Project description:PurposeOnly a few Asian studies have discussed the impact of statin intensity on clinical outcomes in patients with peripheral artery disease (PAD). We aimed to investigate the clinical impact of statin intensity in patients with PAD after endovascular revascularization.Materials and methodsFrom April 2009 to June 2019, 376 patients with lower extremity PAD treated with endovascular revascularization were enrolled. They were classified into three groups according to statin intensity: no-statin, low-to-moderate intensity (LMI), and high-intensity (HI). The primary outcomes were major adverse cardiovascular events (MACE) and major adverse limb events (MALE).ResultsDuring the 40-month follow-up, MACE occurred less frequently in the HI and LMI groups than the no-statin group (11.4% vs. 16.0% vs. 39%, p<0.001). In adjusted Cox models, the HI group had the fewest MACE [hazard ratio (HR): 0.447; 95% confidence interval (CI): 0.244-0.834; p=0.018] and MALE (HR: 0.360; 95% CI: 0.129-1.006; p=0.051) events, while the LMI group had fewer MACE (HR: 0.571; 95% CI: 0.326-1.0; p=0.050) events than the no-statin group. HI statin therapy was associated with better outcomes in terms of MALE (HR: 0.432; 95% CI: 0.223-0.837; p=0.003) than LMI statin therapy after inverse probability treatment weighting analysis.ConclusionHI and LMI statin use is associated with a significant reduction in MACE events than no-statin use. HI statin use was associated with better MALE outcomes than no-statin or LMI statin use.
Project description:BackgroundCurrently, the main treatment for lower extremity artery disease (LEAD) is revascularization, including endovascular revascularization (EVR) and open surgical revascularization (OSR), but the specific revascularization strategy for LEAD is controversial. This review provided the comprehensive and recent evidence for the treatment of LEAD.MethodsMedline, Embase, and the Cochrane Library databases were searched for relevant articles. Randomized controlled trials (RCTs) and cohort studies comparing the short-term or long-term outcomes between EVR and OSR of LEAD were identified. Short-term outcomes were 30-day mortality, major amputation, wound complication, major adverse cardiovascular events (MACEs), and length of hospital stay (LOS), while long-term outcomes included overall survival (OS), amputation-free survival (AFS), freedom from re-intervention (FFR), primary patency (PP), and secondary patency (SP).Results11 RCTs and 105 cohorts involving 750,134 patients were included in this analysis. For the pooled results of cohort studies, EVR markedly decreased the risk of 30-day mortality, wound complication, MACEs, LOS, but increased the risk of OS, FFR, PP, and SP. For the pooled outcomes of RCTs, EVR was associated with obviously lower 30-day mortality, less wound complication and shorter LOS, but higher risk of PP, and SP. However, both RCTs and cohorts did not show obvious difference in 30-day major amputation and AFS.ConclusionsBoth the pooled results of cohorts and RCTs indicated that EVR was associated with a lower short-term risk for LEAD, while OSR was accompanied by a substantially lower long-term risk. Therefore, the life expectancy of LEAD should be strictly considered when choosing the revascularization modality. As the current findings mainly based on data of retrospective cohort studies, additional high-quality studies are essential to substantiate these results.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/#recordDetails, identifier CRD42022317239.
Project description:Objectives: Evidence for antithrombotic therapy after endovascular therapy (EVT) is limited. Methods: This retrospective, multicenter, observational study enrolled 732 consecutive patients with lower extremity artery disease who underwent EVT between January 2018 and December 2019. Overall, 570 patients who received single antiplatelet therapy (SAPT) and dual antiplatelet therapy (DAPT) were selected and divided into the SAPT (n = 189) and DAPT (n = 381) groups. The primary outcome was bleeding events at 24 months. The secondary outcomes were bleeding events at 30 days and 24 months after 30 days, ischemic events, and all-cause death at 24 months. Bleeding and ischemic events at 24 months were investigated in subgroups. Results: A propensity score matching yielded 164 patients in both groups. There were no significant differences in bleeding events between the SAPT and DAPT groups (14.2% and 11.3% at 24 months, p = 0.775; 2.5% and 6.1% at 30 days, p = 0.106; 11.7% and 6.7% at 24 months after 30 days, p = 0.162). Additionally, there was no significant difference in ischemic events at 24 months between the two groups (32.7% and 30.6%, p = 0.625). Bleeding and ischemic events at 24 months were similar between subgroups. Conclusions: No significant differences in bleeding or ischemic events between SAPT and DAPT were observed.
Project description:BackgroundTimely and economic provision of revascularisation procedures is a major healthcare need. We aimed to examine the safety and efficacy of daycase-based lower extremity endovascular revascularisation procedures in patients with peripheral artery disease.MethodsIn this systematic review and meta-analysis, we searched MEDLINE and Embase for studies from Jan 01, 2000 through Apr 01, 2024 reporting complications of lower limb endovascular revascularisation procedures with same-day discharge. Eligibility-criteria, complications, and patient characteristics were extracted, methodological quality assessed (adapted Newcastle-Ottawa Scale), and meta-analyses of complications and technical success performed to provide pooled estimates. This study is registered with PROSPERO, CRD42022316466.FindingsThirty observational studies (17 retrospective, 13 prospective) and 1 RCT reported 2427 minor and 653 major complications after 99,600 daycase procedures (93,344 patients). Eighteen studies reported daycase eligibility-criteria including 'responsible adult companion' (78%), 'proximity to hospital', and 'telephone availability' and excluding unstable and severe co-morbidities, offset coagulation, and severe chronic kidney disease. Pooled incidences of minor (4.7% [95% CI 3.8-5.6%], I 2 = 96%) and major (0.64% [95% CI 0.48-0.79%], I 2 = 46%) complications were low and technical success high (93% [95% CI 91-96%], I 2 = 97%). Most complications were related to the puncture site. Pooled conversion-to-hospitalisation rates and re-admission after discharge were 1.6% (95% CI 1.1-2.2%, I 2 = 82%) and 0.11% (95% CI 0.095-0.23%, I 2 = 97%), respectively. Meta-regression identified that minor complications decreased since 2000. Male sex and coronary artery disease were associated with more frequent, and higher age and closure device use with less minor complications. Diabetes mellitus and chronic kidney disease were associated with less major complications. Six studies reported complication rates both in daycases and inpatients and there was no significant difference (-0.8% [95% CI -1.9 to 0.3%]).InterpretationAfter careful evaluation of eligibility, lower limb angioplasty can be performed safely with high technical success in a daycase setting. Most complications arise from the puncture site and not the procedure itself highlighting the importance of optimal access site management. The heterogeneity between studies warrants standardised monitoring of complications and outcomes.FundingEuropean Partnership on Metrology, co-financed from European Union's Horizon Europe Research and Innovation Programme and UK Research and Innovation, and Medical Research Council.
Project description:ObjectiveThe objective of this study was to describe the epidemiology, clinical features, outcomes, and predictors of mortality in veterans with peripheral artery disease (PAD).MethodsWe used national data from the Veterans Health Administration from fiscal years 2009 to 2011 to identify patients with a new diagnosis of PAD. Within this cohort, we describe characteristics of the patients, use of recommended medications, and clinical outcomes during a 3-year follow-up (fiscal year 2014). We used Cox proportional hazards regression to examine predictors of mortality and adverse limb outcomes (amputation and hospitalization for critical limb ischemia [CLI]) during follow-up.ResultsA total of 175,865 patients with a new diagnosis of PAD were included. The mean age was 69.9 years; 97.8% were male, and 67.7% were white. Nearly 77% of patients had hypertension, 46.5% had diabetes, 23% had chronic obstructive pulmonary disease, and 12.9% had renal failure. A prescription for statins was filled by 60.8%, and 34.9% received high-intensity statins within 90 days of PAD diagnosis. At 1 year, 2.6% underwent revascularization, 1.3% developed CLI, and 1.1% underwent amputation. During a median follow-up of 3.8 years, a total of 28.6% patients died (6.7% at 1 year), and 3.7% developed a limb outcome (2.0% at 1 year). Predictors of mortality included advanced age, comorbidities, and CLI or amputation at presentation. In contrast, prescription with statins was associated with lower mortality. Similar findings were present with regard to predictors of adverse limb outcomes, except that older age was associated with a lower risk of amputation or CLI.ConclusionsWe found that veterans with PAD have a high prevalence of comorbid conditions and have a significant risk of mortality and limb loss. A substantial proportion of veterans with PAD are not prescribed recommended medications, especially statin therapy. Our data highlight important opportunities for improving care of veterans with PAD.
Project description:ObjectivePeripheral artery disease affects approximately 250 million people globally. Multiple randomised controlled trials have compared bypass and endovascular interventions but the optimum revascularisation approach remains unclear. The recently published BEST-CLI and BASIL-2 trials provide current and robust data addressing this question, however their findings are not concordant. This systematic review and meta-analysis provides an overview of the worldwide randomised evidence comparing bypass surgery and endovascular revascularisation in lower limb peripheral artery disease.MethodsA comprehensive literature search of MEDLINE, Embase and CENTRAL databases was performed of all time periods up to 7 May 2023 to identify randomised controlled trials comparing bypass and endovascular revascularisation for treating lower limb peripheral artery disease. The primary outcome was major amputation. Secondary outcomes were mortality, re-intervention, 30-day adverse events and 30-day mortality. Odds ratios were calculated and pooled using the random-effects model. Risk of bias was assessed using the Cochrane risk of bias 2 tool.ResultsFourteen cohorts were identified across thirteen studies, enrolling 3840 patients. There was no significant difference in major amputation (OR 1.12; 95% CI 0.80-1.57) or mortality (OR 0.96; 95% CI 0.79-1.17) between the bypass and endovascular groups. Bypass was associated with a significant reduction in re-intervention compared with endovascular treatment (OR 0.57, 95% CI 0.40-0.82).ConclusionsThese findings suggest that rates of major amputation and mortality are similar following bypass and endovascular interventions. Patients who undergo bypass surgery have a significantly lower re-intervention rate post-operatively.
Project description:IntroductionPatients with chronic kidney disease (CKD) have a high prevalence of peripheral artery disease. How best to manage lower extremity peripheral artery disease remains unclear in this patient population. We therefore sought to compare the outcomes after endovascular versus surgical lower extremity revascularization among patients with CKD.MethodsWe used data from Optum's de-identifed Clinformatics® Data Mart Database, a nationwide database of commercially insured persons in the United States to study patients with CKD who underwent lower extremity endovascular or surgical revascularization. We used inverse probability of treatment weighting to balance covariates. We employed proportional hazard regression to study the primary outcome of major adverse limb events (MALE), defined as a repeat revascularization or amputation. We also studied each of these events separately and death from any cause.ResultsIn our cohort, 60,057 patients underwent endovascular revascularization and 9,338 patients underwent surgical revascularization. Endovascular revascularization compared with surgical revascularization was associated with a higher adjusted hazard of MALE (hazard ratio (HR) 1.52; 95% confidence interval (CI) 1.46-1.59). Endovascular revascularization was also associated with a higher adjusted hazard of repeat revascularization (HR 1.65; 95% CI 1.57-1.72) but a lower adjusted risk of amputation (HR 0.71; CI 0.73-0.89). Patients undergoing endovascular revascularization also had a lower adjusted hazard for death from any cause (0.85; CI 0.82-0.88).ConclusionsIn this analysis of patients with CKD undergoing lower extremity revascularization, an endovascular approach was associated with a higher rate of repeated revascularization but a lower risk of subsequent amputation and death compared with surgical revascularization. Multiple factors must be considered when counseling patients with CKD, who have a high burden of comorbid conditions. Clinical trials should include more patients with kidney disease, who are often otherwise excluded from participation, to better understand the most effective treatment strategies for this vulnerable patient population.
Project description: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.
Project description:ObjectivesTo investigate the clinical benefit of endovascular revascularisation (EVR) in octogenarian (aged ≥80 years) patients with lower extremity artery disease (LEAD).DesignRetrospective single-centre study.SettingUniversity hospital with a specialised centre for vascular medicine.Participants681 LEAD patients undergoing EVR between 2010 and 2016 were stratified by age.Main outcome measureTechnical success, complications and mortality.ResultsThe cohort comprised 172 (25.3%) octogenarian and 509 (74.7%) non-octogenarian patients. Despite higher LEAD stages and complexity of EVR in octogenarians, primary technical success rate (79% octogenarians vs 86% non-octogenarians, p=0.006) and 1-year survival (87% vs 96%, p<0.001) were overall on high levels. Especially for the octogenarians, 1-year survival depends on the presence of chronic limb-threatening ischaemia (CLTI) (octogenarians: non-CLTI 98%; CLTI 79% p<0.001 vs non-octogenarians: non-CLTI 99%; CLTI 91%, p<0.001). In octogenarians, female sex (HR 0.45; 95% CI (0.24 to 0.86); p=0.015), the intake of statins (HR 0.34; 95% CI 0.19 to 0.65; p=0.001) and platelet aggregation inhibitors (HR 0.10; 95% CI 0.02 to 0.45; p=0.003) were independently associated with improved survival after EVR.ConclusionEVR can be performed safely and with sustained clinical benefit also in octogenarian patients with LEAD. After-care including medical adherence is of particular importance to improve long-term survival.
Project description:Background & aimsRenal disease is a risk factor for peripheral artery disease (PAD), yet its impact on outcomes after lower extremity (LE) revascularization is not well established. We aimed to characterize the association between chronic kidney disease (CKD) and/or end stage renal disease (ESRD) and post-procedural outcomes in PAD patients undergoing LE revascularization in the United States.MethodsAdults age ≥18 years undergoing surgical or endovascular LE revascularization for PAD with and without CKD or ESRD were identified from the 2014 Nationwide Readmissions Database. Major adverse cardiovascular events (MACE), defined as a composite of death, myocardial infarction or ischemic stroke, were identified for patients with and without renal disease. All-cause hospital readmissions within 6 months of discharge were determined for all survivors.ResultsAmong 39,441 patients with PAD hospitalized for LE revascularization, 10,530 had renal disease (26.7%), of whom 69% had CKD without ESRD and 31% had ESRD. Patients with renal disease were more likely to have MACE after LE revascularization (5.2% vs. 2.5%; adjusted OR [aOR] 1.74, 95% CI 1.40-2.16), require LE amputation (26.1% vs. 12.2%; aOR 1.33, 95% CI 1.19-1.50), and require hospital readmission within 6 months (61.0% vs. 43.6%; adjusted HR [aHR] 1.38, 95% CI 1.28-1.48) compared to those without renal disease.ConclusionsRenal disease is common among patients undergoing LE revascularization for PAD and was independently associated with in-hospital MACE, LE amputation, and hospital readmission within 6 months. Additional efforts to improve outcomes of patients with renal disease and PAD requiring LE revascularization are necessary.