scholarly journals Three-Year Outcomes From the LIBERTY 360 Study of Endovascular Interventions for Peripheral Artery Disease Stratified by Rutherford Category

2020 ◽  
pp. 152660282096297
Author(s):  
Stefanos Giannopoulos ◽  
Jihad Mustapha ◽  
William A. Gray ◽  
Gary Ansel ◽  
George Adams ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Peripheral Artery Disease ◽  
Survival Rates ◽  
Target Lesion ◽  
Major Amputation ◽  
Peripheral Artery ◽  
Target Vessel Revascularization ◽  
Endovascular Interventions ◽  
Artery Disease

Purpose: To report the 3-year results of the LIBERTY 360 study, which investigated outcomes of endovascular treatment of symptomatic peripheral artery disease (PAD). Materials and Methods: The LIBERTY trial ( ClinicalTrials.gov identifier NCT01855412) was a prospective, observational, core laboratory–assessed, multicenter study of endovascular interventions enrolling >1200 participants treated at 51 sites. Data from 1189 patients were stratified according to Rutherford category (RC) and analyzed [RC 2-3 (n=500), RC 4-5 (n=589), and RC 6 (n=100)]. The primary outcomes were major amputation of the target limb and all-cause death; secondary outcomes were target vessel revascularization (TVR) or target lesion revascularization (TLR); major adverse events (MAEs; death within 30 days, TVR or TLR, and major amputation); death or major amputation combined; and change in self-reported quality of life (QoL) measures (VascuQol-25). The Kaplan-Meier (KM) method was employed to estimate the outcomes; estimates are presented with the 95% confidence intervals (CI). Predictors of 3-year MAE, death, TVR, and major amputation were analyzed using Cox proportional hazard regression modeling. Results: The 36-month KM survival rates were 86.0% in RC 2-3, 79.8% in RC 4-5, and 62.0% in RC 6 groups. The KM estimates of freedom from major amputation at 36 months were 98.5% in RC 2-3, 94.0% in RC 4-5, and 79.9% in RC 6. The 36-month KM estimates for freedom from TVR/TLR were 71.1% in RC 2-3, 64.2% in RC 4-5 and 61.9% in RC 6 groups. Patients with claudication at baseline were at lower risk for MAEs compared with RC 4-5 and RC 6 patients during the 36-month follow-up. Vascular QoL improved from baseline and persisted up to 36 months in all patients. Conclusion: Endovascular therapy is a viable treatment option for patients with symptomatic PAD, with sustained improved quality of life in both claudicants and patients with chronic limb-threatening ischemia. These results provide important point estimates for midterm outcomes after modern endovascular interventions for PAD.

scholarly journals Implementation of Supervised Exercise Therapy for Patients With Symptomatic Peripheral Artery Disease: A Science Advisory From the American Heart Association

Circulation ◽  
2019 ◽  
Vol 140 (13) ◽  
Author(s):  
Diane Treat-Jacobson ◽  
Mary M. McDermott ◽  
Joshua A. Beckman ◽  
Marsha A. Burt ◽  
Mark A. Creager ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Peripheral Artery Disease ◽  
Exercise Therapy ◽  
Outcome Measurement ◽  
The United States ◽  
Walking Ability ◽  
Peripheral Artery ◽  
Supervised Exercise ◽  
Artery Disease

Patients with lower-extremity peripheral artery disease (PAD) have greater functional impairment, faster functional decline, increased rates of mobility loss, and poorer quality of life than people without PAD. Supervised exercise therapy (SET) improves walking ability, overall functional status, and health-related quality of life in patients with symptomatic PAD. In 2017, the Centers for Medicare & Medicaid Services released a National Coverage Determination (CAG-00449N) for SET programs for patients with symptomatic PAD. This advisory provides a practical guide for delivering SET programs to patients with PAD according to Centers for Medicare & Medicaid Services criteria. It summarizes the Centers for Medicare & Medicaid Services process and requirements for referral and coverage of SET and provides guidance on how to implement SET for patients with PAD, including the SET protocol, options for outcome measurement, and transition to home-based exercise. This advisory is based on the guidelines established by the Centers for Medicare & Medicaid Services for Medicare beneficiaries in the United States and is intended to assist clinicians and administrators who are implementing SET programs for patients with PAD.

scholarly journals Health-related quality of life predicts long-term survival in patients with peripheral artery disease

2010 ◽  
Vol 15 (3) ◽  
pp. 163-169 ◽  
Author(s):  
Samson M Issa ◽  
Sanne E Hoeks ◽  
Wilma JM Scholte op Reimer ◽  
Yvette RBM Van Gestel ◽  
Mattie J Lenzen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Peripheral Artery Disease ◽  
Health Related Quality ◽  
Peripheral Artery ◽  
Term Survival ◽  
Related Quality ◽  
Health Related ◽  
Artery Disease

scholarly journals The Secret of Preserved Quality of Life in Elderly Patients with Peripheral Artery Disease and Decreased Ankle-Brachial Index

2018 ◽  
Vol 15 (3) ◽  
pp. 27-32
Author(s):  
Anna-Boróka Tusa ◽  
Annamária Magdás ◽  
Réka-Júlia Tusa ◽  
Al. Incze
Keyword(s):  
Quality Of Life ◽  
Peripheral Artery Disease ◽  
Ankle Brachial Index ◽  
Inverse Correlation ◽  
Arterial System ◽  
Peripheral Artery ◽  
Significant Difference ◽  
Quitting Smoking ◽  
Artery Disease

SummaryObjective. In lower limb peripheral artery disease the most commonly used method for the assessment of the main arterial system is represented by the determination of ankle-brachial index (ABI). The post-occlusive reactive hyperaemia (PORH) is a controversial method used for the evaluation of primary collateral circulation. The follow-up of these patients has an underestimated part, their quality of life. The aim of this study is to evaluate this and highlight the importance of the PORH in the sight of optimal treatment.Method. 34 patients diagnosed with lower extremity artery disease, receiving conservative treatment, the ankle-brachial index was defined with a Doppler Bistos BT-200, 8 MHz device, the PORH was evaluated with a Bidop ES-100V, an instrument which sends information for a Smart-V-Link software. To assess the quality of life we used the VascuQol-6 test.Results. The age (mean ± SD) of the patients was 67.24±9.51, 52.92% were active smokers. A significant positive correlation was found between PORH and the results of VascuQol-6 test (p=0.02, r=0.38) and an inverse correlation between ABI <0.5 and VascuQol-6 >12. We noticed a significant difference between the VascuQol-6 result at smokers and non-smokers (p=0.02).Conclusions. The quality of life can be acceptable at patients with significant stenosis on the main artery and decreased ankle-brachial index due to presence of the collateral artery system with a maintained ability of vasodilatation represented by PORH. The efficiency of the treatmet is based on quitting smoking, starting programs which are helping patients to quit smoking would be useful.

Stromal Cell–Derived Factor-1 Plasmid Treatment for Patients With Peripheral Artery Disease (STOP-PAD) Trial: Six-Month Results

2020 ◽  
Vol 27 (4) ◽  
pp. 669-675
Author(s):  
Tarek A. Hammad ◽  
John Rundback ◽  
Matthew Bunte ◽  
Leslie Miller ◽  
Parag D. Patel ◽  
...  
Keyword(s):  
Wound Healing ◽  
Peripheral Artery Disease ◽  
Stromal Cell ◽  
Biological Therapy ◽  
Target Lesion ◽  
Major Amputation ◽  
Peripheral Artery ◽  
Below The Knee ◽  
Stromal Cell Derived Factor ◽  
Artery Disease

Purpose: To present the 6-month results of the Stromal Cell–Derived Factor-1 Plasmid Treatment for Patients with Peripheral Artery Disease (STOP-PAD) trial. The trial was an attempt to alter the course of chronic limb-threatening ischemia (CLTI) with a biological agent vs placebo after successful arterial revascularization at or below the knee. Materials and Methods: The multicenter, randomized, double-blinded, placebo-controlled, phase 2B STOP-PAD trial ( ClinicalTrials.gov identifier NCT02544204) randomized 109 patients (mean age 71 years; 68 men) with Rutherford category 5 or 6 CLTI and evidence of persistent impaired forefoot perfusion following recent successful revascularization to 8- (n=34) or 16-mg (n=36) intramuscular injections of a non-viral DNA plasmid–based treatment vs placebo (n=34). The primary efficacy outcome was the 6-month wound healing score evaluated by an independent wound core laboratory; the primary safety endpoint was major adverse limb events (MALE), a composite of major amputation plus clinically-driven target lesion revascularization at 6 months. Results: Only one-third of the patients had complete wound healing at 6 months in the placebo (31%), 8-mg injection (33%), and 16-mg injection (33%) groups. In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups). During the 6-month period, 6 patients (6%) died, and 24 patients (23%) had an amputation [only 4 (4%) major]. Conclusion: Combining revascularization and biological therapy failed to improve outcomes in CLTI at 6 months. STOP-PAD has provided insights for future trials to evaluate biological therapy.

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

2021 ◽  
Author(s):  
Jennifer A. Rymer ◽  
Dennis Narcisse ◽  
Michael Cosiano ◽  
John Tanaka ◽  
Mary M. McDermott ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Outcome Measures ◽  
Peripheral Artery Disease ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Peripheral Artery ◽  
Patient Reported ◽  
Artery Disease ◽  
Disease Specific

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.

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