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Arterial Hypertension and Associated Risk Factors in Kazakhstan: An Analysis of Blood Pressure Screening Results from May Measurement Month 2021-2023. 哈萨克斯坦动脉高血压及相关危险因素:2021-2023年5月测量月血压筛查结果分析
IF 3
Cardiology and Therapy Pub Date : 2025-06-01 Epub Date: 2025-04-29 DOI: 10.1007/s40119-025-00412-w
Dilyara M Mukhtarkhanova, Gulnara A Junusbekova, Meiramgul K Tundybayeva, Tatyana N Leonovich, Lyazat S Baglanova, Eldar M Ismailov, Sabina B Samitova
{"title":"Arterial Hypertension and Associated Risk Factors in Kazakhstan: An Analysis of Blood Pressure Screening Results from May Measurement Month 2021-2023.","authors":"Dilyara M Mukhtarkhanova, Gulnara A Junusbekova, Meiramgul K Tundybayeva, Tatyana N Leonovich, Lyazat S Baglanova, Eldar M Ismailov, Sabina B Samitova","doi":"10.1007/s40119-025-00412-w","DOIUrl":"10.1007/s40119-025-00412-w","url":null,"abstract":"<p><strong>Introduction: </strong>May Measurement Month (MMM) is a global campaign with the aim to improve awareness of arterial hypertension (AH). Kazakhstan participated in the campaign in 2021, 2022 and 2023.</p><p><strong>Methods: </strong>During the cross-sectional 2021-2023 MMM surveys, volunteer adults (≥ 18 years) from cities in Kazakhstan had their blood pressure (BP) measured three times in a seated position, and received a questionnaire on their demographics, lifestyle and medical history. In those not receiving antihypertensive treatment, AH was defined as a mean systolic and/or diastolic BP ≥ 140/90 mmHg.</p><p><strong>Results: </strong>A total of 8231 individuals took part in the survey, with 1805 participants in 2021, 2410 participants in 2022 and 4016 participants in 2023. The prevalence of AH was estimated to be 37% in 2021 and 45% in 2022 and 2023. Of those identified as having AH, 51-70% were aware that they had the condition. Among those who were aware that they had AH, 68-91% were receiving antihypertensive therapy. However, 70-82% of treated participants were only receiving one to two drugs. BP was controlled to < 140/90 mmHg in 43-50% of treated participants and to < 130/80 mmHg in 15-16%.</p><p><strong>Conclusion: </strong>The 2021, 2022 and 2023 MMM campaigns showed that high proportion of AH, a low level of AH awareness and inadequate BP control in Kazakhstan. Programs are needed to increase awareness of the risks of high BP and to improve the diagnosis and effective treatment of AH.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":"283-296"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084456/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143973280","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}
引用次数: 0
Defibrillation Threshold Testing After ICD Implantation in Patients with Chronic Kidney Disease. 慢性肾病患者ICD植入后除颤阈值测定。
IF 3
Cardiology and Therapy Pub Date : 2025-06-01 Epub Date: 2025-04-23 DOI: 10.1007/s40119-025-00403-x
Rohit J Timal, Lano Osman, Joris I Rotmans, Marianne Bootsma, Bart Mertens, Martin J Schalij, Ton J Rabelink, J Wouter Jukema
{"title":"Defibrillation Threshold Testing After ICD Implantation in Patients with Chronic Kidney Disease.","authors":"Rohit J Timal, Lano Osman, Joris I Rotmans, Marianne Bootsma, Bart Mertens, Martin J Schalij, Ton J Rabelink, J Wouter Jukema","doi":"10.1007/s40119-025-00403-x","DOIUrl":"10.1007/s40119-025-00403-x","url":null,"abstract":"<p><strong>Introduction: </strong>Routine defibrillation threshold (DFT) testing at the time of implantable cardioverter-defibrillator (ICD) implantation is no longer recommended because testing did not improve shock efficacy or reduce arrhythmic death. However, patients with severe chronic kidney disease (CKD) were not included in these trials and might benefit from DFT testing. International guidelines shed no light on the subject of the effect of kidney function on DFT testing in patients with CKD.</p><p><strong>Methods: </strong>In this retrospective study, we aimed to identify the success and safety of DFT in patients with CKD stages 1-5 (ages 55-80 years) undergoing primary transvenous ICD implantation.</p><p><strong>Results: </strong>A total of 451 patients were stratified into three groups based on kidney function: group 1 with CKD stage 1-2 (n = 294), group 2 with CKD stage 3-4 (n = 90), and group 3 with CKD stage 5 (n = 67). Ventricular fibrillation was induced 827 times. The median number of threshold testing per patient was two (interquartile range 1-2; range 1-7). No evidence of between CKD-group differences in ICD defibrillation success rates could be found when using all patient attempts, regardless of correction for energy levels (p = 0.262). DFT-related complications occurred in 16 patients (3.5%), predominantly hypoxemia due to hypoventilation (1.6%) and atrial arrhythmias. Five patients (1.1%) underwent ICD or lead revision following abnormal DFT test results.</p><p><strong>Conclusions: </strong>We did not demonstrate a correlation between CKD and increased DFT or an increased rate of inadequate defibrillation safety margin. DFT testing is feasible with a low risk of serious complications in patients with moderate and advanced CKD when clinically deemed necessary. DFT testing is not routinely required in patients with (advanced) CKD.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":"219-230"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12084479/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976930","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}
引用次数: 0
Utility of Screening Fetal Echocardiograms Following Normal Level II Ultrasounds in Fetuses with Siblings with Congenital Heart Disease. 在兄弟姐妹患有先天性心脏病的胎儿中,正常II级超声检查后胎儿超声心动图筛查的应用。
IF 3
Cardiology and Therapy Pub Date : 2025-05-31 DOI: 10.1007/s40119-025-00419-3
Kacy Taylor, Casey Lovelace, Erin Van Pelt, Oluseyi Ogunleye, Karen Texter, Clifford L Cua
{"title":"Utility of Screening Fetal Echocardiograms Following Normal Level II Ultrasounds in Fetuses with Siblings with Congenital Heart Disease.","authors":"Kacy Taylor, Casey Lovelace, Erin Van Pelt, Oluseyi Ogunleye, Karen Texter, Clifford L Cua","doi":"10.1007/s40119-025-00419-3","DOIUrl":"https://doi.org/10.1007/s40119-025-00419-3","url":null,"abstract":"<p><strong>Introduction: </strong>In pregnancies when congenital heart disease (CHD) is present in siblings, fetal echocardiograms (F-echo) are recommended, regardless if there was a prior level II ultrasound (LII-US) that was normal. The goal of this study was to evaluate if any diagnosis of a critical congenital heart disease (CHD) was missed in a fetus who had a sibling with CHD, when a normal LII-US was documented.</p><p><strong>Methods: </strong>Retrospective chart review of all F-echo where the indication was sibling with CHD between January 1, 2019 and December 31, 2023 was performed. Fetuses were included if they had a LII-US that was read as normal and had a F-echo. Critical CHD was defined as CHD requiring catheterization or surgical intervention < 1 month of age.</p><p><strong>Results: </strong>A total of 187 F-echo on fetuses who had a sibling with CHD were evaluated, of which 113 met inclusion criteria. LII-US was performed at 21.1 ± 3.3 weeks gestational age and F-echo was performed at 25.4 ± 3.1 weeks gestational age. No patient with a normal LII-US had a diagnosis of a critical CHD by F-echo (negative predictive value = 100%). Six patients that had a negative LII-US were diagnosed with non-critical CHD or cardiac issues postnatally (negative predictive value = 94.7%). F-echo correctly diagnosed two of the six missed LII-US CHD.</p><p><strong>Conclusion: </strong>Critical CHD was not missed with a normal LII-US in this at-risk population. F-echo also missed the majority of CHD when a LII-US was read as normal. The cost/benefit of screening F-echo in fetuses with siblings with CHD should be evaluated if a normal LII-US has been performed. Larger studies are needed to determine if these findings remain consistent.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144191558","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}
引用次数: 0
Association Between Insulin Resistance and Incomplete Endothelization of LAAC Devices in Patients with Atrial Fibrillation: A Retrospective Study. 房颤患者LAAC装置的胰岛素抵抗与不完全内皮化之间的关系:一项回顾性研究。
IF 3
Cardiology and Therapy Pub Date : 2025-05-31 DOI: 10.1007/s40119-025-00418-4
Jing Zhou, En Zhou, Qing He, Kandi Zhang, Tiantian Zhang, Chengyu Mao, Junfeng Zhang, Zongqi Zhang
{"title":"Association Between Insulin Resistance and Incomplete Endothelization of LAAC Devices in Patients with Atrial Fibrillation: A Retrospective Study.","authors":"Jing Zhou, En Zhou, Qing He, Kandi Zhang, Tiantian Zhang, Chengyu Mao, Junfeng Zhang, Zongqi Zhang","doi":"10.1007/s40119-025-00418-4","DOIUrl":"https://doi.org/10.1007/s40119-025-00418-4","url":null,"abstract":"<p><strong>Introduction: </strong>Incomplete endothelialization (IDE) of left atrial appendage closure (LAAC) devices increases the risk of device-related thrombosis (DRT) and stroke. Insulin resistance (IR) may contribute to IDE by impairing endothelial function, but its role remains unclear. This study aimed to investigate the association between IR markers and IDE and develop a predictive model for identifying high-risk patients.</p><p><strong>Methods: </strong>This retrospective observational study included 168 patients with nonvalvular atrial fibrillation (AF) who underwent successful LAAC at Shanghai Ninth People's Hospital between January 2022 and December 2023. IDE was assessed using transesophageal echocardiography (TEE) and cardiac computed tomography angiography (CCTA) at 6 months post-procedure. IR was evaluated using the triglyceride-glucose (TyG) index, triglyceride-to-high-density lipoprotein cholesterol (TG/HDL-c) ratio, and metabolic score for insulin resistance (METs-IR). Logistic regression analysis was performed to identify independent predictors of IDE, and a predictive model was constructed.</p><p><strong>Results: </strong>Among the 168 patients included in the analysis, 43 (25.5%) exhibited IDE, as determined by TEE or CCTA at 6 months post-procedure. Patients with IDE had a significantly higher body mass index, triglyceride (TG) levels, total TG/high-density lipoprotein ratio, TyG index, METs-IR index, and D-dimer levels, as well as a larger maximum LAA orifice diameter (p < 0.05). Multivariate logistic regression identified D-dimer, METs-IR, and maximum LAA orifice diameter as independent predictors of IDE. The predictive probability model incorporating these factors demonstrated high discriminatory ability (area under the curve 0.800, 95% confidence interval 0.71-0.89, p < 0.0001). The optimal predicted probability cut-off value was 0.284, achieving a sensitivity of 76.2% and a specificity of 85.2%.</p><p><strong>Conclusion: </strong>IR markers, D-dimer levels, and LAA orifice size are significant predictors of IDE following LAAC. The logistic regression model proposed here provides an effective risk stratification tool for identifying patients at higher risk for IDE, enabling personalized anticoagulation strategies and optimizing post-procedural management. Future research should explore whether metabolic interventions can enhance endothelialization and improve long-term outcomes in patients undergoing LAAC.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144191557","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}
引用次数: 0
Correction: Rationale and Design of ANTHOLOGY: An ATTR Amyloidosis Real-World Evidence Program Aiming to Address Gaps in Amyloidosis Care. 纠正:选集的基本原理和设计:ATTR淀粉样变性真实世界证据程序,旨在解决淀粉样变性护理方面的差距。
IF 3
Cardiology and Therapy Pub Date : 2025-05-24 DOI: 10.1007/s40119-025-00417-5
Julian D Gillmore, Katrin Hahn, J Gustav Smith, Isabel Conceição, Zhuang Tian, Martha Grogan, Christina Pao, Eric Wittbrodt, Krister Järbrink, Mia A Papas, Margot K Davis
{"title":"Correction: Rationale and Design of ANTHOLOGY: An ATTR Amyloidosis Real-World Evidence Program Aiming to Address Gaps in Amyloidosis Care.","authors":"Julian D Gillmore, Katrin Hahn, J Gustav Smith, Isabel Conceição, Zhuang Tian, Martha Grogan, Christina Pao, Eric Wittbrodt, Krister Järbrink, Mia A Papas, Margot K Davis","doi":"10.1007/s40119-025-00417-5","DOIUrl":"https://doi.org/10.1007/s40119-025-00417-5","url":null,"abstract":"","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144136012","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}
引用次数: 0
Safety and Efficacy of Tafamidis in Chinese Patients with Transthyretin Amyloid Cardiomyopathy. 他法非地治疗甲状腺素转淀粉样心肌病的安全性和有效性。
IF 3
Cardiology and Therapy Pub Date : 2025-05-23 DOI: 10.1007/s40119-025-00408-6
Zhuang Tian, Daoquan Peng, Wei Ma, Jiangtao Yan, Jian'an Wang, Yida Tang, Wei Jin, Ying Liu, Caiping Jia, Yingxu Gao, Yankun Gong, Xiaohong Sun, Naihan Chen, Shuiqing Zhu, Shuyang Zhang
{"title":"Safety and Efficacy of Tafamidis in Chinese Patients with Transthyretin Amyloid Cardiomyopathy.","authors":"Zhuang Tian, Daoquan Peng, Wei Ma, Jiangtao Yan, Jian'an Wang, Yida Tang, Wei Jin, Ying Liu, Caiping Jia, Yingxu Gao, Yankun Gong, Xiaohong Sun, Naihan Chen, Shuiqing Zhu, Shuyang Zhang","doi":"10.1007/s40119-025-00408-6","DOIUrl":"https://doi.org/10.1007/s40119-025-00408-6","url":null,"abstract":"<p><strong>Introduction: </strong>Tafamidis is approved in many countries for the treatment of patients with transthyretin amyloid cardiomyopathy (ATTR-CM). Approval is largely based on findings from an international phase 3 trial. This post-approval commitment study aimed to evaluate the safety and efficacy of tafamidis in patients with ATTR-CM in China.</p><p><strong>Methods: </strong>A multicenter, single-arm study in Chinese patients with symptomatic ATTR-CM in China. All patients received once-daily, open-label tafamidis free acid 61 mg for 12 months. Safety reporting was ongoing with efficacy assessments at months 6 and 12, including 6-min walk test distance, New York Heart Association (NYHA) functional classification, National Amyloidosis Centre staging, N-terminal pro-B-type natriuretic peptide and troponin I concentrations, Kansas City Cardiomyopathy Questionnaire Overall Summary score, 5-level EQ-5D index score, EQ visual analog scale, and 12-item Short Form Survey.</p><p><strong>Results: </strong>Patients (n = 53) were aged 60 (standard deviation [SD]: 12) years, 89% were male, and 94% had variant ATTR-CM (21% had A97S [p.A117S]). At baseline, most (81%) patients had NYHA class II symptoms (6% class I; 13% class III) and National Amyloidosis Centre stage I disease (74%; 21% stage II; 6% stage III). Median treatment exposure was 345 (range, 24‒418) days. Overall, 85% of patients reported treatment-emergent adverse events (TEAEs). The nature and incidence of TEAEs were consistent with the known safety profile of tafamidis. There were no serious or severe treatment-related TEAEs. At 6 and 12 months, there were minimal changes from baseline in all efficacy outcomes with tafamidis, and a high proportion of patients (≥ 44%) showed clinically relevant stability or improvement in each measure.</p><p><strong>Conclusions: </strong>The safety of tafamidis in Chinese patients with ATTR-CM was consistent with that previously determined. Tafamidis treatment was associated with a stable disease profile over 12 months in a population of patients where most had variant ATTR-CM and mild heart failure symptoms.</p><p><strong>Trial registration: </strong>NCT04814186.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144132212","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}
引用次数: 0
Correction: Prevalence, Patient Characteristics, and Treatment of Patients with Hypertrophic Cardiomyopathy: A Nationwide Payer Database Study. 更正:肥厚性心肌病的患病率、患者特征和治疗:一项全国付款人数据库研究。
IF 3
Cardiology and Therapy Pub Date : 2025-05-20 DOI: 10.1007/s40119-025-00414-8
Yuika Ikeda, Tsunehisa Yamamoto, Makio Torigoe, Bruno Casaes Teixeira, Thomas Laurent
{"title":"Correction: Prevalence, Patient Characteristics, and Treatment of Patients with Hypertrophic Cardiomyopathy: A Nationwide Payer Database Study.","authors":"Yuika Ikeda, Tsunehisa Yamamoto, Makio Torigoe, Bruno Casaes Teixeira, Thomas Laurent","doi":"10.1007/s40119-025-00414-8","DOIUrl":"https://doi.org/10.1007/s40119-025-00414-8","url":null,"abstract":"","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109956","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}
引用次数: 0
Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Polyvascular Disease. 多血管疾病患者经导管与手术主动脉瓣置换术的比较。
IF 3
Cardiology and Therapy Pub Date : 2025-05-18 DOI: 10.1007/s40119-025-00415-7
Abdelrhman Abomoawad, Ramy Sedhom, Harsh Golwala, Mohamed Abdelazeem, Mamas Mamas, Hani Jneid, Anthony A Bavry, Dharam J Kumbhani, Samir Kapadia, Ayman Elbadawi
{"title":"Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Polyvascular Disease.","authors":"Abdelrhman Abomoawad, Ramy Sedhom, Harsh Golwala, Mohamed Abdelazeem, Mamas Mamas, Hani Jneid, Anthony A Bavry, Dharam J Kumbhani, Samir Kapadia, Ayman Elbadawi","doi":"10.1007/s40119-025-00415-7","DOIUrl":"https://doi.org/10.1007/s40119-025-00415-7","url":null,"abstract":"<p><strong>Introduction: </strong>There is a paucity of data regarding the trends and comparative outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) among patients with polyvascular disease (PVD).</p><p><strong>Methods: </strong>The Nationwide Readmissions Database (2016-2020) was queried for patients undergoing AVR. Propensity score matching was used to compare the outcomes of TAVR versus SAVR among patients with PVD, and for comparing TAVR among those with versus without PVD. The primary outcome was in-hospital mortality.</p><p><strong>Results: </strong>The final cohort included 545,409 hospitalizations for AVR. During the study years, there was an increase in the utilization of TAVR versus SAVR among patients with PVD. Patients with PVD undergoing TAVR were older and more likely to be women compared with patients with PVD undergoing SAVR. Compared with SAVR, patients with PVD undergoing TAVR had lower odds of in-hospital mortality (adjusted odds ratio (aOR) 0.26; 95% confidence interval (CI) 0.19-0.35), acute myocardial infarction (AMI), ischemic stroke, hemorrhagic stroke, and major bleeding, but higher odds of pacemaker and non-elective 90-day readmissions (aOR 1.13; 95% CI 1.01-1.26). TAVR among patients with versus without PVD showed similar in-hospital mortality (aOR 1.10; 95% CI 0.94-1.20), while there were higher odds of AMI, ischemic stroke, and vascular complications after TAVR in patients with PVD. A higher burden of atherosclerotic vascular beds conferred higher mortality with SAVR more than with TAVR, while a higher burden of atherosclerotic vascular beds conferred a higher risk of ischemic stroke and readmissions after both TAVR and SAVR.</p><p><strong>Conclusions: </strong>Nationwide data demonstrated that patients with PVD who undergo TAVR were associated with lower in-hospital mortality and major cardiovascular complications compared with those who undergo SAVR. Patients with PVD have similar mortality to those with no PVD undergoing TAVR, but were associated with a higher risk for complications and readmission.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093001","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}
引用次数: 0
An External Control Arm for the Oral Factor XIa Inhibitor Asundexian Phase 2 Trial in Atrial Fibrillation (PACIFIC-AF) Using Electronic Health Records. 使用电子健康记录治疗心房颤动(PACIFIC-AF)的口服XIa因子抑制剂Asundexian 2期临床试验的外部控制臂
IF 3
Cardiology and Therapy Pub Date : 2025-05-16 DOI: 10.1007/s40119-025-00411-x
Tatsiana Vaitsiakhovich, Alexander Hartenstein, Stephen Privitera, Manesh R Patel, Jonathan P Piccini, Craig I Coleman, Khaled Abdelgawwad, Gerlind Holberg, Igor Khorlo, Hardi Mundl, Bernhard Schaefer, Thomas Viethen, Kai Vogtländer, Alexander Vowinkel, Frank Kleinjung
{"title":"An External Control Arm for the Oral Factor XIa Inhibitor Asundexian Phase 2 Trial in Atrial Fibrillation (PACIFIC-AF) Using Electronic Health Records.","authors":"Tatsiana Vaitsiakhovich, Alexander Hartenstein, Stephen Privitera, Manesh R Patel, Jonathan P Piccini, Craig I Coleman, Khaled Abdelgawwad, Gerlind Holberg, Igor Khorlo, Hardi Mundl, Bernhard Schaefer, Thomas Viethen, Kai Vogtländer, Alexander Vowinkel, Frank Kleinjung","doi":"10.1007/s40119-025-00411-x","DOIUrl":"https://doi.org/10.1007/s40119-025-00411-x","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to assess the applicability of an external control arm (ECA) approach in the clinical development of the oral factor XIa inhibitor asundexian for stroke prevention in patients with atrial fibrillation (AF), using prospectively collected data from the phase 2 PACIFIC-AF trial (NCT04218266) and real-world individual-level data from patients with AF treated with apixaban in the Optum<sup>®</sup> de-identified Electronic Health Record data set (Optum<sup>®</sup> EHR) 2013-2019.</p><p><strong>Methods: </strong>To build ECAs, real-world patients meeting trial eligibility criteria were matched to patients enrolled in PACIFIC-AF. The primary outcome was the composite of International Society on Thrombosis and Haemostasis-defined major bleeding or clinically relevant non-major bleeding. Event rates were compared between PACIFIC-AF and ECAs at 85 days of trial duration and projected up to 2 years.</p><p><strong>Results: </strong>Overall, 160,153 real-world patients met PACIFIC-AF eligibility criteria and were matched to patients from the PACIFIC-AF apixaban arm on 101 variables, with matching ratios of 1:10, 1:5, and 1:1. At day 85, the number of events for the primary outcome was 92 (3.68%) in the 1:10 ECA (2500 patients) and 6 (2.40%) in the PACIFIC-AF apixaban arm (250 patients), with incidence rates of 16.67 (90% confidence interval [CI] 13.92-19.63) and 11.10 (90% CI 4.83-19.45) per 100 person-years, respectively.</p><p><strong>Conclusions: </strong>ECAs matching the PACIFIC-AF apixaban arm could be built from EHRs with concordant event rates for key trial endpoints. The ECA approach enabled the determination of event rates for treatment duration up to 2 years, thereby informing the asundexian pivotal phase 3 trial in AF.</p>","PeriodicalId":9561,"journal":{"name":"Cardiology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076200","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}
引用次数: 0
Patient Experience of Heart Disease with Elevated Lipoprotein(a): Views from a Patient, His Physician, and a Patient Association. 心脏病伴脂蛋白升高的患者经验(a):来自患者、医生和患者协会的观点。
IF 3
Cardiology and Therapy Pub Date : 2025-05-11 DOI: 10.1007/s40119-025-00416-6
Stéphane Favereaux, Vincent Durlach, Bernard Vercoustre
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