Clinical and Applied Thrombosis/Hemostasis最新文献

{"title":"Evaluation of Rivaroxaban Exposure via Anti-Xa Levels During VTE Prophylaxis in Hospitalized Patients.","authors":"Kaitlin Blotske, Toral Patel, Toby Trujillo, Matthew Marlar, Stuart Lind, Henry Kramer, Kathryn Hassell, Tyree H Kiser","doi":"10.1177/10760296251319961","DOIUrl":"10.1177/10760296251319961","url":null,"abstract":"<p><p>Rivaroxaban was FDA-approved in 2019 for venous thromboembolism (VTE) prophylaxis in acutely ill hospitalized patients. Little to no published data is available to determine the level of correlation between rivaroxaban drug concentration and UFH/LMWH calibrated anti-Xa assays at VTE prophylactic doses of rivaroxaban 10 mg daily. This study aimed to assess the anticoagulant effects of rivaroxaban prophylactic doses using LMWH calibrated anti-Xa levels at the University of Colorado Hospital (UCH). This prospective cohort study evaluated seventy-three hospitalized patients at UCH taking rivaroxaban 10 mg daily for VTE prophylaxis from June 2023 to April 2024. Patients were enrolled if they were between the ages of 18-89 years old, received rivaroxaban 10 mg daily, and had active orders for coagulation studies. A linear regression model and coefficient of determination was used to evaluate the primary outcome assessing the relationship between rivaroxaban drug concentrations and anti-Xa levels. The LMWH calibrated anti-Xa assays were strongly correlated to rivaroxaban concentrations ranging from (1-59 ng/ml) in patients receiving rivaroxaban 10 mg daily, r² = 0.99 (<i>P</i> < .00001). Our data suggests that LMWH calibrated anti-Xa levels less than 1.40 IU/ml may indicate minimal anticoagulation effects for rivaroxaban 10 mg daily. The secondary outcomes assessing the relationship between rivaroxaban drug concentrations and time since administration, r² = 0.16 (<i>P</i> = .049), as well as time since administration of rivaroxaban and anti-Xa activity, r² = 0.15 (<i>P</i> = .066), were weakly correlated and showed a trend. Characterizing the high correlation between anti-Xa levels and rivaroxaban plasma concentrations at 10 mg daily doses, provides additional insight to rivaroxaban's anticoagulant effects in clinical practice. This can be beneficial in various clinical scenarios and has the potential to reduce the waiting time for clinical procedures.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"31 ","pages":"10760296251319961"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11808744/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Characteristics and Influencing Factors of New-Onset Atrial Fibrillation in Patients with Acute Pulmonary Embolism: A Case-Control Study.","authors":"Rui Liang, Dong Liu, Yinong Chen, Ying Tang, Qian Gao, Wanmu Xie, Yihong Sun, Zhenguo Zhai","doi":"10.1177/10760296251322779","DOIUrl":"https://doi.org/10.1177/10760296251322779","url":null,"abstract":"<p><p>BackgroundAtrial fibrillation (AF) after acute pulmonary embolism (PE) may lead to a poor prognosis. We conducted this study to explore influencing factors of new-onset AF in patients after acute PE.MethodsPatients with objectively confirmed acute PE at the China-Japan Friendship Hospital from first January 2015 to 31st May 2022 were retrospectively included in the study, and patients with new-onset AF confirmed by electrocardiography were defined as the case group. The control group was obtained from the above PE patients without new-onset AF in age matching. Patients with a history of AF, pulmonary hypertension, acute myocardial infarction, valvular heart disease and hyperthyroidism were excluded. Logistic regression was conducted to identify potential influencing factors for the development of new-onset AF in patients with acute PE. To assess the prediction value of potential variables, receiver operating characteristic curves were plotted.ResultsAmong 853 patients diagnosed with acute PE, 732 patients met the including criteria, and 29 patients with new-onset AF were identified. The median age of all patients was 74 years, with 77.6% being male. No statistically significant differences were observed between the case and control groups regarding demographic characteristics. Patients with new-onset AF had significantly enlarged right atrium, right ventricle and left atrium in echocardiography compared with control group, but no significant differences were observed in the diameter of the left ventricle and the proportion of left ventricular ejection fraction (LVEF) ≤ 40%. Right atrial enlargement (OR, 4.19; 95%CI, 1.24-15.09; P = 0.023), left atrial enlargement (OR, 14.76; 95%CI, 4.79-57.28; P < 0.001) and the simplified pulmonary embolism severity index (sPESI) (OR, 2.04; 95%CI, 1.19-3.67; P = 0.012) were associated with increased risk of new-onset AF.ConclusionsBoth severity of acute PE and enlargement of left and right atrium were associated with an increased risk of new-onset AF in patients with acute PE. In patients with high-risk acute PE, greater vigilance is needed for the occurrence of new-onset AF.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"31 ","pages":"10760296251322779"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12049626/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of Risk Factors and the Establishment of a Predictive Model for Thrombosis in Patients with Immune Thrombocytopenia.","authors":"Hui Liang, Lingxue Duan, Manyu Long, Songyuan Tie, Changyan Sun, Sha Ma, Jing Wang, Shuya Wang","doi":"10.1177/10760296241301398","DOIUrl":"https://doi.org/10.1177/10760296241301398","url":null,"abstract":"<p><strong>Objectives: </strong>To explore the risk factors for thrombi occurring in patients with immune thrombocytopenia (ITP) and establish a risk prediction model to better predict the risk of thrombosis in patients with ITP.</p><p><strong>Methods: </strong>We retrospectively analyzed 350 ITP patients who had been hospitalized in the First People's Hospital of Yunnan Province between January 2024 and June 2024. For all patients, we recorded demographic characteristics and clinical data, analyzed the risk factors for thrombosis in ITP patients and then developed a risk prediction model.</p><p><strong>Results: </strong>Stepwise logistic regression analysis indicated that a high D-dimer level, a low PC (platelet count) and a high Padua score were independent risk factors for thrombosis in ITP patients. According to multivariate analysis, a predictive model for thrombus risk showed that the area; the area under the ROC curve (AUC) was 0.673 (95% CI: 0.615-0.730) and the maximum Youden index, sensitivity and specificity were 0.272, 47.0% and 80.2%, respectively.</p><p><strong>Conclusion: </strong>A high D-dimer level, low PC, and high Padua score were shown to be independent risk factors for thrombosis in ITP patients. Also, the study showed that these three risk factors might be used as a risk predictors for thrombosis in ITP patients to some extent.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"31 ","pages":"10760296241301398"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11705361/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cardiovascular Symposium on Perspectives in Long COVID.","authors":"Robert S Dieter, Prakasha Kempaiah, Elizabeth G Dieter, Andrew Alcazar, Alfonso Tafur, Grigoris Gerotziafas, Alejandro Gonzalez Ochoa, Salem Abdesselem, Jose Biller, Nicholas Kipshidze, Patrick Vandreden, Marco Guerrini, Raymond A Dieter, Ravi Durvasula, Meharvan Singh, Jawed Fareed","doi":"10.1177/10760296251319963","DOIUrl":"10.1177/10760296251319963","url":null,"abstract":"<p><p>Significant progress has been made in treating Coronavirus disease (COVID) - an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). An ominous turn in the pandemic is the evolving public health crisis emanating from persistent SARS-CoV-2 infection and its associated long-term impact. Long COVID or post-COVID syndrome describes protean symptoms that persist at least 3 months after the onset of acute illness and last for at least 2 months in individuals with a history of confirmed SARS-CoV-2 infection. Long COVID has become a public health concern. Millions of infected individuals are now facing chronic multi-organ failures, including neuropsychiatric, cardiovascular, pulmonary, and kidney complications. In general, the cause of long COVID syndrome is unclear but factors such as prolonged activation of immune responses, and viral persistence triggering transcription dysregulation of genes associated with normal thrombotic disease may play a role in cardiovascular complications. Although inflammatory biomarkers are reported in other disorders, it remains unclear whether similar biomarkers are associated with cardiovascular manifestations following COVID. Medications such as sulodexide directed at glycocalyx and coagulation have demonstrated benefits for long COVID in smaller studies. Here, we describe the outcomes of the symposium on the underlying cardiovascular mechanisms of the long COVID.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"31 ","pages":"10760296251319963"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11822813/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406127","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Systemic Immune-Inflammatory Index as a Prognostic Biomarker in Patients with Heart Failure: A Comprehensive Analysis.","authors":"Aihaidan Abudouwayiti, Yanxiao Li, Tumaresi Tuerxun, Muyashaer Abudurexiti, Dongqin Duan, Ying-Ying Zheng, Ailiman Mahemuti","doi":"10.1177/10760296251328361","DOIUrl":"10.1177/10760296251328361","url":null,"abstract":"<p><p>ObjectiveThis study aimed to assess the prognostic significance of the Systemic Immune-Inflammatory Index (SII) in chronic heart failure (CHF) patients and evaluate its potential as a predictive biomarker.MethodsA retrospective analysis was conducted on 2748 CHF patients from the First Affiliated Hospital of Xinjiang Medical University from 2012 to 2022. The primary outcome was all-cause mortality (ACM), with readmission rates as secondary endpoints. An optimal SII cutoff value of 916.68 was determined for predicting ACM.ResultsElevated SII levels were significantly correlated with an increased risk of ACM in CHF patients across all left ventricular ejection fraction (LVEF) categories. The high SII group had a 43.8% increased risk of ACM compared to the low SII group.ConclusionSII is a significant prognostic biomarker in CHF, independent of traditional risk factors, highlighting its importance in risk stratification and clinical decision-making, and necessitating further investigation in prospective studies.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"31 ","pages":"10760296251328361"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11907554/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Value and Potential Molecular Mechanism of miR-373-3p in Coronary Atherosclerosis.","authors":"JiaYang Shen, Lihong Tang, Zhe Wang, Qiaoli Ma, Fei Lin, Hong Liu","doi":"10.1177/10760296251319953","DOIUrl":"10.1177/10760296251319953","url":null,"abstract":"<p><p>BackgroundCoronary atherosclerosis (CAS) is a chronic inflammatory condition marked by damage to the coronary artery endothelium, lipid accumulation, and fibrosis. It stands as the principal etiology of coronary heart disease (CHD).AimsThe rationale of this study was to investigate the clinical value and potential mechanism of miR-373-3p in carotid CAS.MethodsA total of 95 patients with CAS and 35 controls were enrolled in the study. RT-qPCR was used to evaluate the relative expression of miR-373-3p. ROC curve was used to analyze the diagnostic value of miR-373-3p in CAS. Logistic regression analysis was utilized to evaluate whether miR-373-3p serves as a risk factor for CAS. In addition, miR-373-3p overexpression and knockdown models of endothelial progenitor (EPCs) were established to investigate the mechanism of miR-373-3p in the regulation of EPCs.ResultsThe level of miR-373-3p in CAS patients was significantly increased. MiR-373-3p can well distinguish patients with CAS and is a risk factor for CAS. The over-expression of miR-373-3p can substantially inhibit the proliferation, migration and invasion of EPCs, and stimulate the apoptosis of EPCs. MiR-373-3p is involved in the progression of CAS by targeting VEGFA.ConclusionsAs a highly sensitive potential biomarker, miR-373-3p can predict the occurrence and progression of CAS. Additionally, miR-373-3p is involved in the progression of CAS by targeting VEGFA, which may play an essential role in the pathogenesis of CAS.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"31 ","pages":"10760296251319953"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11930461/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Graft-Versus-Host Disease Sustains Coagulation Activity for two Years After Pediatric Allogeneic Hematopoietic Stem Cell Transplantation.","authors":"Satu Långström, Minna Koskenvuo, Pasi Huttunen, Riitta Lassila, Mervi Taskinen, Susanna Ranta, Markku Heikinheimo, Anne Mäkipernaa","doi":"10.1177/10760296241304771","DOIUrl":"10.1177/10760296241304771","url":null,"abstract":"<p><strong>Aim: </strong>To evaluate the longitudinal coagulation profile after allogeneic hematopoietic stem cell transplantation (HSCT) in pediatric patients with hematological malignancies.</p><p><strong>Methods: </strong>Several coagulation variables were measured at predetermined time points for two years after HSCT in 30 pediatric patients.</p><p><strong>Results: </strong>At six months post-HSCT, endothelial activation was reflected by 1.4-fold increase in circulating von Willebrand factor activity (p < 0.05), and by 2-fold increase in thrombin-antithrombin complex levels (p < 0.05), suggesting sustained coagulation system activity. In six patients with chronic graft-versus-host disease (cGVHD), specifically in those having gastrointestinal (GI) tract cGVHD, we observed continued longitudinal alterations in the coagulation system. The activities of both, coagulation factors (FV, FVII, FVIII, fibrinogen), and natural anticoagulants (antithrombin and protein C) were higher than prior to conditioning (p < 0.05) at most time points in patients with cGVHD. Moreover, fibrin turnover marker D-dimer was elevated from 6 to 18 months after HSCT (p < 0.05).</p><p><strong>Conclusion: </strong>Pediatric patients undergoing HSCT demonstrate prolonged derangement of the coagulation system, with a new alleviating balance after 6 months post-HSCT. However, in patients with cGVHD, and in particular when cGVHD affects the GI tract, the persisting derangement of coagulation suggest its contributing role in cGVHD and related complications.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"31 ","pages":"10760296241304771"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795608/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143188515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correlation Between the Transient Increase of D-Dimer and Thrombolysis at 30d after Anticoagulation Therapy in Patients with Pulmonary Embolism.","authors":"Yang Danrong, Zhang Yan, Liu Yi","doi":"10.1177/10760296251335250","DOIUrl":"https://doi.org/10.1177/10760296251335250","url":null,"abstract":"<p><p>ObjectiveThis study aimed to investigate the relationship between the transient increase in D-dimer following anticoagulant therapy and thrombolysis at 30 days in patients with pulmonary embolism (PE).MethodPatients diagnosed with PE at our hospital were included in the study. CT pulmonary angiography (CTPA) was performed 7-10 days after starting anticoagulant therapy. Patients were divided into two groups: the change group and the non-change group, based on whether the thrombus had broken into smaller clots and/or dissolved compared to baseline. Plasma D-dimer levels were measured 1-10 days after anticoagulant therapy to observe any transient increase. The correlation between the transient D-dimer increase and thrombolysis at 30 days in PE patients was analyzed.ResultsA total of 172 patients with PE were included. The rate of thrombus change was 63.4% (75/172) at 7-10 days after anticoagulant therapy. The proportion of thrombolysis at 30 days was 68.6% (118/172). Spearman correlation analysis showed a significant correlation between the transient increase in D-dimer and thrombus changes (Rs = 0.482, <i>P</i> < .001), between thrombus changes and thrombolysis at 30 days (Rs = 0.413, <i>P</i> < .001), and between the transient increase in D-dimer and thrombolysis at 30 days (Rs = 0.540, <i>P</i> < .001). ROC curve analysis indicated that the transient increase in D-dimer predicted thrombus changes (AUC: 0.750, 95%CI: 0.673-0.827, <i>P</i> < .001), and predicted thrombolysis at 30 days (AUC: 0.786, 95%CI: 0.714-0.858, <i>P</i> < .001). Thrombus changes also predicted thrombolysis at 30 days (AUC: 0.712, 95%CI: 0.626-0.797, <i>P</i> = .001).ConclusionAfter anticoagulant therapy for PE, D-dimer levels may transiently increase. The rate of thrombolysis at 30 days was higher, and a transient increase in D-dimer indicated a higher likelihood of thrombolysis at 30 days.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"31 ","pages":"10760296251335250"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12035247/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Incidence, Risk Factors and Characteristics of Late (>2 Years) Recurrence of Deep Venous Thrombosis.","authors":"Bo Wu, Jian Fu, Haiyang Wang, Haiyan Yan, Jianming Sun, Haoyuan Wang, Lili Zhang","doi":"10.1177/10760296251332937","DOIUrl":"https://doi.org/10.1177/10760296251332937","url":null,"abstract":"<p><p>ObjectiveRecurrent deep venous thrombosis (RDVT) is a relatively frequent phenomenon; however, scarce literature is available on late RDVT (>2 years). This study aimed to investigate the incidence, associated risk factors, and characteristics of late RDVT.MethodsWe conducted a retrospective analysis of patients diagnosed with symptomatic lower extremity deep venous thrombosis (DVT) between April 2017 and April 2022. The incidence and mortality rates of late RDVT, as well as the demographic data, risk factors, and characteristics, were assessed. Additionally, a comprehensive Cox regression analysis was performed to evaluate 14 potential risk factors.ResultsOf the 638 patients with DVT, 89 (13.9%) experienced recurrence during a mean follow-up period of 30.10 ± 15.23 months. The RDVT group comprised 50 males and 39 females (the male-to-female ratio: 50/39), with a mean age of 64.08 ± 13.23 years (the age range: 26-88 years). Among them, early recurrence was observed in 57 (64%) patients, while late recurrence occurred in 32 (36%) after their initial symptomatic DVT episode. Late RDVT predominantly manifested in the contralateral lower extremity. Multivariate Cox regression analysis further identified proximal DVT, immobility, non-retrieved inferior vena cava filter (IVCF), and ≥50% stent extension into the inferior vena cava (IVC) as significant risk factors for late RDVT. Moreover, mortality among patients with late RDVT was low, with 2 (6.25%) dying during the follow-up period.ConclusionsLate RDVT is relatively infrequent within the RDVT cohort and primarily manifests in the contralateral lower extremity. Furthermore, patients with late RDVT have a low mortality rate. Proximal DVT, immobility, non-retrieved IVCF, and ≥50% stent extension into the IVC are strongly correlated with the development of late RDVT.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"31 ","pages":"10760296251332937"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12033397/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143964014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Efficacy of the Use of pdVWF/FVIII-C in Patients with von Willebrand Disease: A Prospective, Observational, Post-Authorization Study.","authors":"Olga Benítez Hidalgo, Cristina Marzo Alonso, Francisco José López Jaime, Marina Carrasco, Maria Del Mar Nieto Hernández, Natalia Afonso, Alejhandra Lei, Dermot Whyms, Kim Hanna, Maria Esperança Aragonés, Mireia Torres, Juan Oliveras","doi":"10.1177/10760296251327593","DOIUrl":"10.1177/10760296251327593","url":null,"abstract":"<p><p>IntroductionPlasma-derived von Willebrand factor containing FVIII concentrates (pdVWF/FVIII-C) are indicated as replacement therapy for patients with von Willebrand disease (VWD). This study assessed safety and efficacy associated with long-term real-world experience of the pdVWF/FVIII-C, Fanhdi^®, in patients with VWD.MethodsThis observational, prospective, post-authorization cohort study was conducted at five centers in Spain. Patients with VWD were treated with the pdVWF/FVIII-C to achieve satisfactory hemostasis for on-demand (bleeding episodes and surgical/invasive procedures) and prophylaxis treatment. Clinical efficacy was evaluated as the response to treatment in both settings. Safety parameters were assessed.ResultsFifteen VWD patients received at least one dose of the pdVWF/FVIII-C and were followed for 12 months. Forty-six bleeding episodes were reported for 9 (60.0%) patients, and 6 surgical/invasive procedures for 5 (33.3%) patients. Most frequently reported bleedings were gastrointestinal (3 [33.0%] patients) and gynecological (3 [33.0%] patients). No complications nor bleeding episodes related to surgical/invasive procedures were reported. Overall clinical efficacy of treatment (including on-demand and prophylaxis) achieved 100% excellent and/or good (n = 15 patients), being excellent for 7 (46.7%) patients. There were 27 treatment-emergent adverse events in 8 (53.3%) patients, 11 serious adverse events in 3 (20.0%) patients, but none of them were drug-related. No clinical signs and symptoms of immunogenicity or thromboembolic events were reported.ConclusionsThis real-world evidence study confirmed the efficacy of the pdVWF/FVIII-C as on-demand and/or prophylaxis treatment in patients with bleeding episodes or surgical procedures in VWD. Fanhdi^® was well tolerated without any safety concerns.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"31 ","pages":"10760296251327593"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11907537/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}