Abstract 24: Health Status Differences Between Early Invasive and Non Invasive Treatment Strategies in Patients With Peripheral Artery Disease: Insights From Portrait Registry

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Suveen Angraal ◽  
Vittal Hejjaji ◽  
Laith Derbas ◽  
Manesh R Patel ◽  
Jan Heyligers ◽  
...  

Background: In patients with symptomatic peripheral artery disease (PAD), a key treatment goal is to improve their health status; their symptoms, function, and quality of life (QoL). While medical therapy with lifestyle changes is recommended in all, revascularization can be a consideration to alleviate PAD symptoms. We sought to compare the real-world impact of either treatment strategy on patients’ health status improvement. Methods: Patients with new or worsening PAD symptoms (Rutherford category 1-3), from 10 U.S. specialty vascular clinics between 2011-2015, who either underwent early revascularization (using stent, angioplasty or surgery within 3 months of enrolment) or medical management alone (statin, aspirin, cilostazol, supervised exercise therapy, risk factor (diabetes, hypertension) management) were identified from the Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) registry. 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. The differences in PAQ overall summary scores, and each subdomain, were compared using an adjusted generalized linear model for repeated measures (Figure 1). Results: Among 797 patients (mean age of 68.6 years, 58.1% male), 226 underwent early revascularization and 571 were managed medically. At baseline, patients in the revascularization vs. medical management cohort had lower PAQ summary scores (mean ± SD; 42.6 ± 20.7 vs. 48.5 ± 22.3, P<0.001) and QoL scores (43.4 ± 23.9 vs. 50.4 ± 26.4, P<0.001). Over 1 year of follow-up, patients who underwent revascularization reported significantly higher health status over time than patients managed medically without revascularization (P <0.001 for all PAQ sub-domains; Figure 1). Conclusion: Patients with PAD who received early revascularization had worse health status at baseline, but they reported a greater degree of improvement over 1 year of follow-up when compared to patients managed medically without revascularization. Summarizing real-world health status benefits following a PAD diagnosis is critical to help guide preference-sensitive decisions on PAD management.

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Suveen Angraal ◽  
Vittal Hejjaji ◽  
Yuanyuan Tang ◽  
Laith Derbas ◽  
Manesh R Patel ◽  
...  

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<0.001) and quality of life scores (45.52 ± 23.95 vs 52.43 ± 26.19, P<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 <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.


2019 ◽  
Vol 25 (1) ◽  
pp. 13-24 ◽  
Author(s):  
Qurat-ul-ain Jelani ◽  
Sunny Jhamnani ◽  
Erica S Spatz ◽  
John Spertus ◽  
Kim G Smolderen ◽  
...  

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


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Joshua Slysz ◽  
Lu Tian ◽  
Lihui Zhao ◽  
Dongxue Zhang ◽  
Mary M McDermott

Introduction: Supervised exercise therapy (SET) improves functional capacity in people with peripheral artery disease (PAD). However, the effects of SET on improving cardiovascular health remain unclear. This study investigated the effects of a 6-month SET intervention on the blood pressure (BP) response to walking exercise in patients with PAD. Methods: Participants with PAD randomized to either SET or control group in the NHLBI sponsored PROPEL clinical trial were included. The SET intervention consisted of 3X weekly supervised treadmill exercise for 6 months. Participants in the control group attended weekly education sessions for 6 months. A Gardner-Skinner treadmill test (GSTT) and six-minute walk (6MW) test were completed at baseline and 6-month follow-up. BP was measured at the end of each 2-min stage of the GSTT. Mixed-effects regression models compared the 6-month change in systolic BP (SBP) & diastolic BP (DBP) between groups for each of the first 5 stages of the GSTT. Pearson correlation coefficients were used to relate the average 6-month change in DBP & SBP for the first 5 stages of the GSTT with the 6-month change in 6MW distance. Results: Ninety-seven participants with PAD (67 ± 9 years, 39 (40%) female, 65 (67%) black) completed a 6-month GSTT. Compared to the control group, SET significantly decreased SBP at stage 1, stage 2, stage 3, and stage 4 of the GSTT (Table 1). There were no effects of SET on DBP (Table 1). A greater reduction in SBP during the first 5 stages the GSTT test was associated with significantly greater improvement in 6MW distance at 6-month follow-up of SET (Pearson’s r = -0.37; 95%CI: -0.52, -0.19; p < 0.001). However, there were no associations of reduction in DBP with improvement in 6MW distance. Conclusions: These results show that SET improves cardiovascular health in people with PAD. Furthermore, results suggest that improved CV health in part explains the improved 6MW in response to SET in people with PAD.


2020 ◽  
Vol 9 (19) ◽  
Author(s):  
Jennifer A. Rymer ◽  
Hillary Mulder ◽  
Kim G. Smolderen ◽  
William R. Hiatt ◽  
Michael S. Conte ◽  
...  

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


Heart ◽  
2021 ◽  
pp. heartjnl-2020-318758
Author(s):  
Gilles R Dagenais ◽  
Leanne Dyal ◽  
Jacqueline J Bosch ◽  
Darryl P Leong ◽  
Victor Aboyans ◽  
...  

ObjectiveIn patients with chronic coronary or peripheral artery disease enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies trial, randomised antithrombotic treatments were stopped after a median follow-up of 23 months because of benefits of the combination of rivaroxaban 2.5 mg two times per day and aspirin 100 mg once daily compared with aspirin 100 mg once daily. We assessed the effect of switching to non-study aspirin at the time of early stopping.MethodsIncident composite of myocardial infarction, stroke or cardiovascular death was estimated per 100 person-years (py) during randomised treatment (n=18 278) and after study treatment discontinuation to non-study aspirin (n=14 068).ResultsDuring randomised treatment, the combination compared with aspirin reduced the composite (2.2 vs 2.9/100 py, HR: 0.76, 95% CI 0.66 to 0.86), stroke (0.5 vs 0.8/100 py, HR: 0.58, 95% CI 0.44 to 0.76) and cardiovascular death (0.9 vs 1.2/100 py, HR: 0.78, 95% CI 0.64 to 0.96). During 1.02 years after early stopping, participants originally randomised to the combination compared with those randomised to aspirin had similar rates of the composite (2.1 vs 2.0/100 py, HR: 1.08, 95% CI 0.84 to 1.39) and cardiovascular death (1.0 vs 0.8/100 py, HR: 1.26, 95% CI 0.85 to 1.86) but higher stroke rate (0.7 vs 0.4/100 py, HR: 1.74, 95% CI 1.05 to 2.87) including a significant increase in ischaemic stroke during the first 6 months after switching to non-study aspirin.ConclusionDiscontinuing study rivaroxaban and aspirin to non-study aspirin was associated with the loss of cardiovascular benefits and a stroke excess.Trial registration numberNCT01776424.


2020 ◽  
pp. 019394592097747
Author(s):  
Mary O. Whipple ◽  
Erica N. Schorr ◽  
Kristine M.C. Talley ◽  
Julian Wolfson ◽  
Ruth Lindquist ◽  
...  

Nonresponse to exercise has been extensively examined in young athletes but is seldom reported in studies of aerobic exercise interventions in older adults. This study examined the prevalence of nonresponse and poor response to exercise in functional and quality of life outcomes and response patterns between and among older adults undergoing 12-weeks of supervised exercise therapy for the management of peripheral artery disease ( N = 44, mean age 72.3 years, 47.7% female). The prevalence of nonresponse (no change/decline in performance) in walking distance was 31.8%. The prevalence of poor response (lack of a clinically meaningful improvement) was 43.2%. Similar patterns of response were observed in both objective and patient-reported measures of physical function. All participants improved in at least one outcome; only two participants improved in all measured outcomes. Additional research should examine modifiable predictors of response to inform programming and maximize an individual’s potential benefit from exercise therapy.


Circulation ◽  
2012 ◽  
Vol 125 (1) ◽  
pp. 130-139 ◽  
Author(s):  
Timothy P. Murphy ◽  
Donald E. Cutlip ◽  
Judith G. Regensteiner ◽  
Emile R. Mohler ◽  
David J. Cohen ◽  
...  

Circulation ◽  
2018 ◽  
Vol 138 (Suppl_1) ◽  
Author(s):  
Erica Schorr ◽  
Mary Whipple ◽  
Diane Treat-Jacobson

Introduction: Evidence supporting the effects of supervised exercise therapy (SET) on alleviating symptoms and improving walking ability for patients with symptomatic peripheral artery disease (PAD) is robust and well recognized. However, little is known about the impact of SET on free-living physical activity (PA). The aim of this study was to examine the relationship between participation in SET and changes in free-living PA among individuals in the the EX ercise Training to Reduce Claudication: Arm ER gometry versus T readmill Walking ( EXERT ) trial. Methods: In this randomized, controlled trial, 104 participants (mean age 68±9; 29% female) were allocated to receive treadmill (TM) exercise (n=41), upper body ergometry (UBE) exercise (n=42), or usual-care (UC) (n=21) for 12 weeks. Exercise participants attended SET three times per week; UC participants met with study staff weekly. PA was measured over 7 days via waist-worn ActiGraph accelerometers at baseline, 6, and 12 weeks. Steps per day was the primary outcome. Secondary outcomes were proportion of time in light and moderate to vigorous physical activity (MVPA), and sedentary time. PA was controlled for in TM participants by using SET logs. Results were analyzed using descriptive statistics, two-sample t-tests, and analysis of variance. Results: Regardless of randomization, average daily steps were low at baseline and 6 weeks (4,013 steps, p =.72; and 3,911 steps, p =.84, respectively), and slightly higher at 12 weeks (4,307 steps; p =.93). Although not statistically significant but perhaps clinically relevant, UBE participants exhibited greater increases in MVPA over 12 weeks (0.9% to 1.3%; F =.48, p =.62) compared to TM (1.2% to 1.3%; F =.35, p =.71) and UC (1.3% to 1.5%, F =.03, p =.97); similarly all participants exhibited reductions in sedentary time and increases in free-living PA between baseline and 12 weeks. Conclusions: These data suggest individuals with PAD attending SET replace sedentary time with light or moderate intensity PA regardless of exercise modality. Despite study participants meeting the recommended daily steps for adults with chronic conditions (3,500-5,500 steps), it is suspected that they did not reach the daily goal of 30 minutes of enhanced PA to reduce health risks. Future research should incorporate activity tracking devices that can provide feedback on PA as an approach to meet daily PA goals. Activity tracking devices used in conjunction with SET may further improve walking distance, symptom management, and quality of life among patients with symptomatic PAD.


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