Real-world antithrombotic treatment variability in patients undergoing peripheral vascular intervention: Insights from the VQI registry.

For those undergoing peripheral vascular interventions (PVI), guidelines indicate the use of dual antiplatelet therapy (DAPT) is reasonable (Class IIb), but recommendations have not reached the highest level of evidence. In the largest effort to date, we found that antithrombotic prescription was dominated by single antiplatelet therapy (SAPT) (51.4%) before PVI, which switched to DAPT (57.7%) following PVI, with some patients still remaining on no therapy (8%). High site variability in prescription rates (median odds ratio: 1.40, 95% confidence interval: 1.32, 1.48) was not much explained by patient and provider factors, revealing a need for the creation and integration of the newest trial data and for interventions at the health system or practice level to help physicians determine the optimal medical therapy following PVI.

Patient representativeness of a peripheral artery disease cohort in a randomized control trial versus a real-world cohort: The CLEVER trial versus the PORTRAIT registry.

INTRODUCTION: Peripheral artery disease (PAD) is a burdensome disease. It is unclear whether PAD cohorts enrolled in contemporary randomized control trials (RCT) are representative of the real-world PAD populations in terms of their patient characteristics. METHODS: We compared baseline patient characteristics and health status (as measured by the Peripheral Artery Questionnaire [PAQ]) between the randomized CLEVER study, and the real-world PORTRAIT registry. CLEVER was an RCT of PAD patients enrolled from 29 centers across the US and Canada comparing revascularization with stenting versus optimal medical therapy (OMT) and supervised exercise therapy (SET) plus OMT. PORTRAIT was a multicenter, prospective study of patients with new or worsening PAD symptoms across ten sites in the US. RESULTS: The final cohort consisted of 879 patients (n = 119 from CLEVER, n = 760 from PORTRAIT (24.5% black, 41.4% women). While CLEVER enrolled patients with aortoiliac disease, only 16.0% of the PORTRAIT cohort had isolated aortoiliac disease. Compared with CLEVER, patients from PORTRAIT were older (64.0 ± 9.5 versus 68.9 ± 9.5 yrs., p ≤0.001), had more severe disease as measured by the ankle brachial index (0.7 ± 0.2 versus 0.9 ± 0.2, p ≤0.001) and a higher prevalence of cardiovascular risk factors including hyperlipidemia and diabetes (all p values<0.05). Both cohorts had similar disease-specific health status as measured by the PAQ summary score (47.4 ± 21.9 versus 43.6 ± 18.4, p = 0.07). CONCLUSION: In this comparative study, real-world patients with PAD were older and sicker when compared to an RCT with similar indications. This gap may be bridged by improving enrollment of underrepresented high-risk patients in PAD trials testing strategies for PAD symptom relief. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01419080?term=portrait&rank=1NCT01419080.

Guideline-Directed Medical Therapy in Patients with Chronic Kidney Disease Undergoing Peripheral Vascular Intervention.

INTRODUCTION: Guideline-directed medical therapy (GDMT) is imperative to improve cardiovascular and limb outcomes for patients with critical limb ischemia (CLI), especially amongst those at highest risk for poor outcomes, including those with comorbid chronic kidney disease (CKD). Our objective was to examine GDMT prescription rates and their variation across individual sites for patients with CLI undergoing peripheral vascular interventions (PVIs), by their comorbid CKD status. METHODS: Patients with CLI who underwent PVI (October 2016-April 2019) were included from the Vascular Quality Initiative (VQI) database. CKD was defined as GFR <60 mL/min/1.73 m2. GDMT included the composite use of antiplatelet therapy and a statin, as well as an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker if hypertension was present. The use of GDMT before and after the index procedure was summarized in those with and without CKD. Adjusted median odds ratios (MORs) for site variability were calculated. RESULTS: The study included 28,652 patients, with a mean age of 69.4 ± 11.7 years, and 40.8% were females. A total of 47.5% had CKD. Patients with CKD versus those without CKD had lower prescription rates both before (31.7% vs. 38.9%) and after (36.5% vs. 48.8%) PVI (p < 0.0001). Significant site variability was observed in the delivery of GDMT in both the non-CKD and CKD groups before and after PVI (adjusted MORs: 1.31-1.41). DISCUSSION/CONCLUSION: In patients with CLI undergoing PVI, patients with comorbid CKD were less likely to receive GDMT. Significant variability of GDMT was observed across sites. These findings indicate that significant improvements must be made in the medical management of patients with CLI, particularly in patients at high risk for poor clinical outcomes.

Association of sleep apnea with outcomes in peripheral artery disease: Insights from the PORTRAIT study.

BACKGROUND: Sleep apnea is a predictor of adverse cardiovascular outcome in many cardiovascular diseases but whether it is associated with worse health status outcomes or mortality in peripheral artery disease (PAD) is unknown. METHODS: PORTRAIT is an international (US, Netherlands, Australia) prospective PAD registry that consecutively enrolled patients who presented with new-onset or recent exacerbations of PAD symptoms to any of 16 vascular specialty clinics. Health status was assessed upon presentation and at 12 months with the disease-specific Peripheral Artery Questionnaire (PAQ). Higher PAQ scores indicate better health status. A sequentially-adjusted hierarchical linear regression model examined the association between sleep apnea and 1-year PAQ symptoms, quality of life, and summary scores. Five-year survival curves by comorbid sleep apnea status for US patients were compared using the log-rank test. RESULTS: The mean age of the 1204 PORTRAIT participants was 67.6 ± 9.4 years with 37.5% women and 8.3% (n = 100) having sleep apnea. Patients with sleep apnea were more likely to be from the US, more sedentary, and to have diabetes, obesity, coronary disease, more depressive symptoms and a history of prior peripheral interventions. Paradoxically, they also had higher ankle-brachial indices, but lower PAQ Summary scores at presentation and 12 months (41.2 ± 22.0 vs. 49. 9± 21.6 and 58.6 ± 27.9 vs. 71.3 ± 24.9, respectively, p = <0.05). The association between sleep apnea and 1-year health status persisted after multivariable adjustment, but there were no differences in all-cause mortality over 5 years (28.0% vs. 23.4%, p = 0.76). CONCLUSION: In patients presenting with PAD, comorbid sleep apnea is independently associated with worse health status over time. Future studies should test whether better treatment of sleep apnea can improve the health status of patients with PAD. CLINICAL TRIAL REGISTRATION: NCT01419080.

Establishing Thresholds for Minimal Clinically Important Differences for the Peripheral Artery Disease Questionnaire.

BACKGROUND: Understanding minimum clinically important differences (MCID) in patient-reported outcomes is essential in interpreting the magnitude of changes in these measures. No MCID from patients' perspectives has ever been published for peripheral artery disease-specific health status assessment tools. The Peripheral Artery Questionnaire (PAQ) is a commonly used, validated peripheral artery disease-specific health status instrument for which we sought to prospectively establish its MCID from patients' perspectives. METHODS AND RESULTS: Patients presenting to vascular clinics with new or worsened claudication in the US cohort of the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry who completed baseline and follow-up PAQ assessments along with the Global Assessment of Functioning scale were included. Mean change in PAQ summary scores from 3- to 6-month follow-up was calculated according to Global Assessment of Functioning category. MCID was defined as the mean difference in scores between those with small improvement or deterioration and those with no change. Multivariable linear regression was used to provide an MCID estimate after adjusting for patients' 3-month PAQ score. Of the 483 patients who completed the Global Assessment of Functioning score at 6 months and who had available 3- and 6-month PAQ assessments, the mean age was 69 years, 42% were female, and 71% were White. The MCIDs for PAQ summary scale improvement and worsening were 8.7 (2.9-14.5) and -11.0 (-18.6 to -3.3), respectively. After multivariable adjustment, these were 8.9 (3.0-14.8) and -11.2 (-18.2 to -4.2), respectively. There was no significant interaction between treatment (invasive versus noninvasive) and Global Assessment of Functioning response (P=0.75). CONCLUSIONS: In patients with new or worsened claudication, a 10-point change in PAQ summary score represents an MCID. This estimate needs external validation and may inform the interpretation of PAQ scores when used as outcomes in clinical trials or in routine clinical care. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01419080.

Safety and efficacy outcomes of the Pioneer Plus catheter in endovascular revascularization of lower extremity chronic total occlusions.

OBJECTIVE: Our aim was to evaluate the efficacy and safety outcomes of the Pioneer Plus catheter (Philips, San Diego, Calif) and report the in-hospital and 30-day outcomes of lower extremity chronic total occlusion (CTO) interventions assisted by the Pioneer Plus catheter. In addition, we explored the factors associated with procedural success. METHODS: We conducted a retrospective review of 135 consecutive procedures in 116 patients from July 2011 to September 2018 performed by eight operators with various levels of experience at a high-volume center where the Pioneer Plus catheter was used for lower extremity CTO. The patient demographics, preprocedural symptoms, preprocedural testing results, procedural setting, and angiography findings were abstracted. The outcomes were divided into device-related and procedure-related outcomes. Device-related efficacy outcome included procedural success. Device-related safety outcomes included device-related complications. Procedure-related outcomes included procedure-related complications, 30-day major adverse cardiovascular events, and 30-day major adverse limb events. We conducted univariate comparisons of the provider, patient, and procedural characteristics stratified by procedural success. RESULTS: Procedural success was observed in 118 procedures overall (87.4%), and success rates ≤95.8% were observed for operators with an experience level of >25 devices deployed. No device-related complications, such as pseudoaneurysm formation, vessel perforation, or arteriovenous fistula formation, were observed. The Pioneer Plus catheter was mostly often used for CTO in the superficial femoral and popliteal arteries. Overall, the procedure-related complications included access site hematoma (5.2%), major bleeding (0.7%), pseudoaneurysm formation (0.7%), distal embolization (1.5%), and acute arterial thrombosis (1.5%). The 30-day major adverse limb events included index limb unplanned amputation (0.7%), index limb reintervention (4.4%), and index limb acute limb ischemia (0.7%) and occurred in 5.9% of the procedures. The only factor associated with procedural success was operator experience (P < .0001). CONCLUSIONS: The results from the present study have shown that Pioneer Plus catheter use is safe and effective when used to cross lower extremity CTO. However, further investigation is needed to identify patient- and provider-level factors to optimize patient outcomes.

Treatment decisions for patients with peripheral artery disease and symptoms of claudication: Development process and alpha testing of the SHOW-ME PAD decision aid.

Patients with peripheral artery disease (PAD) face a range of treatment options to improve survival and quality of life. An evidence-based shared decision-making tool (brochure, website, and recorded patient vignettes) for patients with new or worsening claudication symptoms was created using mixed methods and following the International Patient Decision Aids Standards (IPDAS) criteria. We reviewed literature and collected qualitative input from patients (n = 28) and clinicians (n = 34) to identify decisional needs, barriers, outcomes, knowledge, and preferences related to claudication treatment, along with input on implementation logistics from 59 patients and 27 clinicians. A prototype decision aid was developed and tested through a survey administered to 20 patients with PAD and 23 clinicians. Patients identified invasive treatment options (endovascular or surgical revascularization), non-invasive treatments (supervised exercise therapy, claudication medications), and combinations of these as key decisions. A total of 65% of clinicians thought the brochure would be useful for medical decision-making, an additional 30% with suggested improvements. For patients, those percentages were 75% and 25%, respectively. For the website, 76.5% of clinicians and 85.7% of patients thought it would be useful; an additional 17.6% of clinicians and 14.3% of patients thought it would be useful, with improvements. Suggestions were incorporated in the final version. The first prototype was well-received among patients and clinicians. The next step is to implement the tool in a PAD specialty care setting to evaluate its impact on patient knowledge, engagement, and decisional quality. ClinicalTrials.gov Identifier: NCT03190382.

Paclitaxel-coated devices in the treatment of femoropopliteal stenosis among patients ≥65 years old: An ACC PVI Registry Analysis.

BACKGROUND: The connection between paclitaxel-coated devices (PCD) use during peripheral vascular interventions (PVI) and mortality is debated. We aimed to analyze patterns of PCD use and the safety and effectiveness of PCD use in the superficial femoral and/or popliteal arteries. METHODS: Patients undergoing PVI of femoropopliteal lesions with and without PCD between January 1, 2015 and June 30, 2017 were compared using the American College of Cardiology's National Cardiovascular Data Registry PVI Registry. Outcomes were derived from Centers for Medicare & Medicaid claims data. The primary outcome was all-cause mortality at 6-, 12-, and 24-months following PVI. Inverse probability weighting and frailty models were used to assess the differences between groups. The analysis was IRB-approved. RESULTS: In the overall cohort consisting of 6,302 femoropopliteal PVIs, PCD-PVI patients were more likely to be treated for claudication (63.5% vs 51.3%, P< .001), less likely to have a chronic total occlusion (24.6% vs 34.7%, P < .001), and more likely to be treated in certain geographic and practice settings. In the analytic cohort consisting of 1,666 femoropopliteal PVIs with linked claims outcomes (888 PCD-PVI, 53.3%), unadjusted rates of all outcomes were lower in PCD-PVI patients. After adjustment, there were no significant differences in mortality following PCD-PVI versus non-PCD PVI at 1 year (adjusted RR 0.78, 95% CI 0.60-1.01, P= .055) or 2 years (aRR 0.98, 95% CI 0.77-1.24, P= .844). CONCLUSION: There were significant differences between the patients in whom and settings in which PCD-PVI was versus was not used. PCD-PVI was not associated with an increased risk of 2-year mortality in real-world use.

Patient profiles and health status outcomes for peripheral artery disease in high-income countries: a comparison between the USA and The Netherlands.

AIMS: Peripheral artery disease (PAD) is a global disease. Understanding variability in patient profiles and PAD-specific health status outcomes across health system countries can provide insights into improving PAD care. We compared these features between two high-income countries, the USA and The Netherlands. METHODS AND RESULTS: Patients were identified from the patient-centred outcomes related to treatment practices in peripheral arterial disease: investigating trajectories study-a prospective, international registry of patients presenting to vascular specialty clinics for new onset, or exacerbation of PAD symptoms. PAD-specific health status was measured with the peripheral artery questionnaire. General linear mixed models for repeated measures were used to study baseline, 3, 6, and 12-month PAD-specific health status outcomes (peripheral artery questionnaire summary score) between the USA and The Netherlands. Out of a total of 1114 patients, 748 patients (67.1%) were from the USA and 366 (32.9%) from The Netherlands. US patients with PAD were older, with more financial barriers, higher cardiovascular risk factor burden, and lower referral rates for exercise treatment (P < 0.001). They had significantly worse PAD-specific adjusted health status scores at presentation, 3, 6, and 12 months of follow-up (all P < 0.0001). Magnitude of change in 1-year health status scores was smaller in the US cohort when compared with The Netherlands. CONCLUSION: Compared with the Dutch cohort, US patients had worse adjusted PAD-specific health status scores at all time point, improving less over time, despite treatment. Leveraging inter-country differences in care and outcomes could provide important insights into optimizing PAD outcomes. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01419080? term=portrait&rank=1 NCT01419080.

Systematic review and meta-analysis of outcomes of lower extremity peripheral arterial interventions in patients with and without chronic kidney disease or end-stage renal disease.

OBJECTIVE: Patients with chronic kidney disease (CKD) have a greater risk of peripheral arterial disease (PAD). Although individual studies have documented an association between CKD and/or end-stage renal disease (ESRD) and adverse outcomes in patients undergoing PAD interventions in an era of technological advances in peripheral revascularization, the magnitude of the effect size is unknown. Therefore, we performed a meta-analysis to compare the outcomes of PAD interventions for patients with CKD/ESRD with those patients with normal renal function, stratified by intervention type (endovascular vs surgical), reflecting contemporary practice. METHODS: Five databases were analyzed from January 2000 to June 2019 for studies that had compared the outcomes of lower extremity PAD interventions for patients with CKD/ESRD vs normal renal function. We included both endovascular and open interventions, with an indication of either claudication or critical limb ischemia. We analyzed the pooled odds ratios (ORs) across studies with 95% confidence intervals (CIs) using a random effects model. Funnel plot and exclusion sensitivity analyses were used for bias assessment. RESULTS: Seventeen observational studies with 13,140 patients were included. All included studies, except for two, had accounted for unmeasured confounding using either multivariable regression analysis or case-control matching. The maximum follow-up period was 114 months (range, 0.5-114 months). The incidence of target lesion revascularization (TLR) was greater in those with CKD/ESRD than in those with normal renal function (OR, 1.68; 95% CI, 1.25-2.27; P = .001). The incidence of major amputations (OR, 1.97; 95% CI, 1.37-2.83; P < .001) and long-term mortality (OR, 2.28; 95% CI, 1.45-3.58; P < .001) was greater in those with CKD/ESRD. The greater TLR rates with CKD/ESRD vs normal renal function were only seen with endovascular interventions, with no differences for surgical interventions. The differences in rates of major amputations and long-term mortality between the CKD/ESRD and normal renal function groups were statistically significant, regardless of the intervention type. CONCLUSIONS: Patients with CKD/ESRD who have undergone lower extremity PAD interventions had worse outcomes than those of patients with normal renal function. When stratifying our results by intervention (endovascular vs open surgery), greater rates of TLR for CKD/ESRD were only seen with endovascular and not with open surgical approaches. Major amputations and all-cause mortality were greater in the CKD/ESRD group, irrespective of the indication. Evidence-based strategies to manage this at-risk population who require PAD interventions are essential.

Association of perceived stress with health status outcomes in patients with peripheral artery disease.

OBJECTIVE: To assess association of chronic self-perceived stress with health status outcomes of patients with peripheral artery disease. METHODS: The PORTRAIT study is a prospective registry that enrolled 1275 patients with symptoms of peripheral artery disease across 16-sites in US, Netherlands, and Australia from June 2011 to December 2015. Demographics, comorbidities and diagnostic information was abstracted from chart review. Self-perceived stress was assessed using the 4-item perceived stress scale at baseline, 3- and 6-month follow-up. Scores range from 0 to 16 with higher scores indicating greater stress. Sum scores were calculated at each time point and averaged to quantify average exposure to stress from enrollment through 6 months. Disease-specific health status were assessed at baseline and 12-months using the peripheral artery disease questionnaire summary score. RESULTS: The mean age of the analytical cohort (n = 1060) was 67.7 ± 9.3 years, 37.1% were females, and 82.3% were white. Comorbidities were highly prevalent with 80.9% having hypertension, 32.6% having diabetes, and 36.4% being smokers. In models adjusted for demographics, comorbidities, disease severity and socioeconomic status, having a higher average stress score was associated with poorer recovery (from baseline) in peripheral artery disease questionnaire summary score at 12-months (-1.4 points per +1-point increase in averaged 4-point perceived stress score, 95% CI -2.1, -0.6 p < 0.001). CONCLUSION: In patients with peripheral artery disease, experiencing higher chronic stress throughout the 6-months following their diagnosis, was independently associated with poorer recovery in 12-month disease-specific health status outcomes. (ClinicalTrial.gov identifier: NCT01419080).

Relationship Between Depressive Symptoms and Health Status in Peripheral Artery Disease: Role of Sex Differences.

Background The association of depressive symptoms with health status in peripheral artery disease (PAD) is understudied. No reports of differential impact on women have been described. Methods and Results The PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Artery Disease Investigating Trajectories) registry enrolled 1243 patients from vascular specialty clinics with new or worsening PAD symptoms. Depressive symptoms were assessed at baseline and 3 months using the 8-Item Patient Health Questionnaire (score ≥10 indicating clinically relevant depressive symptoms). Disease-specific and generic health status were measured by Peripheral Artery Questionnaire and EQ-5D Visual Analogue Scale at baseline and 3, 6, and 12 months. An adjusted general linear model for repeated measures was constructed for baseline and 3-, 6-, and 12-month health status outcomes by depressive symptoms at baseline. Differences by sex were tested with interaction effects. The mean age was 67.6±9.4 years with 38% (n=470) women. More women than men (21.1% versus 12.9%; P<0.001) presented with severe depressive symptoms. In the adjusted model, patients with depressive symptoms had worse health status at each time point (all P<0.0001). Results were similar for EQ-5D Visual Analogue Scale scores. The magnitude in 1-year change in health status scores did not differ by sex. Depressive symptoms explained 19% of the association between sex differences in 1-year Peripheral Artery Questionnaire summary scores. Conclusions Women with PAD have a high burden of depressive symptoms. Depressive symptoms were associated with a strikingly worse disease-specific health status recovery path over the year following PAD diagnosis in men and women. Developing and testing interventions to address depressive symptoms in PAD are urgently needed. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01419080.

Association of Perceived Stress Levels With Long-term Mortality in Patients With Peripheral Artery Disease.

Importance: Identifying modifiable risk factors, such as stress, that could inform the design of peripheral artery disease (PAD) management strategies is critical for reducing the risk of mortality. Few studies have examined the association of self-perceived stress with outcomes in patients with PAD. Objective: To examine the association of high levels of self-perceived stress with mortality in patients with PAD. Design, Setting, and Participants: This cohort study analyzed data from the registry of the Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study, a multicenter study that enrolled patients with new or worsening symptoms of PAD who presented to 16 subspecialty clinics across the US, the Netherlands, and Australia from June 2, 2011, to December 3, 2015. However, the present study included only patients in the US sites because assessments of mortality for patients in the Netherlands and Australia were not available. Data analysis was conducted from July 2019 to March 2020. Exposure: Self-perceived stress was quantified using the 4-item Perceived Stress Scale (PSS-4), with a score range of 0 to 16. A score of 6 or higher indicated high stress in this cohort. Missing scores were imputed using multiple imputation by chained equations with predictive mean matching. Stress was assessed at baseline and at 3-, 6-, and 12-month follow-up. Patients who reported high levels of stress at 2 or more follow-up assessments were categorized as having chronic stress. Main Outcomes and Measures: All-cause mortality was the primary study outcome. Such data for the subsequent 4 years after the 12-month follow-up were obtained from the National Death Index. Results: The final cohort included 765 patients, with a mean (SD) age of 68.4 (9.7) years. Of these patients, 57.8% were men and 71.6% were white individuals. High stress levels were reported in 65% of patients at baseline and in 20% at the 12-month follow-up. In an adjusted Cox proportional hazards regression model accounting for demographics, comorbidities, disease severity, treatment type, and socioeconomic status, exposure to chronic stress during the 12 months of follow-up was independently associated with increased risk of all-cause mortality in the subsequent 4 years (hazard ratio, 2.12; 95% CI, 1.14-3.94; P = .02). Conclusions and Relevance: In thie cohort study of patients with PAD, higher stress levels in the year after diagnosis appeared to be associated with greater long-term mortality risk, even after adjustment for confounding factors. These findings suggest that, given that stress is a modifiable risk factor for which evidence-based management strategies exist, a holistic approach that includes assessment of chronic stress has the potential to improve survival in patients with PAD.

Cilostazol and peripheral artery disease-specific health status in ambulatory patients with symptomatic PAD.

BACKGROUND: Improvement of symptoms and functional status is one of the main peripheral artery disease (PAD) treatment goals but pharmacological options are limited. The objective of this study was to assess the use of cilostazol and its association with patient-reported health status quantified by the Peripheral Artery Questionnaire (PAQ). METHODS: Initiation of cilostazol therapy was assessed in 567 patients in the US cohort of PORTRAIT between June 2011 and December 2015. Patients with heart failure history, on cilostazol prior to enrollment, with no baseline or follow-up PAQ scores were excluded. Health status over time was quantified using linear mixed models adjusting for baseline PAQ scores and patient characteristics. RESULTS: Of the 567 cilostazol-naïve patients, 65 (11%) were started on cilostazol. Mean age was 68.5 ± 9.6 years, 43% were female and 71.1% white. There was no significant difference in the mean PAQ score changes from baseline to 12 months between the cilostazol and non-cilostazol group, with difference of 3.8 [CI (-2.6, 10.1), p = .24] for summary scores, 1.6 [CI (-5.5, 8.6), p = .66] for quality of life, 3.6 [CI (-4.3, 11.6), p = .37] for symptoms, 6.2 [CI (-3.1, 15.5), p = .19] for physical limitation and 3.2 [CI (-3.9, 10.2), p = .38] for social limitation scores. CONCLUSIONS: We found a low rate of cilostazol use and while there was no significant association between cilostazol initiation and subsequent health status, the ability to define small differences in health status was limited due to the small sample size.

Utility of Intravascular Ultrasound in Peripheral Vascular Interventions: Systematic Review and Meta-Analysis.

OBJECTIVES: We sought to compare outcomes between intravascular ultrasound- (IVUS) versus angiography (AO)-guided peripheral vascular interventions (PVIs). Introduction: Intravascular ultrasound facilitates plaque visualization and angioplasty during PVIs for peripheral arterial disease. It is unclear whether IVUS may improve the durability of PVIs and lead to improved clinical outcomes. METHODS: This is a study-level meta-analysis of observational studies. The primary end points of this study were rates of primary patency and reintervention. Secondary end points included rates of vascular complications, periprocedural adverse events, amputations, technical success, all-cause mortality, and myocardial infarction. RESULTS: Eight observational studies were included in this analysis with 93 551 patients. Mean follow-up was 24.2 ± 15 months. Intravascular ultrasound-guided PVIs had similar patency rates when compared with AO-guided PVIs (relative risk [RR]: 1.30, 95% confidence interval [CI]: 0.99-1.71, P = .062). There was no difference in rates of reintervention in IVUS-guided PVIs when compared to non-IVUS-guided PVIs (RR: 0.41, 95% CI: 0.15-1.13, P = .085). There is a lower risk of periprocedural adverse events (RR: 0.81, 95% CI: 0.70-0.94, P = .006) and vascular complications (RR: 0.81, 95% CI: 0.68-0.96, P = .013) in the IVUS group. All-cause mortality (RR: 0.76, 95% CI: 0.56-1.04, P = .084), amputation rates (RR 0.83, 95% CI: 0.32-2.15, P = .705), myocardial infarctions (RR: 1.19, 95% CI: 0.58-2.41, P = .637), and technical success (RR: 1.01, 95% CI: 0.86-1.19, P = .886) were similar between the groups. Conclusions: Intravascular ultrasound-guided PVIs had similar primary patency and reintervention when compared with AO-guided PVIs with significantly lower rates of periprocedural adverse events and vascular complications in the IVUS-guided group.

Financial barriers in accessing medical care for peripheral artery disease are associated with delay of presentation and adverse health status outcomes in the United States.

Patient-reported difficulties in affording health care and their association with health status outcomes in peripheral artery disease (PAD) have never been studied. We sought to determine whether financial barriers affected PAD symptoms at presentation, treatment patterns, and patient-reported health status in the year following presentation. A total of 797 United States (US) patients with PAD were identified from the Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study, a prospective, multicenter registry of patients presenting to vascular specialty clinics with PAD. Financial barriers were defined as a composite of no insurance and underinsurance. Disease-specific health status was measured by Peripheral Artery Questionnaire (PAQ) and general health-related quality of life was measured by EuroQol 5 (EQ5D) dimensions at presentation and at 3, 6, and 12 months of follow-up. Among 797 US patients, 21% (n = 165) of patients reported financial barriers. Patients with financial barriers presented at an earlier age (64 ± 9.5 vs 70 ± 9.4 years), with longer duration of symptoms (59% vs 49%) (all p ⩽ 0.05), were more depressed and had higher levels of perceived stress and anxiety. After multivariable adjustment, health status was worse at presentation in patients with financial barriers (PAQ: -7.0 [-10.7, -3.4]; p < 0.001 and EQ5D: -9.2 [-12.74, -5.8]; p < 0.001) as well as through 12 months of follow-up (PAQ: -8.4 [-13.0, -3.8]; p < 0.001 and EQ5D: -9.7 [-13.2, -6.2]; p < 0.001). In conclusion, financial barriers are associated with later presentation as well as poorer health status at presentation and at 12 months. ClinicalTrials.gov Identifier: NCT01419080.

Endovascular Treatment of Inferior Vena Cava Thrombosis in Metastatic Malignancy: A Case Report and Review of Literature.

Inferior vena cava (IVC) thrombosis is a specific form of thromboembolism that occurs at a rate of 1.5% in all patients hospitalized with a deep vein thrombosis. Malignant IVC thrombosis may occur due to compression from a tumor mass or metastasis or may also occur through tumor invasion of the venous vasculature. Obstruction of the IVC can lead to IVC syndrome, marked by ascites, lower extremity edema, and even congestive hepatic failure. We present a case of extensive IVC thrombosis in a 69-year-old female with metastatic adrenal cell carcinoma, presenting with severe bilateral lower extremity edema and ascites. Computed tomography showed IVC compression by the caudate lobe due to a metastatic liver mass and extensive clot burden of the IVC extending from the renal veins to the right atrium (RA). She underwent percutaneous IVC stenting with 4 stents placed in tandem from the IVC to the RA. Her hospital course was complicated by gastrointestinal bleed requiring clipping, acute liver failure, and hypophysitis due to trial therapy. Although her IVC symptoms were partially relieved with percutaneous intervention, her acute liver failure worsened and she was ultimately transitioned to hospice care.

Drug-coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta-analysis of randomized controlled trials.

BACKGROUND: Drug-coated balloon (DCB) angioplasty has emerged as a mainstay of therapy for the treatment of peripheral arterial disease (PAD) involving the superficial femoral and popliteal arteries. We performed a meta-analysis including all available randomized controlled trials (RCTs) to date which compare DCB to plain balloon angioplasty (POBA) in femoropopliteal disease (FPD). METHODS: Five databases were analyzed including EMBASE, PubMed, Cochrane, Scopus, and Web-of-Science from January 2000 to September 2018 for RCTs comparing DCB to POBA in patients with FPD. Heterogeneity was determined using Cochrane's Q-statistics. Random effects model was used. RESULTS: Twenty-two RCTs, including five trials of in-stent restenosis (ISR) intervention, with 3,217 patients were included in the analysis. Mean follow-up was approximately 21.6 ± 14.4 months. Overall, DCB use was associated with a 51% reduction in target vessel revascularization (TLR) when compared to POBA at follow-up (relative risk [RR]: 0.49, 95% confidence interval [CI]: 0.40-0.61, P < 0.0001). Rates of TLR were 45% lower in the DCB group when compared to POBA in patients with ISR (RR: 0.55, 95% CI: 0.37-0.81, P = 0.002). DCB was associated with lower rates of binary stenosis, late lumen loss and higher primary safety endpoints. Major amputation and mortality were not different between DCB and POBA. CONCLUSIONS: Use of DCBs is associated with improved vessel patency and a lower risk of TLR when compared to POBA in patients with FPD, especially in the setting of ISR. There was no difference in mortality between DCB and POBA in our meta-analysis. Extended follow-up of the available RCT data will be essential to analyze long-term device-related mortality.