scholarly journals Perceived Versus Objective Change in Walking Ability in Peripheral Artery Disease: Results from 3 Randomized Clinical Trials of Exercise Therapy

2021 ◽  
Author(s):  
Mary M. McDermott ◽  
Lu Tian ◽  
Michael H. Criqui ◽  
Luigi Ferrucci ◽  
Philip Greenland ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Exercise Group ◽  
Control Group ◽  
Walking Ability ◽  
Peripheral Artery ◽  
Distance Score ◽  
Artery Disease ◽  
Minute Walk Distance ◽  
Minute Walk

Background In people with lower‐extremity peripheral artery disease, the effects of exercise on patient‐reported outcomes remain unclear. Methods and Results Four hundred four people with peripheral artery disease in 3 clinical trials were randomized to exercise (N=205) or a control group (N=199) and completed the 6‐minute walk and the Walking Impairment Questionnaire distance score (score 0–100, 100=best) at baseline and 6‐month follow‐up. Compared with the control group, exercise improved 6‐minute walk distance by +39.8 m (95% CI, 26.8–52.8, P <0.001) and the Walking Impairment Questionnaire distance score by +7.3 (95% CI, 2.4–12.1, P =0.003). In all, 2828 individual Walking Impairment Questionnaire distance score questions were completed at baseline and follow‐up. Among participants who perceived no change in ability to walk 1 or more distances between baseline and follow‐up, 6‐minute walk improved in the exercise group and declined in the control group (+26.8 versus −6.5 m, P <0.001). Among participants who perceived that their walking ability worsened for 1 or more distances between baseline and follow‐up, the 6‐minute walk improved in the exercise group and declined in the control group (+18.4 versus –27.3 m, P <0.001). Among participants who reported worsening calf symptoms at follow‐up, the exercise group improved and the control group declined (+28.9 versus −12.5 m, P <0.01). Conclusions In 3 randomized trials, exercise significantly improved the 6‐minute walk distance in people with peripheral artery disease, but many participants randomized to exercise reported no change or decline in walking ability. These findings suggest a significant discrepancy in objectively measured walking improvement relative to perceived walking improvement in people with peripheral artery disease. Registration Information clinicaltrials.gov. Identifiers: NCT 00106327, NCT 01408901.

scholarly journals Association of six-minute walk distance with subsequent lower extremity events in peripheral artery disease

2020 ◽  
Vol 25 (4) ◽  
pp. 319-327
Author(s):  
Pooja Nayak ◽  
Jack M Guralnik ◽  
Tamar S Polonsky ◽  
Melina R Kibbe ◽  
Lu Tian ◽  
...  
Keyword(s):  
Lower Extremity ◽  
Peripheral Artery Disease ◽  
Prognostic Significance ◽  
Ankle Brachial Index ◽  
Peripheral Artery ◽  
Walk Distance ◽  
Artery Disease ◽  
Minute Walk Distance ◽  
Minute Walk

The prognostic significance of the six-minute walk distance for lower extremity events in people with peripheral artery disease (PAD) is unknown. This longitudinal study assessed whether a poorer six-minute walk distance at baseline was associated with higher rates of subsequent lower extremity atherosclerotic disease events in PAD. A total of 369 patients (mean age 69.4 ± 10.0 years; mean ankle–brachial index (ABI) 0.67 ± 0.17; 31% women; 30% black individuals) from Chicago-area medical centers with PAD were enrolled. Participants underwent baseline six-minute walk testing and returned for annual study visits. Lower extremity events consisted of one or more of the following: ABI decline greater than 15% or medical record adjudicated lower extremity revascularization, critical limb ischemia, or amputation. At a mean follow-up of 33.3 months, lower extremity events occurred in 66/123 (53.7%) people in the first (worst) tertile of six-minute walk performance, 55/124 (44.4%) in the second tertile, and 56/122 (45.9%) in the third (best) tertile. After adjusting for age, sex, race, ABI, comorbidities, and other confounders, participants in the first (worst) tertile of six-minute walk distance at baseline had higher rates of lower extremity events during follow-up, compared to those in the best tertile at baseline (HR = 1.74, 95% CI 1.17–2.60, p = 0.0067). Among people with PAD, a poorer six-minute walk distance was associated with higher rates of subsequent lower extremity PAD-related events after adjusting for confounders. Further study is needed to determine whether interventions that improve six-minute walk distance can reduce lower extremity adverse events in people with PAD.

scholarly journals Minimal clinically important differences in treadmill, 6-minute walk, and patient-based outcomes following supervised and home-based exercise in peripheral artery disease

2018 ◽  
Vol 23 (4) ◽  
pp. 349-357 ◽  
Author(s):  
Andrew W Gardner ◽  
Polly S Montgomery ◽  
Ming Wang
Keyword(s):  
Peripheral Artery Disease ◽  
Exercise Program ◽  
Exercise Group ◽  
Treadmill Test ◽  
Peripheral Artery ◽  
Exercise Programs ◽  
Supervised Exercise ◽  
Home Based ◽  
Artery Disease ◽  
Minute Walk

We estimated minimal clinically important differences (MCIDs) for small, moderate, and large changes in measures obtained from a standardized treadmill test, a 6-minute walk test, and patient-based outcomes following supervised and home-based exercise programs in symptomatic patients with peripheral artery disease (PAD). Patients were randomized to either 12 weeks of a supervised exercise program ( n=60), a home-based exercise program ( n=60), or an attention-control group ( n=60). Using the distribution-based method to determine MCIDs, the MCIDs for small, moderate, and large changes in peak walking time (PWT) in the supervised exercise group were 38, 95, and 152 seconds, respectively, and the changes in claudication onset time (COT) were 35, 87, and 138 seconds. Similar MCID scores were noted for the home-based exercise group. An anchor-based method to determine MCIDs yielded similar patterns of small, moderate, and large change scores in PWT and COT, but values were 1–2 minutes longer than the distribution approach. In conclusion, 3 months of supervised and home-based exercise programs for symptomatic patients with PAD results in distribution-based MCID small, moderate, and large changes ranging from 0.5 and 2.5 minutes for PWT and COT. An anchor-based approach yields higher MCID values, ranging from a minimum of 73 seconds for COT to a maximum of 4 minutes for PWT. The clinical implication is that a goal for eliciting MCIDs in symptomatic PAD patients through a walking exercise intervention is to increase PWT and COT by up to 4 minutes, which corresponds to two work stages during the standardized progressive treadmill test.

Abstract P144: One-year Change In Walking Performance And Mobility Loss In People With Peripheral Artery Disease: The Walking And Leg Circulation Study (walcs)

Circulation ◽  
2021 ◽  
Vol 143 (Suppl_1) ◽  
Author(s):  
Michael M Hammond ◽  
Mary M McDermott ◽  
Lu Tian ◽  
Dongxue Zhang ◽  
Lihui Zhao
Keyword(s):  
Peripheral Artery Disease ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Peripheral Artery ◽  
Cox Proportional Hazards Models ◽  
Walking Performance ◽  
Artery Disease ◽  
One Year ◽  
Minute Walk

Introduction: Peripheral artery disease (PAD) affects 10-15% of people age 65 and older, and the prevalence is expected to rise as the population ages. People with PAD have greater functional impairment and faster decline in walking performance than people without PAD. Objectives: To determine the association between 1-year change in walking performance and mobility loss. We hypothesized that greater declines in walking performance over one year would be associated with higher rates of mobility loss. Methods: Participants underwent measurement of 6-minute walk and 4-meter walking velocity at baseline, and returned yearly for repeat measurement of walking performance and assessment of mobility. Participants were categorized into tertiles based on their 1-year change in walking performance (Tertile 1: greatest decline). Mobility loss was defined as becoming newly unable to walk one-quarter mile or walk up and down 1 flight of stairs without assistance after the 1-year follow-up. We used Cox proportional hazards models to examine the association between 1-year change in walking performance and mobility loss, adjusting for potential confounders. Results: 907 participants with PAD (mean age 71 +/- 9 years, 40% female, 23% black) were included. Median follow-up time was 38 months. Participants in Tertile 1 were older (mean 73 ± 9 years compared to 71 ± 9 in Tertile 2, and 70 ± 9 in Tertile 3; p=0.0004), had lower ABI (p=0.001), and included a higher prevalence of female (42% vs. 40% in Tertile 2, and 37% in Tertile 3; p=0.36). Participants with greater decline in 6-minute walk at 1-year follow-up had higher rates of mobility loss than participants with less decline. No significant associations of change in 4-meter walking speed and mobility loss were observed (Table). Conclusion: Among people with PAD, greater 1-year declines in six-minute walk distance are associated with higher rates of mobility loss. Further study is needed to determine whether interventions that prevent decline in six-minute walk can also prevent mobility loss.

Abstract 14290: Treadmill Exercise Training Reduces the Systolic Blood Pressure Response to Walk Exercise in Patients With Peripheral Artery Disease

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Joshua Slysz ◽  
Lu Tian ◽  
Lihui Zhao ◽  
Dongxue Zhang ◽  
Mary M McDermott
Keyword(s):  
Blood Pressure ◽  
Peripheral Artery Disease ◽  
Cardiovascular Health ◽  
Treadmill Exercise ◽  
Pearson Correlation ◽  
Control Group ◽  
Peripheral Artery ◽  
Supervised Exercise ◽  
Artery Disease

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.

scholarly journals Cardiovascular consequences of discontinuing low-dose rivaroxaban in people with chronic coronary or peripheral artery disease

Heart ◽  
2021 ◽  
pp. heartjnl-2020-318758
Author(s):  
Gilles R Dagenais ◽  
Leanne Dyal ◽  
Jacqueline J Bosch ◽  
Darryl P Leong ◽  
Victor Aboyans ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Low Dose ◽  
Cardiovascular Death ◽  
Stroke Rate ◽  
Early Stopping ◽  
Peripheral Artery ◽  
Once Daily ◽  
Registration Number ◽  
Artery Disease

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.

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 ◽  
...  
Keyword(s):  
Health Status ◽  
Peripheral Artery Disease ◽  
Real World ◽  
Medical Management ◽  
World Health ◽  
Peripheral Artery ◽  
Supervised Exercise ◽  
Early Revascularization ◽  
Artery Disease

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.

461Modulation of ischemic and bleeding risk by peripheral artery disease after an acute coronary syndrome

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Cespon Fernandez ◽  
S Raposeiras Roubin ◽  
E Abu-Assi ◽  
S Manzano-Fernandez ◽  
F Dascenzo ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Peripheral Artery Disease ◽  
Cumulative Incidence ◽  
Bleeding Risk ◽  
Peripheral Artery ◽  
Data Set ◽  
Coronary Syndrome ◽  
Artery Disease ◽  
The Impact

Abstract Introduction Peripheral artery disease (PAD) is associated with heightened ischemic and bleeding risk in patients with acute coronary syndrome (ACS). With this study from real-life patients, we try to analyze the balance between ischemic and bleeding risk during treatment with dual antiplatelet therapy (DAPT) after an ACS according to the presence or not of PAD. Methods The data analyzed in this study were obtained from the fusion of 3 clinical registries of ACS patients: BleeMACS (2004–2013), CardioCHUVI/ARRITXACA (2010–2016) and RENAMI (2013–2016). All 3 registries include consecutive patients discharged after an ACS with DAPT and undergoing PCI. The merged data set contain 26,076 patients. A propensity-matched analysis was performed to match the baseline characteristics of patients with and without PAD. The impact of prior PAD in the ischemic and bleeding risk was assessed by a competitive risk analysis, using a Fine and Gray regression model, with death being the competitive event. For ischemic risk we have considered a new acute myocardial infarction (AMI), whereas for bleeding risk we have considered major bleeding (MB) defined as bleeding requiring hospital admission. Follow-up time was censored by DAPT suspension/withdrawal. Results From the 26,076 ACS patients, 1,600 have PAD (6.1%). Patients with PAD were older, and with more cardiovascular risk factors. DAPT with prasugrel/ticagrelor was less frequently prescribed in patients with PAD in comparison with the rest of the population (8.2% vs 22.8%, p<0.001). During a mean follow-up of 12.2±4.8 months, 964 patients died (3.7%), and 640 AMI (2.5%) and 685 MB (2.6%) were reported. After propensity-score matching, we obtained two matched groups of 1,591 patients. Patients with PAD showed a significant higher risk of both AMI (sHR 2.17, 95% CI 1.51–3.10, p<0.001) and MB (sHR 1.51, 95% CI 1.07–2.12, p=0.018), in comparison with those without PAD. The cumulative incidence of AMI was 63.9 and 29.8 per 1,000 patients/year in patients with and without PAD, respectively. The cumulative incidence of MB was 55.9 and 37.6 per 1,000 patients/year in patients with and without PAD, respectively. The rate difference per 1,000 patient-years for AMI between patients with and without PAD was +34.1 (95% CI 30.1–38.1), and for MB +18.3 (16.1–20.4). The net balance between ischemic and bleeding events comparing patients with and without PAD was positive (+15.8 per 1,000 patients/year, 95% CI 9.7–22.0). Conclusions PAD was associated with higher ischemic and bleeding risk after hospital discharge for ACS treated with DAPT. However, the balance between ischemic and bleeding risk was positive for patients with PAD in comparison with patients without PAD. As summary, ACS patients with PAD had an ischemic risk greater than the bleeding risk.

Adherence to statin therapy favours survival of patients with symptomatic peripheral artery disease

2019 ◽  
Author(s):  
Jörn F Dopheide ◽  
Jonas Veit ◽  
Hana Ramadani ◽  
Luise Adam ◽  
Lucija Papac ◽  
...  
Keyword(s):  
Statin Therapy ◽  
Peripheral Artery Disease ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Peripheral Artery ◽  
All Cause Mortality ◽  
Statin Medication ◽  
Artery Disease ◽  
Statin Adherence

Abstract Aims  We hypothesized that adherence to statin therapy determines survival in patients with peripheral artery disease (PAD). Methods and results  Single-centre longitudinal observational study with 691 symptomatic PAD patients. Mortality was evaluated over a mean follow-up of 50 ± 26 months. We related statin adherence and low-density lipoprotein cholesterol (LDL-C) target attainment to all-cause mortality. Initially, 73% of our PAD patients were on statins. At follow-up, we observed an increase to 81% (P &lt; 0.0001). Statin dosage, normalized to simvastatin 40 mg, increased from 50 to 58 mg/day (P &lt; 0.0001), and was paralleled by a mean decrease of LDL-C from 97 to 82 mg/dL (P &lt; 0.0001). The proportion of patients receiving a high-intensity statin increased over time from 38% to 62% (P &lt; 0.0001). Patients never receiving statins had a significant higher mortality rate (31%) than patients continuously on statins (13%) or having newly received a statin (8%; P &lt; 0.0001). Moreover, patients on intensified statin medication had a low mortality of 9%. Those who terminated statin medication or reduced statin dosage had a higher mortality (34% and 20%, respectively; P &lt; 0.0001). Multivariate analysis showed that adherence to or an increase of the statin dosage (both P = 0.001), as well as a newly prescribed statin therapy (P = 0.004) independently predicted reduced mortality. Conclusion  Our data suggest that adherence to statin therapy is associated with reduced mortality in symptomatic PAD patients. A strategy of intensive and sustained statin therapy is recommended.

scholarly journals P1234SNF472 IMPROVES LIMB BLOOD PERFUSION AND WALKING ABILITY IN A PERIPHERAL ARTERY DISEASE VASCULAR CALCIFICATION RAT MODEL

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Firas Bassissi ◽  
Miguel David Ferrer Reynes ◽  
M Mar Pérez ◽  
Joan Perelló ◽  
Carolina Salcedo
Keyword(s):  
Peripheral Artery Disease ◽  
Vascular Calcification ◽  
Rat Model ◽  
Blood Perfusion ◽  
Walking Distance ◽  
Arterial Calcification ◽  
Walking Ability ◽  
Peripheral Artery ◽  
Increased Risk ◽  
Artery Disease

Abstract Background and Aims Peripheral Artery disease (PAD) is a common vascular disease associated with functional impairment and increased risk of cardiovascular events in End Stage Kidney Disease (ESKD) patients undergoing dialysis. Poor limb salvage outcomes and high post-amputation mortality in hemodialysis (HD) patients highlight the need for earlier medical therapies. Cilostazol and pentoxifylline are approved for PAD. Their use in HD patients stays limited and cilostazol use requires caution in this population. Clinical studies demonstrate associations between arterial calcification and adverse outcomes in PAD patients. SNF472, a selective calcification inhibitor that interferes in the formation and growth of hydroxyapatite, is in Phase 3 for calciphylaxis treatment. This study aims to evaluate the effects of SNF472 on limb functional recovery and blood perfusion in a Vitamin D3 (VitD)-induced arterial calcification rat model. Method Arterial calcification was induced in 32 Sprague Dawley rats by 3 consecutive daily s.c. doses of 120 kIU/kg VitD. Rats were divided into four groups and treated during 12 days by: placebo s.c, placebo p.o, SNF472 (20 mg/kg/day, s.c.) or cilostazol (20 mg/kg/day, p.o.). An additional group of 8 rats without VitD received vehicle only (sham). Efficacy was evaluated at day 12 and 17 (5 days after treatment stop). Posterior limb blood perfusion was measured using Laser Doppler Imaging and limb walking ability was evaluated by measuring Maximum Walking Distance (MWD) and Maximum Walking Time (MWT) using a treadmill. Rats were sacrificed at day 26 (14 days after treatment stop), and aortas were collected for calcium analysis. Results VitD-induced arterial calcification was associated with decreased blood perfusion and impairment of limb walking ability (MWT and MWD) compared to sham. SNF472 reduced aorta calcification by 41% compared to placebo. No effects of cilostazol on vascular calcification were observed. The inhibition of calcification in SNF472-treated animals was associated with significant higher limb blood perfusion compared to placebo or Cilostazol (1.28 and 1.37-fold higher, respectively at day 12: p&lt; 0.001) and it was translated into a significant improvement in walking ability compared to placebo (515±114 meters vs 334±187 meters, respectively: p&lt;0.05). Conclusion SNF472 shows improvements in vascular calcification, blood perfusion and a functional parameter like walking distance in a PAD vascular calcification rat model. These results suggest that SNF472 may represent a new therapeutic approach for the treatment of PAD associated with high vascular calcification such as in renal disease.

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