Статті в журналах: "Major adverse lower limb events"

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Bonaca, Marc P., Naomi M. Hamburg, and Mark A. Creager. "Contemporary Medical Management of Peripheral Artery Disease." Circulation Research 128, no. 12 (June 11, 2021): 1868–84. http://dx.doi.org/10.1161/circresaha.121.318258.

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Peripheral artery disease (PAD) is a manifestation of systemic atherosclerosis. Modifiable risk factors including cigarette smoking, dyslipidemia, diabetes, poor diet quality, obesity, and physical inactivity, along with underlying genetic factors contribute to lower extremity atherosclerosis. Patients with PAD often have coexistent coronary or cerebrovascular disease, and increased likelihood of major adverse cardiovascular events, including myocardial infarction, stroke and cardiovascular death. Patients with PAD often have reduced walking capacity and are at risk of acute and chronic critical limb ischemia leading to major adverse limb events, such as peripheral revascularization or amputation. The presence of polyvascular disease identifies the highest risk patient group for major adverse cardiovascular events, and patients with prior critical limb ischemia, prior lower extremity revascularization, or amputation have a heightened risk of major adverse limb events. Medical therapies have demonstrated efficacy in reducing the risk of major adverse cardiovascular events and major adverse limb events, and improving function in patients with PAD by modulating key disease determining pathways including inflammation, vascular dysfunction, and metabolic disturbances. Treatment with guideline-recommended therapies, including smoking cessation, lipid lowering drugs, optimal glucose control, and antithrombotic medications lowers the incidence of major adverse cardiovascular events and major adverse limb events. Exercise training and cilostazol improve walking capacity. The heterogeneity of risk profile in patients with PAD supports a personalized approach, with consideration of treatment intensification in those at high risk of adverse events. This review highlights the medical therapies currently available to improve outcomes in patients with PAD.

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Stone, Patrick A., Stephanie N. Thompson, David Williams, Zachary AbuRahma, Luke Grome, Haley Schlarb, and Ali F. AbuRahma. "Biochemical markers in patients with open reconstructions with peripheral arterial disease." Vascular 24, no. 5 (July 10, 2016): 461–68. http://dx.doi.org/10.1177/1708538115611302.

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The purpose of our study was to determine outcome differences as a function of baseline high-sensitivity C-reactive protein (hsCRP) and B-type natriuretic peptide (BNP) levels in patients receiving lower extremity open reconstructions for the treatment of peripheral arterial occlusive disease. We retrospectively examined patients who underwent surgical reconstructions performed by a single operator during a seven-year time span who received preoperative hsCRP and BNP testing and post-procedure imaging. Outcomes of interest included major adverse limb events, a composite end point of target vessel revascularization, limb amputation, and disease progression, and major adverse cardiovascular events comprised of stroke, myocardial infarction, and death. A total of 89 limbs in 82 patients were included in analysis. Multivariate analysis demonstrated that higher hsCRP levels (>3.0 mg/L) trended toward, but failed to significantly associate with major adverse limb events at 24 months (hazard ratio: 2.2 [1.0–5.2], p = 0.06), however the use of a vein bypass conduit (vs. prosthetic reconstruction) significantly predicted major adverse limb events (hazard ratio: 3.2 [1.5–6.9], p < 0.01). Elevated BNP levels (>100 pg/ml), but not hsCRP, associated with major adverse cardiovascular events (hazard ratio: 3.5 [1.2–10.3], p = 0.03). Preoperative biochemical markers may assist in clinical decision making and stratifying patients regarding adverse events following open reconstructions.

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Guédon, Alexis F., Jean-Baptiste De Freminville, Tristan Mirault, Nassim Mohamedi, Bastien Rance, Natalie Fournier, Jean-Louis Paul, Emmanuel Messas, and Guillaume Goudot. "Association of Lipoprotein(a) Levels With Incidence of Major Adverse Limb Events." JAMA Network Open 5, no. 12 (December 8, 2022): e2245720. http://dx.doi.org/10.1001/jamanetworkopen.2022.45720.

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ImportanceHigh lipoprotein(a) (Lp[a]) levels are involved in the development of cardiovascular events, particularly in myocardial infarction, stroke, and peripheral artery disease. Studies assessing the Lp(a) levels associated with adverse lower-limb events are lacking.ObjectiveTo assess the association between Lp(a) levels and incidence of major adverse limb events in unselected hospitalized patients.Design, Setting, and ParticipantsThis large retrospective monocentric cohort study was conducted from January 1, 2000, to December 31, 2020. Data were derived from the clinical information system of the Hôpital Européen Georges-Pompidou, a Paris-based university hospital. Patients who underwent at least 1 Lp(a) measurement at the center during the study period were included. Patients who had no follow-up data or who had the first Lp(a) measurement after the study outcome had occurred were excluded. Data analyses were performed from May 2021 to January 2022.Main Outcomes and MeasuresThe primary outcome was the first inpatient major adverse limb event, defined as a major amputation, peripheral endovascular revascularization, or peripheral surgical revascularization, during follow-up. Secondary outcomes included individual components of the primary outcome. Lipoprotein(a) levels were categorized as follows: normal (&lt;50 mg/dL), high (50 to &lt;134 mg/dL), and very high (≥134 mg/dL); to convert Lp(a) values to milligrams per liter, multiply by 0.1.ResultsA total of 16 513 patients (median [IQR] age, 58.2 [49.0-66.7] years; 9774 men [59.2%]) were included in the cohort. The median (IQR) Lp(a) level was 24 (10.0-60.0) mg/dL. The 1-year incidence of major adverse limb event was 2.44% in the overall population and 4.54% among patients with very high Lp(a) levels. High (adjusted accelerated failure time [AFT] exponential estimate: 0.43; 95% CI, 0.24-0.78; Benjamini-Hochberg–corrected P = .01) and very high (adjusted AFT exponential estimate: 0.17; 95% CI, 0.07-0.40; Benjamini-Hochberg–corrected P &lt; .001) Lp(a) levels were independently associated with an increased risk of major adverse limb event.Conclusions and RelevanceResults of this study showed that higher Lp(a) levels were independently associated with an increased risk of a major adverse limb event in hospitalized patients. The Lp(a) measurement needs to be taken into account to improve lower-limb vascular risk assessment.

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Fashandi, Anna Z., J. Hunter Mehaffey, Robert B. Hawkins, Irving L. Kron, Gilbert R. Upchurch, and William P. Robinson. "Major adverse limb events and major adverse cardiac events after contemporary lower extremity bypass and infrainguinal endovascular intervention in patients with claudication." Journal of Vascular Surgery 68, no. 6 (December 2018): 1817–23. http://dx.doi.org/10.1016/j.jvs.2018.06.193.

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Mehaffey, James H., Robert Hawkins, Anna Fashandi, Margret C. Tracci, Kenneth Cherry, Irving Kron, Gilbert Upchurch, and William P. Robinson. "Lower Extremity Bypass Is Associated with Lower Short-Term Major Adverse Limb Events and Equivalent Major Adverse Cardiac Events Compared with Endovascular Intervention in A National Cohort with Critical Limb Ischemia." Journal of Vascular Surgery 65, no. 1 (January 2017): e4-e5. http://dx.doi.org/10.1016/j.jvs.2016.10.018.

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Habib, Salim, Othman Abdul-Malak, Michael Madigan, Karim Salem, and Mohammad Eslami. "Completion Imaging Use After Lower Extremity Bypass and Association With Major Adverse Limb Events." Journal of Vascular Surgery 76, no. 3 (September 2022): e40-e41. http://dx.doi.org/10.1016/j.jvs.2022.06.070.

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Singh, Kuldeep, Amandeep Juneja, Tushar Bajaj, Christian Voto, Jonathan Schor, Saqib Zia, and Jonathan Deitch. "Single Tertiary Care Center Outcomes After Lower Extremity Cadaveric Vein Bypass for Limb Salvage." Vascular and Endovascular Surgery 54, no. 5 (June 3, 2020): 430–35. http://dx.doi.org/10.1177/1538574420925586.

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Objective: Cadaveric saphenous vein (CV) conduits are used in rare instances for limb salvage in patients without autogenous veins although long-term outcome data are scarce. This study was designed to evaluate the outcomes of CV bypass in patients with threatened limbs. Methods: We retrospectively reviewed the charts from 2010 to 2017 of 25 patients who underwent 30 CV allografts for critical limb ischemia and acute limb ischemia. Patient charts were reviewed for demographics, comorbidities, smoking status, indications for bypass, and outcomes. Primary outcomes included graft patency, major amputation rates, and mortality. Secondary outcomes measured included infection rates, 30-day major adverse cardiac events (MACE) and major adverse limb events (MALE). Statistical analysis was performed using time series and Kaplan-Meier survival curves. Results: A total of 30 limbs received CV lower extremity bypasses (20 males, 10 female), and the average age was 68 ± 4 years. Primary patency rates were 71%, 42%, and 28% at 3, 6, and 12 months, respectively. Assisted primary patency rates were 78%, 56%, and 37% at 3, 6, and 12 months, respectively. Secondary patency rates were 77%, 59%, and 28% at 3, 6, and 12 months, respectively. Minor amputations, defined as amputations below the transmetatarsal level occurred in 5 (20%) patients. Wound infection occurred in 8 (32%) patients which was managed with local wound care and no patients required an extraanatomic bypass for limb salvage. Thirty-day MALE occurred in 7 (23.3%) patients. We had no 30-day mortality or MACE. The average graft length was 64.2 ± 8 cm with an average graft diameter of 3.9 ± 2 mm. Amputation-free survival and overall survival at 12 months were 20 (68%) and 21 (84%), respectively. Conclusions: Cadaveric saphenous vein allograft may be used as a bypass conduit as a viable surgical option before limb amputation. Despite the poor patency rates, the limb salvage rates of cadaveric vein grafts demonstrate that this alternate conduit may be considered when no autogenous vein is available.

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Niiranen, Oskari, Juha Virtanen, Ville Rantasalo, Amer Ibrahim, Maarit Venermo, and Harri Hakovirta. "The Association between Major Adverse Cardiovascular Events and Peripheral Artery Disease Burden." Journal of Cardiovascular Development and Disease 11, no. 6 (May 21, 2024): 157. http://dx.doi.org/10.3390/jcdd11060157.

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Objective: The aim of the present study was to investigate the possible relationship between the segmental burden of lower limb atherosclerosis and Major Adverse Cardiovascular Events (MACEs). Methods: All the consecutive symptomatic peripheral artery disease (PAD) patients admitted for digital subtraction angiography (DSA) at Turku University Hospital department of Vascular Surgery between 1 January 2009 and 30 July 2011 were retrospectively analyzed. Angiography due to symptomatic PAD was used as the index date for the inclusion in the study. The segmental burden of atherosclerosis based on DSA was divided into three categories according to the highest disease burden of the defined artery segment: aorto-iliac, femoropopliteal, or tibial segments. The major association for the study was MACEs (defined as a cerebrovascular event, heart failure (HF) and myocardial infarction requiring hospital admission). Demographic data and MACEs were obtained from the hospital electronic medical records system. Results. The lower limb atherosclerosis burden of tibial vessels was related to an increased probability for HF (OR 3.9; 95%CI 2.4–6.5) and for MACEs overall (OR 2.3; 95%CI 1.4–3.6). The probability of both HF and MACEs overall rose with the increasing severity of the atherosclerosis burden. Moreover, the more severe the tibial vessel atherosclerosis, the higher the risk of HF and MACEs. The most extensive tibial atherosclerosis patients had an OR 4.5; 95%CI 2.6–8.0 for HF and an OR 3.1; and 95%CI 1.7–5.6 for MACEs overall. The femoropopliteal disease burden was also associated with an increased risk of HF (OR 2.3; 95%CI 1.6–3.2) and MACE (OR 1.9; 95%CI 1.3–2.7). However, the increasing extent of atherosclerosis of the femoropopliteal segment solely increased the risk of MACEs. Conclusions: PAD patients with severe tibial atherosclerosis are likely to present with MACEs. The risk is further enhanced as the extent of tibial vessel atherosclerosis is increased. An association between MACE and severe atherosclerosis on the aortoiliac segment was not detected. However, when the femoropopliteal segment was the most affected artery segment, the risk of MACEs was increased.

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Mehaffey, J. Hunter, Robert B. Hawkins, Anna Fashandi, Kenneth J. Cherry, John A. Kern, Irving L. Kron, Gilbert R. Upchurch, and William P. Robinson. "Lower extremity bypass for critical limb ischemia decreases major adverse limb events with equivalent cardiac risk compared with endovascular intervention." Journal of Vascular Surgery 66, no. 4 (October 2017): 1109–16. http://dx.doi.org/10.1016/j.jvs.2017.04.036.

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Sunitha Therese, S., and N. Gayathri. "LOWER EXTREMITY PHERIPHERALARTERIAL DISEASE - AN UPDATE." International Journal of Advanced Research 10, no. 02 (February 28, 2022): 1049–52. http://dx.doi.org/10.21474/ijar01/14311.

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Lower-extremity arterial disease (LEAD) is a major endemic disease with an alarming increased prevalence worldwide. It is a common and severe condition with excess risk of major cardiovascular events and death. It also leads to a high rate of lower-limb adverse events and non-traumatic amputation. The American Diabetes Association recommends a widespread medical history and clinical examination to screen for LEAD. The ankle brachial index (ABI) is the first non-invasive tool recommended to diagnose LEAD although its variable performance in patients with diabetes. The performance of ABI is particularly affected by the presence of peripheral neuropathy, medial arterial calcification, and incompressible arteries. There is no strong evidence today to support an alternative test for LEAD diagnosis in these conditions. The management of LEAD requires a strict control of cardiovascular risk factors including diabetes, hypertension, and dyslipidaemia. The benefit of intensive versus standard glucose control on the risk of LEAD has not been clearly established. Antihypertensive, lipid-lowering, and antiplatelet agents are obviously worthful to reduce major cardiovascular adverse events, but few randomised controlled trials (RCTs) have evaluated the benefits of these treatments in terms of LEAD and its related adverse events. Smoking cessation, physical activity, supervised walking rehabilitation and healthy diet are also crucial in LEAD management. Several advances have been achieved in endovascular and surgical revascularization procedures, with obvious improvement in LEAD management. The revascularization strategy should take into account several factors including anatomical localizations of lesions, medical history of each patient and operator experience. Further studies, especially RCTs, are needed to evaluate the interest of different therapeutic strategies on the occurrence and progression of LEAD and its related adverse events in patients with diabetes.

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Lam, Alexander, Adam Schwertner, James Katrivesis, Dayantha Fernando, Kari Nelson, and Nadine Abi-Jaoudeh. "Atherectomy with balloon angioplasty compared to balloon angioplasty alone for the treatment of chronic limb threatening ischemia: A national surgical quality improvement program database analysis." Vascular 28, no. 6 (June 17, 2020): 747–55. http://dx.doi.org/10.1177/1708538120932713.

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Objectives To compare perioperative outcomes related to atherectomy with percutaneous transluminal angioplasty versus percutaneous transluminal angioplasty alone for the treatment of lower extremity chronic limb threatening ischemia using a national patient database. Methods Patients with chronic limb threatening ischemia treated with atherectomy and percutaneous transluminal angioplasty or percutaneous transluminal angioplasty alone from 2011 to 2016 in the National Surgical Quality Improvement Program database were identified. Primary outcomes were major adverse limb events (30-day untreated loss of patency, major reintervention, major amputation) and major adverse cardiac events (cardiac arrest, composite outcome of myocardial infarction or stroke). Secondary outcomes included 30-day mortality, length of stay, and any unplanned readmission within 30 days. Multivariate regression analyses were performed to determine independent predictors of outcome. Propensity score matched cohort analysis was performed. A p-value <0.05 was considered statistically significant. Subgroup analyses of femoropopliteal and infrapopliteal interventions were performed. Results In total, 2636 (77.2%) patients were treated with percutaneous transluminal angioplasty and 778 (22.8%) were treated with atherectomy and percutaneous transluminal angioplasty. Multivariate analyses of the unadjusted cohort revealed no significant differences in major adverse cardiac events or major adverse limb events between the two groups ( p-value >0.05). Subgroup analysis of femoropopliteal interventions demonstrated a significantly decreased likelihood of untreated loss of patency in 30 days in the atherectomy group compared to the percutaneous transluminal angioplasty group (1.1% vs. 2.7%, respectively; p-value = 0.034), which persisted on propensity score matched analysis (1.1% vs. 3.1%, respectively; p-value = 0.026). Conclusion Atherectomy with balloon angioplasty of femoropopliteal disease provides a significant decrease in untreated loss of patency compared to balloon angioplasty alone.

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Krzanowski, Marek, and Lukasz Partyka. "Regarding “Lower extremity bypass for critical limb ischemia decreases major adverse limb events with equivalent cardiac risk compared with endovascular intervention”." Journal of Vascular Surgery 67, no. 5 (May 2018): 1637. http://dx.doi.org/10.1016/j.jvs.2017.12.024.

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Shah, Aangi J., Nicholas Pavlatos, and Dinesh K. Kalra. "Preventive Therapies in Peripheral Arterial Disease." Biomedicines 11, no. 12 (November 27, 2023): 3157. http://dx.doi.org/10.3390/biomedicines11123157.

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Atherosclerosis, while initially deemed a bland proliferative process, is now recognized as a multifactorial-lipoprotein-mediated inflammation-driven pathway. With the rising incidence of atherosclerotic disease of the lower extremity arteries, the healthcare burden and clinical morbidity and mortality due to peripheral artery disease (PAD) are currently escalating. With a healthcare cost burden of over 21 billion USD and 200 million patients afflicted worldwide, accurate knowledge regarding the pathophysiology, presentation, and diagnosis of the disease is crucial. The role of lipoproteins and their remnants in atherosclerotic vessel occlusion and plaque formation and progression has been long established. This review paper discusses the epidemiology, pathophysiology, and presentation of PAD. PAD has been repeatedly noted to portend to poor cardiovascular and limb outcomes. We discuss major therapeutic avenues for the prevention of major cardiovascular adverse events and major limb adverse events in patients with PAD.

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Pomozi, Enikő, Rita Nagy, Péter Fehérvári, Péter Hegyi, Boldizsár Kiss, Fanni Dembrovszky, Annamária Kosztin, Sándor Nardai, Endre Zima, and Zoltán Szeberin. "Direct Oral Anticoagulants as the First Choice of Anticoagulation for Patients with Peripheral Artery Disease to Prevent Adverse Vascular Events: A Systematic Review and Meta-Analysis." Journal of Cardiovascular Development and Disease 10, no. 2 (February 3, 2023): 65. http://dx.doi.org/10.3390/jcdd10020065.

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The best method of anticoagulation for patients with peripheral artery disease (PAD) is still a topic of interest for physicians. We conducted a meta-analysis to compare the effects of direct oral anticoagulants (DOACs) with those of vitamin-K-antagonist (VKA) anticoagulants in patients with peripheral artery disease. Five databases (Medline (via PubMed), EMBASE, Scopus, Web of Science, and CENTRAL) were searched systematically for studies comparing the effects of the two types of anticoagulants in patients with PAD, with an emphasis on lower-limb outcomes, cardiovascular events, and mortality. In PAD patients with concomitant non-valvular atrial fibrillation (NVAF), the use of DOACs significantly reduced the risk of major adverse limb events (HR = 0.58, 95% CI, 0.39–0.86, p < 0.01), stroke/systemic embolism (HR 0.76; 95% CI 0.61–0.95; p < 0.01), and all-cause mortality (HR 0.78; 95% CI 0.66–0.92; p < 0.01) compared with warfarin, but showed similar risks of MI (HR = 0.81, 95% CI, 0.59–1.11, p = 0.2) and cardiovascular mortality (HR = 0.77, 95% CI, 0.58–1.02, p = 0.07). Rivaroxaban at higher doses significantly increased the risk of major bleeding (HR = 1.16, 95% CI, 1.07–1.25, p < 0.01). We found no significant difference in terms of revascularization (OR = 1.49, 95% CI, 0.79–2.79, p = 0.14) in PAD patients in whom a poor distal runoff was the reason for the anticoagulation. DOACs have lower rates of major limb events, stroke, and mortality than VKAs in PAD patients with atrial fibrillation. Rivaroxaban at higher doses increased the risk of major bleeding compared with other DOAC drugs. More high-quality studies are needed to determine the most appropriate anticoagulation regimen for patients with lower-limb atherosclerosis.

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Latz, Christopher Alan, Laura Boitano, Linda J. Wang, Anna A. Pendleton, Charles DeCarlo, Brandon Sumpio, Samuel Schwartz, Sunita Srivastava, and Anahita Dua. "Contemporary Endovascular 30-Day Outcomes for Critical Limb Threatening Ischemia Relative to Surgical Bypass Grafting." Vascular and Endovascular Surgery 55, no. 5 (February 19, 2021): 441–47. http://dx.doi.org/10.1177/1538574421989516.

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Objectives: Data from 2011-2014 showed lower extremity bypass(LEB) outperforming infrainguinal endovascular intervention(IEI) regarding major adverse limb events(MALE) but noted no significant difference in major adverse cardiac events(MACE) in propensity matched cohorts. This study aimed to determine if more recent(2015-2018) endovascular outcomes data have improved relative to surgical bypass. Methods: Patients who underwent intervention for chronic limb threatening ischemia (CLTI) from 2015-2018 were identified using the American College of Surgeons National Quality Improvement Program(NSQIP) Vascular Surgery module. The cohort was categorized as undergoing lower extremity bypass(LEB) or infrainguinal endovascular intervention(IEI). Primary 30-day outcomes included major adverse cardiac events(MACE), major adverse limb events(MALE), and major amputation. Inverse probability weighting was used for multivariable analysis. Results: A total of 10,783 patients underwent an infrainguinal intervention for CLTI from 2015-2018. Of these, 6,003(55.7%) underwent LEB and 4,780(44.3%) underwent IEI. Forty percent of the cohort was considered “high anatomic risk” by Objective Performance Goals(OPG) standards, and 13.6% were considered “high clinical risk.” The IEI cohort vs. the LEB cohort experienced a Myocardial infarction(MI)/Stroke rate of 1.8% vs. 3.6%(p < .001), and had a mortality rate of 2.0% vs. 1.7%(p = .22), which yielded a composite MACE of 3.4% vs. 4.8%(p = .001). The rate of reintervention for IEI vs LEB was 4.4% vs. 5.3%(p = .04), the loss of patency (without re-intervention) rate was 1.8% vs. 1.8%(p = 1.0), and the major amputation rate was 4.1% vs. 3.5%(p = .15), which resulted in a MALE rate of 9.1% vs. 8.8%(p = .50). Following inverse probability weighting, comparing the IEI to the referent LEB, MALE AOR = 1.17, 95% CI[1.01 -1.36], p = .036, MACE AOR = 0.61, 95% CI[0.49-0.74], p < .001, and major amputation AOR = 1.31, 95% CI[1.05 -1.62], p = .016. Conclusion: Endovascular outcomes continue to demonstrate inferiority in major amputation and overall MALE. However, endovascular intervention has a significantly reduced incidence of MACE. Overall, these results demonstrate an improvement in endovascular MACE rates in recent years relative to surgical bypass.

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Rogers, R. Kevin, Manesh Patel, Mark Nehler, Sonia Anand, Connie Hess, Judith Hsia, Michael Szarek, et al. "TCT-243 Early Risk of Major Adverse Limb Events Following Lower Extremity Revascularization in the VOYAGER-PAD Trial." Journal of the American College of Cardiology 82, no. 17 (October 2023): B95. http://dx.doi.org/10.1016/j.jacc.2023.09.250.

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Hiatt, William R., Marc P. Bonaca, Manesh R. Patel, Mark R. Nehler, Eike Sebastian Debus, Sonia S. Anand, Warren H. Capell, et al. "Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization." Circulation 142, no. 23 (December 8, 2020): 2219–30. http://dx.doi.org/10.1161/circulationaha.120.050465.

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Background: The VOYAGER PAD trial (Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) demonstrated superiority of rivaroxaban plus aspirin versus aspirin to reduce major cardiac and ischemic limb events after lower extremity revascularization. Clopidogrel is commonly used as a short-term adjunct to aspirin after endovascular revascularization. Whether clopidogrel modifies the efficacy and safety of rivaroxaban has not been described. Methods: VOYAGER PAD was a phase 3, international, double-blind, placebo-controlled trial in patients with symptomatic PAD undergoing lower extremity revascularization randomized to rivaroxaban 2.5 mg twice daily plus 100 mg aspirin daily or rivaroxaban placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety end point was TIMI (Thrombolysis in Myocardial Infarction) major bleeding, with International Society on Thrombosis and Haemostasis major bleeding a secondary safety outcome. Clopidogrel use was allowed at the discretion of the investigator for up to 6 months after the qualifying revascularization. Results: Of the randomized patients, 3313 (50.6%) received clopidogrel for a median duration of 29.0 days. Over 3 years, the hazard ratio for the primary outcome of rivaroxaban versus placebo was 0.85 (95% CI, 0.71–1.01) with clopidogrel and 0.86 (95% CI, 0.73–1.01) without clopidogrel without statistical heterogeneity ( P for interaction=0.92). Rivaroxaban resulted in an early apparent reduction in acute limb ischemia within 30 days (hazard ratio, 0.45 [95% CI, 0.14–1.46] with clopidogrel; hazard ratio, 0.48 [95% CI, 0.22–1.01] without clopidogrel; P for interaction=0.93). Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use ( P for interaction=0.71). With clopidogrel use >30 days, rivaroxaban was associated with more International Society on Thrombosis and Haemostasis major bleeding within 365 days (hazard ratio, 3.20 [95% CI, 1.44–7.13]) compared with shorter durations of clopidogrel ( P for trend=0.06). Conclusions: In the VOYAGER PAD trial, rivaroxaban plus aspirin reduced the risk of adverse cardiovascular and limb events with an early benefit for acute limb ischemia regardless of clopidogrel use. The safety of rivaroxaban was consistent regardless of clopidogrel use but with a trend for more International Society on Thrombosis and Haemostasis major bleeding with clopidogrel use >30 days than with a shorter duration. These data support the addition of rivaroxaban to aspirin after lower extremity revascularization regardless of concomitant clopidogrel, with a short course (≤30 days) associated with less bleeding. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02504216.

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Rannelli, Luke, Eric Kaplovitch, and Sonia Anand. "Oral Hypoglycemics in Patients with type 2 Diabetes and Peripheral Artery Disease." Canadian Journal of General Internal Medicine 14, no. 2 (May 21, 2019): 13–17. http://dx.doi.org/10.22374/cjgim.v14i2.282.

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Worldwide, in 2010, 202 million people were living with PAD, with a prevalence between 3-12 percent. The prevalence of PAD is three times greater in diabetic patients compared to those with normal glycaemia. PAD of the limbs is associated with increased cardiovascular morbidity and mortality, as well as major adverse limb events including acute limb ischemia and amputation. These risks are particularly high in patients who smoke and/or have type 2 diabetes. The goal of treatment in diabetic patients with PAD is to prevent cardiovascular events and prevent further peripheral artery stenosis leading to limb ischemia, and amputation. Poor glycemic control contributes to atherosclerotic progression; however, no randomized control trial evidence exists that demonstrates improved glycemic control reduces the risk of PAD. Oral diabetic medications are designed to lower glucose levels, reduce symptoms and the microvascular complications of diabetes without the inconvenience of daily injections. However, the data supporting benefit of these medications in diabetic populations with concurrent PAD are limited. We review the evidence for oral hypoglycemic agents in the treatment of patients with concurrent PAD and diabetes.

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Tsai, Shang-Yu, Ying-Sheng Li, Che-Hsiung Lee, Shion-Wei Cha, Yao-Chang Wang, Ta-Wei Su, Sheng-Yueh Yu, and Chi-Hsiao Yeh. "Mono or Dual Antiplatelet Therapy for Treating Patients with Peripheral Artery Disease after Lower Extremity Revascularization: A Systematic Review and Meta-Analysis." Pharmaceuticals 15, no. 5 (May 12, 2022): 596. http://dx.doi.org/10.3390/ph15050596.

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The efficacy of dual antiplatelet therapy (DAPT) for patients with peripheral artery disease (PAD) after lower-limb intervention remains controversial. Currently, the prescription of DAPT after an intervention is not fully recommended in guidelines due to limited evidence. This study compares and analyzes the prognosis for symptomatic PAD patients receiving DAPT versus monotherapy after lower-limb revascularization. Up to November 2021, PubMed/MEDLINE, Embase, and Cochrane databases were searched to identify studies reporting the efficacy, duration, and bleeding complications when either DAPT or monotherapy were used to treat PAD patients after revascularization. Three randomized controlled trials and seven nonrandomized controlled trials were included in our study. In total, 74,651 patients made up these ten studies. DAPT in PAD patients after intervention was associated with lower rates of all-cause mortality (HR = 0.86; 95% CI, 0.79–0.94; p < 0.01), major adverse limb events (HR = 0.60; 95% CI, 0.47–0.78; p < 0.01), and major amputation (HR = 0.78; 95% CI, 0.64–0.96) when follow-up was for more than 1-year. DAPT was not associated with major bleeding events when compared with monotherapy (OR = 1.22; 95% CI, 0.69–2.18; p = 0.50) but was associated with a higher rate of minor bleeding as a complication (OR = 2.54; 95% CI, 1.59–4.08; p < 0.01). More prospective randomized studies are needed to provide further solid evidence regarding the important issue of prescribing DAPT.

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O'Donnell, Thomas F. X., Sarah E. Deery, Jeremy D. Darling, Katie E. Shean, Murray A. Mittleman, Gabrielle N. Yee, Matthew R. Dernbach, and Marc L. Schermerhorn. "Adherence to lipid management guidelines is associated with lower mortality and major adverse limb events in patients undergoing revascularization for chronic limb-threatening ischemia." Journal of Vascular Surgery 66, no. 2 (August 2017): 572–78. http://dx.doi.org/10.1016/j.jvs.2017.03.416.

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St. Hilaire, Cynthia. "Medial Arterial Calcification: A Significant and Independent Contributor of Peripheral Artery Disease." Arteriosclerosis, Thrombosis, and Vascular Biology 42, no. 3 (March 2022): 253–60. http://dx.doi.org/10.1161/atvbaha.121.316252.

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Over 200 million individuals worldwide are estimated to have peripheral artery disease (PAD). Although the term peripheral can refer to any outer branch of the vasculature, the focus of this review is on lower-extremity arteries. The initial sequelae of PAD often include movement-induced cramping pain in the hips and legs or loss of hair and thinning of the skin on the lower limbs. PAD progresses, sometimes rapidly, to cause nonhealing ulcers and critical limb ischemia which adversely affects mobility and muscle tone; acute limb ischemia is a medical emergency. PAD causes great pain and a high risk of amputation and ultimately puts patients at significant risk for major adverse cardiovascular events. The negative impact on patients’ quality of life, as well as the medical costs incurred, are huge. Atherosclerotic plaques are one cause of PAD; however, emerging clinical data now shows that nonatherosclerotic medial arterial calcification (MAC) is an equal and distinct contributor. This ATVB In Focus article will present the recent clinical findings on the prevalence and impact of MAC in PAD, discuss the known pathways that contribute specifically to MAC in the lower extremity, and highlight gaps in knowledge and tools that limit our understanding of MAC pathogenesis.

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Bérczi, Ákos, Dat Tin Nguyen, Hunor Sarkadi, Balázs Bence Nyárádi, Piroska Beneda, Ádám Szőnyi, Márton Philippovich, Zoltán Szeberin, and Edit Dósa. "Amputation and mortality rates of patients undergoing upper or lower limb surgical embolectomy and their predictors." PLOS ONE 17, no. 12 (December 15, 2022): e0279095. http://dx.doi.org/10.1371/journal.pone.0279095.

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Purpose To provide information on the outcomes of upper and lower limb surgical embolectomies and the factors influencing amputation and mortality. Methods A retrospective, single-center analysis of 347 patients (female, N = 207; male, N = 140; median age, 76 years [interquartile range {IQR}, 63.2–82.6 years]) with acute upper or lower limb ischemia due to thromboembolism who underwent surgery between 2005 and 2019 was carried out. Patient demographics, comorbidities, medical history, the severity of acute limb ischemia (ALI), preoperative medication regimen, embolus/thrombus localization, procedural data, in-hospital complications/adverse events and their related interventions, and 30-day mortality were reviewed in electronic medical records. Statistical analysis was performed using the Mann–Whitney U test and Fisher’s exact test; in addition, univariate and multivariate logistic regression was conducted. Results The embolus/thrombus was localized to the upper limb in 134 patients (38.6%) and the lower limb in 213 patients (61.4%). The median length of hospital stay was 3.8 days (IQR, 2.1–6.6 days). The in-hospital major amputation rates for the upper limb, lower limb, and total patient population were 2.2%, 14.1%, and 9.5%, respectively, and the in-hospital plus 30-day mortality rates were 4.5%, 9.4%, and 7.5%, respectively. In patients with lower limb embolectomy, the predictor of in-hospital major amputation was the time between the onset of symptoms and embolectomy (OR, 1.78), while the predictor of in-hospital plus 30-day mortality was previous stroke (OR, 7.16). In the overall patient cohort, there were two predictors of in-hospital major amputation: 1) the time between the onset of symptoms and embolectomy (OR, 1.92) and 2) compartment syndrome (OR, 3.51). Conclusion Amputation and mortality rates after surgical embolectomies in patients with ALI are high. Patients with prolonged admission time, compartment syndrome, and history of stroke are at increased risk of limb loss or death. To avoid amputation and death, patients with ALI should undergo surgical intervention as soon as possible and receive close monitoring in the peri- and postprocedural periods.

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Singh, Gagan D., Ehrin J. Armstrong, Stephen W. Waldo, Bejan Alvandi, Ellen Brinza, Justin Hildebrand, Ezra A. Amsterdam, Misty D. Humphries, and John R. Laird. "Non-compressible ABIs are associated with an increased risk of major amputation and major adverse cardiovascular events in patients with critical limb ischemia." Vascular Medicine 22, no. 3 (March 20, 2017): 210–17. http://dx.doi.org/10.1177/1358863x16689831.

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Ankle–brachial indices (ABIs) are important for the assessment of disease burden among patients with peripheral artery disease. Although low values have been associated with adverse clinical outcomes, the association between non-compressible ABI (ncABI) and clinical outcome has not been evaluated among patients with critical limb ischemia (CLI). The present study sought to compare the clinical characteristics, angiographic findings and clinical outcomes of those with compressible (cABI) and ncABI among patients with CLI. Consecutive patients undergoing endovascular evaluation for CLI between 2006 and 2013 were included in a single center cohort. Major adverse cardiovascular events (MACE) were then compared between the two groups. Among 284 patients with CLI, 68 (24%) had ncABIs. These patients were more likely to have coronary artery disease ( p=0.003), diabetes ( p<0.001), end-stage renal disease ( p<0.001) and tissue loss ( p=0.01) when compared to patients with cABI. Rates of infrapopliteal disease were similar between the two groups ( p=0.10), though patients with ncABI had lower rates of iliac ( p=0.004) or femoropopliteal stenosis ( p=0.003). Infrapopliteal vessels had smaller diameters ( p=0.01) with longer lesions ( p=0.05) among patients with ncABIs. After 3 years of follow-up, ncABIs were associated with increased rates of mortality (HR 1.75, 95% CI: 1.12–2.78), MACE (HR 2.04, 95% CI: 1.35–3.03) and major amputation (HR 1.96, 95% CI: 1.11–3.45) when compared to patients with cABIs. In conclusion, ncABIs are associated with higher rates of mortality and adverse events among those undergoing endovascular therapy for CLI.

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Hageman, Steven H. J., Gert Jan de Borst, Johannes A. N. Dorresteijn, Michiel L. Bots, Jan Westerink, Folkert W. Asselbergs, and Frank L. J. Visseren. "Cardiovascular risk factors and the risk of major adverse limb events in patients with symptomatic cardiovascular disease." Heart 106, no. 21 (March 13, 2020): 1686–92. http://dx.doi.org/10.1136/heartjnl-2019-316088.

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AimTo determine the relationship between non-high-density lipoprotein cholesterol (non-HDL-c), systolic blood pressure (SBP) and smoking and the risk of major adverse limb events (MALE) and the combination with major adverse cardiovascular events (MALE/MACE) in patients with symptomatic vascular disease.MethodsPatients with symptomatic vascular disease from the Utrecht Cardiovascular Cohort - Secondary Manifestations of ARTerial disease (1996–2017) study were included. The effects of non-HDL-c, SBP and smoking on the risk of MALE were analysed with Cox proportional hazard models stratified for presence of peripheral artery disease (PAD). MALE was defined as major amputation, peripheral revascularisation or thrombolysis in the lower limb.ResultsIn 8139 patients (median follow-up 7.8 years, IQR 4.0–11.8), 577 MALE (8.7 per 1000 person-years) and 1933 MALE/MACE were observed (29.1 per 1000 person-years). In patients with PAD there was no relation between non-HDL-c and MALE, and in patients with coronary artery disease (CAD), cerebrovascular disease (CVD) or abdominal aortic aneurysm (AAA) the risk of MALE was higher per 1 mmol/L non-HDL-c (HR 1.14, 95% CI 1.01 to 1.29). Per 10 mm Hg SBP, the risk of MALE was higher in patients with PAD (HR 1.06, 95% CI 1.01 to 1.12) and in patients with CVD/CAD/AAA (HR 1.15, 95% CI 1.08 to 1.22). The risk of MALE was higher in smokers with PAD (HR 1.45, 95% CI 0.97 to 2.14) and CAD/CVD/AAA (HR 7.08, 95% CI 3.99 to 12.57).ConclusionsThe risk of MALE and MALE/MACE in patients with symptomatic vascular disease differs according to vascular disease location and is associated with non-HDL-c, SBP and smoking. These findings confirm the importance of MALE as an outcome and underline the importance of risk factor management in patients with vascular disease.

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Davis, Sarah, Steve Goodacre, Abdullah Pandor, Daniel Horner, John Stevens, Kerstin de Wit, and Beverley Hunt. "009 Decision-analysis modelling of the effects of thromboprophylaxis for people with lower limb immobilisation for injury." Emergency Medicine Journal 36, no. 12 (November 21, 2019): 776–77. http://dx.doi.org/10.1136/emermed-2019-rcem.9.

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BackgroundPharmacological thromboprophylaxis reduces the risk of symptomatic venous thromboembolism (VTE) in people with lower limb immobilisation due to injury but can increase the risk of bleeding. We used decision-analytic modelling to compare the risks and benefits of thromboprophylaxis and determine the overall benefit of treatment.Method and resultsA decision-analytic model was developed to simulate the management of a cohort of people with lower limb immobilisation due to injury according to different thromboprophylaxis strategies, including thromboprophylaxis for all and thromboprophylaxis for none. Costs were estimated from the perspective of the UK National Health Service and Personal Social Services. A six-month decision tree was used to model rates of prophylaxis, VTE events (pulmonary embolism [PE], deep vein thrombosis [DVT]) and major bleeds). A Markov model with a lifetime horizon was used to extrapolate costs and QALY losses associated with chronic complications following VTE or bleeding events. The health states included within the Markov model captured the risk of post-thrombotic syndrome (PTS) following VTE and the risk of chronic thromboembolic pulmonary hypertension (CTEPH) following PE. QALYs were estimated by applying estimates of health utility to life expectancy after each of the events in the model.ConclusionsThe results suggest that the combined rate of serious acute adverse outcomes (intracranial haemorrhage [ICH], death from VTE or bleeding) would be around 1 in 4000 regardless of thromboprophylaxis use. As shown in table 1, the short-term benefits of thromboprophylaxis lie in reducing the rates of non-fatal PE, symptomatic DVT and asymptomatic DVT, with associated longer-term benefits of reduced risks of PTS and CTEPH. Overall, thromboprophylaxis is estimated to result in 0.015 additional QALYs per patient.Abstract 009 Figure 1Predicted clinical outcomes per 100,000 patients with lower limb immobilisation due to injuryOur findings suggest that the benefits of thromboprophylaxis lie in reducing long-term consequences of VTE rather than reducing the risk of acute serious adverse events.

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De Matteis, Giuseppe, Federico Biscetti, Davide Antonio Della Polla, Amato Serra, Maria Livia Burzo, Mariella Fuorlo, Maria Anna Nicolazzi, et al. "Sex-Based Differences in Clinical Characteristics and Outcomes among Patients with Peripheral Artery Disease: A Retrospective Analysis." Journal of Clinical Medicine 12, no. 15 (August 3, 2023): 5094. http://dx.doi.org/10.3390/jcm12155094.

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Peripheral arterial disease (PAD) is a prevalent medical condition associated with high mortality and morbidity rates. Despite the high clinical burden, sex-based differences among PAD patients are not well defined yet, in contrast to other atherosclerotic diseases. This study aimed to describe sex-based differences in clinical characteristics and outcomes among hospitalized patients affected by PAD. This was a retrospective study evaluating all patients with a diagnosis of PAD admitted to the Emergency Department from 1 December 2013 to 31 December 2021. The primary endpoint of the study was the difference between male and female PAD patients in cumulative occurrence of Major Adverse Cardiovascular Events (MACEs) and Major Adverse Limb Events. A total of 1640 patients were enrolled. Among them, 1103 (67.3%) were males while females were significantly older (median age of 75 years vs. 71 years; p =< 0.001). Females underwent more angioplasty treatments for revascularization than men (29.8% vs. 25.6%; p = 0.04); males were treated with more amputations (19.9% vs. 15.3%; p = 0.012). A trend toward more MALEs and MACEs reported in the male group did not reach statistical significance (OR 1.27 [0.99–1.64]; p = 0.059) (OR 0.75 [0.50–1.11]; p = 0.153). However, despite lower extremity PAD severity seeming similar between the two sexes, among these patients males had a higher probability of undergoing lower limb amputations, of cardiovascular death and of myocardial infarction. Among hospitalized patients affected by PAD, even if there was not a sex-based significant difference in the incidence of MALEs and MACEs, adverse clinical outcomes were more common in males.

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Ipema, Jetty, Rutger H. A. Welling, Olaf J. Bakker, Reinoud P. H. Bokkers, Jean-Paul P. M. de Vries, and Çagdas Ünlü. "Short-Term Clinical Outcomes of Single Versus Dual Antiplatelet Therapy after Infrainguinal Endovascular Treatment for Peripheral Arterial Disease." Journal of Clinical Medicine 9, no. 11 (October 30, 2020): 3515. http://dx.doi.org/10.3390/jcm9113515.

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After infrainguinal endovascular treatment for peripheral arterial disease (PAD), it is uncertain whether single antiplatelet therapy (SAPT) or dual antiplatelet therapy (DAPT) should be preferred. This study investigated major adverse limb events (MALE) and major adverse cardiovascular events (MACE) between patients receiving SAPT and DAPT. Patient data from three centers in the Netherlands were retrospectively collected and analyzed. All patients treated for PAD by endovascular revascularization of the superficial femoral, popliteal, or below-the-knee (BTK) arteries and who were prescribed acetylsalicylic acid or clopidogrel, were included. End points were 1-, 3-, and 12-month MALE and MACE, and bleeding complications. In total, 237 patients (258 limbs treated) were included, with 149 patients receiving SAPT (63%) and 88 DAPT (37%). No significant differences were found after univariate and multivariate analyses between SAPT and DAPT on 1-, 3-, and 12-month MALE and MACE, or bleeding outcomes. Subgroup analyses of patients with BTK treatment showed a significantly lower 12-month MALE rate when treated with DAPT (hazard ratio 0.33; 95% confidence interval 0.12–0.95; p = 0.04). In conclusion, although patient numbers were small, no differences were found between SAPT and DAPT regarding MALE, MACE, or bleeding complications. DAPT should, however, be considered over SAPT for the subgroup of patients with below-the-knee endovascular treatment.

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Djahanpour, Niousha, Naiyara Ahsan, Ben Li, Hamzah Khan, Kim Connelly, Howard Leong-Poi, and Mohammad Qadura. "A Systematic Review of Interleukins as Diagnostic and Prognostic Biomarkers for Peripheral Artery Disease." Biomolecules 13, no. 11 (November 12, 2023): 1640. http://dx.doi.org/10.3390/biom13111640.

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Background: Peripheral artery disease (PAD) involves atherosclerosis of the lower extremity arteries and is a major contributor to limb loss and death worldwide. Several studies have demonstrated that interleukins (ILs) play an important role in the development and progression of PAD; however, a comprehensive literature review has not been performed. Methods: A systematic review was conducted and reported according to PRISMA guidelines. MEDLINE was searched from inception to 5 December 2022, and all studies assessing the association between ILs and PAD were included. Results: We included 17 studies from a pool of 771 unique articles. Five pro-inflammatory ILs (IL-1β, IL-2, IL-5, IL-6, and IL-8) and one pro-atherogenic IL (IL-12) were positively correlated with PAD diagnosis and progression. In contrast, two anti-inflammatory ILs (IL-4 and IL-10) were protective against PAD diagnosis and adverse limb events. Specifically, IL-6 and IL-8 were the most strongly associated with PAD and can act as potential disease biomarkers to support the identification and treatment of PAD. Conclusions: Ongoing work to identify and validate diagnostic/prognostic inflammatory biomarkers for PAD has the potential to assist clinicians in identifying high-risk patients for further evaluation and management which could reduce the risk of adverse cardiovascular and limb events.

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Alsheef, Mohammed Abdullah, Sam Schulman, Marco Donadini, and Abdul Rehman Z. Zaidi. "Venous Thromboembolism in Lower Extremity Amputees: A Systematic Review of the Literature." Blood 134, Supplement_1 (November 13, 2019): 4980. http://dx.doi.org/10.1182/blood-2019-130751.

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Patients undergoing lower extremity amputation (LEA) are at risk of developing deep venous thrombosis (DVT) and pulmonary embolism (PE), but no generally accepted prevention guidelines exist. This systematic review aimed at understanding the incidence of VTE with or without thromboprophylaxis in adult patients with major lower extremity amputation (LEA). Primary outcomes were onset of DVT, PE, or mortality. Secondary outcomes were any major adverse events due to treatment. We searched English language full-text papers in multiple databases using keywords, including amputation/adverse effects, amputation/complications, venous thromboembolism, deep vein thrombosis, and pulmonary embolism. Twenty-eight studies providing observations for 4,841 patients were selected. The fatal PE risk was 2.6% without prophylaxis and significantly decreased to a non-zero residual risk of 0.9% with VTE prophylaxis. Above-knee amputees were at greatest risk of VTE and subsequent complications. The risk was not confined to the amputated stump and can involve the contralateral limb. The role of compression ultrasonography screening in asymptomatic patients remains controversial in various populations at risk for VTE. All patients undergoing major LEA should be considered at high risk for the development of VTE, even after discharge from hospital. We recommend prophylactic anticoagulation (if not contraindicated) and clinical surveillance in all patients undergoing LEA and further studies to determine the optimal prophylactic strategy. Disclosures No relevant conflicts of interest to declare.

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Suzuki, Kenji, Yukiko Mizutani, Yoshimitsu Soga, Osamu Iida, Daizo Kawasaki, Yasutaka Yamauchi, Keisuke Hirano, et al. "Efficacy and Safety of Endovascular Therapy for Aortoiliac TASC D Lesions." Angiology 68, no. 1 (September 29, 2016): 67–73. http://dx.doi.org/10.1177/0003319716638005.

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Background: Although there is increasing evidence of the effectiveness of endovascular therapy for complex aortoiliac (AI) occlusive disease, it is not universally applied to TASC D lesions. Methods: A total of 2096 patients, 2601 limbs with AI occlusive disease, were enrolled. The lesions were categorized as TASC D (395) or TASC A-C (2206), and we compared baseline data, procedure, and follow-up result between the 2 groups. Results: The success rate of the procedure was significantly lower in the TASC D group (91.6% vs 99.3%, P < .01), and more procedure complications occurred in the TASC D group (11.1% vs 5.2%, P < .01). The results of a 5-year follow-up revealed no significant difference in primary patency (77.9% vs 77.1%, P = .17) and major adverse cardiovascular and limb events (MACLE; 30.5% vs 33.4%, P = .42) between the 2 groups. A multivariate analysis revealed complications and critical limb ischemia are independent predictors of MACLE in the TASC D group. Conclusion: The success rate of the procedure was lower in the TASC D group. Complications were more frequent in the TASC D group, and they were related to MACLE.

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Singh, Satinder, Ehrin J. Armstrong, Walid Sherif, Bejan Alvandi, Gregory G. Westin, Gagan D. Singh, Ezra A. Amsterdam, and John R. Laird. "Association of elevated fasting glucose with lower patency and increased major adverse limb events among patients with diabetes undergoing infrapopliteal balloon angioplasty." Vascular Medicine 19, no. 4 (June 17, 2014): 307–14. http://dx.doi.org/10.1177/1358863x14538330.

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Sullivan, Alexander E., and Joshua A. Beckman. "Medical Management of Peripheral Artery Disease." Seminars in Interventional Radiology 40, no. 02 (April 2023): 119–28. http://dx.doi.org/10.1055/s-0043-57257.

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AbstractPeripheral artery disease (PAD) is a common type of atherosclerotic disease of the lower extremities associated with reduced quality of life and ambulatory capacity. Major adverse cardiovascular events and limb amputations are the leading cause of morbidity and mortality in this population. Optimal medical therapy is therefore critical in these patients to prevent adverse events. Risk factor modifications, including blood pressure control and smoking cessation, in addition to antithrombotic agents, peripheral vasodilators, and supervised exercise therapy are key pillars of medical therapy. Revascularization procedures represent key touch points between patients and health care providers and serve as opportunities to optimize medical therapy and improve long-term patency rates and outcomes. This review summarizes the aspects of medical therapy that all providers should be familiar with when caring for patients with PAD in the peri-revascularization period.

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Prouse, Andrew F., Paula Langner, Mary E. Plomondon, P. Michael Ho, Javier A. Valle, Anna E. Barón, Ehrin J. Armstrong, and Stephen W. Waldo. "Temporal trends in the management and clinical outcomes of lower extremity arterial thromboembolism within a national Veteran population." Vascular Medicine 24, no. 1 (August 14, 2018): 41–49. http://dx.doi.org/10.1177/1358863x18793210.

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Lower extremity arterial thromboembolism is associated with significant morbidity and mortality. We sought to establish temporal trends in the incidence, management and outcomes of lower extremity arterial thromboembolism within the Veterans Affairs Healthcare System (VAHS). We identified patients admitted to VAHS between 2003 and 2014 with a primary diagnosis of lower extremity arterial thromboembolism. Medical and procedural management were ascertained from pharmaceutical and administrative data. Subsequent rates of major adverse limb events (MALE), major adverse cardiovascular events (MACE), and mortality were calculated using Cox proportional hazards models. From 2003 to 2014, there were 10,636 patients hospitalized for lower extremity thromboembolism across 140 facilities, of which 8474 patients had adequate comorbid information for analysis. Age-adjusted incidence decreased from 7.98 per 100,000 patients (95% CI: 7.28–8.75) in 2003 to 3.54 (95% CI: 3.14–3.99) in 2014. On average, the likelihood of receiving anti-platelet or anti-thrombotic therapy increased 2.3% (95% CI: 1.2–3.4%) per year during this time period and the likelihood of undergoing endovascular revascularization increased 4.0% (95% CI: 2.7–5.4%) per year. Clinical outcomes remained constant over time, with similar rates of MALE, MACE and mortality at 1 year after adjustment. In conclusion, the incidence of lower extremity arterial thromboembolism is decreasing, with increasing utilization of anti-thrombotic therapies and endovascular revascularization among those with this condition. Despite this evolution in management, patients with lower extremity thromboembolism continue to experience high rates of amputation and death within a year of the index event.

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Lin, Cheng-Wei, Shih-Yuan Hung, Chung-Huei Huang, Jiun-Ting Yeh, and Yu-Yao Huang. "Diabetic Foot Infection Presenting Systemic Inflammatory Response Syndrome: A Unique Disorder of Systemic Reaction from Infection of the Most Distal Body." Journal of Clinical Medicine 8, no. 10 (September 25, 2019): 1538. http://dx.doi.org/10.3390/jcm8101538.

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Diabetic foot infection (DFI) is a major complication of diabetic foot that lead to nontraumatic lower-extremity amputation (LEA). Such distal infection of the body having systemic inflammatory response syndrome (SIRS) is rarely reported. Consecutive patients treated for limb-threatening DFI in a major diabetic foot center in Taiwan were analyzed between the years 2014 to 2017. Clinical factors, laboratory data, perfusion, extent, depth, infection and sensation (PEDIS) wound score in 519 subjects with grade 3 DFI and 203 presenting SIRS (28.1%) were compared. Major LEA and in-hospital mortality were defined as poor prognosis. Patients presenting SIRS had poor prognosis compared with those with grade 3 DFI (14.3% versus 6.6% for major LEA and 6.4% versus 3.5% for in-hospital mortality). Age, wound size, and HbA1c were independent risk factors favoring SIRS presentation. Perfusion grade 3 (odds ratio 3.37, p = 0.044) and history of major adverse cardiac events (OR 2.41, p = 0.036) were the independent factors for poor prognosis in treating patients with DFI presenting SIRS. SIRS when presented in patients with DFI is not only limb- but life-threatening as well. Clinicians should be aware of the clinical factors that are prone to develop and those affecting the prognosis in treating patients with limb-threatening foot infections.

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Canonico, Mario Enrico, Raffaele Piccolo, Marisa Avvedimento, Attilio Leone, Salvatore Esposito, Anna Franzone, Giuseppe Giugliano, et al. "Antithrombotic Therapy in Peripheral Artery Disease: Current Evidence and Future Directions." Journal of Cardiovascular Development and Disease 10, no. 4 (April 10, 2023): 164. http://dx.doi.org/10.3390/jcdd10040164.

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Patients with peripheral artery disease (PAD) are at an increased risk of major adverse cardiovascular events, and those with disease in the lower extremities are at risk of major adverse limb events primarily driven by atherothrombosis. Traditionally, PAD refers to diseases of the arteries outside of the coronary circulation, including carotid, visceral and lower extremity peripheral artery disease, and the heterogeneity of PAD patients is represented by different atherothrombotic pathophysiology, clinical features and related antithrombotic strategies. The risk in this diverse population includes systemic risk of cardiovascular events as well as risk related to the diseased territory (e.g., artery to artery embolic stroke for patients with carotid disease, lower extremity artery to artery embolism and atherothrombosis in patients with lower extremity disease). Moreover, until the last decade, clinical data on antithrombotic management of PAD patients have been drawn from subanalyses of randomized clinical trials addressing patients affected by coronary artery disease. The high prevalence and related poor prognosis in PAD patients highlight the pivotal role of tailored antithrombotic therapy in patients affected by cerebrovascular, aortic and lower extremity peripheral artery disease. Thus, the proper assessment of thrombotic and hemorrhagic risk in patients with PAD represents a key clinical challenge that must be met to permit the optimal antithrombotic prescription for the various clinical settings in daily practice. The aim of this updated review is to analyze different features of atherothrombotic disease as well as current evidence of antithrombotic management in asymptomatic and secondary prevention in PAD patients according to each arterial bed.

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Gressler, L., D. Marinac-Dabic, S. Dosreis, P. Goodney, C. D. Mullins, and F. T. Shaya. "PMD21 The Association of Major Adverse LIMB Events and Combination Stent and Atherectomy in Patients Undergoing Revascularization for Lower Extremity Peripheral Artery Disease." Value in Health 24 (June 2021): S127. http://dx.doi.org/10.1016/j.jval.2021.04.619.

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Henke, Peter. "Re: Association of elevated fasting glucose with lower patency and increased major adverse limb events among patients with diabetes undergoing infrapopliteal balloon angioplasty." Vascular Medicine 19, no. 4 (July 21, 2014): 315–16. http://dx.doi.org/10.1177/1358863x14542460.

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Rymer, Jennifer A., Hillary Mulder, Kim G. Smolderen, William R. Hiatt, Michael S. Conte, Jeffrey S. Berger, Lars Norgren, et al. "Association of Health Status Scores With Cardiovascular and Limb Outcomes in Patients With Symptomatic Peripheral Artery Disease: Insights From the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) Trial." Journal of the American Heart Association 9, no. 19 (October 6, 2020). http://dx.doi.org/10.1161/jaha.120.016573.

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Background There are limited data on health status instruments in patients with peripheral artery disease and cardiovascular and limb events. We evaluated the relationship between health status changes and cardiovascular and limb events. Methods and Results In an analysis of the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) trial, we examined the characteristics of 13 801 patients by tertile of health status instrument scores collected in the trial (EuroQol 5‐Dimensions [EQ‐5D], EQ visual analog scale [VAS], and peripheral artery questionnaire). We assessed the association between the baseline health status measurements and major adverse cardiovascular events, major adverse limb events, and lower‐extremity revascularization procedures during trial follow‐up and the association between 12‐month health status change scores and subsequent end points during follow‐up. There were 13 217 (95%) patients with EQ‐5D scores, 13 533 (98%) with VAS scores, and 4431 (32%) with peripheral artery questionnaire scores. Patients in the lowest baseline EQ‐5D tertile (0 to <0.69) were more likely to be female with severe claudication compared with the highest tertile (0.79–1.0; P <0.01). Patients in the lowest VAS (0–60) and peripheral artery questionnaire (0–49) tertiles had lower ankle–brachial indices compared with the highest tertiles (80–100 and 76–108, respectively; P <0.01). There was a significant association between baseline EQ‐5D, VAS, and peripheral artery questionnaire scores and adjusted major adverse cardiovascular events, major adverse limb events, and lower‐extremity revascularization ( P <0.05). Improved EQ‐5D and VAS scores over 12 months were associated with reduced risk of subsequent major adverse cardiovascular events or lower‐extremity revascularization (all P <0.01). Conclusions Although health status instruments are rarely used in clinical practice, these measures are associated with outcomes, including major adverse cardiovascular events, major adverse limb events, and lower‐extremity revascularization. Further research is needed to determine the relationship between changes in these instruments, revascularization, and outcomes.

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Guedon, A., J. B. De Freminville, T. Mirault, N. Mohamedi, B. Rance, N. Fournier, J. L. Paul, E. Messas, and G. Goudot. "Elevated Lipoprotein(a) levels increase Major Adverse Limb Event." European Heart Journal 43, Supplement_2 (October 1, 2022). http://dx.doi.org/10.1093/eurheartj/ehac544.1980.

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Abstract Background High lipoprotein(a) levels are involved in the development of cardiovascular events, as particularly in myocardial infarction, stroke, and peripheral artery disease. Studies assessing prognostic values of lipoprotein(a) levels on the lower limbs are lacking. Purpose The aim of our study was to look after a relationship between the lipoprotein(a) level and the incidence of major adverse limb events (MALE) defined as major amputation, peripheral artery endovascular revascularization or peripheral artery bypass. Methods We included 16,513 patients with lipoprotein(a) measurements from our clinical information system. Normal lipoprotein(a) level was under 50 mg/dL and we defined: high lipoprotein(a) level as a lipoprotein(a) level between 50 mg/dL and 134 mg/dL and very high lipoprotein(a) level as a lipoprotein(a) levels over 134 mg/dL, i.e the 95th percentile in this cohort. Accelerated Failure Time models were used to assess the relationship between the lipoprotein(a) level and the incidence of MALE retrieved from the patient's electronic record during a median (interquartile range) follow-up of 3.74 (1.07; 7.30) years after the lipoprotein(a) measurement. MALE was defined as the occurrence of one of the following during follow-up: aortofemoral bypass surgery, limb bypass surgery, percutaneous transluminal angioplasty revascularization of the iliac, or infrainguinal arteries; or major amputation above the forefoot. Secondary outcomes included individual components of the primary Results Median lipoprotein(a) level was 24 mg/dL (10; 60), with 70.3%; 24.7%; and 5.0% within normal; high and very high lipoprotein(a) level respectively. The 1-year MALE incidence was 2.2% [95% CI: 1.96; 2.51]; 2.60% [95% CI: 2.09; 3.10] and 4.54% [95% CI: 3.08; 5.98] among the normal, high and very high lipoprotein(a) level patients respectively. High and very high lipoprotein(a) levels were independently associated with an increased risk of MALE (adjusted Accelerated Failure Time Exponential Estimate) 0.43 [95% CI: 0.24; 0.78], p=0.01 and 0.17 [95% CI: 0.07; 0.40], p<0.001, respectively. Conclusion In this large cohort of unselected real-world hospital inpatients, higher lipoprotein(a) levels were independently associated with an increased risk of MALE. Though, lipoprotein(a) measurement shall be taken into account not only to refine the cardiovascular risk but also the lower limb risk of revascularization or amputation. Funding Acknowledgement Type of funding sources: None.

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Kiani, Sarah, Usman Salahuddin, Haekyung Jeon Slaughter, Atif Mohammad, Emmanouil S. Brilakis, and Subhash Banerjee. "Abstract 511: Adverse Outcomes in Patients with Diabetes Mellitus Following Stenting for Lower Extremity Peripheral Arterial Disease." Arteriosclerosis, Thrombosis, and Vascular Biology 36, suppl_1 (May 2016). http://dx.doi.org/10.1161/atvb.36.suppl_1.511.

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Introduction: There is limited data on outcomes of percutaneous endovascular intervention for lower extremity peripheral artery disease (PAD) in patients with diabetes mellitus (DM). We assessed the hypothesis that patients with DM, in comparison to patients without DM, have higher rates of major adverse cardiovascular and limb events after lower extremity PAD stenting. Methods: 1,006 patients with primary stent implant procedures between January 2005 and October 2015 enrolled in the observational XLPAD registry (NCT01904851) were analyzed for 12 month major adverse cardiovascular events (MACE; all-cause death, myocardial infarction, and stroke) and major adverse limb events (MALE; target limb repeated endovascular intervention, surgical revascularization, and major amputation). Cochran-Mantel-Haenszel statistics was used for overall association of categorical baseline characteristics; Cox proportional regressions and Kaplan-Meier curves were used for median time to event analysis. Results: At baseline, patients with DM had higher prevalence of coronary artery disease (74.9% vs. 56.2%; p<0.0001), heart failure (22.9% vs. 10.9%; p<0.001), prior myocardial infarction (27.3% vs. 22.5%; p=0.0076) and prior stroke (10.3% vs. 5.8%; p<0.0001) in comparison to patients without DM. Cox proportional regressions after adjusting for baseline characteristics showed significantly higher MACE (8.5% vs. 4.0%; Hazard ratio (HR) 1.99; 95% CI 1.26-3.50; p=0.003, Figure 1A ) as well as MALE (49.0% vs. 40.9%; HR 1.22; 95% CI 1.01-1.48; p=0.043, Figure 1B ) in patients with DM at 12-months. Conclusion: PAD in patients with DM is associated with significantly higher rates of major adverse cardiovascular and limb events.

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VOSGIN-DINCLAUX, VALÉRIAN, KAMEL MOHAMMEDI, and CAROLINE CARADU. "483-P: Predictors of Major Adverse Lower Limb Events for Chronic Arterial Trophic Disorders." Diabetes 71, Supplement_1 (June 1, 2022). http://dx.doi.org/10.2337/db22-483-p.

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Background: Peripheral arterial disease (PAD) affects more than 200 million people with an ever-increasing prevalence. Faced with this public health issue, it seems crucial to take an interest in PAD management. In this study, we evaluated the predictors of major adverse lower limb events (MALEs) and wound healing following revascularization for chronic arterial trophic disorders in people with and without diabetes. Methods: This retrospective study included all patients with Rutherford-Becker stage 5 or 6 who required a minor amputation in combination with a revascularization procedure in our vascular surgery department at Bordeaux University Hospital, from January 2016 to December 2018. The primary endpoint was MALEs. The secondary endpoints were wound healing at 6 months and 2 years, in-hospital and all-cause mortality. Results: We included 241 patients, 180 with diabetes (74,7%) , with an average age of 74 years, 79,7% men. According to the Wound, Ischemia and foot Infection classification, 95,9% were ranked clinical stage 4, and to the TransAtlantic Inter-Society Consensus for the management of PAD (TASC) below-the-knee classification, 50,7% were stage C/D. Among patients with diabetes, 63,3% had post-operative uncontrolled diabetes. One-hundred seven MALEs occurred during 2-year follow-up (estimated rate of patients free of MALEs 48,7%, 95% CI: 41,7-55,4) , 78 MALEs in patients with diabetes. Revascularization failure predicted the occurrence of MALEs in multivariate analysis, while the lack of revascularization option predicted major amputation. Wound healing was adversely affected by haemodialysis, TASC C/D below-the-knee lesions, the number of bacteria, and reocclusion of the target artery. The in-hospital mortality rate was 5,4% and the overall 2-year mortality rate was 22,8%. Conclusion: This study highlights the necessity to provide optimal revascularization associated with comprehensive medical care using multidisciplinary approaches to those patients affected by PAD. Disclosure V.Vosgin-dinclaux: None. K.Mohammedi: Board Member; Lilly, Novo Nordisk, Sanofi, Research Support; Cyclerion Therapeutics, Inc., Speaker's Bureau; Abbott, AstraZeneca. C.Caradu: None.

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Jamil, Yasser, Joshua Huttler, Dana Alameddine, Zhen Wu, Haoran Zhuo, Carlos Mena-Hurtado, Eric Velazquez, Raul J. Guzman, and Cassius Iyad Ochoa Chaar. "The Impact of Ejection Fraction on Major Adverse Limb Events After Lower Extremity Revascularization." Annals of Vascular Surgery, October 2023. http://dx.doi.org/10.1016/j.avsg.2023.08.009.

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Vosgin-Dinclaux, Valérian, Paul Bertucat, Loubna Dari, Claire Webster, Ninon Foussard, Kamel Mohammedi, Eric Ducasse, and Caroline Caradu. "Predictors of major adverse lower limb events in patients with tissue loss secondary to critical limb-threatening ischemia." Cardiovascular Revascularization Medicine, February 2024. http://dx.doi.org/10.1016/j.carrev.2024.01.018.

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Bonaca, M., R. P. Giugliano, C. P. Cannon, J. G. Park, S. A. Murphy, M. A. Creager, E. Braunwald, and M. S. Sabatine. "Reduction in the risk of major adverse limb events with ezetimibe versus placebo in addition to statin therapy: insights from the IMPROVE IT trial." European Heart Journal 44, Supplement_2 (November 2023). http://dx.doi.org/10.1093/eurheartj/ehad655.2034.

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Abstract Background/Introduction Patients with peripheral artery disease (PAD) are at risk of developing progressive symptoms leading to revascularization as well as major adverse limb events such as critical limb ischemia and amputation. Recently, two trials of PCSK9 inhibitors, which lower both LDL-C and Lp(a) have demonstrated reductions in MALE and peripheral revascularization. Whether this benefit is present for other LDL-C lowering therapies has not been well described. Purpose To evaluate whether LDL-C lowering with ezetimibe reduces the risk of adverse limb events. Methods IMPROVE-IT randomized 18,144 patients with acute coronary syndrome (ACS), including 1,005 with PAD, to ezetimibe or placebo on top of statin and followed for a median of 6 years. Two vascular specialists blinded to treatment allocation independently reviewed all adverse events to categorize limb outcomes including critical limb ischemia (CLI), and related amputation as well as progressive symptoms leading to lower extremity revascularization (worsening PAD). Total limb outcomes over follow up were compared by treatment groups using negative binomial regression and relative risks (RR) are presented. Results A total of 397 patients had worsening symptoms (in 346 PAD patients) and 43 developed CLI (in 36 patients) during follow up. The risk of total PAD events (CLI or worsening symptoms) was lower with ezetimibe versus placebo (RR 0.77, 95% CI 0.62 – 0.96, p=0.018) with a consistent trend for both components (Figure Panel A). When evaluating the relationship of achieved LDL-C at 1-month post-randomization and the risk of first PAD event, there appeared to a linear relationship extending to an LDL-C less than 25 mg/dL (Figure Panel B). Conclusion Further lowering of LDL-C with ezetimibe on top of statin therapy in patients with ACS was associated with a lower risk of adverse limb events over long-term follow up including CLI and progressive disease leading to revascularization. These data support the importance of intensive lipid lowering therapies in improving limb outcomes in patients with atherosclerotic vascular disease. In addition, these data support LDL-C as a treatment target for optimizing outcomes in patients with peripheral artery disease.Figure Panel AFigure Panel B

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Tawil, Michael, Thomas S. Maldonado, Yuhe Xia, Todd Berland, Neal Cayne, Glenn Jacobowitz, Joanelle Lugo, et al. "Response to clopidogrel in patients undergoing lower extremity revascularization." Vascular, May 19, 2022, 170853812211034. http://dx.doi.org/10.1177/17085381221103417.

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Objectives Clopidogrel is effective at decreasing cardiovascular events in patients with peripheral artery disease (PAD); however, its effect on limb outcomes are less known. This study investigated the variability in response to clopidogrel and its relationship with clinical limb outcomes. Methods Three hundred subjects were enrolled in the Platelet Activity and Cardiovascular Events (PACE) study prior to lower extremity revascularization, of whom 104 were on clopidogrel. Light transmission platelet aggregation was measured in response to ADP 2 [Formula: see text]m immediately prior to revascularization. Patients were followed longitudinally for a median follow-up of 18 months. The primary endpoint was major adverse limb events (MALE) defined by major amputation or reoperation of the affected limb. Patients were stratified into groups according to percent ADP-induced aggregation. Poor response to clopidogrel was defined by >50% aggregation. Results Overall, the median age was 70 (63, 76) and 35.6% were female. Twenty-nine (27.9%) patients experienced MALE during their follow-up. Median aggregation to ADP 2 [Formula: see text] m was 22.5% (Q1-Q3: 10%, 50%) and 27 subjects (26%) were clopidogrel poor responders. Baseline aggregation was higher in subjects who went on to develop a MALE than those without MALE (43% vs 20%, p = .017). Subjects with aggregation > median (22.5%) were more likely to experience MALE than aggregation < median (38.5% vs 17.3%, p = .029). After multivariable adjustment for age, sex, race/ethnicity, BMI, diabetes, coronary artery disease, and aspirin use, aggregation > median was associated with MALE (adjusted HR [aHR] 2.67, 95% CI 1.18–6.01, p = .018). When stratified by established cut-offs for responsiveness to clopidogrel (50% aggregation), poor responders were more likely to experience MALE than normal responders (44.4% vs 22.1%, aHR 2.18, 95% CI 1.00–4.78, p = .051). Conclusions Among patients undergoing lower extremity revascularization on clopidogrel, higher baseline percent aggregation is associated with increased risk for major adverse limb events.

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Juneja, Amandeep, Melissa Garuthara, Sonia Talathi, Amit Rao, Gregg Landis, and Yana Etkin. "Predictors of poor outcomes after lower extremity revascularization for acute limb ischemia." Vascular, January 25, 2023, 170853812311542. http://dx.doi.org/10.1177/17085381231154290.

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Objectives Acute lower extremity ischemia is one of the most common emergencies in vascular surgery and is a cause of considerable morbidity and mortality. The goal of this study was to evaluate outcomes of revascularization for acute lower extremity ischemia and to determine factors associated with perioperative morbidity and mortality. Methods A total of 354 patients underwent urgent revascularization for acute lower extremity ischemia at an academic medical center between 2014 and 2019. A retrospective review of patients’ demographics, comorbidities, etiology and severity of limb ischemia, and procedural characteristics was recorded. Outcomes, including postoperative complications, perioperative limb loss, and mortality, were analyzed. Results The mean patient age was 69 ± 17 years, and 52% were females. 50% of patients presented with Rutherford Class IIb ischemia. Arterial embolization was the most common cause of limb ischemia, seen in 33% of cases. Open surgical revascularization was performed in 241 (68%) patients, while endovascular and hybrid approaches were utilized in 53 (15%) and 60 (17%) cases, respectively. Postoperative adverse events occurred in 44% of patients, including wound complications (11%), cardiac (5%) and pulmonary (16%) complications, strokes (4%), UTIs (10%), renal failure (14%), bleeding (5%), and compartment syndrome (3%). The rate of unplanned return to the operating room was 21%. Major adverse cardiovascular events were seen in 103 (29%) patients and major adverse limb events were seen in 57 (16%) patients. The median length of stay was 10 days (IQR = 4); 49% patients were discharged to skilled nursing facility and 19% were readmitted within 30 days. The rate of amputation during index admission was 10%, and perioperative mortality was 20%. Gender, tibial runoff, and etiology of limb ischemia were independent predictors of limb loss. Women had lower risk of limb loss than men (OR, 0.11; 95% CI, 0.023, 0.38). Poor tibial runoff (one-vessel or absence of flow below the knee) was a significant predictor of limb loss as compared to three-vessel runoff (OR, 14.92; 95% CI, 1.92, 115.88). Aneurysmal disease (OR, 38.35; 95% CI, 3.54, 42.45) and traumatic injuries (OR, 108.08; 95% CI, 8.21, 159.06) were the strongest predictors of amputation as compared to other etiologies of limb ischemia. Multivariate model identified ESRD (OR, 9.2; 95% CI, 1.8–46.3), degree of ischemia (class IIb or higher vs class IIa; OR, 3.5; 95% CI, 1.2–10.6), and age (OR, 1.5; 95% CI 1.1–2.0 for every 10 years) as independent predictors of perioperative mortality. Conclusions Urgent revascularization for management of acute limb ischemia is associated with high morbidity and mortality. Elderly patients with ESRD presenting with severely threatened limbs have especially high risk of perioperative mortality and may not be ideal candidates for limb salvage.

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GUPTA, ASHISH, and ASHU RASTOGI. "1815-LB: Lower Limb Vascularity Indices for Major Adverse Limb Events and Mortality in Individuals with Diabetic Foot Ulcer." Diabetes 73, Supplement_1 (June 14, 2024). http://dx.doi.org/10.2337/db24-1815-lb.

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Objectives: We aimed to assess correlation between baPWV and ABI, specifically role of baPWV in participants with normal ABI for major adverse limb events (MALE) and mortality in people with diabetes and first diabetic foot ulcer (DFU). Research Design and Methods: A total of 16000 patients with type 2 diabetes were screened and 2186 individuals followed until 31st December 2022 or the time of death, whichever occurred earlier. A detailed demographic and diabetes complications were recorded. Whole cohort was divided into three groups based on the presenting ABI: group A: ABI 0.7-0.9, group B-ABI: 0.9-1.2 and Group C:ABI>1.2. Presenting baPWV was divided into quartiles as <1642cm/sec, 1642-1896cm/sec,1897-2210 cm/sec and >2210cm/sec for all individuals.. A stepwise logistic regression was used to determine the most relevant predictors of MALE and all-cause mortality. Results: Median age of participants was 61(53-67) years, duration of diabetes 10(6-15)years and follow up duration of 6(2-8) years. In comparison with participants having a baPWV<1642 cm/sec, the odds for mortality was significantly higher in individuals with baPWV >2210 cm/sec [OR 1.745(1.315-2.315); p<0.001]. At baPWV 1678 cm/sec, sensitivity was 68% and specificity of 62% for predicting mortality. On multivariate logistic regression predictors of mortality were- Age>57.5 years [OR 1.285(1.007-1.639), p-0.004], eGFR<71.5 ml/min/1.73 m2 [OR 1.434(1.128-1.824); p -0.003], any amputation [OR 1.290(1.002-1.660), p-0.049] and bAPWV >2210cm/sec [OR 1.603(1.160-2.214); p<0.001]. Conclusion: High baPWV is a significant predictor of mortality in people with diabetes presenting with a DFU despite a normal ABI. Disclosure A. Gupta: None. A. Rastogi: None.

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Amlani, Vishal, Karin Ludwigs, Aidin Rawshani, Marcus Thuresson, Mårten Falkenberg, Kristian Smidfelt, and Joakim Nordanstig. "Major Adverse Limb Events in Patients Undergoing Revascularisation for Lower Limb Peripheral Arterial Disease: A Nationwide Observational Study★." European Journal of Vascular and Endovascular Surgery, August 2024. http://dx.doi.org/10.1016/j.ejvs.2024.07.041.

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Jamil, Yasser, Joshua Huttler, Dana Alameddine, Haoran Zhuo, Carlos Mena-Hurtado, Eric J. Velazquez, Raul J. Guzman, and Cassius Iyad I. Ochoa Chaar. "Abstract 12311: The Impact of Ejection Fraction on Major Adverse Limb Events After Lower Extremity Revascularization." Circulation 146, Suppl_1 (November 8, 2022). http://dx.doi.org/10.1161/circ.146.suppl_1.12311.

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Objective: Peripheral arterial disease (PAD) is commonly associated with cardiac disease and echocardiography is frequently performed prior to lower extremity revascularization (LER). However, the incidence of various echocardiographic findings and their impact on the outcomes of LER have not been well studied. Hypothesis: Low ejection fraction (EF) ≤ 40% is associated with increased major adverse limb events (MALE) after LER. Methods: The electronic records of patients undergoing LER in a single center were reviewed. Patients were divided based on the presence or absence of reduced EF ≤ 40%. Patient, echocardiographic, and procedural characteristics were compared as well as outcomes. Results: A total of 1,034 patients (N=130, 12.5% with EF≤ 40%) underwent LER. Patients with reduced EF were more likely to be males, with coronary artery disease and heart failure. On echocardiography, patients with reduced EF had significantly higher mean right ventricular pressure and were more likely to have diastolic dysfunction. Moderate to severe regurgitation affecting the mitral and tricuspid valves were significantly higher in patients with reduced EF. There was no difference in indication but patients with reduced EF were more likely to be treated with endovascular procedures. Perioperatively, patients with reduced EF were more likely to develop myocardial infarction. (Table) There was no difference in MALE or major amputation between the 2 groups but MALE-free survival was significantly lower for patients with EF≤ 40%. (Figure). Conclusion: Reduced EF is associated with decreased survival of patients with PAD after LER but does not seem to significantly impact MALE.

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Hsiao, Fu-Chih, Yi-Hsin Chan, Ying-Chang Tung, Chia-Pin Lin, Ting-Hein Lee, Yu-Chiang Wang, and Pao-Hsien Chu. "Visit-to-visit hemoglobin A1c variation and long-term risk of major adverse limb events in patients with type 2 diabetes." Journal of Clinical Endocrinology & Metabolism, April 6, 2023. http://dx.doi.org/10.1210/clinem/dgad203.

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Abstract Context Glycemic variation had been demonstrated to be associated with several complications of diabetes. Objective Investigation of the association between visit-to-visit hemoglobin A1c (HbA1c) variation and the long-term risk of major adverse limb events (MALEs). Design Retrospective database study. Average real variability was used to represent glycemic variations with all the HbA1c measurements during the 4 following years after the initial diagnosis of type 2 diabetes. Participants were followed from the beginning of the 5th year until death or the end of the follow-up. The association between HbA1c variations and MALEs was evaluated after adjusting for mean HbA1c and baseline characteristics. Setting Referral center Patients 56,872 Patients with a first diagnosis of type 2 diabetes, no lower extremity arterial disease, and at least one HbA1c measurement in each of the 4 following years were identified from a multi-center database. Intervention None Main Outcome Measures Incidence of MALEs, which was defined as the composite of revascularization, foot ulcers, and lower limb amputations. Results The average number of HbA1c measurements was 12.6. The mean follow-up time was 6.1 years. The cumulative incidence of MALEs was 9.25 per 1000 person-years. Visit-to-visit HbA1c variations were significantly associated with MALEs and lower limb amputation after multivariate adjustment. Persons in the highest quartile of variations had increased risks for MALEs (HR 1.25, 95% CI 1.10-1.41) and lower limb amputation (HR 3.05, 95% CI 1.97-4.74). Conclusions HbA1c variation was independently associated with a long-term risk of MALEs and lower limb amputations in patients with type 2 diabetes.

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