Peripheral Artery Questionnaire Research Articles

Psychosocial and socioeconomic factors are most predictive of health status in patients with claudication

BackgroundAs a key treatment goal for patients with symptomatic peripheral artery disease (PAD), improving health status has also become an important end point for clinical trials and performance-based care. An understanding of patient factors associated with 1-year PAD health status is lacking in patients with PAD. MethodsThe health status of 1073 consecutive patients with symptomatic PAD in the international multicenter PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry was measured at baseline and 1 year with the Peripheral Artery Questionnaire (PAQ). The association of 47 patient characteristics with 1-year PAQ scores was assessed using a random forest algorithm. Variables of clinical significance were retained and included in a hierarchical multivariable linear regression model predicting 1-year PAQ summary scores. ResultsThe mean age of patients was 67.7 ± 9.3 years, and 37% were female. Variables with the highest importance ranking in predicting 1-year PAQ summary score were baseline PAQ summary score, Patient Health Questionnaire-8 depression score, Generalized Anxiety Disorder-2 anxiety score, new onset symptom presentation, insurance status, current or prior diagnosis of depression, low social support, initial invasive treatment, duration of symptoms, and race. The addition of 19 clinical variables in an extended model marginally improved the explained variance in 1-year health status (from R2 0.312 to 0.335). ConclusionsPatients’ 1-year PAD-specific health status, as measured by the PAQ, can be predicted from 10 mostly psychosocial and socioeconomic patient characteristics including depression, anxiety, insurance status, social support, and symptoms. These characteristics should be validated and tested in other PAD cohorts so that this model can inform risk adjustment and prediction of PAD health status in comparative effectiveness research and performance-based care.

Abstract 14025: Health Status Profiles in Patients With New or Worsening Peripheral Artery Disease Symptoms and 12-month Hospitalization Risk From the Portrait Registry

Introduction: Risk stratification for healthcare utilization in PAD is critical given rising costs. The association between health status measures and hospitalization is unknown. We examined the association between a disease-specific patient-reported outcome measure and risk of hospitalization at 12 months. Methods: Patients with new or worsened lower extremity claudication enrolled at US sites in the PORTRAIT registry from 2011 to 2015 were included. The Peripheral Artery Questionnaire, a PAD-specific patient-reported outcome measure, was used to measure health status. PAQ summary scores range from 0 to 100 (better health status). Kaplan-Meier failure curves and adjusted Cox proportional hazards models assessed the association between baseline PAQ summary score and (1) the combined endpoint of all-cause hospital admission and ED visit (AD-ED) and (2) all-cause hospital admission (AD) at 12 months. Results: Of the 796 patients (mean age 69 ± 10 years, 42% female, 72% white, mean baseline PAQ summary score 46.8 ± 22.0) included, 349 (44%) had a hospital admission or ED visit at 12 months, with a total of 661 visits. Patients in the lowest PAQ quartile had higher rates of AD-ED at 30 days (16.1% vs. 4.3%), 90 days (29.8% vs. 12.8%), and 12 months (53.3% vs. 22.4%). In the fully adjusted model, lower PAQ score was associated with higher risk for AD-ED (HR per 10-point decrease, 1.12, 95% CI, 1.06-1.19, P<0.001) and AD (HR per 10-point decrease, 1.14, 95% CI, 1.06-1.22, P<0.001). Conclusion: Lower PAD-specific health status is associated with an increased risk in the combined endpoint of hospital admission or ED visits and all-cause hospital admission. These results support the use of baseline health status as a strong predictor for healthcare utilization in a high-risk population and may help to offset costs.

Abstract 16108: Impact of Early Intervention on Quality of Life Outcomes in Peripheral Artery Disease Patients With Chronic Total Occlusion Lesions: Results From the PORTRAIT Registry

Background: Peripheral artery disease (PAD) is associated with functional impairment, decreased quality of life, and increased risk of cardiovascular events and mortality. Chronic total occlusion (CTO) lesions occur in up to 40% of PAD patients and pose a challenge for successful endovascular revascularization. We aim to evaluate the baseline characteristics, presentations, procedural outcomes, and quality of life (QOL) outcomes of CTO lesions in PAD compared to non-CTO lesions and the interaction with invasive therapy. Methods: The PORTRAIT registry is a prospective, multicenter, international study that enrolled patients with new or worsening claudication symptoms and an abnormal resting or post-exercise ankle brachial index. Patients with CTO lesions were compared to those without CTO lesions and divided into those who received early invasive treatment (revascularization within three months of enrollment) or noninvasive treatment with medical management. Quality of life outcomes were evaluated using the Peripheral Artery Questionnaire (PAQ) at baseline and during follow-up at 3, 6, and 12 months. Results: A total of 581 matched patients were identified, of which 39% had CTOs and 61% did not. Of the patients with CTOs, 31% underwent early invasive treatment and 69% were noninvasively managed. Patients with CTOs were more likely to present with higher Rutherford classification. The PAQ Summary Score was similar at baseline in patients with CTOs compared to those without CTOs. At 12-month follow-up, early invasive treatment resulted in higher PAQ summary scores in the non CTO arm (82.48 ± 22.79 vs. 67.83 ± 27.00, P<0.001). In the CTO arm, while PAQ summary score was higher at 3 and 6 months in the early invasive arm, the difference was not significant at 12 months (76.18 ± 25.16 vs. 70.60 ± 24.24, P=0.14) Conclusions: Patients with CTO lesions present with higher Rutherford classification than their non-CTO counterparts and both have similar PAQ summary scores at presentation. Early invasive treatment for CTO and non-CTO lesions in PAD patients is associated with significant improvements in quality-of-life outcomes.

Predictors of Revascularization in Lower-Extremity Peripheral Artery Disease: Insights From the PORTRAIT Study.

Peripheral artery disease (PAD) guidelines recommend revascularization only for patients with lifestyle-limiting claudication that is refractory to goal-directed medical therapy (class IIA, level of evidence A). However, real-world invasive treatment patterns and predictors of revascularization in patients with symptomatic lower-extremity PAD are still largely unknown. We aimed to examine rates, patient-level predictors, and site variability of early revascularization in patients with new or worsening PAD symptoms. Among patients with new-onset or recent exacerbation of PAD in the 10-center Patient-centered Outcomes Related to TReatment practices in peripheral Arterial disease: Investigating Trajectories (PORTRAIT) study enrolled between June 2011 and September 2015, we classified early revascularization (endovascular or surgical) as procedures being performed within 3 months of presentation. Hierarchical logistic regression was used to identify patient characteristics associated with early revascularization. Variability across sites was estimated using the median odds ratio (OR). Among 797 participants, early revascularization procedures were performed in 224 (28.1%). Rutherford class 3 (vs Rutherford class 1; OR=1.86, 95% confidence interval [CI] 1.04-3.33) and having lesions in both iliofemoral and below-the-knee arterial segments (vs below the knee only; OR=1.75, 95% CI: 1.15-2.67) were associated with a higher odds of revascularization. Longer PAD duration >12 months (vs 1-6 months; OR=0.50, 95% CI: 0.32-0.77), higher ankle-brachial index scores (per 0.1 unit increase; OR=0.86, 95% CI: 0.78-0.96), and higher Peripheral Artery Questionnaire Summary scores (per 10 unit increase; OR=0.89, 95% CI: 0.80-0.99) were associated with a lower odds of revascularization. The raw rates for revascularization in different sites ranged from 6.25% to 66.28%, and the median OR was 1.88, 95% CI: 1.38-3.57. About 1 in 3 patients with symptomatic PAD received early revascularization. A more extensive disease and symptom burden were the main predictors of receiving early revascularization in PAD. There was significant site variability in revascularization patterns, and further studies will better understand the source of this variability and optimal selection criteria for early revascularization. Real world patterns and predictors of early revascularization in peripheral artery disease are not well understood. In this retrospective analysis of the POTRAIT study, about 1 out of 3 patients with PAD symptoms received early revascularization, with significant site variability. A more extensive disease and symptom burden were the main predictors of receiving early revascularization in PAD.

Treating post-angioplasty dissection in the femoropopliteal arteries using the tack endovascular system: Tack optimized balloon angioplasty II 24-month results.

The TOBA (Tack Optimized Balloon Angioplasty) II trial is a prospective, single-arm, multicenter study that investigated Tack treatment for patients with dissection after angioplasty in the superficial femoral artery and/or proximal popliteal artery. The Tack device is a nitinol-based, short (6mm), stent-like implant with low outward force that can be deployed in a targeted fashion to treat vascular dissection. TOBA II primary results through 12 months have been published previously. This report provides follow-up safety and efficacy results through 24 months (RC). The TOBA II trial enrolled 213 patients with Rutherford classification 2 to 4 and a de novo or non-stented restenotic lesion in the superficial femoral artery and/or proximal popliteal artery who developed a dissection of any grade after treatment with plain balloon or drug-coated balloon (DCB) angioplasty. Participants were followed for 30 days, 6 months, 12 months, 24 months, and 36 months following the procedure. Evaluations included clinically driven target lesion revascularization (CD-TLR), ankle-brachial index, Rutherford classification, peripheral artery questionnaire, quality of life assessed by the EQ-5D-3L, and the Walking Impairment Questionnaire. At enrollment, mean age was 68.2 ± 9.1 years, 70.9% were male, and 95.8% of patients were categorized as RC 2 or 3. The distribution of balloon types in the study were standard balloons: 42.3%; and drug-coated balloons: 57.7%. At 24-month follow-up, 167 patients (78.4%) had available data. The overall survival rate at 24 months was 95.4% and there were no major amputations during this time. After 24 months of follow-up, the Kaplan-Meier freedom from CD-TLR was 77.7%. Rutherford classification, ankle-brachial index, and quality of life were significantly improved compared with baseline through 24 months. The TOBA II 24-month data demonstrate durable intermediate-term outcomes with the use of the Tack Endovascular System. Tack deployment was a safe and effective therapeutic option for dissection repair following angioplasty.

Abstract 15064: Health Status Profiles in Patients With New or Worsening Peripheral Artery Disease Symptoms and One-Year Hospitalization Risk

Introduction: Patients with peripheral artery disease (PAD) have an elevated risk of cardiovascular and limb-related events, resulting in increased hospitalizations and costs. In patients with new or worsening PAD symptoms, we used patients’ baseline health status information as a way of identifying patients’ hospitalization. Methods: We included patients enrolled in the United States cohort of the multicenter PORTRAIT Registry from June 2011 and December 2015. PAD-specific health status was assessed at baseline using the Peripheral Artery Questionnaire (PAQ), with scores of 0-100 (higher scores indicating better health status). The primary outcome was 1-year all-cause hospitalizations. The association between PAQ score category (0 to <25, 25 to <50, 50 to <75, and 75-100 used as the reference category) and cumulative hospitalization risk was derived using proportional means models, adjusting for demographics and comorbidities. Results: Of the 797 patients (mean age of 68.6±9.7 years, 41.9% were female), 272 (34%) were admitted over 12 months of follow up. Compared with the best health status (PAQ 75-100), scoring in the lowest health status category (PAQ < 25) was associated with a higher risk of 1-year hospitalization (4.8% vs. 48.6%, adjusted hazard ratio 2.86 [95% confidence interval = 1.61-5.08]). A dose-response relationship was noted for the association between lower health status and increased risk of hospitalization. Similar associations were found for all PAQ domains except symptom stability. Conclusion: In patients with symptomatic PAD, presenting health status profiles were a robust predictor of 1-year hospitalization risk, with a >2-fold difference between those in the lower versus upper scoring segments. Given the potentially modifiable nature of health status, there is a need for monitoring and multicomponent interventions that can improve patients’ health status and potentially also their hospitalization risk.

Abstract 13810: Development and Validation of the Peripheral Artery Questionnaire for Critical Limb Ischemia-(PAQ-CLI) Instrument

Background: Patients with critical limb ischemia (CLI) experience pain, non-healing wounds, and amputation, which impacts their health status. There are no CLI-specific health status instruments that meet FDA standards. We sought to develop and validate a CLI-specific health status instrument to supplement the Peripheral Artery Questionnaire (PAQ). Methods: Using the PAQ conceptual framework, the PAQ-CLI was created in 3 phases: (1) construct validity was established through qualitative input from patients and vascular specialists; (2) items were elicited for CLI clinical phenotypes (rest pain; wound; post-amputation) and tested with cognitive interviewing; (3) psychometric testing in the prospective SCOPE-CLI registry was completed to confirm factor structure, convergent validity (against the EQ-5D, maximum walking distance, and Wifi), internal consistency, and 1-month test-retest reliability (against 46 stable patients determined by global assessment of functioning change). Results: The original domain structure of the PAQ captured the full range of health status experiences, including physical function, symptom stability, symptoms, treatment satisfaction, quality of life, and social limitations, confirmed by eigenvalues >1.77. After item-reduction (30 items for all clinical phenotype modules combined), the correlation with the PAQ-CLI summary score, EQ-5D Index, maximum walking distance, and Wifi wound and Ischemia score was 0.67, 0.38, -0.23 and -0.28, respectively. Cronbach’s alphas ranged from 0.85-0.88 and one-month test-retest reliability for the summary score was r=0.67. Baseline PAQ-CLI summary scores were lowest for rest pain (39.7±17.2), followed by wounds (49.0± 20.2), and highest for post amputation status (52.2±21.4) ( Figure) . Conclusion: The PAQ-CLI is a novel, validated instrument for patients with CLI meeting quality benchmarks for instrument development as defined by classical test theory.

Abstract 14944: Comorbid Obesity in Symptomatic Peripheral Artery Disease: A Modifiable Factor Associated With Health Status

Introduction: Obesity is a modifiable risk factor for peripheral artery disease (PAD). While highly prevalent, the association between obesity and health status outcomes in PAD has not been studied. We aim to summarize obesity management and its association with health status in patients with PAD. Methods: We conducted a longitudinal cohort study of patients with symptomatic PAD from the international multicenter PORTRAIT registry. Body mass index (BMI) was analyzed continuously (per 10kg/m2) and categorically as underweight (BMI < 18.5 kg/m 2 ), normal weight (BMI 18.5 - 24.9 kg/m 2 ), overweight (BMI 25 - 29.9 kg/m 2 ) and obesity (BMI > 30 kg/m 2 ). Obesity management strategies included diet or weight counseling and anti-obesity medications. Disease-specific health status was assessed with the Peripheral Artery Questionnaire (PAQ) (range=0-100, higher scores indicate better health status). Linear regression models examined the association between obesity and both baseline and 12-month PAQ summary scores. Results: Obesity was present in 37% (370/989) of patients (mean age 68.0 + 9.1 years, 40.1% female). No patients received anti-obesity medications. Weight and/or diet counseling were prescribed in only 12% of overweight and in 21% of patients with obesity. BMI (per 10 kg/m 2 ) was associated with worse PAQ summary scores at baseline (-5.7, 95% CI -8.0 to -3.5, p <0.01) and 12 months (-7.8, 95% CI -12.3 to -3.4, p <0.01) in unadjusted and models adjusting for medical comorbidities and PAD-associated factors. This was consistent when obesity was compared categorically to normal/overweight at baseline (mean difference = -7.2, 95% CI -10.4 to -4.1, p< 0.01) and at 12 months (-7.4, 95% CI -11.4 to -3.5, p< 0.01). Conclusions: Obesity is a potentially modifiable comorbidity in PAD that is currently under addressed and a strong correlate of PAD-specific health status following PAD diagnosis and treatment.

Abstract 10465: Abnormal Post Exercise Skeletal Muscle Microvascular Response and Metabolism Correlate With Patient Reported Outcomes in Patients With Intermittent Claudication From Peripheral Artery Disease

Background and Aims: Intermittent claudication (IC) in patients with peripheral artery disease (PAD) is thought to be caused by reduced lower extremity macrovascular blood flow. However, the ankle-brachial index (ABI) (a macrovascular measure) does not correlate well with patient-reported outcome measures. We aimed to study microvascular and metabolic skeletal muscle responses to exercise in patients with IC using positron emission tomography (PET). Methods: We enrolled 19 patients with IC (ABI < 0.90 and imaging/angiographic evidence of PAD) and 12 healthy controls (HCs) (normal ABI). All subjects underwent rest perfusion imaging of the legs with 13 N-ammonia or 11 C-acetate PET followed by a graded treadmill test. Subjects exercised until limited by claudication or the end of the 20-minute protocol. Subjects then underwent immediately post-exercise PET imaging of the legs. Skeletal muscle blood flow (SMBF) was quantified in each leg at rest and immediately post-exercise. Skeletal muscle oxygen utilization (SMVO 2 ) normalized to SMBF was also quantified for patients who underwent imaging with 11 C-acetate. Peripheral artery questionnaire (PAQ) summary score was obtained for all subjects. Results: We found that SMBF was increased post-exercise in all subjects, and stress/rest SMBF was higher in the legs of subjects with PAD than in the legs of HCs ( Figure 1A ). We also found that stress SMVO 2 /SMBF was higher in legs of patients with PAD than in the legs of HCs ( Figure 1B ). There was a moderate, significant correlation between limb stress/rest SMBF and PAQ score ( Figure 1C ) and a strong, significant correlation between limb stress SMVO 2 /SMBF and PAQ score ( Figure 1D ). Conclusions: In conclusion, we found that SMBF increased in all subjects after treadmill exercise and paradoxically to the greatest degree in patients with IC. We also found that PET-derived markers of post-exercise microvascular perfusion and metabolism correlated with patient-reported outcomes.

Abstract 13818: Health System Integrated Measurement-Based Care Using Patient-Reported Outcomes Assessment in Lower-Extremity Peripheral Artery Disease

Introduction: Peripheral artery disease (PAD) is a chronic disease that requires continuous and individualized disease-management to optimize patients’ symptoms, function and quality of life. Directly capturing patient-reported outcomes (PROs) in routine practice has the potential to increase the patient-centeredness of PAD care. We designed and implemented a system to measure health status within the workflow of a vascular specialty clinic. Methods: In a large academic center, from February 2020 until March 2022, an in-person patient navigation system (Yale PRO-QI) supported by a online data collection workbench was implemented to collect the EQ-5D, Peripheral Artery Questionnaire (PAQ), and VascuQol-6 as part of the outpatient consultations for lower-extremity PAD. Completion rates by month, and domain and summary scores for each PRO were derived per clinical phenotype: new patient/pre-procedural patient, post-procedural/follow-up patient. Results: Of 1071 eligible patient visits, 841 PRO assessments (n=446 unique patients) were completed, for an overall completion rate of 78.5% (monthly completion range 56.4%-100.0%). Patients had a mean age of 70.5±10.2 years, 39.4% were female, 9.6% Hispanics, 14.6% blacks, and 74.7% whites. Of the PROs administered, only the Symptom Stability, Treatment Satisfaction, and Quality of Life subscales of the PAQ were able to discriminate between the clinical phenotypes with differences that reached the minimal clinically important difference threshold of ~10 points ( Figure ). Conclusions: In anticipation of measurement-based care metrics that assess quality of care benchmarks for patient-centered PAD care, our health system integrated PRO workflow had a high response rate, and was able to successfully discriminate between highly symptomatic vs. stable patients as measured by validated disease-specific PRO benchmarks for PAD treatment success.

One-Year Health Status Outcomes Following Early Invasive and Noninvasive Treatment in Symptomatic Peripheral Artery Disease.

Lifestyle changes and medications are recommended as the first line of treatment for claudication, with revascularization considered for treatment-resistant symptoms, based on patients' preferences. Real-world evidence comparing health status outcomes of early invasive with noninvasive management strategies is lacking. In the international multicenter prospective observational PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry, disease-specific health status was assessed by the Peripheral Artery Questionnaire in patients with new-onset or worsening claudication at presentation and 3, 6, and 12 months later. One-year health status trajectories were compared by early revascularization versus noninvasive management on a propensity-matched sample using hierarchical generalized linear models for repeated measures adjusted for baseline health status. In a propensity-matched sample of 1000 patients (67.4±9.3 years, 62.8% male, and 82.4% White), 297 (29.7%) underwent early revascularization and 703 (70.3%) were managed noninvasively. Over 1 year of follow-up, patients who underwent early invasive management reported significantly higher health status than patients managed noninvasively (interaction term for time and treatment strategy; P<0.001 for all Peripheral Artery Questionnaire domains). The average 1-year change in Peripheral Artery Questionnaire summary scores was 30.8±25.2 in those undergoing early invasive, compared with 16.7±23.4 in those treated noninvasively (P<0.001). Patients with claudication undergoing early invasive treatment had greater health status improvements over the course of 1 year than those treated noninvasively. These data can be used to support shared decision-making with patients. URL: https://www. gov; Unique identifier: NCT01419080.

Association of Disease-Specific Health Status With Long-Term Survival in Peripheral Artery Disease.

BackgroundWhile peripheral artery disease (PAD) is associated with increased cardiovascular morbidity with mortality remaining high and challenging to predict, accurate understanding of serial PAD‐specific health status around the time of diagnosis may prognosticate long‐term mortality risk.Methods and ResultsPatients with new or worsening PAD symptoms enrolled in the PORTRAIT Registry across 10 US sites from 2011 to 2015 were included. Health status was assessed by the Peripheral Artery Questionnaire (PAQ) Summary score at baseline, 3‐month, and change from baseline to 3‐month follow‐up. Kaplan‐Meier using 3‐month landmark and hierarchical Cox regression models were constructed to assess the association of the PAQ with 5‐year all‐cause mortality. Of the 711 patients (mean age 68.8±9.6 years, 40.9% female, 72.7% white; mean PAQ 47.5±22.0 and 65.9±25.0 at baseline and 3‐month, respectively), 141 (19.8%) died over a median follow‐up of 4.1 years. In unadjusted models, baseline (HR, 0.90 per‐10‐point increment; 95% CI, 0.84–0.97; P=0.008), 3‐month (HR [95% CI], 0.87 [0.82–0.93]; P<0.001) and change in PAQ (HR [95% CI], 0.92 [0.85–0.99]; P=0.021) were each associated with mortality. In fully adjusted models including combination of scores, 3‐month PAQ was more strongly associated with mortality than either baseline (3‐month HR [95% CI], 0.85 [0.78–0.92]; P<0.001; C‐statistic, 0.77) or change (3‐month HR [95% CI], 0.79 [0.72–0.87]; P<0.001).ConclusionsPAD‐specific health status is independently associated with 5‐year survival in patients with new or worsening PAD symptoms, with the most recent assessment being most prognostic. Future work is needed to better understand how this information can be used proactively to optimize care.

Patient-Reported Outcome Measures in Symptomatic, Non-Limb-Threatening Peripheral Artery Disease: A State-of-the-Art Review.

Patient-reported outcome measures (PROMs) are health outcomes directly reported by the patient that can be used to measure the effect of disease and treatments on patient perceived well-being. This review summarizes current evidence regarding the validation of PROMs in people with symptomatic, nonlimb-threatening peripheral artery disease. A literature search was conducted to identify studies of symptomatic peripheral artery disease without limb-threatening ischemia that included PROMs and had sample sizes ≥25. PROMs were summarized along a continuum of validation using classical test theory framework and according to whether they fulfilled defined criteria for (1) content validity; (2) psychometric validation; and (3) further validation evidence base expansion. Of 2198 articles identified, 157 (7.1%) met inclusion criteria. Twenty-four PROMs in patients with symptomatic peripheral artery disease were reviewed. Among disease-specific PROMs, 8 of 15 had excellent reliability as measured by a Cronbach alpha ≥0.80. Based on established criteria for PROM responsiveness, 6 of 15 disease-specific PROMs demonstrated excellent sensitivity to change. Of these, the disease-specific peripheral artery questionnaire, vascular quality of life questionnaire, and walking impairment questionnaire met criteria for validation at each stage of the continuum. For generic (nondisease specific) PROMs, the European Quality of Life 5-Dimension and SF-36 had the most extensive evidence of validation. Evidence from this review can inform selection of PROMs aligned with scientific and clinical goals, given the variable degree of validation and potential complementary nature of the measures.

Abstract 11854: Longitudinal Improvement in Patient Reported Outcome Measures Following Supervised Exercise Therapy for Symptomatic Peripheral Artery Disease

Background: Symptomatic peripheral artery disease (PAD) is associated with severe morbidity and poor quality of life. Although data suggest that supervised exercise therapy (SET) may improve symptoms, few studies have evaluated longitudinal changes in patient reported outcomes among a real-world PAD population. Methods: Consecutive patients with symptomatic PAD treated at a single tertiary care center and referred for SET were enrolled. Patient reported outcomes were assessed at baseline and at 30 days, 6-months, and 1-year post-treatment through an electronic survey. The primary outcome was the change in the Peripheral Artery Questionnaire (PAQ) summary score from baseline to each time point. A change in PAQ summary score of &gt;8 has been established as clinically meaningful improvement. Results: Twenty-nine patients enrolled in the study received SET who had a mean baseline PAQ score 46.9±16.5. Following treatment, the mean PAQ score at 30 days, 6 months and 1 year were 61.0 ±20.7, 70.4 ±16.2 and 67.0 ±13.9, respectively (Figure 1), corresponding to a 14.1 point, 23.5 point and 20.1 point improvement in PAQ score. Conclusion: In this real-world assessment of patient reported outcomes following SET for the management of symptomatic PAD, treatment demonstrated consistent long-term improvement in patient reported outcomes as measured by the PAQ. Future work assessing the long-term durability of these changes is ongoing.

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

IntroductionPeripheral 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. MethodsWe 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. ResultsThe 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). ConclusionIn 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 registrationhttps://clinicaltrials.gov/ct2/show/NCT01419080?term=portrait&rank=1NCT01419080.

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

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. 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. 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). 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. NCT01419080.

Abstract 15943: Health Status and Quality of Life With Early Invasive and Non-invasive Treatment Strategies for Patients With Claudication

Introduction: Improving health status; symptoms, function, and quality of life (QoL) are key treatment goals in patients with peripheral arterial disease (PAD) and claudication. Hypothesis: Compared with medical management only, early revascularization in patients with claudication is associated with greater improvements in disease-specific health status. Methods: Patients with new or worsening claudication, who underwent revascularization within 3 months of enrolment or were treated non-invasively (statin, aspirin, cilostazol, supervised exercise therapy, risk factor management) were identified from 16 vascular medicine clinics in the US, Netherlands and Australia participating in the PORTRAITregistry. Patients were propensity-matched on the likelihood of receiving invasive therapy. The Peripheral Artery Questionnaire (PAQ) was used to assess patients’ disease-specific health status at enrollment, and at 3, 6 and 12 months of follow-up using hierarchical Generalized Linear Models for repeated measures. Results: Among 1142 patients (mean age of 67.7 years, 63.0% male), 229 (20.1%) underwent early revascularization while 913 (79.9%) were managed non-invasively. At baseline, patients who underwent invasive vs. non-invasive management had lower PAQ summary (mean ± SD; 44.41 ± 19.98 vs 50.98 ± 21.79, P&lt;0.001) and quality of life scores (45.52 ± 23.95 vs 52.43 ± 26.19, P&lt;0.001). Compared with patients treated non-invasively, patients who underwent revascularization reported improved health status over time, through 1 year of follow up (P &lt;0.001 for all PAQ domains) ( Figure 1 ). Conclusion: Patients who underwent early revascularization had worse baseline health status but a greater improvement over 1 year of follow-up when compared with patients managed without revascularization. Summarizing real-world health status benefits following a PAD diagnosis can support preference-sensitive decisions for PAD management.

Association of Diabetes Mellitus With Health Status Outcomes in Patients With Peripheral Artery Disease: Insights From the PORTRAIT Registry.

BackgroundPatients with peripheral artery disease (PAD) and coexisting diabetes mellitus (DM) have greater PAD progression and adverse limb events. Our aim was to study whether PAD‐specific health status differs by DM.Methods and ResultsThe PORTRAIT (Patient‐Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) trial is a 16‐center international registry that includes patients with recent exacerbations or new‐onset symptomatic PAD presenting to specialty clinics. We assessed PAD‐specific health status initially and at 3, 6, and 12 months (Peripheral Artery Questionnaire [PAQ]). We used hierarchical, multivariable, linear regression, and repeated measures analyses to study the association between DM and baseline health status initially and over 3 to 12 months. Models were adjusted for demographics, socioeconomic factors, PAD severity, comorbidities, and psychosocial characteristics. The interaction of DM with PAD revascularization on 3‐ to 12‐month health status was also tested. Of 1204 patients, 398 (33%) had DM (94% type 2). Patients with versus those without DM had lower unadjusted PAQ summary scores at baseline and 3, 6, and 12 months (46.1 versus 50.8, 63.6 versus 68.2, 65.7 versus 71.7, and 65.4 versus 72.6; P≤0.01). In fully adjusted models, the effect of DM on baseline (mean difference, −0.65; 95% CI, −2.86 to 1.56 [P=0.56]) and over 3‐ to 12‐month PAQ summary scores (mean difference, −1.59; 95% CI, −4.06 to 0.88 [P=0.21]) was no longer significant. Twelve‐month health status gains following revascularization were similar in both groups (P=0.69).ConclusionsPatients with PAD with coexisting DM have poorer health status, mostly explained by the differences in their psychosocial and other comorbidity burden. Patients with PAD and DM versus those without DM experience similar health status benefits following PAD revascularization.

Physical Activity After Treatment for Symptomatic Peripheral Artery Disease

The association of invasive versus noninvasive treatment and physical activity level in patients with claudication remains unclear. Participants with claudication were enrolled from US vascular clinics. Treatment was categorized as invasive (surgical or endovascular treatment <3 months of initial visit) versus noninvasive. Self-reported leisure time (LTPA) and work related physical activity (WRPA) (sedentary, mild, moderate/strenuous), and health status (peripheral artery questionnaire summary score [PAQ SS]) was measured at baseline and 12 months. Change in PA was also categorized as increased, decreased, persistent sedentary [reference] and persistent active based on activity status at baseline and 12 months. Multivariable logistic regression assessed the association of treatment with 12-month LTPA and WRPA. Multivariable linear regression examined the association between 12-month change in PA with a 12-month change in PAQ. A total of 196of 656 patients (29.9%) underwent invasive treatment. There was no association between treatment and 12-month LTPA (p = 0.77) or WRPA (p = 0.26). Compared with being persistently sedentary, increased LTPA was associated with increased PAQ SS (OR 11.1 95% CI [4.4 to 17.7], p <0.01). In conclusion, there was no association between invasive treatment and physical activity at follow up despite a greater health status change in the invasive group. As increased physical activity was associated with more health status gains than remaining sedentary, additional ways to improve physical activity levels could potentially improve PAD outcomes.

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.

BackgroundThere 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 ResultsIn 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).ConclusionsAlthough 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.