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Among older men in Denmark, the incidence of death from any cause at a median follow-up of 5.6 years was not significantly lower among those randomly invited to undergo screening for subclinical cardiovascular disease.

Abdominal aortic aneurysm is the only cardiovascular disease targeted by population screening. In this study, we test the effect of screening and subsequent intervention for abdominal aortic aneurysm, peripheral arterial disease, and hypertension combined. In this randomised controlled trial, we randomly allocated (1:1) all men aged 65–74 years living in the Central Denmark Region to screening for abdominal aortic aneurysm, peripheral arterial disease, and hypertension, or to no screening. We based allocation on computer-generated random numbers from 1 to 100 in blocks of 1067 to 4392, stratified by 19 municipalities. Only the non-screening group and the investigator assessing outcomes were masked. We invited participants who were found to have abdominal aortic aneurysm or peripheral arterial disease back for confirmation and eventual initiation of relevant pharmacological therapy. We further offered participants with abdominal aortic aneurysm annual control or surgical repair. We referred participants with suspected hypertension to their general practitioner. The primary outcome was all-cause mortality, assessed 5 years after randomisation, analysed in all randomly allocated participants except for those who had incorrect person identification numbers. This trial is registered at ClinicalTrials.gov, number NCT00662480. Between Oct 8, 2008, and Jan 11, 2011, we randomly allocated 50 156 participants, with 25 078 (50%) each in the screening and non-screening groups. Four (<1%) participants in the screening group were lost to follow-up. After a median follow-up of 4·4 years (IQR 3·9–4·8), 2566 (10·2%) of 25 074 participants in the screening group and 2715 (10·8%) of 25 078 in the non-screening group had died. This finding resulted in a significant hazard ratio of 0·93 (95% CI 0·88–0·98; p=0·01), an absolute risk reduction of 0·006 (0·001–0·011), and a number needed to invite of 169 (89–1811). Incidences of diabetes (3995 per 100 000 person-years in the screening group vs 4129 per 100 000 person-years in the non-screening group), intracerebral haemorrhage (146 vs 140), renal failure (612 vs 649), cancer (3578 vs 3719), or 30 day mortality after cardiovascular surgery (44·57 vs 39·33) did not differ between groups. The observed reduction of mortality risk from abdominal aortic aneurysm, peripheral arterial disease, and hypertension has never been seen before in the population screening literature and can be linked primarily to initiation of pharmacological therapy. Health policy makers should consider implementing combined screening whether no screening or isolated abdominal aortic aneurysm screening is currently offered. The 7th European Framework Programme, Central Denmark Region, Viborg Hospital, and the Danish Council for Independent Research.

Purpose: To compare the safety and efficacy of laser debulking (LD) and drug-eluting balloon (DEB) angioplasty to treatment with DEB angioplasty alone in patients affected by critical limb ischemia (CLI) and superficial femoral artery (SFA) chronic stent occlusion in a prospective, randomized study. Methods: Among 448 CLI patients treated from December 2009 to March 2011, 48 patients (39 men; mean age 72.7±7.8 years) with chronic SFA in-stent occlusion were randomly assigned to treatment using LD+DEB (n=24) or DEB angioplasty alone (n=24). Patency at 12 months was the primary outcome measure; secondary outcomes were target lesion revascularization (TLR) and clinical success at 12 months. Results: In the LD+DEB group, the patency rates at 6 and 12 months (91.7% and 66.7%, respectively) were significantly higher (p=0.01) than in the DEB only patients (58.3% and 37.5%, respectively). TLR at 12 months was 16.7% in the LD+DEB group and 50% in the DEB only group (p=0.01). Two (8%) patients needed major amputations in the LD+DEB group vs. 11 (46%) in the DEB only group at 12 months (p=0.003). Conclusion: In this small initial experience, combined treatment with LD and DEB angioplasty is correlated with better outcomes in CLI patients with occluded SFA stents.

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).

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.

Purpose: To compare clinical and hemodynamic outcome in patients undergoing treatment of common femoral artery (CFA) atherosclerotic lesions by bioabsorbable stent implantation (BASI group) or by common femoral artery endarterectomy (CFE group). Methods: A randomized, controlled, single-center, open-label trial was initiated to compare outcomes of BASI or CFE in patients with chronic atherosclerotic occlusive lesions in the CFA. From May 2011 to April 2013, 116 consecutive patients were recruited; after excluding 36 patients, 80 patients (52 men; mean age 72.2±9.6 years) were enrolled 1:1 and are the subject of this intention-to-treat interim analysis (40 patients in each group). The primary endpoint was surgical site infections; secondary outcome measures were technical success, hemodynamic improvement, clinical improvement, patency, limb salvage, and survival. Results: There was no statistically significant difference between both groups regarding demographic data, cardiovascular risk factors, or CFA occlusions. The CFE patients presented with 7 surgical site infections (all minor) vs. none in the BASI group (p=0.002) and a longer mean postoperative hospital stay of 7 vs. 2 days for BASI patients (p<0.001). Technical success rates were 97.5% and 100% for the BASI and CFE groups, respectively. Postoperative ankle-brachial index means were comparable (p=0.38). The 30-day primary patency rates were 92.5% and 100% for the BASI and CFE groups, respectively (p=0.038). There were 6 reconstruction failures in CFE patients vs. none in the BASI group (p=0.02); 5 failures involved initial CFA occlusions. At 1 year, the primary and secondary patency rates were 80% vs. 100% (p=0.007) and 84% vs. 100% (p=0.01) for BASI and CFE patients, respectively. Limb salvage was equivalent, and survival rates were 88% and 90% for BASI vs. CFE patients (p=0.51) at 1 year. Conclusion: This interim analysis suggests that BASI is not an option for CFA occlusion and is only a limited option for CFA stenosis. Clinical and hemodynamic results are comparable for BASI and CFE. An increased rate of redo procedures in the BASI patients outweighs lower surgical site infection rates compared to CFE. Short-term patency rates are significantly worse in patients undergoing CFA stenting with BASI.

Abstract Aims To determine the characteristics of patients with coronary artery disease (CAD), peripheral artery disease (PAD), or both, initiating dual pathway inhibition (DPI) using rivaroxaban 2.5 mg twice daily plus aspirin, and to report their clinical outcomes and bleeding rates in clinical practice compared to the COMPASS randomized trial, which provided the basis for using DPI in this patient population. Methods and results XATOA is a prospective registry of 5532 patients: of which, 72.7% had CAD, 58.9% had PAD, and 31.6% had both. The mean age of patients was 68 years and 25.5% were women. The mean follow-up period was 15 months. The most frequently reported reason for initiating DPI was the presence of existing, worsening or newly diagnosed risk characteristics (n = 4753, 85.9%). Before initiating DPI, 75.3% received a single antiplatelet and 18.3% received various antiplatelet combinations. The incidence of major adverse cardiovascular events (MACE), major adverse limb events (MALE) and acute or severe limb ischaemia was 2.26, 3.57, and 1.54 per 100 patient-years, respectively, among the 5532 patients in XATOA. Corresponding rates in COMPASS were 2.18, 0.19, and 0.12 per 100 patient-years, respectively. Major bleeding rates were 0.95 and 1.67 per 100 patient-years in XATOA and COMPASS, respectively. Conclusion High-risk vascular patients are prioritized for DPI in clinical practice, and rates of MACE are similar to COMPASS, but MALE rates are higher in XATOA, consistent with the greater proportion of PAD patients. Major bleeding rates were lower in XATOA. The findings provide support for favourable net clinical benefit of DPI in high-risk vascular patients. One-sentence summary The characteristics of patients initiated on dual pathway inhibition (DPI: rivaroxaban 2.5  mg twice daily plus aspirin) have not previously been defined in clinical practice and the XATOA registry findings demonstrate patient outcomes are consistent with those of the COMPASS trial, despite geographic differences in recruitment and the higher proportion of PAD patients.

Background 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. Methods 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. Discussion 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. Trial registration ISRCTN Registry, identifier: ISRCTN14469736 . Registered on 22 October 2015.

The aim of this secondary analysis of ELIMIT (The Effect of Lipid Modification on Peripheral Artery Disease after Endovascular Intervention Trial) was to determine longitudinal changes over 24 months in skeletal thigh muscle volumes and individual muscle compartments in patients with peripheral artery disease (PAD) with and without diabetes. A total of 48 patients with available magnetic resonance imaging of the distal superficial femoral artery at baseline and 2 years were included in this analysis. Muscle volumes and superficial femoral artery wall, lumen, and total vessel volumes were quantified. Intrareader reproducibility of muscle tracings was assessed with the intraclass correlation coefficient using a 2-way model. Baseline characteristics were similar between patients with PAD with and without diabetes, except for smoking history (p = 0.049), cholesterol levels (p <0.050), and calf walking pain (p = 0.049). Interobserver reproducibility of the muscle volume tracings was excellent for all muscle groups (all intraclass correlation coefficients >0.86, confidence interval 0.69 to 0.94). Total muscle and total leg volumes increased significantly between baseline and 24 months among patients with PAD without diabetes (31 ± 6.4 cm3 vs 32 ± 7.0 cm3, p <0.001; 18 ± 4.4 cm3 vs 19 ± 4.8 cm3, p = 0.045), whereas there was no change in patients with PAD and diabetes. Total muscle volume was inversely associated with age and body mass index in patients with PAD both with and without diabetes (p <0.05). In conclusion, magnetic resonance imaging–quantified thigh muscle volumes are highly reproducible and may be of interest in assessing PAD patients with and without diabetes.

Purpose To present the 12-month results of a trial investigating the effects of dual antiplatelet therapy on target lesion revascularization (TLR) after balloon angioplasty ± stenting in the femoropopliteal segment. Methods A prospective, randomized, single-center, double-blinded and placebo-controlled clinical trial randomly assigned 40 patients to receive pre- and postinterventional therapy with aspirin and clopidogrel. Another 40 patients received the same doses of aspirin and placebo instead of clopidogrel. Clopidogrel and placebo were stopped after 6 months, and patients remained on aspirin only. At 12 months after the intervention, 36 clopidogrel patients and 37 placebo patients were reevaluated. Results At 6 months, clopidogrel patients had significantly lower rates of TLR compared to placebo patients [2 (5%) vs. 8 (20%), p=0.04]. After stopping clopidogrel/placebo after 6 months, there was no significant difference in TLR at 12 months after treatment [9 (25%) clopidogrel vs. 12 (32.4%) placebo, p=0.35]. Mortality was 0 vs. 1 in the placebo group at 6 months (p=0.32) and 0 vs. 3 at 12 months (p=0.08). Conclusion In contrast to the first report of a reduction in the TLR at 6 months, this advantage of dual antiplatelet therapy does not persist after stopping clopidogrel. Prolonged dual therapy (>6 months) should be considered in patients who are at high risk for restenosis.