Sebastian Heyne, Christopher Hohmann, Sascha Macherey-Meyer, Max M Meertens, Elmar Kuhn, Ursula Marschall, Hendrik Wienemann, Victor Mauri, Matti Adam, Stephan Baldus, Samuel Lee
{"title":"Antithrombotic strategy following valve-in-valve transcatheter aortic valve replacement. A German Statutory Health Claims data analysis.","authors":"Sebastian Heyne, Christopher Hohmann, Sascha Macherey-Meyer, Max M Meertens, Elmar Kuhn, Ursula Marschall, Hendrik Wienemann, Victor Mauri, Matti Adam, Stephan Baldus, Samuel Lee","doi":"10.1007/s00392-025-02635-2","DOIUrl":"https://doi.org/10.1007/s00392-025-02635-2","url":null,"abstract":"<p><strong>Aims: </strong>Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) procedures are increasingly used. Specific recommendations on antithrombotic strategies following ViV-TAVR are lacking. We aimed to assess the efficacy of different antithrombotic strategies following ViV-TAVR.</p><p><strong>Methods and results: </strong>We performed a retrospective analysis of German Statutory Health Claims data following ViV-TAVR stratified by antithrombotic strategies according to prescription within 90 days. Antithrombotic regimens included antiplatelet therapy (APT), direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). The composite endpoint was all-cause mortality, stroke and/or systemic embolism (SSE) and mechanical complication of heart valve prosthesis at 12 months. Cox proportional hazard regression models were used to compare outcomes. In total, 908 patients between 2005 and 2022 were identified. Of these, 286 received DOACs, 99 received VKAs, 351 received APT exclusively and 172 had no prescription. The incidence of the composite endpoint was 20.8% in the APT group, 20.3% in the DOAC group and 25.3% in the VKA group which was not statistically significantly different. The rate of SSE in the acetylsalicylic acid (ASA) mono group was higher compared to the dual antiplatelet therapy (DAPT) group (27.3% vs. 12.4%, univariable HR 0.42, 95% CI [0.19, 0.95], p = 0.03).</p><p><strong>Conclusion: </strong>In this analysis of German Health Claims data, DOACs seemed to be a safe alternative to VKAs and APT. ASA monotherapy was associated with higher rates of SSE compared to DAPT. Given the high risk of bias of this retrospective analysis and the growing use of valve-in-valve procedures, randomized controlled trials are needed to confirm these findings.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669349","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jaehyun Lim, Hyun-Jung Lee, Soongu Kwak, Bongseong Kim, Kyung-Do Han, Heesun Lee, Jun-Bean Park, Yong-Jin Kim, Hyung-Kwan Kim
{"title":"Clinical outcomes according to the average daily dose of sacubitril/valsartan: a nationwide longitudinal cohort study.","authors":"Jaehyun Lim, Hyun-Jung Lee, Soongu Kwak, Bongseong Kim, Kyung-Do Han, Heesun Lee, Jun-Bean Park, Yong-Jin Kim, Hyung-Kwan Kim","doi":"10.1007/s00392-025-02602-x","DOIUrl":"https://doi.org/10.1007/s00392-025-02602-x","url":null,"abstract":"<p><strong>Aims: </strong>A minority of patients with heart failure (HF) are prescribed the maximal dose of the angiotensin receptor-neprilysin inhibitor sacubitril/valsartan. We investigated the effectiveness of submaximal doses of sacubitril/valsartan in a real-world cohort.</p><p><strong>Methods and results: </strong>Patients with HF with reduced ejection fraction prescribed sacubitril/valsartan for ≥ 180 days between 2016 and 2020 were included from a nationwide database, and categorized into tertiles based on the average daily sacubitril/valsartan dosage. Baseline characteristics were balanced using inverse probability of treatment weighting with propensity scores. The primary outcome was a composite of HF hospitalization and all-cause mortality. The study included 3,953 patients (age 62.6 ± 12.4 years, 73.0% men). Patients on lower sacubitril/valsartan doses were older, more likely to be women, and had more comorbidities, with lower blood pressure, reduced kidney function, and lower body mass index; however, baseline characteristics were well balanced across the groups after weighting. During a mean follow-up of 2.0 ± 0.7 years, there were 808 events (20.4%). The risk of the primary outcome in the middle (HR 0.93, 95% CI 0.78-1.10) and the highest dosage tertiles (HR 0.88, 95% CI 0.74-1.06) did not significantly differ compared with the lowest dosage tertile (p-value = 0.384). Regarding individual outcomes, there was no significant difference in HF hospitalization; however, there was a trend toward lower mortality with higher sacubitril/valsartan dose (p-value = 0.047).</p><p><strong>Conclusions: </strong>No significant difference was observed in the composite risk of HF hospitalization and all-cause mortality across different sacubitril/valsartan dosage groups. This suggests that the benefits of sacubitril/valsartan treatment may not necessarily be dose-dependent.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gema Miñana, Joan Carles Trullàs, Rafael de la Espriella, Raquel Núñez-Aragon, Andrea Gasull, Juan-Bosco López-Saez, Jorge Montiel, Miguel Lorenzo-Hernández, Agustín Fernández-Cisnal, Ernesto Valero, Gonzalo Núñez, Vicent Bodí, Òscar Miró, Juan Sanchis, Antoni Bayés-Genis, Julio Núñez
{"title":"Prognostic effect of the combined use of thiazides and loop diuretics at discharge following a hospitalization for acute heart failure.","authors":"Gema Miñana, Joan Carles Trullàs, Rafael de la Espriella, Raquel Núñez-Aragon, Andrea Gasull, Juan-Bosco López-Saez, Jorge Montiel, Miguel Lorenzo-Hernández, Agustín Fernández-Cisnal, Ernesto Valero, Gonzalo Núñez, Vicent Bodí, Òscar Miró, Juan Sanchis, Antoni Bayés-Genis, Julio Núñez","doi":"10.1007/s00392-025-02631-6","DOIUrl":"https://doi.org/10.1007/s00392-025-02631-6","url":null,"abstract":"<p><strong>Aims: </strong>There is limited information regarding the clinical impact of the concurrent use of thiazides and loop diuretics (LD) after an episode of acute heart failure (AHF) hospitalization. We aimed to evaluate the impact of thiazide prescription at discharge on top of LD on the short-term risk of AHF readmission.</p><p><strong>Methods: </strong>We included 3384 consecutive patients discharged from January 2008 to September 2021 after an admission for AHF in a single teaching center. The association between thiazides on discharge across the intensity of LD treatment and 30-day AHF readmission was explored by Cox regression analysis. A validation cohort of 622 patients was also examined.</p><p><strong>Results: </strong>The mean age of the patients was 73.8 ± 11.2 years, 1672 (47.5%) were women, and 1733 (51.2%) patients showed left ventricular ejection fraction > 50%. The median (IQR) NT-proBNP was 3409 (1829-6963) pg/mL. At discharge, 754 (22.3%) patients received high LD doses (> 80 mg/day) and 187 (5.5%) thiazides. At 30 days, we registered 76 (2.2%) deaths and 449 (13.3%) AHF readmissions. Thiazides at discharge were not associated with the risk of 30-day AHF readmission (HR = 0.92). However, this association was differentially influenced by the intensity of LD doses (p-value for interaction = 0.030), with a lower AHF-readmission risk in those with LD dose > 80 mg/day (p = 0.038), and a neutral association in those receiving low LD dose (≤ 80 mg/day) (p = 0.541).</p><p><strong>Conclusions: </strong>In patients discharged after an episode of AHF, thiazide prescription was associated with a lower risk of 30-day AHF readmission when they were prescribed in patients receiving high LD doses.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656029","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alexander Dressel, Felix Fath, Bernhard K Krämer, Gerald Klose, Winfried März
{"title":"Statins for primary prevention of cardiovascular disease in Germany: benefits and costs.","authors":"Alexander Dressel, Felix Fath, Bernhard K Krämer, Gerald Klose, Winfried März","doi":"10.1007/s00392-025-02608-5","DOIUrl":"https://doi.org/10.1007/s00392-025-02608-5","url":null,"abstract":"<p><strong>Background: </strong>The reduction of LDL cholesterol lowers the risk of coronary and cerebrovascular events in individuals without manifest cardiovascular diseases. In Germany, statins at the expense of statutory health insurance had only been permitted for patients with atherosclerosis-related diseases or those at high cardiovascular risk (over 20 percent event probability within the next 10 years, calculated using one of the \"available risk calculators\"). However, international guidelines recommend lower risk thresholds for the use of statins.</p><p><strong>Methods: </strong>The health and economic impacts of different risk thresholds for statin use in primary prevention within the German population are estimated for thresholds of 7.5, 10, and 15 percent over 10 years, based on the US Pooled Cohort Equation (PCE) which is valid for Germany, using Markov models.</p><p><strong>Findings: </strong>Cost-effectiveness increases with a rising risk threshold, while individual benefit decreases with age at the start of treatment. The use of statins at a risk of 7.5 percent or more is cost-effective at any age (cost per QALY between 410 and 2100 Euros). In none of the examined scenarios does the proportion of the population qualifying for statin therapy exceed 25 percent.</p><p><strong>Interpretation: </strong>Lowering the threshold for statin therapy to a risk of 7.5 percent of either non-fatal myocardial infarction, coronary heart disease death, non-fatal or fatal stroke would align statin prescription in Germany with international standards. There is no urgent rationale for applying age-stratified risk thresholds.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
J Michael Altstidl, Merve Günes-Altan, Maximilian Moshage, Florian Weidinger, Lennart Lorenz, Dominik Weimann, Christina Chapuzot, Monique Tröbs, Mohamed Marwan, Stephan Achenbach, Luise Gaede
{"title":"Absence of chest discomfort in type 1 NSTEMI patients: predictors and impact on outcome.","authors":"J Michael Altstidl, Merve Günes-Altan, Maximilian Moshage, Florian Weidinger, Lennart Lorenz, Dominik Weimann, Christina Chapuzot, Monique Tröbs, Mohamed Marwan, Stephan Achenbach, Luise Gaede","doi":"10.1007/s00392-025-02628-1","DOIUrl":"https://doi.org/10.1007/s00392-025-02628-1","url":null,"abstract":"<p><strong>Background: </strong>The absence of chest discomfort has been hypothesized to delay treatment and consequently result in worse outcomes in patients with non-ST-elevation myocardial infarction (NSTEMI).</p><p><strong>Methods: </strong>In 888 consecutive patients with type 1 NSTEMI, symptoms were systematically classified as chest discomfort defined as chest pain or pressure, dyspnea or other symptoms, e.g. epigastric pain. Patient characteristics predictive for the absence of chest discomfort and the impact of the symptom type on adverse in-hospital events (all-cause mortality, cardiogenic shock, and mechanical ventilation) were analyzed.</p><p><strong>Results: </strong>Chest discomfort was reported in 81.0%, dyspnea without chest discomfort in 12.2%, and only other symptoms in the remaining 6.9% of patients. In a multivariable regression analysis, female sex (p = 0.035), diabetes mellitus (p = 0.003), the absence of any family history of coronary artery disease (CAD) (p = 0.002), anemia (p < 0.001), and atrial fibrillation or flutter at presentation (p = 0.017) were independent predictors for the absence of chest discomfort. The absence of chest discomfort was associated with a higher rate of in-hospital adverse events (10.6% for chest discomfort vs. 29.6% for dyspnea and 27.9% for other symptoms, p < 0.001), which appeared partially mediated (p = 0.044) by longer times from diagnosis to invasive management (p < 0.001).</p><p><strong>Conclusions: </strong>In type 1 NSTEMI, the absence of chest discomfort is associated with a higher rate of adverse in-hospital events. Women, diabetics, patients without a family history of CAD, patients with anemia, and patients with atrial fibrillation are more likely to present without chest discomfort and special attention may be required to avoid delayed invasive management in these patients.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jan M Wrobel, Johannes Kirchner, Kai Friedrichs, Thorsten Gietzen, Jan Althoff, Caroline Hasse, Philipp von Stein, Jonas Wörmann, Jennifer von Stein, Jonathan Curio, Felix Rudolph, Maria Ivannikova, Christos Iliadis, Daniel Steven, Stephan Baldus, Volker Rudolph, Roman Pfister, Muhammed Gerçek, Maria I Koerber
{"title":"Cardiac implantable electronic device carriers undergoing transcatheter tricuspid valve annuloplasty: real-world insights.","authors":"Jan M Wrobel, Johannes Kirchner, Kai Friedrichs, Thorsten Gietzen, Jan Althoff, Caroline Hasse, Philipp von Stein, Jonas Wörmann, Jennifer von Stein, Jonathan Curio, Felix Rudolph, Maria Ivannikova, Christos Iliadis, Daniel Steven, Stephan Baldus, Volker Rudolph, Roman Pfister, Muhammed Gerçek, Maria I Koerber","doi":"10.1007/s00392-025-02616-5","DOIUrl":"https://doi.org/10.1007/s00392-025-02616-5","url":null,"abstract":"<p><strong>Background: </strong>Transtricuspid cardiac implantable electronic devices (CIEDs) complicate the management of tricuspid regurgitation (TR). Transcatheter tricuspid valve annuloplasty (TTVA) offers a promising approach due to minimal interaction with leaflets and transvalvular CIEDs, though real-world evidence is limited.</p><p><strong>Methods: </strong>This bi-center, retrospective study includes 204 consecutive patients who underwent TTVA with the Cardioband (Edwards Lifesciences) for severe symptomatic TR. Patients were divided into CIED carriers and non-CIED carriers. CIED carriers were further classified into those with lead-associated TR (LTR-A) and those with TR unrelated to CIED leads (LTR-B).</p><p><strong>Results: </strong>Among the 204 patients, 41 (20%) were CIED carriers. Of these, 24% had mixed TR etiology (functional and LTR-A), while 76% had predominantly functional TR (LTR-B). Compared to non-CIED-carriers, CIED carriers were more symptomatic (NYHA-FC > II; 93% vs. 89%; p = 0.026) with comparable TR severity at baseline. Intraprocedural success according to the Tricuspid Valve Academic Research Consortium was 68% in CIED carriers and 70% in non-CIED carriers (p = 0.851). LTR-A was associated with poorer TR reduction immediately after TTVA (p = 0.022). Overall safety was comparable, with right ventricular lead dislodgement occurring in one patient. Beyond that, CIED function remained unimpaired. At 30 days, echocardiographic follow-up showed comparable TR reduction (TR ≤ II: 56% vs. 68%; p = 0.219) and NYHA-FU ≤ II (63% vs. 70%; p = 0.524) in CIED-and non-CIED carriers, respectively.</p><p><strong>Conclusions: </strong>TTVA achieves significant TR reduction, providing a safe and effective therapeutic option for TR treatment in CIED carriers. WHAT IS KNOWN?: TTVA using the Cardioband has been approved for severe, symptomatic TR patients, however data on the safety and efficacy in CIED carriers is lacking. WHAT THE STUDY ADDS?: Intraprocedural success and safety were comparable in CIED and non-CIED carriers treated with TTVA. Subgroup analyses showed a trend towards worse outcome and efficiency of TTVA in patients with LTR-A. Postinterventional CIED interrogations did not show critical technical issues.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143596280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Angela Dettling, Kurt Huber, Steen D Kristensen, Daniel Aradi, Benedikt Schrage, Peter Clemmensen
{"title":"Antiplatelet therapy in acute myocardial infarction complicated by cardiogenic shock.","authors":"Angela Dettling, Kurt Huber, Steen D Kristensen, Daniel Aradi, Benedikt Schrage, Peter Clemmensen","doi":"10.1007/s00392-025-02619-2","DOIUrl":"https://doi.org/10.1007/s00392-025-02619-2","url":null,"abstract":"<p><p>Coronary revascularization represents a cornerstone in the treatment of infarct-related cardiogenic shock (CS). Early and effective antithrombotic therapy is critical and has been shown to improve mortality in most patients with acute coronary syndrome. Achieving early effective platelet inhibition and anticoagulation, with minimal risk, is particularly important in those high-risk patients with CS as the mortality remains high at approximately 50%. However, patients with CS are at high risk for both early thrombotic as well as bleeding events and striking the right balance remains a challenge due to a multitude of factors related to drug administration, metabolism and mechanical issues related to therapeutic interventions such as increasing use of mechanical circulatory support (MCS). This review therefore aims to provide an overview of the current practice, the underlying challenges and existing evidence on safety, efficacy and outcomes of adjunctive antiplatelet and antithrombotic therapy in patients with acute myocardial infarction (AMI) complicated by CS and discusses the use of parenteral platelet inhibitors.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Richard J Nies, Svenja Ney, Jasper F Nies, Katharina Seuthe, Lukas Klösges, Monique Brüwer, Stephan Nienaber, Sascha Macherey-Meyer, Matthieu Schäfer, Roman Pfister
{"title":"Outpatient diuretic intensification: a simple prognostic marker in cardiac transthyretin amyloidosis.","authors":"Richard J Nies, Svenja Ney, Jasper F Nies, Katharina Seuthe, Lukas Klösges, Monique Brüwer, Stephan Nienaber, Sascha Macherey-Meyer, Matthieu Schäfer, Roman Pfister","doi":"10.1007/s00392-025-02617-4","DOIUrl":"https://doi.org/10.1007/s00392-025-02617-4","url":null,"abstract":"<p><strong>Background: </strong>Currently, simple clinical parameters indicating disease progression are lacking in patients with transthyretin amyloid cardiomyopathy (ATTR-CM). This study aimed to evaluate the prognostic value of outpatient diuretic intensification (ODI) in ATTR-CM patients.</p><p><strong>Methods: </strong>This retrospective study examined ATTR-CM patients at a tertiary care center between August 1, 2020, and June 30, 2023. ODI was defined as any loop diuretic increase within 6 months after baseline visit, and its impact on all-cause mortality and hospitalization for heart failure (HF) was analyzed.</p><p><strong>Results: </strong>Altogether, 182 patients were included (median age 80 [76; 84] years; 88% male), and 25% experienced ODI (median increase 10 [10; 40] mg furosemide equivalent). Independent predictors of ODI were higher baseline New York Heart Association (NYHA) class and polyneuropathy. Both any ODI and the magnitude of furosemide equivalent increase were significantly associated with mortality and HF hospitalization during a median follow-up of 17 months. After adjusting for baseline NYHA class and National Amyloidosis Centre stage, significantly increased risk of all-cause mortality (hazard ratio [HR] 2.38, 95% confidence interval [CI] 1.03-5.53; p = 0.043) and HF hospitalization (HR 3.27, 95% CI 1.41-7.60; p = 0.006) persisted in patients with ODI. Its prognostic value was similar in strata of age, ATTR subtype, previous cardiac decompensation, biomarkers, left ventricular ejection fraction, six-minute walk distance, and tafamidis treatment.</p><p><strong>Conclusion: </strong>ODI occurred in one in four ATTR-CM patients within 6 months and was associated with more severe baseline amyloid organ manifestations. ODI and the magnitude of diuretic dose increase provide easily assessable clinical markers of disease progression in patient monitoring.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Daphne van Vliet, Eline H Ploumen, Tineke H Pinxterhuis, Carine J M Doggen, Adel Aminian, Carl E Schotborgh, Peter W Danse, Ariel Roguin, Rutger L Anthonio, Edouard Benit, Marlies M Kok, Gerard C M Linssen, Clemens von Birgelen
{"title":"Elderly patients treated with Onyx versus Orsiro drug-eluting coronary stents in a randomized clinical trial with long-term follow-up.","authors":"Daphne van Vliet, Eline H Ploumen, Tineke H Pinxterhuis, Carine J M Doggen, Adel Aminian, Carl E Schotborgh, Peter W Danse, Ariel Roguin, Rutger L Anthonio, Edouard Benit, Marlies M Kok, Gerard C M Linssen, Clemens von Birgelen","doi":"10.1007/s00392-025-02622-7","DOIUrl":"https://doi.org/10.1007/s00392-025-02622-7","url":null,"abstract":"<p><strong>Background: </strong>Percutaneous coronary intervention (PCI) with new-generation drug-eluting stents is increasingly performed in elderly patients, who generally have more comorbidities and more technically challenging target lesions. Nevertheless, there is a paucity of reported data on the long-term safety and efficacy of PCI with contemporary stents in elderly all-comers.</p><p><strong>Methods: </strong>This prespecified secondary analysis of a large-scale randomized clinical trial (BIONYX; clinicaltrials.gov:NCT02508714) compared in elderly all-comers (≥ 75 years) the 5-year outcome after PCI with the novel, more radiopaque Onyx zotarolimus-eluting stent (ZES) versus the Orsiro sirolimus-eluting stent (SES). We assessed the main composite endpoint target vessel failure (TVF: cardiac death, target vessel myocardial infarction, or target vessel revascularization) and several secondary endpoints.</p><p><strong>Results: </strong>Of 2,488 trial participants, 475(19.1%) were elderly (79.5 ± 3.5 years), including 165(34.7%) women. There was a significant between-stent difference in the main endpoint TVF in favor of the Onyx ZES (14.4% vs. 24.2%, HR: 0.60, 95% CI 0.39-0.93, p<sub>log-rank</sub> = 0.02). The time-to-event curves displayed between-stent dissimilarities across all components of TVF, yet not statistically significant. Landmark analysis between 1- and 5-year follow-up showed in Onyx ZES-treated patients significantly lower rates of TVF (7.8% vs.8.9%, p = 0.002) and target vessel revascularization (3.0% vs.8.3%, p = 0.029). In addition, the 5-year rates of all-cause mortality and several composite endpoints were lower (p < 0.03) in Onyx ZES-treated patients.</p><p><strong>Conclusions: </strong>In elderly all-comer patients, those treated with Onyx ZES showed a lower 5-year incidence of the main endpoint of safety and efficacy, as well as several secondary endpoints, than patients treated with Orsiro SES. Further research on this issue is warranted.</p><p><strong>Clinical trial registration information: </strong>https://clinicaltrials.gov/study/NCT02508714.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joshua Teik Ann Tan, George Shiyao He, Jolene Li Ling Chia, Gladys Qiao Xuan Tan, Yao Neng Teo, Yao Hao Teo, Nicholas L Syn, Ping Chai, Raymond C C Wong, Tiong-Cheng Yeo, William K F Kong, Kian-Keong Poh, Ching-Hui Sia
{"title":"Natural history of initially asymptomatic severe aortic stenosis: a one-stage meta-analysis.","authors":"Joshua Teik Ann Tan, George Shiyao He, Jolene Li Ling Chia, Gladys Qiao Xuan Tan, Yao Neng Teo, Yao Hao Teo, Nicholas L Syn, Ping Chai, Raymond C C Wong, Tiong-Cheng Yeo, William K F Kong, Kian-Keong Poh, Ching-Hui Sia","doi":"10.1007/s00392-024-02465-8","DOIUrl":"10.1007/s00392-024-02465-8","url":null,"abstract":"<p><strong>Background: </strong>Current guidelines on the management strategy for patients with asymptomatic severe aortic stenosis (AS) remain unclear. This uncertainty stems from the lack of data regarding the natural history of these patients. To address this gap, we performed a systematic review and meta-analysis examining the natural history of asymptomatic severe AS patients receiving conservative treatment.</p><p><strong>Methods: </strong>The PubMed, Cochrane, and Embase databases were searched from inception to 24 January 2024 using the keywords \"asymptomatic\" AND \"aortic\" AND \"stenosis\". We included studies examining patients with asymptomatic severe AS. In interventional trials, only data from conservatively managed arms were collected. A one-stage meta-analysis was conducted using individual patient data reconstructed from published Kaplan-Meier curves. Sensitivity analysis was performed for major adverse cardiovascular outcomes in patients who remained asymptomatic throughout follow-up.</p><p><strong>Results: </strong>A total of 46 studies were included (n = 9545). The median time to the development of symptoms was 1.11 years (95% CI 0.90-1.53). 49.36% (40.85-58.59) of patients who were asymptomatic had suffered a major adverse cardiovascular event by 5 years. The median event-free time for heart failure hospitalization (HFH) was 5.50 years (95% CI 5.14-5.91) with 36.34% (95% CI 33.34-39.41) of patients experiencing an HFH by year 5. By 5 years, 79.81% (95% CI 69.26-88.58) of patients developed symptoms (angina, dyspnoea, syncope and others) and 12.36% (95% CI 10.01-15.22) of patients died of cardiovascular causes. For all-cause mortality, the median survival time was 9.15 years (95% CI 8.50-9.96) with 39.43% (CI 33.41-36.40) of patients dying by 5 years. The median time to AVR was 4.77 years (95% CI 4.39-5.17), with 52.64% (95% CI 49.85-55.48) of patients requiring an AVR by 5 years.</p><p><strong>Conclusion: </strong>Our results reveal poor cardiovascular outcomes for patients with asymptomatic severe AS on conservative treatment. A significant proportion eventually requires an AVR. Further research is needed to determine if early intervention with AVR is more effective than conservative treatment.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":"350-367"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619563","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}