Journal of comparative effectiveness research最新文献

{"title":"Comparing the efficacy of cipaglucosidase alfa plus miglustat with alglucosidase alfa for late-onset Pompe disease: an expanded network meta-analysis utilizing patient-level and aggregate data.","authors":"Shuai Fu, Noemi Hummel, Simon Shohet, Neil Johnson, Alasdair MacCulloch, Jeff Castelli, William Kerr, Brian Fox, Vera Gielen","doi":"10.57264/cer-2025-0174","DOIUrl":"10.57264/cer-2025-0174","url":null,"abstract":"<p><p><b>Aim:</b> Treatment options for late-onset Pompe disease (LOPD) include enzyme replacement therapy (ERT) with alglucosidase alfa (alg), cipaglucosidase alfa plus miglustat (cipa + mig) and avalglucosidase alfa. However, only one randomized controlled trial (RCT) directly compared cipa + mig and alg and had relatively few ERT-naive patients. A multilevel network meta-regression (ML-NMR) integrated individual patient data and aggregate data into indirect treatment comparisons, with relative effects adjusted to any target population, to compare the efficacy of cipa + mig and alg. <b>Materials & methods:</b> A Bayesian ML-NMR was conducted to compare the efficacy of cipa + mig and alg for 6-minute walk distance (6MWD, meters) and percent predicted forced vital capacity (ppFVC) across any target population, using patient-level and aggregate data from RCTs (PROPEL, COMET, LOTS) and phase I/II and open-label extension (OLE) trials (PROPEL OLE, LOTS OLE, COMET OLE, ATB200-02, NEO-1/NEO-EXT), adjusting for baseline covariates. Relative effect estimates were obtained for 6MWD and ppFVC change from baseline to week 52. Two networks were analyzed: network A (RCTs only) and network B (RCTs and single-arm OLE and phase I/II studies matched to comparator arms). To assess the impact of prior ERT exposure, simulations were conducted by only varying ERT duration among included covariates. <b>Results:</b> For cipa + mig compared with alg, both networks were associated with relative increases in 6MWD (mean difference [95% credible interval], Bayesian probability for network A: 13.48 m [6.79, 19.85], >99.9%; network B: 12.59 m [7.89, 17.45], >99.9%) and ppFVC (network A: 1.63% [0.71, 2.60], >99.9%; network B: 3.17% [2.53, 3.81], >99.9%). Network B suggested cipa + mig was favorable (>99.9%) in all groups for both end points and appeared more favorable with increasing ERT duration. <b>Conclusion:</b> Cipa + mig was associated with an improvement in 6MWD and ppFVC relative to alg independent of prior ERT exposure, which appeared more favorable when all available evidence was used. These data could inform decision-making in treating ERT-naive and ERT-experienced patients with LOPD.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e250174"},"PeriodicalIF":2.8,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12976639/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147306753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world clinical outcomes of patients with localized prostate cancer treated with radical prostatectomy in SEER-Medicare.","authors":"Lawrence Karsh, Shawn Du, Jinghua He, Neal Shore","doi":"10.57264/cer-2025-0004","DOIUrl":"10.57264/cer-2025-0004","url":null,"abstract":"<p><p><b>Aim:</b> This study examined the clinical outcomes of patients in the US with low/intermediate-risk localized prostate cancer (LIR-LPC) and high-risk localized prostate cancer (HR-LPC) who received radical prostatectomy (RP) as initial treatment. <b>Materials & methods:</b> This is a retrospective analysis of the SEER-Medicare database. Patients newly diagnosed with LPC at age of ≥65 years during 2012-2019 who underwent RP as initial definitive treatment and had continuous Medicare Fee-For-Service for ≥12 months prior to RP were included. Eligible patients were stratified into LIR-LPC and HR-LPC cohorts. Overall survival, metastatic free survival and time to advanced prostate cancer treatment (TTAT) were described and compared using the Kaplan-Meier method and Cox proportional-hazards model. <b>Results:</b> The LIR-LPC cohort (n = 4120) and the HR-LPC cohort (n = 5359) had comparable socio-demographic characteristics, with a mean age of approximately 70 years. Survival analysis showed that HR-LPC was associated with significantly shorter overall survival, metastatic free survival and TTAT than LIR-LPC (log rank p < 0.001). After adjusting for comprehensive socio-demographic and baseline clinical characteristics, patients with HR-LPC had an approximately 70% increased risk for all-cause death (hazard ratio [HR]: 1.72; confidence interval [CI]:1.39-2.12), 2.5-fold increased risk for metastasis or death (HR: 2.57; CI: 2.14-3.09), and ninefold increased risk for initiating advanced treatments (HR: 9.06; CI: 6.22-13.18) compared with patients with LIR-LPC. <b>Conclusion:</b> In patients with LPC who received RP as initial definitive treatment, high risk is strongly associated with suboptimal clinical outcomes. Novel therapeutic approaches are needed to enhance the management and improve the outcomes for this patient population.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e250004"},"PeriodicalIF":2.8,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12976643/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146201793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost of hepatic decompensation and liver transplantation events in primary biliary cholangitis: a retrospective observational study.","authors":"Robert G Gish, Joanna P MacEwan, Yutong Liu, Dannielle Lebovitch, Radhika Nair, Leona Bessonova, Jing Li, Zobair M Younossi","doi":"10.57264/cer-2025-0110","DOIUrl":"10.57264/cer-2025-0110","url":null,"abstract":"<p><p><b>Aim:</b> Complications of primary biliary cholangitis (PBC) are proposed to confer substantial economic burden to patients and healthcare systems. This retrospective observational study evaluated the cost of PBC-related hepatic decompensation and liver transplantation using a large administrative claims database. <b>Materials & methods:</b> Patients aged ≥18 years at the time of first claim with a diagnosis of PBC were identified using Optum's de-identified Clinformatics^® Data Mart Database. Two cohorts were established based on the type of event (hepatic decompensation or liver transplantation) that patients experienced on or after the date of their first claim with the PBC diagnosis. Costs for the hepatic decompensation hospitalization and 30-day post-discharge period were examined at the event level. Hospitalizations occurring within the 30-day post-discharge period after a hepatic decompensation event were considered readmissions, and costs from the initial event were combined with those from the ensuing readmissions. In the liver transplantation cohort, costs for the pretransplant evaluation, hospitalization for transplantation, and post-transplant care and complications were assessed per patient. <b>Results:</b> A total of 2118 and 163 patients met study inclusion criteria in the hepatic decompensation and liver transplantation cohorts, respectively. The overall mean cost per hepatic decompensation event (n = 3581) was $63,612.09. The mean cost per event with readmission within 30 days (n = 991, 27.7%) was $116,424.25; for events without readmission, the mean cost was $43,404.81. The mean total cost of liver transplantation per patient was $328,336.60. The mean cost per patient was highest for the hospitalization for transplantation ($226,908.70). <b>Conclusion:</b> This comprehensive cost analysis demonstrates the high-cost burden of PBC disease progression. Appropriate patient management may help to mitigate the economic burden of PBC-related hepatic decompensation and liver transplantation.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e250110"},"PeriodicalIF":2.8,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12976642/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146201782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 24.","authors":"Paul Arora, Sreeram V Ramagopalan","doi":"10.57264/cer-2026-0019","DOIUrl":"10.57264/cer-2026-0019","url":null,"abstract":"<p><p>In this update, we review a new bias appraisal tool, explore lessons from a trial emulation study, and describe the development of real-world evidence guidance in the Philippines.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e260019"},"PeriodicalIF":2.8,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12976641/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146142620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An economic analysis of Chemo Mouthpiece^® versus supportive care for the reduction of oral mucositis incidence in patients receiving chemotherapy.","authors":"Richard Zuniga, Aidan Dineen, Rosemarie Velasquez, Donghyun D Lee, Anthony Zara, Bonni Tattoli, Megan Bourque, Frank Jacobucci","doi":"10.57264/cer-2025-0164","DOIUrl":"10.57264/cer-2025-0164","url":null,"abstract":"<p><p><b>Aim:</b> Oral mucositis (OM) is a common, burdensome complication of chemotherapy (CT), associated with pain, weight loss and increased infection risk. OM can result in CT dose reductions or delay subsequent cycles, compromising treatment efficacy. Current guidelines recommend oral cryotherapy with basic multiagent oral care for prevention of CT-induced OM. Chemo Mouthpiece^® (CMP) is a cryotherapy medical device with FDA 510(k) marketing clearance. A randomized controlled trial demonstrated that CMP effectively reduced the incidence and severity of OM caused by long or short half-life CT regimens in adults, compared with basic supportive oral care (BSOC) alone. The objective of this study was to estimate OM-related clinical and cost impacts associated with reductions in CT-induced OM from use of CMP. <b>Materials & methods:</b> A model was developed to simulate 1000 adult patients undergoing stomatotoxic CT from a US healthcare payer perspective under two scenarios: optimal practice: 100% using CMP plus best supportive oral care (BSOC); and current practice: 100% using BSOC. Clinical outcomes and costs were modeled to estimate the incremental difference between the two scenarios. Two different time horizons were tested in the model: conservative base case (single CT cycle) and real-world base case (six CT cycles). Additional sensitivity analyses were also conducted. <b>Results:</b> The cost of CMP in optimal practice was offset by cost savings from other sources, for a net total cost savings. In the conservative base case, optimal practice with CMP use for a single CT cycle was associated with over one million dollars in cost savings compared with current practice ($20,094,565 vs $21,260,470), largely attributed to reduced hospitalization length of stay. Use of CMP in optimal practice was associated with $1166 total cost savings per patient. Of note, substantially greater cost savings were estimated in the real-world base case with a time horizon of six CT cycles (additional savings of $2846 per patient each subsequent CT cycle). Three of the four sensitivity analyses were also found to result in net cost savings. <b>Conclusion:</b> Adoption of CMP was projected to be associated with reduced OM-associated clinical events and healthcare resource use. For 1000 adults using CMP for one CT cycle, cost savings accumulated to over one million dollars, amounting to $1166 per patient. Results of the real-world base case indicated that the value of CMP is likely underestimated, with cost savings over 15 million dollars, amounting to $15,395 per patient.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e250164"},"PeriodicalIF":2.8,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12976640/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147306728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Availability of secondary healthcare data for conducting pharmacoepidemiology studies in Mexico: a systematic review.","authors":"Carla Ceballos Ruiz, Angelica Navarro","doi":"10.57264/cer-2025-0160","DOIUrl":"10.57264/cer-2025-0160","url":null,"abstract":"<p><p><b>Aim:</b> To investigate the data sources available in Mexico for real-world research. <b>Materials & methods:</b> A systematic literature review on PubMed, EMBASE and VHL using a combination of controlled vocabulary and keywords for the concepts of electronic health records, epidemiologic studies and Mexico was performed. <b>Results:</b> A total of 331 articles and 89 conference abstracts reporting real-world studies were identified. These included 320 data sources: 142 unique named databases, 172 unnamed databases from specified providers, and 26 electronic medical record datasets. The main data sources came from healthcare institutions (35%), followed by government agencies (26%). The most frequent database design corresponded to surveys (34%) and disease registries (20%). Most databases included cohort studies (43%), population-based (25%) and cross-sectional studies (18%). Specific diagnostic tests (28%), access (22%) and pharmacological treatment (21%) were the most common issues analyzed in databases at patient-level data. Neoplasms, cardiac disorders and infections/infestations were the most common therapeutic areas analyzed in databases. <b>Conclusion:</b> In Mexico, the use of databases has increased, driven by governmental and nongovernmental organisations and companies. However, further efforts are still needed to improve the quality and knowledge of real-world evidence.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e250160"},"PeriodicalIF":2.8,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12976644/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147355288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The importance and challenge of comparing stroke care, utilization and outcomes in Medicare Advantage and Fee-for-Service Medicare: a narrative review and vision for the future.","authors":"Emily J Bian, Priyanka Menon, Kathleen A McManus, Timothy J Layton, Bradford B Worrall, Jonathan R Crowe","doi":"10.57264/cer-2025-0157","DOIUrl":"10.57264/cer-2025-0157","url":null,"abstract":"<p><p>Stroke prevalence is highest in adults ≥65 years, the majority of whom are Medicare beneficiaries. Fee-for-Service Medicare (FFS) incentivizes utilization by paying for each service. Medicare Advantage (MA) uses capitated payments to reduce overutilization. It is not clear if stroke patients with FFS or MA receive different stroke preventive care and whether those differences are associated with differences in post-acute care utilization, cost and clinical outcomes. We performed an empirical narrative review of published peer-reviewed studies in the PubMed, EMBASE and Web of Science databases comparing stroke preventive care between FFS and MA using the American Heart Association's Life's Essential 8 and American Heart Association/American Stroke Association national guidelines. We added atrial fibrillation (AF), post-acute care utilization and outcomes, including mortality. 7/1356 studies met inclusion criteria. Studies were heterogenous in their design and settings. There was limited availability of clinical data. Within those limitations, published studies suggest that MA appears to allow for guideline-directed stroke preventive care for hyperlipidemia, smoking cessation and AF in specific study populations. Post-acute care utilization was generally lower in MA. Functional outcomes improvements were similar but occurred in fewer days in MA, though the absence of acute stroke treatment data is notable. Mortality data were mixed. Given the importance of stroke in Medicare and the growth in MA enrollment, comparing the effectiveness of MA and FFS warrants further study among appropriately matched MA and FFS beneficiaries with stroke.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e250157"},"PeriodicalIF":2.8,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12884340/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145952073","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acthar Gel versus standard of care for adults with proteinuria in nephrotic syndrome due to focal segmental glomerulosclerosis: cost-per-response analysis from the US healthcare perspective.","authors":"Jas Bindra, Ishveen Chopra, Kyle Hayes, John Niewoehner, Mary Panaccio, George J Wan","doi":"10.57264/cer-2025-0155","DOIUrl":"10.57264/cer-2025-0155","url":null,"abstract":"<p><p><b>Aim:</b> Proteinuria poses a significant challenge in focal segmental glomerulosclerosis (FSGS), particularly when resistant to standard treatments. Acthar^® Gel, a Food and Drug Administration (FDA)-approved treatment, may be a potential option for proteinuria in nephrotic syndrome (NS) due to FSGS, particularly given the limited alternative therapies. This study assessed the cost-per-response of Acthar Gel versus standard of care (SoC) for the treatment of refractory proteinuria in NS due to FSGS among adults from a US healthcare payer perspective over a 1- to 3-year horizon. <b>Materials & methods:</b> A probabilistic, cohort-based state-transition model tracked adults with nephrotic-range proteinuria due to FSGS through clinically relevant health states in 6-month cycles. All patients entered in relapse and received either Acthar Gel or SoC. At each cycle, individuals could transition to response or remain uncontrolled, progress to renal failure, or continue in relapse; death was permitted from any state. Responders were allowed to either sustain response or experience relapse in subsequent cycles. Model inputs for clinical event rates, healthcare utilization and medical costs were sourced from the published literature, and drug costs were valued using wholesale acquisition cost. Cost-per-response was defined as total healthcare costs (drug and nondrug medical costs) per patient divided by the response rate. <b>Results:</b> Acthar Gel showed a lower cost-per-response ($469,735) versus cyclophosphamide ($2,140,400) and rituximab ($1,272,477) over 1 year. This advantage for Acthar Gel was sustained for 2 and 3 years. Acthar Gel was potentially a dominant treatment option at 2 and 3 years, with a lower overall cost of care and higher response rates than SoC. <b>Conclusion:</b> From a US healthcare payer perspective, Acthar Gel appears to be a cost-effective, value-based treatment option for adults with proteinuria in NS due to FSGS over 1 to 3 years. These findings may aid providers and payers in making informed treatment decisions when conventional therapies are ineffective for these patients.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e250155"},"PeriodicalIF":2.8,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12884336/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146064151","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sieving for gold: external comparator studies to prioritize drugs for late-stage clinical trial.","authors":"Samuel Vennin, Will Sopwith, Emiliano Calvo, Chiara Cantoni, Paula Cárdenes Del Valle, Benedikt Maissenhaelter, Gerd Rippin, Bettina Ryll, Bruno Osterwalder","doi":"10.57264/cer-2024-0201","DOIUrl":"10.57264/cer-2024-0201","url":null,"abstract":"<p><p>External comparator (EC) studies can improve identification of compounds with the most promising performance in pre-pivotal single-arm trials (SAT). As SAT output lacks comparative insights, EC studies allow efficient contextualization of compound performance in early phases of drug development. Improving insights from pre-pivotal SATs allows more informed prioritization of compounds and investment choices and enables faster and more substantiated development of the most promising molecules to the benefit of patients. The extensive digitization of healthcare information routinely generated during patient treatment journeys makes EC studies using real-world data an attractive alternative to other approaches (such as systematic literature review and repurposed trial data). Using oncology as an illustration, this paper presents how real-world data EC studies can address some of the fundamental challenges the pharmaceutical sector faces in developing novel therapies, and especially those pertaining to emerging biopharma companies.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e240201"},"PeriodicalIF":2.8,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12884337/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146113339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Difference in hospital readmission among patients with atrial fibrillation undergoing ablation using nonintegrated pulsed field catheter with CARTO™ 3 versus EnSite™ electroanatomical mapping system.","authors":"Alexandru I Costea, Rahul Khanna, Maximiliano Iglesias, Yiran Rong","doi":"10.57264/cer-2025-0151","DOIUrl":"10.57264/cer-2025-0151","url":null,"abstract":"<p><p><b>Aim:</b> Pulsed field ablation (PFA) is a minimally thermal alternative to traditional thermal catheter ablation for atrial fibrillation (AF), with comparable efficacy and minimal risk of collateral tissue injury. Three-dimensional (3D) electroanatomical mapping systems have been adopted with nonintegrated PFA catheters to improve precision and procedural efficiency. This study compared arrhythmia-related hospital readmissions and procedure-related complications among patients with AF treated with PFA, using either the CARTO™ 3 or EnSite™ electroanatomical mapping system. <b>Materials & methods:</b> Patients who underwent PFA for AF using nonintegrated pulsed field catheters with either CARTO 3 or EnSite were identified from the 2023-2024 Premier Healthcare Database (PHD). The primary outcome was 30-day inpatient readmission and emergency room (ER) visit for AF/atrial flutter (AFL)/atrial tachycardia following the index PFA procedure. Secondary outcomes included 30-day cardiovascular-related readmissions and procedure-related complications. Cohorts were balanced using inverse probability of treatment weighting. Descriptive analyses and a weighted Generalized Estimating Equation (GEE) model were used to assess differences in outcomes between groups. <b>Results:</b> A total of 2894 patients were treated using CARTO 3 and 2015 using EnSite. After weighting, patient and hospital characteristics were well balanced across cohorts. The CARTO 3 group was significantly less likely to experience AF/AFL/atrial tachycardia-related readmissions (0.3% vs 0.9%, chi-square p = 0.023; odds ratio [OR], 0.39; 95% CI, 0.17-0.90, GEE p = 0.028) and a composite outcome of AF/AFL/atrial tachycardia-related inpatient readmission or ER visits (0.5% vs 1.1%, chi-square p = 0.020; OR: 0.44, 95% CI: 0.21-0.89, GEE p = 0.023) within 30 days of PFA procedure than the EnSite group. No differences were observed in cardiovascular-related readmission or complications. <b>Conclusion:</b> In this retrospective, real-world study, patients with AF who underwent PFA using CARTO 3 had lower 30-day AF/AFL/atrial tachycardia-related readmissions rates than those treated with EnSite suggesting that choice of mapping system may influence early AF outcomes and could translate into reduced downstream hospitalizations and resource use.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e250151"},"PeriodicalIF":2.8,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12884346/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145933374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}