466 results on '"COSMI B"'
Search Results
102. Review: recombinant factor VIIa does not differ from placebo for prevention or treatment of bleeding in patients without hemophilia.
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Cosmi B
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- 2007
- Full Text
- View/download PDF
103. An abnormal D-dimer test result indicated that anticoagulant therapy should be continued.
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Palareti, G., Cosmi, B., and Legnani, C.
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THROMBOEMBOLISM , *VITAMIN K , *ANTICOAGULANTS , *THROMBOSIS , *DIMERS , *PATIENTS - Abstract
The article presents a study on the effect of vitamin K antagonists for 3 months or over on patients with venous thromboembolism (VTE). The study involved 619 patients with a first episode of symptomatic VTE who received vitamin K antagonist and had D-dimer testing 30 days after anticoagulation was stopped. It shows that an abnormal D-dimer test result 30 days after anticoagulation therapy was discontinued in patients who had a first episode of unprovoked VTE and received vitamin K antagonist.
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- 2007
104. Long-term risk of recurrent venous thromboembolism among patients receiving extended oral anticoagulant therapy for first unprovoked venous thromboembolism:A systematic review and meta-analysis
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Charlotte Bradbury, Cecilia Becattini, Toshihiko Takada, Grégoire Le Gal, Tobias Tritschler, Benilde Cosmi, Faizan Khan, Giancarlo Agnelli, Francis Couturaud, Marc A. Rodger, Clive Kearon, Geert-Jan Geersing, Gary E. Raskob, Anthonie W. A. Lensing, Sergio Siragusa, Minggao Shi, Maria Cristina Vedovati, Jeffrey I. Weitz, Gualtiero Palareti, Ranjeeta Mallick, Kednapa Thavorn, Lisbeth Eischer, Sabine Eichinger, Cristina Legnani, Philip S. Wells, Paul A. Kyrle, Miriam Kimpton, Martin Gebel, Walter Ageno, Paolo Prandoni, Sameer Parpia, Dean Fergusson, Michael A. Grosso, Harry R. Büller, Antonio Palla, Letizia Marconi, Drahomir Aujesky, Brian Hutton, Khan, F., Tritschler, T., Kimpton, M., Wells, P.S., Kearon, C., Weitz, J.I., Büller, H.R., Raskob, G.E., Ageno, W., Couturaud, F., Prandoni, P., Palareti, G., Legnani, C., Kyrle, P.A., Eichinger, S., Eischer, L., Becattini, C., Agnelli, G., Vedovati, M.C., Geersing, G.-J., Takada, T., Cosmi, B., Aujesky, D., Marconi, L., Palla, A., Siragusa, S., Bradbury, C.A., Parpia, S., Mallick, R., Lensing, A.W.A., Gebel, M., Grosso, M.A., Shi, M., Thavorn, K., Hutton, B., Le Gal, G., Rodger, M., Fergusson, D., Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, Khan F., Tritschler T., Kimpton M., Wells P.S., Kearon C., Weitz J.I., Buller H.R., Raskob G.E., Ageno W., Couturaud F., Prandoni P., Palareti G., Legnani C., Kyrle P.A., Eichinger S., Eischer L., Becattini C., Agnelli G., Vedovati M.C., Geersing G.-J., Takada T., Cosmi B., Aujesky D., Marconi L., Palla A., Siragusa S., Bradbury C.A., Parpia S., Mallick R., Lensing A.W.A., Gebel M., Grosso M.A., Shi M., Thavorn K., Hutton B., Le Gal G., Rodger M., and Fergusson D.
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Pediatrics ,medicine.medical_specialty ,pulmonary embolism ,anticoagulant therapy, prognosis, pulmonary embolism, systematic review, venous thromboembolism, Anticoagulants, Humans, Prospective Studies, Recurrence, Risk Factors, Pulmonary Embolism, Venous Thromboembolism ,venous thromboembolism ,MEDLINE ,030204 cardiovascular system & hematology ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,anticoagulant therapy ,prognosis ,systematic review ,Anticoagulants ,Humans ,Prospective Studies ,Recurrence ,Risk Factors ,Pulmonary Embolism ,Venous Thromboembolism ,Randomized controlled trial ,law ,Medicine ,030212 general & internal medicine ,cardiovascular diseases ,Prospective cohort study ,business.industry ,Incidence (epidemiology) ,Hematology ,medicine.disease ,equipment and supplies ,3. Good health ,Pulmonary embolism ,Long term risk ,Meta-analysis ,business ,Venous thromboembolism ,prognosi - Abstract
Background: The long-term risk for recurrent venous thromboembolism (VTE) during extended anticoagulation for a first unprovoked VTE is uncertain. Objectives: To determine the incidence of recurrent VTE during extended anticoagulation of up to 5years in patients with a first unprovoked VTE. Methods: MEDLINE, EMBASE, and the Cochrane CENTRAL were searched to identify randomized trials and prospective cohort studies reporting recurrent VTE among patients with a first unprovoked VTE who were to receive anticoagulation for a minimum of six additional months after completing ≥3months of initial treatment. Unpublished data on number of recurrent VTE and person-years, obtained from authors of included studies, were used to calculate study-level incidence rate, and random-effects meta-analysis was used to pool results. Results: Twenty-six studies and 15603 patients were included in the analysis. During 11631 person-years of follow-up, the incidence of recurrent VTE and fatal pulmonary embolism per 100 person-years was 1.41 (95% CI, 1.03–1.84) and 0.09 (0.04–0.16), with 5-year cumulative incidences of 7.1% (3.0%–13.2%) and 1.2% (0.4%–4.6%), respectively. The incidence of recurrent VTE was 1.08 (95% CI, 0.77–1.44) with direct oral anticoagulants and 1.55 (1.01–2.20) with vitamin K antagonists. The case-fatality rate of recurrent VTE was 4.9% (95% CI, 2.2%–8.7%). Conclusions: In patients with a first unprovoked VTE, the long-term risk of recurrent VTE during extended anticoagulation is low but not negligible. Thus, clinicians and patients should be aware of this risk and take appropriate and timely action in case of suspicion of recurrent VTE. Estimates from this study can be used to advise patients on what to expect while receiving extended anticoagulation, and estimate the net clinical benefit of extended treatment to guide long-term management of unprovoked VTE. © 2021 International Society on Thrombosis and Haemostasis.
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- 2021
105. Long-term risk for major bleeding during extended oral anticoagulant therapy for first unprovoked venous thromboembolism: A systematic review and meta-analysis
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Sabine Eichinger, Geert-Jan Geersing, Cecilia Becattini, Walter Ageno, Tobias Tritschler, Grégoire Le Gal, Benilde Cosmi, Paolo Prandoni, Ranjeeta Mallick, Francis Couturaud, Clive Kearon, Kednapa Thavorn, Gary E. Raskob, Charlotte Bradbury, Paul A. Kyrle, Dean Fergusson, Gualtiero Palareti, Harry R. Büller, Letizia Marconi, Philip S. Wells, Lisbeth Eischer, Sameer Parpia, Marc A. Rodger, Giancarlo Agnelli, Cristina Legnani, Michael A. Grosso, Jeffrey I. Weitz, Maria Cristina Vedovati, Antonio Palla, Drahomir Aujesky, Martin Gebel, Faizan Khan, Brian Hutton, Sergio Siragusa, Toshihiko Takada, Miriam Kimpton, Anthonie W. A. Lensing, Khan F., Tritschler T., Kimpton M., Wells P.S., Kearon C., Weitz J.I., Buller H.R., Raskob G.E., Ageno W., Couturaud F., Prandoni P., Palareti G., Legnani C., Kyrle P.A., Eichinger S., Eischer L., Becattini C., Agnelli G., Vedovati M.C., Geersing G.-J., Takada T., Cosmi B., Aujesky D., Marconi L., Palla A., Siragusa S., Bradbury C.A., Parpia S., Mallick R., Lensing A.W.A., Gebel M., Grosso M.A., Thavorn K., Hutton B., Le Gal G., Fergusson D.A., Rodger M.A., Khan, F., Tritschler, T., Kimpton, M., Wells, P.S., Kearon, C., Weitz, J.I., Büller, H.R., Raskob, G.E., Ageno, W., Couturaud, F., Prandoni, P., Palareti, G., Legnani, C., Kyrle, P.A., Eichinger, S., Eischer, L., Becattini, C., Agnelli, G., Vedovati, M.C., Geersing, G.-J., Takada, T., Cosmi, B., Aujesky, D., Marconi, L., Palla, A., Siragusa, S., Bradbury, C.A., Parpia, S., Mallick, R., Lensing, A.W.A., Gebel, M., Grosso, M.A., Thavorn, K., Hutton, B., Le Gal, G., Fergusson, D.A., and Rodger, M.A.
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Oral ,medicine.medical_specialty ,medicine.drug_class ,Administration, Oral ,Hemorrhage ,030204 cardiovascular system & hematology ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Risk Factors ,Internal medicine ,Internal Medicine ,Medicine ,Humans ,Cumulative incidence ,Age Factor ,030212 general & internal medicine ,Prospective cohort study ,610 Medicine & health ,Administration, Oral, Age Factors, Aged, Anticoagulants, Hemorrhage, Humans, Middle Aged, Risk Factors, Venous Thromboembolism ,Aged ,business.industry ,Incidence (epidemiology) ,Risk Factor ,Anticoagulant ,Age Factors ,Anticoagulants ,General Medicine ,Venous Thromboembolism ,Vitamin K antagonist ,Middle Aged ,3. Good health ,Concomitant ,Meta-analysis ,Administration ,business ,Cohort study ,Human - Abstract
BACKGROUND The long-term risk for major bleeding in patients receiving extended (beyond the initial 3 to 6 months) anticoagulant therapy for a first unprovoked venous thromboembolism (VTE) is uncertain. PURPOSE To determine the incidence of major bleeding during extended anticoagulation of up to 5 years among patients with a first unprovoked VTE, overall, and in clinically important subgroups. DATA SOURCES MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from inception to 23 July 2021. STUDY SELECTION Randomized controlled trials (RCTs) and prospective cohort studies reporting major bleeding among patients with a first unprovoked VTE who were to receive oral anticoagulation for a minimum of 6 additional months after completing at least 3 months of initial anticoagulant treatment. DATA EXTRACTION Two reviewers independently abstracted data and assessed study quality. Unpublished data required for analyses were obtained from authors of included studies. DATA SYNTHESIS Among the 14 RCTs and 13 cohort studies included in the analysis, 9982 patients received a vitamin K antagonist (VKA) and 7220 received a direct oral anticoagulant (DOAC). The incidence of major bleeding per 100 person-years was 1.74 events (95% CI, 1.34 to 2.20 events) with VKAs and 1.12 events (CI, 0.72 to 1.62 events) with DOACs. The 5-year cumulative incidence of major bleeding with VKAs was 6.3% (CI, 3.6% to 10.0%). Among patients receiving either a VKA or a DOAC, the incidence of major bleeding was statistically significantly higher among those who were older than 65 years or had creatinine clearance less than 50 mL/min, a history of bleeding, concomitant use of antiplatelet therapy, or a hemoglobin level less than 100 g/L. The case-fatality rate of major bleeding was 8.3% (CI, 5.1% to 12.2%) with VKAs and 9.7% (CI, 3.2% to 19.2%) with DOACs. LIMITATION Data were insufficient to estimate incidence of major bleeding beyond 1 year of extended anticoagulation with DOACs. CONCLUSION In patients with a first unprovoked VTE, the long-term risks and consequences of anticoagulant-related major bleeding are considerable. This information will help inform patient prognosis and guide decision making about treatment duration for unprovoked VTE. PRIMARY FUNDING SOURCE Canadian Institutes of Health Research. (PROSPERO: CRD42019128597).
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- 2021
106. Anticoagulation in Italian patients with venous thromboembolism and thrombophilic alterations: findings from START2 register study
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Margaglione, Maurizio, Antonucci, Emilia, D’Andrea, Giovanna, Migliaccio, Ludovica, Ageno, Walter, Bucherini, Eugenio, Cosmi, Benilde, Falanga, Anna, Martini, Giuliana, Mastroiacovo, Daniela, Paparo, Carmelo, Poli, Daniela, Testa, Sophie, Palareti, Gualtiero, Margaglione M., Antonucci E., D'Andrea G., Migliaccio L., Ageno W., Bucherini E., Cosmi B., Falanga A., Martini G., Mastroiacovo D., Paparo C., Poli D., Testa S., Palareti G., Margaglione, M, Antonucci, E, D'Andrea, G, Migliaccio, L, Ageno, W, Bucherini, E, Cosmi, B, Falanga, A, Martini, G, Mastroiacovo, D, Paparo, C, Poli, D, Testa, S, and Palareti, G
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Adult ,Aged, 80 and over ,Male ,Risk ,Anticoagulants ,Comorbidity ,Venous Thromboembolism ,Middle Aged ,bleeding ,Antithrombins ,Blood Coagulation Factors ,Haemostasis and Thrombosis ,Young Adult ,Italy ,Recurrence ,Anticoagulation, venous thromboembolism, thrombophilia, platelet, VTE ,Humans ,Mass Screening ,thrombosi ,Female ,Prospective Studies ,Registries ,anticoagulation ,Aged ,thrombophilia - Abstract
BACKGROUND: Randomised control trials have assessed the efficacy and safety of direct oral anticoagulants in the prophylaxis and treatment of venous thromboembolism (VTE). Positive but limited results have been reported in patients with inherited thrombophilia. Using an Italian, multicentre, prospective registry of consecutive patients presenting with symptomatic, acute VTE, we aimed to assess which factors are involved in making the choice of the drug that best fits the patient's risk profile in a large real-world setting of VTE patients. MATERIALS AND METHODS: We investigated 4,866 VTE patients who took oral anticoagulants in the period between 2012 and April 2018 to prevent a new thromboembolic episode. RESULTS: The large majority of patients who underwent thrombophilic screening, regardless of the results obtained, were prescribed direct oral anticoagulants rather than conventional anticoagulant therapy (p
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- 2020
107. Thrombocytopenia and Mortality Risk in Patients With Atrial Fibrillation: An Analysis From the START Registry
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Daniele Pastori, Emilia Antonucci, Francesco Violi, Gualtiero Palareti, Pasquale Pignatelli, Sophie Testa, Oriana Paoletti, Benilde Cosmi, Giuliana Guazzaloca, Ludovica Migliaccio, Daniela Poli, Rossella Marcucci, Niccolò Maggini, Vittorio Pengo, Anna Falanga, Teresa Lerede, Lucia Ruocco, Giuliana Martini, Simona Pedrini, Federica Bertola, Lucilla Masciocco, Pasquale Saracino, Angelo Benvenuto, Claudio Vasselli, Elvira Grandone, Donatella Colaizzo, Marco Marzolo, Mauro Pinelli, Walter Ageno, Giovanna Colombo, Eugenio Bucherini, Domizio Serra, Andrea Toma, Pietro Barbera, Carmelo Paparo, Antonio Insana, Serena Rupoli, Giuseppe Malcangi, Maddalena Loredana Zighetti, Catello Mangione, Domenico Lione, Paola Casasco, Giovanni Nante, Alberto Tosetto, Vincenzo Oriana, Nicola Lucio Liberato, Pastori D., Antonucci E., Violi F., Palareti G., Pignatelli P., Testa S., Paoletti O., Cosmi B., Guazzaloca G., Migliaccio L., Poli D., Marcucci R., Maggini N., Pengo V., Falanga A., Lerede T., Ruocco L., Martini G., Pedrini S., Bertola F., Masciocco L., Saracino P., Benvenuto A., Vasselli C., Grandone E., Colaizzo D., Marzolo M., Pinelli M., Ageno W., Colombo G., Bucherini E., Serra D., Toma A., Barbera P., Paparo C., Insana A., Rupoli S., Malcangi G., Zighetti M.L., Mangione C., Lione D., Casasco P., Nante G., Tosetto A., Oriana V., Liberato N.L., Pastori, D, Antonucci, E, Violi, F, Palareti, G, Pignatelli, P, Testa, S, Paoletti, O, Cosmi, B, Guazzaloca, G, Migliaccio, L, Poli, D, Marcucci, R, Maggini, N, Pengo, V, Falanga, A, Lerede, T, Ruocco, L, Martini, G, Pedrini, S, Bertola, F, Masciocco, L, Saracino, P, Benvenuto, A, Vasselli, C, Grandone, E, Colaizzo, D, Marzolo, M, Pinelli, M, Mastroiacovo, D, Ageno, W, Colombo, G, Bucherini, E, Serra, D, Toma, A, Barbera, P, Paparo, C, Insana, A, Rupoli, S, Malcangi, G, Zighetti, M, Mangione, C, Lione, D, Casasco, P, Nante, G, Tosetto, A, Oriana, V, and Liberato, N
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Male ,medicine.medical_specialty ,Population ,thrombocytopenia ,Arrhythmias ,030204 cardiovascular system & hematology ,Risk Assessment ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Arrhythmia and Electrophysiology ,In patient ,atrial fibrillation ,Prospective Studies ,Registries ,mortality ,education ,Aged ,Original Research ,education.field_of_study ,business.industry ,Atrial fibrillation ,medicine.disease ,Italy ,030220 oncology & carcinogenesis ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background Thrombocytopenia is associated with increased mortality in the general population, but few data exist in patients with atrial fibrillation ( AF ) taking oral anticoagulants. We investigated factor determinants of thrombocytopenia in a large cohort of patients affected by AF and its association with total mortality. Methods and Results Multicenter prospective cohort study, including 5215 patients with AF from the START (Survey on Anticoagulated Patients Register) registry, 3877 (74.3%) and 1338 (25.7%) on vitamin K or non–vitamin K antagonist oral anticoagulants, respectively. Thrombocytopenia was defined by a platelet count 9 /L. Determinants of thrombocytopenia were investigated, and all‐cause mortality was the primary survival end point of the study. Thrombocytopenia was present in 592 patients (11.4%). At multivariable logistic regression analysis, chronic kidney disease (odds ratio [ OR], 1.257; P =0.030), active cancer ( OR, 2.065; P =0.001), liver cirrhosis ( OR, 7.635; P OR, 1.234; P =0.046) were positively associated with thrombocytopenia, whereas female sex ( OR, 0.387; P OR, 0.787; P =0.032) were negatively associated. During a median follow‐up of 19.2 months (9942 patient‐years), 391 deaths occurred (rate, 3.93%/year). Mortality rate increased from 3.8%/year to 9.9%/year in patients with normal platelet count and in those with moderate‐severe thrombocytopenia, respectively (log‐rank test, P =0.009). The association between moderate‐severe thrombocytopenia and mortality persisted after adjustment for CHA 2 DS 2 VAS c score (hazard ratio, 2.431; 95% CI, 1.254–4.713; P =0.009), but not in the fully adjusted multivariable Cox regression analysis model. Conclusions Thrombocytopenia is common in patients with AF . Despite an increased incidence of mortality, thrombocytopenia was not associated with mortality at multivariable analysis. Thrombocytopenia may reflect the presence of comorbidities associated with poor survival in AF .
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- 2019
108. Thigh-length versus below-knee compression elastic stockings for prevention of the postthrombotic syndrome in patients with proximal-venous thrombosis: a randomized trial
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Prandoni P, Noventa F, Quintavalla R, Bova C, Siragusa S, Bucherini E, Astorri F, Cuppini S, Dalla Valle F, Lensing AW, Prins MH, Villalta S, Canano Investigators Collaborators […, Vedovetto V, Barbar S, Campello E, Milan M, Filippi L, Rocci A, Chiappetta P, Pellegrini R, Fiaschi E, Vallone G, D'Amico E, Noto A, Pili C, Costantini E, Gasperon M, Palareti G, Malato A, Saccullo G, Brini C, Bitti G, Marzolo M, Ramazzina E, Zamboni S., COSMI, BENILDE, Epidemiologie, MUMC+: KIO Kemta (9), RS: CAPHRI School for Public Health and Primary Care, Prandoni P, Noventa F, Quintavalla R, Bova C, Cosmi B, Siragusa S, Bucherini E, Astorri F, Cuppini S, Dalla Valle F, Lensing AW, Prins MH, Villalta S, Canano Investigators Collaborators […, Vedovetto V, Barbar S, Campello E, Milan M, Filippi L, Rocci A, Chiappetta P, Pellegrini R, Fiaschi E, Vallone G, D'Amico E, Noto A, Pili C, Costantini E, Gasperon M, Palareti G, Malato A, Saccullo G, Brini C, Bitti G, Marzolo M, Ramazzina E, Zamboni S., …], Prandoni, P, Noventa, F, Quintavalla, R, Bova, C, Cosmi, B, Siragusa, S, Bucherini, E, Astorri, F, Cuppini, S, Dalla Valle, F, Lensing, A, Prins, M, and Villalta, S
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Adult ,Male ,musculoskeletal diseases ,medicine.medical_specialty ,Time Factors ,Immunology ,Thigh ,behavioral disciplines and activities ,Biochemistry ,Postthrombotic Syndrome ,Settore MED/15 - Malattie Del Sangue ,law.invention ,POST-THROMBOTIC SYNDROME ,Young Adult ,Randomized controlled trial ,law ,medicine ,Humans ,Knee ,Aged ,Aged, 80 and over ,Venous Thrombosis ,First episode ,VENOUS THROMBOEMBOLISM ,business.industry ,Pruritus ,Hazard ratio ,Cell Biology ,Hematology ,Middle Aged ,musculoskeletal system ,medicine.disease ,Thrombosis ,humanities ,Confidence interval ,Discontinuation ,Surgery ,Venous thrombosis ,Treatment Outcome ,medicine.anatomical_structure ,Erythema ,Patient Compliance ,Female ,venous thrombosis ,business ,Stockings, Compression ,Follow-Up Studies - Abstract
Although below-knee compression elastic stockings (CES) are effective for the prevention of the postthrombotic syndrome (PTS), a substantial number of patients with deep venous thrombosis still develop PTS. In the present open-label, randomized clinical trial, we compared thigh-length with below-knee CES for the prevention of PTS. A total of 267 patients with the first episode of proximal deep venous thrombosis were randomized to wear either thigh-length or below-knee CES for 2 years. After 3, 6, 12, 18, 24, and 36 months, they were assessed for PTS manifestations according to the Villalta scale. PTS developed in 44 (32.6%) of the 135 patients randomized to thigh-length CES and in 47 (35.6%) of the 132 allocated to below-knee CES, for an adjusted hazard ratio of 0.93 (95% confidence interval, 0.62-1.41). Severe PTS developed in 3 patients in each group. CES-related side effects developed in 55 (40.7%) of the 135 patients allocated to thigh-length CES and in 36 (27.3%) of those randomized to the below-knee group (P = .017), and led to premature discontinuation of their use in 29 (21.5%) and 18 (13.6%) patients, respectively. We conclude that thigh-length CES do not offer a better protection against PTS than below-knee CES and are less well tolerated. This study is registered as Clinical Trial number NCT00426075.
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- 2012
109. Relevance of immobility as a risk factor for symptomatic proximal and isolated distal deep vein thrombosis in acutely ill medical inpatients
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Elisabetta Favaretto, Benilde Cosmi, Michelangelo Sartori, Sartori, M., Favaretto, E., and Cosmi, B.
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medical inpatient ,Deep vein ,medicine.medical_treatment ,venous thromboembolism (VTE) ,030204 cardiovascular system & hematology ,Bed rest ,Cohort Studies ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,deep vein thrombosis (DVT) ,medicine ,Humans ,In patient ,cardiovascular diseases ,030212 general & internal medicine ,Risk factor ,Aged ,Ultrasonography ,Aged, 80 and over ,Venous Thrombosis ,Inpatients ,business.industry ,Anticoagulants ,Middle Aged ,medicine.disease ,Thrombosis ,medicine.anatomical_structure ,risk factor ,Deep vein thrombosis (DVT) ,Anesthesia ,Female ,Cardiology and Cardiovascular Medicine ,business ,immobility ,Cohort study ,Surgical patients - Abstract
Immobility is a well-recognized risk factor for deep vein thrombosis (DVT) in surgical patients, whereas the level of DVT risk conferred by immobility is less defined in patients on medical wards. The aim of this study was to establish whether immobility and its duration are associated with the risk of DVT in acutely ill medical inpatients. We conducted a cohort study in acutely ill medical inpatients. Patients underwent whole leg ultrasound for suspected lower extremity DVT and were divided into two groups according to presence or absence of immobility, defined as total bed rest or sedentary without bathroom privileges. The endpoint was the detection of proximal DVT or isolated distal DVT (IDDVT). Among the 252 acutely ill medical inpatients with immobility (age 82.6 ± 10.3 years, female 63.9%), ultrasound showed 36 (14.3%) proximal DVTs and 39 (15.5%) IDDVTs, while there were 11 (4.4%) proximal DVTs and 26 (10.5%) IDDVTs among the 248 inpatients without immobility (age 73.6 ± 14.2 years, female 54.8%). The risk of proximal DVT was higher in immobile than in mobile patients (OR 3.59, 95% CI: 1.78–7.23, p = 0.0001), whereas the risk of IDDVT was similar between the two groups (OR 1.56, 95% CI: 0.92–2.66, p = 0.111). During the first 3 days of hospitalization, the frequency of all DVTs was similar in patients with and without immobility, but it was 0.26 ± 0.03 vs 0.18 ± 0.03, respectively, after 4 days. In conclusion, immobility for more than 3 days is a risk factor for proximal DVT in acutely ill medical inpatients. © The Author(s) 2021.
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- 2021
110. Thromboembolic Disease in Patients With Cancer and COVID-19: Risk Factors, Prevention and Practical Thromboprophylaxis Recommendations-State-of-the-Art
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Evangelos, Dimakakos1, Georgia, Gomatou1, Mariella, Catalano2, DAN-MIRCEA, Olinic3, Spyropoulos4, ALEX C., 5, Anna, Falanga6, 7, Anthony, Maraveyas8, Aaron, Liew9, Sam, Schulman10, Jill, Belch11, Grigorios, Gerotziafas12, Peter, Marschang14, BENILDE COSMI 15, Jonas, Spaak16, Konstantinos, Syrigos1, Darko, Antic, Ales, Blinc, Vinko, Boc, Francesco, Boccardo, Marianne, Brodmann, Patrick, Carpentier, Denisa, Celovska, DE MARCHI, Sergio, Gabriel, Dimitrov, Katalin, Farkas, Olga, Fionik, Eleni, Fyta, Ioannis, Gkiozos, Anders, Gottsater, Paolo, Gresele, Amer, Hamade, Christian, Heiss, Oguz, Karahan, Stamatis, Karakatsanis, Maryam, Kavousi, Anastasios, Kollias, Endre, Kolossvary, Elias, Kotteas, Matija, Kozak, Abraham, Kroon, Emre, Kubat, Eleftheria, Lefkou, Gianfranco, Lessani, Chris, Manu, Lucia, Mazzolai, Dragan, Milic, Jasminka, Nancheva, Kosmas, Pantazopoulos, Vasileios, Patriarcheas, Evelina, Pazvanska, Zsolt, Pecsvarady, Sergio, Pillon, Manilo, Prior, Nikolaos, Ptohis, Isabelle, Quere, Marc, Righini, Karel, Roztocil, Gerit-Holger, Schernthaner, Oliver, Schlager, Aleksander, Sieron, Muriel, Sprynger, Agata, Stanek, Igor, Stojkovski, Stvrtinova, Viera, Dusan, Suput, Nikolaos, Syrigos, Ioannis, Trontzas, Dragan, Vasic, Adriana, Visona, Sokol, Xhepa, and Dimakakos E, Gomatou G, Catalano M, Olinic DM, Spyropoulos AC, Falanga A, Maraveyas A, Liew A, Schulman S, Belch J, Gerotziafas G, Marschang P, Cosmi B, Spaak J, Syrigos K
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Cancer Research ,SARS-CoV-2 ,review ,Anticoagulants ,COVID-19 ,Endothelial Cells ,CAT ,Thrombosis ,General Medicine ,Venous Thromboembolism ,Heparin, Low-Molecular-Weight ,COVID-19, cancer, thromboprophylaxis ,Anticoagulation ,SDG 3 - Good Health and Well-being ,Oncology ,Risk Factors ,Neoplasms ,Humans ,RNA, Viral ,Prospective Studies ,thromboprophylaxis - Abstract
Cancer and COVID-19 are both well-established risk factors predisposing to thrombosis. Both disease entities are correlated with increased incidence of venous thrombotic events through multifaceted pathogenic mechanisms involving the interaction of cancer cells or SARS-CoV2 on the one hand and the coagulation system and endothelial cells on the other hand. Thromboprophylaxis is recommended for hospitalized patients with active cancer and high-risk outpatients with cancer receiving anticancer treatment. Universal thromboprophylaxis with a high prophylactic dose of low molecular weight heparins (LMWH) or therapeutic dose in select patients, is currentlyindicated for hospitalized patients with COVID-19. Also, prophylactic anticoagulation is recommended for outpatients with COVID-19 at high risk for thrombosis or disease worsening. However, whether there is an additive risk of thrombosis when a patient with cancer is infected with SARS-CoV2 remains unclear In the current review, we summarize and critically discuss the literature regarding the epidemiology of thrombotic events in patients with cancer and concomitant COVID-19, the thrombotic risk assessment, and the recommendations on thromboprophylaxis for this subgroup of patients. Current data do not support an additive thrombotic risk for patients with cancer and COVID-19. Of note, patients with cancer have less access to intensive care unit care, a setting associated with high thrombotic risk. Based on current evidence, patients with cancer and COVID-19 should be assessed with well-established risk assessment models for medically ill patients and receive thromboprophylaxis, preferentially with LMWH, according to existing recommendations. Prospective trials on well-characterized populations do not exist.
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- 2022
111. Objectives and methodology: Guidelines of the Italian Society for Haemostasis and Thrombosis (SISET)
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Marco Cattaneo, Walter Ageno, Alberto Tosetto, Benilde Cosmi, Daniela Tormene, Sergio Siragusa, Federico Lussana, Davide Imberti, Alfonso Iorio, Iorio A, Ageno W, Cosmi B, Imberti D, Lussana F, Siragusa S, Tormene D, Tosetto A, Cattaneo M., Iorio, A, Ageno, W, Cosmi, B, Imberti, D, Lussana, F, Siragusa, S, Tormene, D, Tosetto, A, and Cattaneo, M
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Medical education ,Reference Document ,Hemostasis ,business.industry ,Thrombosis ,Hematology ,Guideline ,Settore MED/15 - Malattie Del Sangue ,Clinical Practice ,guidelines, methodology ,Guideline implementation ,Italy ,Multidisciplinary approach ,EVIDENCE BASED MEDICINE ,Practice Guidelines as Topic ,Medicine ,Humans ,Guideline development ,Grading (education) ,business ,Working group - Abstract
A current goal of the Italian Society for Thrombosis and Haemostasis (SISET) is the production of guidelines for clinical conditions related to haemostasis and thrombosis. In 2006, the Executive Committee of SISET adopted a new program for the production of methodologically and scientifically sound guidelines aimed at both addressing clinical practice and stimulating new research. The first major step for this program was to train methodologists to manage working groups that compose the guidelines, and to create a reference document that describes the development of the program. The aim of the present paper is to report a short version of this methodological document, for those who wish to follow SISET guidelines. We start by giving a brief outline of the SISET mission, then present the SISET guideline development process, which includes: project funding, selection of guidelines topics, multidisciplinary group composition, definition of clinical questions, literature search, evidence appraisal, grading recommendations, guideline implementation, external peer review, and guideline updating.
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- 2009
112. The Post-thrombotic Syndrome-Prevention and Treatment: VAS-European Independent Foundation in Angiology/Vascular Medicine Position Paper
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Benilde Cosmi, Agata Stanek, Matja Kozak, Paul W. Wennberg, Raghu Kolluri, Marc Righini, Pavel Poredos, Michael Lichtenberg, Mariella Catalano, Sergio De Marchi, Katalin Farkas, Paolo Gresele, Peter Klein-Wegel, Gianfranco Lessiani, Peter Marschang, Zsolt Pecsvarady, Manlio Prior, Attila Puskas, Andrzej Szuba, and Cosmi B, Stanek A, Kozak M, Wennberg PW, Kolluri R, Righini M, Poredos P, Lichtenberg M, Catalano M, De Marchi S, Farkas K, Gresele P, Klein-Wegel P, Lessiani G, Marschang P, Pecsvarady Z, Prior M, Puskas A, Szuba A.
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treatment ,post-thrombotic syndrome, deep vein thrombosis, prevention,management ,post-thrombotic syndrome ,Cardiology and Cardiovascular Medicine ,deep vein thrombosis - Abstract
ImportanceThe post-thrombotic syndrome (PTS) is the most common long-term complication of deep vein thrombosis (DVT), occurring in up to 40–50% of cases. There are limited evidence-based approaches for PTS clinical management.ObjectiveTo provide an expert consensus for PTS diagnosis, prevention, and treatment.Evidence-ReviewMEDLINE, Cochrane Database review, and GOOGLE SCHOLAR were searched with the terms “post-thrombotic syndrome” and “post-phlebitic syndrome” used in titles and abstracts up to September 2020.Filters WereEnglish, Controlled Clinical Trial / Systematic Review / Meta-Analysis / Guideline. The relevant literature regarding PTS diagnosis, prevention and treatment was reviewed and summarized by the evidence synthesis team. On the basis of this review, a panel of 15 practicing angiology/vascular medicine specialists assessed the appropriateness of several items regarding PTS management on a Likert-9 point scale, according to the RAND/UCLA method, with a two-round modified Delphi method.FindingsThe panelists rated the following as appropriate for diagnosis: 1-the Villalta scale; 2- pre-existing venous insufficiency evaluation; 3-assessment 3–6 months after diagnosis of iliofemoral or femoro-popliteal DVT, and afterwards periodically, according to a personalized schedule depending on the presence or absence of clinically relevant PTS. The items rated as appropriate for symptom relief and prevention were: 1- graduated compression stockings (GCS) or elastic bandages for symptomatic relief in acute DVT, either iliofemoral, popliteal or calf; 2-thigh-length GCS (30–40 mmHg at the ankle) after ilio-femoral DVT; 3- knee-length GCS (30–40 mmHg at the ankle) after popliteal DVT; 4-GCS for different length of times according to the severity of periodically assessed PTS; 5-catheter-directed thrombolysis, with or without mechanical thrombectomy, in patients with iliofemoral obstruction, severe symptoms, and low risk of bleeding. The items rated as appropriate for treatment were: 1- thigh-length GCS (30–40 mmHg at the ankle) after iliofemoral DVT; 2-compression therapy for ulcer treatment; 3- exercise training. The role of endovascular treatment (angioplasty and/or stenting) was rated as uncertain, but it could be considered for severe PTS only in case of stenosis or occlusion above the inguinal ligament, followed by oral anticoagulation.Conclusions and RelevanceThis position paper can help practicing clinicians in PTS management.
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- 2022
113. Thrombophilia testing in the real-world clinical setting of thrombosis centres taking part in the Italian Start 2-Register
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Legnani, Cristina, Palareti, Gualtiero, Antonucci, Emilia, Poli, Daniela, Cosmi, Benilde, Falanga, Anna, Mastroiacovo, Daniela, Testa, Sophie, Paoletti, Oriana, Morandini, Rossella, Marcucci, Rossella, Maggini, Niccolò, Guazzaloca, Giuliana, Lerede, Teresa, Barcella, Luca, Bucherini, Eugenio, Chiarugi, Paolo, Grandone, Elvira, Colaizzo, Donatella, Pengo, Vittorio, Pignatelli, Pasquale, Pastori, Daniele, Piana, Antonietta, Cibecchini, Francesco, Martini, Giuliana, Bradamante, Salvatore, Masciocco, Lucilla, Paparo, Carmelo, Ageno, Walter, Colombo, Giovanna, Vasselli, Claudio, Toma, Andrea, Visonà, Adriana, Tonello, Diego, Legnani, C., Palareti, G., Antonucci, E., Poli, D., Cosmi, B., Falanga, A., Mastroiacovo, D., and Testa, S.
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Haemostasis And Thrombosis ,Recurrent event ,Incidence ,anticoagulant ,Bleeding ,Thrombosis ,Venous Thromboembolism ,Italy ,thrombofilia ,Humans ,Thrombophilia ,VTE ,thrombosis ,Prospective Studies ,Anticoagulant therapy ,Factor Xa Inhibitors ,Follow-Up Studies - Abstract
Background - Even though it rarely influences venous thromboembolism (VTE) treatment and the fact that it is generally discouraged, thrombophilia testing is still largely prescribed. We assessed: 1) whether/how frequently Italian thrombosis centres requested thrombophilia testing; 2) what results were obtained; and 3) if the results affected treatment and clinical results. Materials and methods - We examined data from 4,826 VTE patients enrolled by 19 clinical centres participating in the START 2-Register. Results - 57.2% of patients were tested. Numbers varied widely among centres (2.9-99.7%). Thrombophilic alterations were recorded in 18.2% of patients and the percentage of positive results was inversely correlated with that of patients tested. Significantly less patients with deep vein thrombosis (DVT) were tested, whereas more were tested when the event was idiopathic, presenting as isolated pulmonary embolism (PE), or in unusual sites. Patients with thrombophilic alterations were younger, more frequently treated with direct oral anticoagulants (DOACs), with lower mortality and less frequently discontinued anticoagulation. DOACs were more frequently prescribed in patients with heterozygous Factor V (FV) Leiden or prothrombin mutations, whereas vitamin K antagonists were preferred in patients with inhibitor deficiencies, combined alterations or antiphospholipid syndrome (APLS). There was no difference in duration of treatment among those with or without alterations, though more APLS patients received an extended treatment course. Bleeding and thrombotic complications occurred with a similar and fairly low incidence in patients with or without thrombophilic alterations. Discussion - Although general testing for thrombophilia in VTE patients is currently discouraged, more than half of the VTE patients included in the START2-Register were tested. However, there were marked differences in practice between Italian thrombosis centres. About 60% of all patients with alterations were treated with DOACs, confirming that DOACs can be a useful option for treatment of thrombophilic VTE patients, with the exclusion of those with APLS. IMTIPRO Sr © SIMTIPRO Srl
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- 2021
114. Coronary artery disease and restenosis after peripheral endovascular intervention are predictors of poor outcome in peripheral arterial disease
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Michelangelo Sartori, Elisabetta Favaretto, Antonio Pacelli, Eleonora Conti, Benilde Cosmi, Favaretto E., Sartori M., Pacelli A., Conti E., and Cosmi B.
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endocrine system ,medicine.medical_specialty ,cardiovascular outcome ,Percutaneous ,Arterial disease ,030204 cardiovascular system & hematology ,urologic and male genital diseases ,Transluminal Angioplasty ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,Restenosis ,Duplex sonography ,Intervention (counseling) ,Internal medicine ,Peripheral arterial disease ,otorhinolaryngologic diseases ,medicine ,restenosi ,030212 general & internal medicine ,thrombosis ,endovascular procedure ,business.industry ,General Medicine ,medicine.disease ,Thrombosis ,Peripheral ,body regions ,surgical procedures, operative ,Cardiology ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background: Few data are available on long-term atherothrombotic events after percutaneous transluminal angioplasty (PTA) for peripheral arterial disease (PAD). Restenosis after PTA may be a marker of a more aggressive atherothrombosis. Aim: To ascertain whether restenosis detected by duplex sonography (DUS) after PTA for iliac and femoro-popliteal disease is associated with a higher risk of cardiovascular events. Methods: We conducted a prospective cohort study of patients undergoing iliac or femoro-popliteal PTA for PAD. Patients were seen at one month, six months, one year and every year thereafter after PTA. At each visit, DUS was performed and accordingly restenosis was stratified into two categories (absent/present). The outcome was the composite of major adverse cardiovascular events (MACE). Results: Two hundred and fifty patients (aged 69 ± 11 years, male 59.2%) were enrolled. During a mean follow-up of 1207 ± 904 days, 102 (40.8%) patients developed restenosis. Restenosis was more frequent in patients with diabetes and critical limb ischaemia. MACEs (n = 76) were more frequent in the patients that developed restenosis vs. those that did not (40.2 vs. 23.6%, p =.005). Predictors of MACEs were diabetes (HR 2.02, 95%CI: 1.19–3.41, p =.009), presence of coronary heart disease at enrolment (HR 2.84, 95%CI: 1.78–4.53, p =.001) and restenosis (HR 1.87, 95%CI: 1.16–3.00, p =.010). Conclusion: Restenosis at DUS, diabetes, and coronary heart disease in patients who underwent iliac or femoro-popliteal PTA for PAD are associated with increased risk of arterial thrombotic event. Intervention trials are required to show the benefit of different therapeutic approaches in such patients at high risk of clinical deterioration.
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- 2019
115. An in vitro study to investigate the interference of enoxaparin on plasma levels of direct oral factor Xa inhibitors measured by chromogenic assays
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Gualtiero Palareti, Cristina Legnani, Benilde Cosmi, Sophie Testa, Michela Cini, Armando Tripodi, Cini M., Legnani C., Testa S., Tripodi A., Cosmi B., and Palareti G.
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medicine.drug_mechanism_of_action ,Clinical Biochemistry ,Factor Xa Inhibitor ,apixaban ,interference ,In Vitro Techniques ,030204 cardiovascular system & hematology ,Pharmacology ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Edoxaban ,medicine ,Humans ,Dosing ,rivaroxaban ,Rivaroxaban ,Chromogenic ,business.industry ,Biochemistry (medical) ,enoxaparin ,Original Articles ,Hematology ,General Medicine ,Heparin ,Plasma levels ,Blood Coagulation Test ,chemistry ,edoxaban ,Original Article ,Apixaban ,Blood Coagulation Tests ,business ,Human ,Factor Xa Inhibitors ,030215 immunology ,medicine.drug - Abstract
Introduction: Co-administration of enoxaparin and a direct oral factor Xa inhibitor (xabans: apixaban, edoxaban, rivaroxaban) could give rise to the problem of overlapping the anti-Xa activity when measuring direct oral anticoagulant (DOAC) levels. We aimed to evaluate in vitro the degree of the interference of increasing enoxaparin concentrations on xaban plasma levels measured by different chromogenic anti-Xa assays with drug-specific calibrators and controls. Methods: Seven plasma samples were spiked with apixaban, edoxaban, or rivaroxaban at fixed concentration, and enoxaparin at increasing concentrations (0, 0.125, 0.250, 0.50, 1.0, 1.50, and 2.0IU/mL). The evaluated chromogenic assays were as follows: Biophen DiXaI and Biophen Heparin LRT (Hyphen BioMed), Berichrom Heparin and Innovance Heparin (Siemens), STA-Liquid Anti-Xa (Stago Diagnostics), Technochrom anti-Xa (Technoclone), and HemosIL Liquid Anti-Xa (Werfen). Results: The presence of enoxaparin caused increased DOAC levels, with over-estimation depending on the anti-Xa assay and on the heparin concentration in the sample. The smallest over-estimation was in the sample with enoxaparin 0.125IU/mL and the greatest in the sample with enoxaparin 2.0IU/mL (0%, 3.1%, and 7.4% vs 583.8%, 526.1%, and 415.2% for apixaban, edoxaban, and rivaroxaban, respectively). Biophen DiXaI showed lower interference compared to other methods (maximum over-estimation in the presence of enoxaparin 2.0IU/mL: 56.4% dosing rivaroxaban by Biophen DIXaI vs 583.8% dosing apixaban by Berichrom Heparin). Conclusion: The presence of enoxaparin interferes with xabans measurement by chromogenic anti-Xa assays causing falsely elevated DOAC levels, the over-estimation being dependent on the anti-Xa assay and on the heparin concentration in the sample.
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- 2019
116. Heparin-induced thrombocytopenia and COVID-19
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Michelangelo Sartori, Benilde Cosmi, Sartori, M., and Cosmi, B.
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Coronavirus disease 2019 (COVID-19) ,Case Report ,thrombocytopenia ,heparin ,Argatroban ,deep vein thrombosis ,law.invention ,law ,Deep vein thrombosi ,Heparin-induced thrombocytopenia ,medicine ,Platelet ,business.industry ,lcsh:RC633-647.5 ,SARS-CoV-2 ,COVID-19 ,Hematology ,Heparin ,lcsh:Diseases of the blood and blood-forming organs ,medicine.disease ,Intensive care unit ,Thrombosis ,Anesthesia ,Heparin-induced thrombocytope-nia ,Complication ,business ,medicine.drug - Abstract
Heparin-induced thrombocytopenia (HIT) has not been included as a possible cause of thrombocytopenia in Coronavirus Disease 2019 (COVID-19) patients. We report a case of HIT in a patient with COVID-19 treated with heparin. A 78-year-old man was admitted to our hospital for acute respiratory failure and acute renal failure due to SARS-CoV-2 infection; in intensive care unit, one 5000IU heparin dose (day 0, platelet count 305000/μL). On day 2, haemoglobin started to decrease and heparin was stopped. On day 10, platelet count was 153000/μL and 5000IU calcium heparin subcutaneously twice daily was started. The platelet further decreased, reaching 49000/μL on day 17, and the patient was investigated for suspected HIT: an IgG specific chemiluminescence test for heparin-PF4 antibodies was positive and a femoral DVT was found at ultrasound. Argatroban was started, platelet count increased without any bleeding and thrombosis complication. Our experience shows that HIT may develop in heparin treated COVID-19 patients and should be included among the possible cause of thrombocytopenia in such patients. © the Author(s), 2021.
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- 2021
117. Do women with venous thromboembolism bleed more than men during anticoagulation? Data from the real-life, prospective START-Register
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Gualtiero Palareti, Cristina Legnani, Emilia Antonucci, Benilde Cosmi, Anna Falanga, Daniela Poli, Daniela Mastroiacovo, Vittorio Pengo, Walter Ageno, Sophie Testa, Palareti, G., Legnani, C., Antonucci, E., Cosmi, B., Falanga, A., Poli, D., Mastroiacovo, D., Pengo, V., Ageno, W., and Testa, S.
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anticoagulation ,bleeding ,venous thromboembolism ,women ,Pharmacology (medical) ,Therapeutics. Pharmacology ,RM1-950 ,Original Research - Abstract
Background: Venous thromboembolism (VTE) is a frequent and serious disease that requires immediate and long-term anticoagulant treatment, which is inevitably associated with a risk of bleeding complications. Some studies, though not all, reported a higher risk of bleeding in female patients treated with either old anticoagulants [vitamin k antagonists (VKAs)] or recent anticoagulants [direct oral anticoagulants (DOACs)]. Furthermore, analyses of clinical trials reported an abnormal vaginal bleeding in women of reproductive age treated with DOACs. This study aimed at comparing the risk of bleeding in an inception cohort of VTE women and men included in a prospective observational registry. Methods: Baseline characteristics and bleeding events occurring during anticoagulation in patients of both sexes, included in the START-Register after a first VTE, were analyzed. Results: In all, 1298 women were compared with 1290 men. Women were older and more often had renal diseases; their index events were often provoked (often by hormonal contraception and pregnancy), and more frequently presented as isolated pulmonary embolism (PE). The rate of bleeding was similar in women (2.9% patient-years) and men (2.1% patient-years), though it was higher when uterine bleeds were included (3.5% patient-years, p = 0.0141). More bleeds occurred in VKA- than DOAC-treated patients (6.4% versus 2.6%, respectively; p = 0.0013). At multivariate analysis, age ⩾ 75 years was associated with higher prevalence of bleeds. Conclusion: The occurrence of bleeding was not different between women and men during anticoagulation after VTE. Only after inclusion of vaginal/uterine bleeds, the rate of bleeding was higher in women. The incidence of bleeding was higher in women treated with VKAs. Plain Language Summary The risk of bleeding in women anticoagulated for deep vein thrombosis or pulmonary embolism is not higher than that in men, except for vaginal bleeding Background: The occurrence of a venous thromboembolic event (VTE, including deep vein thrombosis and pulmonary embolism) necessarily requires a period of at least 3–6 months of treatment with anticoagulant drugs [either vitamin k antagonists (VKA) or, more recently, direct oral anticoagulants (DOACs)]. Anticoagulation therapy, however, is associated with a risk of bleeding that is influenced by several factors. Sex is one of these factors as some authors have hypothesized that women are at higher risk than men. Furthermore, some studies have recently found more vaginal bleeding in VTE women treated with a DOAC compared with those who received VKAs. Methods: The present study aimed to compare the frequency of bleeds occurring in women and in men who were treated with DOACs or VKAs for a first VTE event and followed in real-life conditions. Since the beginning of their anticoagulant treatment, the patients were included in a prospective, multicenter, observational registry (the START-Register), and bleeding events were recorded. Results: A total of 1298 women were compared with 1290 men. Women were older and more often were affected by renal diseases; their VTE events were often associated with risk factors (especially hormonal contraception and pregnancy) and presented as isolated pulmonary embolism. The rate of all bleeding events (including major, non-major but clinically relevant, and minor bleeds) was higher in women (3.5% patient-years) than in men (2.1% patient-years, p = 0.0141); however, the difference was no longer statistically significant after exclusion of uterine bleeds (2.9% patient years). More bleeding occurred in women receiving VKA as anticoagulant drug compared with those treated with a DOAC (6.4% versus 2.6%, respectively; p = 0.0013). At multivariate analysis, age ⩾ 75 years was associated with higher prevalence of bleeds. Conclusion: In conclusion, we found that in real-life conditions, the rate of bleeding events occurring during anticoagulation after a VTE episode is not higher in women than in men. Only after inclusion of vaginal bleeds, the rate of bleeding was higher in women. More bleeds (including vaginal bleeding) occurred in women treated with VKA than DOACs.
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- 2021
118. An update on the efficacy and safety of novel anticoagulants for cancer associated thrombosis
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Benilde Cosmi and Cosmi B.
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medicine.medical_specialty ,pulmonary embolism ,medicine.drug_class ,Low molecular weight heparin ,Administration, Oral ,direct oral anticoagulant ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Neoplasms ,medicine ,Cancer associated thrombosis ,Humans ,Pharmacology (medical) ,cardiovascular diseases ,Pharmacology ,business.industry ,Cancer associated thrombosi ,low molecular weight heparin ,Direct factor Xa inhibitors ,deep vein thrombosi ,Cancer ,Anticoagulants ,Thrombosis ,General Medicine ,Venous Thromboembolism ,Heparin, Low-Molecular-Weight ,medicine.disease ,Pulmonary embolism ,vitamin K antagonists ,030220 oncology & carcinogenesis ,Thromboembolic complication ,direct Factor Xa inhibitor ,business ,Venous thromboembolism ,030217 neurology & neurosurgery - Abstract
Introduction: Cancer-associated thrombosis (CAT) refers to the most common thromboembolic complication of cancer which is venous thromboembolism (VTE). CAT primary prophylaxis, treatment, and secondary prevention are challenging for the complexity of cancer patients, who exhibit hypercoagulability with concomitant-heightened bleeding risk. Areas covered: In this review, the author examines the role of low molecular weight heparins (LMWH), which have been the standard of care for CAT treatment for many years. Direct oral anticoagulants (DOACS) have practical advantages over subcutaneous LMWH, especially for long-term therapy. The author then discusses the results of two RCTs which separately compared the direct oral factor Xa inhibitors, apixaban or rivaroxaban, with placebo for CAT prophylaxis in ambulatory high-risk cancer patients and found that DOACS reduced VTE but increased bleeding. Finally, the author discusses four RCTS separately comparing an oral direct factor Xa inhibitor (edoxaban, rivaroxaban, or apixaban) with LMWH for CAT treatment. DOACS showed non-inferior efficacy, although rivaroxaban and edoxaban showed higher bleeding rates, especially in gastrointestinal cancers. Expert opinion: DOACS have a convenient route of administration and do not require laboratory monitoring, although choice of anticoagulants for CAT depends on factors such as tumor type, bleeding risk, concomitant drugs, and comorbidities.
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- 2020
119. Use of Enoxaparin to Counteract COVID-19 Infection and Reduce Thromboembolic Venous Complications: A Review of the Current Evidence
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Lucia Gozzo, Filippo Drago, Benilde Cosmi, Li Li, Andrea Stella, Drago F., Gozzo L., Li L., Stella A., and Cosmi B.
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0301 basic medicine ,medicine.medical_specialty ,2019-20 coronavirus outbreak ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,coronavirus ,Review ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Medicine ,Pharmacology (medical) ,induced thrombosis inflammation ,Intensive care medicine ,Pharmacology ,business.industry ,lcsh:RM1-950 ,food and beverages ,COVID-19 ,enoxaparin ,Heparan sulfate ,Heparin ,thromboembolism ,medicine.disease ,coronaviru ,030104 developmental biology ,lcsh:Therapeutics. Pharmacology ,chemistry ,030220 oncology & carcinogenesis ,business ,Cytokine storm ,medicine.drug - Abstract
The impact of the COVID-19 pandemic has been dramatic worldwide, with China, Italy, and now US at its epicenter. Researchers and clinicians are studying and testing different approaches in the attempt to prevent the infection and minimize its severity. Major efforts are focused on optimizing mechanical ventilation, antiviral, and supportive treatment; however, the role of heparin and low molecular weight (LMW) heparin in this setting has been largely overlooked. This review summarizes the available evidence about the role of heparan sulfate as a key entry mechanism for SARS-CoV-2; the efficacy of heparin and LMW heparin in counteracting its entry into the cell, the recent experimental findings obtained in in vitro studies using the LMW heparin enoxaparin Inhixa®, the role of heparin and LMW heparin in modulating the cytokine storm, and the evidence for the use of LMW heparin in the prevention and treatment of the thromboembolic complications of COVID-19. The available evidence suggests that LMW heparin appears as a promising tool in the treatment of COVID-19. Whether its systematic use is associated with a reduction in complications and ultimately mortality of these patients is being tested in several studies starting worldwide.
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- 2020
120. Preliminary Experience With Low Molecular Weight Heparin Strategy in COVID-19 Patients
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Renato Pascale, Luca Bergamaschi, Benilde Cosmi, F Donati, Giulia Tesini, Carmine Pizzi, Maddalena Giannella, Nazzareno Galiè, Sara K. Tedeschi, Pasquale Paolisso, Mauro Biffi, Pierluigi Viale, Michele Bartoletti, E.C D'Angelo, Paolisso P., Bergamaschi L., D'Angelo E.C., Donati F., Giannella M., Tedeschi S., Pascale R., Bartoletti M., Tesini G., Biffi M., Cosmi B., Pizzi C., Viale P., and Galie N.
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0301 basic medicine ,COVID- 19 ,medicine.medical_specialty ,Dose ,medicine.drug_class ,Deep vein ,Low molecular weight heparin ,heparin ,LMWH (low molecular weight heparin) ,03 medical and health sciences ,0302 clinical medicine ,DVT prophylaxis ,Internal medicine ,medicine ,Pharmacology (medical) ,Pharmacology ,business.industry ,lcsh:RM1-950 ,Retrospective cohort study ,DVT prophylaxi ,Heparin ,Brief Research Report ,medicine.disease ,Thrombosis ,Regimen ,lcsh:Therapeutics. Pharmacology ,030104 developmental biology ,medicine.anatomical_structure ,030220 oncology & carcinogenesis ,Propensity score matching ,business ,in-hospital mortality ,medicine.drug - Abstract
Background Heparin administration in COVID-19 patients is recommended by expert consensus, although evidence about dosage, duration and efficacy are limited. We aim to investigate the association between different dosages of low molecular weight heparin (LMWH) and mortality among COVID-19 hospitalized patients. Methods and results Retrospective study of 450 laboratory-confirmed COVID-19 patients admitted to Sant'Orsola Bologna Hospital from March 01 to April 10, 2020. Clinical, laboratory and treatment data were collected and analyzed. The in-hospital mortality between COVID-19 patients treated with standard prophylactic LMWH dosage vs. intermediate LMWH dosage was compared. Out of 450 patients, 361 received standard deep vein thrombosis (DVT) prophylaxis enoxaparin treatment (40-60mg daily) and 89 patients received intermediate enoxaparin dosage (40-60 mg twice daily) for 7 days. No significant differences in the main demographic characteristics and laboratory testings at admission were observed in the two heparin regimen subgroups, except for older age and prevalence of hypertension in the group treated with "standard" prophylaxis LMWH dosage. The intermediate LMWH administration was associated with a lower in-hospital all-cause mortality compared to the "standard" prophylactic LMWH dosage (18.8% vs. 5.8%, p = 0.02). This difference remained significant after adjustment with the propensity score for variables that differed significantly between the dosage groups (OR= 0.260, 95% CI 0.089-0.758, p=0.014). Conclusions Intermediate LMWH dosage seems to be associated with lower incidence of mortality compared to standard DVT prophylaxys in hospitalized COVID-19 patients. Our study paves the way to further pathophysiological investigations and controlled studies of anticoagulation therapy in Covid-19 disease.
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- 2020
121. DOAC plasma levels measured by chromogenic anti-Xa assays and HPLC-UV in apixaban- and rivaroxaban-treated patients from the START-Register
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Sophie Testa, Daniela Poli, Rossella Marcucci, Claudia Dellanoce, Michela Cini, Benilde Cosmi, Cristina Legnani, Roberto Padrini, Giovanni De Rosa, Vittorio Pengo, Gualtiero Palareti, Cini M., Legnani C., Padrini R., Cosmi B., Dellanoce C., De Rosa G., Marcucci R., Pengo V., Poli D., Testa S., and Palareti G.
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Male ,HPLC-UV ,apixaban ,chromogenic anti-Xa assay ,laboratory testing ,rivaroxaban ,medicine.drug_mechanism_of_action ,Pyridones ,Clinical Biochemistry ,Factor Xa Inhibitor ,030204 cardiovascular system & hematology ,Pyridone ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Edoxaban ,medicine ,Humans ,In patient ,Registries ,Chromatography, High Pressure Liquid ,Rivaroxaban ,Chromatography ,Chromogenic ,Biochemistry (medical) ,Antithrombin ,Hematology ,General Medicine ,Plasma levels ,chemistry ,Pyrazole ,Pyrazoles ,Apixaban ,Female ,Drug Monitoring ,030215 immunology ,medicine.drug ,Human ,Factor Xa Inhibitors - Abstract
Introduction: To measure direct factor Xa inhibitor (apixaban, edoxaban, rivaroxaban) concentrations, dedicated chromogenic anti-Xa assays are recommended as suitable methods to provide rapid drug quantification. Moreover, the high-performance liquid chromatography with ultraviolet detection (HPLC-UV) is reported as a reliable quantitative technique. We investigated seven anti-Xa assays and an HPLC-UV method for measurement of apixaban and rivaroxaban levels in patients enrolled in the START-Register. Methods: A total of 127 apixaban and 124 rivaroxaban samples were tested by HPLC-UV and the following anti-Xa assays: Biophen DiXaI and Heparin LRT (Hyphen BioMed), Berichrom and Innovance Heparin (Siemens), STA-Liquid Anti-Xa (Stago Diagnostics), Technochrom anti-Xa (Technoclone), and HemosIL Liquid Anti-Xa (Werfen). Each method was performed in one of the participating laboratories: Bologna, Cremona, Florence, and Padua. Results: Our data confirmed the overestimation of apixaban and rivaroxaban levels by the antithrombin-supplemented anti-Xa method (Berichrom). Performances and reproducibility of the six anti-Xa assays not supplemented with antithrombin and the HPLC-UV method were good, with limits of quantification from 8-39ng/mL (apixaban) and 15-33ng/mL (rivaroxaban). The six chromogenic methods showed good concordances with the quantitative HPLC-UV [bias: −26.9-22.3ng/mL (apixaban), −11.3-18.7ng/mL (rivaroxaban)]. Higher bias and wider range between limits of agreement were observed at higher concentrations [200ng/mL: bias −42.2-36.8ng/mL (apixaban) and −20.1-68.9ng/mL (rivaroxaban)]. Conclusion: Overall, the anti-Xa assays not supplemented with antithrombin and the HPLC-UV method proved to be suitable for apixaban and rivaroxaban quantification.
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- 2020
122. The direct oral anticoagulants may also be effective against the risk of post-thrombotic syndrome
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Gualtiero Palareti, Benilde Cosmi, Palareti G., and Cosmi B.
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Venous Thrombosis ,medicine.medical_specialty ,business.industry ,Anticoagulants ,macromolecular substances ,medicine.disease ,Postthrombotic Syndrome ,Deep vein thrombosis, oral anticoagulants, recurrence, vitamin K antagonists, direct oral anticoagulants ,Emergency Medicine ,Internal Medicine ,medicine ,Humans ,Intensive care medicine ,business ,Post-thrombotic syndrome - Abstract
The post-thrombotic syndrome (PTS) is a long-term complication of deep vein thrombosis (DVT) of the lower limbs occurring in 40–50% of patients (1). Impaired thrombus resolution with persistent obstruction is involved in the pathogenesis of PTS, similarly to chronic thromboembolic pulmonary hypertension (CTEPH), which however develops only in a small minority of subjects after pulmonary embolism (PE)(2). Both PTS and CTEPH are associated with substantial morbidity and high healthcare expenses (2). PTS epidemiology reflects that of venous thromboembolism (VTE), which is estimated to affect 104–183 subjects per 100,000 person-years among Caucasians (3, 4), encompassing PE and DVT, with an incidence ranging from 29 to 78 and 45 to 117, per 100,000 person-years, respectively (5, 6). PTS can occur in severe forms in 10% and with the development of leg ulcers in 1–3% of patients (1). Leg ulcers …
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- 2020
123. 'Early thrombus removal' in iliac-femoral deep vein thrombosis for prevention of post-thrombotic syndrome
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Gualtiero Palareti, Benilde Cosmi, Cosmi B, and Palareti G.
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medicine.medical_specialty ,business.industry ,Deep vein ,General Medicine ,030204 cardiovascular system & hematology ,medicine.disease ,post-thrombotic syndrome, deep vein thrombosis, anticoagulation, recurrence ,Thrombosis ,Pulmonary embolism ,Pathogenesis ,03 medical and health sciences ,Editorial Commentary ,0302 clinical medicine ,medicine.anatomical_structure ,Internal medicine ,Cardiology ,Medicine ,Chronic thromboembolic pulmonary hypertension ,cardiovascular diseases ,030212 general & internal medicine ,Thrombus ,business ,Complication ,Post-thrombotic syndrome - Abstract
The post-thrombotic syndrome (PTS) is a long-term complication of deep vein thrombosis (DVT) of the lower limbs occurring in 40–50% of patients (1). Impaired thrombus resolution with persistent obstruction is involved in the pathogenesis of PTS, similarly to chronic thromboembolic pulmonary hypertension (CTEPH), which however develops only in a small minority of subjects after pulmonary embolism (PE) (2).
- Published
- 2019
124. Is there a role for intervention radiology for the treatment of lower limb deep vein thrombosis in the era of direct oral anticoagulants? A comprehensive review
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Benilde Cosmi, Mario Luppi, Marco Marietta, Valeria Coluccio, Elisa Romagnoli, and Marietta M, Romagnoli E, Cosmi B, Coluccio V, Luppi M.
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medicine.medical_specialty ,Mechanical Thrombolysis ,medicine.medical_treatment ,Deep vein ,deep vein thrombosi, thrombolytic therapy, post-thrombotic syndrome ,030204 cardiovascular system & hematology ,Radiography, Interventional ,Postthrombotic Syndrome ,03 medical and health sciences ,0302 clinical medicine ,Rivaroxaban ,Internal Medicine ,medicine ,Humans ,Apixaban ,030212 general & internal medicine ,Intensive care medicine ,Randomized Controlled Trials as Topic ,Thrombectomy ,Venous Thrombosis ,Interventional ,business.industry ,Angioplasty ,Warfarin ,Anticoagulants ,Thrombolysis ,medicine.disease ,Dabigatran ,Deep Vein Thrombosis ,Thrombolytic therapy ,Radiography ,Anticoagulant drugs ,Venous thrombosis ,medicine.anatomical_structure ,Lower Extremity ,Practice Guidelines as Topic ,Edoxaban ,Mechanical thrombolysis ,business ,medicine.drug ,Post-thrombotic syndrome - Abstract
© 2018 European Federation of Internal Medicine Despite recent advances in the treatment of Deep Vein Thrombosis (DVT) provided by Direct Oral Anticoagulants (DOAC), a substantial proportion of lower limb DVT patients will develop some degree of post-thrombotic syndrome (PTS) within 2 years. Systemic thrombolysis, although effective in reducing the risk of PTS and leg ulceration, is associated with a high risk of major bleeding, making it unsuitable for the vast majority of patients. A local approach, aimed at delivering the fibrinolytic drug directly into, or near to, the thrombus surface, is attractive because of the possibility of lowering of the administered drug dose, thus reducing the bleeding risks. However, even after the recent publication of the ATTRACT trial, only weak evidence is available about the efficacy and safety of Catheter Directed Thrombolysis (CDT), either alone (pharmacological technique) or in combination with additional endovascular approaches (pharmacomechanical technique, PMT) including percutaneous mechanical thrombectomy, angioplasty with or without stenting and ultrasound-assisted CDT. The present review is aimed at providing the physicians with a comprehensive evaluation of the current evidence about this relevant topic, in order to build a reliable conceptual framework for a more appropriate use of this resource.
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- 2018
125. Proximal and isolated distal deep vein thrombosis and Wells score accuracy in hospitalized patients
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Massimo Filippini, Michelangelo Sartori, Elisabetta Favaretto, Ludovica Migliaccio, Benilde Cosmi, Filippo Gabrielli, Academic Medical Center, Vascular Medicine, Sartori M., Gabrielli F., Favaretto E., Filippini M., Migliaccio L., and Cosmi B.
- Subjects
Male ,medicine.medical_specialty ,Hospitalized patients ,Deep vein ,030204 cardiovascular system & hematology ,Calf deep vein thrombosi ,Calf deep vein thrombosis ,Deep vein thrombosis ,Diagnosis ,Inpatients ,Isolated distal deep vein thrombosis ,03 medical and health sciences ,0302 clinical medicine ,Text mining ,Deep vein thrombosi ,Internal medicine ,Internal Medicine ,medicine ,Prevalence ,Humans ,cardiovascular diseases ,030212 general & internal medicine ,Aged ,Aged, 80 and over ,Venous Thrombosis ,Receiver operating characteristic ,business.industry ,Incidence (epidemiology) ,Middle Aged ,University hospital ,medicine.disease ,Thrombosis ,Surgery ,Pre- and post-test probability ,Hospitalization ,medicine.anatomical_structure ,Cross-Sectional Studies ,ROC Curve ,Research Design ,Emergency Medicine ,Female ,Inpatient ,business ,Wells score ,Diagnosi - Abstract
Deep vein thrombosis (DVT) is an important cause of morbidity and mortality in hospitalized patients. The Wells score for DVT pretest probability (PTP) was validated in outpatients, but its utility for inpatients is unclear. The aim of this study was to establish the prevalence of inpatient proximal and distal DVT and the Wells score performance in inpatients. A single-center cross-sectional study was conducted in a university hospital. During 183days, all inpatients with suspected lower-extremity DVT were evaluated with the Wells score and whole-leg ultrasound. Among 634 inpatients (age 77.5 ± 13.8 years, males 39.3%), 507 (80.0%) were from medical wards and 127 (20.0%) from surgical wards. During the study period, there were 11,662 hospital admissions in the surgical/medical services. Whole-leg ultrasound detected 128 DVTs (20.2%); 51 (39.8%) were proximal and 77 (60.1%) were isolated distal DVTs. Estimated DVT prevalence in hospital setting was 1.09% (95% CI 0.93–1.31), and isolated distal DVT prevalence was 0.66% (95% CI 0.53–0.82). DVT frequency in low-, moderate-, and high-PTP groups was 9.8%, 24.3%, and 41.5%, respectively (p = 0.001). The area under the receiver operating characteristic curve for the Wells score was 0.67 ± 0.03 for all DVTs and 0.75 ± 0.04 for only proximal DVTs. A high PTP had a sensitivity of 24% (95% CI 14–37%) and a specificity of 93% (95% CI 91–95%) for proximal DVT diagnosis. In hospitalized patients, isolated distal DVT has a higher incidence than expected, and the Wells score accuracy for proximal DVT is similar to that found in outpatients.
- Published
- 2019
126. D-dimer levels during and after anticoagulation withdrawal in patients with venous thromboembolism treated with non-vitamin K anticoagulants
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Walter Ageno, Cristina Legnani, Gualtiero Palareti, Sophie Testa, Benilde Cosmi, Ida Martinelli, Maurizio Ciammaichella, Alessandro Ciavarella, Eugenio Bucherini, Daniela Poli, Daniela Mastroiacovo, Nicola Mumoli, Legnani C., Martinelli I., Palareti G., Ciavarella A., Poli D., Ageno W., Testa S., Mastroiacovo D., Ciammaichella M., Bucherini E., Mumoli N., and Cosmi B.
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Male ,Vitamin K ,Pulmonology ,Anticoagulant Therapy ,Glycobiology ,Administration, Oral ,Organic chemistry ,030204 cardiovascular system & hematology ,Gastroenterology ,Vascular Medicine ,Biochemistry ,0302 clinical medicine ,Rivaroxaban ,Medicine and Health Sciences ,030212 general & internal medicine ,Prospective cohort study ,Clinical Trials as Topic ,Multidisciplinary ,Pharmaceutics ,Drugs ,Venous Thromboembolism ,Vitamins ,Vitamin K antagonist ,Middle Aged ,D-dimer, oral anticoagulants, vitamin K antagonists, recurrence, venous thromboembolism ,Deep Vein Thrombosis ,Physical sciences ,Cardiovascular Therapy ,Chemistry ,Italy ,Medicine ,Female ,medicine.drug ,Research Article ,Risk ,medicine.medical_specialty ,medicine.drug_class ,Science ,B vitamins ,Fibrin Fibrinogen Degradation Products ,03 medical and health sciences ,Chemical compounds ,Pharmacokinetics ,Drug Therapy ,Internal medicine ,Thromboembolism ,D-dimer ,Organic compounds ,medicine ,Humans ,Aged ,Retrospective Studies ,Glycoproteins ,Pharmacology ,business.industry ,Clinical Laboratory Techniques ,Case-control study ,Warfarin ,Anticoagulants ,Biology and Life Sciences ,Fibrinogen ,Retrospective cohort study ,Discontinuation ,Case-Control Studies ,business ,Pulmonary Embolism - Abstract
BackgroundD-dimer levels measured during and after vitamin K antagonist withdrawal may be used in clinical practice to assess the individual risk of recurrent venous thromboembolism. Currently, direct oral anticoagulants (DOACs) are frequently used in venous thromboembolism treatment; however, their pharmacokinetics and pharmacodynamics characteristics are completely different than vitamin K antagonists. The present study aimed at comparing the results of D-dimer levels during and after anticoagulation withdrawal in patients with venous thromboembolism treated with DOACs or warfarin.Material and methodsD-dimer levels were measured in 527 patients ("cases") during DOACs treatment (T0) and after 15 (T15), 30 (T30), 60 (T60) and 90 (T90) days after their discontinuation and in 527 patients ("controls") enrolled in the DULCIS study (all treated with warfarin), matched for sex, age (+/-3 y), type of D-dimer assay and site of venous thromboembolism. Both cases and controls received anticoagulant treatment after a first venous thromboembolism event that was unprovoked or associated with weak risk factors.ResultsThe rate of positive D-dimer results was significantly higher in cases than in controls at T0 (10.8% vs 5.1%, p = 0.002) and at T30 (18.8% vs 11.8%, p = 0.019), as well as at the other time-points, though not statistically significant.ConclusionD-dimer levels during and after stopping an anticoagulant treatment for a venous thromboembolism episode differ between patients treated with a DOAC than in those treated with warfarin. Specifically designed prospective studies are warranted to reassess the use of D-dimer as predictor of the risk of recurrent venous thromboembolism in patients treated with DOACs.
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- 2019
127. Drug levels and bleeding complications in atrial fibrillation patients treated with direct oral anticoagulants
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Cristina Legnani, Daniela Poli, Rossella Morandini, Oriana Paoletti, Gualtiero Palareti, Emilia Antonucci, Vittorio Pengo, Benilde Cosmi, Armando Tripodi, Roberto Testa, Claudia Dellanoce, Sophie Testa, Testa S., Legnani C., Antonucci E., Paoletti O., Dellanoce C., Cosmi B., Pengo V., Poli D., Morandini R., Testa R., Tripodi A., and Palareti G.
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Adult ,Male ,medicine.drug_class ,Pyridones ,Administration, Oral ,Hemorrhage ,direct oral anticoagulant ,030204 cardiovascular system & hematology ,Antithrombins ,Dabigatran ,Drug levels ,03 medical and health sciences ,0302 clinical medicine ,Rivaroxaban ,bleed ,Risk Factors ,level ,Atrial Fibrillation ,medicine ,Humans ,In patient ,Registries ,Blood Coagulation ,Aged ,Aged, 80 and over ,Dose-Response Relationship, Drug ,business.industry ,HAEMOSTASIS ,Anticoagulant ,Atrial fibrillation ,Hematology ,Original Articles ,Middle Aged ,medicine.disease ,peak ,bleeds ,Treatment Outcome ,Italy ,Anesthesia ,Pyrazoles ,Apixaban ,Female ,Original Article ,Drug Monitoring ,business ,medicine.drug ,Blood sampling - Abstract
Essentials Currently, DOACs are given at fixed doses and do not require laboratory monitoring. Direct oral anticoagulant-specific measurements were performed at trough and peak. Patients who developed bleeding events showed higher DOAC plasma levels at peak. This study suggests the need of a more accurate DOAC dose assessment. Background: Direct oral anticoagulants (DOACs) are administered at fixed dose. The aim of the study was to evaluate the relationship between DOAC C-trough or C-peak plasma levels and bleeding complications in patients with non-valvular atrial fibrillation (NVAF). Methods: Five hundred sixty five consecutive naive NVAF patients were enrolled. The DOAC measurements at C-trough and at C-peak (available in 411 patients) were performed at steady state, within the first month of treatment. Major bleeding (MB), clinically relevant non-major bleeding (CRNMB), and minor bleeding (MinB), occurring during 1year of follow-up after blood sampling, were recorded. For each DOAC, interval of C-trough and C-peak levels was subdivided into four equal classes and results were attributed to these classes; the median values of results were also calculated. Results: Two hundred eight patients were on apixaban, 185 on dabigatran, and 172 on rivaroxaban. For 1-[qqqdeletezzz]year follow up for all patients, we observed: 19 MB (3.36%), 6 CRNMB (1.06%), and 47 MinB (8.31%). The prevalence of bleeding patients with anticoagulant levels in the upper classes of C-peak activity (II + III + IV) was higher than that in the lowest class. Normalized results of C-peak levels were higher in patients with bleeding than in those without bleeding. Conclusions: Bleeding complications during DOAC treatment were more frequent among atrial fibrillation (AF) patients with higher C-peak anticoagulant levels. In addition to a previous study that showed an increased risk of thrombotic complications in the patients with low C-trough levels, this study seems to indicate that patients with NVAF on DOACs would need a more accurate definition of their optimal therapeutic window.
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- 2018
128. Current management strategies and long‐term clinical outcomes of upper extremity venous thrombosis
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K. Kaasjager, S van Wissen, Giuseppe Camporese, Peter Marschang, Marc Philip Righini, H. M. Otten, Anita Aggarwal, Benilde Cosmi, Suzanne M. Bleker, Jan Beyer-Westendorf, Ettore Porreca, Peter Verhamme, M. Di Nisio, Karina Meijer, A. Kleinjan, T Gary, Teresa Lerede, Angelo Ghirarduzzi, Harry R. Büller, N. van Es, Pieter W. Kamphuisen, Bleker, S.M, van Es, N., Kleinjan, A., Büller, H.R., Kamphuisen, P.W., Aggarwal, A., Beyer-Westendorf, J., Camporese, G., Cosmi, B., Gary, T., Ghirarduzzi, A., Kaasjager, K., Lerede, T., Marschang, P., Meijer, K., Otten, H.-M., Porreca, E., Righini, M., Verhamme, P., van Wissen, S., Di Nisio, M., Other departments, Amsterdam Cardiovascular Sciences, Vascular Medicine, Cardiovascular Centre (CVC), and Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET)
- Subjects
Male ,Superficial vein thrombosis ,medicine.medical_treatment ,neoplasms ,030204 cardiovascular system & hematology ,0302 clinical medicine ,Risk Factors ,Prevalence ,DEEP-VEIN THROMBOSIS ,030212 general & internal medicine ,Prospective cohort study ,Upper extremity deep vein thrombosi ,ddc:616 ,Venous Thrombosis ,upper extremity deep vein thrombosis ,Incidence (epidemiology) ,RIETE REGISTRY ,Hazard ratio ,Venous Thromboembolism ,Hematology ,Middle Aged ,Pulmonary embolism ,Venous thrombosis ,Treatment Outcome ,WEIGHT HEPARIN DALTEPARIN ,Female ,hemorrhage ,Adult ,medicine.medical_specialty ,recurrence ,PULMONARY-EMBOLISM ,POSTTHROMBOTIC SYNDROME ,Compression stockings ,Fibrin Fibrinogen Degradation Products ,03 medical and health sciences ,Internal medicine ,medicine ,Humans ,Survival rate ,Aged ,therapy ,business.industry ,Anticoagulants ,Decision Support Systems, Clinical ,medicine.disease ,mortality ,BLEEDING COMPLICATIONS ,Surgery ,PROSPECTIVE COHORT ,CATHETER-RELATED THROMBOSIS ,RISK-FACTORS ,Neoplasm ,COMPRESSION STOCKINGS ,business ,Follow-Up Studies - Abstract
Essentials Few data exist on outcome of upper extremity deep and superficial vein thrombosis (UEDVT and UESVT). We followed 102 and 55 patients with UEDVT or UESVT, respectively, for a median of 3.5 years. Risk of recurrent venous thromboembolism was low in both diseases, and the mortality high. Postthrombotic symptoms were infrequent and cancer patients had a higher risk of recurrent VTE. Background There is scant information on the optimal management and clinical outcome of deep and superficial vein thrombosis of the upper extremity (UEDVT and UESVT). Objectives To explore treatment strategies and the incidence of recurrent venous thromboembolism (VTE), mortality, postthrombotic symptoms, and bleeding in patients with UEDVT and UESVT and to assess the prognosis of cancer patients with UEDVT. Patients/methods Follow-up of patients with UEDVT or UESVT, who were enrolled previously in a diagnostic management study. Results We followed 102 and 55 patients with UEDVT and UESVT, respectively, both for a median of 3.5 years. Anticoagulant treatment was started in 100 patients with UEDVT (98%) and in 40 (73%) with UESVT. Nine patients with UEDVT (9%) developed recurrent VTE, 26 (26%) died, 6 (8%) of 72 patients had moderate postthrombotic symptoms, and 5 (5%) experienced major bleeding. One patient with UESVT had a recurrent VTE, 18 (33%) died, none had moderate postthrombotic symptoms, and none had major bleeding. Of the cancer patients with UEDVT, 18% had recurrent VTE vs. 7.5% in non-cancer patients (adjusted hazard ratio 2.2, 95%CI 0.6-8.2). The survival rate was 50% in cancer patients with UEDVT vs. 60% in those without (adjusted HR 0.8, 95%CI 0.4-1.4). Conclusions The risk of recurrent VTE was low in patients with UEDVT, and negligible for UESVT. Mortality was high for both diseases. Postthrombotic symptoms were infrequent and mild. Anticoagulant therapy of UEDVT carried a substantial risk of major bleeding. Cancer patients had a significant risk of recurrent VTE
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- 2016
129. Duration of anticoagulation after isolated pulmonary embolism
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Cristina Legnani, Angelo Ghirarduzzi, Benilde Cosmi, Alberto Tosetto, Emilia Antonucci, Nicoletta Erba, Gualtiero Palareti, Sophie Testa, Vittorio Pengo, Daniela Poli, Paolo Prandoni, Palareti G, Cosmi B, Antonucci E, Legnani C, Erba N, Ghirarduzzi A, Poli D, Testa S, Tosetto A, Pengo V, and Prandoni P
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Adult ,Male ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Deep vein ,Subgroup analysis ,030204 cardiovascular system & hematology ,RECURRENT VENOUS THROMBOEMBOLISM ,Body Mass Index ,Fibrin Fibrinogen Degradation Products ,03 medical and health sciences ,Sex Factors ,0302 clinical medicine ,RISK-FACTOR ,Risk Factors ,Internal medicine ,Prevalence ,EPIDEMIOLOGY ,Humans ,Medicine ,Thrombolytic Therapy ,In patient ,DEEP-VEIN THROMBOSIS ,Prospective Studies ,cardiovascular diseases ,030212 general & internal medicine ,Blood Coagulation ,Aged ,Venous Thrombosis ,business.industry ,Anticoagulants ,Venous Thromboembolism ,Middle Aged ,medicine.disease ,Thrombosis ,Pulmonary embolism ,Surgery ,COMMUNITY ,medicine.anatomical_structure ,Multivariate Analysis ,Female ,Ultrasonography ,Pulmonary Embolism ,business ,Venous thromboembolism - Abstract
In the D-dimer and ULtrasonography in Combination Italian Study (DULCIS), serial D-dimer measurement in combination with assessment of residual thrombosis (in patients with deep vein thrombosis (DVT)) identified patients who safely discontinued anticoagulation after an unprovoked venous thromboembolism (VTE).In this subgroup analysis, the value of D-dimer tests was assessed in patients with isolated pulmonary embolism (PE) compared with those with DVT, with or without PE (DVT/PE). The DULCIS database was reanalysed in relation to this target.26.8% of the DULCIS patients had isolated PE as the index event; this was more prevalent in females (34.1%) than in males (21.1%; pversus 3.8% ppy; nonsignificant) who stopped anticoagulation for negative D-dimer, but it was markedly high (11.2% ppy; pversus two (7.4%) out of 27; p=0.0085).Serial D-dimer assessment can inform on the risk of recurrent VTE and help determine the duration of anticoagulation in patients with isolated PE.
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- 2016
130. The effect of plasma proteins and platelet release products on the anti-thrombin activities of standard heparin and dermatan sulfate
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Cosmi, B., Weitz, J.I., and Hirsh, J.
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- 1992
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131. ESC position paper on cardiovascular toxicity of cancer treatments: challenges and expectations-authors' reply
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Fabrizio De Ponti, Emanuel Raschi, Benilde Cosmi, Igor Diemberger, Raschi E., Diemberger I., Cosmi B., and De Ponti F.
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Cardiovascular toxicity ,medicine.medical_specialty ,business.industry ,Cancer ,030204 cardiovascular system & hematology ,medicine.disease ,Cardiovascular System ,03 medical and health sciences ,0302 clinical medicine ,Cardiovascular Diseases ,Cardiovascular Disease ,030220 oncology & carcinogenesis ,Emergency Medicine ,Internal Medicine ,medicine ,Position paper ,Humans ,Intensive care medicine ,business ,Human - Published
- 2018
132. Andexanet alfa to reverse the anticoagulant activity of factor Xa inhibitors: a review of design, development and potential place in therapy
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Michelangelo Sartori, Benilde Cosmi, Sartori, M, and Cosmi, B
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medicine.medical_specialty ,medicine.drug_mechanism_of_action ,medicine.drug_class ,Factor Xa Inhibitor ,Low molecular weight heparin ,030204 cardiovascular system & hematology ,Pharmacology ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Animals ,Humans ,andexanet alfa, factor Xa inhibitors, anticoagulants ,Drug Interactions ,030212 general & internal medicine ,Rivaroxaban ,Hemostasis ,Hematology ,business.industry ,virus diseases ,Recombinant Proteins ,Clinical trial ,Factor Xa ,Apixaban ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug ,Andexanet alfa ,Factor Xa Inhibitors - Abstract
Direct oral anticoagulants are associated with rates of major bleeding which are not negligible, albeit lower than those associated with vitamin K antagonists. No specific reversal agent for factor Xa (FXa) direct inhibitors is currently available for clinical use. A modified activated human FXa decoy protein, andexanet alfa, is being developed that binds FXa direct inhibitors in their active site, thus reversing their anticoagulant effect. The purpose of this article is to review the design, development and clinical trials of andexanet alfa. Andexanet alfa was shown to reverse FXa inhibitors anticoagulant activity both in thrombosis animal models, healthy volunteers and patients with acute major bleeding. Andexanet alfa has been studied in double-blind, placebo-controlled phase II and III studies. A preliminary report of the phase III study showed that an effective hemostasis was obtained after andexanet alfa infusion in the majority of the patients with acute major bleeding associated with FXa inhibitors. Additional studies are ongoing and andexanet alfa is expected to be launched in the market in the near future.
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- 2018
133. Low drug levels and thrombotic complications in high-risk atrial fibrillation patients treated with direct oral anticoagulants
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Claudia Dellanoce, Rossella Morandini, Armando Tripodi, Sophie Testa, Emilia Antonucci, Vittorio Pengo, Cristina Legnani, Gualtiero Palareti, Roberto Testa, Daniela Poli, Benilde Cosmi, Oriana Paoletti, and Testa S., Paoletti O, Legnani C, Dellanoce C, Antonucci E, Cosmi B, Pengo V, Poli D, Morandini R, Testa R, Tripodi A, Palareti G
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Adult ,Male ,medicine.medical_specialty ,Time Factors ,medicine.drug_class ,Pyridones ,Administration, Oral ,030204 cardiovascular system & hematology ,Thrombin time ,Risk Assessment ,Antithrombins ,Dabigatran ,03 medical and health sciences ,0302 clinical medicine ,Rivaroxaban ,Predictive Value of Tests ,Risk Factors ,Internal medicine ,Thromboembolism ,Atrial Fibrillation ,medicine ,Humans ,030212 general & internal medicine ,Registries ,Aged ,Aged, 80 and over ,medicine.diagnostic_test ,business.industry ,Anticoagulant ,Atrial fibrillation ,Hematology ,Middle Aged ,medicine.disease ,Confidence interval ,Treatment Outcome ,Cohort ,Cardiology ,Pyrazoles ,atrial fibrillation, cardiovascular risk, coagulation test, direct oral anticoagulants, thromboembolism, apixaban,dabigatran, rivaroxaban ,Apixaban ,Female ,Blood Coagulation Tests ,Drug Monitoring ,business ,medicine.drug ,Factor Xa Inhibitors ,Preliminary Data - Abstract
Essentials Direct oral anticoagulants (DOACs) do not require laboratory monitoring currently. DOAC specific measurements were performed at trough in patients with atrial fibrillation. Patients who developed thromboembolic events showed lower DOAC plasma levels. This study supports the concept of measuring DOAC levels at steady state. Summary: Background Direct oral anticoagulants (DOACs) are administered at fixed doses without the need for dose adjustment according to laboratory testing. High interindividual variability in drug blood levels has been shown with all DOACs. To evaluate a possible relationship between DOAC C-trough anticoagulant levels and thromboembolic events, 565 consecutive naive patients with atrial fibrillation (AF) were enrolled in this study performed within the START Laboratory Registry. Methods DOAC-specific measurements (diluted thrombin time or anti-activated factor II calibrated for dabigatran; anti-activated FX calibrated for rivaroxaban or apixaban) at C-trough were performed locally at steady state within 15–25 days after the start of treatment. For each DOAC, the interval of C-trough levels, from the limit of quantification to the highest value, was subdivided into four equal classes, and results were attributed to these classes; the median values of results were also calculated. Thromboembolic complications occurring during 1 year of follow-up were recorded. Results Thromboembolic events (1.8%) occurred in 10 patients who had baseline C-trough levels in the lowest class of drug levels. The incidence of thromboembolic events among patients with DOAC C-trough levels in the lowest level class was 2.4%, and that in the remaining groups was 0%. The patients with thrombotic complications also had a higher mean CHA2DS2-VASc score than that of the total patient population: 5.3 (95% confidence interval [CI] 4.3–6.3 versus 3.0 (95% CI 2.9–3.1). Conclusion In this study cohort, thrombotic complications occurred only in DOAC-treated AF patients who had very low C-trough levels, with a relatively high CHA2DS2-VASc score. Larger studies are warranted to confirm these preliminary observations. © 2018 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis.
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- 2017
134. Comparison of five specific assays for determination of dabigatran plasma concentrations in patients enrolled in the START-Laboratory Register
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Rita Paniccia, Armando Tripodi, Vittorio Pengo, C. Legnani, Benilde Cosmi, Claudia Dellanoce, Rossella Marcucci, Sophie Testa, Daniela Poli, Oriana Paoletti, Michela Cini, Gualtiero Palareti, and Cini M, Legnani C, Cosmi B, Testa S, Dellanoce C, Paoletti O, Marcucci R, Poli D, Paniccia R, Pengo V, Tripodi A, Palareti G.
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Quality Control ,medicine.medical_specialty ,Clinical Biochemistry ,Urology ,030204 cardiovascular system & hematology ,chromogenic assay, clotting assay, dabigatran, direct thrombin inhibitor, laboratory testing, Antithrombins, Blood Coagulation Tests, Dabigatran,Humans, Limit of Detection, Quality Control, Reproducibility of Results ,Antithrombins ,Dabigatran ,03 medical and health sciences ,0302 clinical medicine ,Limit of Detection ,medicine ,Humans ,In patient ,Detection limit ,business.industry ,Biochemistry (medical) ,Reproducibility of Results ,Hematology ,General Medicine ,Repeatability ,Plasma levels ,Direct thrombin inhibitor ,Plasma concentration ,Blood Coagulation Tests ,business ,030215 immunology ,medicine.drug ,Discovery and development of direct thrombin inhibitors - Abstract
Introduction: Several specific assays are commercially available to determine dabigatran anticoagulant activity. Aims of this multicenter and multiplatform study were to compare five methods for dabigatran measurement and investigate their performances in the low concentration range. Methods: Dabigatran levels were analyzed in 295 plasma samples from patients enrolled in the START-Laboratory Register by the following methods using dedicated calibrators and controls: STA-ECA II (Diagnostica Stago), standard and low range Hemoclot Thrombin Inhibitors (Hyphen BioMed), Direct Thrombin Inhibitor Assay (Instrumentation Laboratory), Direct Thrombin Inhibitor Assay (Siemens), Technoclot DTI (Technoclone). Results: Methods showed variable agreement with the Hemoclot Thrombin Inhibitors assay used as reference test, with modest under- or overestimations (Bland-Altman bias from −17.3 to 4.0 ng/mL). Limits of detection and quantification varied depending on the assay (4-52 and 7-82 ng/mL, respectively). Between-run precision and accuracy were good for all methods for both quality control levels. Assay's repeatability assessed at very low dabigatran concentrations (from 10 to 60 ng/mL) was also acceptable, variability generally increased at lower drug levels. Conclusion: The five dabigatran-specific assays evaluated in this study provided reliable assessment of dabigatran plasma levels, although showing different performances. © 2018 The Authors. International Journal of Laboratory Hematology Published by John Wiley & Sons Ltd
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- 2017
135. Endothelial activation in patients with superficial vein thrombosis (SVT) of the lower limbs
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Paolo Gresele, Emanuela Falcinelli, Massimo Filippini, Gualtiero Palareti, Rino Migliacci, Benilde Cosmi, Giuseppe Guglielmini, Cristina Legnani, Eleonora Petito, Michela Cini, Falcinelli, E, Cosmi, B, Filippini, M, Petito, E, Legnani, C, Cini, M, Guglielmini, G, Migliacci, R, Palareti, G, and Gresele, P.
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Male ,medicine.medical_specialty ,Superficial vein thrombosis ,030204 cardiovascular system & hematology ,Endothelial activation ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Internal medicine ,Vascular ,medicine ,Endothelium, Vascular ,Female ,Humans ,Lower Extremity ,Venous Thrombosis ,Hematology ,In patient ,Endothelium ,business.industry ,superficial vein thrombosis, endothelial cells, von Willebrand factor ,medicine.disease ,Cardiology ,business ,030215 immunology - Abstract
no abstract available
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- 2017
136. External validation of the DASH prediction rule: a retrospective cohort study
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Cristina Legnani, Francesco Dentali, Francesca Bartolomei, Gualtiero Palareti, Walter Ageno, V. De Stefano, Emilia Antonucci, Luca Barcella, Alberto Tosetto, Paolo Bucciarelli, Ida Martinelli, Sophie Testa, Ilaria Nichele, Corrado Lodigiani, E. Banfi, Oriana Paoletti, Benilde Cosmi, Anna Falanga, Daniela Poli, Tosetto, A., Testa, S, Martinelli, I, Poli, D, Cosmi, B, Lodigiani, C, Ageno, W, Stefano, De, Falanga A, ., Nichele, I, Paoletti, O, Bucciarelli, P, Antonucci, E, Legnani, C, Banfi, E, Dentali, F, Bartolomei, F, Barcella, L, Palareti, G., Tosetto, A, De Stefano, V, Falanga, A, and Palareti, G
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Male ,Pediatrics ,Time Factors ,Administration, Oral ,030204 cardiovascular system & hematology ,D-dimer ,prediction models ,recurrence ,risk ,venous thromboembolism ,Hematology ,0302 clinical medicine ,Recurrence ,Risk Factors ,030212 general & internal medicine ,Venous Thrombosis ,Incidence ,Incidence (epidemiology) ,Age Factors ,Venous Thromboembolism ,Middle Aged ,Pulmonary embolism ,prediction model ,Venous thrombosis ,Treatment Outcome ,Italy ,Adult ,Aged ,Anticoagulants ,Biomarkers ,Decision Support Techniques ,Female ,Fibrin Fibrinogen Degradation Products ,Humans ,Predictive Value of Tests ,Pulmonary Embolism ,Reproducibility of Results ,Retrospective Studies ,Risk Assessment ,Predictive value of tests ,Administration ,Cohort ,Risk assessment ,Oral ,medicine.medical_specialty ,03 medical and health sciences ,Dash ,medicine ,business.industry ,Retrospective cohort study ,medicine.disease ,Settore MED/15 - MALATTIE DEL SANGUE ,D-dimer , deep vein thrombosis ,business ,human activities - Abstract
Essentials Predicting recurrences may guide therapy after unprovoked venous thromboembolism (VTE). We evaluated the DASH score in 827 patients with unprovoked VTE to verify prediction accuracy. A DASH score ≤ 1 had a cumulative recurrence risk at 1 year of 3.6%, as predicted by the model. The DASH score performed better in younger (< 65 years old) subjects. Summary: Background The DASH prediction model has been proposed as a guide to identify patients at low risk of recurrence of venous thromboembolism (VTE), but has never been validated in an independent cohort. Aims To validate the calibration and discrimination of the DASH prediction model, and to evaluate the DASH score in a predefined patient subgroup aged > 65 years. Methods Patients with a proximal unprovoked deep vein thrombosis (DVT) or pulmonary embolism (PE) who received a full course of vitamin K antagonist or direct oral anticoagulant (> 3 months) and had D-dimer measured after treatment withdrawal were eligible. The DASH score was computed on the basis of the D-dimer level after therapy withdrawal and personal characteristics at the time of the event. Recurrent VTE events were symptomatic proximal or distal DVT/PE, and were analyzed with a time-dependent analysis. Observed 12-month and 24-month recurrence rates were compared with recurrence rates predicted by the DASH model. Results We analyzed a total of 827 patients, of whom 100 (12.1%) had an objectively documented recurrence. As compared with the original DASH cohort, there was a greater proportion of subjects with a ‘low-risk’ (≤ 1) DASH score (66.3% versus 51.6%, P < 0.001). The slope of the observed versus expected cumulative incidence at 2 years was 0.71 (95% confidence interval 0.51–1.45). The c-statistic was lower for subjects aged > 65 years (0.54) than for younger subjects (0.72). Conclusions These results confirm the validity of DASH prediction model, particularly in young subjects. The recurrence risk in elderly patients (> 65 years) was, however, > 5% even in those with the lowest DASH scores.
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- 2017
137. Residual vein thrombosis and serial D-dimer for the long-term management of patients with deep venous thrombosis
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Prandoni P, Vedovetto V, Ciammaichella M, Bucherini E, Corradini S, Enea I, Mumoli N, Visonà A, Barillari G, Bova C, Quintavalla R, Zanatta N, Pedrini S, Villalta S, Camporese G, Testa S, Parisi R, Becattini C, Cuppini S, Pengo V, Palareti G. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Paolo Prandoni, Valentina Vedovetto, Maurizio Ciammaichella, Eugenio Bucherini, Sara Corradini, Iolanda Enea, Benilde Cosmi, Nicola Mumoli, Adriana Visonà, Giovanni Barillari, Carlo Bova, Roberto Quintavalla, Nello Zanatta, Simona Pedrini, Sabina Villalta, Giuseppe Camporese, Sofie Testa, Roberto Parisi, Cecilia Becattini, Stefano Cuppini, Vittorio Pengo, Gualtiero Palareti, for the Morgagni Investigators, COSMI, BENILDE, Prandoni P, Vedovetto V, Ciammaichella M, Bucherini E, Corradini S, Enea I, Cosmi B, Mumoli N, Visonà A, Barillari G, Bova C, Quintavalla R, Zanatta N, Pedrini S, Villalta S, Camporese G, Testa S, Parisi R, Becattini C, Cuppini S, Pengo V, Palareti G xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Paolo Prandoni, Valentina Vedovetto, Maurizio Ciammaichella, Eugenio Bucherini, Sara Corradini, Iolanda Enea, Benilde Cosmi, Nicola Mumoli, Adriana Visonà, Giovanni Barillari, Carlo Bova, Roberto Quintavalla, Nello Zanatta, Simona Pedrini, Sabina Villalta, Giuseppe Camporese, Sofie Testa, Roberto Parisi, Cecilia Becattini, Stefano Cuppini, Vittorio Pengo, Gualtiero Palareti, and for the Morgagni Investigators
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Adult ,Male ,medicine.medical_specialty ,Hemorrhage ,030204 cardiovascular system & hematology ,Fibrin Fibrinogen Degradation Products ,03 medical and health sciences ,Anticoagulation ,Young Adult ,0302 clinical medicine ,Recurrence ,Residual thrombosi ,Long term management ,D-dimer ,medicine ,80 and over ,Secondary Prevention ,Humans ,cardiovascular diseases ,030212 general & internal medicine ,Deep venous thrombosi ,Aged ,First episode ,Aged, 80 and over ,Venous Thrombosis ,business.industry ,Pulmonary embolism ,Anticoagulants ,Disease Management ,Hematology ,Venous Thromboembolism ,Middle Aged ,medicine.disease ,Thrombosis ,Residual thrombosis ,Surgery ,Vein thrombosis ,Venous thrombosis ,Deep venous thrombosis ,Venous thromboembolism ,Female ,Follow-Up Studies ,business - Abstract
Background The optimal long-term strategy for preventing recurrent venous thromboembolism (VTE) in patients with deep-vein thrombosis (DVT) is uncertain. Methods In 620 consecutive outpatients with a first proximal DVT who had completed at least three months of anticoagulation (unprovoked in 483, associated with minor risk factors in 137), the ultrasound presence of residual vein thrombosis (RVT) was assessed and defined as an incompressibility of at least 4 mm. In 517 patients without RVT and with negative D-dimer, anticoagulation was stopped and D-dimer was repeated after one and three months. Anticoagulation was resumed in 63 of the 72 patients in whom D-dimer reverted to positivity. Results During a mean follow-up of three years, recurrent VTE developed in 40 (7.7%) of the 517 patients, leading to an annual rate of 3.6% (95% CI, 2.6 to 4.9): 4.1% (95% CI, 2.9 to 5.7) in individuals with unprovoked DVT, and 2.2% (95% CI, 1.1 to 4.5) in those with DVT associated with minor risk factors. Of the 233 males with unprovoked DVT, 17 (7.3%) developed events in the first year of follow-up. Major bleeding complications occurred in 8 patients while on anticoagulation, leading to an annual rate of 1.2% (95% CI, 0.6 to 2.4). Conclusions Discontinuing anticoagulation in patients with a first episode of proximal DVT based on the assessment of RVT and serial D-dimer leads to an overall annual rate of recurrent VTE lower than 5.0%, which is the rate deemed as acceptable by the Subcommittee on Control of Anticoagulation of the ISTH. However, in males with unprovoked DVT there is room for further improving the long-term strategy of VTE prevention. ( ClinicalTrials.gov number, NCT01285661 ).
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- 2016
138. Anticoagulant therapy for symptomatic calf deep vein thrombosis
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Benilde Cosmi, Michelangelo Sartori, Sartori, M, and Cosmi, B.
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Venous Thrombosis ,medicine.medical_specialty ,Leg ,business.industry ,Deep vein ,MEDLINE ,Anticoagulants ,Hematology ,030204 cardiovascular system & hematology ,medicine.disease ,Thrombosis ,deep vein thrombosis ,Surgery ,03 medical and health sciences ,Venous thrombosis ,0302 clinical medicine ,Text mining ,medicine.anatomical_structure ,Anticoagulant therapy ,Mesenteric ischemia ,Mesenteric Ischemia ,medicine ,Humans ,030212 general & internal medicine ,business - Abstract
no abstract available
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- 2016
139. D-dimer and duration of anticoagulation.
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Pernod G, Sevestre M, Labarere J, Mannarino E, Schillaci G, Kevorkian J, Virally M, Bergmann J, Glynn RJ, Goldhaber SZ, Ridker PM, Palareti G, Cosmi B, and Iorio A
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- 2007
140. Low-intensity warfarin therapy for the prevention of recurrent venous thromboembolism.
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van Dongen CJJ, Prins MH, Büller HR, Seneviratne C, Kupfer Y, Tessler S, Krishnan JA, Streiff MB, Cosmi B, Palareti G, Aberegg SK, Ridker PM, Goldhaber SZ, and Glynn RJ
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- 2003
141. Ultrasound Characteristics of Calf Deep Vein Thrombosis and Residual Vein Obstruction After Low Molecular Weight Heparin Treatment
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Benilde Cosmi, Angelo Ghirarduzzi, Elisabetta Favaretto, Gualtiero Palareti, M. Iotti, L. Giusto, G. Lessiani, M. Sartori, Ludovica Migliaccio, Sartori M, Lessiani G, Favaretto E, Migliaccio L, Iotti M, Giusto L, Ghirarduzzi A, Palareti G, and Cosmi B
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Male ,medicine.medical_specialty ,Time Factors ,Deep vein ,Low molecular weight heparin treatment ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Predictive Value of Tests ,Ambulatory Care ,Medicine ,Humans ,030212 general & internal medicine ,Prospective Studies ,Enoxaparin ,Mobility Limitation ,Aged ,Calf deep vein thrombosis, Clot diameter, Heparin, Isolated distal deep vein thrombosis, Residual venous obstruction, Whole leg ultrasound ,Aged, 80 and over ,Venous Thrombosis ,Leg ,Ultrasonography, Doppler, Duplex ,business.industry ,Ultrasound ,Remission Induction ,Anticoagulants ,Reproducibility of Results ,Reduced mobility ,Heparin ,Middle Aged ,medicine.disease ,Thrombosis ,Surgery ,medicine.anatomical_structure ,Treatment Outcome ,Vein obstruction ,Italy ,ROC Curve ,Area Under Curve ,Female ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug ,Lateral gastrocnemius - Abstract
Calf deep vein thrombosis (CDVT) ultrasound diagnostic criteria are still debated. A clot >= 3.5 mm may be an appropriate threshold for CDVT diagnosis. Six week heparin treatment is associated with recanalization in half of patients with CDVT. Objective/Background: Calf deep vein thrombosis (CDVT) is frequently found in symptomatic outpatients, but CDVT ultrasound diagnostic criteria are still debated. It has been proposed that only clots with >= 5 mm maximum diameter can be considered as CDVT. Aims: To assess clot diameters and characteristics of CDVT, and to assess the recanalization rate of CDVT after anticoagulant treatment. Methods: In a prospective, multicenter cohort study symptomatic outpatients in whom CDVT was diagnosed by ultrasound were enrolled. Posterior tibial, fibular, medial and lateral gastrocnemius, and soleal veins were compressed transversally over their entire length. Clot diameter was measured during maximum compression and ultrasound was repeated after 6 weeks of low molecular weight heparin treatment. Results: In 172 patients (age 70 +/- 1 y, male 32%) CDVT was detected in 132 (76.7%) muscle veins only, and in 24 (14%) axial veins only, while 16 (9.3%) patients had both muscular and axial CDVT. A total of 212 clots were found with a diameter of 5.8 +/- 1.8 mm (IQR 4.5-6.8 mm) with the 10th percentile being >= 3.5 mm. A cut off value of >= 5 mm had a sensitivity of 0.76 (95% CI 0.69-0.82), whereas a value of >= 3.5 mm had a sensitivity of 0.94 (95% CI 0.89-0.97). Recanalization (i.e. residual vein obstruction = 5 mm is found in only 76% of CDVT patients and a clot diameter >= 3.5 mm may be more appropriate as a threshold for CDVT. After 6 weeks of anticoagulant treatment, half of CDVT patients had recanalization and recanalization was not correlated with clot characteristics at enrolment, but with mobility of the patients. (C) 2016 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.
- Published
- 2016
142. Risk factors for cancer development after idiopathic venous thromboembolism
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COSMI, BENILDE, Legnani C, Ghirarduzzi A, Micheli V., Pengo V, Testa S, Poli D, Antonucci E, Prisco D, Tripodi A., Cosmi B, Legnani C, Ghirarduzzi A, Micheli V, Pengo V, Testa S, Poli D, Antonucci E, Prisco D, and Tripodi A
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cancer deep vein thrombosis - Abstract
no abstract
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- 2016
143. The incidence of heparin-induced thrombocytopenia in patients treated with low molecular weight heparin for superficial vein thrombosis
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Michelangelo Sartori, Benilde Cosmi, Ludovica Migliaccio, Elisabetta Favaretto, Giuliana Guazzaloca, Gualtiero Palareti, Cristina Legnani, Sartori M, Favaretto E, Migliaccio L, Guazzaloca G, Legnani C, Palareti G, and Cosmi B
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Male ,medicine.medical_specialty ,Superficial vein thrombosis ,medicine.drug_class ,Low molecular weight heparin ,030204 cardiovascular system & hematology ,Fondaparinux ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,Therapeutic index ,Heparin treatment ,Heparin-induced thrombocytopenia ,Internal medicine ,medicine ,Humans ,Platelet ,In patient ,Prospective Studies ,030212 general & internal medicine ,Superficial vein thrombosi ,Aged ,Aged, 80 and over ,Venous Thrombosis ,Platelet Count ,business.industry ,Incidence ,Incidence (epidemiology) ,Anticoagulants ,Hematology ,Heparin, Low-Molecular-Weight ,Middle Aged ,medicine.disease ,Thrombocytopenia ,Surgery ,Female ,business ,medicine.drug - Abstract
Background The risk of heparin induced thrombocytopenia (HIT) associated with low molecular weight heparin (LMWH) for treatment of superficial vein thrombosis (SVT) is uncertain. As a result the necessity of platelet count monitoring is unclear in this setting. Aims To assess the risk of HIT in outpatients treated with LMWH for SVT. Methods In a prospective single centre study we included all symptomatic outpatients in whom a real-time B-mode and color Doppler ultrasonography examination revealed SVT without DVT. Patients treated with vitamin K antagonists or fondaparinux were excluded. Patients received full dose enoxaparin for 1 week followed by half therapeutic dose for 3 weeks or parnaparin 8500 UI aXa for 10 days followed by 6400 UI aXa once daily for 20 days. Platelet count was performed on the day of diagnosis (D0) and 7 (D7), and 14 (D14) days afterward. Primary outcomes were the rate of thromboembolic events and of HIT during a 3-month follow-up. Results 678 outpatients (age: 64.7 ± 16.2 years, male: 42.0%) were evaluated. During follow-up, 7 venous thrombo-embolic events were recorded (1.03% CI 95%: 0.50–2.11%), while no major bleeding was observed (0.0% CI 95%: 0.0–0.56%). Platelet count was 255 ± 93 × 109/L at D0, 245 ± 93 × 109/L at D7 (p = 0.204 vs. D0) and 261 ± 116 × 109/L at D14 (p = 0.405 vs. D0). No fall in platelet count > 50% and no case of HIT were recorded (HR 0.0% CI 95%: 0–0.56%). Conclusions A 4-week LMWH treatment for SVT is associated with an incidence of HIT lower than 0.6% and platelet count monitoring may be omitted in this setting.
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- 2016
144. Diagnosis and treatment of disseminated intravascular coagulation: Guidelines of the Italian Society for Haemostasis and Thrombosis (SISET)
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Di Nisio M, Baudo F, D'Angelo A, De Gasperi A, Malato A, Schiavoni M, Squizzato A, Italian Society for Thrombosis, Haemostasis, COSMI, BENILDE, Di Nisio M, Baudo F, Cosmi B, D'Angelo A, De Gasperi A, Malato A, Schiavoni M, Squizzato A, and Italian Society for Thrombosis and Haemostasis.
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medicine.medical_specialty ,medicine.drug_class ,Low molecular weight heparin ,Guidelines ,Neoplasms ,hemic and lymphatic diseases ,Internal medicine ,medicine ,Humans ,disseminated intravascular coagulation ,Disseminated intravascular coagulation ,Prothrombin time ,biology ,medicine.diagnostic_test ,business.industry ,Septic shock ,Antithrombin ,Venous Thromboembolism ,Hematology ,medicine.disease ,Surgery ,diagnosi ,Treatment Outcome ,Italy ,Recombinant factor VIIa ,Cryoprecipitate ,biology.protein ,Fresh frozen plasma ,business ,circulatory and respiratory physiology ,medicine.drug - Abstract
Background The diagnosis and treatment of disseminated intravascular coagulation (DIC) remain extremely controversial. Purpose The Italian Society for Thrombosis and Haemostasis commissioned a project to develop clinical practice guidelines for the diagnosis and treatment of DIC. Methods Key questions about the diagnosis and treatment of DIC were formulated by a multidisciplinary working group consisting of experts in clinical medicine and research. After a systematic review and discussion of the literature, recommendations were formulated and graded according to the supporting evidence. In the absence of evidence, evidence of low quality, or contradictory evidence, a formal consensus method was used to issue clinical recommendations. Results and Conclusions In suspected DIC, we suggest the use of the diagnostic scores ISTH (grade C), JMHW (grade C) or JAAM (grade D) over stand alone tests. The cornerstone of the management of DIC remains the treatment of the underlying triggering disease. We do not suggest the use of antithrombin (grade D), dermatan sulphate (grade D), gabexate (grade D), recombinant factor VIIa (grade D), activated protein C (grade D), thrombomodulin (grade B). The use of unfractionated heparin or low-molecular-weight heparin is not suggested except for thromboembombolic prophylaxis in patients a high risk who do not have active bleeding (grade D). In patients with severe sepsis/septic shock and DIC we suggest the use of human recombinant activated protein C (grade D). In patients with DIC and active bleeding we suggest the use of transfusion therapy (platelets, plasma, cryoprecipitate) (grade D).
- Published
- 2012
145. Categorization of patients as having provoked or unprovoked venous thromboembolism: guidance from the SSC of ISTH
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Benilde Cosmi, Walter Ageno, Clive Kearon, Paul A. Kyrle, Diagnostic Variables in Thrombotic Disease, Suzanne C. Cannegieter, Geert-Jan Geersing, Predictive, Kearon, C, Ageno, W, Cannegieter S. C, Cosmi B, Geersing GJ, and Kyrle, P. A.
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medicine.medical_specialty ,Time Factors ,PULMONARY-EMBOLISM ,DURATION ,MEDLINE ,030204 cardiovascular system & hematology ,THERAPY ,03 medical and health sciences ,0302 clinical medicine ,Recurrence ,Risk Factors ,Internal medicine ,Terminology as Topic ,medicine ,Humans ,DEEP-VEIN THROMBOSIS ,030212 general & internal medicine ,Risk factor ,Vein ,business.industry ,ASSOCIATION ,Hematology ,Venous Thromboembolism ,medicine.disease ,Prognosis ,PREVENTION ,CANCER ,Pulmonary embolism ,Venous thrombosis ,medicine.anatomical_structure ,Categorization ,RISK-FACTORS ,Cardiology ,business ,Venous thromboembolism ,INFLAMMATORY-BOWEL-DISEASE - Abstract
[No abstract available]
- Published
- 2015
146. Residual emboli on lung perfusion scan or multidetector computed tomography after a first episode of acute pulmonary embolism
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Mathilde Nijkeuter, Libero Barozzi, Menno V. Huisman, Benilde Cosmi, Massimo Valentino, Gualtiero Palareti, Cosmi B, Nijkeuter M, Valentino M, Huisman MV, Barozzi L, and Palareti G.
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Adult ,Male ,medicine.medical_specialty ,Vitamin K ,Cross-sectional study ,Perfusion Imaging ,Predictive Value of Test ,Young Adult ,Predictive Value of Tests ,Recurrence ,Internal Medicine ,medicine ,Perfusion Imaging/*method ,Humans ,Pulmonary multidetector computed tomography ,Young adult ,X-Ray Computed/*method ,Tomography ,Aged ,Pulmonary perfusion lung scan ,Pulmonary Embolism/*radiography ,Aged, 80 and over ,First episode ,business.industry ,Pulmonary embolism ,Heparin ,Middle Aged ,medicine.disease ,Antifibrinolytic Agents ,Cross-Sectional Studies ,Logistic Models ,Vitamin K antagonists ,Embolism ,Predictive value of tests ,Acute Disease ,Cohort ,Vitamin K/therapeutic use ,Emergency Medicine ,Female ,Radiology ,Tomography, X-Ray Computed ,business ,medicine.drug - Abstract
The rate of resolution of a first episode of pulmonary embolism (PE) is uncertain. A baseline test indicating any residual PE is pivotal in aiding a more accurate diagnosis of recurrent PE. This study aimed to assess the rate and risk factors of residual PE with either multidetector computed tomography imaging (MDCT) or lung perfusion scan (LPS) using a cross-sectional study in which consecutive patients were enrolled with a first objectively documented episode of symptomatic PE, and who were considered for possible treatment withdrawal after at least 3 months of anticoagulation. A first cohort of patients (n = 80) underwent MDCT, while the subsequent cohort (n = 93) underwent LPS. The two cohorts had similar characteristics, and 98.3% of patients had non high-risk index PE. MDCT detected residual PE in 15% of subjects (12/80, 95% CI 8-25%) after a mean of 9 months of anticoagulation. No clinical characteristics were significantly associated with residual PE at MDCT. LPS detected residual PE in 28% (26/93, 95% CI 19-38%) of patients after a period of a mean of 9 months of anticoagulation with a significant association with increasing age and known pulmonary disease. Resolution of PE was high after a first episode of non high-risk PE treated with heparin followed by at least 3 months of anticoagulation. Age and coexistent pulmonary disease influence the presence of residual PE detected by LPS, but not by MDCT. Further studies are warranted in which the presence of residual embolism is detected by repetition of the same test that had been initially carried out.
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- 2011
147. The prothrombin time/international normalized ratio (PT/INR) Line: derivation of local INR with commercial thromboplastins and coagulometers – two independent studies
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POLLER L, IBRAHIM S, KEOWN M, PATTISON A, JESPERSEN J, EUROPEAN ACTION ON A.N.T.I.C.O.A.G.U.L.A.T.I.O.N. COLLABORATORS: MARUN S, MUNTEAN W, ASPÖCK G, BAILLEUL E, WIJNS W, MICHEL T, JOCHMANS K, CHATELAIN B, MARCELIS L, NIJS AN, JOHNSTON M, KYNDE K, SYRÄJLÄ M, SAVOLAINEN ER, IVASKA K, RAJAMÄKI A, VANHARANTA R, JUHAN I, AILLAUD MF, GUILLIN MC, HUISSE MG, SIE P, LECOMPTE T, SCHMITT Y, HARENBERG J, PLESCH W, ARONIS S, THEODOSSIADES G, TSOUKANAS B, MARKALA D, DITSA M, CAHILL M, MADDEN M, FITZGERALD H, MCCARTHY D, COLLINS B, ROONEY S, NAPARSTEK E, MARONGIU F, ERBA N, TESTA S, MARIANI G, POTÌ R, MANNUCCI PM, TRIPODI A, BADER R, PENGO V, GRESELE P, D'INCÀ M, AGENO W, TOSETTO A, HENSGENS HE, IDEMA RN, OOSTERHOUT DH, MULDER AB, HAMULYAK K, VD DUSSEN H, MUSIAL J, GAGO T, PALMEIRO A, CAMPOS M, MARQUES DIAS DA, CUNHA MONTEIRO Á, ANGELA CUNHA M, DE GAIA WN, PETERNEL P, STEGNAR M, FONTCUBERTA J, BORRELL M, REVERTER JC, SANTASUSANA PD, LOPEZ FERNANDEZ MF, MONTERO J, RIBERA CASADO C, VICENTE V, EDLUND B, EGBERG N, LÄMMLE B, ALBERIO L, DE MOERLOOSE P, REBER G, MACHIN SJ, MACKIE I, LAWRIE A, LUCKIT J, SHANKS D, DOLAN G, FLAHERTY T, LUDLAM CA, WALKER ID, LAWSON DE, TRISCOTT M, MARLAR RA, HEIT JA, WATZKE H, WEISSER B, GALLUS AS, OSMOND J, CORNET I, MUNSTER AM, LEED B, CHILLOU C, DEFARD M, HORELLOU MH, HALKIN H, LOEBSTEIN R, KIRGNER I, DENTALI F, TRAPANI LOMBARDO V, SOTTILOTTA G, CONSIGLIO P, DE MICHELE S, MOIA M, CARPENEDO M, OLIVIERO B, MANOTTI C, TASSONI MI, PALARETI G, BRUSI C, LEGNANI C, PEGORARO C, ANDRIANI C, GRAZIA CIRIGLIANO M, RIBALDI E, ABBATE R, POLI D, PERRICONE C, SCHIAVULI M, CASIERA C, LUPONE MR, ROSSI E, CRIVELLI S, BIROLINI A, PARENTE F, MIGLIETTA AM, CAMPOBASSO M, SYDOR W, KREVEL B, FERNANDEZ MA, LOZANO M, SHIACH C, BOWYER C, CHARLES F., PALARETI, GUALTIERO, COSMI, BENILDE, POLLER L, IBRAHIM S, KEOWN M, PATTISON A, JESPERSEN J, EUROPEAN ACTION ON ANTICOAGULATION. COLLABORATORS: MARUN S, MUNTEAN W, ASPÖCK G, BAILLEUL E, WIJNS W, MICHEL T, JOCHMANS K, CHATELAIN B, MARCELIS L, NIJS AN, JOHNSTON M, KYNDE K, SYRÄJLÄ M, SAVOLAINEN ER, IVASKA K, RAJAMÄKI A, VANHARANTA R, JUHAN I, AILLAUD MF, GUILLIN MC, HUISSE MG, SIE P, LECOMPTE T, SCHMITT Y, HARENBERG J, PLESCH W, ARONIS S, THEODOSSIADES G, TSOUKANAS B, MARKALA D, DITSA M, CAHILL M, MADDEN M, FITZGERALD H, MCCARTHY D, COLLINS B, ROONEY S, NAPARSTEK E, PALARETI G, MARONGIU F, ERBA N, TESTA S, MARIANI G, POTÌ R, MANNUCCI PM, TRIPODI A, BADER R, PENGO V, GRESELE P, D'INCÀ M, AGENO W, TOSETTO A, HENSGENS HE, IDEMA RN, OOSTERHOUT DH, MULDER AB, HAMULYAK K, VD DUSSEN H, MUSIAL J, GAGO T, PALMEIRO A, CAMPOS M, MARQUES-DIAS DA, CUNHA MONTEIRO Á, ANGELA CUNHA M, DE GAIA WN, PETERNEL P, STEGNAR M, FONTCUBERTA J, BORRELL M, REVERTER JC, SANTASUSANA PD, LOPEZ-FERNANDEZ MF, MONTERO J, RIBERA CASADO C, VICENTE V, EDLUND B, EGBERG N, LÄMMLE B, ALBERIO L, DE MOERLOOSE P, REBER G, MACHIN SJ, MACKIE I, LAWRIE A, LUCKIT J, SHANKS D, DOLAN G, FLAHERTY T, LUDLAM CA, WALKER ID, LAWSON DE, TRISCOTT M, MARLAR RA, HEIT JA, WATZKE H, WEISSER B, GALLUS AS, OSMOND J, CORNET I, MUNSTER AM, LEED B, CHILLOU C, DEFARD M, HORELLOU MH, HALKIN H, LOEBSTEIN R, KIRGNER I, DENTALI F, TRAPANI LOMBARDO V, SOTTILOTTA G, CONSIGLIO P, DE MICHELE S, MOIA M, CARPENEDO M, OLIVIERO B, MANOTTI C, TASSONI MI, COSMI B, BRUSI C, LEGNANI C, PEGORARO C, ANDRIANI C, GRAZIA CIRIGLIANO M, RIBALDI E, ABBATE R, POLI D, PERRICONE C, SCHIAVULI M, CASIERA C, LUPONE MR, ROSSI E, CRIVELLI S, BIROLINI A, PARENTE F, MIGLIETTA AM, CAMPOBASSO M, SYDOR W, KREVEL B, FERNANDEZ MA, LOZANO M, SHIACH C, BOWYER C, CHARLES F., Interne Geneeskunde, Biochemie, and RS: CARIM School for Cardiovascular Diseases
- Subjects
INR correction ,endocrine system ,medicine.medical_specialty ,coagulometers ,Prothrombin Time/*standard ,Reproducibility of Result ,PT ,World Health Organization ,International Normalized Ratio/*standard ,Thromboplastin ,Automation ,Laboratory/standard ,ECAA plasmas ,Predictive Value of Tests ,health services administration ,medicine ,Animals ,Humans ,heterocyclic compounds ,International Normalized Ratio ,cardiovascular diseases ,thromboplastins ,Blood Coagulation ,Reference standards ,Mathematics ,Automation, Laboratory ,Observer Variation ,Prothrombin time ,Analysis of Variance ,medicine.diagnostic_test ,business.industry ,fungi ,Reproducibility of Results ,Hematology ,Reference Standards ,Surgery ,INR Line ,Multicenter study ,Calibration ,Linear Models ,Prothrombin Time ,Cattle ,Rabbits ,Observer variation ,Nuclear medicine ,business - Abstract
The WHO scheme for prothrombin time (PT) standardization has been limited in application, because of its difficulties in implementation, particularly the need for mandatory manual PT testing and for local provision of thromboplastin international reference preparations (IRP).The value of a new simpler procedure to derive international normalized ratio (INR), the PT/INR Line, based on only five European Concerted Action on Anticoagulation (ECAA) calibrant plasmas certified by experienced centres has been assessed in two independent exercises using a range of commercial thromboplastins and coagulometers. INRs were compared with manual certified values with thromboplastin IRP from expert centres and in the second study also with INRs from local ISI calibrations.In the first study with the PT/INR Line, 8.7% deviation from certified INRs was reduced to 1.1% with human reagents, and from 7.0% to 2.6% with rabbit reagents. In the second study, deviation was reduced from 11.2% to 0.4% with human reagents by both local ISI calibration and the PT/INR Line. With rabbit reagents, 10.4% deviation was reduced to 1.1% with both procedures; 4.9% deviation was reduced to 0.5% with bovine/combined reagents with local ISI calibrations and to 2.9% with the PT/INR Line. Mean INR dispersion was reduced with all thromboplastins and automated systems using the PT/INR Line.The procedure using the PT/INR Line provides reliable INR derivation without the need for WHO ISI calibration across the range of locally used commercial thromboplastins and automated PT systems included in two independent international studies.? 2010 International Society on Thrombosis and Haemostasis.
- Published
- 2011
148. D-dimer and residual vein obstruction as risk factors for recurrence during and after anticoagulation withdrawal in patients with a first episode of provoked deep-vein thrombosis
- Author
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Cristina Legnani, Michela Cini, Benilde Cosmi, Giuliana Guazzaloca, Gualtiero Palareti, Cosmi B, Legnani C, Cini M, Guazzaloca G, and Palareti G.
- Subjects
Adult ,Male ,0301 basic medicine ,medicine.medical_specialty ,Adolescent ,medicine.drug_class ,Deep vein ,030204 cardiovascular system & hematology ,VITAMIN K ANTAGONISTS ,Thrombophilia ,Gastroenterology ,HYPERCOAGULABILITY ,Veins ,Cohort Studies ,Fibrin Fibrinogen Degradation Products ,03 medical and health sciences ,0302 clinical medicine ,Predictive Value of Tests ,Recurrence ,Risk Factors ,Internal medicine ,medicine ,Humans ,Risk factor ,Aged ,Ultrasonography ,DEEP VEIN THROMBOSIS ,Aged, 80 and over ,Venous Thrombosis ,First episode ,VENOUS THROMBOEMBOLISM ,business.industry ,Anticoagulants ,Hematology ,Middle Aged ,Vitamin K antagonist ,medicine.disease ,Thrombosis ,Venous Obstruction ,Substance Withdrawal Syndrome ,Surgery ,Venous thrombosis ,030104 developmental biology ,medicine.anatomical_structure ,Female ,business ,Follow-Up Studies - Abstract
SummaryD-dimer and residual venous obstruction (RVO) have been separately shown to be risk factors for recurrent venous thromboembolism (VTE) after a first episode of unprovoked proximal deep-vein thrombosis (DVT). It was the objective of this study to assess the predictive value of D-dimer and residual vein obstruction (RVO), alone and in combination, for recurrence after provoked DVT of the lower limbs. A total of 296 consecutive patients with a first episode of symptomatic provoked proximal DVT were evaluated at a university hospital in Bologna, Italy. On the day of anticoagulation withdrawal (T0), RVO was determined by compression ultrasonography. D-dimer levels (cut-off: 500 ng/ml) were measured at T0 and after 30 ±10 days (T1). The main outcome was recurrent VTE during a two-year follow-up. D-dimer was abnormal in 11.6% (32/276) and 31% (85/276) of subjects at T0 and at T1, respectively. RVO was present in 44.8% (132/294) of patients. Recurrence rate was 5.1% (15/296; 95% confidence interval [CI]: 3–8%; 3% patient-years; 95% CI: 2–5 %). An abnormal D-dimer either at T0 or at T1 was associated with an adjusted hazard ratio (HR) for recurrence of 4.2 (95% CI:1.2–14.2; p=0.02) and 3.8 (95%CI: 1.2–12.1; p=0.02), respectively, when compared with normal D-dimer. The HR for recurrence associated with RVO was not significant, and RVO did not increase the recurrence risk associated with an abnormal D-dimer either at T0 or T1. In conclusion, an abnormal D-dimer during vitamin K antagonist (VKA) treatment or at one month after VKA withdrawal is a risk factor for recurrence in patients with provoked DVT, while RVO at the time of anticoagulation withdrawal is not.
- Published
- 2011
149. Abnormal Protac-induced coagulation inhibition chromogenic assay results are associated with an increased risk of recurrent venous thromboembolism
- Author
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Pier Mannuccio Mannucci, Laura Lemma, G. Palareti, Veena Chantarangkul, Armando Tripodi, C. Legnani, Benilde Cosmi, Tripodi A, Legnani C, Lemma L, Cosmi B, Palareti G, Chantarangkul V, and Mannucci PM.
- Subjects
Male ,Time Factors ,Vitamin K ,Kaplan-Meier Estimate ,Gastroenterology ,Recurrence ,Risk Factors ,Prospective Studies ,Prospective cohort study ,Blood coagulation test ,Aged, 80 and over ,First episode ,Thrombin ,Venous Thromboembolism ,Hematology ,Middle Aged ,Treatment Outcome ,Italy ,Predictive value of tests ,Intercellular Signaling Peptides and Proteins ,Female ,Blood Coagulation Tests ,Cardiology and Cardiovascular Medicine ,Adult ,medicine.medical_specialty ,Thrombomodulin ,Thrombophilia ,Risk Assessment ,Drug Administration Schedule ,Thromboplastin ,Young Adult ,Fibrinolytic Agents ,Predictive Value of Tests ,Internal medicine ,medicine ,Humans ,Blood Coagulation ,Aged ,Proportional Hazards Models ,business.industry ,Proportional hazards model ,Anticoagulants ,medicine.disease ,Surgery ,Chromogenic Compounds ,Peptides ,business ,Biomarkers ,Fibrinolytic agent ,Protein C - Abstract
Evaluation of the risk of recurrent venous thromboembolism (VTE) is required to determine the optimal duration of secondary prophylaxis. Application of global assays reflecting the pro- versus anti-coagulant balance in vivo would be desirable. We aimed at investigating the relationship between recurrent VTE and the Protac-induced coagulation inhibition (PICI) assay, which is based on tissue factor-induced thrombin generation measured by a chromogenic substrate. One-hundred-ninety patients were followed-up after a first episode of unprovoked, objectively documented VTE for 2.7 years after stopping treatment with vitamin K antagonists (VKA). PICI was measured 1 month after stopping treatment as the percentage of the OD values recorded without or with Protac. The lower the PICI%, the greater the pro- versus anti-coagulant imbalance. The study outcome was objectively-documented symptomatic recurrent VTE. Patients with PICI% ≤ 74% had crude hazard-ratios (HR) (95% CI) for recurrent VTE of 2.86 (1.01–8.12) as compared to those with PICI% > 87%. After adjustment for age, gender, type of index event, VKA duration and normal/abnormal D-Dimer, HR (95% CI) were substantially unchanged [2.91 (1.01–8.38)]. The corresponding values after further adjustment for the above variables plus the absence/presence of the most frequent thrombophilic alterations were 3.38 (1.16–9.84). These HR values compare favorably with those obtained in a previous study investigating the thrombin generation test performed in the presence of thrombomodulin. In conclusion, the measurement of PICI helps to identify patients at higher risk of VTE recurrence. Advantages of PICI over thrombin generation tests are easy performance in general clinical laboratories, easy standardization and no special equipment.
- Published
- 2010
150. Usefulness of repeated D-dimer testing after stopping anticoagulation for a first episode of unprovoked venous thromboembolism: the PROLONG II prospective study
- Author
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Cristina Legnani, Benilde Cosmi, Gualtiero Palareti, Angelo Ghirarduzzi, Daniela Poli, Alberto Tosetto, Armando Tripodi, Francesco Marongiu, Domenico Prisco, Sophie Testa, Vittorio Pengo, Cosmi B, Legnani C, Tosetto A, Pengo V, Ghirarduzzi A, Testa S, Prisco D, Poli D, Tripodi A, Marongiu F, and Palareti G
- Subjects
Adult ,Male ,Periodicity ,medicine.medical_specialty ,Pediatrics ,Adolescent ,medicine.drug_class ,Immunology ,D-DIMER ,Biochemistry ,law.invention ,Fibrin Fibrinogen Degradation Products ,Randomized controlled trial ,Predictive Value of Tests ,Recurrence ,law ,medicine ,Humans ,Prospective Studies ,Prospective cohort study ,Aged ,ORAL ANTICOAGULANTS ,Aged, 80 and over ,First episode ,VENOUS THROMBOEMBOLISM ,business.industry ,Anticoagulant ,Hazard ratio ,Anticoagulants ,Cell Biology ,Hematology ,Blood Coagulation Disorders ,Middle Aged ,Prognosis ,medicine.disease ,Confidence interval ,Surgery ,Venous thrombosis ,Withholding Treatment ,Predictive value of tests ,Female ,business ,Blood Chemical Analysis ,Follow-Up Studies - Abstract
The PROLONG randomized trial showed that a normal D-dimer (D-d) 1 month after anticoagulation suspension for unprovoked venous thromboembolism (VTE) was associated with a low risk of late recurrences (4.4% patient years). However, it is unknown whether D-d changes subsequently. The aim of this prospective multicenter study was to assess D-d time course and its relation with late recurrences in patients with normal D-d 1 month after anticoagulation suspension for a first episode of unprovoked VTE. D-d was measured with a qualitative method (Clearview Simplify D-dimer; Inverness Medical Professional Diagnostics). Patients with a normal D-d 1 month after stopping anticoagulation repeated D-d testing every 2 months for 1 year. D-d was normal in 68% (243/355) of patients 1 month after anticoagulation suspension. Patients in whom D-d became abnormal at the third month and remained abnormal afterward had a higher risk of recurrence (7/31; 27% patient years; 95% confidence interval [CI]: 12-48) than patients in whom D-d remained normal at the third month and afterward (4/149; 2.9% patient years; 95% CI: 1-7; adjusted hazard ratio: 7.9; 95% CI: 2.1-30; P = .002). Repeated D-d testing after anticoagulation suspension for a first episode of unprovoked VTE could help tailor the duration of treatment. This trial is registered at http://clinicaltrials.gov as NCT00266045.
- Published
- 2010
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