Clinical and Applied Thrombosis/Hemostasis最新文献

{"title":"Platelet Function Testing to Guide Cangrelor Dosing in Patients with Temporary Mechanical Circulatory Support or as a Bridge to Procedure.","authors":"Margaret M Buck, Chelsea I Barry, Courtney A Montepara, Nathan J Verlinden","doi":"10.1177/10760296241237228","DOIUrl":"10.1177/10760296241237228","url":null,"abstract":"<p><p>Cangrelor is a rapid-acting, intravenous P2Y12 inhibitor that can be used in patients after percutaneous coronary intervention who require mechanical circulatory support or as a bridge to procedure. We retrospectively reviewed adult patients who received platelet function testing (PFT) with the VerifyNow P2Y12 assay while on cangrelor from March 2021 through November 2022. All patients were initiated on 0.75 mcg/kg/min of cangrelor with P2Y12 reaction unit (PRU) values collected 12-24 h after initiation. Cangrelor doses were adjusted per protocol to maintain PRU values of 85-208. A total of 42 patients were included. Thirty-eight patients (90.5%) required temporary mechanical circulatory support while on cangrelor, and 4 patients (9.5%) received cangrelor as a bridge to procedure. The median cangrelor maintenance dose was 0.5 (interquartile range [IQR]: 0.375-0.75) mcg/kg/min, and the median time in therapeutic range with a PRU value between 85 and 208 was 66.6% (IQR: 39.6%-100%). No patients experienced stent thrombosis. A composite major adverse cardiovascular event occurred in 4 patients (9.5%), and major bleeding occurred in 16 patients (38.1%). Compared to empiric cangrelor dosing of 0.75 mcg/kg/min, PFT-guided cangrelor dose adjustment was associated with a median drug cost savings of $1605.60 (IQR: $0-4281.56). Utilizing PFT with cangrelor may allow for lower, individualized dosing while preventing stent thrombosis.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"30 ","pages":"10760296241237228"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10916455/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140027479","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 Contribution of Inherited Thrombophilia to Venous Thromboembolism in Cancer Patients.","authors":"José Costa, António Araújo","doi":"10.1177/10760296241232864","DOIUrl":"10.1177/10760296241232864","url":null,"abstract":"<p><p>Although the relationship between venous thromboembolism (VTE) and cancer has been a subject of study, knowledge of the contribution of thrombophilia to thrombosis in patients with cancer is still very limited. The aim of this article is to collect present knowledge on the contribution of inherited thrombophilia to VTE in cancer patients. We performed a search in Google Scholar and PubMed and selected 21 from 76 returned articles. Then we made a narrative review of the selected articles. We describe 11 studies on the contribution of inherited thrombophilia to VTE in cancer patients in general and 10 on that contribution in specific types of cancer: 1 in colorectal cancer, 4 in breast cancer, 1 in gynecologic cancer and 4 in hematopoietic malignancies. All studies investigate the relation of factor V Leiden (FVL) to VTE, 13 that of the prothrombin G20210A mutation (PTG20210A) and 7 studies also investigate other inherited thrombophilias, such methylenetetrahydrofolate reductase gene mutations, although only 2 investigate the contribution of deficiencies of the natural anticoagulants. Studies are very heterogeneous, in design and sample size and conclusions differ considerably. There is no consensus on the contribution of inherited thrombophilia to VTE in cancer patients except for acute lymphoblastic leukemia in children. Probably, that contribution is not the same for all types of cancer and more studies are needed to bring more knowledge on this subject.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"30 ","pages":"10760296241232864"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10916497/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140038877","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 Role of HATCH Score in the Prediction of Ischemic Cerebrovascular Events in Patients with Heart Failure and Atrial Fibrillation.","authors":"Sidar Şiyar Aydın, Emrah Aksakal","doi":"10.1177/10760296241227935","DOIUrl":"10.1177/10760296241227935","url":null,"abstract":"<p><p>The presence of both atrial fibrillation (AF) and heart failure (HF) increases the risk of an ischemic cerebrovascular event (CVE) by roughly fivefold. The HATCH score is a score used to predict new-onset AF. Although there are some differences, it contains risk factors similar to the CHA2DS2-VASc score. Our study aimed to investigate the relationship between the HATCH score and ischemic CVE. This retrospective study obtained data from 1719 HF patients between 2015 and 2022. About 673 patients with AF were included in the study. In the univariate and multivariate Cox regressions, we found that CHA2DS2-VASc and HATCH scores were independent predictors of ischemic CVE (<b>p = 0.001</b> and <b>< p = 0.001</b>, respectively). The ROC analysis, AUC for the CHA2DS2-VASc score was 0.884 (95% CI 0.828-0.940, <b><p = 0.001</b>). For the HATCH score, the AUC was 0.978 (95% CI 0.966-0.991, <b><p = 0.001</b>). The HATCH score can be an independent predictor of the development of ischemic CVE in HF patients with AF.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"30 ","pages":"10760296241227935"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10798104/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139490818","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":"Coagulation Testing in Real-World Setting: Insights From a Comprehensive Survey.","authors":"Hae In Bang, Ja Young Lee, Hyun-Young Kim, Saeam Shin, Myung Hyun Nam, In-Suk Kim, Ji Myung Kim, Jong-Hyun Yoon, Myung-Geun Shin, Sang Mee Hwang, Sun-Young Kong","doi":"10.1177/10760296241228239","DOIUrl":"10.1177/10760296241228239","url":null,"abstract":"<p><p>The objective of this survey was to gain a real-world perspective on coagulation testing by evaluating the availability of various coagulation laboratory tests, assessing specific analytic and postanalytic steps in clinical laboratories in Korea.Participants were surveyed using a 65-question questionnaire specifically focused on their coagulation testing practices related to prothrombin time (PT), activated partial thromboplastin time (aPTT), plasma-mixing studies, lupus anticoagulant (LA) tests, platelet function tests, coagulation factor assays, and the composition of hemostasis and thrombosis test panels. The survey was performed between July and September 2022.The survey achieved a 77.9% (81 of 104) response rate. PT or aPTT tests were performed directly at all participating institutions, followed by D-dimer and fibrinogen tests, platelet function test, and plasma-mixing studies in order of frequency. Variations existed in the performance of mixing test and LA assessment. Patterns of coagulating testing differed depending on the size of the hospital. The survey revealed that most laboratories conducted coagulation tests following the international guidelines such as Clinical Laboratory Standards Institute guidelines and the Korean Laboratory Certification system. However, some coagulation tests, including mixing test and LA tests, are yet to be standardized in Korea.Continuous education on coagulation test methods and internal and external quality control are required to encourage laboratories to enhance the performance of coagulation testing.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"30 ","pages":"10760296241228239"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10851719/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139696975","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":"Endogenous Dysregulation of Thromboinflammatory Biomarkers in End-Stage Renal Disease, and Their Amplification by Heart Failure.","authors":"Vanessa Robbin, Vinod Bansal, Fakiha Siddiqui, Madeline Allen, Debra Hoppensteadt-Moorman, Bulent Kantarcioglu, Emma Abulencia, Evangeline Magpoc, Jawed Fareed, Mushabbar Syed","doi":"10.1177/10760296241263858","DOIUrl":"10.1177/10760296241263858","url":null,"abstract":"<p><p>In patients with end-stage renal disease (ESRD), heart failure with reduced ejection fraction (HFrEF) is a common comorbidity. Thromboinflammatory processes in both conditions represent complex pathophysiology, demonstrated by dysregulation of thromboinflammatory biomarkers, and commonly resulting in the combined pathology of cardiorenal syndrome. We sought to investigate the effects of HFrEF on these biomarkers in patients with ESRD, and observe the relationship to mortality. Blood samples from 73 patients with ESRD (mean age 67 ± 13 years, 56% male) and 40 healthy controls were analyzed via enzyme-linked immunosorbent assay and other chromogenic methods for angiopoietin-2 (Ang2), endogenous glycosaminoglycans, fatty acid binding protein, interleukin-6, lipopolysaccharide, free fatty acids, NT-pro B-type natriuretic peptide, tumor necrosis factor α, vascular endothelial growth factor, and von Willebrand factor. Patients were stratified into those with or without HFrEF (EF < 50%). Patients had highly prevalent comorbidities including coronary artery disease 46%, diabetes 69%, hypertension 97%, and smoking 49%. Most biomarkers were upregulated in ESRD compared to controls. Patients with HFrEF and ESRD had greater interleukin-6 and NT-pro B-type natriuretic peptide and lesser lipopolysaccharide compared to ESRD only. Spearman correlations between most biomarkers were increased in HFrEF + ESRD over ESRD only. Ang-2 was associated with mortality in this cohort. The dysregulation of thromboinflammation in ESRD is somewhat amplified in comorbid HFrEF. Correlation among biomarkers in this cohort indicates the mechanisms of thromboinflammatory biomarker generation in ESRD and HFrEF share an integrative process. Ang2, interleukin-6, and lipopolysaccharide show promise as biomarkers for risk stratification among patients with both HFrEF and ESRD.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"30 ","pages":"10760296241263858"},"PeriodicalIF":2.3,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11325466/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975239","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":"Optimal Antithrombotic Regimen After Cryptogenic Stroke: A Systematic Review and Network Meta-Analysis.","authors":"Mohamed Abuelazm, Ahmed Mazen Amin, Hossam Tharwat Ali, Mohammed Ayyad, Abubakar Nazir, Mohammad Tanashat, Shrouk Ramadan, Basel Abdelazeem, James Robert Brašić","doi":"10.1177/10760296241309639","DOIUrl":"10.1177/10760296241309639","url":null,"abstract":"<p><p>Although several antithrombotic strategies have been investigated for the management of cryptogenic strokes, ie, ischemic strokes without known etiologies, an optimal antithrombotic strategy for cryptogenic strokes is unknown. We aim to assess oral antithrombotic agents' comparative efficacy and safety after cryptogenic stroke to identify an optimal treatment.A systematic review and meta-analysis synthesizing evidence from randomized controlled trials (RCTs) obtained from PubMed, Embase Cochrane, Scopus, and Web of Science until February 2024. We used the random-effects model to report dichotomous outcomes using a risk ratio (RR) with a 95% confidence interval (CI). Frequentist network meta-analysis was conducted using R, version 4.3.1.Seven RCTs with 15,240 patients were included. None of the OACs showed a significant efficacy in preventing all-cause mortality, stroke recurrence, cardiovascular mortality, and major adverse cardiac events compared to aspirin. Also, safety measures were similar between different OACs and aspirin regarding safety measures, including major bleeding, intracranial hemorrhage, and gastrointestinal bleeding. However, only rivaroxaban significantly increased the incidence of major bleeding (RR: 2.69, CI [1.67, 4.33]).There was no difference between various OACs and aspirin regarding efficacy and safety outcomes. There is a greater risk of major bleeding with rivaroxaban. Further research is still warranted to define a personalized strategy for selecting antithrombotic strategies after cryptogenic stroke on a case-by-case basis.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"30 ","pages":"10760296241309639"},"PeriodicalIF":2.3,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11672598/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881308","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":"Immature Platelet Fraction and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation.","authors":"Lee Oppenheim, Ranel Loutati, David Marmor, Nimrod Perel, Meir Tabi, Louay Taha, Danny Dvir, Mony Shuvy, Rami Jubeh, Michael Glikson, Elad Asher","doi":"10.1177/10760296241232852","DOIUrl":"10.1177/10760296241232852","url":null,"abstract":"<p><strong>Introduction: </strong>Immature platelets or reticulated platelets are newly released thrombocytes. They can be identified by their large size and high RNA cytoplasm concentration. Immature platelet fraction (IPF) represents the percentage of immature circulative platelets relative to the total number of platelets. The role of IPF in patients undergoing transcatheter aortic valve implantation (TAVI) is unknown. The aim of the current trial was to assess the levels of IPF in patients undergoing TAVI and correlation with clinical outcomes.</p><p><strong>Material and methods: </strong>Immature platelet fraction levels were measured 3 times in all patients (preprocedure, 1-2 days post-procedure and 1-month post-procedure). Immature platelet fraction measurement was carried out using an autoanalyzer (Sysmex XE-2100). Patients were followed for 12 months. Primary outcomes were defined as complications during hospitalizations, rehospitalization, and mortality.</p><p><strong>Results: </strong>Fifty-one patients were included in the study. Mean age was 79.8 (±9.6), and 28 (55%) were women. Twenty-one patients (41%) had complications: Of them, 6 of 21 (29%) occurred during hospitalizations (2-vascular complications; 2-sepsis, 2-implantation of a pacemaker), 9 of 21 (43%) patients were rehospitalized after the index admission, and 6 patients died during the follow-up period. Multivariate Cox regression analysis found that IPF < 7% in at least one of the 3 tests was associated with worse outcomes (hazard ratio 3.42; 95% CI 1.11-10.5, <i>P</i> = .032).</p><p><strong>Conclusion: </strong>Immature platelet fraction >7% in patients undergoing TAVI is associated with worse outcomes. Further studies are needed to better understand this phenomenon.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"30 ","pages":"10760296241232852"},"PeriodicalIF":2.9,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10880521/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139912180","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":"Specific Reversal Agents for Direct Oral Anticoagulants in Acute Stroke.","authors":"Senta Frol, Janja Pretnar Oblak, Mišo Šabovič, Wim H van Zwam, George Ntaios, Karl Olof Lövblad, Andreas Gruber, Pawel Kermer","doi":"10.1177/10760296241279545","DOIUrl":"10.1177/10760296241279545","url":null,"abstract":"<p><p>Direct oral anticoagulants (DOACs) changed stroke prevention and decreased the risk of ischemic and hemorrhagic complications in patients on oral anticoagulation (OAC) therapy. The numbers of patients prescribed DOACs has increased rapidly. Availability of specific reversal agents opened new avenues in the prevention and management of DOAC complications. An ideal specific reversal agent for a DOAC in acute stroke is an agent which lacks safety concerns and immediately reverses DOAC anticoagulation activity, thereby enabling effective treatment. Reversal of anticoagulant activity is mandatory in patients with acute ischemic stroke (AIS) before performing therapeutic procedures such as intravenous thrombolysis (IVT) and neurosurgery in intracranial hemorrhage (ICH) in order to improve clinical outcomes. In this manuscript we pursue an interdisciplinary approach in discussing advantages and concerns of specific reversal agents in acute stroke DOAC-treated patients in everyday clinical practice.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"30 ","pages":"10760296241279545"},"PeriodicalIF":2.3,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11348480/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142055117","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":"Factor Xa Inhibitors Versus Vitamin K Antagonists in Atrial Fibrillation Patients with End-Stage Kidney Disease on Dialysis: A Meta-Analysis.","authors":"Meimei Xiong, Linjuan Guo, Yun Wan","doi":"10.1177/10760296241271423","DOIUrl":"10.1177/10760296241271423","url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation (AF) is prevalent among patients with end-stage kidney disease (ESKD) undergoing dialysis, and both conditions are associated with a heightened risk of cardiovascular diseases. Anticoagulation is essential for preventing thromboembolic complications in these patients. This study aimed to evaluate the effects of factor Xa inhibitors compared to vitamin K antagonists (VKAs) for AF patients on dialysis.</p><p><strong>Methods: </strong>A comprehensive search of PubMed and Embase databases was conducted to identify relevant studies published up to June 2024. Eligible studies compared factor Xa inhibitors (rivaroxaban, apixaban, edoxaban) with VKAs in AF patients on dialysis, with primary outcomes of stroke or systemic embolism(SSE) and major bleeding.</p><p><strong>Results: </strong>A total of 7 studies (3 randomized controlled trials and 4 observational cohorts) were included. For the RCTs, the use of factor Xa inhibitors was associated with a reduced risk of SSE compared to VKAs (odds ratio [OR] = 0.37, 95% confidence interval [CI]:0.15-0.93). There was no significant difference in the risk of major bleeding events between the two groups (OR = 0.65, 95%CI:0.32-1.33). Observational cohort studies yielded similar results with a decreased risk of SSE (hazard ratio [HR] = 0.74, 95%CI:0.57-0.96) and no significant difference in major bleeding (HR = 0.87, 95%CI:0.62-1.22). No differences in treatment effect between apixaban and rivaroxaban were observed for efficacy (p-interaction = 0.44) and safety (p-interaction = 0.21) outcomes.</p><p><strong>Conclusion: </strong>Factor Xa inhibitors, particularly apixaban and rivaroxaban, were associated with a lower risk of SEE without an increase in major bleeding, which might be convenient alternatives to VKAs in managing AF in patients with ESKD on dialysis.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":"30 ","pages":"10760296241271423"},"PeriodicalIF":2.3,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11325465/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975240","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":"Real-World Efficacy and Safety of Plasma-Derived Von Willebrand Factor-Containing Factor VIII Concentrates in Patients With Von Willebrand Disease in Italy.","authors":"Augusto B Federici, Rita Carlotta Santoro, Cristina Santoro, Lisa Pieri, Roberto Mario Santi, Giovanni Barillari, Alessandra Borchiellini, Alberto Tosetto, Ezio Zanon, Raimondo De Cristofaro, Esther Mairal, Roser Mir","doi":"10.1177/10760296241264541","DOIUrl":"10.1177/10760296241264541","url":null,"abstract":"<p><p>Plasma-derived von Willebrand factor-containing factor VIII concentrates (pd-VWF/FVIII-C) are the mainstay of treatment in von Willebrand disease (VWD). Real-world data on efficacy and safety of these pd-VWF/FVIII-C are required. To retrospectively evaluate the efficacy and safety of pd-VWF/FVIII-C (Fanhdi® and Alphanate®, Grifols) in clinical practice in Italy. A multicentric, observational, retrospective study at 10 Italian centers was conducted. Eligible patients diagnosed with inherited VWD (ISTH criteria) were treated with either Fanhdi® or Alphanate® for bleeding episodes, prevention of surgical bleeding and secondary long-term prophylaxis (SLTP) according to clinical practice with medical records collected from January 2007 to December 2019. Efficacy/safety of pd-VWF/FVIII-C was assessed according to FDA-agreed objective criteria following regulatory procedures. Fifty-seven patients (M/F: 21/36) were enrolled in the study with the following VWD types: VWD1 (n = 29, 52%), VWD2A (n = 10, 18%), VWD2B (n = 7, 12%), VWD2M (n = 2, 4%), VWD2N (n = 1, 2%), VWD2 unclassified (n = 1, 2%), and VWD3 (n = 7, 12%). These pd-VWF/FVIII-C were used to manage 58 bleeding episodes (n = 24 patients), 100 surgeries (n = 47 patients), and 7 SLTP (n = 6 patients). Global clinical efficacy with these pd-VWF/FVIII-C was reported to be excellent/good in 85% of bleeding episodes, 98% of surgeries, and 100% of SLTP. As far as safety, no adverse-drug-related episodes, immunogenic or thrombotic events were reported. This study confirmed that Fanhdi® and Alphanate® were effective and safe in the management of bleeding episodes, the prevention of bleeding during surgeries and for SLTP in Italian patients with inherited VWD.</p>","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":" ","pages":"10760296241264541"},"PeriodicalIF":2.3,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11403693/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141733696","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}