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Purpose To evaluate longer outcomes of primary nitinol stenting for the treatment of femoropopliteal lesions up to 15 cm long after these stents were found to have superior short-term patency vs. balloon angioplasty. Methods Two hundred and six patients (143 men; mean age 67 years) with intermittent claudication due to superficial femoral and proximal popliteal artery lesions were randomized (2:1) to treatment with nitinol stents or balloon angioplasty at 24 US and European centers and followed for 3 years. In that time, 15 patients died, 20 withdrew consent, and 10 were lost to follow-up, leaving 161 (78.2%) patients for 36-month assessment. Results The 12-month freedom from target lesion revascularization (TLR) was 87.3% for the stent group vs. 45.2% for the angioplasty group (p<0.0001). At 3 years, there was no difference in survival (90.0% vs. 91.7%, p=0.71) or major adverse events (75.2% vs. 75.2%, p=0.98) between the stent and angioplasty groups. Duplex ultrasound was not mandated after the first year, so stent patency could not be ascertained beyond 1 year, but freedom from TLR at 3 years was significantly better in the stent group (75.5% vs. 41.8%, p<0.0001), as was clinical success (63.2% vs. 17.9%, p<0.0001). At 18 months, a 4.1% (12/291) stent fracture rate was documented. Conclusion In this multicenter trial, primary implantation of a nitinol stent for moderate-length lesions in the femoropopliteal segment of patients with claudication was associated with better long-term results vs. balloon angioplasty alone.

Peripheral artery disease is a highly morbid type of atherosclerotic vascular disease involving the legs and is estimated to affect over 230 million individuals globally. Few therapies improve functional capacity and health-related quality of life in people with lower limb peripheral artery disease. We aimed to evaluate whether semaglutide improves function as measured by walking ability as well as symptoms, quality of life, and outcomes in people with peripheral artery disease and type 2 diabetes. STRIDE was a double-blind, randomised, placebo-controlled trial done at 112 outpatient clinical trial sites in 20 countries in North America, Asia, and Europe. Participants were aged 18 years and older, with type 2 diabetes and peripheral artery disease with intermittent claudication (Fontaine stage IIa, able to walk >200 m) and an ankle–brachial index of less than or equal to 0·90 or toe–brachial index of less than or equal to 0·70. Participants were randomly assigned (1:1) using an interactive web response system to receive subcutaneous semaglutide 1·0 mg once per week for 52 weeks or placebo. The primary endpoint was the ratio to baseline of the maximum walking distance at week 52 measured on a constant load treadmill in the full analysis set. Safety was evaluated in the safety analysis set. This trial is registered with ClinicalTrials.gov, NCT04560998 and is now completed. From Oct 1, 2020, to July 12, 2024, 1363 patients were screened for eligibility, of whom 792 were randomly assigned to semaglutide (n=396) or placebo (n=396). 195 (25%) participants were female and 597 (75%) were male. Median age was 68·0 years (IQR 61·0–73·0). The estimated median ratio to baseline in maximum walking distance at week 52 was significantly greater in the semaglutide group than the placebo group (1·21 [IQR 0·95–1·55] vs 1·08 [0·86–1·36]; estimated treatment ratio 1·13 [95% CI 1·06–1·21]; p=0·0004). Six serious adverse events in five (1%) participants in the semaglutide group and nine serious adverse events in six (2%) participants in the placebo group were possibly or probably treatment related, with the most frequent being serious gastrointestinal events (two events reports by two [1%] in the semaglutide group and five events reported by three [1%] in the placebo group). There were no treatment-related deaths. Semaglutide increased walking distance in patients with symptomatic peripheral artery disease and type 2 diabetes. Research implications include the need for future studies to further elucidate mechanisms of benefit and to assess the efficacy and safety in patients with peripheral artery disease who do not have type 2 diabetes. Novo Nordisk.

Implantation of stainless-steel stents for disease of the superficial femoral artery has been associated with high rates of late clinical failure, and balloon angioplasty is therefore the preferred procedure. In this randomized trial, the use of nitinol stents was associated with lower rates of restenosis and better treadmill exercise performance at 6 months and 12 months than was the use of balloon angioplasty. The use of nitinol stents was associated with lower rates of restenosis and better treadmill exercise performance at 6 months and 12 months than was the use of balloon angioplasty. The use of percutaneous transluminal angioplasty to revascularize the superficial femoral artery can result in initial technical success rates of more than 95 percent, with a low risk of complications. 1 However, late clinical failure remains an important concern. Restenosis occurs in 40 to 60 percent of treated segments after one year. 1 – 3 The use of angioplasty to treat extensive disease of the superficial femoral artery has particularly poor results: at one year, the rates of restenosis exceed 70 percent for lesions longer than 100 mm. 4 Endovascular stenting avoids the problems of early elastic recoil, residual stenosis, and flow-limiting dissection after . . .

In a randomized phase 3 trial involving patients with acute intermittent porphyria, the use of givosiran, an oligonucleotide drug designed to target messenger RNA encoding aminolevulinic acid synthase, led to a 74% lower annualized porphyria attack rate than the use of placebo at 6 months.

Background: The effective treatment of chronic lower limb ischemia is one of the most challenging issues confronting vascular surgeons. Current pharmacological therapies play an auxiliary role and cannot prevent disease progression, and new treatment methods are needed. In 2011, a plasmid VEGF65-gene therapy drug was approved in Russia for the treatment of chronic lower limb ischemia (ClinicalTrials.gov identifier: NCT03068585). The objective of this follow-up study was to evaluate the long-term safety and efficacy of gene therapy in patients with limb ischemia of atherosclerotic genesis. Aims: To evaluate the long-term safety and efficacy of the therapeutic angiogenesis, 36 patients in the treatment group (pl-VEGF165) and 12 patients in the control group participated in a 5-year follow-up study. Planned examinations were carried out annually for 5 years after pl-VEGF165 administration. Results: Differences in the frequency of major cardiovascular events (pl-VEGF165 5/36 versus control 2/12; p = 0.85), malignancies (pl-VEGF165 1/36 versus control 0/12; p = 0.38) and impaired vision (there was none in either group) over the 5-year follow-up period did not achieve statistical significance. The target limb salvage was 95% (n = 36) and 67% (n = 12) in the pl-VEGF165 and control groups, respectively. The pain-free walking distance value increased by 288% from 105.7 ± 16.5 m to 384 ± 39 m in the treatment group by the end of the fifth year, with a peak of 410.6 ± 86.1 m achieved by the end of the third year. The ankle-brachial index (ABI) increased from 0.47 ± 0.01 to 0.56 ± 0.02 by the end of the first year, with a subsequent slight decrease to 0.51 ± 0.02 by the fifth year. The maximum increment of transcutaneous oximetry test (tcoO2) by 36%, from 66.6 ± 3.7 mm Hg to 90.7 ± 4.9 mm Hg, was observed by the end of the second year. Conclusion: The therapeutic effect of angiogenesis induction by gene therapy persists for 5 years.

Drug-coated devices are widely used to reduce restenosis after lower limb revascularisation in patients with peripheral artery disease, but their effect on patient-centred outcomes remains unclear. We assessed the effect of paclitaxel-coated devices on clinically important outcomes in patients with intermittent claudication undergoing infrainguinal endovascular revascularisation. The Swedish Drug-Elution Trial in Peripheral Arterial Disease 2 (SWEDEPAD 2) was a pragmatic, nationwide, multicentre, participant-masked, registry-based, randomised controlled trial conducted at 22 Swedish vascular centres. Adults 18 years or older with intermittent claudication (Rutherford categories 1–3) undergoing infrainguinal endovascular treatment and with no acute thromboembolic disease of the lower limb or infrainguinal aneurysmal disease were eligible for inclusion. Participants were randomly assigned in a 1:1 ratio after successful guidewire crossing to receive either paclitaxel-coated devices or uncoated balloons or stents. Randomisation was stratified by centre and performed using a computer-generated sequence with allocation concealment via a secure, registry-embedded web system. The primary efficacy endpoint was the between-group difference in quality of life at 1 year, assessed with the six-item Vascular Quality of Life Questionnaire (VascuQoL-6), a peripheral artery disease-specific quality of life instrument. The trial is registered at ClinicalTrials.gov (NCT02051088) and the primary analysis is complete; further analyses are ongoing. Between Nov 5, 2014, and Sept 27, 2023, a total of 1155 patients were enrolled and randomly assigned across 22 vascular centres in Sweden, of whom 1136 (98·3%) had follow-up data available for analysis. 577 patients were randomly assigned to paclitaxel-coated devices and 578 to uncoated devices, of whom 565 (97·9%) and 571 (98·7%) were included in the intention-to-treat population, respectively. The median age in the analysed cohort was 73·0 years (IQR 68·0–78·0). Of the 1136 patients, 612 (53·9%) were male and 524 (46·1%) were female; and 382 (33·7%) of 1135 had preoperative diabetes (one participant in the paclitaxel-coated device group was missing data). Most patients (677 [59·6%] of 1135) presented with severe claudication (Rutherford category 3). Femoropopliteal interventions were performed in 1092 patients (96·1%). At 1 year, VascuQoL-6 scores did not differ between groups (mean difference –0·02 [95% CI –0·66 to 0·62]; p=0·96). All-cause mortality did not differ over a median 7·1 years (IQR 3·9–8·2); hazard ratio (HR) 1·18 (95% CI 0·94–1·48); p=0·16, although 5-year mortality incidence was higher in patients randomly assigned to the paclitaxel-coated devices group (4·57 vs 3·28 per 100 person-years; HR 1·47 [95% CI 1·09–1·98]; p=0·010). In patients with Rutherford stage 1–3 peripheral artery disease undergoing infrainguinal endovascular revascularisation, paclitaxel-coated devices did not improve disease-specific quality of life at 1 year compared with uncoated devices. All-cause mortality was not different over the total follow-up time, but significantly higher over 5 years. These findings do not support routine use of paclitaxel-coated devices in this patient population. The Swedish Research Council, the Swedish Heart Lung Foundation, the Swedish state under the agreement between the Swedish Government and the county councils.

Purpose Study aimed to compare incidence of urinary tract infection (UTI), type of bacteria grown, development of antibiotic resistance over 2 years in children whose caregivers underwent training based on the Roy Adaptation Model with an android phone application for patients clean intermittent catheterization (RAMACIC) versus those whose caregivers received routine training in hospital. Method This study was conducted as a descriptive, prospective study with 40 patients and caregivers between October 2021 and 2023 as a continuation of a previously conducted randomized controlled experimental study by the researchers. Data were collected the “Participant Form,” and “Urine Test Form” analyzed with the SPSS 22 package. Descriptive data were determined by number (n), percentage (%), mean, and standard deviation. The frequency of UTI between the two groups was determined by the Chi-square test, and the effect size of the data was determined by Cramer’s V value of the Chi-square test. Results A significant reduction in UTI incidence among children of RAMACIC-trained caregivers during the first, second, third, and fourth 6-month periods compared with those under routine CIC training was observed ( p  < 0.05). It was determined that E. coli was the most frequently grown bacteria in both groups, with a higher rate in the group receiving routine training in the hospital, and antibiotic resistance was higher in the group receiving routine training in the hospital compared with RAMACIC. Conclusion RAMACIC, when administered to caregivers, effectively lowers the long-term risk of UTI development in patients undergoing CIC, also effective in reducing the antibiotic resistance that developed in patients.

Background People with lower extremity peripheral artery disease (PAD) suffer from a high burden of symptoms and significant functional impairment. There are few therapies that improve function and reduce symptoms in this population. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have been shown to improve glycaemic control, reduce body weight, and reduce the risk of major adverse cardiovascular events in people with atherosclerotic cardiovascular disease and type 2 diabetes (T2D). Methods and results STRIDE (NCT04560998) is a randomized, placebo-controlled, double-blind phase 3b trial evaluating 1 mg once-weekly subcutaneous semaglutide (GLP-1 RA) vs. placebo, in people with symptomatic PAD (Fontaine IIa claudication) and T2D. Eligible participants were ≥18 years, had haemodynamically stable PAD, had no planned intervention, and were not receiving a GLP-1 RA. The primary endpoint is change in maximum walking distance on a constant-load treadmill (CLT). Secondary endpoints include quality of life and cardiometabolic assessments. A total of 792 participants were randomized in 20 countries. Participants’ median age was 68 and median T2D duration 12 years. Risk factors included 25.6% current smokers, 87.9% with hypertension, and 42.7% with coronary heart disease. The mean BMI was 29.6 kg/m2 and the mean HbA1C was 7.3%. Participants exhibited baseline functional impairment with a median maximum walking distance of 186 m on a CLT. Conclusion STRIDE has enrolled participants with symptomatic PAD and T2D, frequent risk factors and comorbidities, and functional impairment. The trial will provide evidence for the functional outcomes with semaglutide in people with PAD and T2D. Graphical Abstract Graphical Abstract Overview of the STRIDE trial design and characteristics of participants at baseline.

Background Inflammation is the driving force in atherosclerosis. One central strategy in the treatment of peripheral arterial disease (PAD) is the promotion of angiogenesis. Here, proangiogenic Tie-2 expressing monocytes (TEM) and circulating angiogenic cells (CAC) play a crucial role. Exercise training (ET) is recommended in PAD patients at Fontaine stage II to promote angiogenesis. Methods 40 patients with intermittend claudication (IC) [2 groups: supervised ET (SET) vs. non-supervised ET (nSET), each n  = 20] and 20 healthy controls were included in the study. Analysis of TEM and CAC was performed from whole blood by flow-cytometry. TEM were identified via CD45, CD86, CD14, CD16 and analysed for the expression of Tie-2. CAC were identified via their expression of CD45 (CD45dim), CD34 and VEGF-R2 (CD309/KDR). Follow up was performed after mean of 7.65 ± 1.62 months. Results In comparison to healthy controls, we found increased proportions of CAC ( p  < 0.0001) and similar TEM numbers in both ET groups. At follow-up (FU) TEM poroportions increased ( p  < 0.001) and CAC proportions decreased (p < 0.01), but both more significantly in SET ( p  < 0.001) than nSET ( p  = 0.01). Only in SET fibrinogen levels decreased and VEGF-A increased (both p  < 0.05). Finally, we found in both ET groups a significant increase in absolute walking distance but with a higher individual increase in SET ( p  < 0.01). TEM and CAC proportions correlated inversely with the absolute walking distance (CAC: r  = −0.296, p  = 0.02; TEM: r  = −0.270, p  = 0.04) as well as with ABI (CAC: r  = −0.394, p  < 0.01; TEM: r  = −0.382, p  < 0.01). Conclusions ET influences the distribution of CAC and TEM proportions. nSET, although still effective in regard to an improved walking distance, is less effective in the influence of proangiogenic cells and inflammatory burden than SET. Our results indicate SET to be a more preferential exercise form, supporting the necessity to establish more SET programs.