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

{"title":"Potential bias in efficacy estimates due to intercurrent treatment discontinuations.","authors":"Bjorn Redfors, Jacky Choi, Mario Gaudino, Harmony R Reynolds, Judy Zhong","doi":"10.1093/ehjqcco/qcag084","DOIUrl":"10.1093/ehjqcco/qcag084","url":null,"abstract":"<p><strong>Aims: </strong>Treatment discontinuation is a common intercurrent event in randomized clinical trials (RCTs) that can bias treatment effect estimates, yet it remains under recognized and inconsistently addressed. Antithrombotic trials provide a relevant case, as bleeding-related discontinuation is common and more often occur in patients at increased risk also for ischaemic events.</p><p><strong>Methods and results: </strong>We reviewed large antithrombotic RCTs published in The New England Journal of Medicine (2020-2025) to assess reporting and analytic handling of treatment discontinuation. We also conducted simulations to examine how discontinuation patterns influence efficacy estimates under three scenarios: discontinuation only in the treatment arm, in both arms with similar patterns, and in both arms but outcome-associated only in the treatment arm. Treatment policy (intention-to-treat) and while-on-treatment strategies were compared within the ICH E9(R1) framework. Among fourteen reviewed antithrombotic RCTs, about one-third of patients discontinued treatment in trials with more than 6 months follow-up, with higher imbalance in open-label studies. Over half of discontinuations were safety-related, yet timing and temporary interruptions were rarely reported. Most reported both ITT and per-protocol (PP) analyses, with PP assuming non-informative censoring and yielding larger efficacy estimates. In simulations, treatment policy and while-on-treatment strategies were biased when discontinuation was outcome-associated, while Simon-Makuch curves helped identify prognostic discontinuation differing by treatment arm.</p><p><strong>Conclusion: </strong>Discontinuation is common, prognostically meaningful, and often oversimplified in analysis, threatening the validity of RCT findings. Explicitly addressing discontinuation as an intercurrent event within the estimand framework, along with stratified outcome curves, can improve interpretation and support more robust trial conclusions.</p>","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":"1011-1022"},"PeriodicalIF":4.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13579332/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148102490","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":"Strengthening the Pre-Hospital Chain of Survival for Out-of-Hospital Cardiac Arrest.","authors":"Alexander Calderone, Eli Segal, Emilie Belley-Côté, Marc-André d'Entremont, Thao Huynh","doi":"10.1093/ehjqcco/qcag140","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcag140","url":null,"abstract":"","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":""},"PeriodicalIF":4.6,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148946444","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":"Pericoronary inflammation beyond stenosis: does sex modify its prognostic significance?","authors":"Reza Eshraghi, Ashkan Bahrami, Farhad Hasanvand","doi":"10.1093/ehjqcco/qcag143","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcag143","url":null,"abstract":"","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":""},"PeriodicalIF":4.6,"publicationDate":"2026-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148922530","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":"Risk-Score Guided Estimation of Absolute Benefit From Beta-blockers after Myocardial Infarction in Patients Without Heart Failure.","authors":"Harun Caglar, Therese Holmager, Anna Meta Dyrvig Kristensen, Arnhild Bakken, Frida Rykind-Eriksen, Peter Deeg, Kristoffer Andresen, Michael Maeng, Erik Øie, Dan Atar, John Munkhaugen, Eva Prescott","doi":"10.1093/ehjqcco/qcag142","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcag142","url":null,"abstract":"<p><strong>Aims: </strong>To assess whether a modified clinical risk-score can stratify baseline risk and estimate expected absolute benefit from beta-blocker therapy in post-MI (myocardial infarction) patients with LVEF (left ventricular ejection fraction) ≥40%.</p><p><strong>Methods: </strong>This substudy of the BETAMI-DANBLOCK trial included patients with a recent MI and LVEF ≥40% who were randomized to beta-blocker or no beta-blocker therapy. A modified Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS-2P) was constructed, and patients were categorized as low-, intermediate-, or high-risk. The primary outcome was a composite of all-cause mortality, new-MI, unplanned coronary revascularization, ischemic stroke, heart failure, or malignant ventricular arrhythmia. Treatment effects across TRS-2P strata were estimated using Cox proportional hazards and Fine-Gray subdistribution hazard models. Three-year absolute risk reduction (ARR) and number needed to treat (NNT) were calculated for each risk stratum.</p><p><strong>Results: </strong>Among 5558 patients, 38.4% were classified as low-risk, 52.8% as intermediate-risk, and 8.8% as high-risk. Event rates increased stepwise with higher modified TRS-2P, with no evidence of heterogeneity in the relative treatment effects across risk-strata (hazard ratios: 0.88, 0.81 and 0.88, respectively). However, the score translated the modest relative effects into clinically distinct absolute benefits: Three-year ARR was 1.4% (NNT=72 [95% CI: 41 to 361]) in low-risk, 2.1% (NNT=47 [95% CI: 27 to 239]) in intermediate-risk, and 3.6% (NNT=28 [95% CI: 16 to 140]) in high-risk patients.</p><p><strong>Conclusions: </strong>The modified TRS-2P stratified baseline risk and provided estimates of absolute beta-blocker benefit, supporting further evaluation of individualized, risk-guided treatment after MI in patients with LVEF ≥40%.</p>","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":""},"PeriodicalIF":4.6,"publicationDate":"2026-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148922510","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":"Reading Between the Waves: What Does AI-ECG Capture When Estimating NT-proBNP?","authors":"Dokyeong Lee, Ulrike Grittner, Julian Friebel","doi":"10.1093/ehjqcco/qcag141","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcag141","url":null,"abstract":"","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":""},"PeriodicalIF":4.6,"publicationDate":"2026-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148901866","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":"Economic Evaluations of Invasive Devices for Remote Cardiac Monitoring in Chronic Heart Failure: A Scoping Review.","authors":"Angelo Capodici, Francesca Noci, Michele Alessandro Coceani, Claudio Passino, Michele Emdin, Alberto Giannoni","doi":"10.1093/ehjqcco/qcag138","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcag138","url":null,"abstract":"<p><strong>Objectives: </strong>Heart failure presents a substantial global clinical and economic burden. While invasive hemodynamic and device-based remote monitoring effectively guide its management, their economic value across diverse healthcare systems remains incompletely characterized. This scoping review evaluates the cost-effectiveness of these distinct monitoring strategies.</p><p><strong>Design and methods: </strong>Following established scoping-review reporting guidelines, we searched PubMed and Scopus (March 2026) for original peer-reviewed economic evaluations (for example, cost-effectiveness or cost-utility analyses) of invasive cardiac monitoring or cardiac implantable electronic device remote monitoring in adult heart failure patients.</p><p><strong>Results: </strong>Nineteen studies across 11 countries were included, divided into two categories: standalone invasive sensors (predominantly CardioMEMS, ten studies) and cardiac implantable electronic device remote monitoring (nine studies), the latter spanning standard platforms and advanced alerts (HeartLogic, TriageHF Plus). The first category showed pulmonary pressure-guided monitoring is cost-effective in high-income settings (United Kingdom, continental Europe, United States), though device pricing exceeded cost-effectiveness thresholds in Argentina. The second category consistently showed cost-neutral or cost-saving outcomes compared with in-office follow-up, with the largest savings in resynchronization-defibrillator recipients. Advanced alert algorithms showed highly favorable economic profiles, although both lacked ideal comparators testing identical device platforms with the algorithm deactivated. These findings align with recent national health-technology guidance recommending both technologies.</p><p><strong>Conclusions: </strong>Both technologies are economically advantageous for heart failure management across multiple healthcare systems. Future research should prioritize standardized health-economic modeling, explicit separation of technology subcategories with distinct comparators, randomized algorithm-on versus algorithm-off designs, and dedicated evaluations in low- and middle-income countries to guide equitable global deployment.</p>","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":""},"PeriodicalIF":4.6,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148957720","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":"COVID-19 Vaccination and Risk of Post-COVID-19 Cardiovascular Disease: A Population-Based Cohort and Target Trial Emulation Study.","authors":"Binyam Tariku Seboka, Dianna J Magliano, Thomas H Marwick, Quan Huynh","doi":"10.1093/ehjqcco/qcag139","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcag139","url":null,"abstract":"<p><strong>Background: </strong>Whether COVID-19 vaccination is associated with lower long-term cardiovascular risk after SARS-CoV-2 infection and how much infection prevention mediates this association remain unclear.</p><p><strong>Objective: </strong>To evaluate associations of vaccination, including its timing relative to SARS-CoV-2 infection, with post-COVID-19 cardiovascular disease (CVD), and quantify the contribution of infection prevention.</p><p><strong>Methods: </strong>This statewide population-based cohort study used linked administrative health data for 2,391,456 adults in Victoria, Australia (2019-2025). Associations of pre- or post-infection vaccination with major adverse cardiovascular events (MACE; primary outcome), stroke, heart failure, acute myocardial infarction (AMI), acute coronary syndrome (ACS), atrial fibrillation (AF), and venous thromboembolism (VTE) were evaluated using time-varying Cox proportional hazards regression, causal mediation analysis, and target trial emulation.</p><p><strong>Results: </strong>Vaccination was associated with lower hazards of MACE and all secondary outcomes. Estimated absolute risk reductions for MACE were 0.21% with pre-infection vaccination and 0.24% with post-infection vaccination. Three or more vaccine doses were associated with progressively lower hazards across cardiovascular outcomes. Mediation analysis suggested that approximately 68% of the estimated association between vaccination and lower post-COVID cardiovascular risk was not explained by prevention of SARS-CoV-2 infection.</p><p><strong>Conclusion: </strong>Vaccination before or after SARS-CoV-2 infection was associated with lower hazards of post-COVID-19 cardiovascular outcomes, with stronger observed associations at higher dose numbers. Most of the estimated association was not explained by infection prevention alone. These findings support COVID-19 vaccination as an important component of strategies to reduce the burden of post-COVID-19 CVD while highlighting the need for further studies to clarify the mechanisms underlying these associations.</p>","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":""},"PeriodicalIF":4.6,"publicationDate":"2026-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148858059","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":"The effect of integrated lifestyle modification on quality of life and cost-effectiveness in atrial fibrillation ablation - results from the POP-AF RCT.","authors":"Jasper Vermeer, Gijs van Steenbergen, Fabienne Vervaat, Sabine Grimm, Dennis van Veghel, Lukas Dekker","doi":"10.1093/ehjqcco/qcag135","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcag135","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the impact of an integrated lifestyle intervention on quality of life and cost-effectiveness in patients undergoing catheter ablation for atrial fibrillation (AF), compared with usual care.</p><p><strong>Methods: </strong>The POP-AF trial randomized patients for their first AF ablation who had at least one modifiable lifestyle-related risk factor between lifestyle intervention and usual care. Quality of life was assessed throughout the trial using the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. Treatment burden was evaluated using the Treatment Burden Questionnaire (TBQ). Health state was assessed using the EuroQol 5-Dimension (EQ-5D). Quality-adjusted life years (QALYs) were calculated from health states over time and used to calculate incremental cost-effectiveness ratio (ICER).</p><p><strong>Results: </strong>A total of 145 patients participated (74% male; median age 62 years). At 3 months post-ablation, both groups demonstrated significant improvement in AFEQT (p<0.001), with higher scores in the intervention group (88.9 vs 80.6; p=0.026). At 12 months, this difference diminished due to continued improvement in the control group. Throughout the study, TBQ, EQ-5D and QALYs did not differ significantly between groups. The lifestyle intervention was associated with lower costs at the expense of a small reduction in QALYs, resulting in an ICER of €16,589 saved per QALY lost.</p><p><strong>Conclusions: </strong>Both lifestyle intervention and usual care were associated with marked improvements in AF-specific quality of life following ablation. The lifestyle intervention reduced healthcare costs with minimal impact on health outcomes, supporting structured lifestyle modification as a cost-effective addition to pre-ablation AF care. Trial registration number: NCT05148338.</p>","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":""},"PeriodicalIF":4.6,"publicationDate":"2026-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148842478","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":"Recording of Hypertensive Disorders of Pregnancy and Subsequent Cardiovascular Risk Among New Zealand Women.","authors":"Nikki J Earle, Yeunhyang Choi, Jane Ullmer, Rachel Roskvist, Owen Mugridge, Vanessa Selak, Allan Moffitt, Larry Chamley, Lynn Sadler, Sue Wells, Katrina K Poppe","doi":"10.1093/ehjqcco/qcag136","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcag136","url":null,"abstract":"<p><strong>Aims: </strong>Hypertensive disorders of pregnancy (HDP) are established markers of cardiovascular disease (CVD) risk yet are not routinely incorporated into primary prevention. We aimed to (1) assess how HDP is recorded across primary care and national hospitalisation data in New Zealand, and (2) estimate the association between a history of HDP and incident CVD over 5 years.</p><p><strong>Methods: </strong>This cohort study used linked health records from the ProCare Primary Health Organisation and national datasets. HDP was identified from Read-coded and free-text general practice records and ICD-10-AM hospital data. Two analyses were undertaken: (1) comparison of HDP recording between primary care and hospital discharge data among women aged 18-64 years; and (2) estimation of 5-year incident CVD risk among women aged 30-64 years without prior CVD. Cox proportional hazards models estimated adjusted hazard ratios (aHRs), incorporating the linear predictor from a national primary prevention CVD risk equation.</p><p><strong>Results: </strong>Among 172,328 women aged 18-64 years, a history of HDP was recorded in 4.7% (population-level prevalence), with 91% of this recorded in hospital discharge data only. Over five years, 2,391 women experienced incident CVD events. A recorded history of HDP was associated with a 72% higher CVD risk (aHR=1.72, 95%CI 1.49-1.98). Women with HDP experienced cardiovascular events at younger ages than those without (median 50.2 vs 57.3 years).</p><p><strong>Conclusion: </strong>HDP is inadequately recorded in primary care in New Zealand. When documented, it identifies women at significantly higher and earlier CVD risk. Improving HDP documentation in primary care may enable earlier and more equitable CVD prevention.</p>","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":""},"PeriodicalIF":4.6,"publicationDate":"2026-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148835938","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":"Noninferiority as a Moving Target in LAAC Trials.","authors":"Alberto Cereda, Marco Stracqualursi, Antonio Gabriele Franchina, Matteo Carlà, Valentina De Regibus, Stefano Lucreziotti","doi":"10.1093/ehjqcco/qcag137","DOIUrl":"https://doi.org/10.1093/ehjqcco/qcag137","url":null,"abstract":"","PeriodicalId":520616,"journal":{"name":"European heart journal. Quality of care & clinical outcomes","volume":" ","pages":""},"PeriodicalIF":4.6,"publicationDate":"2026-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148820908","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}