scholarly journals Efficacy and Safety of Tinzaparin in CAT Patients with Hematological Malignancy

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4273-4273
Author(s):  
Agnes Y. Lee ◽  
Pieter W. Kamphuisen ◽  
Rupert Bauersachs ◽  
Nicolas Janus ◽  
Randall Leeder ◽  
...  
Keyword(s):  
Risk Factors ◽  
High Risk ◽  
Major Bleeding ◽  
Phase Iii ◽  
Severe Thrombocytopenia ◽  
Hematological Cancer ◽  
Factors Associated ◽  
Risk Of Bleeding ◽  
Hematological Cancers ◽  
Post Hoc

Abstract Introduction In patients with hematological cancers, the high risk of bleeding raises serious concerns when anticoagulant therapy is initiated for treatment of acute venous thromboembolism (VTE). In the CATCH trial, we showed that tinzaparin is associated with a significantly lower risk of clinically relevant bleeding (CRB) and clinically relevant non-major bleeding (CRNMB) compared with warfarin therapy in patients with a solid tumor or hematological cancer. Hence, we performed a post-hoc analysis to assess the risk of recurrent VTE (rVTE) and bleeding in the hematological cancer patient subgroup. Risk factors associated with rVTE and bleeding were also explored. Methods CATCH (ClinicalTrials.govNCT01130025; Lee A et al. JAMA 2015) was a Phase III, multinational, randomized, active-controlled, open-label trial. Patients with solid tumors or hematological malignancies were randomized to receive therapeutic dosing of tinzaparin (175 IU/kg OD) vs warfarin (INR target 2.0 - 3.0) for treatment of acute VTE. Treatment was given for up to 6 months but was withheld during periods of severe thrombocytopenia (platelet count < 50 x 10 9/L). The primary efficacy outcome was the composite of symptomatic deep vein thrombosis (DVT), symptomatic nonfatal pulmonary embolism (PE), fatal PE, incidental proximal DVT and incidental proximal PE. All thrombosis and bleeding outcomes, including rPE, rDVT, major bleeding (MB), CRB, and CRNMB were objectively documented and centrally adjudicated in a treatment-blinded fashion. Patients with myeloma, lymphoma or leukemia were included in this sub-group analysis. Treatment effect was assessed by means of a cox-regression with time to first event as outcome and deaths not due to fatal PE as a competing risk factor. The cumulative incidence functions and the corresponding 95% CIs were estimated. Results 94 of 900 subjects (10.4%) in CATCH had a hematological cancer. Of these patients, 44 and 50 received tinzaparin and warfarin, respectively. The most common hematological cancer was lymphoma (59.6%), followed by myeloma (30.9%), chronic leukemia (5.3%) and acute leukemia (4.3%). rVTE occurred in fewer patients assigned to tinzaparin versus warfarin (2.4% vs 6.4%) but this difference was not statistically significant (HR 0.36; 95%CI 0.04-3.14). All recurrent thrombotic events were PE; no rDVT occurred. Also, trends for less bleeding with tinzaparin were noted for MB (tinzaparin 0.0% versus warfarin 5.0%), CRB (tinzaparin 10.4% vs warfarin 23.5%; HR 0.53; 95%CI 0.15-1.83) and CRNMB (tinzaparin 10.4% vs warfarin 19.5%; HR 0.69; 95%CI 0.19-2.51). 3 patients in each treatment arm had a fatal bleeding event and there was no difference in overall mortality (tinzaparin 22.7% vs warfarin 22.0%). There were no risk factors associated with rVTE identified. Factors associated with CRB in patients with hematological cancer included the use of antiplatelet agents (HR 7.63; 95%CI 1.17-49.6; p=0.033) and renal insufficiency (HR 12.4; 95%CI 2.15-72.0; p=0.005). Conclusion In this post-hoc subgroup analysis of patients with hematological cancers who received anticoagulation for acute VTE, tinzaparin may be a more effective and safer alternative to warfarin. Randomized controlled trials are warranted to test this hypothesis in this challenging population with a high risk of bleeding. Figure 1 Figure 1. Disclosures Lee: Leo Pharma: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria; Servier: Consultancy, Honoraria. Bauersachs: Bayer: Honoraria, Speakers Bureau; BMS: Honoraria, Speakers Bureau; LEO Pharma: Honoraria, Speakers Bureau; Pfizer: Honoraria, Speakers Bureau. Janus: LEO Pharma: Current Employment. Leeder: LEO Pharma: Current Employment. Thoning: LEO Pharma: Current Employment. Khorana: Anthos: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Bristol Myers Squibb: Consultancy, Honoraria.

A Risk Model for Thrombocytopenia Requiring Platelet Transfusion After Cytotoxic Chemotherapy

Blood ◽  
1998 ◽  
Vol 92 (2) ◽  
pp. 405-410 ◽  
Author(s):  
J.Y. Blay ◽  
A. Le Cesne ◽  
C. Mermet ◽  
C. Maugard ◽  
A. Ravaud ◽  
...  
Keyword(s):  
Risk Factors ◽  
Platelet Count ◽  
High Risk ◽  
Risk Model ◽  
Univariate Analysis ◽  
Cytotoxic Chemotherapy ◽  
Phase Iii ◽  
Severe Thrombocytopenia ◽  
Increased Risk ◽  
Platelet Transfusions

Abstract Severe thrombocytopenia is a rare but life-threatening side effect of cytotoxic chemotherapy for which risk factors are not well known. Our objective was to delineate a risk model for chemotherapy-induced thrombocytopenia requiring platelet transfusions in cancer patients. Univariate and multivariate analysis of risk factors for chemotherapy-induced thrombocytopenia requiring platelet transfusions were performed on the cohort of the 1,051 patients (CLB 1996) treated with chemotherapy in the Department of Medicine of the Centre Léon Bérard (CLB) in 1996. In univariate analysis, performance status (PS) greater than 1, platelet count less than 150,000/μL at day 1 (d1) before the initiation of chemotherapy, d1 lymphocyte count ≤700/μL, d1 polymorphonuclear leukocyte count less than 1,500/μL, and the type of chemotherapy (high risk v others) were significantly associated (P < .01) with an increased risk of severe thrombocytopenia requiring platelet transfusions. Using logistic regression, d1 platelet count less than 150,000/μL (odds ratio [OR], 4.3; 95% confidence interval [CI], 1.9 to 9.6), d1 lymphocyte counts ≤700/μL (OR, 3.37; 95% CI, 1.77 to 6.4), the type of chemotherapy (OR, 3.38; 95% CI, 1.77 to 6.4), and PS greater than 1 (OR, 2.23; 95% CI, 1.22 to 4.1) were identified as independent risk factors for platelet transfusions. The observed incidences of platelet transfusions were 45%, 13%, 7%, and 1.5% for patients with ≥3, 2, 1, or 0 risk factors, respectively. This model was then tested in 3 groups of patients treated with chemotherapy used as validation samples: (1) the series of 340 patients treated in the CLB in the first 6 months of 1997, (2) the prospective multicentric cohort of 321 patients of the ELYPSE 1 study, and (3) the series of 149 patients with non-Hodgkin's lymphoma treated in the CLB within prospective phase III trials (1987 to 1995). In these 3 groups, the observed incidences of platelet transfusions in the above-defined risk groups did not differ significantly (P > .1) from those calculated in the model. This risk index could be useful to identify patients at high risk for chemotherapy-induced thrombocytopenia requiring platelet transfusions.

A Risk Model for Thrombocytopenia Requiring Platelet Transfusion After Cytotoxic Chemotherapy

Blood ◽  
1998 ◽  
Vol 92 (2) ◽  
pp. 405-410
Author(s):  
J.Y. Blay ◽  
A. Le Cesne ◽  
C. Mermet ◽  
C. Maugard ◽  
A. Ravaud ◽  
...  
Keyword(s):  
Risk Factors ◽  
Platelet Count ◽  
High Risk ◽  
Risk Model ◽  
Univariate Analysis ◽  
Cytotoxic Chemotherapy ◽  
Phase Iii ◽  
Severe Thrombocytopenia ◽  
Increased Risk ◽  
Platelet Transfusions

Severe thrombocytopenia is a rare but life-threatening side effect of cytotoxic chemotherapy for which risk factors are not well known. Our objective was to delineate a risk model for chemotherapy-induced thrombocytopenia requiring platelet transfusions in cancer patients. Univariate and multivariate analysis of risk factors for chemotherapy-induced thrombocytopenia requiring platelet transfusions were performed on the cohort of the 1,051 patients (CLB 1996) treated with chemotherapy in the Department of Medicine of the Centre Léon Bérard (CLB) in 1996. In univariate analysis, performance status (PS) greater than 1, platelet count less than 150,000/μL at day 1 (d1) before the initiation of chemotherapy, d1 lymphocyte count ≤700/μL, d1 polymorphonuclear leukocyte count less than 1,500/μL, and the type of chemotherapy (high risk v others) were significantly associated (P < .01) with an increased risk of severe thrombocytopenia requiring platelet transfusions. Using logistic regression, d1 platelet count less than 150,000/μL (odds ratio [OR], 4.3; 95% confidence interval [CI], 1.9 to 9.6), d1 lymphocyte counts ≤700/μL (OR, 3.37; 95% CI, 1.77 to 6.4), the type of chemotherapy (OR, 3.38; 95% CI, 1.77 to 6.4), and PS greater than 1 (OR, 2.23; 95% CI, 1.22 to 4.1) were identified as independent risk factors for platelet transfusions. The observed incidences of platelet transfusions were 45%, 13%, 7%, and 1.5% for patients with ≥3, 2, 1, or 0 risk factors, respectively. This model was then tested in 3 groups of patients treated with chemotherapy used as validation samples: (1) the series of 340 patients treated in the CLB in the first 6 months of 1997, (2) the prospective multicentric cohort of 321 patients of the ELYPSE 1 study, and (3) the series of 149 patients with non-Hodgkin's lymphoma treated in the CLB within prospective phase III trials (1987 to 1995). In these 3 groups, the observed incidences of platelet transfusions in the above-defined risk groups did not differ significantly (P > .1) from those calculated in the model. This risk index could be useful to identify patients at high risk for chemotherapy-induced thrombocytopenia requiring platelet transfusions.

Development of an Emergency Revisit Score for Patients With Drug-Related Problems

2021 ◽  
pp. 875512252110117
Author(s):  
Jesus Ruiz Ramos ◽  
Laura Gras-Martin ◽  
Ana María Juanes Borrego ◽  
Marta Blazquez-Andion ◽  
Mireia Puig Campmany ◽  
...  
Keyword(s):  
Risk Factors ◽  
High Risk ◽  
Receiver Operating Curve ◽  
Drug Related Problems ◽  
Derivation Cohort ◽  
Factors Associated ◽  
Final Score ◽  
Anticholinergic Burden ◽  
Risk Categories ◽  
Frequent Reason

Background: Drug-related problems (DRPs) are a frequent reason for emergency departments (EDs) visits. However, data about the risk factors associated with EDs revisits are limited. Objective: To develop and validate a predictive model indicating the risk factors associated with EDs revisit within 30 days of the first visit. Methods: A retrospective cohort study was conducted involving patients who attended an ED for DRPs related to cardiovascular drugs. A 30-day prediction model was created in a derivation cohort by logistic regression. An integer score proportional to the regression coefficient was assigned to the variables with P < .100 in the multivariate analysis. Results: 581 patients (mean age: 80.0 [12.6] years) were included, 133 (22.9%) revisited the ED within 30 days from discharge. Six factors (chronic kidney disease, chronic heart failure, visit to an ED in the preceding 3 months, high anticholinergic burden, DRPs associated with heparin, and safety-related DRPs) were identified as risk factors and combined into a final score, termed the DREAMER score. The model reached an area under the receiver operating curve values of 0.72 (95% confidence interval [CI] = 0.67-0.77) in the referral cohort and 0.71 (95% CI = 0.65-0.74) in the validation cohort ( P = .273). Three risk categories were generated, with the following scores and estimated risks: low risk (0-8 points): 11.6%; intermediate risk (9-14 points): 21.3%; and high risk (>14 points): 41.2%. Conclusion and Relevance: The DREAMER score identifies patients at high risk for ED revisit within 30 days from the first visit for a DRPs, being a useful tool to prioritize interventions on discharge.

scholarly journals High-risk human papillomavirus infection and associated factors in the anal canal of HIV-positive patients in Medellín, 2017–2018

2020 ◽  
Vol 54 ◽  
pp. 93
Author(s):  
Daniela Herrera Posada ◽  
Lucia Stella Tamayo Acevedo ◽  
Marleny Valencia Arredondo ◽  
Gloria Inéz Sánchez Vásquez
Keyword(s):  
Risk Factors ◽  
Health Care ◽  
Human Papillomavirus ◽  
High Risk ◽  
Elementary Education ◽  
Associated Factors ◽  
Casual Sex ◽  
Hiv Positive ◽  
Factors Associated ◽  
High Risk Hpv

OBJECTIVE: To estimate the prevalence of high-risk human papillomavirus (HR-HPV) anal infection and associated factors in human immunodeficiency virus (HIV) positive patients in Medellín. METHODS: Descriptive cross-sectional study in 300 HIV-positive patients, adults, with history of anal intercourse, treated in two health care services of Medellín 2017–2018. We conducted a structured survey on sociodemographics, sexual behavior and medical history. HPV was detected in anal swabs tested by the COBAS 4800 system. Exploratory data analysis of risk factors associated with HR-HPV was conducted by chi-square test of independence and both raw and adjusted prevalence ratios used the Poisson regression model, at a 95% confidence interval. RESULTS: The high-risk HPV had a prevalence of 82.7%; HPV16 had a prevalence of 32.7%, HPV18 a prevalence of 21.7% and other HPV types scored 78.3%. The high-risk HPV prevalence in women was of 68.2% and 83.8% in men. The risk factors associated with high-risk HPV after adjustment were age under 30 years, elementary education, casual sex partners, and first sexual activity before 18 years old. CONCLUSIONS: The high incidence of high-risk HPV, along with the occurrence of coinfections by multiple types in the study population shows their susceptibility to develop some type of anal intra-epithelial neoplasia. It is important to establish sexual health programs focused on primary health care.

scholarly journals PARAMETERS OF ECG DISPERSION MAPPING AMONG STUDENTS OF NORTHERN UNIVERSITY

2019 ◽  
pp. 98-104 ◽  
Author(s):  
I. A Pogonysheva ◽  
D. A Pogonyshev ◽  
I. I Lunyak
Keyword(s):  
Risk Factors ◽  
Cardiovascular Diseases ◽  
High Risk ◽  
Questionnaire Survey ◽  
Cardiac Activity ◽  
State University ◽  
Men And Women ◽  
Factors Associated ◽  
Far North ◽  
Pathological Characteristics

The cardiac activity of students who have been born and live in the territory equated to regions of Far North was assessed. In total, 132 students of Nizhnevartovsk State University were examined using the CardioVisor-06c analyser that helps to diagnose dysfunctions of the cardiovascular system at preclinical level. The authors conducted a questionnaire survey to identify risk factors associated with cardiovascular diseases in students and analyzed the results of ECG dispersion mapping. The deterioration of the functional state of the myocardium was more pronounced among students with a high risk of developing cardiovascular diseases. The young men and women with pre-pathological characteristics of electrophysiological indicators were referred for additional examination and cardiology consultation.

scholarly journals Efficacy and Safety of Long‐Term Antithrombotic Strategies in Patients With Chronic Coronary Syndrome: A Network Meta‐analysis of Randomized Controlled Trials

2021 ◽  
Author(s):  
Houyong Zhu ◽  
Xiaoqun Xu ◽  
Xiaojiang Fang ◽  
Fei Ying ◽  
Liuguang Song ◽  
...  
Keyword(s):  
Risk Factors ◽  
High Risk ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Coronary Syndrome ◽  
High Risk Factors ◽  
Cerebrovascular Events

Background Long‐term antithrombotic strategies for patients with chronic coronary syndrome with high‐risk factors represent an important treatment dilemma in clinical practice. Our aim was to conduct a network meta‐analysis to evaluate the efficacy and safety of long‐term antithrombotic strategies in patients with chronic coronary syndrome. Methods and Results Four randomized studies were included (n=75167; THEMIS [Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study], COMPASS [Cardiovascular Outcomes for People Using Anticoagulation Strategies], PEGASUS‐TIMI 54 [Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin–Thrombolysis in Myocardial Infarction 54], and DAPT [Dual Anti‐platelet Therapy]). The odds ratios (ORs) and 95% CIs) were calculated as the measure of effect size. The results of the network meta‐analysis showed that, compared with aspirin monotherapy, the ORs for trial‐defined major adverse cardiovascular and cerebrovascular events were 0.86; (95% CI, 0.80–0.93) for ticagrelor plus aspirin, 0.89 (95% CI, 0.78–1.02) for rivaroxaban monotherapy, 0.74 (95% CI, 0.64–0.85) for rivaroxaban plus aspirin, and 0.72 (95% CI, 0.60,–0.86) for thienopyridine plus aspirin. Compared with aspirin monotherapy, the ORs for trial‐defined major bleeding were 2.15 (95% CI, 1.78–2.59]) for ticagrelor plus aspirin, 1.51 (95% CI, 1.23–1.85) for rivaroxaban monotherapy, and 1.68 (95% CI, 1.37–2.05) for rivaroxaban plus aspirin. For death from any cause, the improvement effect of rivaroxaban plus aspirin was detected versus aspirin monotherapy (OR, 0.76; 95% CI, 0.65–0.90), ticagrelor plus aspirin (OR, 0.79; 95% CI, 0.66–0.95), rivaroxaban monotherapy (OR, 0.82; 95% CI, 0.69–0.97), and thienopyridine plus aspirin (OR, 0.58; 95% CI, 0.41–0.82) regimens. Conclusions All antithrombotic strategies combined with aspirin significantly reduced the incidence of major adverse cardiovascular and cerebrovascular events and increased the risk of major bleeding compared with aspirin monotherapy. Considering the outcomes of all ischemic and bleeding events and all‐cause mortality, rivaroxaban plus aspirin appears to be the preferred long‐term antithrombotic regimen for patients with chronic coronary syndrome and high‐risk factors.

Machine Learning Algorithms to Predict the Mortality of Carbapenem Resistant Klebsiella Pneumoniae bacteremia

2019 ◽  
Author(s):  
Qiqiang Liang ◽  
Fang Qian ◽  
Yibing Chen ◽  
Zhijun Xu ◽  
Zhijiang Xu ◽  
...  
Keyword(s):  
Machine Learning ◽  
Risk Factors ◽  
Septic Shock ◽  
High Risk ◽  
Klebsiella Pneumoniae ◽  
Severe Thrombocytopenia ◽  
Acute Renal Injury ◽  
High Risk Factors ◽  
Carbapenem Resistant ◽  
Logical Regression

Abstract Purpose To establish mortality prediction models in 14 days of Carbapenem-Resistant Klebsiella Pneumoniae bacteremia using Machine learning.Materials and Methods It is a single-center retrospective study. We collect the relevant clinical information of all patients with Carbapenem-Resistant Klebsiella Pneumoniae (CRKP) bacteremia in the past 5 years using the local database. Data analysis and verification are carried out by multiple logical regression, decision tree, random forest, support vector machine (SVM), and XGBoost.Result This study includes 187 patients with 40 related variables. In multiple logical regression, acute renal injury (P=0.003), Apache II score (P=0.036), immunodeficiency (P=0.025), severe thrombocytopenia (P=0.025) and septic shock (P=0.044) are the high-risk factors for 14 days mortality of CRKP bloodstream infections. According to the importance of those parameters, risk scoring is established to predict the survival rate of CRKP bacteremia. The analysis of the five models, with 70% training set and 30% test set, show the comprehensive performance of random forest (AUROC=0.953, precision=91.85%) is slightly better than that of XGBoost (AUROC=0.912, precision=86.41%) and SVM (AUROC=0.936, precision=79.89%) in predicting 14-day mortality of CRKP bacteremia. The multiple logical regression model (AUROC=0.825, precision=81.52%) is the second, and the decision tree model (AUROC=0.712, precision=79.89%) is not very ideal.Conclusion Machine learning has good performances in predicting 14-day mortality of CRKP bacteremia than multiple logical regression. Acute renal injury, severe thrombocytopenia, and septic shock are the high-risk factors of CRKP bacteremia mortality.

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