Diversity in randomized clinical trials for peripheral artery disease: a systematic review.

BACKGROUND: Significant race and sex disparities exist in the prevalence, diagnosis, and outcomes of peripheral artery disease (PAD). However, clinical trials evaluating treatments for PAD often lack representative patient populations. This systematic review aims to summarize the demographic representation and enrollment strategies in clinical trials of lower-extremity endovascular interventions for PAD. METHODS: Following the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched multiple sources (Medline, EMBASE, Cochrane, Clinicaltrials.gov, WHO clinical trial registry) for randomized controlled trials (RCTs), RCT protocols, and peer-reviewed journal publications of RCTs conducted between January 2012 and December 2022. Descriptive analysis was used to summarize trial characteristics, publication or study protocol characteristics, and the reporting of demographic characteristics. Meta-regression was used to explore associations between demographic characteristics and certain trial characteristics. RESULTS: A total of 2,374 records were identified. Of these, 59 met the inclusion criteria, consisting of 35 trials, 14 publications, and 10 protocols. Information regarding demographic representation was frequently missing. While all 14 trial publications reported age and sex, only 4 reported race/ethnicity, and none reported socioeconomic or marital status. Additionally, only 4 publications reported clinical outcomes by demographic characteristics. Meta-regression analysis revealed that 6% more women were enrolled in non-European trials (36%) than in European trials (30%). CONCLUSIONS: The findings of this review highlight potential issues that may compromise the reliability and external validity of study findings in lower-extremity PAD RCTs when applied to the real-world population. Addressing these issues is crucial to enhance the generalizability and impact of clinical trial results in the field of PAD, ultimately leading to improved clinical outcomes for patients in underrepresented populations. REGISTRATION: The systematic review methodology was published in the International Prospective Register of Systematic Reviews (PROSPERO: CRD42022378304).

Cost to Medicare of acute kidney injury in percutaneous coronary intervention.

BACKGROUND: Acute kidney injury (AKI), including contrast-induced AKI (CI-AKI), is an important complication of percutaneous coronary intervention (PCI), resulting in short- and long-term adverse clinical outcomes. While prior research has reported an increased cost burden to hospitals from CI-AKI, the incremental cost to payers remains unknown. Understanding this incremental cost may inform decisions and even policy in the future. The objective of this study was to estimate the short- and long-term cost to Medicare of AKI overall, and specifically CI-AKI, in PCI. METHODS: Patients undergoing inpatient PCI between January 2017 and June 2020 were selected from Medicare 100% fee-for-service data. Baseline clinical characteristics, PCI lesion/procedural characteristics, and AKI/CI-AKI during the PCI admission, were identified from diagnosis and procedure codes. Poisson regression, generalized linear modelling, and longitudinal mixed effects modelling, in full and propensity-matched cohorts, were used to compare PCI admission length of stay (LOS) and cost (Medicare paid amount inflated to 2022 US$), as well as total costs during 1-year following PCI, between AKI and non-AKI patients. RESULTS: The study cohort included 509,039 patients, of whom 104,033 (20.4%) were diagnosed with AKI and 9,691 (1.9%) with CI-AKI. In the full cohort, AKI was associated with +4.12 (95% confidence interval = 4.10, 4.15) days index PCI admission LOS, +$11,313 ($11,093, $11,534) index admission costs, and +$14,800 ($14,359, $15,241) total 1-year costs. CI-AKI was associated with +3.03 (2.97, 3.08) days LOS, +$6,566 ($6,148, $6,984) index admission costs, and +$13,381 ($12,118, $14,644) cumulative 1-year costs (all results are adjusted for baseline characteristics). Results from the propensity-matched analyses were similar. CONCLUSIONS: AKI, and specifically CI-AKI, during PCI is associated with significantly longer PCI admission LOS, PCI admission costs, and long-terms costs.

Racial and socioeconomic disparities in surgical care for post-prostate cancer treatment complications: A nationwide Medicare-based analysis.

Objectives: To investigate the racial and socioeconomic (income) differences in receipt of and time to surgical care for urinary incontinence (UI) and erectile dysfunction (ED) occurring post-radical prostatectomy (RP) and/or radiation therapy (RT). Materials and Methods: Utilizing the Medicare Standard Analytical Files (SAF), a retrospective cohort study was performed on data of patients diagnosed with prostate cancer (PCa) from 2015 to 2021. Patients who underwent RP and/or RT and who subsequently developed UI and/or ED were grouped into four cohorts: RP-ED, RP-UI, RT-ED and RT-UI. County-level median household income was cross-referenced with SAF county codes, classified into income quartiles, and used as a proxy for patient income status. The rate of surgical care was compared between groups using two-sample t-test and log-rank test. Cox proportional hazards modelling was used to determine covariate-adjusted impact of race on time to surgical care. Results: The rate of surgical care was 6.8, 3.61 3.07, and 1.54 per 100 person-years for the RP-UI, RT-UI, RP-ED, and RT-ED cohorts, respectively. Cox proportional 'time-to-surgical care' regression analysis revealed that Black men were statistically more likely to receive ED surgical care (RP-ED AHR:1.79, 95% CI:1.49-2.17; RT-ED AHR:1.50, 95% CI:1.11-2.01), but less likely to receive UI surgical care (RP-UI AHR:0.80, 95% CI:0.67-0.96) than White men, in all cohorts except RT-UI. Surgical care was highest among Q1 (lowest income quartile) patients in all cohorts except RT-UI. Conclusions: Surgical care for post-PCa treatment complications is low, and significantly impacted by racial and socioeconomic (income) differences. Prospective studies investigating the basis of these results would be insightful.

Clinical and economic outcomes of assigning percutaneous coronary intervention patients to contrast-sparing strategies based on the predicted risk of contrast-induced acute kidney injury.

OBJECTIVE: Contrast-sparing strategies have been developed for percutaneous coronary intervention (PCI) patients at increased risk of contrast-induced acute kidney injury (CI-AKI), and numerous CI-AKI risk prediction models have been created. However, the potential clinical and economic consequences of using predicted CI-AKI risk thresholds for assigning patients to contrast-sparing regimens have not been evaluated. We estimated the clinical and economic consequences of alternative CI-AKI risk thresholds for assigning Medicare PCI patients to contrast-sparing strategies. METHODS: Medicare data were used to identify inpatient PCI from January 2017 to June 2021. A prediction model was developed to assign each patient a predicted probability of CI-AKI. Multivariable modeling was used to assign each patient two marginal predicted values for each of several clinical and economic outcomes based on (1) their underlying clinical and procedural characteristics plus their true CI-AKI status in the data and (2) their characteristics plus their counterfactual CI-AKI status. Specifically, CI-AKI patients above the predicted risk threshold for contrast-sparing were reassigned their no CI-AKI (counterfactual) outcomes. Expected event rates, resource use, and costs were estimated before and after those CI-AKI patients were reassigned their counterfactual outcomes. This entailed bootstrapped sampling of the full cohort. RESULTS: Of the 542,813 patients in the study cohort, 5,802 (1.1%) had CI-AKI. The area under the receiver operating characteristic curve for the prediction model was 0.81. At a predicted risk threshold for CI-AKI of >2%, approximately 18.0% of PCI patients were assigned to contrast-sparing strategies, resulting in (/100,000 PCI patients) 121 fewer deaths, 58 fewer myocardial infarction readmissions, 4,303 fewer PCI hospital days, $11.3 million PCI cost savings, and $25.8 million total one-year cost savings, versus no contrast-sparing strategies. LIMITATIONS: Claims data may not fully capture disease burden and are subject to inherent limitations such as coding inaccuracies. Further, the dataset used reflects only individuals with fee-for-service Medicare, and the results may not be generalizable to Medicare Advantage or other patient populations. CONCLUSIONS: Assignment to contrast-sparing regimens at a predicted risk threshold close to the underlying incidence of CI-AKI is projected to result in significant clinical and economic benefits.

Impact of Racial and Socioeconomic Disparities on Access to Interspinous Spacer for Treatment of Lumbar Spinal Stenosis: A Nationwide Medicare Analysis.

BACKGROUND: In mild to moderate lumbar spinal stenosis (LSS) where conservative care treatments fail, minimally invasive treatments, such as interspinous spacers without decompression or fusion (ISD), may be appropriate. While previous studies have demonstrated racial and socioeconomic disparities in the surgical treatment of LSS, there are limited data on how those factors impact accessibility to these procedures. This study explored demographic, socioeconomic, and geographic differences in the use of ISD. METHODS: Using the Medicare 100% files from 2017 through 2022, this retrospective claims analysis identified when and if patients diagnosed with LSS received ISD implantation. Cox proportional hazards regression was used to examine the association between racial and socioeconomic characteristics and the rate of ISD implantation, stratified by geographic region. RESULTS: A total of 1,316,622 individuals met the inclusion criteria; 4730 (0.4%) underwent ISD implantation, with a mean (standard deviation) time to treatment of 11.9 (13.2) months after diagnosis. The likelihood of ISD implantation was higher for older patients (except for the oldest group), males, those with lower disease burden, and White patients. Cox regression revealed that the associations of racial and socioeconomic factors with ISD implantation varied by U.S. region. In the Midwest and Northeast, lower median household income was associated with a decreased likelihood of ISD implantation regardless of race, while in the South, Black patients were less likely to undergo ISD implantation regardless of income. CONCLUSIONS: The observed disparities in access to ISD implantation mirror existing trends in surgical interventions for LSS, suggesting further study and interventions are needed to address inequities.

Long-Term Reductions in Opioid Medication Use After Spinal Stimulation: A Claims Analysis Among Commercially-Insured Population.

Purpose: Chronic, non-cancer pain significantly and negatively impacts patient quality of life. Neuromodulation is a major component of multi-modal interdisciplinary approaches to chronic pain management, which includes opioid and nonopioid medications. In randomized controlled trials, spinal cord stimulation (SCS) has been shown to reduce pain and decrease short-term opioid use for patients. This study sought to evaluate the effect of SCS on longer term opioid and non-opioid pain medication usage among patients over ≥3 years of follow-up. Patients and Methods: Claims analysis was conducted using the Merative™ MarketScan® Commercial Database. Patients aged ≥18 who initiated SCS between 1/1/2010 and 3/31/2021 with ≥1 year of baseline data and ≥3 years of follow-up data were included. Opioid discontinuation, daily dose (DD) reduction, proportion of days covered (PDC), concomitant co-medication with benzodiazepines and/or gabapentinoids, and polypharmacy were evaluated during the baseline and follow-up periods. Adjusted logistic regression was used to evaluate the impact of baseline dosages on discontinuation and dose reduction. Results: During follow-up, 60% of 2,669 SCS patients either discontinued opioid use or reduced opioid DD by at least 20% from baseline; another 15% reduced DD by 1-19%. Logistic regression showed patients with higher baseline dosages were less likely to discontinue opioids completely (odds ratio[OR] 95% confidence intervals[CI]: 0.31[0.18,0.54]) but more likely to reduce their daily dose (OR[CI]: 7.14[4.00,12.73], p<0.001). Mean PDC with opioids decreased from 0.58 (210 of 365 days) at baseline to 0.51 at year 3 (p<0.001). With SCS, co-medication with benzodiazepines decreased from 47.3% at baseline to 30.3% at year 3, co-medication with gabapentinoids reduced from 58.6% to 42.2%, and polypharmacy dropped from 15.6% to 9.6% (all p<0.001). Conclusion: Approximately three-quarters of patients who received SCS therapy either discontinued or reduced systemic opioid use over the study period. SCS could assist in reducing long-term reliance on opioids and other pain medications to treat chronic non-cancer pain.

Patient out-of-pocket costs for guideline-recommended treatments for erectile dysfunction: a medicare cost modeling analysis.

Patient out-of-pocket (OOP) cost represents an access barrier to erectile dysfunction (ED) treatment. We determined OOP cost for men with ED covered by Fee-for-Service Medicare. Coverage policies were obtained from the Medicare Coverage Database for treatments recommended by the 2018 American Urological Association (AUA) guidelines. OOP cost was retrieved from the 2023 Centers for Medicare & Medicaid Services Final Rule. OOP cost for treatments without Medicare coverage were extracted from GoodRx® or literature and inflated to 2022 dollars. Annual prescription costs were calculated using the published estimate of 52.2 yearly instances of sexual intercourse. Medicare has coverage for inflatable penile prostheses (IPP; strong recommendation), non-coverage for vacuum erection devices (VED; moderate recommendation) and phosphodiesterase type-5 inhibitors (PDE5i; strong recommendation), and no policies for intracavernosal injections (ICI; moderate recommendation), intraurethral alprostadil (IA; conditional recommendation), or low-intensity extracorporeal shock wave therapy (ESWT; conditional recommendation). Annual IA prescription is most costly ($4022), followed by ICI prescription ($3947), one ESWT course ($3445), IPP ($1600), PDE5i prescription ($696), and one VED ($213). PDE5i and IPP, both strongly recommended by AUA guidelines, are associated with lower OOP cost. Better understanding of patient financial burden may inform healthcare decision-making.

Improved Health Care Utilization Among Men With Depression Undergoing Inflatable Penile Prosthesis in a U.S. Commercial Population.

We evaluated depression-related health care resource utilization and antidepressant prescription medication utilization among commercially insured men in the United States who underwent inflatable penile prosthesis (IPP) implantation between January 1, 2007 and December 31, 2020, and who received a depression diagnosis in the year preceding the IPP procedure. A total of 11,177 patients received an IPP during the index period, 808 of whom were diagnosed with depression. A statistically significant reduction in overall depression-related health care visits occurred from pre- to post-IPP, decreasing from 4.9 to 3.8, p < .001. In addition, there was a significant reduction in depression-related inpatient visits (0.07 vs. 0.03, p = .02) and office visits (4.25 vs. 3.29, p < .001) from pre- to post-IPP. Of the 678 men who received an antidepressant medication within 1 year prior to their IPP date, 15% stopped antidepressant medication use entirely post-IPP. Among patients with continued antidepressant medication use post-IPP (n = 574), there was a significant decrease in the number of prescriptions (7.55 vs. 8.09, p < .0001) and refills (7.52 vs. 8.11, p = .0015), with a higher likelihood of discontinuation (17.6% vs. 10.5%, p < .0001) and a lower proportion of days covered (0.79 vs. 0.83, p = .0004) post-IPP compared with pre-IPP. In conclusion, IPP was associated with reduced depression-related health care utilization and antidepressant medication use among recipients. This suggests potential mental health benefits for IPP recipients beyond restoration of erectile function. Comprehensive insurance coverage for IPP, especially for men with depression, may be beneficial to both patients and insurers.

Downstream Revenue Realized by Facilities Placing Inflatable Penile Prosthesis in Medicare Beneficiaries to Treat Erectile Dysfunction.

OBJECTIVE: To quantify the incremental downstream revenue generated from subsequent treatment of men who received an inflatable penile prosthesis (IPP) to treat erectile dysfunction (ED), compared to men without ED. METHODS: The 100% Medicare Standard Analytic Files were used to conduct a retrospective claims analysis of the 5-year revenue generated by patients receiving IPP to treat their ED, compared to a propensity-matched cohort of men without ED. Men aged 65 years or older with ED who underwent IPP implantation (Current Procedural Terminology 54405) in a hospital outpatient setting between January 1, 2016 and December 31, 2021, and who had continuous Medicare Parts A and B enrollment for 12 months pre-index IPP and 5 years post-index IPP discharge date were included in the study. Men without ED but with comparable characteristics were identified and used as a comparator group. Revenue received by hospitals from Medicare was defined as the sum of payments for patient services, other payor-paid amounts, patient deductibles, copayments, and coinsurance. Revenue was inflated to 2022 US dollars. The mean values and their corresponding standard deviations (SD) are reported. RESULTS: After matching, there were 2905 men with ED who received an IPP and 7462 men without ED. The IPP cohort showed a significantly higher 5-year cumulative revenue (mean=$34,571 [SD=$50,234]) compared to the men without ED (mean=$3189 [SD=$11,527]). When stratified by diagnosis type, the differences in revenue were $10,258 for circulatory disease, $2646 for diabetes, $2013 for urology, and $1043 for prostate cancer. Significantly more IPP patients had at least 1 health encounter for these conditions over the 5-year follow-up period than their matched controls (55.0% vs 7.8% for circulatory, 46.7% vs 16.8% for urology, 19.3% vs 3.6% for diabetes, and 19.0% vs 3.0% for prostate cancer). CONCLUSION: Men with ED who received IPP generated substantially higher revenue for the healthcare system over a 5-year period, nearly 10 times as much, compared to men without ED, excluding the initial cost of the IPP procedure. The presence of ED, coupled with IPP usage, is associated with significantly increased healthcare revenue across a range of medical conditions compared to men without ED. These findings emphasize the financial implications for advanced ED programs to improve access to necessary care for these patients. Healthcare facilities may leverage these insights to effectively allocate resources to deliver critical healthcare to men with ED.

Comparative Costs to Medicare and Medicare Beneficiaries of Alternative AF Stroke Risk Reduction Strategies.

Background: As healthcare costs are increasingly being shifted from payers to patients, it is important to understand the economic consequences of therapeutic strategies to both payers and patients. Objective: To determine the relative costs to Medicare and Medicare beneficiaries (patients) of warfarin, non-vitamin K oral anticoagulants (NOACs), and left atrial appendage closure (LAAC) for stroke risk reduction in nonvalvular atrial fibrillation. Methods: An economic model was developed to assess costs at 5 and 10 years. For warfarin and NOACs, inputs were derived from published meta-analyses; for LAAC with the Watchman device, inputs were derived from pooled 5-year PROTECT AF and PREVAIL trial results. The model captured therapy costs vs clinical event costs, including procedural complications and follow-up clinical outcomes. Costs were based on 2023 Medicare reimbursement and copayment rates. Results: At 10 years, overall LAAC costs ($48,337) were lower than those of NOACs ($81,198) and warfarin ($52,359). Overall LAAC costs were lower than those of NOACs by year 5 and warfarin by year 9. At 5 years, patient LAAC costs were lowest at $4,764, compared to $7,146 and $6,453 for NOACs and warfarin, respectively. LAAC patient costs were lower than those of NOACs by year 3 and warfarin by year 4. Clinical events comprised 96% of overall warfarin costs vs 48% for LAAC and 40% for NOACs. Conclusion: LAAC yielded the lowest overall and patient costs. Warfarin costs were largely driven by clinical events, which may represent an unplanned financial burden for patients. These considerations should be incorporated into shared decision-making discussions about stroke prophylaxis strategies.

A systematic review of discounting in national health economic evaluation guidelines: healthcare value implications.

Aim: This review summarizes the discounting approaches recommended in current economic evaluation (EE) guidelines for healthcare programs and interventions. Materials & methods: A systematic review of EE guidelines for healthcare, published up to July 2022, was conducted. Results: A total of 52 EE guidelines were reviewed. The majority of these guidelines recommend equal discounting (80.8%) rather than differential discounting (9.6%). The rationale for equal discounting includes recommendations by the government, consistency with other countries, and economic development. However, the rationale for differential discounting is based on the interest in short-term government bonds and anticipated budget changes. Discussion: This review demonstrates variation in both discounting approaches and rates across EE guidelines and underscores the need for a global consensus on discounting approaches.

Diversity in clinical trial inclusion for peripheral artery disease lower extremity endovascular interventions: a systematic review protocol.

Aim: This review provides a study protocol for a systematic review of peripheral artery disease (PAD) clinical trials to examine the eligibility criteria, demographic representation, and enrollment strategies among PAD patients undergoing lower extremity (LE) endovascular interventions. Methods: This systematic review will be conducted according to the Cochrane Collaboration methodology for systematic reviews and following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P). Eligible studies will include randomized controlled trials (RCTs) between January 2012 and December 2022. The primary outcome will be a description and summary of the frequency of the reporting of demographic characteristics. The feasibility of a meta-analysis or meta-regression will be explored, but if determined to be infeasible, the Synthesis Without Meta-analysis (SWiM) reporting guideline will be followed for the reporting of findings. Discussion: The findings may help to quantify existing inequities in clinical trial participation that may be addressed through optimizing enrollment strategies for future PAD trials. Systematic review registration: PROSPERO (CRD42022378304).

Cost-effectiveness of left atrial appendage closure with Watchman for non-valvular atrial fibrillation patients in Japan.

AIMS: Left atrial appendage closure (LAAC) has been demonstrated to be cost-saving relative to oral anticoagulants for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF) in the United States and Europe. This study assessed the cost-effectiveness of LAAC with the Watchman device relative to warfarin and direct oral anticoagulants (DOACs) for stroke risk reduction in NVAF from a Japanese public healthcare payer perspective. METHODS: A Markov model was developed with 70-year-old patients using a lifetime time horizon. LAAC clinical inputs were from pooled, 5-year PROTECT AF and PREVAIL trials; warfarin and DOAC inputs were from published meta-analyses. Baseline stroke and bleeding risks were from the SALUTE trial on LAAC. Cost inputs were from the Japanese Medical Data Vision database. Probabilistic and one-way sensitivity analyses were performed. RESULTS: Over the lifetime time horizon, LAAC was less costly than warfarin (savings of JPY 1,878,335, equivalent to US $17,600) and DOACs (savings of JPY 1,198,096, equivalent to US $11,226). LAAC also provided 1.500 more incremental quality-adjusted life years (QALYs) than warfarin and 0.996 more than DOACs. In probabilistic sensitivity analysis, LAAC was cost-effective relative to warfarin and DOACs in 99.98% and 99.73% of simulations, respectively. LAAC dominated (had higher cumulative QALYs and was less costly than) warfarin and DOACs in 89.94% and 83.35% of simulations, respectively. CONCLUSIONS: Over a lifetime time horizon, LAAC is cost-saving relative to warfarin and DOACs for stroke risk reduction in NVAF patients in Japan and is associated with improved quality-of-life.

This study examined the cost-effectiveness of left atrial appendage closure (LAAC) compared to oral anticoagulants for stroke risk reduction among individuals with a specific type of irregular heart rhythm called non-valvular atrial fibrillation (NVAF). This study evaluated the cost-effectiveness of LAAC using the Watchman device in comparison to warfarin and direct oral anticoagulants (DOACs) from the perspective of Japan's public healthcare system. To investigate this, a computer-based model was developed involving 70-year-old patients over their lifetime. Data from notable studies such as the PROTECT AF and PREVAIL trials (covering 5 years) for LAAC and published meta-analyses for warfarin and DOACs were incorporated into the model. Baseline stroke and bleeding risks were derived from the SALUTE trial on LAAC. Cost inputs were based on data from the Japanese Medical Data Vision database. Additionally, we performed thorough cost-effectiveness analyses, including probabilistic and one-way sensitivity assessments. Our findings revealed that, over a lifetime, LAAC was more cost-effective than both warfarin and DOACs. Further, LAAC contributed an additional 1.500 quality-adjusted life years (QALYs) compared to warfarin and 0.996 QALYs compared to DOACs. In the long-term, adopting LAAC as an alternative to warfarin and DOACs is a cost-effective strategy for reducing stroke risk in NVAF patients in Japan. Moreover, it is associated with enhanced quality-of-life. These findings hold significant implications for informing decision-making in healthcare policies and clinical practices for NVAF patients.

Cost-effectiveness of a paclitaxel-eluting stent (Eluvia) compared to Zilver PTX for endovascular femoropopliteal intervention.

OBJECTIVES: Antiproliferative therapies based on paclitaxel have been developed to extend the durability of endovascular interventions for lower-extremity atherosclerotic peripheral artery disease, resulting in improved primary vessel patency and fewer target lesion revascularizations. This study evaluated the cost-effectiveness of the sustained-release, paclitaxel-eluting Eluvia stent (Boston Scientific, Marlborough, MA) versus the paclitaxel-coated Zilver PTX stent (Cook Medical, Bloomington, IN) for endovascular intervention in the superficial femoral or proximal popliteal artery. DESIGN: A microsimulation model was constructed from a United States Medicare perspective with a 24-month time horizon. Patients entering the model were assigned to initial endovascular intervention with either Eluvia or Zilver PTX. Each month patients were exposed to the risks of primary vessel patency loss, target lesion revascularization, amputation, and death. Clinical input parameters were taken from a randomized trial (IMPERIAL) comparing the two interventions at 24-months follow-up. Cost parameters were obtained from analyses of Medicare administrative and claims data. Cost-effectiveness analysis entailed sampling a complete set of clinical and cost parameters from their respective distributions, and then running cohorts of 10,000 patients through each intervention arm of the model. One-way and probabilistic sensitivity analyses were performed. RESULTS: In the base case microsimulation, at 24 months, the modeled target lesion revascularization was 11.6% for Eluvia and 19.0% for Zilver PTX, and the mean total direct costs were $20,010 and $21,356, respectively (Eluvia average savings=$1,346). In probabilistic sensitivity analyses, Eluvia was cost-effective in 87.8% of all simulations at a willingness-to-pay threshold of $10,000 per target lesion revascularization prevented. Eluvia was more effective and less costly (dominant) than Zilver PTX in 73.6% of simulations. CONCLUSIONS: In this comparison of a paclitaxel-eluting to a paclitaxel-coated stent for endovascular femoropopliteal intervention, Eluvia was more effective and less costly (dominant) than Zilver PTX from a US Medicare perspective. These findings should be considered when formulating reimbursement policy and clinical practice guidelines.

Paclitaxel is a drug used in the treatment of peripheral artery disease (PAD) to help maintain primary vessel patency and reduce the need for revascularization procedures. This study evaluated the cost-effectiveness of the paclitaxel-eluting Eluvia stent (Boston Scientific, Marlborough, MA) versus the paclitaxel-coated Zilver PTX stent (Cook Medical, Bloomington, IN) in Medicare patients with PAD. Cost-effectiveness is defined as the degree to which a particular treatment option is effective relative to its costs. Therefore, this study compared both the effectiveness, in terms of target lesion revascularization rates, and the costs of Eluvia versus Zilver PTX over 24 months.A microsimulation model was developed from a United States Medicare perspective with a 24-month time horizon. Simulated patients entered the model and were assigned to receive either Eluvia or Zilver PTX. Monthly, patients were exposed to the risks of primary vessel patency loss, target lesion revascularization (TLR), amputation, and death. These risks were taken from a randomized controlled trial that compared Eluvia and Zilver PTX over 24 months. Patients also accrued costs over time. The costs used in the model were obtained from Medicare administrative and claims data analyses.In health economics, a treatment is considered to be the dominant treatment option if it is both more effective and less costly than the alternative treatment. In this case, Eluvia was found to be dominant over Zilver PTX because it was associated with lower TLR rates and lower costs. These findings should be considered when formulating reimbursement policy and clinical practice guidelines.