Anticoagulants; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Combined Modality Therapy; Endovascular Procedures; Extremities; Humans; Ischemia; Meta-Analysis as Topic; Minimally Invasive Surgical Procedures; Multicenter Studies as Topic; Peripheral Arterial Disease; Postoperative Complications; Radiography, Interventional; Randomized Controlled Trials as Topic; Risk; Thrombophilia; Vascular Surgical Procedures

To investigate whether cilostazol reduces restenosis and revascularization after infrapopliteal angioplasty.. This study was a retrospective analysis of a multicenter prospective registry.. Between February and April 2011, 63 patients (68 limbs, 101 lesions) with critical limb ischemia (CLI) were enrolled. Of these, 32 were cilostazol treated and 31 were the non-cilostazol-treated group. Outcome measures were binary restenosis by angiogram, reocclusion, target lesion revascularization (TLR), limb salvage rate and complete wound healing at 3 months.. Procedural success was obtained in all patients. The backgrounds and lesion characteristics of patients with isolated tibial artery disease and CLI did not differ significantly between the two groups. In a lesion-based analysis, binary restenosis and reocclusion were significantly lower in the cilostazol group than in the non-cilostazol group (56.8% vs. 86.0%; p = 0.015, 20.5% vs. 43.6%; p = 0.015, respectively). The TLR was also significantly lower in the cilostazol group (27.5% vs. 52.8%, p = 0.014). After adjustment for covariables, cilostazol was found to be associated with reduced angiographic restenosis, reocclusion and TLR rates in CLI patients at 3 months after infrapopliteal angioplasty. However, it remained unclear whether cilostazol was also associated with improved clinical outcomes.. Cilostazol may be associated with reduced restenosis, reocclusion and clinically driven TLR at 3 months after infrapopliteal angioplasty.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Chi-Square Distribution; Cilostazol; Constriction, Pathologic; Female; Humans; Ischemia; Japan; Limb Salvage; Logistic Models; Male; Peripheral Arterial Disease; Popliteal Artery; Radiography; Registries; Retrospective Studies; Secondary Prevention; Tetrazoles; Time Factors; Treatment Outcome; Wound Healing

We report a prospective 2-year, multicenter study of patients presenting with intermittent claudication (IC; ankle brachial blood pressure index, ABPI ≤ 0.9). Mean age of the 473 patients enrolled was 68 years, 20% were diabetics, 30% had prior symptomatic coronary heart disease (CHD), 7% had prior stroke, and 39% were current smokers. At baseline, 26.2% of patients had BP ≤ 140/85 mm Hg or lower and at 2 years this figure was 32.5% (P = .01). Current smokers had fallen to 27% (from 39%) at 2 years (P < .001). Use of antiplatelet agents, statins, and angiotensin converting enzyme inhibitors increased significantly during the course of the study as did claudication distance. Death and the composite of death, stroke or myocardial infarction (MI), occurred in 8.4% and 11.6% of patients, respectively. Prognosis was worse in patients with prior history of CHD, older age, those with diabetes and a lower ABPI.

Topics: Aged; Ambulatory Care; Cardiovascular Agents; Female; Humans; Intermittent Claudication; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Registries; Risk Factors; Survival Rate; Time Factors; United Kingdom

To examine the current medical management of arteriopathic patients attending a vascular surgical service at a university teaching hospital over a 6-month period. The prescribing of antiplatelets, statins, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers and beta-blockers was specifically examined. Vascular patients are often under the care of multiple specialties, and therefore the influence of different medical specialties on the patients' medical management was also examined.. Between January and June 2009, data were recorded on sequential patients with arterial disease attending the vascular surgical service. Patients' demographics, type of arterial disease, medical consultations within the previous 12 months, and current medications were recorded.. The study included 180 patients with a mean age of 69 years (39-88 years). All but 4% were taking an antiplatelet or anticoagulant, predominantly aspirin. There were 86% taking a statin, 44% taking a beta-blocker, and 51% taking an ACE inhibitor. Suboptimal prescription of ACE inhibitors and beta-blockers was evident regardless of the type of medical consultations in the previous year. No specialty group differed significantly from vascular surgeons in their prescribing pattern.. While almost all arteriopaths receive some form of antiplatelet and statin in line with clinical evidence, ACE inhibitors and beta-blockers appear to be under-prescribed in this arteriopathic population. We conclude that opportunity exists for vascular surgeons to embrace recent guidelines and lead the way in both surgical and medical optimization of arteriopathic patients through improving links with primary care physicians or taking greater responsibility themselves for the medical as well as the surgical care of their arteriopathic patients.

Topics: Adrenergic beta-Antagonists; Adult; Aged; Aged, 80 and over; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Agents; Drug Therapy, Combination; Drug Utilization; Female; Guideline Adherence; Hospitals, University; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Ireland; Male; Middle Aged; Outpatient Clinics, Hospital; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Practice Patterns, Physicians'; Prospective Studies; Referral and Consultation; Vascular Surgical Procedures

Peripheral arterial disease (PAD) is associated with an increased risk of early death in cardiovascular (CV) disease. The majority of PAD subjects are asymptomatic with a prevalence of 11 per cent among the elderly. Long-term drug prevention aiming to minimize disease progression and CV events in these subjects is probably beneficial, but expensive. The purpose of this analysis was to evaluate the cost-effectiveness of pharmacological risk reduction in subclinical PAD. Long-term costs and quality-adjusted life years (QALYs) were estimated by employing a decision-analytic model for ACE-inhibitor, statin, aspirin and non-aspirin anti-platelet therapy. Rates of CV events without treatment were derived from epidemiological studies and event rate reduction were retrieved from clinical trials. Costs and health-related quality of life estimates were obtained from published sources. All four drugs reduced CV events. Using ACE-inhibition resulted in a heart rate (HR) of 0.67 (95% CI: 0.55-0.79), statins 0.74 (0.70-0.79), and clopidogrel 0.72 (0.43-1.00). Aspirin had a HR of 0.87 and the 95% CI passed included one (0.72-1.03). ACE-inhibition was associated with the largest reduction in events leading to the highest gain in QALYs (7.95). Furthermore, ACE-inhibitors were associated with the lowest mean cost €40.556. In conclusion, while all drugs reduced CV events, ACE-inhibition was the most cost-effective. These results suggest that we should consider efforts to identify patients with asymptomatic PAD and, when identified, offer ACE-inhibition.

Topics: Aged; Angiotensin-Converting Enzyme Inhibitors; Asymptomatic Diseases; Cardiovascular Agents; Cardiovascular Diseases; Cost-Benefit Analysis; Decision Support Techniques; Drug Costs; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Middle Aged; Models, Economic; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Preventive Health Services; Quality-Adjusted Life Years; Registries; Risk Assessment; Risk Factors; Sweden; Time Factors; Treatment Outcome

We compared the prevalence and management of metabolic syndrome (MetS) and its components in men and women with peripheral artery disease (PAD). A total of 70 men and 70 women with PAD were evaluated for presence of MetS. There was no significant gender difference in presence of MetS (P = .399) and the number of MetS components (P = .411). Among PAD patients with each MetS component, there was no significant gender difference in the use (P = .617) and number (P = .716) of blood pressure medications, the use (P = .593) and number (P = .591) of lipid-lowering medications, and the number (P = .155) of diabetic medications. Significantly more women were treated with diabetic medications compared with men (85 vs 57%, P = .026). The prevalence and management of MetS and its components was similar between men and women with PAD, except that more women were treated for diabetes. Patients with PAD having MetS did not receive optimal medical management.

Topics: Aged; Cardiovascular Agents; Cross-Sectional Studies; Female; Follow-Up Studies; Humans; Hypoglycemic Agents; Intermittent Claudication; Male; Metabolic Syndrome; Peripheral Arterial Disease; Prevalence; Risk Factors; Sex Distribution; Sex Factors; Treatment Outcome; United States

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Diagnostic Imaging; Endovascular Procedures; Exercise Therapy; Female; Humans; Male; Medical History Taking; Middle Aged; Peripheral Arterial Disease; Physical Examination; Prognosis; Reperfusion; Risk Assessment; Risk Factors; Vascular Surgical Procedures

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Drug Delivery Systems; Equipment Design; Humans; Peripheral Arterial Disease; Radiography; Recurrence; Time Factors; Treatment Outcome

Patients with peripheral atherosclerotic disease often have multiple affected vascular beds (AVB), however, data on long-term follow-up and medical therapy are scarce. We assessed the prevalence and prognostic implications of polyvascular disease on long-term outcome in symptomatic peripheral arterial disease (PAD) patients.. Two thousand nine hundred and thirty-three consecutive patients were screened prior to surgery for concomitant documented cerebrovascular disease and coronary artery disease. The number of AVB was determined. Cardiovascular medication as recommended by guidelines was noted at discharge. Single, two, and three AVB were detected in 1369 (46%), 1249 (43%), and 315 (11%) patients, respectively. During a median follow-up of 6 years, 1398 (48%) patients died, of which 54% secondary to cardiovascular cause. After adjustment for baseline cardiac risk factors and discharge-medication, the presence of 2-AVB or 3-AVB was associated with all-cause mortality (HR 1.3 95% CI 1.2-1.5; HR 1.8 95% CI 1.5-2.2) and cardiovascular mortality (HR 1.5 95% CI 1.2-1.7; HR 2.0 95% CI 1.6-2.5) during long-term follow-up, respectively. Patients with 2- and 3-AVB received extended medical treatment compared with 1-AVB at the time of discharge.. Polyvascular atherosclerotic disease in PAD patients is independently associated with an increased risk for all-cause and cardiovascular mortality during long-term follow-up.

Topics: Aged; Cardiovascular Agents; Cerebrovascular Disorders; Coronary Artery Disease; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Peripheral Arterial Disease; Postoperative Care; Prognosis; Retrospective Studies; Risk Factors

Studies in the primary care setting are of high interest for assessing the management situation of patients with manifestations of atherothrombosis.. Therefore, we documented diagnostic procedures, characteristics, and management of patients with symptomatic and asymptomatic peripheral arterial disease (PAD).. Prospective cross-sectional study in primary care practices throughout Germany.. A total of 671 patients with newly diagnosed PAD were included (mean age 69.1 years; 62.1% men). Cardiovascular risk factors were highly prevalent in the total PAD group: arterial hypertension in 84.2%, hyperlipidaemia in 75.5%, present smoking in 45.0% and diabetes mellitus in 47.3%. Atherothrombotic comorbidities were also frequent: coronary artery disease in 44.9% and cerebrovascular disease in 28.1%. For confirmation of diagnosis, patients were referred to specialists in 66.9% of cases. Overall, ankle brachial index was measured in 89.0%, and a clinical PAD score assessed in 66.6% (agreement of both measures with Cohen's kappa only, kappa = 0.039; p = 0.209). Drug treatment of risk factors (as secondary prophylaxis) in line with current guidelines was reported in a high percentage of patients: 88.6% with any antiplatelet drug, 69.3% with statins, 62.4% with angiotensin converting enzyme inhibitors, 23.5% with AT(1) receptor blockers and 43.9% with beta-blockers. Between asymptomatic and symptomatic PAD, differences in the risk factor/comorbidity profiles were small; however, the latter group received intensified treatment.. Our findings confirm that patients with PAD pose a substantial challenge to physicians because of their high number of comorbidities. Compared with previous studies, management of such patients appears to have improved.

Topics: Adult; Aged; Aged, 80 and over; Arteriosclerosis; Cardiovascular Agents; Cross-Sectional Studies; Female; Humans; Male; Middle Aged; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Prospective Studies; Risk Factors; Thrombosis

Topics: Aged; Ankle Brachial Index; Aspirin; Cardiovascular Agents; Cardiovascular Diseases; Clinical Trials as Topic; Diabetes Complications; Diabetes Mellitus, Type 2; Evidence-Based Medicine; Female; Humans; Male; Middle Aged; Patient Selection; Peripheral Arterial Disease; Primary Prevention; Time Factors; Treatment Outcome

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

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

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

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

Topics: Cardiovascular Agents; Hypertension; Muscle Relaxants, Central; Peripheral Arterial Disease; Salts; Thromboangiitis Obliterans

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