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2. Reshaping Anticoagulation: Factor XI Inhibition in Thrombosis Management.

Author

Verstraete A, Engelen MM, Van Edom C, Vanassche T, and Verhamme P

Subjects
Humans, Blood Coagulation, Anticoagulants therapeutic use, Anticoagulants pharmacology, Factor XI pharmacology, Thrombosis drug therapy
Abstract

Competing Interests: T.V. has participated in advisory boards and/or acted as a speaker on behalf of Bayer, BMS/Pfizer, Boehringer Ingelheim, Daiichi Sankyo, Leo Pharma, Sanofi Aventis. T.V. is supported by a grant from research foundation Flanders (FWO) grant no. 1843423N. P.V. has received research funding from Bayer, BMS, Pfizer and Leo Pharma, and honoraria from Bayer, Pfizer, BMS, Daiichi-Sankyo, Sanofi-Aventis, Leo Pharma, Anthos Therapeutics and Astra-Zeneca. The other authors have no conflicts of interest.

Published
2024
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3. The 2023 Belgian clinical guidance on anticoagulation management in hospitalized and ambulatory COVID-19 patients.

Author

Vanassche T, Engelen MM, Orlando C, Vandenbosch K, Gadisseur A, Hermans C, Jochmans K, Minon JM, Motte S, Peperstraete H, Péters P, Sprynger M, Lancellotti P, Dehaene I, Emonts P, Vandenbriele C, Verhamme P, and Oury C

Subjects
Humans, Anticoagulants therapeutic use, Belgium epidemiology, COVID-19 complications, Venous Thromboembolism drug therapy, Thrombosis complications, Thrombosis drug therapy, Thrombosis prevention & control
Abstract

COVID-19 is associated with an increased risk for thrombotic complications. The trials investigating the optimal thromboprophylactic dose are performed in challenging times and seemingly produce conflicting evidence. The burdensome circumstances, divergent endpoints, and different analytical approaches hamper comparison and extrapolation of available evidence. Most importantly, clinicians should provide thromboprophylaxis in hospitalized COVID-19 patients while (re)assessing bleeding and thrombotic risk frequently. The COVID-19 Thromboprophylaxis Working Group of the BSTH updated its guidance document. It aims to summarize the available evidence critically and to guide clinicians in providing the best possible thromboprophylaxis.

Published
2023
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4. Clotting of the Extracorporeal Circuit in Hemodialysis: Beyond Contact-Activated Coagulation.

Author

Engelen MM, Verhamme P, and Vanassche T

Subjects
Humans, Anticoagulants therapeutic use, Renal Dialysis, Blood Coagulation physiology, Thrombosis etiology, Kidney Failure, Chronic therapy, Kidney Failure, Chronic complications
Abstract

Thrombotic complications in patients with end-stage kidney disease are frequent. While being a lifesaving treatment for these patients, hemodialysis introduces a thromboinflammatory environment. Additionally, the extracorporeal hemodialysis circuit itself is prone to clotting because of an interaction between different activation mechanisms of the coagulation system, platelets, and the immune system. Anticoagulation of the patient and the machine is frequently complicated by bleeding. We discuss the factors important in this balancing act and touch on potential strategies that are on the horizon to target thromboinflammation., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Published
2023
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5. Pharmacokinetic drug-drug interactions with direct anticoagulants in the management of cancer-associated thrombosis.

Author

Van der Linden L, Vanassche T, Van Cutsem E, Van Aelst L, and Verhamme P

Subjects
Humans, Anticoagulants, Rivaroxaban therapeutic use, Rivaroxaban pharmacokinetics, Hemorrhage chemically induced, Heparin, Low-Molecular-Weight therapeutic use, Drug Interactions, Administration, Oral, Thrombosis etiology, Thrombosis chemically induced, Venous Thromboembolism chemically induced, Neoplasms complications, Neoplasms drug therapy, Neoplasms chemically induced
Abstract

Drug-drug interactions (DDIs) are common in cancer management and complicate the choice of anticoagulation in cancer-associated thrombosis. Cancer confers an increased risk of thrombotic events. Also, more bleeding events are observed in those who receive anticoagulation compared to those without cancer. In the treatment of cancer-associated thrombosis, direct oral anticoagulants (DOACs) have been found to be at least as effective as low-molecular weight heparins, which became the standard of care after several trials demonstrated superiority over vitamin K antagonists. Non-inferiority compared to low-molecular weight heparins has been shown for rivaroxaban, edoxaban and apixaban with a signal of fewer recurrent thrombotic events, albeit with an increase in bleeding events. Yet, potentially major pharmacokinetic drug-drug interactions have been identified as a reason to withhold DOACs and to rather choose an alternative. Practical guidance on what constitutes a major pharmacokinetic interaction and/or how to deal with these interactions in clinical practice is limited. Hence, here we have provided a framework to allow clinicians to better deal with pharmacokinetic drug-drug interactions between DOACs and cancer therapies in the management of cancer-associated thrombosis. In this review we have discussed the current literature, how the pharmacokinetic profile links to the label information on DDI, and have provided a practical proposal, applied to a clinical case., (© 2023 British Pharmacological Society.)

Published
2023
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6. Clinical application of multigene panel testing for bleeding, thrombotic, and platelet disorders: a 3-year Belgian experience.

Author

Van Laer C, Jacquemin M, Baert S, Labarque V, Thys C, Vanassche T, Van Geet C, Verhamme P, Willekens K, Corveleyn A, Peerlinck K, and Freson K

Subjects
Humans, Belgium, Retrospective Studies, Hemorrhage diagnosis, Hemorrhage genetics, Genetic Testing, Blood Platelet Disorders diagnosis, Blood Platelet Disorders genetics, Thrombosis genetics
Abstract

Background: The international study ThromboGenomics has evaluated the diagnostic rate using a targeted multigene panel test for the screening of inherited bleeding, thrombotic and platelet disorders., Objectives: We retrospectively analyzed the results of the implementation of genetic testing for inherited bleeding, thrombotic and platelet disorders in Belgian clinical practice and evaluated possible reclassification of reported variants., Patients/methods: We implemented a Thrombosis-Hemostasis multigene panel test using whole exome sequencing to diagnose 487 patients recruited by 27 different Belgian hospitals with the implementation of stringent laboratory accreditation standards and by studying up to 100 diagnostic-grade genes., Results: This Thrombosis-Hemostasis multigene panel test was able to detect at least one genetic variant in 58% of the 487 patients of which 50% were (likely) pathogenic variants and the others were variants of unknown significance. Polygenic variants were detected in 65 patients (13%). A multi-step workflow for results discussion by multidisciplinary team meetings and patients' recalls for segregation studies and additional laboratory testing was set up. Variants were also submitted to the GoldVariants database from the International Society on Thrombosis and Haemostasis (ISTH). The aim of these approaches is to optimize variant interpretation and to (re)classify variants of unknown significance as (likely) pathogenic or (likely) benign., Conclusions: The growing implementation of multigene panel tests in clinical diagnostics comes with difficulties in interpreting genetic results. Additional efforts are needed to continuously optimize the diagnostic outcome., Competing Interests: Declaration of competing interest All authors declare they have no conflict of interest to disclose., (Copyright © 2022 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved.)

Published
2023
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7. Anticoagulation for Percutaneous Ventricular Assist Device-Supported Cardiogenic Shock: JACC Review Topic of the Week.

Author

Vandenbriele C, Arachchillage DJ, Frederiks P, Giustino G, Gorog DA, Gramegna M, Janssens S, Meyns B, Polzin A, Scandroglio M, Schrage B, Stone GW, Tavazzi G, Vanassche T, Vranckx P, Westermann D, Price S, and Chieffo A

Subjects
Anticoagulants therapeutic use, Critical Illness, Hemorrhage chemically induced, Humans, Retrospective Studies, Shock, Cardiogenic etiology, Treatment Outcome, Heart-Assist Devices adverse effects, Thrombosis complications, Thrombosis prevention & control
Abstract

Interest in the use of mechanical circulatory support for patients presenting with cardiogenic shock is growing rapidly. The Impella (Abiomed Inc), a microaxial, continuous-flow, short-term, ventricular assist device (VAD), requires meticulous postimplantation management. Because systemic anticoagulation is needed to prevent pump thrombosis, patients are exposed to increased bleeding risk, further aggravated by sepsis, thrombocytopenia, and high shear stress-induced acquired von Willebrand syndrome. The precarious balance between bleeding and thrombosis in percutaneous VAD-supported cardiogenic shock patients is often the main reason that patient outcomes are jeopardized, and there is a lack of data addressing optimal anticoagulation management strategies during percutaneous VAD support. Here, we present a parallel anti-Factor Xa/activated partial thromboplastin time-guided anticoagulation algorithm and discuss pitfalls of heparin monitoring in critically ill patients. This review will guide physicians toward a more standardized (anti)coagulation approach to tackle device-related morbidity and mortality in this critically ill patient group., Competing Interests: Funding Support and Author Disclosures Drs Vandenbriele, Meyns, Chieffo, Schrage, and Westermann have received research and/or travel funding, as well as speaker fees, from Abiomed outside of this paper. Dr Vandenbriele has received grant support from University Hospitals Leuven (Klinische onderzoeks-en opleidingsraad); and is funded by MRC Uk (MR/V037633/1). Dr Polzin has received support from the Forschungskommission of the Medical Faculty of the Heinrich Heine University (No. 18-2019) and from the German Research Foundation (PO 2247/2-1 and SFB1116). Dr Vranckx has received personal fees from Bayer, Daiichi-Sankyo, and CLS Behring. Dr Schrage has received speaker fees from AstraZeneca. Dr Chieffo has received consultant/speaker fees from Abbott, Biosensor, Boston Scientific, Edwards, and Magenta. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Published
2022
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8. Estimating Bleeding Risk in Patients with Cancer-Associated Thrombosis: Evaluation of Existing Risk Scores and Development of a New Risk Score.

Author

de Winter MA, Dorresteijn JAN, Ageno W, Ay C, Beyer-Westendorf J, Coppens M, Klok FA, Moustafa F, Riva N, Ruiz Artacho PC, Vanassche T, and Nijkeuter M

Subjects
Anticoagulants therapeutic use, Hemorrhage chemically induced, Humans, Risk Factors, Neoplasms complications, Neoplasms diagnosis, Neoplasms drug therapy, Thrombosis complications, Venous Thromboembolism diagnosis, Venous Thromboembolism drug therapy, Venous Thromboembolism etiology
Abstract

Background:  Bleeding risk is highly relevant for treatment decisions in cancer-associated thrombosis (CAT). Several risk scores exist, but have never been validated in patients with CAT and are not recommended for practice., Objectives:  To compare methods of estimating clinically relevant (major and clinically relevant nonmajor) bleeding risk in patients with CAT: (1) existing risk scores for bleeding in venous thromboembolism, (2) pragmatic classification based on cancer type, and (3) new prediction model., Methods:  In a posthoc analysis of the Hokusai VTE Cancer study, a randomized trial comparing edoxaban with dalteparin for treatment of CAT, seven bleeding risk scores were externally validated (ACCP-VTE, HAS-BLED, Hokusai, Kuijer, Martinez, RIETE, and VTE-BLEED). The predictive performance of these scores was compared with a pragmatic classification based on cancer type (gastrointestinal; genitourinary; other) and a newly derived competing risk-adjusted prediction model based on clinical predictors for clinically relevant bleeding within 6 months after CAT diagnosis with nonbleeding-related mortality as the competing event ("CAT-BLEED")., Results:  Data of 1,046 patients (149 events) were analyzed. Predictive performance of existing risk scores was poor to moderate (C-statistics: 0.50-0.57; poor calibration). Internal validation of the pragmatic classification and "CAT-BLEED" showed moderate performance (respective C-statistics: 0.61; 95% confidence interval [CI]: 0.56-0.66, and 0.63; 95% CI 0.58-0.68; good calibration)., Conclusion:  Existing risk scores for bleeding perform poorly after CAT. Pragmatic classification based on cancer type provides marginally better estimates of clinically relevant bleeding risk. Further improvement may be achieved with "CAT-BLEED," but this requires external validation in practice-based settings and with other DOACs and its clinical usefulness is yet to be demonstrated., Competing Interests: The Hokusai VTE Cancer study was sponsored and funded by Daiichi Sankyo, Inc. The authors are solely responsible for the content of this article. This study has been independently initiated by academic investigators. W.A. received research support from Bayer, and participated in advisory boards for Aspen, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Janssen, Portola, and Sanofi. C.A. has received honoraria for lectures from Bayer, Daiichi Sankyo, BMS/Pfizer, and Sanofi; and participated in advisory boards for Bayer, Daiichi Sankyo, BMS/Pfizer, and Sanofi. M.C. reports research support or lecture and consultancy fees from Bayer, Boehringer Ingelheim, Pfizer, Daiichi Sankyo, Portola/Alexion, Sanquin Blood Supply Medcon International, and MEDtalks. F.A.K. reports research grants from Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, MSD, the Netherlands Organization for Health Research and Development, Actelion, the Dutch Heart Foundation, and the Dutch Thrombosis Association, all outside the submitted work. F.M. has served as a consultant for Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, and Sanofi, been a speaker for Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, Daiichi Sankyo, and Sanofi, and received grants from Sanofi, Bayer HealthCare, Roche Diagnosis, and LFB. P.C.R.A. reports personal fees from Bristol-Myers Squibb, Pfizer, Daiichi Sankyo, Leo Pharma, and ROVI, outside the submitted work. T.V. has received honoraria for acting as a speaker or participation in advisory boards from Bayer, Boehringer Ingelheim, Daiichi Sankyo, BMS/Pfizer, Sanofi Aventis, and Leo Pharma. M.N. reports a research grant from the Netherlands Organization for Health Research and Development. The other authors have no conflicts of interest to disclose., (Thieme. All rights reserved.)

Published
2022
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9. Targeting Coagulase Activity in Staphylococcus aureus Bacteraemia: A Randomized Controlled Single-Centre Trial of Staphylothrombin Inhibition.

Author

Peetermans M, Liesenborghs L, Peerlinck K, Wijngaerden EV, Gheysens O, Goffin KE, Hoylaerts MF, Jacquemin M, Verhaegen J, Peetermans WE, Verhamme P, and Vanassche T

Subjects
Administration, Intravenous, Administration, Oral, Aged, Aged, 80 and over, Anticoagulants adverse effects, Antithrombins adverse effects, Arginine analogs & derivatives, Bacteremia diagnosis, Bacteremia microbiology, Belgium, Blood Coagulation drug effects, Coagulase metabolism, Dabigatran adverse effects, Enoxaparin adverse effects, Feasibility Studies, Female, Hemorrhage chemically induced, Humans, Injections, Subcutaneous, Male, Middle Aged, Partial Thromboplastin Time, Pilot Projects, Pipecolic Acids adverse effects, Prospective Studies, Staphylococcal Infections diagnosis, Staphylococcal Infections microbiology, Staphylococcus aureus enzymology, Sulfonamides, Thrombin metabolism, Thrombosis blood, Thrombosis diagnosis, Thrombosis microbiology, Time Factors, Treatment Outcome, Anticoagulants administration & dosage, Antithrombins administration & dosage, Bacteremia drug therapy, Coagulase antagonists & inhibitors, Dabigatran administration & dosage, Enoxaparin administration & dosage, Pipecolic Acids administration & dosage, Staphylococcal Infections drug therapy, Staphylococcus aureus drug effects, Thrombin antagonists & inhibitors, Thrombosis prevention & control
Abstract

Background: Staphylococcus aureus ( S. aureus ) bacteraemia is frequent and carries a high morbidity and mortality. Coagulases secreted by S. aureus initiate blood coagulation by directly activating prothrombin. This pathogen-activated coagulation is insensitive to most antithrombotic drugs, with the exception of small molecule direct thrombin inhibitors (DTIs). DTIs inhibit the coagulase-prothrombin complex, or staphylothrombin, and improve outcome in preclinical models of S. aureus infection., Objective: A single-centre, randomized, controlled feasibility and safety trial of staphylothrombin inhibition with DTIs in patients with S. aureus bacteraemia., Patients and Methods: Consecutive eligible adult patients with S. aureus positive blood cultures in the University Hospitals Leuven (Belgium) were randomized 1:1 to DTI (oral dabigatran 110 mg twice daily or intravenous argatroban according to activated partial thromboplastin time [aPTT]) for 7 to 10 days, or subcutaneous enoxaparin 40 mg once daily. Primary outcomes were feasibility and safety of DTI in patients with S. aureus bacteraemia. Secondary outcomes include D-dimer evolution (day 0-4) as marker of coagulation activation; inflammatory and microbiological parameters; and clinical outcomes including metastatic infections., Results: Thirty-one percent (94/303) of screened patients were enrolled. Dabigatran plasma levels inhibited staphylothrombin. Clinically relevant bleeding (5/47 vs. 5/47) and thrombotic (7/47 vs. 7/47) complications were similar in both groups. Coagulase inhibition with DTIs was associated with a trend towards faster D-dimer decrease at day 4 (-662 ± 249 ng/mL vs. -40 ± 213 ng/mL for DTI-treated patients vs. control; p  = 0.06) and a numerically lower number of persistently positive blood cultures. No differences in inflammatory parameters or other clinical outcomes were observed., Conclusion: Targeting staphylothrombin with DTIs is feasible in a subset of S. aureus bacteraemic patients, with comparable safety to standard thromboprophylaxis. In future studies of staphylothrombin inhibition, feasibility can be further improved by rapid diagnostics and by strategies without concomitant anticoagulant effect., Competing Interests: M.P. reports non-financial support from Pfizer outside the submitted work. P.V. reports grants and personal fees from Boehringer Ingelheim, Bayer, Daiichi Sankyo and personal fees from Pfizer, outside the submitted work. T.V. reports grants and personal fees from Boehringer Ingelheim, Bayer, Daiichi Sankyo and Pfizer, outside the submitted work. W.P. reports grants and personal fees from Pfizer, Astellas and Merck Sharp Dome, outside the submitted work. The other authors have no disclosures to report., (Schattauer GmbH Stuttgart.)

Published
2018
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10. Absence of Pear1 does not affect murine platelet function in vivo.

Author

Criel M, Izzi B, Vandenbriele C, Liesenborghs L, Van Kerckhoven S, Lox M, Cludts K, Jones EA, Vanassche T, Verhamme P, and Hoylaerts M

Subjects
Animals, Humans, Mice, Blood Platelets metabolism, Receptors, Cell Surface metabolism, Thrombosis metabolism
Abstract

Background: Platelet Endothelial Aggregation Receptor-1 (PEAR1) is a transmembrane platelet receptor that amplifies the activation of the platelet fibrinogen receptor (αIIbβ3) during platelet aggregation. In man, Pear1 polymorphisms are associated with changes in platelet aggregability. In this report, we characterized Pear1 expression and function in murine platelets., Methods: Pear1 phosphorylation and signaling, platelet aggregation, α-degranulation and clot retraction were studied in WT and Pear1 -/- platelets. The function of Pear1 in haemostasis and thrombosis was studied in a mouse tail vein bleeding and ferric chloride-induced mesenteric thrombosis model., Results: Mature murine platelets express Pear1 on their membrane and clustering of Pear1 by anti-Pear1 antibodies triggered platelet aggregation. Pear1 was weakly phosphorylated during collagen-induced murine platelet aggregation and was translocated to the cytoskeleton. Absence of murine Pear1 impaired dextran sulfate-induced platelet aggregation, but did not impact collagen-, AYPGK and ADP-induced platelet aggregation, coupled to a lower Pear1 expression in murine than in human platelets and to weaker Pear1-mediated downstream signaling. Neither clot retraction nor α-degranulation was affected in Pear1 -/- mice. Likewise, in vivo tests like the tail vein bleeding time and thrombus formation in mesenteric veins were similar in WT and Pear1 -/- mice., Conclusion: Murine platelet Pear1 shares a number of characteristics with human platelet PEAR1. Nevertheless, murine Pear1 contributes less to platelet function as does human PEAR1 and does not overtly impact haemostasis and thrombosis in mice., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Published
2016
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11. Symptomatic subsegmental versus more central pulmonary embolism: Clinical outcomes during anticoagulation

Author

Carmen Fernández‐Capitán, Ana Rodriguez Cobo, David Jiménez, Olga Madridano, Maurizio Ciammaichella, Esther Usandizaga, Remedios Otero, Pierpaolo Di Micco, Farès Moustafa, Manuel Monreal, M.D. Adarraga, M.A. Aibar, M. Alfonsa, J.I. Arcelus, P. Azcarate‐Agüero, A. Ballaz, P. Baños, R. Barba, M. Barrón, B. Barrón‐Andrés, J. Bascuñana, A. Blanco‐Molina, A.M. Camón, L. Chasco, A.J. Cruz, R. del Pozo, J. de Miguel, J. del Toro, M.C. Díaz‐Pedroche, J.A. Díaz‐Peromingo, J.C. Escribano, C. Falgá, C. Fernández‐Aracil, M.A. Fidalgo, C. Font, L. Font, M.A. García, F. García‐Bragado, M. García‐Morillo, A. García‐Raso, A.I. García‐Sánchez, O. Gavín, I. Gaya, C. Gómez, V. Gómez, J. González, E. Grau, R. Guijarro, J. Gutiérrez, G. Hernández‐Comes, L. Hernández‐Blasco, E. Hernando, L. Jara‐Palomares, M.J. Jaras, D. Jiménez, M.D. Joya, J. Lima, P. Llamas, J.L. Lobo, R. López‐Reyes, J.B. López‐Sáez, M.A. Lorente, A. Lorenzo, M. Lumbierres, A. Maestre, P.J. Marchena, F. Martín‐Martos, M. Martín‐Romero, M.V. Morales, J.A. Nieto, S. Nieto, A. Núñez, M.J. Núñez, M. Odriozola, M.C. Olivares, S. Otalora, J.M. Pedrajas, G. Pellejero, C. Pérez‐Ductor, M.L. Peris, I. Pons, J.A. Porras, L. Ramírez, O. Reig, A. Riera‐Mestre, D. Riesco, A. Rivas, M.A. Rodríguez‐Dávila, V. Rosa, P. Ruiz‐Artacho, J.C. Sahuquillo, M.C. Sala‐Sainz, A. Sampériz, R. Sánchez‐Martínez, S. Soler, B. Sopeña, J.M. Suriñach, C. Tolosa, M.I. Torres, J. Troya, J. Trujillo‐Santos, F. Uresandi, B. Valero, R. Valle, J. Vela, L. Vela, G. Vidal, A. Villalobos, T. Vanassche, C. Vandenbriele, P. Verhamme, H.H.B. Yoo, P. Wells, J. Hirmerova, R. Malý, E. Salgado, L. Bertoletti, A. Bura‐Riviere, N. Falvo, D. Farge‐Bancel, A. Hij, I. Mahé, I. Quere, A. Braester, B. Brenner, M. Ellis, I. Tzoran, G. Antonucci, G. Barillari, F. Bilora, C. Bortoluzzi, E. Bucherini, A. Camerota, C. Cattabiani, F. Dentali, R. Duce, M. Giorgi‐Pierfranceschi, E. Grandone, E. Imbalzano, G. Lessiani, R. Maida, D. Mastroiacovo, F. Pace, R. Pesavento, M. Pesavento, R. Poggio, P. Prandoni, R. Quintavalla, A. Rocci, C. Siniscalchi, E. Tiraferri, D. Tonello, A. Visonà, B. Zalunardo, V. Gibietis, A. Skride, B. Vitola, A. Alatri, H. Bounameaux, L. Calanca, and L. Mazzolai

Subjects
Subsegmental, medicine.medical_specialty, anticoagulant, deep vein thrombosis, outcomes, pulmonary embolism, subsegmental, medicine.drug_class, Deep vein, Outcomes, Deep vein thrombosis, Internal medicine, medicine, First episode, lcsh:RC633-647.5, business.industry, Pulmonary embolism, Hazard ratio, Anticoagulant, Anticoagulants, lcsh:Diseases of the blood and blood-forming organs, Hematology, Heparin, Original Articles ‐ Thrombosis, medicine.disease, Thrombosis, Confidence interval, medicine.anatomical_structure, Cardiology, Original Article, business, medicine.drug
Abstract

The RIETE Investigators., [Background] The optimal therapy of patients with acute subsegmental pulmonary embolism (PE) is controversial., [Methods] We used the RIETE (Registro Informatizado Enfermedad TromboEmbólica) database to compare the rate of symptomatic PE recurrences during anticoagulation in patients with subsegmental, segmental, or more central PEs. [Results] Among 15 963 patients with a first episode of symptomatic PE, 834 (5.2%) had subsegmental PE, 3797 (24%) segmental, and 11 332 (71%) more central PE. Most patients in all subgroups received initial therapy with low‐molecular‐weight heparin, and then most switched to vitamin K antagonists. Median duration of therapy was 179, 185, and 204 days, respectively. During anticoagulation, 183 patients developed PE recurrences, 131 developed deep vein thrombosis (DVT), 543 bled, and 1718 died (fatal PE, 135). The rate of PE recurrences was twofold higher in patients with subsegmental PE than in those with segmental (hazard ratio [HR], 2.13; 95% confidence interval [CI], 1.16‐3.85) or more central PE (HR, 1.89; 95% CI, 1.12‐3.13). On multivariable analysis, patients with subsegmental PE had a higher risk for PE recurrences than those with central PE (adjusted HR, 1.75; 95% CI, 1.02‐3.03). After stratifying patients with subsegmental PE according to ultrasound imaging in the lower limbs, the rate of PE recurrences was similar in patients with DVT, in patients without DVT, and in those with no ultrasound imaging. [Conclusions] Our study reveals that the risk for PE recurrences in patients with segmental PE is not lower than in those with more central PE, thus suggesting that the risk of PE recurrences is not influenced by the anatomic location of PE.

Published
2021
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12. A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19: the DAWn-Antico study

Author

T, Vanassche, M M, Engelen, Q, Van Thillo, J, Wauters, J, Gunst, C, Wouters, C, Vandenbriele, S, Rex, L, Liesenborghs, A, Wilmer, P, Meersseman, G, Van den Berghe, D, Dauwe, G, Verbeke, M, Thomeer, T, Fivez, D, Mesotten, D, Ruttens, L, Heytens, I, Dapper, S, Tuyls, B, De Tavernier, P, Verhamme, Ann, Belmans, Vanassche, T., Engelen, M. M., Van Thillo, Q., Wauters, J., Gunst, J., Wouters, C., Vandenbriele, C., Rex, S., LIESENBORGHS, L., Wilmer, A., Meersseman, P., Van den Berghe, G., Dauwe, D., VERBEKE, Geert, Thomeer, M., Fivez, T., MESOTTEN, Dieter, RUTTENS, David, Heytens, L., Dapper, I., Tuyls, S., De Tavernier, B., and Verhamme, P.

Subjects
Male, Oncology, medicine.medical_treatment, Medicine (miscellaneous), Disease, 030204 cardiovascular system & hematology, Severity of Illness Index, law.invention, Study Protocol, 0302 clinical medicine, Belgium, Randomized controlled trial, Low molecular weight heparins, law, Outcome Assessment, Health Care, Pharmacology (medical), Aprotinin, lcsh:R5-920, 0303 health sciences, Incidence, Venous Thromboembolism, Anakinra, Antirheumatic Agents, Drug Therapy, Combination, Female, Kallikreins, lcsh:Medicine (General), medicine.drug, medicine.medical_specialty, Critical Care, Bradykinin, 03 medical and health sciences, Intensive care, Internal medicine, Fibrinolysis, medicine, Humans, Thromboinflammatory response, 030304 developmental biology, Inflammation, SARS-CoV-2, business.industry, COVID-19, Thrombosis, Heparin, Low-Molecular-Weight, Clinical trial, Interleukin 1 Receptor Antagonist Protein, Regimen, business
Abstract

Background The peak of the global COVID-19 pandemic has not yet been reached, and many countries face the prospect of a second wave of infections before effective vaccinations will be available. After an initial phase of viral replication, some patients develop a second illness phase in which the host thrombotic and inflammatory responses seem to drive complications. Severe COVID-19 disease is linked to high mortality, hyperinflammation, and a remarkably high incidence of thrombotic events. We hypothesize a crucial pathophysiological role for the contact pathway of coagulation and the kallikrein-bradykinin pathway. Therefore, drugs that modulate this excessive thromboinflammatory response should be investigated in severe COVID-19. Methods In this adaptive, open-label multicenter randomized clinical trial, we compare low molecular weight heparins at 50 IU anti-Xa/kg twice daily—or 75 IU anti-Xa twice daily for intensive care (ICU) patients—in combination with aprotinin to standard thromboprophylaxis in hospitalized COVID-19 patients. In the case of hyperinflammation, the interleukin-1 receptor antagonist anakinra will be added on top of the drugs in the interventional arm. In a pilot phase, the effect of the intervention on thrombotic markers (D-dimer) will be assessed. In the full trial, the primary outcome is defined as the effect of the interventional drugs on clinical status as defined by the WHO ordinal scale for clinical improvement. Discussion In this trial, we target the thromboinflammatory response at multiple levels. We intensify the dose of low molecular weight heparins to reduce thrombotic complications. Aprotinin is a potent kallikrein pathway inhibitor that reduces fibrinolysis, activation of the contact pathway of coagulation, and local inflammatory response. Additionally, aprotinin has shown in vitro inhibitory effects on SARS-CoV-2 cellular entry. Because the excessive thromboinflammatory response is one of the most adverse prognostic factors in COVID-19, we will add anakinra, a recombinant interleukin-1 receptor antagonist, to the regimen in case of severely increased inflammatory parameters. This way, we hope to modulate the systemic response to SARS-CoV-2 and avoid disease progressions with a potentially fatal outcome. Trial registration The EU Clinical Trials Register 2020-001739-28. Registered on April 10, 2020.

Published
2020
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13. Timing and characteristics of venous thromboembolism after noncancer surgery

Author

Manuela Expósito-Ruiz, Juan Ignacio Arcelus, Joseph A. Caprini, Cristina López-Espada, Alessandra Bura-Riviere, Cristina Amado, Mónica Loring, Daniela Mastroiacovo, Manuel Monreal, Paolo Prandoni, Benjamin Brenner, Dominique Farge-Bancel, Raquel Barba, Pierpaolo Di Micco, Laurent Bertoletti, Sebastian Schellong, Inna Tzoran, Abilio Reis, Marijan Bosevski, Henri Bounameaux, Radovan Malý, Peter Verhamme, Hanh My Bui, M.D. Adarraga, M. Agud, J. Aibar, M.A. Aibar, C. Amado, J.I. Arcelus, C. Baeza, A. Ballaz, R. Barba, C. Barbagelata, M. Barrón, B. Barrón-Andrés, A. Blanco-Molina, E. Botella, A.M. Camon, S. Campos, I. Cañas, I. Casado, J. Castro, J. Criado, C. de Ancos, J. de Miguel, J. del Toro, P. Demelo-Rodríguez, C. Díaz-Pedroche, J.A. Díaz-Peromingo, J. Díez-Sierra, I.M. Domínguez, J.C. Escribano, C. Falgá, A.I. Farfán, K. Fernández de Roitegui, C. Fernández-Aracil, C. Fernández-Capitán, J.L. Fernández-Reyes, M.A. Fidalgo, K. Flores, C. Font, L. Font, I. Francisco, I. Furest, C. Gabara, F. Galeano-Valle, M.A. García, F. García-Bragado, R. García-Hernáez, A. García-Raso, O. Gavín-Sebastián, A. Gil-Díaz, C. Gómez-Cuervo, J. González-Martínez, E. Grau, M. Giménez-Suau, L. Guirado, J. Gutiérrez, L. Hernández-Blasco, E. Hernando, M. Herreros, L. Jara-Palomares, M.J. Jaras, D. Jiménez, R. Jiménez, M.D. Joya, I. Jou, A. Lalueza, R. Lecumberri, J. Lima, P. Llamas, J.L. Lobo, L. López-Jiménez, P. López-Miguel, J.J. López-Núñez, R. López-Reyes, J.B. López-Sáez, A. Lorenzo, M. Loring, O. Madridano, A. Maestre, P.J. Marchena, M. Martín del Pozo, F. Martín-Martos, C. Mella, M. Mellado, M.I. Mercado, J. Moisés, M. Monreal, M.V. Morales, A. Muñoz-Blanco, D. Muñoz-Guglielmetti, N. Muñoz-Rivas, J.A. Nieto, A. Núñez-Ares, M.J. Núñez-Fernández, B. Obispo, M.C. Olivares, J.L. Orcastegui, M.D. Ortega-Recio, J. Osorio, S. Otalora, R. Otero, D. Paredes, P. Parra, V. Parra, J.M. Pedrajas, G. Pellejero, D. Pesántez, J.A. Porras, J. Portillo, A. Riera-Mestre, A. Rivas, F. Rivera, A. Rodríguez-Cobo, C. Rodríguez-Matute, J. Rogado, V. Rosa, C.M. Rubio, P. Ruiz-Artacho, N. Ruiz-Giménez, J. Ruiz-Ruiz, P. Ruiz-Sada, J.C. Sahuquillo, G. Salgueiro, A. Sampériz, J.F. Sánchez-Muñoz-Torrero, T. Sancho, P. Sigüenza, S. Soler, J.M. Suriñach, M.I. Torres, C. Tolosa, J. Trujillo-Santos, F. Uresandi, R. Valle, J.R. Vela, G. Vidal, P. Villares, C. Zamora, P. Gutiérrez, F.J. Vázquez, T. Vanassche, C. Vandenbriele, P. Verhamme, J. Hirmerova, R. Malý, I. Benzidia, L. Bertoletti, A. Bura-Riviere, B. Crichi, P. Debourdeau, O. Espitia, D. Farge-Bancel, H. Helfer, I. Mahé, F. Moustafa, G. Poenou, S. Schellong, A. Braester, B. Brenner, I. Tzoran, F. Bilora, B. Brandolin, E. Bucherini, M. Ciammaichella, D. Colaizzo, P. Di Micco, E. Grandone, D. Marchi, D. Mastroiacovo, R. Maida, F. Pace, R. Pesavento, P. Prandoni, R. Quintavalla, N. Rinzivillo, A. Rocci, C. Siniscalchi, A. Tufano, A. Visonà, B. Zalunardo, V. Gibietis, D. Kigitovica, A. Skride, M. Ferreira, S. Fonseca, F. Martins, J. Meireles, M. Bosevski, G. Krstevski, H. Bounameaux, L. Mazzolai, J.A. Caprini, A.J. Tafur, I. Weinberg, H. Wilkins, H.M. Bui, Exposito-Ruiz, M., Arcelus, J. I., Caprini, J. A., Lopez-Espada, C., Bura-Riviere, A., Amado, C., Loring, M., Mastroiacovo, D., Monreal, M., Prandoni, P., Brenner, B., Farge-Bancel, D., Barba, R., Di Micco, P., Bertoletti, L., Schellong, S., Tzoran, I., Reis, A., Bosevski, M., Bounameaux, H., Maly, R., Verhamme, P., Bui, H. M., Adarraga, M. D., Agud, M., Aibar, J., Aibar, M. A., Baeza, C., Ballaz, A., Barbagelata, C., Barron, M., Barron-Andres, B., Blanco-Molina, A., Botella, E., Camon, A. M., Campos, S., Canas, I., Casado, I., Castro, J., Criado, J., de Ancos, C., de Miguel, J., Toro, J. D., Demelo-Rodriguez, P., Diaz-Pedroche, C., Diaz-Peromingo, J. A., Diez-Sierra, J., Dominguez, I. M., Escribano, J. C., Falga, C., Farfan, A. I., Fernandez de Roitegui, K., Fernandez-Aracil, C., Fernandez-Capitan, C., Fernandez-Reyes, J. L., Fidalgo, M. A., Flores, K., Font, C., Font, L., Francisco, I., Furest, I., Gabara, C., Galeano-Valle, F., Garcia, M. A., Garcia-Bragado, F., Garcia-Hernaez, R., Garcia-Raso, A., Gavin-Sebastian, O., Gil-Diaz, A., Gomez-Cuervo, C., Gonzalez-Martinez, J., Grau, E., Gimenez-Suau, M., Guirado, L., Gutierrez, J., Hernandez-Blasco, L., Hernando, E., Herreros, M., Jara-Palomares, L., Jaras, M. J., Jimenez, D., Jimenez, R., Joya, M. D., Jou, I., Lalueza, A., Lecumberri, R., Lima, J., Llamas, P., Lobo, J. L., Lopez-Jimenez, L., Lopez-Miguel, P., Lopez-Nunez, J. J., Lopez-Reyes, R., Lopez-Saez, J. B., Lorenzo, A., Madridano, O., Maestre, A., Marchena, P. J., Martin del Pozo, M., Martin-Martos, F., Mella, C., Mellado, M., Mercado, M. I., Moises, J., Morales, M. V., Munoz-Blanco, A., Munoz-Guglielmetti, D., Munoz-Rivas, N., Nieto, J. A., Nunez-Ares, A., Nunez-Fernandez, M. J., Obispo, B., Olivares, M. C., Orcastegui, J. L., Ortega-Recio, M. D., Osorio, J., Otalora, S., Otero, R., Paredes, D., Parra, P., Parra, V., Pedrajas, J. M., Pellejero, G., Pesantez, D., Porras, J. A., Portillo, J., Riera-Mestre, A., Rivas, A., Rivera, F., Rodriguez-Cobo, A., Rodriguez-Matute, C., Rogado, J., Rosa, V., Rubio, C. M., Ruiz-Artacho, P., Ruiz-Gimenez, N., Ruiz-Ruiz, J., Ruiz-Sada, P., Sahuquillo, J. C., Salgueiro, G., Samperiz, A., Sanchez-Munoz-Torrero, J. F., Sancho, T., Siguenza, P., Soler, S., Surinach, J. M., Torres, M. I., Tolosa, C., Trujillo-Santos, J., Uresandi, F., Valle, R., Vela, J. R., Vidal, G., Villares, P., Zamora, C., Gutierrez, P., Vazquez, F. J., Vanassche, T., Vandenbriele, C., Hirmerova, J., Benzidia, I., Crichi, B., Debourdeau, P., Espitia, O., Helfer, H., Mahe, I., Moustafa, F., Poenou, G., Braester, A., Bilora, F., Brandolin, B., Bucherini, E., Ciammaichella, M., Colaizzo, D., Grandone, E., Marchi, D., Maida, R., Pace, F., Pesavento, R., Quintavalla, R., Rinzivillo, N., Rocci, A., Siniscalchi, C., Tufano, A., Visona, A., Zalunardo, B., Gibietis, V., Kigitovica, D., Skride, A., Ferreira, M., Fonseca, S., Martins, F., Meireles, J., Krstevski, G., Mazzolai, L., Tafur, A. J., Weinberg, I., and Wilkins, H.

Subjects
Adult, Male, Registrie, medicine.medical_specialty, Time Factors, Time Factor, Duration of risk, 030204 cardiovascular system & hematology, Drug Administration Schedule, 03 medical and health sciences, Postoperative Complications, 0302 clinical medicine, Risk Factors, Deep vein thrombosi, Interquartile range, medicine, Humans, Registries, cardiovascular diseases, 030212 general & internal medicine, Aged, Venous Thrombosis, Benign disease, business.industry, Risk Factor, Incidence (epidemiology), Pulmonary embolism, Anticoagulant, Anticoagulants, Venous Thromboembolism, Heparin, Low-Molecular-Weight, Middle Aged, equipment and supplies, medicine.disease, Thrombosis, Surgery, Time course, Thromboprophylaxi, Female, Postoperative Complication, Cardiology and Cardiovascular Medicine, business, Venous thromboembolism, Human, Surgical patients
Abstract

Background Venous thromboembolism (VTE) is a major cause of morbidity and mortality postoperatively. The use of pharmacologic prophylaxis is effective in reducing the incidence of VTE. However, the prophylaxis is often discontinued at hospital discharge, especially for those with benign disease. The implications of this practice are not known. We assessed the data from a large, ongoing registry regarding the time course of VTE and outcomes after noncancer surgery. Methods We analyzed the RIETE (Computerized Registry on Venous Thromboembolism) registry, which includes data from consecutive patients with symptomatic confirmed VTE. In the present study, we focused on general surgical patients who had developed symptomatic postoperative VTE in the first 8 weeks after noncancer surgery. The main objective was to assess the interval between surgery and the occurrence of VTE. Additional variables included the clinical presentation associated with the event, the use of thrombosis prophylaxis, and unfavorable outcomes. Results The data from 3296 patients were analyzed. The median time from surgery to the detection of VTE was 16 days (interquartile range, 8-30 days). Of the VTE events, 77% were detected after the first postoperative week and 27% after 4 weeks. Overall, 43.9% of the patients with VTE had received pharmacologic prophylaxis after surgery for a median of 8 days (interquartile range, 5-14 days), and three quarters of the VTE events were detected after pharmacologic prophylaxis had been discontinued. Overall, 54% of the patients with VTE had presented with pulmonary embolism. For 15% of the patients, the clinical outcome was unfavorable, including 4% who had died within 90 days. Conclusions The risk of VTE after noncancer general surgery remains high for ≤2 months. More than one half of the patients had presented with symptomatic PE as the VTE event, and 15% had had unfavorable outcomes. Only 44% of these patients had received pharmacologic prophylaxis for around 1 week.

Published
2021
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14. Vitamin K Antagonists After 6 Months of Low-Molecular-Weight Heparin in Cancer Patients with Venous Thromboembolism

Author

Chatree Chai-Adisaksopha, Alfonso Iorio, Mark A. Crowther, Javier de Miguel, Estuardo Salgado, Marija Zdraveska, Carmen Fernández-Capitán, José Antonio Nieto, Giovanni Barillari, Laurent Bertoletti, Manuel Monreal, M.A. Aibar, J.I. Arcelus, A. Ballaz, R. Barba, M. Barrón, B. Barrón-Andrés, J. Bascuñana, A. Blanco-Molina, T. Bueso, B. Calvo, G. Cañada, I. Cañas, I. Casado, A. Culla, J. de Miguel, J. del Toro, J.A. Díaz-Peromingo, C. Falgá, C. Fernández-Capitán, C. Font, L. Font, P. Gallego, F. García-Bragado, V. Gómez, J. González, E. Grau, M. Guil, L. Guirado, J. Gutiérrez, G. Hernández, L. Hernández-Blasco, V. Isern, L. Jara-Palomares, M.J. Jaras, D. Jiménez, B. Lacruz, R. Lecumberri, J.L. Lobo, L. López-Jiménez, R. López-Reyes, J.B. López-Sáez, M.A. Lorente, A. Lorenzo, O. Madridano, A. Maestre, I. Manrique-Abos, P.J. Marchena, J.M. Martín-Antorán, F. Martín-Martos, M. Monreal, M.V. Morales, R. Morillo, D. Nauffal, J.A. Nieto, S. Nieto, M.J. Núñez, M. Odriozola, S. Otalora, R. Otero, B. Pagán, J.M. Pedrajas, C. Pérez, M.L. Peris, I. Pons, J.A. Porras, L. Ramirez, A. Riera, A. Rivas, C. Rodríguez, M.A. Rodríguez-Dávila, V. Rosa, N. Ruiz-Giménez, A. Sampériz, R. Sánchez, M.C. Sala, J.C. Sahuquillo, O. Sanz, S. Soler, I. Suárez-González, J.M. Suriñach, G. Tiberio, C. Tolosa, J. Trujillo-Santos, F. Uresandi, B. Valero, R. Valle, J. Vela, M.P. Vicente, G. Vidal, V. Vilella-Tomás, J. Villalta, P.C. Malfante, T. Vanassche, P. Verhamme, P. Wells, J. Hirmerova, R. Malý, T. Tomko, G. Celis, E. Salgado, G.T. Sánchez, L. Bertoletti, A. Bura-Riviere, D. Farge-Bancel, A. Hij, I. Mahé, A. Merah, I. Quere, M. Papadakis, A. Braester, B. Brenner, I. Tzoran, A. Apollonio, G. Barillari, A. Bertone, F. Bilora, E. Bucherini, G. Candelero, M. Ciammaichella, P. Di Micco, P. Ferrazzi, E. Grandone, G. Lessiani, C. Lodigiani, D. Mastroiacovo, F. Pace, R. Pesavento, M. Pinelli, P. Prandoni, M. Rosa, L. Rota, E. Tiraferri, D. Tonello, A. Tufano, U. Venturelli, A. Visonà, B. Zalunardo, E. Drucka, D. Kigitovica, A. Skride, M.S. Sousa, M. Bosevski, M. Zdraveska, H. Bounameaux, L. Mazzolai, and J.C. Serrano

Subjects
Male, medicine.medical_specialty, Vitamin K, medicine.drug_class, Deep vein, Low molecular weight heparin, Anticoagulants, Cancer, Low-molecular-weight heparin, Thromboembolism, Warfarin, 030204 cardiovascular system & hematology, Recurrent deep vein thrombosis, 03 medical and health sciences, 0302 clinical medicine, Recurrence, Neoplasms, medicine, Humans, Registries, Propensity Score, Aged, Retrospective Studies, business.industry, Retrospective cohort study, General Medicine, Venous Thromboembolism, Heparin, Low-Molecular-Weight, medicine.disease, Thrombosis, Pulmonary embolism, Surgery, Venous thrombosis, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Female, business, medicine.drug
Abstract

BACKGROUND: Low-molecular-weight heparin (LMWH) is the treatment of choice in cancer patients with venous thromboembolism. However, data on continuing LMWH treatment beyond 6 months remain scanty. METHODS: We used the RIETE (Registro Informatizado Enfermedad TromboEmbolica) registry to compare the rate of venous thromboembolism recurrences and major bleeding appearing beyond the first 6 months of anticoagulant therapy in cancer patients with venous thromboembolism, according to therapy with LMWH or vitamin K antagonists (VKA). We performed a propensity score-matched cohort study. RESULTS: After propensity matching, 482 cancer patients continued to receive LMWH and 482 switched to VKA. During the course of anticoagulant therapy (mean 275.5 days), 57 patients developed venous thrombosis recurrences (recurrent pulmonary embolism 26, recurrent deep vein thrombosis 29, both 2), 28 had major bleeding, 38 had nonmajor bleeding, and 129 died. No patient died of recurrent venous thrombosis, and 5 patients died of bleeding (2 were on LMWH, 3 on VKA). Patients who continued with LMWH had a similar rate of deep vein thrombosis recurrences (relative risk [RR] 1.41; 95% confidence interval [CI], 0.68-2.93), pulmonary embolism recurrences (RR 0.73; 95% CI, 0.34-1.58), major bleeding (RR 0.96; 95% CI, 0.51-1.79), or nonmajor bleeding (RR 1.15; 95% CI, 0.55-2.40), compared with those who switched to VKA, but a higher mortality rate (RR 1.58; 95% CI, 1.13-2.20). CONCLUSIONS: In cancer patients with venous thromboembolism who completed 6 months of LMWH therapy, switching to VKA was associated with a similar risk of venous thrombosis recurrences or bleeding when compared with patients who continued LMWH. (C) 2018 Elsevier Inc. All rights reserved.

Published
2017

15. Treatment of Right Heart Thrombi Associated with Acute Pulmonary Embolism

Author

Deisy Barrios, Jeremy Chavant, David Jiménez, Laurent Bertoletti, Vladimir Rosa-Salazar, Alfonso Muriel, Alain Viallon, Carmen Fernández-Capitán, Roger D. Yusen, Manuel Monreal, Hervè Decousus, Paolo Prandoni, Benjamin Brenner, Raquel Barba, Pierpaolo Di Micco, Inna Tzoran, Abilio Reis, Marijan Bosevski, Henri Bounameaux, Radovan Malý, Philip Wells, Peter Verhamme, M.D. Adarraga, M.A. Aibar, M. Alfonso, J.I. Arcelus, P.M. Azcarate-Agüero, A. Ballaz, R. Barba, M. Barrón, B. Barrón-Andrés, J. Bascuñana, A. Blanco-Molina, G. Cañada, I. Cañas, I. Casado, N. Chic, R. del Pozo, J. del Toro, M.C. Díaz-Pedroche, J.A. Díaz-Peromingo, C. Falgá, C. Fernández-Aracil, C. Fernández-Capitán, M.A. Fidalgo, C. Font, L. Font, P. Gallego, M.A. García, F. García-Bragado, P. García-Brotons, O. Gavín, C. Gómez, V. Gómez, J. González, E. Grau, A. Grimón, L. Guirado, J. Gutiérrez, G. Hernández-Comes, L. Hernández-Blasco, L. Jara-Palomares, M.J. Jaras, D. Jiménez, J. Jiménez, M.D. Joya, P. Llamas, J.L. Lobo, P. López, L. López-Jiménez, R. López-Reyes, J.B. López-Sáez, M.A. Lorente, A. Lorenzo, J.M. Luque, P.J. Marchena, C. Martínez, F. Martín-Martos, M. Monreal, J.A. Nieto, S. Nieto, A. Núñez, M.J. Núñez, S. Otalora, R. Otero, J.M. Pedrajas, G. Pérez, C. Pérez-Ductor, M.L. Peris, I. Pons, J.A. Porras, O. Reig, A. Riera-Mestre, D. Riesco, A. Rivas, M. Rodríguez, M.A. Rodríguez-Dávila, V. Rosa, J.C. Sahuquillo, M.C. Sala-Sainz, A. Sampériz, R. Sánchez-Martínez, O. Sanz, S. Soler, B. Sopeña, J.M. Suriñach, C. Tolosa, M.I. Torres, J. Trujillo-Santos, F. Uresandi, E. Usandizaga, B. Valero, R. Valle, J. Vela, G. Vidal, C. Vilar, B. Xifre, T. Vanassche, P. Verhamme, H.H.B. Yoo, P. Wells, J. Hirmerova, R. Malý, E. Salgado, L. Bertoletti, A. Bura-Riviere, D. Farge-Bancel, A. Hij, I. Mahé, A. Merah, F. Moustafa, A. Braester, B. Brenner, I. Tzoran, G. Antonucci, G. Barillari, F. Bilora, A. Bonanome, C. Bortoluzzi, B. Brandolin, M. Ciammaichella, P. De Ciantis, F. Dentali, P. Di Micco, R. Duce, M. Giorgi-Pierfranceschi, E. Grandone, E. Imbalzano, G. Lessiani, R. Maida, D. Mastroiacovo, F. Pace, R. Parisi, R. Pesavento, M. Pinelli, R. Poggio, P. Prandoni, R. Quintavalla, A. Rocci, E. Tiraferri, D. Tonello, A. Tufano, U. Venturelli, A. Visonà, V. Gibietis, A. Skride, B. Vitola, M. Bosevski, M. Zdraveska, H. Bounameaux, and L. Mazzolai

Subjects
Male, medicine.medical_specialty, Heart Diseases, medicine.medical_treatment, Hemorrhage, 030204 cardiovascular system & hematology, Lower risk, 03 medical and health sciences, Anticoagulation, 0302 clinical medicine, Reperfusion therapy, Recurrence, Internal medicine, Cause of Death, medicine, Humans, Thrombolytic Therapy, 030212 general & internal medicine, Propensity Score, Cause of death, Right heart thrombi, Aged, business.industry, Pulmonary embolism, Anticoagulants, Thrombosis, General Medicine, Thrombolysis, Middle Aged, medicine.disease, Confidence interval, Treatment, Treatment Outcome, Propensity score matching, Cardiology, Female, business, Pulmonary Embolism
Abstract

Background Evidence-based recommendations do not adequately address the treatment of right heart thrombi in patients who present with acute symptomatic pulmonary embolism. Methods This study included patients who had acute pulmonary embolism associated with right heart thrombi and participated in the Registro Informatizado de la Enfermedad TromboEmbolica registry. We assessed the effectiveness of anticoagulation versus reperfusion treatment for the outcomes of all-cause mortality, pulmonary embolism–related mortality, recurrent venous thromboembolism, and major bleeding rates through 30 days after initiation of pulmonary embolism treatment. We used propensity score matching to adjust for the likelihood of receiving reperfusion treatment. Results Of 325 patients with pulmonary embolism and right heart thrombi, 255 (78%; 95% confidence interval, 74-83) received anticoagulation and 70 (22%; 95% confidence interval, 17-26) also received reperfusion treatment. Propensity score–matched pairs analyses did not detect a statistically lower risk of all-cause death (6.2% vs 14%, P = .15) or pulmonary embolism–related mortality (4.7% vs 7.8%; P = .47) for reperfusion compared with anticoagulation. Of the patients who received reperfusion treatment, 6.2% had a recurrence during the study follow-up period, compared with 0% of those who received anticoagulation ( P = .049). The incidence of major bleeding events was not statistically different between the 2 treatment groups (3.1% vs 3.1%; P = 1.00). Conclusions In patients with pulmonary embolism and right heart thrombi, no significant difference was found between reperfusion therapy and anticoagulant therapy for mortality and bleeding. The risk of recurrences was significantly higher for reperfusion therapy compared with anticoagulation. Right heart thrombi may not warrant riskier interventions than standard anticoagulation.

Published
2017

16. A prognostic score to identify low-risk outpatients with acute deep vein thrombosis in the upper extremity

Author

V. Rosa‐Salazar, J. Trujillo‐Santos, J.A. Díaz Peromingo, A. Apollonio, O. Sanz, R. Malý, F.J. Muñoz‐Rodriguez, J.C. Serrano, S. Soler, M. Monreal, H. Decousus, P. Prandoni, B. Brenner, R. Barba, P. Di Micco, L. Bertoletti, S. Schellong, I. Tzoran, A. Reis, M. Bosevski, H. Bounameaux, P. Wells, M. Papadakis, M.D. Adarraga, A. Alibalic, A. Alvarado‐Faria, J.I. Arcelus, T. Auguet, A. Ballaz, M. Barrón, B. Barrón‐Andrés, J. Bascuñana, J.F. Benítez, A. Blanco‐Molina, T. Bueso, A. Cañas, A. Casado, N. Castejón‐Pina, E.L. Chaves, F del Molino, J del Toro, C. Falgá, C. Fernández‐Capitán, L. Font, P. Gallego, F. García‐Bragado, A. García‐Ortega, V. Gómez, J. González, D. González‐Marcano, E. Grau, R. Guijarro, M. Guil, L. Guirado, J. Gutiérrez‐Guisado, L. Hernández‐Blasco, L. Jara‐Palomares, M.J. Jaras, D. Jiménez, R. Jiménez, B. Lacruz, R. Lecumberri, J.L. Lobo, L. López‐Jiménez, L. López‐Montes, R. López‐Reyes, J.B. López‐Sáez, M.A. Lorente, A. Lorenzo, O. Madridano, A. Maestre, P.J. Marchena, J.M. Martín‐Antorán, F. Martín‐Martos, M.V. Morales, D. Nauffal, J.A. Nieto, M.J. Núñez, S. Otalora, R. Otero, B. Pagán, J.M. Pedrajas, M.L. Peris, I. Pons, J.A. Porras, A. Riera‐Mestre, A. Rivas, M.A. Rodríguez‐Dávila, N. Ruiz‐Giménez, P. Sabio, A. Sampériz, R. Sánchez, M.J. Soto, J.M. Suriñach, G. Tiberio, R. Tirado, C. Tolosa, F. Uresandi, B. Valero, R. Valle, J. Vela, A. Villalobos, J. Villalta, P. Malfante, P. Verhamme, T. Vanassche, T. Tomko, J. Hirmerova, A. Bura‐Riviere, D. Farge‐Bancel, A. Hij, I. Mahe, A. Merah, F. Moustafa, I. Quere, D. Babalis, I. Tzinieris, A. Braester, G. Barillari, E. Bucherini, J. Campodomico, M. Ciammaichella, P. Ferrazzi, R. Maida, F. Pace, S. Pasca, R. Pesavento, C. Piovella, L. Rota, E. Tiraferri, A. Tufano, A. Visonà, A. Skride, A. Belovs, M. Moreira, J.L. Ribeiro, M.S. Sousa, A. Alatri, L. Calanca, L. Mazzolai, Rosa-Salazar, V., Trujillo-Santos, J., Diaz Peromingo, J. A., Apollonio, A., Sanz, O., Maly, R., Munoz-Rodriguez, F. J., Serrano, J. C., Soler, S., Monreal, M., Decousus, H., Prandoni, P., Brenner, B., Barba, R., Di Micco, P., Bertoletti, L., Schellong, S., Tzoran, I., Reis, A., Bosevski, M., Bounameaux, H., Wells, P., Papadakis, M., Adarraga, M. D., Alibalic, A., Alvarado-Faria, A., Arcelus, J. I., Auguet, T., Ballaz, A., Barron, M., Barron-Andres, B., Bascunana, J., Benitez, J. F., Blanco-Molina, A., Bueso, T., Canas, A., Casado, A., Castejon-Pina, N., Chaves, E. L., del Molino, F., del Toro, J., Diaz, J. A., Falga, C., Fernandez-Capitan, C., Font, L., Gallego, P., Garcia-Bragado, F., Garcia-Ortega, A., Gomez, V., Gonzalez, J., Gonzalez-Marcano, D., Grau, E., Guijarro, R., Guil, M., Guirado, L., Gutierrez-Guisado, J., Hernandez-Blasco, L., Jara-Palomares, L., Jaras, M. J., Jimenez, D., Jimenez, R., Lacruz, B., Lecumberri, R., Lobo, J. L., Lopez-Jimenez, L., Lopez-Montes, L., Lopez-Reyes, R., Lopez-Saez, J. B., Lorente, M. A., Lorenzo, A., Madridano, O., Maestre, A., Marchena, P. J., Martin-Antoran, J. M., Martin-Martos, F., Montreal, M., Morales, M. V., Nauffal, D., Nieto, J. A., Nunez, M. J., Otalora, S., Otero, R., Pagan, B., Pedrajas, J. M., Peris, M. L., Pons, I., Porras, J. A., Riera-Mestre, A., Rivas, A., Rodriguez-Davila, M. A., Ruiz-Gimenez, N., Sabio, P., Samperiz, A., Sanchez, R., Soto, M. J., Surinach, J. M., Tiberio, G., Tirado, R., Tolosa, C., Uresandi, F., Valero, B., Valle, R., Vela, J., Villalobos, A., Verhamme, P., Tomko, T., Villalta, J., Malfante, P., Mahe, I., Vanassche, T., Moustafa, F., Babalis, D., Hirmerova, J., Barillari, G., Bucherini, E., Farge-Bance, D., Ciammaichella, M., Ferrazzi, P., Maida, R., Pace, F., Quere, I., Pesavento, R., Piovella, C., Rota, L., Tzinieris, I., Tufano, A., Skride, A., Moreira, M., Ribeiro, J. L., Alatri, A., Calanca, L., Visona, A., Belovs, A., Sousa, M. S., Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), and Université Montpellier 1 (UM1)-Université de Montpellier (UM)

Subjects
Adult, Male, Canada, medicine.medical_specialty, Time Factors, Upper extremity, Deep vein, Renal function, Hemorrhage, Risk Assessment, deep vein thrombosis, Decision Support Techniques, Hospital, Predictive Value of Tests, Risk Factors, Deep vein thrombosi, Upper Extremity Deep Vein Thrombosis, Humans, Medicine, Registries, Israel, Adverse effect, Anticoagulant therapy, Aged, Outcome, Deep vein thrombosis, Outpatients, Anticoagulants, Europe, Female, Middle Aged, Pulmonary Embolism, South America, Treatment Outcome, business.industry, Cancer, Outpatient, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, Hematology, medicine.disease, Thrombosis, Confidence interval, 3. Good health, Pulmonary embolism, Surgery, outpatients, medicine.anatomical_structure, Heart failure, business
Abstract

International audience; BACKGROUND:No studies have identified which patients with upper-extremity deep vein thrombosis (DVT) are at low risk for adverse events within the first week of therapy.METHODS:We used data from Registro Informatizado de la Enfermedad TromboEmbólica to explore in patients with upper-extremity DVT a prognostic score that correctly identified patients with lower limb DVT at low risk for pulmonary embolism, major bleeding, or death within the first week.RESULTS:As of December 2014, 1135 outpatients with upper-extremity DVT were recruited. Of these, 515 (45%) were treated at home. During the first week, three patients (0.26%) experienced pulmonary embolism, two (0.18%) had major bleeding, and four (0.35%) died. We assigned 1 point to patients with chronic heart failure, creatinine clearance levels 30-60 mL min(-1) , recent bleeding, abnormal platelet count, recent immobility, or cancer without metastases; 2 points to those with metastatic cancer; and 3 points to those with creatinine clearance levels < 30 mL min(-1) . Overall, 759 (67%) patients scored ≤ 1 point and were considered to be at low risk. The rate of the composite outcome within the first week was 0.26% (95% confidence interval [CI] 0.004-0.87) in patients at low risk and 1.86% (95% CI 0.81-3.68) in the remaining patients. C-statistics was 0.73 (95% CI 0.57-0.88). Net reclassification improvement was 22%, and integrated discrimination improvement was 0.0055.CONCLUSIONS:Using six easily available variables, we identified outpatients with upper-extremity DVT at low risk for adverse events within the first week. These data may help to safely treat more patients at home.

Published
2015
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