Dataset Information

Clinical Outcomes and Cost Comparisons of Stent and Non-Stent Interventions in Infrainguinal Peripheral Artery Disease: Insights From the Excellence in Peripheral Artery Disease (XLPAD) Registry.

ABSTRACT: BACKGROUND:The contemporary limb outcomes and costs of stent-based vs non-stent based strategies in endovascular revascularization of femoropopliteal (FP) peripheral artery disease (PAD) are not well understood. METHODS AND RESULTS:We present data from the ongoing United States multicenter Excellence in Peripheral Artery Disease Registry between 2006-2016 to compare stent vs non-stent treatment outcomes and associated costs in FP interventions. A total of 2910 FP interventions were performed in 2162 patients (mean age, 66 years), comprising 1339 stent based (superficial femoral artery, 93%) in 1007 patients and 1571 non-stent interventions (superficial femoral artery, 85%) in 1155 patients. A growing trend for non-stent based interventions and a declining trend in repeat revascularization rate at 1 year were observed across years of registry enrollment. Stent implantation was the prevailing strategy in treating longer FP lesions (mean length, 152 mm vs 105 mm; P<.001) and chronic total occlusions (65% vs 40%; P<.001), while stent implantation was employed less frequently when treating in-stent restenotic lesions (14% vs 20%; P<.001). Stent and non-stent interventions had similar 1-year limb outcomes in all-cause death, target-limb revascularization, target-vessel revascularization, and major or minor amputation. The average procedure costs for the stent group were significantly higher than the non-stent group ($6215 vs $4790; P<.001). CONCLUSION:There is a growing trend for non-stent FP artery interventions, with a significant decline in 1-year target-limb revascularization rates over time. One-year limb outcomes in stent-based compared to non-stent interventions are similar; however, at a significantly higher procedural cost.

SUBMITTER: Banerjee S

PROVIDER: S-EPMC6428413 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Clinical Outcomes and Cost Comparisons of Stent and Non-Stent Interventions in Infrainguinal Peripheral Artery Disease: Insights From the Excellence in Peripheral Artery Disease (XLPAD) Registry.

Banerjee Subhash S Jeon-Slaughter Haekyung H Armstrong Ehrin J EJ Bajzer Christopher C Abu-Fadel Mazen M Khalili Houman H Prasad Anand A Bou Dargham Bassel B Kamath Preeti P Addo Tayo T Luna Michael M Gigliotti Osvaldo O Foteh Mazin M Cawich Ian I Kinlay Scott S Ali Mujtaba M Ramanan Bala B Niazi Khusrow K Tsai Shirling S Shammas Nicolas W NW Brilakis Emmanouil S ES

The Journal of invasive cardiology 20190101 1

<h4>Background</h4>The contemporary limb outcomes and costs of stent-based vs non-stent based strategies in endovascular revascularization of femoropopliteal (FP) peripheral artery disease (PAD) are not well understood.<h4>Methods and results</h4>We present data from the ongoing United States multicenter Excellence in Peripheral Artery Disease Registry between 2006-2016 to compare stent vs non-stent treatment outcomes and associated costs in FP interventions. A total of 2910 FP interventions wer ...[more]

PMID: 30611122

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Project description:PurposePatients with diabetes mellitus (DM) are known to be at higher risk for peripheral artery disease (PAD), amputations, and major adverse cardiovascular events, though it is unclear whether they are at any higher risk for repeat intervention. LIBERTY 360 offered an opportunity to study a real-world cohort of patients who underwent distal superficial femoral artery endovascular revascularizations. We aimed to describe patients with DM, their outcomes following peripheral vascular intervention, and the effect of DM on outcomes in the LIBERTY 360 cohort.MethodsLIBERTY 360 is a prospective, multi-center, non-randomized, mono-industry funded observational study of patients undergoing endovascular revascularization. Outcomes included 30-day and 1-year all-cause mortality, major amputation, target vessel/lesion revascularization, and a composite of those events. A multivariable regression model including DM was constructed to examine the effect of DM on outcomes. Multivariable survival estimates were made using Cox proportional hazards models.ResultsA total of 1,204 patients were enrolled, of whom 727 had DM (60.4%). Patients with DM had significantly more comorbidities and a third required insulin for DM management. Patients with DM had more severe disease based on Rutherford classification at baseline. After adjusting for comorbidities and disease severity, DM patients had more frequent major amputations at 1 year (5.2% versus 1.2%; HR 2.71, 95%CI 1.05-6.98, p = 0.040). The 1-year rates of all-cause mortality and target vessel/lesion revascularization were not significantly higher for patients with DM.ConclusionsDiabetes mellitus was associated with increased major amputations at 1 year following endovascular revascularization after accounting for demographics, comorbidities, and PAD-related characteristics. Further research is needed to determine which aspects of PAD and DM are most strongly associated with poor outcomes following lower extremity revascularization.

Project description:BackgroundRadial access (RA) may offer advantages in peripheral interventions, but previous studies on this approach have been limited to retrospective or single-center studies. Our aim was to prospectively evaluate the safety and feasibility of RA for complex endovascular lower extremity interventions.MethodsIn this prospective, multicenter, and observational study, eligible patients with peripheral artery disease scheduled for intervention through RA were enrolled. Primary efficacy end point was procedural success, defined as successful completion of the intended procedure without conversion to femoral access and without RA complications periprocedure. Primary safety end point included evaluation of RA-related complications at 30 days.ResultsFrom June 2020 to June 2021, 120 patients at 8 US centers were enrolled. Mean age was 68.7 years, and 31.7% were women. The 224 lesions treated were in iliac (12.9%), femoropopliteal (55.3%), isolated popliteal (11.9%), and tibial (19.5%) vessels. The primary efficacy end point was achieved in 112 (93.3%) patients. One patient (<1%) required femoral access conversion to complete the procedure. Thirty (25.0%) patients required 1 or more additional access to facilitate crossing and/or to complete the planned treatment (5 femoral, 10 tibial, and 17 pedal accesses). No serious adverse events were adjudicated to the procedure. Mean procedure time and time to ambulation was 74 minutes and 3 hours 30 minutes; respectively, with 93.3% same-day discharge. At 30 days, 97.2% of patients recorded ultrasound-confirmed RA patency.ConclusionsThis is the first prospective and multicenter registry to show the safety and efficacy of RA approach for complex endovascular lesions and multilevel disease. RA allowed early ambulation and same-day discharge with no serious adverse events. Future randomized trials should examine the clinical and cost effectiveness of this approach compared with those of femoral access for patients with peripheral artery disease.

Project description:IntroductionCurrently, 15-20% of individuals with coronary artery disease (chronic coronary syndrome [CCS]) or peripheral artery disease (PAD) receiving routine treatment experience cardiovascular events (CVEs) within 3-4 years. Using PICOSTEPS (Patients-Intervention-Comparators-Outcomes-Setting-Time-Effects-Perspective-Sensitivity analysis) reporting, we evaluated the cost-effectiveness of recently approved rivaroxaban 2.5 mg twice daily in combination with acetylsalicylic acid 100 mg daily (RIV?+?ASA) for the prevention of CVEs among Finns with CCS or symptomatic PAD.MethodsMyocardial infarction, ischemic stroke, intracranial hemorrhage, acute limb ischemia, amputations, major extracranial bleeding, venous thromboembolism, and cardiovascular deaths were modeled in a Markov model examining a cohort of patients with CCS or symptomatic PAD. Relative effects of the intervention (RIV?+?ASA) and comparator (ASA) were based on the COMPASS trial. The primary outcome was 3%/year discounted incremental cost-effectiveness ratio (ICER), defined as cost (2019 euros) per quality-adjusted life year (QALY) gained in the Finnish setting over a lifetime horizon. In addition to nonfatal and fatal CVEs, the effects factored Finnish non-CVE mortality, quality of life, and direct costs from a public payer perspective. Disaggregated costs and QALYs, costs per life year gained (LYG), and ischemic strokes avoided, net monetary benefit (NMB), expected value of perfect information (EVPI), economic value-added (EVA), cost-effectiveness table, and acceptability frontier were examined. Probabilistic and deterministic sensitivity analyses were conducted.ResultsIn the deterministic comparison with ASA over a lifetime horizon, RIV?+?ASA resulted in a benefit of 0.404 QALYs and 0.474 LYGs for an additional cost of €3241, resulting in an ICER of €8031/QALY. The probabilistic ICER was €4313/QALY (EVPI €1829/patient). RIV?+?ASA had positive NMB (€8791/patient), low EVPI (€88/patient), high EVA (€8703/patient), and 91% probability of cost-effectiveness using the willingness-to-pay of €25,254/QALY. The primary result was conservative and robust for RIV?+?ASA.ConclusionRIV?+?ASA was a cost-effective treatment alternative compared with ASA in patients with CCS or symptomatic PAD in Finland.

Project description:ObjectiveA physically active lifestyle reduces the risk of cardiovascular events and functional impairment in patients with peripheral artery disease (PAD). There are limited data on the patterns of physical activity in patients with PAD compared between countries.MethodsSelf reported physical activity (sedentary vs. not) was obtained at enrolment, 3, 6, and 12 months in the US and Netherlands' cohorts of the Patient-centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) registry of patients with new or worsening claudication. Multivariable repeated measures using modified Poisson regression analysis compared the proportion of sedentary participants over time between countries to identify factors that attenuate intercountry differences.ResultsOf 1 098 participants, 743 (67.7%) and 355 (32.3%) were recruited from the USA and the Netherlands respectively. Compared with the Netherlands, participants from the US were older (mean age 68.6 vs. 65.3 years; p < .001), more obese (41.3% vs. 20.5%; p < .001), and more likely to be female (41.3% vs. 31.4%; p = .002). There were fewer current smokers (30.1% vs. 52.8%; p < .001) and supervised exercise referrals (1.6% vs. 63.9%; p < .001) in the US compared with the Netherlands. US participants were more sedentary at baseline (43.7% vs. 34.1%; p < .001). Sedentary behaviour decreased after three months in both countries, then diverged with an increase in sedentary participants in the USA. Risk of sedentary behaviour was significantly greater in the USA compared with the Netherlands at 12 months, after adjustment of sociodemographic, lifestyle factors, and comorbidities (relative risk [RR] 1.56, 95% confidence interval [CI] 1.08-2.25; p = .020) but was attenuated after accounting for referral to supervised exercise (RR 1.20, 95% CI 0.67-2.16; p = .54).ConclusionReferral to supervised exercise was key in explaining the observed difference in the physical activity levels between patients with PAD in the USA and the Netherlands. Further promotion of supervised exercise for PAD may improve physical activity in patients with PAD and modify cultural norms of inactivity in the US.

Dataset Information

Clinical Outcomes and Cost Comparisons of Stent and Non-Stent Interventions in Infrainguinal Peripheral Artery Disease: Insights From the Excellence in Peripheral Artery Disease (XLPAD) Registry.

Publications

Clinical Outcomes and Cost Comparisons of Stent and Non-Stent Interventions in Infrainguinal Peripheral Artery Disease: Insights From the Excellence in Peripheral Artery Disease (XLPAD) Registry.

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