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Patients with peripheral artery disease were randomly assigned to receive endovascular intervention with paclitaxel-coated or uncoated devices. In an unplanned interim analysis, there was no significant difference in all-cause mortality between the two groups.

In this trial, patients with femoropopliteal artery disease were assigned to standard angioplasty or treatment with a paclitaxel-coated balloon. At 12 months, primary patency was seen more frequently with the drug-coated balloon than with standard angioplasty. Atherosclerotic disease in the femoral and popliteal (femoropopliteal) arteries compromises perfusion to the legs and feet. Although treatment with percutaneous transluminal angioplasty is effective in initially restoring blood flow, restenosis from vessel recoil and neointimal hyperplasia occur in more than 60% of patients within 1 year after the procedure. 1 Stents act as scaffolds to prevent recoil and reduce the incidence of restenosis, 2 – 9 but the permanent presence of an intravascular prosthesis may limit subsequent therapeutic options. Stent fracture, although infrequent, can have negative consequences. 10 – 13 Results with drug-eluting stents in peripheral vessels have varied, 14 – 18 although a recent study showed . . .

In patients with peripheral artery disease (PAD), we evaluated the effects of 12 months of walking exercise at a pace inducing ischemic leg symptoms (high intensity) on the attainment of meaningful improvement in patient-reported outcome measures (PROMs) and 6-minute walk, compared to walking exercise at a comfortable pace (low intensity) and a nonexercise control. Participants completed the 6-minute walk test (6MWT) to evaluate objective walking ability. PROMs included the Walking Impairment Questionnaire (WIQ) distance and speed scores (range 0 to 100, 100-best, minimal clinically important difference (MCID) = 15 and 11, respectively). 240 participants (61.7% Black, 48.3% female) participated. High intensity exercise increased 6MWT compared to control (+44.8 meters (95% CI:21.7,68.0) and compared to low-intensity exercise (+37.6 meters [95% CI:18.6,56.5]). Low intensity exercise had no significant benefit compared to control (+7.3 meters [95% CI:-16.3,30.9]). High intensity significantly increased attainment of the MCID for the 6MWT compared to low intensity (OR:2.43 [95% CI:1.35,4.38]) and compared to control (OR:5.22 [95% CI:2.32,11.76]). Compared to control, high intensity exercise significantly increased the odds of attaining an MCID for the WIQ distance score (OR:2.30 [95% CI:1.05,5.04]) and WIQ speed score (OR:2.94 [95% CI:1.27,6.83]). Compared to low intensity, high intensity did not significantly increase the odds of attaining an MCID for the WIQ distance (OR:0.93 [95% CI:0.53,1.66]) or the WIQ speed score (OR:1.31 [95% CI:0.71,2.43]). In conclusion, in people with PAD, high intensity walking exercise increased the odds of meaningful improvement in PROMs compared to control, but not compared to low-intensity exercise. Despite this, high intensity exercise improved 6MWT more than the low intensity exercise and nonexercise control groups (NCT02538900).

Patients with peripheral artery disease who underwent revascularization were randomly assigned to receive rivaroxaban (2.5 mg twice daily) or placebo. All patients received aspirin. The primary outcome of acute limb ischemia, major amputation for vascular causes, MI, ischemic stroke, or cardiovascular death occurred less frequently with rivaroxaban.

Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential of dabigatran to prevent major vascular complications among such patients. In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial design, patients not taking a proton-pump inhibitor were also randomly assigned (1:1) to omeprazole 20 mg once daily, for which results will be reported elsewhere, or matched placebo to measure its effect on major upper gastrointestinal complications. Research personnel randomised patients through a central 24 h computerised randomisation system using block randomisation, stratified by centre. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary efficacy outcome was the occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening, major, and critical organ bleeding. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01661101. Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive dabigatran (n=877) or placebo (n=877); 556 patients were also randomised in the omeprazole partial factorial component. Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to placebo. The composite primary efficacy outcome occurred in fewer patients randomised to dabigatran than placebo (97 [11%] of 877 patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to placebo; hazard ratio [HR] 0·72, 95% CI 0·55–0·93; p=0·0115). The primary safety composite outcome occurred in 29 patients (3%) randomised to dabigatran and 31 patients (4%) randomised to placebo (HR 0·92, 95% CI 0·55–1·53; p=0·76). Among patients who had MINS, dabigatran 110 mg twice daily lowered the risk of major vascular complications, with no significant increase in major bleeding. Patients with MINS have a poor prognosis; dabigatran 110 mg twice daily has the potential to help many of the 8 million adults globally who have MINS to reduce their risk of a major vascular complication. Boehringer Ingelheim and Canadian Institutes of Health Research.

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.

Chronic limb-threatening ischemia (CLTI) is a major public health problem. Low-intensity pulsed ultrasound (LIPUS) has been shown to improve ischemic limb conditions in patients with CLTI. However, the possible mechanisms of these benefits require further understanding. A total of 37 atherosclerotic peripheral artery disease patients with CLTI (Fontaine class III or IV) who were not suitable for standard revascularization therapies were enrolled. Patients were treated with LIPUS daily for 20 min. Clinical parameters were evaluated at baseline and after 4 weeks and 12 weeks of treatment with LIPUS. Rest pain intensity on a visual analog scale (P = 0.018), walking impairment questionnaire score (P < 0.001), skin perfusion pressure (P < 0.001), flow-mediated vasodilation (P < 0.001), nitroglycerine-induced vasodilation (P = 0.002), white blood cell count (P = 0.013), ALT (P = 0.001), AST (P = 0.017), and high-sensitivity C-reactive protein (P = 0.011) were significantly improved after LIPUS treatment. None of the patients withdrew from the study due to adverse effects associated with LIPUS. During a mean follow-up period of 91.4 ± 49.0 months, the rate of survival was 88.9% at 1 year and the rate of limb survival was 88.6% at 1 year. LIPUS exposure may have favorable effects on clinical symptoms, inflammation, perfusion parameters, and vascular function in patients with CLTI and it can be used safely. Clinical Trial Registration Information: URL for Clinical Trial: https://www.umin.ac.jp/ctr/index.htm ; Registration Number for Clinical Trial: UMIN000004901, UMIN000014757; https://jrct.niph.go.jp/search ; Registration Number for Clinical Trial: jRCTs062200008.

In a trial involving patients with infrapopliteal artery disease, the use of a drug-eluting resorbable scaffold was superior to angioplasty in reducing reintervention and maintaining patency at 1 year.

Background Peripheral arterial disease (PAD) is known to be associated with high cardiovascular risk, but the individual impact of PAD presentations on risk of macrovascular and microvascular events has not been reliably compared in patients with type 2 diabetes. We aimed to evaluate the impact of major PAD, and its different presentations, on the 10-year risk of death, major macrovascular events, and major clinical microvascular events in these patients. Methods Participants in the action in diabetes and vascular disease: PreterAx and DiamicroN modified-release controlled evaluation (ADVANCE) trial and the ADVANCE-ON post-trial study were followed for a median of 5.0 (in-trial), 5.4 (post-trial), and 9.9 (overall) years. Major PAD at baseline was subdivided into lower-extremity chronic ulceration or amputation secondary to vascular disease and history of peripheral revascularization by angioplasty or surgery. Results Among 11,140 participants, 516 (4.6 %) had major PAD at baseline: 300 (2.7 %) had lower-extremity ulceration or amputation alone, 190 (1.7 %) had peripheral revascularization alone, and 26 (0.2 %) had both presentations. All-cause mortality, major macrovascular events, and major clinical microvascular events occurred in 2265 (20.3 %), 2166 (19.4 %), and 807 (7.2 %) participants, respectively. Compared to those without PAD, patients with major PAD had increased rates of all-cause mortality (HR 1.35, 95 % CI 1.15–1.60, p = 0.0004), and major macrovascular events (1.47 [1.23–1.75], p < 0.0001), after multiple adjustments for region of origin, cardiovascular risk factors and treatments, peripheral neuropathy markers, and randomized treatments. We have also observed a trend toward an association of baseline PAD with risk of major clinical microvascular events [1.31 (0.96–1.78), p = 0.09]. These associations were comparable for patients with a lower-extremity ulceration or amputation and for those with a history of peripheral revascularization. Furthermore, the risk of retinal photocoagulation or blindness, but not renal events, increased in patients with lower-extremity ulceration or amputation [1.53 (1.01–2.30), p = 0.04]. Conclusions Lower-extremity ulceration or amputation, and peripheral revascularization both increased the risks of death and cardiovascular events, but only lower-extremity ulceration or amputation increased the risk of severe retinopathy in patients with type 2 diabetes. Screening for major PAD and its management remain crucial for cardiovascular prevention in patients with type 2 diabetes (ClinicalTrials.gov number, NCT00949286).

AbstractObjectiveTo determine which primary endovascular revascularisation strategy represents the most clinically effective treatment for patients with chronic limb threatening ischaemia who require endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.DesignThree arm, open label, pragmatic, multicentre, randomised, phase 3 superiority trial (BASIL-3).Setting35 UK NHS vascular units.ParticipantsPatients with chronic limb threatening ischaemia who required endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.InterventionsParticipants were randomly assigned (1:1:1) to femoro-popliteal plain balloon angioplasty with or without bare metal stenting (PBA±BMS), drug coated balloon angioplasty with or without bare metal stenting (DCBA±BMS), or drug eluting stenting (DES) as their first revascularisation strategy.Main outcome measuresThe primary outcome was amputation free survival defined as time to first major amputation or death from any cause. Secondary outcomes included the composite components of the primary outcome, major adverse limb events, major adverse cardiac events, and other prespecified clinical and patient reported outcome measures. Serious adverse events were collected up to 30 days after the first revascularisation procedure.ResultsBetween 29 January 2016 and 31 August 2021, 481 participants were randomised (167 (35%) women, mean age 71.8 years (standard deviation 10.8)). Major amputation or death occurred in 106 of 160 (66%) participants in the PBA±BMS group, 97 of 161 (60%) in the DCBA±BMS group, and 93 of 159 (58%) in the DES group (adjusted hazard ratios: PBA±BMS v DCBA±BMS: 0.84, 97.5% confidence interval 0.61 to 1.16, P=0.22; PBA±BMS v DES: 0.83, 0.60 to 1.15, P=0.20). No differences in serious adverse events were reported between the groups.ConclusionsNeither DCBA±BMS nor DES conferred significant clinical benefit over PBA±BMS in the femoro-popliteal segment in patients with chronic limb threatening ischaemia undergoing endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.Trial registrationISRCTN registry ISRCTN14469736