Aenne S von Falkenhausen, Christina Krewitz, Raphaela Winter, Anna Kern, Dorothee Brunner, Stefan Brunner, Moritz F Sinner
{"title":"The level of acute alcohol exposure during binge drinking associates with the extent of cardiac response.","authors":"Aenne S von Falkenhausen, Christina Krewitz, Raphaela Winter, Anna Kern, Dorothee Brunner, Stefan Brunner, Moritz F Sinner","doi":"10.1007/s00392-025-02722-4","DOIUrl":"10.1007/s00392-025-02722-4","url":null,"abstract":"<p><strong>Introduction: </strong>The cardiovascular effects of acute alcohol exposure remain incompletely understood, despite its reported association with arrhythmias like atrial fibrillation (AF). The Munich-BREW II study supported a link between excessive alcohol consumption, elevated heart rate, impaired heart rate variability (HRV), and increased arrhythmia incidence. Here, we present sub-analyses exploring how the amount of congested alcohol during binge drinking and the maximum breath alcohol concentration (BAC) influence these findings.</p><p><strong>Methods: </strong>The Munich-BREW II study is a prospective, single-center cohort study conducted at LMU University Hospital, Munich between October 2016 and July 2017. Participants consumed alcohol under supervision, with hourly BAC measurements and continuous 3-lead Holter monitoring for ECG analyses of heart rate, HRV, and arrhythmias. Subgroup analyses stratified participants by quartiles of alcohol consumption and peak BAC, respectively.</p><p><strong>Results: </strong>We analyzed 193 participants (mean age 29.9 ± 10.6 years, 36% women). Subgroup analyses revealed that higher alcohol intake during binge drinking correlated with significantly elevated heart rate (p < 0.001) and suppressed HRV measures (SDNN, p = 0.003; RMSSD, p = 0.001). Similarly, higher BAC levels were associated with increased heart rates (p < 0.001) and both reduced SDNN (p < 0.001) and RMSSD (p = 0.002). Both subgroups indicated a more pronounced effect in the highest quartile. Clinically relevant arrhythmias were not differentially distributed across subgroups.</p><p><strong>Discussion: </strong>In this subgroup analysis of the Munich-BREW II study, higher alcohol intake and BAC during binge drinking were associated with increased heart rate and suppressed cardiac autonomic tone. The results suggest a dose response relation and discourages excessive alcohol use. Further research will need to investigate the degree of alcohol exposure to modify clinical outcomes.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871769","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}
{"title":"Valve morphology and timing of surgery in bicuspid aortic valve disease.","authors":"Sandra Wulffeld, Michelle Dalgas Skøtt Schmiegelow, Riina Oksjoki, Dorte Guldbrand Nielsen, Søren Skøtt Schmiegelow, Anh Thuc Ngo, Jakob Raunsø, Morten Kranker Larsen, Niels Eske Bruun, Kristina Procida","doi":"10.1007/s00392-025-02725-1","DOIUrl":"10.1007/s00392-025-02725-1","url":null,"abstract":"<p><strong>Background: </strong>The anatomy of bicuspid aortic valves (BAV) varies considerably and is broadly classified into two main types: two-sinus and fused BAV. Possible prognostic implications of these two main types remain unclear. This study aimed to assess potential associations between BAV morphology and the timing of surgery of the aortic valve or ascending aorta.</p><p><strong>Methods: </strong>A multi-center cohort study including 1004 adult outpatients with BAV. BAV morphology was classified as either two-sinus or fused type. The primary outcome was a composite of surgical or endovascular intervention on the aortic valve or ascending aorta. The effect of morphology on the primary outcome was investigated using delayed-entry cause-specific Cox regression models using age as timescale.</p><p><strong>Results: </strong>A total of 835 patients with fused BAV and 169 with two-sinus BAV were followed for 2044 person-years. Two-sinus BAV patients were younger (median age 47.2 vs. 53.6 years, p = 0.0002) with a higher prevalence of aortic coarctation (24% vs. 12%, p = 0.0003). The incidence rate of surgery was 9.3 per 100 person-years in fused BAV patients and 10.7 per 100 person-years in two-sinus BAV patients (difference [95%CI]: 1.42 [- 2.3, 5.1] per 100 person-years). Two-sinus morphology was associated with a higher age-related hazard of surgery compared to fused BAV (HR [95%CI]: 1.46 [1.02, 2.09]), a finding that remained significant after adjusting for sex.</p><p><strong>Conclusion: </strong>Two-sinus BAV morphology was associated with a significantly higher age-related likelihood of requiring surgery on the aortic valve or ascending aorta.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871770","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}
Francesco Tartaglia, Mauro Gitto, Won-Keun Kim, Pier Pasquale Leone, Tommaso Fabris, Chiara De Biase, Giuliano Costa, Nicholas Montarello, Andrea Scotti, Michele Bellamoli, Mesfer Alfadhel, Ofir Koren, Simone Fezzi, Barbara Bellini, Mauro Massussi, Giulia Costa, Chiara Fraccaro, Alessandro Mazzapicchi, Enrico Giacomin, Francesco Burzotta, Andrea Zito, Riccardo Gorla, Marco Angelillis, Karsten Hug, Carlo Briguori, Luca Bettari, Antonio Messina, Michele Galasso, Damiano Regazzoli, Greta Cattaneo, Mauro Boiago, Gianmaria Calamita, Giulia Laterra, Matthias Renker, Mario Garcia Gomez, Alfonso Ielasi, Uri Landes, Tobias Rheude, Francesco Bedogni, Ignacio Amat Santos, Francesco Saia, Lin Bai, Mao Chen, Marianna Adamo, Marco De Carlo, Matteo Montorfano, Raj R Makkar, Darren Mylotte, Daniel J Blackman, Marco Barbanti, Didier Tchetche, Giuseppe Tarantini, Azeem Latib, Diego Maffeo, Ole De Backer, Andrea Buono, Antonio Mangieri
{"title":"High residual gradients after transcatheter aortic valve implantation in raphe-type bicuspid aortic valve stenosis: insights from the AD-HOC registry.","authors":"Francesco Tartaglia, Mauro Gitto, Won-Keun Kim, Pier Pasquale Leone, Tommaso Fabris, Chiara De Biase, Giuliano Costa, Nicholas Montarello, Andrea Scotti, Michele Bellamoli, Mesfer Alfadhel, Ofir Koren, Simone Fezzi, Barbara Bellini, Mauro Massussi, Giulia Costa, Chiara Fraccaro, Alessandro Mazzapicchi, Enrico Giacomin, Francesco Burzotta, Andrea Zito, Riccardo Gorla, Marco Angelillis, Karsten Hug, Carlo Briguori, Luca Bettari, Antonio Messina, Michele Galasso, Damiano Regazzoli, Greta Cattaneo, Mauro Boiago, Gianmaria Calamita, Giulia Laterra, Matthias Renker, Mario Garcia Gomez, Alfonso Ielasi, Uri Landes, Tobias Rheude, Francesco Bedogni, Ignacio Amat Santos, Francesco Saia, Lin Bai, Mao Chen, Marianna Adamo, Marco De Carlo, Matteo Montorfano, Raj R Makkar, Darren Mylotte, Daniel J Blackman, Marco Barbanti, Didier Tchetche, Giuseppe Tarantini, Azeem Latib, Diego Maffeo, Ole De Backer, Andrea Buono, Antonio Mangieri","doi":"10.1007/s00392-025-02726-0","DOIUrl":"https://doi.org/10.1007/s00392-025-02726-0","url":null,"abstract":"<p><strong>Background: </strong>Bicuspid aortic valve (BAV) stenosis poses several challenges when transcatheter aortic valve implantation (TAVI) is performed, including the risk of high residual gradients (HRG).</p><p><strong>Objective: </strong>To identify incidence, predictors and outcomes of HRG after TAVI in Sievers type 1 BAV stenosis.</p><p><strong>Methods: </strong>Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVI at 24 international centers from 2016 to 2023 were enrolled. HRG were defined as a mean transvalvular gradient ≥ 20 mmHg at 30 days, according to Valve Academic Research Consortium-3 (VARC-3) criteria. The primary endpoint was major adverse cardiovascular events (MACE), defined as a composite of all-cause death, neurologic events or hospitalization for heart failure, assessed at 3 years after TAVI. Secondary endpoints included the single components of the primary outcome. Endpoints were assessed according to the presence of HRG, before and after covariate adjustment for clinically relevant confounders.</p><p><strong>Results: </strong>A total of 972 patients were enrolled. HRG post-TAVI were found in 35 patients (3.6%). Patients with HRG had a higher preprocedural aortic valve gradient (57.0 [interquartile range: 49.0-69.0] mmHg vs 48.0 [40.0-58.0] mmHg, p < 0.001) and received smaller transcatheter heart valve (THV) (26.0 [23.0-29.0] mm vs 29.0 [26.0-29.0] mm, p < 0.001) when compared to patients with normal residual gradients (NRG). The only independent predictor of HRG was a bioprosthesis size ≤ 23 mm. At 3 years, MACE occurred in 35.0% of HRG patients and 22.3% of NRG patients (adjusted hazard ratio [HR]: 2.41, 95% confidence interval [CI]: 1.15-5.04; p = 0.019). HRG patients had a higher risk of neurologic events as compared to NRG patients (13.3% versus 4.5%, adjusted HR: 4.50, 95% CI: 1.52-13.30, p = 0.007).</p><p><strong>Conclusions: </strong>After TAVI in Sievers type 1 BAV stenosis, HRG occurred in around 4% of cases and were associated with an increased risk of MACE and neurologic events.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144788434","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}
{"title":"DCB therapy: quo vadis?","authors":"Bruno Scheller, Bernhard Haring","doi":"10.1007/s00392-025-02733-1","DOIUrl":"https://doi.org/10.1007/s00392-025-02733-1","url":null,"abstract":"","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144788433","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}
Klaus G Parhofer, David Pittrow, Andreas L Birkenfeld, Uwe Fraass, Bernd Hohenstein, Carsten Siegert, Jens Klotsche, Elisabeth Steinhagen-Thiessen, Stefan Dexl, Volker J J Schettler, Ulrich Laufs
{"title":"Treatment persistence, lipid lowering, and 3-year clinical outcomes in patients at very high cardiovascular risk on PCSK9 monoclonal antibodies.","authors":"Klaus G Parhofer, David Pittrow, Andreas L Birkenfeld, Uwe Fraass, Bernd Hohenstein, Carsten Siegert, Jens Klotsche, Elisabeth Steinhagen-Thiessen, Stefan Dexl, Volker J J Schettler, Ulrich Laufs","doi":"10.1007/s00392-025-02719-z","DOIUrl":"https://doi.org/10.1007/s00392-025-02719-z","url":null,"abstract":"<p><p>In a cohort of patients with dyslipidemia at very high cardiovascular risk, we investigated differences in LDL-C lipid target achievement, clinical outcomes, and persistence rates between users and non-users of PCSK9 monoclonal antibodies (PCSK9-mAb) over a 3-year observation period. The prospective, multi-center observational study included 1695 patients with dyslipidemia. Eligible patients were adults with familial or non-familial hypercholesterolemia, mixed dyslipidemia, or other therapy-refractory lipid disorders in line with the G-BA reimbursement regulations. Treatment decisions, including PCSK9-mAb administration, were made at the discretion of the treating physician. At baseline, 804 (47.4%) patients received PCSK9-mAb therapy, and 891 (52.5%) did not. There were 42 (4.7%) new PCSK9-mAb receivers during the follow-up. Median propensity-score adjusted LDL-C levels in PCSK9-mAb non-receivers decreased over time from 106.0 to 68.4 mg/dL. LDL-C in PCSK9-mAb receivers dropped from 112.5 mg/dL at baseline to 58.0 mg/dL at 3 years, consistently outperforming non-receivers. Target LDL-C goal attainment (< 55mg/dL) after 3 years was higher in the PCSK9-mAb group (43.2% vs. 34.5%). Persistence with PCSK9-mAb therapy over 3 years since treatment initiation was high (91.5%). Higher discontinuation rates of PCSK9-mAb were associated with baseline statin intolerance (HR = 2.3, p = 0.012). The use of PCSK9-mAb was associated with numerically fewer cardiovascular events (9.3 versus 15.7 per 100 patient-years, p not significant) and lower hospitalization rates due to cardiovascular events compared to non-users (6.3 versus 12.4 per 100 patient years, p = 0.001). This study underscores the real-world efficacy and safety of PCSK9-mAb therapy in achieving sustained LDL-C reduction. Identifier: Clinicaltrials.gov NCT03110432.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144783580","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}
Gjin Ndrepepa, Salvatore Cassese, Michael Joner, Hendrik B Sager, Sebastian Kufner, Erion Xhepa, Karl-Ludwig Laugwitz, Heribert Schunkert, Adnan Kastrati
{"title":"Left ventricular systolic function after percutaneous coronary intervention: patterns of change and prognosis according to clinical presentation of coronary artery disease.","authors":"Gjin Ndrepepa, Salvatore Cassese, Michael Joner, Hendrik B Sager, Sebastian Kufner, Erion Xhepa, Karl-Ludwig Laugwitz, Heribert Schunkert, Adnan Kastrati","doi":"10.1007/s00392-024-02588-y","DOIUrl":"10.1007/s00392-024-02588-y","url":null,"abstract":"<p><strong>Background: </strong>Whether there are differences in the left ventricular ejection fraction change (ΔLVEF) after percutaneous coronary intervention (PCI) and its association with long-term prognosis according to coronary artery disease (CAD) presentations is unknown. We assessed ΔLVEF after PCI and its association with 5-year mortality in various CAD presentations.</p><p><strong>Methods: </strong>This study included 8181 patients with paired (before and 6-8 months after PCI) angiographic LVEF measurements: 4582 patients with chronic coronary disease (CCD), 1972 patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) and 1627 patients with ST-segment elevation myocardial infarction (STEMI). ΔLVEF (LVEF at 6-8 months minus baseline LVEF) was classified as follows: decline (ΔLVEF < 0), moderate improvement (ΔLVEF > 0 to < 10%) and large improvement (ΔLVEF ≥ 10%). The primary endpoint was 5 year mortality.</p><p><strong>Results: </strong>In patients with CCD, NSTE-ACS and STEMI, ΔLVEF (median [25th-75th percentiles]) was 0.0% [- 3.0%; 4.0%], 1.0% [- 2.0%; 5.0%] and 3.0% [- 2.0%; 10.0%], respectively (P < 0.001). In patients with a decline, moderate improvement and large improvement of LVEF, 5-year mortality was 10.0%, 10.4% and 12.3% in patients with CCD, 10.8%, 10.7% and 18.1% in patients with NSTE-ACS and 10.6%, 8.2% and 5.2% in patients with STEMI. After adjustment, ΔLVEF was associated with 5-year mortality in patients with CCD (adjusted hazard ratio [HR] = 0.90, 95% confidence interval [0.83-0.97]) and STEMI (adjusted HR = 0.85 [0.75-0.95]) but not in patients with NSTE-ACS (adjusted HR = 0.97 [0.85-1.10]), with all 3 risk estimates calculated for 5% increment in the ΔLVEF.</p><p><strong>Conclusions: </strong>The type of CAD presentation appears to impact both LVEF change after PCI and its association with 5-year mortality.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":"1030-1040"},"PeriodicalIF":3.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827575","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}
Constantin von Zur Mühlen, Marvin Jeuck, Timo Heidt, Thomas Maulhardt, Tau Hartikainen, Alexander Supady, Ingo Hilgendorf, Dennis Wolf, Klaus Kaier, Dirk Westermann, Jonathan Rilinger
{"title":"One-year outcome of robotical vs. manual percutaneous coronary intervention.","authors":"Constantin von Zur Mühlen, Marvin Jeuck, Timo Heidt, Thomas Maulhardt, Tau Hartikainen, Alexander Supady, Ingo Hilgendorf, Dennis Wolf, Klaus Kaier, Dirk Westermann, Jonathan Rilinger","doi":"10.1007/s00392-024-02524-0","DOIUrl":"10.1007/s00392-024-02524-0","url":null,"abstract":"<p><strong>Background: </strong>Robotic-assisted percutaneous coronary intervention (R-PCI) is a promising technology for optimizing the treatment of patients with coronary heart disease. For a better understanding of the potential of R-PCI in clinical routine compared to conventional manual PCI (M-PCI) both initial treatment success of the index procedure and long-term outcome have to be analysed.</p><p><strong>Methods: </strong>Prospective evaluation from the FRiK (DRKS00023868) registry of all R-PCI cases with the CorPath GRX Cardiology by Siemens Healthineers and Corindus in the Freiburg University Heart Center between 04/2022 and 03/2023. Index procedure success and safety, radiation dose of patients and personnel, and 1-year outcome will be reported. Findings will be compared to a prospective control group of M-PCI patients treated by the same team of interventionalists during the same observation period.</p><p><strong>Results: </strong>Seventy patients received R-PCI and were included in the registry. PCI success rate was 100%, with 19% requiring manual assistance. No complications (MACE-major adverse cardiovascular events) occurred. Compared with 70 matched-pair M-PCI patients, there was a higher median procedural time (103 min vs. 67 min, p < 0.001) and fluoroscopy time (18 min vs. 15 min, p = 0.002), and more contrast volume was used (180 ml vs. 160 ml, p = 0.041) in R-PCI vs. M-PCI patients. However, there was no significant difference of the dose-area product (4062 vs. 3242 cGycm<sup>2</sup>, p = 0.361). One year after the intervention, there was no difference in mortality, rehospitalisation, unscheduled PCI or target vessel failure. Health-related quality of life evaluation 6 and 12 months after the index procedure (NYHA, CCS, SAQ7 and EQ-5D-5L) was similar in both groups.</p><p><strong>Conclusion: </strong>R-PCI is feasible and safe. Compared to M-PCI, index procedure success rate is high, safety profile is favourable, and manual assistance was required in only few cases. At 1-year follow-up results for R-PCI vs. M-PCI considering mortality, rehospitalisation, morbidity and target vessel failure were equal.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":"1000-1007"},"PeriodicalIF":3.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12283869/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gabor G Toth, Marianne Brodmann, Sadeek S Kanoun Schnur, Stanislaw Bartus, Mislav Vrsalovic, Oleg Krestianinov, Petr Kala, Jacek Bil, Robert Gil, Jan Kanovsky, Luigi Di Serafino, Luca Paolucci, Emanuele Barbato, Fabio Mangiacapra, Zoltan Ruzsa
{"title":"Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial.","authors":"Gabor G Toth, Marianne Brodmann, Sadeek S Kanoun Schnur, Stanislaw Bartus, Mislav Vrsalovic, Oleg Krestianinov, Petr Kala, Jacek Bil, Robert Gil, Jan Kanovsky, Luigi Di Serafino, Luca Paolucci, Emanuele Barbato, Fabio Mangiacapra, Zoltan Ruzsa","doi":"10.1007/s00392-024-02487-2","DOIUrl":"10.1007/s00392-024-02487-2","url":null,"abstract":"<p><strong>Objectives: </strong>INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018.</p><p><strong>Background: </strong>Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes.</p><p><strong>Methods: </strong>INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality.</p><p><strong>Results: </strong>Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1 year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68]).</p><p><strong>Conclusion: </strong>This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":"991-999"},"PeriodicalIF":3.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12283901/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141579160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rodolfo Caminiti, Giampiero Vizzari, Alfonso Ielasi, Giampaolo Vetta, Antonio Parlavecchio, Domenico Giovanni Della Rocca, Carolina Montonati, Dario Pellegrini, Mariano Pellicano, Maurizio Tespili, Antonio Micari
{"title":"Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients.","authors":"Rodolfo Caminiti, Giampiero Vizzari, Alfonso Ielasi, Giampaolo Vetta, Antonio Parlavecchio, Domenico Giovanni Della Rocca, Carolina Montonati, Dario Pellegrini, Mariano Pellicano, Maurizio Tespili, Antonio Micari","doi":"10.1007/s00392-024-02481-8","DOIUrl":"10.1007/s00392-024-02481-8","url":null,"abstract":"<p><strong>Introduction: </strong>Drug-coated balloon (DCB) is an established treatment option for in-stent restenosis and small vessel, de novo, coronary artery disease (CAD). Although the use of this tool is increasing in everyday practice, data regarding performance in the treatment of de novo, large vessel CAD (LV-CAD) is still lacking. A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB versus drug-eluting stent (DES) in this setting.</p><p><strong>Methods: </strong>A comprehensive literature search was performed including Medline, Embase, and Cochrane electronic databases up to January 24, 2024, for studies which compared the efficacy and safety of DCB versus DES in the treatment of de novo lesions in large vessels (≥ 2.5 mm), reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The analyzed outcomes were cardiovascular death (CVD), myocardial infarction (MI), target lesion revascularization (TLR), all-cause death (ACD), and late lumen loss (LLL) at follow-up. The effect size was estimated using a random effects model as risk ratio (RR) and mean difference (MD) and relative 95% confidence interval (CI).</p><p><strong>Results: </strong>A total of 13 studies (6 randomized controlled trials and 7 observational studies) involving 2888 patients (DCB n = 1334; DES n = 1533) with de novo LV-CAD were included in this meta-analysis following our inclusion criteria. No differences were observed between DCB and DES in terms of CVD (RR 0.49; 95% CI [0.23-1.03]; p = 0.06), MI (RR 0.48; 95% CI [0.16-1.45]; p = 0.89), TLR (RR 0.73; 95% CI [0.40-1.34]; p = 0.32), ACD (RR 0.78; 95% CI [0.57-1.07]; p = 0.12), and LLL (MD - 0.14; 95% CI [- 0.30 to 0.02]; p = 0.10) at follow-up. DES proved a higher mean acute gain versus DCB [1.94 (1.73, 2.14) vs 1.31 (1.02, 1.60); p = 0.0006].</p><p><strong>Conclusion: </strong>Our meta-analysis showed that DCB PCI might provide a promising option for the management of selected, de novo LV-CAD compared to DES. However, more focused RCTs are needed to further prove the benefits of a \"metal-free\" strategy in this subset of CAD.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":"978-990"},"PeriodicalIF":3.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141491163","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}
Tobias Harm, Shqipdona Lahu, Katharina Mayer, Dominik Rath, Tobias Geisler, Karin Anne Lydia Müller, Marion Janisch, Kristin Adler, Götz Münch, Steffen Massberg, Adnan Kastrati, Meinrad Paul Gawaz
{"title":"Plasma chemokines indicate enhanced bleeding in patients with chronic coronary syndrome undergoing percutaneous coronary stenting.","authors":"Tobias Harm, Shqipdona Lahu, Katharina Mayer, Dominik Rath, Tobias Geisler, Karin Anne Lydia Müller, Marion Janisch, Kristin Adler, Götz Münch, Steffen Massberg, Adnan Kastrati, Meinrad Paul Gawaz","doi":"10.1007/s00392-025-02675-8","DOIUrl":"10.1007/s00392-025-02675-8","url":null,"abstract":"<p><strong>Background: </strong>Patients with coronary artery disease (CAD) are at increased risk of developing ischemic events and contemporary antiplatelet therapy often leads to bleeding events following percutaneous coronary intervention (PCI). Glycoprotein VI (GPVI) is the key receptor of collagen-dependent thrombus formation and crucial for platelet homeostasis.</p><p><strong>Methods: </strong>We analysed the influence of GPVI inhibition with revacept in a randomized double-blinded trial enrolling 334 patients with CAD undergoing elective PCI. Ex vivo platelet function analyses were assessed alongside plasma chemokine concentrations. We then elucidate changes of GPVI-dependent chemokine concentrations in patients with bleeding events during the 30-day clinical follow-up.</p><p><strong>Results: </strong>Changes in platelet function occur in patients with revacept treatment and are associated with a characteristic alteration of circulating chemokine concentrations. Further, patients with adverse bleeding events share a distinct fingerprint of chemokines that is associated with modulation of in vitro platelet functions. In addition, assessment of GPVI-associated changes in chemokine signalling and platelet functions demonstrated an increased diagnostic value in patients with CAD and might improve early risk discrimination for bleeding events.</p><p><strong>Conclusion: </strong>The composition of platelet-derived chemokines correlated with platelet functions following antiplatelet treatment. Thus, assessment of chemokines may offer the perspective to identify patients at increased risk for bleeding events. Likewise, modulation of platelet chemokines in patients with revacept treatment contributes to the efficacy of antiplatelet treatment and might attenuate pathophysiological cascades leading to haemorrhagic diathesis in patients with CAD.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":"1071-1083"},"PeriodicalIF":3.7,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12283909/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109670","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}