Long-term outcomes following endovascular and surgical revascularization for peripheral artery disease: a propensity score-matched analysis.

Patients 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. We 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. In 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). In 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.

Background: Patient, lesion, and procedural characteristics may impact the long-term risks of adverse limb outcomes differently after successful endovascular revascularization for lower extremity peripheral artery disease. The study objective was to assess the relationships of patient, lesion, and procedural characteristics to the subsequent risk of major and minor adverse limb events over the decade after successful endovascular revascularization of the superficial femoral artery for chronic limb-threatening ischemia (CLTI) or lifestyle-limiting claudication. MethodsA retrospective cohort of patients who underwent endovascular revascularization between 2003-2011 were followed for a median of 9.3 (IQR, 6.8-11.1) years. Hazard ratios (HR) and 95% CI from Cox proportional hazards models assessed the risk of major adverse limb events (MALE) (major amputation, bypass, or thrombolysis) or minor revascularization, MALE alone, and minor revascularization alone. ResultsThere were 232 index limb revascularizations in 185 patients. Longer lesion length was associated with a higher risk of MALE or minor revascularization (HR, 2.09; 95% CI, 1.22-3.60) and minor revascularization alone (HR, 2.53; 95% CI, 1.39-4.61). Current smoking was linked with minor revascularization (HR, 3.83; 95% CI, 1.54-9.56). CLTI was associated with MALE or minor revascularization (HR, 1.89; 95% CI, 1.09-3.29), and MALE alone (HR, 7.43; 95% CI, 3.11-17.79). Black race/ethnicity (HR, 4.74; 95% CI, 1.51-14.9) and low-density lipoprotein >100 mg/dL (HR, 2.76; 95% CI, 1.20-6.35) were linked to MALE alone. ConclusionsFactors related to MALE differed from those related to minor revascularization. Lesion length and smoking were linked to minor revascularization, whereas CLTI, Black race/ethnicity, and elevated low-density lipoprotein were linked to MALE.

Background: Patient, lesion, and procedural characteristics may impact the long-term risks of adverse limb outcomes differently after successful endovascular revascularization for lower extremity peripheral artery disease. Objective: To assess the relationships of patient, lesion, and procedural characteristics to the subsequent risk of major and minor adverse limb events over the decade after successful endovascular revascularization of the superficial femoral artery for chronic limb threatening ischemia (CLTI) or lifestyle limiting claudication. Methods : A retrospective cohort of patients who underwent endovascular revascularization between 2003-2011 were followed for a median of 9.3 (25-75%: 6.8, 11.1) years. Hazard ratios and 95% confidence intervals (HR, 95% CI) from Cox proportional hazards models assessed the risk of major adverse limb events (MALE) or minor revascularization, MALE alone, and minor revascularization alone. Results: There were 232 index limb revascularizations in 185 patients. Longer lesion length was associated with a higher risk of MALE or minor revascularization (HR=2.09, 95% CI=1.22, 3.60) and minor revascularization alone (HR=2.53, 95% CI=1.39, 4.61). Current smoking was linked with minor revascularization (HR=3.83, 95% CI=1.54, 9.56). CLTI was associated with MALE or minor revascularization (HR=1.89, 95% CI=1.09, 3.29), and MALE alone (HR=7.43, 95% CI=3.11, 17.79). Black race/ethnicity (HR=4.74, 95% CI=1.51, 14.9) and low density lipoprotein (LDL) >100 mg/dL (HR=2.76, 95% CI=1.20, 6.35) were linked to MALE alone. Conclusion Factors related to MALE differed from those related to minor revascularization. Lesion length and smoking were linked to minor revascularization, whereas CLTI, Black race/ethnicity and elevated LDL were linked to MALE.

Propensity Score-Based Analysis of Initial Endovascular and Open Revascularization for Peripheral Arterial Disease in a Long-Term Population-Based Study

Surgical Revascularization Versus Endovascular Therapy to Treat Chronic Limb-Threatening Ischemia: Perhaps Less Invasive Is Not Always Better

Endovascular therapy is a viable treatment option for symptomatic peripheral artery disease (PAD). Diabetes mellitus is a major risk factor for PAD. We evaluated the long-term impact of diabetes mellitus in patients with PAD who underwent endovascular therapy. In this prospective registry of 765 patients who underwent endovascular therapy for symptomatic PAD, 560 had diabetes and 205 did not have diabetes. Propensity score matching (PSM) analysis was performed to adjust for any potential confounders. The primary endpoints were 5-year major adverse cardiac and cerebrovascular events (MACE) and major adverse limb events (MALE). After PSM analysis, baseline clinical and limb characteristics were similar in patients with diabetes and in patients without diabetes. Patients with diabetes had a higher rate of major hematoma (> 4 cm) (9.9% vs 3.3%, p = 0.038). At 5-year clinical follow-up, patients with diabetes and patients without diabetes had similar rates of MACE (20.7% vs 20.7%, log rank p = 0.989) and MALE (19.8% vs 24.5%, log rank p = 0.312), as well as the individual endpoints. In subgroup analysis adjusted by PSM, female patients with diabetes had a higher risk of MALE (hazard ratio 0.31, 95% CI 0.13-0.69, p = 0.004). Although there was a higher rate of major hematoma, patients with diabetes who underwent endovascular therapy had similar 5-year cardiac and vascular outcomes compared with patients without diabetes. Bleeding avoidance strategies, including optimal antiplatelet and antithrombotic therapy, and meticulous vascular access techniques, are needed in patients with diabetes to reduce the risk of bleeding and its deleterious impact on morbidity and mortality.

Myeloproliferative Neoplasms Are Associated with Increased Risk of Major Adverse Limb Events Among Patients Hospitalized for Peripheral Arterial Disease

Severe inframalleolar disease is an independent predictor of adverse limb outcomes after endovascular revascularization in chronic limb-threatening ischemia

Time to Wound Healing and Major Adverse Limb Events in Patients with Critical Limb Ischemia Treated with Endovascular Revascularization

Peripheral artery disease (PAD) is associated with a high risk of cardiovascular events. While glucagon-like peptide-1 receptor agonists (GLP-1RAs) have demonstrated cardiovascular benefit in patients with diabetes, their role in patients with PAD without diabetes is not well understood. This study aimed to assess the impact of GLP-1RA therapy on cardiovascular outcomes in nondiabetic PAD patients. We conducted a retrospective cohort study using the TriNetX U.S. collaborative network, identifying adults aged 18-89 with PAD and no history of diabetes from January 2014 to January 2024. Patients treated with GLP-1RAs were compared with untreated counterparts. A 1:1 greedy nearest neighbor propensity score matching was performed to balance baseline characteristics. The primary outcomes were 3-point major adverse cardiovascular events (MACE) defined as nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death, all-cause mortality; major adverse limb events (MALE) defined as limb-threatening ischemia, revascularization procedures, or major amputation. Cox regression and Kaplan-Meier analysis were used to assess outcomes over a 5-year follow-up period. After matching, 13,555 patients remained in each group with well-balanced covariates. GLP-1RA use was associated with lower risk of MACE (hazard ratio (HR): 0.61; 95% confidence interval (CI): 0.57-0.66; p < 0.001), all-cause mortality (HR: 0.40; 95% CI: 0.35-0.46; p < 0.001), and MALE (HR: 0.22; 95% CI: 0.17-0.28; p < 0.001). In a sensitivity analysis focusing on semaglutide use initiated post-2021, the benefits remained robust for both MACE (HR: 0.55; 95% CI: 0.50-0.60) and all-cause mortality (HR: 0.303; 95% CI: 0.25-0.36). In this large real-world cohort, GLP-1RA therapy was associated with significantly reduced cardiovascular and limb-related events in nondiabetic patients with PAD. These findings support the potential role of GLP-1RAs in cardiovascular risk reduction beyond diabetes and highlight the need for prospective randomized trials in this population.

Characteristics of multidisciplinary limb preservation teams and their impact on outcomes in the BEST-CLI trial.

Although symptomatic peripheral arterial disease (PAD) is common in patients with hemodialysis (HD), few studies have evaluated the long-term clinical outcomes of revascularization in this population. The aim of the current study was to investigate the 10-year clinical outcomes of HD patients with PAD undergoing endovascular therapy (EVT). We retrospectively analyzed 750 limbs from 578 HD patients with symptomatic PAD due to infrainguinal lesions, treated with EVT, between May 2004 and November 2011. The primary outcome was 10-year mortality and the secondary outcome was 10-year freedom from major adverse limb events (MALEs). Predictors for each outcome were evaluated by Cox proportional-hazards model. The 10-year rate of survival and freedom from MALEs was 23.6 ± 3.1% and 76.4 ± 2.9%, respectively. In the multivariate analysis, patients with over 80years [hazard ratio (HR) 2.10; 95% confidence interval (CI) 1.58-2.80; p < 0.001], non-ambulatory status (HR 1.55; 95% CI 1.19-2.03; p = 0.001), absence of hypertension (HR 1.59; 95% CI 1.19-2.08; p = 0.001), heart failure (HR 1.36; 95% CI 1.02-1.80; p = 0.03), and tissue loss (HR 1.65; 95% CI 1.28-2.12; p < 0.001) were at an increased risk of 10-year mortality. Cerebrovascular diseases (HR 1.60; 95% CI 1.03-2.49; p = 0.038), no cilostazol use (HR 1.69; 95% CI 1.09-2.70; p = 0.021), tissue loss (HR 3.87; 95% CI 2.37-6.34; p < 0.001), and poor below-the-knee (BTK) run-off (HR 1.68; 95% CI 1.04-2.71; p = 0.035) were significantly associated with MALEs. After risk stratification analysis based on risk score assignment according to number of predictors, 10-year survival and freedom from MALE were lower in the higher score groups (10-year survival rates according to number of risk factors: 0, 35.1%; 1, 20.3%; 2-5, 10.8%; respectively, p < 0.001, 10-year freedom from MALE rates in patients with greater number of risk factors: 0-1, 90.2%; 2-3, 65.5%; 4-5, 61.6%; respectively, p < 0.001). The 10-year clinical outcomes after EVT for HD patients with PAD due to infrainguinal disease were clinically suboptimal. Risk stratification based on these predictors before EVT would be useful in estimating future adverse outcome.

The impact of diabetes mellitus (DM) on outcomes of lower extremity revascularization (LER) for peripheral artery disease (PAD) is uncertain. We characterized associations between DM and post-procedural outcomes in PAD patients undergoing LER. Adults undergoing surgical or endovascular LER were identified from the 2014 Nationwide Readmissions Database. DM was defined by ICD-9 diagnosis codes and sub-classified based on the presence or absence of complications (poor glycaemic control or end-organ damage). Major adverse cardiovascular and limb events (MACLEs) were defined as the composite of death, myocardial infarction, ischaemic stroke, or major limb amputation during the index hospitalization for LER. For survivors, all-cause 6-month hospital readmission was determined. Among 39441 patients with PAD hospitalized for LER, 50.8% had DM. The composite of MACLE after LER was not different in patients with and without DM after covariate adjustment, but patients with DM were more likely to require major limb amputation [5.5% vs. 3.2%, P < 0.001; adjusted odds ratio (aOR) 1.22, 95% confidence interval (CI) 1.03-1.44] and hospital readmission (59.2% vs. 41.3%, P < 0.001; aOR 1.44, 95% CI 1.34-1.55). Of 20039 patients with DM hospitalized for LER, 55.7% had DM with complications. These patients were more likely to have MACLE after LER (11.1% vs. 5.2%, P < 0.001; aOR 1.56 95% CI 1.28-1.89) and require hospital readmission (61.1% vs. 47.2%, P < 0.001; aOR 1.41 95% CI 1.27-1.57) than patients with uncomplicated DM. DM is present in ≈50% of patients undergoing LER for PAD and is an independent risk factor for major limb amputation and 6-month hospital readmission.

Background/Introduction Peripheral artery disease (PAD) increases the risk of stroke, cardiovascular death, and major adverse limb events (MALE) in patients with atrial fibrillation (AF). However, the effectiveness and safety of rivaroxaban compared with apixaban in patients with both NVAF and PAD is unclear, especially for MALE, a critical outcome in PAD. Purpose To compare the effectiveness and safety of rivaroxaban versus apixaban in patients with NVAF and PAD. Methods Using the UK Clinical Practice Research Datalink, a large primary care database, we formed a cohort of patients aged ≥45 years with incident NVAF and PAD who initiated rivaroxaban or apixaban between 2013 and 2021. Cohort entry was defined as the first prescription for rivaroxaban or apixaban following NVAF diagnosis. The primary effectiveness outcomes were MALE, defined as hospitalization for acute limb ischemia or major amputation, and a composite of ischemic stroke, transient ischemic attack (TIA), or systemic embolism (SE). The primary safety outcome was major bleeding defined as bleeding requiring hospitalization or resulting in death. We used propensity score fine stratification and weighting for confounding control. We fit weighted Cox proportional hazards models to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) for each outcome associated with rivaroxaban compared with apixaban. Results The cohort included 6,170 new-users of rivaroxaban and 9,990 new-users of apixaban. Rivaroxaban and apixaban had similar incidence rates of MALE (adjusted rates 6.7 vs. 5.6 per 1,000 person-years; adjusted HR (aHR) 1,20; 95% CI 0.87-1.65) and stroke/TIA/SE (adjusted rates 24.5 vs. 21.3 per 1,000 person-years; aHR 1,15; 95% CI 0.97-1.36). Major bleeding rates were higher with rivaroxaban (adjusted rates 46.1 vs. 29.8 per 1,000 person-years; aHR 1,55; 95% CI 1.36-1.77). The risk remained higher for all bleeding sites (intracranial hemorrhage: (HR 1.65; 95% CI 1.03-2.66), gastro-intestinal bleeding: (HR 1.52; 95% CI 1.17-1.98) and other bleeding: (HR 1.59; 95% CI 1.22-2.08)) Conclusion In patients with NVAF and PAD, rivaroxaban and apixaban showed similar effectiveness for preventing MALE and stroke/TIA/SE. However, rivaroxaban was associated with a higher risk of major bleeding. These findings support apixaban as a potentially safer anticoagulant in this high-risk population.

Society for Vascular Surgery limb stage and patient risk correlate with outcomes in an amputation prevention program