European heart journal. Quality of care & clinical outcomes最新文献

{"title":"Validating national registry data for randomized trials: comparison of registry-derived cardiovascular events with and without adjudication in the BETAMI-DANBLOCK trial.","authors":"Therese Lucia Friis Holmager, Anna Meta Dyrvig Kristensen, Morten Wang Fagerland, Dan Atar, Michael Hecht Olsen, Arnhild Bakken, John Munkhaugen, Eva Prescott","doi":"10.1093/ehjqcco/qcag055","DOIUrl":"10.1093/ehjqcco/qcag055","url":null,"abstract":"<p><strong>Aims: </strong>Registry-based randomized clinical trials are increasingly applied in clinical research, providing advantages in feasibility and data capture. However, registry-based data may introduce bias through misclassification or missing information.</p><p><strong>Methods and results: </strong>In the BETAMI-DANBLOCK trial, 5574 patients with myocardial infarction (MI) and no heart failure were randomized to beta-blocker or no beta-blocker therapy. The primary endpoint events (all-cause mortality, MI, ischemic stroke, heart failure, unplanned coronary revascularization, and malignant ventricular arrhythmias) were identified from the Danish/Norwegian national patient registries, self-reported questionnaires, and medical records. All registry-identified events, except all-cause mortality, underwent blinded adjudication. We compared non-adjudicated and adjudicated events by calculating incidence rates and hazard ratios (HRs) for beta-blocker therapy vs. controls. National registries captured 99.7% of primary endpoint events registered by self-report and medical records. Of the primary endpoint events identified through the registries, 75% were confirmed by adjudication (incidence rate 6.23 vs. 4.43/100 person-years). The confirmation rate was lower during the first 6 months and varied by event type (from 92% for ischaemic stroke to 45% for unplanned coronary revascularizations and heart failure). Estimated treatment effects were consistent for the primary endpoint with non-adjudicated and adjudicated events (HR 0.88, 95% confidence interval (CI): 0.78-0.98 and HR 0.85, 95% CI: 0.75-0.98, respectively), with no apparent differences across event types except for heart failure and revascularization.</p><p><strong>Conclusion: </strong>Registry data provided effect estimates of beta-blockers comparable to adjudicated data. However, adjudication substantially reduced the number of cardiovascular endpoint events and event-specific misclassification appeared, particularly during the first months after the index event.</p><p><strong>Trial registration number: </strong>BETAMI-DANBLOCK ClinicalTrials.gov numbers, NCT03646357 and NCT03778554.</p>","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":"903-911"},"PeriodicalIF":4.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147619361","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reshaping the concept of efficacy estimates in clinical trials: does antithrombotic therapy come to an end?","authors":"Antonio Curcio, Pierangelo Calvelli, Laura Pagnotta, Letizia Rosa Romano","doi":"10.1093/ehjqcco/qcag100","DOIUrl":"10.1093/ehjqcco/qcag100","url":null,"abstract":"","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":"1023-1025"},"PeriodicalIF":4.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148177465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Heart failure guideline-directed medical therapy in young adults with dystrophin-related cardiomyopathy: the HOPE-MD registry.","authors":"Luca Monzo, Emanuele Bobbio, Giulia Montrasio, Valentina A Rossi, Daniela Leone, Kevin Duarte, Carlo Pirazzi, Priscilla Lamendola, Marta Boi, Entela Bollano, Lance V Sese, Christian L Polte, Massimiliano Camilli, Frank Ruschitzka, Nicolas Girerd, Kostantinos Savvatis, Karim Wahbi","doi":"10.1093/ehjqcco/qcag088","DOIUrl":"10.1093/ehjqcco/qcag088","url":null,"abstract":"<p><strong>Aims: </strong>Duchenne (DMD) and Becker (BMD) muscular dystrophies often progress to dilated cardiomyopathy and heart failure with reduced ejection fraction (HFrEF), a major cause of death in affected patients. Although guideline-directed medical therapy (GDMT) improves HFrEF outcomes, its real-world use in dystrophinopathies is poorly defined. We assessed GDMT utilization and optimization in the study population.</p><p><strong>Methods and results: </strong>HOPE-MD (Heart failure treatment OPtimization in patiEnts with Muscular Dystrophy) is a European, multicentre, registry including adults with genetically confirmed DMD or BMD and left ventricular ejection fraction (LVEF) ≤ 40%. GDMT was defined as concurrent use of a renin-angiotensin system inhibitor (RASi), beta-blocker, mineralocorticoid receptor antagonist (MRA), and sodium-glucose cotransporter-2 inhibitor (SGLT2i). Doses were categorized as target (≥100%), intermediate (50-99%), or low (<50%). Among 274 patients (age, 28 years; LVEF, 35%; DMD, 80%), 44 (16%) received GDMT at baseline, with only one quarter at ≥50% of the target dose. Underutilization was greatest for MRAs (n = 140, 51%) and SGLT2i (n = 60, 22%), whereas RASi (n = 246, 90%) and beta-blockers (n = 235, 86%) were frequently prescribed. After 24 months (n = 141), 40% received GDMT, and 22% received ≥50% of the target dose, primarily through MRA and SGLT2i initiation/uptitration. Contraindications accounted for only a small proportion of undertreatment. At a median follow-up of 2.2 (1.7-2.6) years, optimized GDMT was not associated with a statistically significant difference in the rates of death or HF hospitalization compared with low-dose or no GDMT (adjusted HR 0.70, 95% CI 0.28-1.74).</p><p><strong>Conclusion: </strong>In this European, multicentre registry, GDMT use and dose escalation were suboptimal in young patients with DMD/BMD and HFrEF.</p>","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":"1026-1035"},"PeriodicalIF":4.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147990389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inequalities in access to cardiac implantable electronic devices across EuroAsia.","authors":"Camilla Normand","doi":"10.1093/ehjqcco/qcag112","DOIUrl":"10.1093/ehjqcco/qcag112","url":null,"abstract":"","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":"1081-1083"},"PeriodicalIF":4.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148521808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Heart failure outcomes in a virtually run hospital-at-home setting.","authors":"Harsh Patolia, Alexandra Manaila-Nabi, Faysal Massad, Yifan Wang, Xiaofeng Wang, Jessica Hohman, Adurawunmi Okiji, Nancy M Albert, Samir Kapadia, Raed Dweik, Lars Svensson, Amanda R Vest, Jerry Estep, Richard Rothman, Trejeeve Martyn","doi":"10.1093/ehjqcco/qcag049","DOIUrl":"10.1093/ehjqcco/qcag049","url":null,"abstract":"","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":"1126-1128"},"PeriodicalIF":4.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147577547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient-physician sex concordance in cardiovascular care: context matters.","authors":"Ilias Kyriopoulos, Elias Mossialos","doi":"10.1093/ehjqcco/qcag077","DOIUrl":"10.1093/ehjqcco/qcag077","url":null,"abstract":"","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":"1108-1110"},"PeriodicalIF":4.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147825505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Affordability of innovation: cost-effectiveness and budget impact analysis of acoramidis in transthyretin amyloid cardiomyopathy in the German healthcare system.","authors":"Bent Estler, Hanna Fröhlich, Tobias Täger, Lutz Frankenstein","doi":"10.1093/ehjqcco/qcag093","DOIUrl":"10.1093/ehjqcco/qcag093","url":null,"abstract":"<p><strong>Aims: </strong>Transthyretin amyloid cardiomyopathy (ATTR-CM) causes heart failure with substantial morbidity, mortality, and healthcare utilization. ATTRibute-CM [Efficacy and Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy (Phase 3 trial)] showed that acoramidis improves clinical outcomes, but its cost-effectiveness and budget impact in the German statutory health insurance (SHI) system remain uncertain.</p><p><strong>Methods and results: </strong>We developed a cohort Markov model (lifetime horizon) discounting costs and outcomes at 3% annually. Overall survival was modelled with recalibrated Weibull functions fitted to randomized-phase ATTRibute-CM data and anchored to match Month 30 survival. Health-related quality of life used Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) trajectories mapped to EQ-5D utilities, with a plateau after 30 months in the base case. Direct medical costs (2025€) included drug, background management, and hospitalization costs. Uncertainty was assessed with sensitivity analyses, scenario analyses, and a budget impact analysis. Discounted mean lifetime costs were €13 881.50 (placebo) and €828 127.07 (acoramidis), for an incremental €814 245.57. Quality-adjusted life-years (QALYs) increased from 2.743 to 4.029 (incremental 1.286) and life-years from 4.023 to 6.045 (incremental 2.022), yielding an incremental cost-effectiveness ratio (ICER) of €633 081 per QALY. Survival scenario analyses produced lifetime ICERs from €458 953/QALY in an optimistic scenario to €2 139 712/QALY in a pessimistic waning-benefit scenario. At a willingness-to-pay (WTP) of €100 000/QALY, the probability of cost-effectiveness was very low and the results were driven primarily by acoramidis acquisition cost. In the budget impact analysis, Year 1 SHI expenditure was €80 813 995, €134 689 992, and €269 379 983 for 30, 50, and 100% uptake, respectively.</p><p><strong>Conclusion: </strong>Despite benefits, acoramidis is unlikely to be cost-effective at current prices in Germany and could increase SHI spending. Price reductions could better align value with affordability.</p>","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":"1053-1064"},"PeriodicalIF":4.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148145976","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation of sodium-glucose co-transporter 2 inhibitors use in patients with heart failure across the ejection fraction: data from the Swedish heart failure registry.","authors":"Giulia Ferrannini, Francesca Musella, Lina Benson, Valeria Valente, Felix Lindberg, Marco Boccalatte, Carin Corovic Cabrera, Ulf Dahlström, Lars H Lund, Davide Stolfo, Gianluigi Savarese","doi":"10.1093/ehjqcco/qcag063","DOIUrl":"10.1093/ehjqcco/qcag063","url":null,"abstract":"<p><strong>Aims: </strong>The aim of this study was to assess the implementation of sodium-glucose co-transporter-2 inhibitors (SGLT2i) use in a real-world heart failure (HF) cohort.</p><p><strong>Methods and results: </strong>Patients from the Swedish HF Registry enrolled 1 September 2022 to 16 December 2024 were included. Characteristics independently associated with SGLT2i use were investigated by multivariable logistic regression models, in the overall cohort and stratified by ejection fraction (EF).Of 24 578 patients (median age [Q1-Q3]:75 [65-81] years, 33% female), 43% had HF with reduced EF(HFrEF), 31% had HF with mildly reduced EF(HFmrEF), and 26% had HF with preserved EF(HFpEF). During the study period, SGLT2i use increased from 78% to 89% in HFrEF, from 54% to 80% in HFmrEF, and from 41% to 80% in HFpEF.Independent predictors of SGLT2i use included male sex, HF hospitalization during the past year, impaired kidney function, obesity, higher socioeconomic profile, and beta-blocker use. Follow-up in specialist care was associated with higher use in HFrEF and HFmrEF. Type 2 diabetes (T2DM) was independently associated with use across EF, with a stronger association in HFpEF. Renin-angiotensin-aldosterone system inhibitors were associated with SGLT2i use across the EF spectrum, with stronger associations in HFrEF and HFmrEF, while mineralocorticoid receptor antagonists showed similar associations across EF categories, stronger in HFrEF and HFmrEF.</p><p><strong>Conclusion: </strong>SGLT2i were rapidly implemented in clinical practice, with their use reaching ∼90% in HFrEF and approaching a plateau at ∼80% in HFmrEF and HFpEF in December 2024. There is still room for treatment optimization, particularly among women, patients with HFpEF without T2DM, those followed in primary care, and with lower socioeconomic status.</p>","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":"947-961"},"PeriodicalIF":4.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13579327/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147725373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Current prevalence and remaining challenges of sodium-glucose cotransporter 2 inhibitors in patients with heart failure.","authors":"Akito Nakagawa","doi":"10.1093/ehjqcco/qcag070","DOIUrl":"10.1093/ehjqcco/qcag070","url":null,"abstract":"","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":"962-964"},"PeriodicalIF":4.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147719351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Beyond body mass index: consistent benefits of sodium-glucose cotransporter 2 inhibitors and the limits of a convenient metric.","authors":"Martina Chiriacò, Vincenzo Castiglione, Michele Emdin","doi":"10.1093/ehjqcco/qcag090","DOIUrl":"10.1093/ehjqcco/qcag090","url":null,"abstract":"","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":"924-926"},"PeriodicalIF":4.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148008514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}