ObjectiveTo investigate the correlation between neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and risk stratification indicators as well as thrombus burden in patients with moderate-to-high risk acute pulmonary embolism (APE), and to assess the changes in these parameters following interventional therapy.MethodsThis study retrospectively included patients with moderate-to-high risk APE who were admitted to the Department of Interventional Vascular Surgery at Putian First Hospital from May 2020 to May 2024. All patients received anticoagulation therapy, pulmonary artery catheter-directed thrombolysis, and/or mechanical thrombectomy. Patients were further divided into subgroup A if they did not present with any of the following conditions at admission: a) acute inflammatory diseases (including lung infections); b) malignant tumors; c) history of trauma or surgery within the past 2 months. Patients with any of the aforementioned conditions were classified as subgroup B. Additionally, 50 healthy individuals were randomly selected as the healthy control group.ResultsThe NLR and PLR in subgroup A were significantly lower than those in subgroup B ( P < .01). Compared with the healthy control group, the NLR in the APE group and subgroup A was significantly higher ( P < .001). There were no significant differences in NLR and PLR between the troponin I-negative and troponin I-positive groups ( P > .05), or between the N-terminal pro-B-type natriuretic peptide (NT-proBNP)-negative and NT-proBNP-positive groups ( P > .05). There were no significant correlations between NLR and PLR with risk stratification indicators and pulmonary artery embolism index ( P > .05). Compared with before treatment, NLR, troponin I, NT-proBNP, right ventricular diameter/left ventricular diameter ratio, and pulmonary artery embolism index were significantly reduced after treatment ( P < .05), while there was no significant difference in PLR before and after treatment ( P > .05).ConclusionElevated NLR in patients with APE, which decreases after effective treatment, may be used for assessing disease status and treatment efficacy. However, there is no correlation between NLR and risk stratification indicators or thrombus burden. PLR does not demonstrate significant value in assessing APE.
目的探讨中高危急性肺栓塞（APE）患者的中性粒细胞与淋巴细胞比值（NLR）、血小板与淋巴细胞比值（PLR）、风险分层指标以及血栓负荷之间的相关性，并评估介入治疗后这些指标的变化。方法本研究回顾性纳入了2020年5月至2024年5月期间莆田市第一医院介入血管外科收治的中高危APE患者。所有患者均接受了抗凝治疗、肺动脉导管引导溶栓和/或机械取栓术。如果患者在入院时没有出现以下情况，则进一步分为 A 亚组：a) 急性炎症性疾病（包括肺部感染）；b) 恶性肿瘤；c) 在过去 2 个月内有外伤或手术史。结果A亚组的NLR和PLR明显低于B亚组（P< .01）。与健康对照组相比，APE 组和 A 亚组的 NLR 明显更高（P < .001）。肌钙蛋白 I 阴性组和肌钙蛋白 I 阳性组之间的 NLR 和 PLR 没有明显差异（P > .05），N-末端前 B 型钠尿肽（NT-proBNP）阴性组和 NT-proBNP 阳性组之间也没有明显差异（P > .05）。NLR和PLR与风险分层指标和肺动脉栓塞指数无明显相关性（P > .05）。与治疗前相比，NLR、肌钙蛋白 I、NT-proBNP、右室直径/左室直径比值和肺动脉栓塞指数在治疗后明显降低（P <.05），而 PLR 在治疗前后无明显差异（P >.05）。然而，NLR 与风险分层指标或血栓负荷之间没有相关性。PLR在评估APE方面没有显示出重要价值。
{"title":"Correlation Between Neutrophil-to-Lymphocyte Ratio and Platelet-to-Lymphocyte Ratio with Risk Stratification Indicators and Thrombus Burden in Patients with Moderate-to-High Risk Acute Pulmonary Embolism, and Changes After Treatment","authors":"Xiaojie Gao, Huang Chen, Zhongjie Huang, Jianxiong Lin, Jinqi Huang, Qihong Chen","doi":"10.1177/10760296241285446","DOIUrl":"https://doi.org/10.1177/10760296241285446","url":null,"abstract":"ObjectiveTo investigate the correlation between neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and risk stratification indicators as well as thrombus burden in patients with moderate-to-high risk acute pulmonary embolism (APE), and to assess the changes in these parameters following interventional therapy.MethodsThis study retrospectively included patients with moderate-to-high risk APE who were admitted to the Department of Interventional Vascular Surgery at Putian First Hospital from May 2020 to May 2024. All patients received anticoagulation therapy, pulmonary artery catheter-directed thrombolysis, and/or mechanical thrombectomy. Patients were further divided into subgroup A if they did not present with any of the following conditions at admission: a) acute inflammatory diseases (including lung infections); b) malignant tumors; c) history of trauma or surgery within the past 2 months. Patients with any of the aforementioned conditions were classified as subgroup B. Additionally, 50 healthy individuals were randomly selected as the healthy control group.ResultsThe NLR and PLR in subgroup A were significantly lower than those in subgroup B ( P < .01). Compared with the healthy control group, the NLR in the APE group and subgroup A was significantly higher ( P < .001). There were no significant differences in NLR and PLR between the troponin I-negative and troponin I-positive groups ( P > .05), or between the N-terminal pro-B-type natriuretic peptide (NT-proBNP)-negative and NT-proBNP-positive groups ( P > .05). There were no significant correlations between NLR and PLR with risk stratification indicators and pulmonary artery embolism index ( P > .05). Compared with before treatment, NLR, troponin I, NT-proBNP, right ventricular diameter/left ventricular diameter ratio, and pulmonary artery embolism index were significantly reduced after treatment ( P < .05), while there was no significant difference in PLR before and after treatment ( P > .05).ConclusionElevated NLR in patients with APE, which decreases after effective treatment, may be used for assessing disease status and treatment efficacy. However, there is no correlation between NLR and risk stratification indicators or thrombus burden. PLR does not demonstrate significant value in assessing APE.","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142249581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-14DOI: 10.1177/10760296241279800
You-li Jiang, Qing-shi Zhao, Ao Li, Zong-bi Wu, Lin-lin Liu, Fu Lin, Yan-feng Li
Background: Thrombolytic therapy is essential for acute ischemic stroke (AIS) management but poses a risk of hemorrhagic transformation (HT), necessitating accurate prediction to optimize patient care. Methods: A comprehensive search was conducted across PubMed, Web of Science, Scopus, Embase, and Google Scholar, covering studies from inception until July 10, 2024. Studies were included if they used machine learning (ML) or deep learning algorithms to predict HT in AIS patients treated with thrombolysis. Exclusion criteria included studies involving endovascular treatments and those not evaluating model effectiveness. Data extraction and quality assessment were performed following PRISMA guidelines and using the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) and Prediction Model Risk of Bias Assessment Tool (PROBAST) tools. Results: Out of 1943 identified records, 12 studies were included in the final analysis, encompassing 18 007 AIS patients who received thrombolytic therapy. The ML models demonstrated high predictive performance, with pooled area under the curve (AUC) values ranging from 0.79 to 0.95. Specifically, XGBoost models achieved AUCs of up to 0.953 and Artificial Neural Network (ANN) models reached up to 0.942. Sensitivity and specificity varied significantly, with the highest sensitivity at 0.90 and specificity at 0.99. Significant predictors of HT included age, glucose levels, NIH Stroke Scale (NIHSS) score, systolic and diastolic blood pressure, and radiomic features. Despite these promising results, methodological disparities and limited external validation highlighted the need for standardized reporting and further rigorous testing. Conclusion: ML techniques, especially XGBoost and ANN, show great promise in predicting HT following thrombolysis in AIS patients, enhancing risk stratification and clinical decision-making. Future research should focus on prospective study designs, standardized reporting, and integrating ML assessments into clinical workflows to improve AIS management and patient outcomes.
{"title":"Advanced Machine Learning Models for Predicting Post-Thrombolysis Hemorrhagic Transformation in Acute Ischemic Stroke Patients: A Systematic Review and Meta-Analysis","authors":"You-li Jiang, Qing-shi Zhao, Ao Li, Zong-bi Wu, Lin-lin Liu, Fu Lin, Yan-feng Li","doi":"10.1177/10760296241279800","DOIUrl":"https://doi.org/10.1177/10760296241279800","url":null,"abstract":"Background: Thrombolytic therapy is essential for acute ischemic stroke (AIS) management but poses a risk of hemorrhagic transformation (HT), necessitating accurate prediction to optimize patient care. Methods: A comprehensive search was conducted across PubMed, Web of Science, Scopus, Embase, and Google Scholar, covering studies from inception until July 10, 2024. Studies were included if they used machine learning (ML) or deep learning algorithms to predict HT in AIS patients treated with thrombolysis. Exclusion criteria included studies involving endovascular treatments and those not evaluating model effectiveness. Data extraction and quality assessment were performed following PRISMA guidelines and using the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) and Prediction Model Risk of Bias Assessment Tool (PROBAST) tools. Results: Out of 1943 identified records, 12 studies were included in the final analysis, encompassing 18 007 AIS patients who received thrombolytic therapy. The ML models demonstrated high predictive performance, with pooled area under the curve (AUC) values ranging from 0.79 to 0.95. Specifically, XGBoost models achieved AUCs of up to 0.953 and Artificial Neural Network (ANN) models reached up to 0.942. Sensitivity and specificity varied significantly, with the highest sensitivity at 0.90 and specificity at 0.99. Significant predictors of HT included age, glucose levels, NIH Stroke Scale (NIHSS) score, systolic and diastolic blood pressure, and radiomic features. Despite these promising results, methodological disparities and limited external validation highlighted the need for standardized reporting and further rigorous testing. Conclusion: ML techniques, especially XGBoost and ANN, show great promise in predicting HT following thrombolysis in AIS patients, enhancing risk stratification and clinical decision-making. Future research should focus on prospective study designs, standardized reporting, and integrating ML assessments into clinical workflows to improve AIS management and patient outcomes.","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142249585","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-10DOI: 10.1177/10760296241283821
Lin Zhang, Chuli Jiang, Zheng Chen, Wei Song, Yu Zhao, Fenghe Li
This study aimed to evaluate the safety and efficacy of pharmacomechanical catheter-directed thrombolysis (PCDT) and stenting for treating acute iliofemoral deep venous thrombosis (DVT) combined with iliac vein compression syndrome (IVCS), and to identify the predictors of stent restenosis. Patients with acute proximal DVT combined with IVCS underwent PCDT and stenting from January 2017 to December 2022 were enrolled. Primary and secondary patency were assessed by duplex ultrasound (DUS). The morbidity of postthrombotic syndrome (PTS) was assessed by the Villalta score. Risk factors for stent restenosis were assessed using univariate and multivariate Cox regression models. Total of 254 patients were included. The mean follow-up time was 36.06 ± 17.66 months. The primary patency rates at 1 year, 3 years, and 5 years were 92.5%±1.7%, 85.4%±2.4%, and 82.4%±2.9%, respectively. The incidence of stent restenosis was 14.2%. Discontinuation of anticoagulants within one year [hazard ratio (HR) = 5.03; P = .048] was the factor associated with acute in-stent thrombosis. Previous DVT history (HR =2.29; P = .037) and stent placement across the inguinal ligament (HR =6.70; P < .001) were identified as independent risk factors significantly associated with stent restenosis. The overall PTS rate was 19.3%. PCDT with stenting is safe and effective for patients with iliofemoral DVT secondary to IVCS, leading to low rates of PTS. Previous DVT history and stents placed across the inguinal ligament may be predictors of stent restenosis. Furthermore, stent restenosis typically occurs within one year and is mainly caused by acute thrombosis due to discontinuation of anticoagulants.
{"title":"Three-Year Outcomes, Risk Factors for Restenosis After Stenting for DVT Combined with Iliac Vein Compression Syndrome","authors":"Lin Zhang, Chuli Jiang, Zheng Chen, Wei Song, Yu Zhao, Fenghe Li","doi":"10.1177/10760296241283821","DOIUrl":"https://doi.org/10.1177/10760296241283821","url":null,"abstract":"This study aimed to evaluate the safety and efficacy of pharmacomechanical catheter-directed thrombolysis (PCDT) and stenting for treating acute iliofemoral deep venous thrombosis (DVT) combined with iliac vein compression syndrome (IVCS), and to identify the predictors of stent restenosis. Patients with acute proximal DVT combined with IVCS underwent PCDT and stenting from January 2017 to December 2022 were enrolled. Primary and secondary patency were assessed by duplex ultrasound (DUS). The morbidity of postthrombotic syndrome (PTS) was assessed by the Villalta score. Risk factors for stent restenosis were assessed using univariate and multivariate Cox regression models. Total of 254 patients were included. The mean follow-up time was 36.06 ± 17.66 months. The primary patency rates at 1 year, 3 years, and 5 years were 92.5%±1.7%, 85.4%±2.4%, and 82.4%±2.9%, respectively. The incidence of stent restenosis was 14.2%. Discontinuation of anticoagulants within one year [hazard ratio (HR) = 5.03; P = .048] was the factor associated with acute in-stent thrombosis. Previous DVT history (HR =2.29; P = .037) and stent placement across the inguinal ligament (HR =6.70; P < .001) were identified as independent risk factors significantly associated with stent restenosis. The overall PTS rate was 19.3%. PCDT with stenting is safe and effective for patients with iliofemoral DVT secondary to IVCS, leading to low rates of PTS. Previous DVT history and stents placed across the inguinal ligament may be predictors of stent restenosis. Furthermore, stent restenosis typically occurs within one year and is mainly caused by acute thrombosis due to discontinuation of anticoagulants.","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142178586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-15DOI: 10.1177/10760296241234192
{"title":"Thanks to Reviewers","authors":"","doi":"10.1177/10760296241234192","DOIUrl":"https://doi.org/10.1177/10760296241234192","url":null,"abstract":"","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141059078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-25DOI: 10.1177/10760296241249167
Elise Schapkaitz, Byron Ter Morshuizen, Melanie Mc Cree, Barry F. Jacobson
Apixaban is a direct oral Xa inhibitor and is indicated for the treatment of venous thrombo-embolism (VTE) and prevention of stroke in atrial fibrillation (AF). Recently, a generic (ZyQuis, Zydus Lifesciences Limited, India) has received Food and Drug Administration approval. While bioequivalence has been demonstrated with Eliquis (Bristol-Myers Squibb/Pfizer, UK), it is necessary to monitor its effectiveness prior to acceptance in medical practice. This prospective study independently evaluated Apixaban (ZyQuis) at two accredited laboratories. Participants were converted from Warfarin or Rivaroxaban to Apixaban 5 mg bd for a duration of one month. Peak anti-Xa levels were measured 3-4 h post the morning dose. The samples were processed on the Atellica COAG 360 (Siemens Healthineers, Marburg, Germany) analyzers with a chromogenic anti-Xa assay (Innovance, reference interval 69-321 ng/mL). There were 26 participants; 5 men, 21 women; mean ± standard deviation age of 46 ± 12 years. Indications for anticoagulation included: VTE (88.5%) and AF (11.5%). 69.2% of the participants had at least one comorbidity. 96.2% of the anti-Xa levels were within the laboratory's 95% reference interval. Mean anti-Xa activity was 191 ± 69 ng/mL and 186 ± 68 ng/mL measured at respective laboratories. Mean differences in anti-Xa measurements represented by Bland–Altman statistics were small (bias of −2.6%, 95% confidence interval −1.11 to −4.09) and a strong correlation was observed on Deming regression analysis (0.995). Apixaban (ZyQuis) was effective for the management of VTE and AF as evidenced by anti-Xa activity.
阿哌沙班是一种直接口服 Xa 抑制剂，适用于治疗静脉血栓栓塞（VTE）和预防心房颤动（AF）患者中风。最近，一种仿制药（ZyQuis，Zydus Lifesciences Limited，印度）获得了美国食品药品管理局的批准。虽然与 Eliquis（英国百时美施贵宝/辉瑞公司）的生物等效性已得到证实，但有必要在医疗实践中接受该药之前对其有效性进行监测。这项前瞻性研究在两家获得认证的实验室对阿哌沙班（ZyQuis）进行了独立评估。参与者从华法林或利伐沙班转为每天服用 5 毫克阿哌沙班，疗程为一个月。早上服药后 3-4 小时测量抗 Xa 峰值水平。样本在 Atellica COAG 360（德国马尔堡，西门子 Healthineers）分析仪上进行处理，并使用色原抗 Xa 分析法（Innovance，参考区间为 69-321 纳克/毫升）。共有 26 名参与者；5 名男性，21 名女性；平均年龄为 46±12 岁。抗凝适应症包括VTE（88.5%）和房颤（11.5%）。69.2%的参与者至少有一种合并症。96.2%的抗 Xa 水平在实验室 95% 的参考区间内。在各实验室测得的平均抗 Xa 活性分别为 191 ± 69 纳克/毫升和 186 ± 68 纳克/毫升。Bland-Altman 统计法显示抗 Xa 测量值的平均差异很小（偏差为-2.6%，95% 置信区间为-1.11 至-4.09），戴明回归分析（0.995）也观察到了很强的相关性。从抗 Xa 活性来看，阿哌沙班（ZyQuis）可有效治疗 VTE 和房颤。
{"title":"Anti-Xa Monitoring of Apixaban (ZyQuis) in Venous Thrombo-Embolism and Atrial Fibrillation","authors":"Elise Schapkaitz, Byron Ter Morshuizen, Melanie Mc Cree, Barry F. Jacobson","doi":"10.1177/10760296241249167","DOIUrl":"https://doi.org/10.1177/10760296241249167","url":null,"abstract":"Apixaban is a direct oral Xa inhibitor and is indicated for the treatment of venous thrombo-embolism (VTE) and prevention of stroke in atrial fibrillation (AF). Recently, a generic (ZyQuis, Zydus Lifesciences Limited, India) has received Food and Drug Administration approval. While bioequivalence has been demonstrated with Eliquis (Bristol-Myers Squibb/Pfizer, UK), it is necessary to monitor its effectiveness prior to acceptance in medical practice. This prospective study independently evaluated Apixaban (ZyQuis) at two accredited laboratories. Participants were converted from Warfarin or Rivaroxaban to Apixaban 5 mg bd for a duration of one month. Peak anti-Xa levels were measured 3-4 h post the morning dose. The samples were processed on the Atellica COAG 360 (Siemens Healthineers, Marburg, Germany) analyzers with a chromogenic anti-Xa assay (Innovance, reference interval 69-321 ng/mL). There were 26 participants; 5 men, 21 women; mean ± standard deviation age of 46 ± 12 years. Indications for anticoagulation included: VTE (88.5%) and AF (11.5%). 69.2% of the participants had at least one comorbidity. 96.2% of the anti-Xa levels were within the laboratory's 95% reference interval. Mean anti-Xa activity was 191 ± 69 ng/mL and 186 ± 68 ng/mL measured at respective laboratories. Mean differences in anti-Xa measurements represented by Bland–Altman statistics were small (bias of −2.6%, 95% confidence interval −1.11 to −4.09) and a strong correlation was observed on Deming regression analysis (0.995). Apixaban (ZyQuis) was effective for the management of VTE and AF as evidenced by anti-Xa activity.","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140803233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-24DOI: 10.1177/10760296241247558
Fakiha Siddiqui, Debra Hoppensteadt, Walter Jeske, Eduardo Ramacciotti, Alfonso Tafur, Jawed Fareed
IntroductionAndexanet alfa (AA) - zhzo, recombinant coagulation factor Xa, is an approved antidote for oral Xa inhibitors (apixaban and rivaroxaban). Unfractionated heparin (UFH) is commonly used for therapeutic, interventional, and surgical indications. Protamine sulfate (PrSO4) is frequently used to neutralize UFH. This study aimed to investigate the comparative neutralization profiles of AA and PrSO4 for heparins of bovine, ovine, and porcine origin.Materials and MethodsThe neutralization effect of PrSO4 at 25 µg/ml and AA at 100 µg/ml was studied on an approximate surgical/interventional concentration of heparin by supplementing whole blood with each of the heparins at 25 µg/ml. For the clotting profile (activated partial thromboplastin time: aPTT), amidolytic (anti-Xa and anti-IIa), and thrombin generation assay each of the heparin were supplemented from –10–0.62 µg/ml.ResultsIn the whole blood ACT studies, all three heparins produced strong anti-coagulant effects (400–450 seconds) compared to saline (130–150 seconds). Both AA and PrSO4 almost fully neutralized the anti-coagulant effects of heparins (140–160 seconds). Both antidotes completely reversed the anticoagulant effects of all three heparins in the aPTT and thrombin generation assay. However, PrSO4 was more effective in neutralizing the anti-Xa, and anti-IIa effects than AA, which only partially neutralized these effects.ConclusionAndexanet alfa at 100 µg/ml effectively neutralizes the therapeutic and surgical/interventional concentrations of heparins in in-vitro settings. While differences in the anti-Xa, and anti-IIa effects between heparins were noted, anti-coagulant effect of these agents in the aPTT assay were comparable. A similar neutralization profile was observed in the ACT and thrombin generation assays by both agents.
导言：重组凝血因子 Xa 安非他酮（AA）是一种已获批准的口服 Xa 抑制剂（阿哌沙班和利伐沙班）的解毒剂。非分叶肝素（UFH）常用于治疗、介入和手术适应症。硫酸原胺（PrSO4）常用于中和 UFH。本研究旨在调查 AA 和 PrSO4 对牛源、绵羊源和猪源肝素的中和效果比较。材料和方法通过在全血中补充 25 µg/ml 的肝素，研究了 25 µg/ml 的 PrSO4 和 100 µg/ml 的 AA 对近似手术/介入浓度肝素的中和效果。结果在全血 ACT 研究中，与生理盐水（130-150 秒）相比，所有三种肝素都产生了很强的抗凝效果（400-450 秒）。AA 和 PrSO4 几乎完全中和了肝素的抗凝作用（140-160 秒）。在 aPTT 和凝血酶生成试验中，两种解毒剂都能完全逆转所有三种肝素的抗凝作用。然而，PrSO4 在中和抗 Xa 和抗 IIa 作用方面比 AA 更有效，后者只能部分中和这些作用。虽然不同肝素的抗 Xa 和抗 IIa 作用存在差异，但这些药物在 aPTT 试验中的抗凝效果相当。在 ACT 和凝血酶生成试验中，两种药物的中和效果相似。
{"title":"Andexanet Alfa Neutralizes the Anticoagulant Effects of Unfractionated Heparin of Bovine, Ovine and Porcine Origin Almost as Protamine Sulfate","authors":"Fakiha Siddiqui, Debra Hoppensteadt, Walter Jeske, Eduardo Ramacciotti, Alfonso Tafur, Jawed Fareed","doi":"10.1177/10760296241247558","DOIUrl":"https://doi.org/10.1177/10760296241247558","url":null,"abstract":"IntroductionAndexanet alfa (AA) - zhzo, recombinant coagulation factor Xa, is an approved antidote for oral Xa inhibitors (apixaban and rivaroxaban). Unfractionated heparin (UFH) is commonly used for therapeutic, interventional, and surgical indications. Protamine sulfate (PrSO<jats:sub>4</jats:sub>) is frequently used to neutralize UFH. This study aimed to investigate the comparative neutralization profiles of AA and PrSO<jats:sub>4</jats:sub> for heparins of bovine, ovine, and porcine origin.Materials and MethodsThe neutralization effect of PrSO<jats:sub>4</jats:sub> at 25 µg/ml and AA at 100 µg/ml was studied on an approximate surgical/interventional concentration of heparin by supplementing whole blood with each of the heparins at 25 µg/ml. For the clotting profile (activated partial thromboplastin time: aPTT), amidolytic (anti-Xa and anti-IIa), and thrombin generation assay each of the heparin were supplemented from –10–0.62 µg/ml.ResultsIn the whole blood ACT studies, all three heparins produced strong anti-coagulant effects (400–450 seconds) compared to saline (130–150 seconds). Both AA and PrSO<jats:sub>4</jats:sub> almost fully neutralized the anti-coagulant effects of heparins (140–160 seconds). Both antidotes completely reversed the anticoagulant effects of all three heparins in the aPTT and thrombin generation assay. However, PrSO<jats:sub>4</jats:sub> was more effective in neutralizing the anti-Xa, and anti-IIa effects than AA, which only partially neutralized these effects.ConclusionAndexanet alfa at 100 µg/ml effectively neutralizes the therapeutic and surgical/interventional concentrations of heparins in in-vitro settings. While differences in the anti-Xa, and anti-IIa effects between heparins were noted, anti-coagulant effect of these agents in the aPTT assay were comparable. A similar neutralization profile was observed in the ACT and thrombin generation assays by both agents.","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140803350","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-24DOI: 10.1177/10760296241247560
Ta Anh Tuan, Tran Dang Xoay, Tran Thi Kieu My, Nguyen Thi Duyen, Nguyen Thi Trang, Nguyen Tat Kien, Chu Thanh Son, Nguyen Van Thang, Thieu Quang Quan, Dau Viet Hung
The objective of this study is to determine the fibrin monomer reference intervals in healthy children. This cross-sectional study was conducted in the Hematology Department at Vietnam National Children's Hospital (April 2023 to March 2024). Children without prior history of clotting disorders or anticoagulants use hospitalized in preparation for orthopedic surgery or inguinal hernia surgery were enrolled in the study. The fibrin monomer test method was the quantitative fibrin monomer test on the STA-R system (Diagnostica Stago™, France). Eighty-six children (58 males and 28 females) were enrolled in the study. The median (interquartile range, 2.5th-97.5th) fibrin monomer value of the study subjects was 2.56 (0.11-5.93) µg/mL, with no statistically significant difference in fibrin monomer values among the age groups of 1 month to 3 years, 3 years to 13 years, and 13 years to 18 years. This is the first study conducted in Vietnam to determine reference values of fibrin monomer in children. This information can help in the diagnosis and treatment of early hypercoagulation stage and disseminated intravascular coagulation in children.
{"title":"Reference Value Fibrin Monomer in Healthy Children: A Cross-Sectional Study","authors":"Ta Anh Tuan, Tran Dang Xoay, Tran Thi Kieu My, Nguyen Thi Duyen, Nguyen Thi Trang, Nguyen Tat Kien, Chu Thanh Son, Nguyen Van Thang, Thieu Quang Quan, Dau Viet Hung","doi":"10.1177/10760296241247560","DOIUrl":"https://doi.org/10.1177/10760296241247560","url":null,"abstract":"The objective of this study is to determine the fibrin monomer reference intervals in healthy children. This cross-sectional study was conducted in the Hematology Department at Vietnam National Children's Hospital (April 2023 to March 2024). Children without prior history of clotting disorders or anticoagulants use hospitalized in preparation for orthopedic surgery or inguinal hernia surgery were enrolled in the study. The fibrin monomer test method was the quantitative fibrin monomer test on the STA-R system (Diagnostica Stago™, France). Eighty-six children (58 males and 28 females) were enrolled in the study. The median (interquartile range, 2.5th-97.5th) fibrin monomer value of the study subjects was 2.56 (0.11-5.93) µg/mL, with no statistically significant difference in fibrin monomer values among the age groups of 1 month to 3 years, 3 years to 13 years, and 13 years to 18 years. This is the first study conducted in Vietnam to determine reference values of fibrin monomer in children. This information can help in the diagnosis and treatment of early hypercoagulation stage and disseminated intravascular coagulation in children.","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140803297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-23DOI: 10.1177/10760296241241524
Jesse Qiao, Minh-Ha Tran
Direct oral anticoagulants (DOACs) exert anticoagulation effect by directly inhibiting Factor Xa (rivaroxaban, apixaban, and edoxaban) or thrombin (dabigatran). Though DOACs are characterized by fixed-dose prescribing and generally do not require routine laboratory drug-level monitoring (DLM), circumstances may arise where the DLM may aid in clinical decision-making, including DOAC dose adjustment, anticoagulant class change, or decisions to withhold or administer reversal agents. We review the current literature that describes high-risk patient groups in which DLM may be beneficial for improved patient anticoagulation management and stewardship. The review also summarizes the limitations of conventional coagulation testing and discuss the emerging utility of quantitative methods for routine and rapid emergent evaluation of DOAC drug levels—in particular, the Anti-Xa activity to detect Factor Xa Inhibitors (rivaroxaban, apixaban, and edoxaban). Both technical and regulatory barriers to widespread DLM implementation are limiting factors to further clinical research that must be overcome, in order to propose universal DOAC DLM strategies and provide clinical-laboratory correlation to formally classify high-risk patient groups.
直接口服抗凝剂（DOAC）通过直接抑制 Xa 因子（利伐沙班、阿哌沙班和依度沙班）或凝血酶（达比加群）来发挥抗凝作用。虽然 DOAC 的特点是固定剂量处方，一般不需要常规实验室药物水平监测 (DLM)，但在某些情况下，DLM 可能有助于临床决策，包括 DOAC 剂量调整、抗凝剂类别变更或暂停或使用逆转剂的决策。我们回顾了当前的文献，其中描述了 DLM 可能有助于改善患者抗凝管理和指导的高风险患者群体。该综述还总结了传统凝血检测的局限性，并讨论了用于常规和快速紧急评估 DOAC 药物水平的定量方法的新兴效用，尤其是检测因子 Xa 抑制剂（利伐沙班、阿哌沙班和埃多沙班）的抗 Xa 活性。广泛实施 DLM 的技术和监管障碍是进一步临床研究的限制因素，必须加以克服，以便提出通用的 DOAC DLM 策略，并提供临床-实验室相关性，对高风险患者群体进行正式分类。
{"title":"Challenges to Laboratory Monitoring of Direct Oral Anticoagulants","authors":"Jesse Qiao, Minh-Ha Tran","doi":"10.1177/10760296241241524","DOIUrl":"https://doi.org/10.1177/10760296241241524","url":null,"abstract":"Direct oral anticoagulants (DOACs) exert anticoagulation effect by directly inhibiting Factor Xa (rivaroxaban, apixaban, and edoxaban) or thrombin (dabigatran). Though DOACs are characterized by fixed-dose prescribing and generally do not require routine laboratory drug-level monitoring (DLM), circumstances may arise where the DLM may aid in clinical decision-making, including DOAC dose adjustment, anticoagulant class change, or decisions to withhold or administer reversal agents. We review the current literature that describes high-risk patient groups in which DLM may be beneficial for improved patient anticoagulation management and stewardship. The review also summarizes the limitations of conventional coagulation testing and discuss the emerging utility of quantitative methods for routine and rapid emergent evaluation of DOAC drug levels—in particular, the Anti-Xa activity to detect Factor Xa Inhibitors (rivaroxaban, apixaban, and edoxaban). Both technical and regulatory barriers to widespread DLM implementation are limiting factors to further clinical research that must be overcome, in order to propose universal DOAC DLM strategies and provide clinical-laboratory correlation to formally classify high-risk patient groups.","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140803227","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-22DOI: 10.1177/10760296241237232
Gökhan Coşkun, Cem Ozde, Osman Kayapinar, Gulsah Aktore, Ensar Ekşi, Hamdi Afşin, Ahmet Egemen Sayın
BackgroundThe anticoagulation and risk factors in atrial fibrillation (ATRIA) score is associated with adverse cardiovascular events. However, its relationship with coronary thrombus burden is unclear. Therefore, we aimed to investigate the relationship between the ATRIA score and thrombus burden in patients with ST-segment elevation myocardial infarction (STEMI) who underwent percutaneous coronary intervention (PCI).Materials and MethodsThe study was designed as a prospective cross-sectional observational study. Our study included 319 patients who were prospectively admitted with STEMI between January 2021 and April 2022. Patients were divided into 2 groups with low thrombus burden (LTB) (grade <3) and high thrombus burden (HTB) (grade ≥3). ATRIA score was calculated and recorded for all patients. ATRIA scores of both groups were compared.ResultsIn our study, 58.9% ( n = 188) of patients in the LTB group and 41% ( n = 131) of patients in the HTB group. The ATRIA risk score ( p < .001) was significantly higher in the HTB group. In multivariate logistic regression analysis, ATRIA score, glomerular filtration rate, hypertensıon, abciximab usage, and no-reflow were found to be independent predictors of HTB in STEMI patients undergoing primary PCI. In receiver operating characteristic analysis, ATRIA score >4 had a sensitivity of 66.2% and specificity of 95.2%, and ATRIA score >8 sensitivity of 98% and specificity of 100% predicted HTB.ConclusionIn this study, we found that thrombus burden may be associated with ATRIA risk score in patients presenting with STEMI.
{"title":"The Relationship of Coronary Thrombus Burden and Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Score in Patients With ST-Segment Elevation Myocardial Infarction","authors":"Gökhan Coşkun, Cem Ozde, Osman Kayapinar, Gulsah Aktore, Ensar Ekşi, Hamdi Afşin, Ahmet Egemen Sayın","doi":"10.1177/10760296241237232","DOIUrl":"https://doi.org/10.1177/10760296241237232","url":null,"abstract":"BackgroundThe anticoagulation and risk factors in atrial fibrillation (ATRIA) score is associated with adverse cardiovascular events. However, its relationship with coronary thrombus burden is unclear. Therefore, we aimed to investigate the relationship between the ATRIA score and thrombus burden in patients with ST-segment elevation myocardial infarction (STEMI) who underwent percutaneous coronary intervention (PCI).Materials and MethodsThe study was designed as a prospective cross-sectional observational study. Our study included 319 patients who were prospectively admitted with STEMI between January 2021 and April 2022. Patients were divided into 2 groups with low thrombus burden (LTB) (grade <3) and high thrombus burden (HTB) (grade ≥3). ATRIA score was calculated and recorded for all patients. ATRIA scores of both groups were compared.ResultsIn our study, 58.9% ( n = 188) of patients in the LTB group and 41% ( n = 131) of patients in the HTB group. The ATRIA risk score ( p < .001) was significantly higher in the HTB group. In multivariate logistic regression analysis, ATRIA score, glomerular filtration rate, hypertensıon, abciximab usage, and no-reflow were found to be independent predictors of HTB in STEMI patients undergoing primary PCI. In receiver operating characteristic analysis, ATRIA score >4 had a sensitivity of 66.2% and specificity of 95.2%, and ATRIA score >8 sensitivity of 98% and specificity of 100% predicted HTB.ConclusionIn this study, we found that thrombus burden may be associated with ATRIA risk score in patients presenting with STEMI.","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140803228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-18DOI: 10.1177/10760296241247205
Xiaolan Chen, Hongning Shi, Jiaqi Chang, Wenjia Guo, Yuanhua Yang, Yong Wang, Lei Pan
To external validate the risk assessment model (RAM) of venous thromboembolism (VTE) in multicenter internal medicine inpatients. We prospectively collected 595 internal medical patients (310 with VTE patients, 285 non-VTE patients) were from Beijing Shijitan Hospital, Beijing Chaoyang Hospital, and the respiratory department of Beijing Tsinghua Changgeng Hospital from January 2022 to December 2022 for multicenter external validation. The prediction ability of Caprini RAM, Padua RAM, The International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) RAM, and Shijitan (SJT) RAM were compared. This study included a total of 595 internal medicine inpatients, including 242 (40.67%) in the respiratory department, 17 (2.86%) in the respiratory intensive care unit, 49 (8.24%) in the neurology department, 34 (5.71%) in the intensive care unit, 26 (4.37%) in the geriatric department, 22 (3.70%) in the emergency department, 71 (11.93%) in the nephrology department, 63 (10.59%) in the cardiology department, 24 (4.03%) in the hematology department, 6 (1.01%) in the traditional Chinese medicine department, 9 (1.51%) cases in the rheumatology department, 7 (1.18%) in the endocrinology department, 14 (2.35%) in the oncology department, and 11 (1.85%) in the gastroenterology department. Multivariate logistic regression analysis showed that among internal medicine inpatients, age > 60 years old, heart failure, nephrotic syndrome, tumors, history of VTE, and elevated D-dimer were significantly correlated with the occurrence of VTE ( P < .05). The incidence of VTE increases with the increase of D-dimer. It was found that the effectiveness of SJT RAM (AUC = 0.80 ± 0.03) was better than Caprini RAM (AUC = 0.74 ± 0.03), Padua RAM (AUC = 0.72 ± 0.03) and IMPROVE RAM (AUC = 0.52 ± 0.03) ( P < .05). The sensitivity and Yoden index of SJT RAM were higher than those of Caprini RAM, Pauda RAM, and IMPROVE RAM ( P < .05), but specificity was not significantly different between the 4 models ( P > .05). The SJT RAM derived from general hospitalized Chinese patients has effective and better predictive ability for internal medicine inpatients at risk of VTE.
{"title":"External Validation of the Risk Assessment Model of Venous Thromboembolism in Multicenter Internal Medicine Inpatients","authors":"Xiaolan Chen, Hongning Shi, Jiaqi Chang, Wenjia Guo, Yuanhua Yang, Yong Wang, Lei Pan","doi":"10.1177/10760296241247205","DOIUrl":"https://doi.org/10.1177/10760296241247205","url":null,"abstract":"To external validate the risk assessment model (RAM) of venous thromboembolism (VTE) in multicenter internal medicine inpatients. We prospectively collected 595 internal medical patients (310 with VTE patients, 285 non-VTE patients) were from Beijing Shijitan Hospital, Beijing Chaoyang Hospital, and the respiratory department of Beijing Tsinghua Changgeng Hospital from January 2022 to December 2022 for multicenter external validation. The prediction ability of Caprini RAM, Padua RAM, The International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) RAM, and Shijitan (SJT) RAM were compared. This study included a total of 595 internal medicine inpatients, including 242 (40.67%) in the respiratory department, 17 (2.86%) in the respiratory intensive care unit, 49 (8.24%) in the neurology department, 34 (5.71%) in the intensive care unit, 26 (4.37%) in the geriatric department, 22 (3.70%) in the emergency department, 71 (11.93%) in the nephrology department, 63 (10.59%) in the cardiology department, 24 (4.03%) in the hematology department, 6 (1.01%) in the traditional Chinese medicine department, 9 (1.51%) cases in the rheumatology department, 7 (1.18%) in the endocrinology department, 14 (2.35%) in the oncology department, and 11 (1.85%) in the gastroenterology department. Multivariate logistic regression analysis showed that among internal medicine inpatients, age > 60 years old, heart failure, nephrotic syndrome, tumors, history of VTE, and elevated D-dimer were significantly correlated with the occurrence of VTE ( P < .05). The incidence of VTE increases with the increase of D-dimer. It was found that the effectiveness of SJT RAM (AUC = 0.80 ± 0.03) was better than Caprini RAM (AUC = 0.74 ± 0.03), Padua RAM (AUC = 0.72 ± 0.03) and IMPROVE RAM (AUC = 0.52 ± 0.03) ( P < .05). The sensitivity and Yoden index of SJT RAM were higher than those of Caprini RAM, Pauda RAM, and IMPROVE RAM ( P < .05), but specificity was not significantly different between the 4 models ( P > .05). The SJT RAM derived from general hospitalized Chinese patients has effective and better predictive ability for internal medicine inpatients at risk of VTE.","PeriodicalId":10335,"journal":{"name":"Clinical and Applied Thrombosis/Hemostasis","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2024-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140623931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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