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1. Update on the safety and bioequivalence of biosimilars – focus on enoxaparin

Author

Jeske W, Walenga JM, Hoppensteadt D, and Fareed J

Subjects
Medicine (General), R5-920
Abstract

Walter Jeske,1 Jeanine M Walenga,1 Debra Hoppensteadt,2 Jawed Fareed2 1Cardiovascular Institute; 2Department of Pathology, Loyola University Chicago, Maywood, IL, USA Abstract: Generic forms of chemically-derived drugs must exhibit chemical identity and be bioequivalent in healthy human subjects. The use of generic drugs results in a considerable savings of healthcare expenditures. Biologic drugs are produced in living systems or are derived from biologic material and extend beyond proteins to include antibodies, polysaccharides, polynucleotides, and live viral material. Such drugs pose a challenge to characterize as they tend to be larger in size than chemically-derived drugs, can exhibit a variety of post-translational modifications, and can have activities that are dependent on specific conformations. Biosimilars are not true generics, but rather, exhibit a high degree of similarity to the reference product and are considered to be biologically and clinically comparable to the innovator product. Therefore, the development process for biosimilars is more complex than for a true generic. Guidance is now available from the US Food and Drug Administration and from the European Medicines Agency for the development of biosimilar drugs. Biosimilar drugs are expected to have a major impact in the management of various diseases in coming years. Keywords: generic, biosimilar, low molecular weight heparin

Published
2013

2. OCCURRENCE AND ELIMINATION OF MYCOBACTERIUM TUBERCULOSIS SUBSTANCES IN SPOTTED DEER (AXIS AXIS) AT JUNGLE MAHAL ZOOLOGICAL PARK, JHARGRAM, INDIA

Author

Chanchal Datta, Sulata Mondal, and Sheik Fareed J

Subjects
axis axis, mycobacterium tuberculosis, first report of mtb, Veterinary medicine, SF600-1100
Abstract

An increased rate of death of Spotted deer (Axis axis) at Jungle Mahal Zoological Park, Jhargram, West Bengal, India was observed. Many other spotted deer of the herd were observed losing body weight. Their body weight was reduced gradually despite the provision of optimum nutrients. During post-mortem examination of the dead spotted deer, typical tuberculosis findings were observed. Samples were sent to the laboratories and were found to be Mycobacterium tuberculosis (MTB) positive. Treatment of MTB was started accordingly. After the treatment phase, multiple samples were sent again to the laboratories and all the samples were negative as per the laboratory reports. It is the first positive report of MTB in Spotted deer in West Bengal, India.

Published
2024
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3. Towards displacing domestic air conditioning in KSA : an assessment of hybrid cooling strategies integrated with 'Fabric First' passive design measures

Author

Hijazi, Jamil Fareed J. and Howieson, Stirling

Subjects
720
Abstract

Reducing energy use and CO2 emissions to curb global warming and climate change are the greatest challenges now facing mankind. The vast majority of energy generated from fossil fuels is burned to run vehicles, fuel power stations and cool or heat homes. Saudi Arabia, the world's largest producer and exporter of petroleum, currently consumes almost three times higher than the world average energy use and hence; ranked ninth among nations for CO2 emissions. Among all fossil energy consumers, residential buildings use almost half of the Saudi’s prime energy sources and are responsible for almost 50% of the emitted CO2. In such a hot climate region, air conditioning (AC) of dwellings is by far the major consumer representing 69% of domestic energy use and drives peak loading. Future projections predict a continuous increase in energy use as the majority of existing buildings are poorly designed for the prevailing climate, leading to excessive use of mechanical AC. Therefore, it is crucial for Saudi Arabia to consider a horizon where hydrocarbons are not the dominant energy resource. The adoption of energy efficiency measures and low carbon cooling strategies may have the potential to displace a substantial percentage of oil currently used to run conventional AC plants. Therefore, the current study investigates the viability of ‘fabric first’ intelligent architectural design measures, in combination with hybrid ground cooling pipes integrated with black-body radiant night cooling systems, with a specific purpose to displace AC systems and decrease the carbon footprint while sustaining year-round thermal comfort. The interrogation of this hypothesis was addressed in three stages. The first stage was to generate a baseline analysis of the thermo-physical and energy performance of a typical residential block in Jeddah. The second stage involved developing an alternative low energy cooling approach that could handle high ambient temperatures. The task involved designing ground pipe ventilation integrated with high emissivity blackbody radiator to displace AC systems. The design of such ‘hybrid’ system required a parametric analysis combined with testing prototypes in field trials to establish actual ground temperatures at various depths and black body emissivity ranges under different sky conditions. This hybrid system became the subject of numerical modelling and simulation using DesignBuilder software in conjunction with EnergyPlus simulation engine. The third stage was to assess the simulation results and validate the cooling efficiency and cost-effectiveness of the hybrid system compared to the baseline. The preliminary results of prototype thermal simulation and field trials suggest that ‘fabric first’ passive designs and measures (PDMs), combined with night hydronic radiant cooling (HRCS) and supply ventilation via ground pipes (GPCS), can negate the necessity for a standard AC system by displacing over 80% of cooling demand and lower the carbon footprint of a typical housing block by over 75%. Such passive and hybrid system applications also have a remarkably short payback period with energy savings offsetting the capital costs associated with building thermo-physical enhancement.

Published
2018
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16. PB0125 Preoperative Thromboelastometry and Pro-Thrombotic Biomarkers According to Clinical Venothromboembolic (VTE) Risk Assessment in Bariatric Surgery Patients

Author

VanDruff, V., primary, Tafur, A., additional, Siddiqui, F., additional, Nikolovski, S., additional, Fareed, J., additional, Kuchta, K., additional, Carbray, J., additional, Meyer, C., additional, Amundson, J., additional, Joseph, S., additional, Che, S., additional, Zimmermann, C., additional, Hedberg, H., additional, Haggerty, S., additional, Linn, J., additional, Denham, W., additional, and Ujiki, M., additional

Published
2023
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20. PB0086 Prospective Assessment of Thrombomodulin Resistance in Oncological Patients and Healthy Subjects Following Vaccination Against Sars-Cov-2 with the mRNAVaccine. The Roadmap-COVID-19-Vaccin Study

Author

Van Dreden, P., primary, Gligorov, J., additional, Terpos, E., additional, Jamelot, M., additional, Grussé, M., additional, Elalamy, I., additional, Fareed, J., additional, Rousseau, A., additional, Dimopoulos, M., additional, and Gerotziafas, G., additional

Published
2023
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25. Guidance for the Management of Patients with Vascular Disease or Cardiovascular Risk Factors and COVID-19: Position Paper from VAS-European Independent Foundation in Angiology/Vascular Medicine

Author

Gerotziafas, G, Catalano, M, Colgan, M, Pecsvarady, Z, Wautrecht, J, Fazeli, B, Olinic, D, Farkas, K, Elalamy, I, Falanga, A, Fareed, J, Papageorgiou, C, Arellano, R, Agathagelou, P, Antic, D, Auad, L, Banfic, L, Bartolomew, J, Benczur, B, Bernardo, M, Boccardo, F, Cifkova, R, Cosmi, B, De Marchi, S, Dimakakos, E, Dimopoulos, M, Dimitrov, G, Durand-Zaleski, I, Edmonds, M, El Nazar, E, Erer, D, Esponda, O, Gresele, P, Gschwandtner, M, Gu, Y, Heinzmann, M, Hamburg, N, Hamade, A, Jatoi, N, Karahan, O, Karetova, D, Karplus, T, Klein-Weigel, P, Kolossvary, E, Kozak, M, Lefkou, E, Lessiani, G, Liew, A, Marcoccia, A, Marshang, P, Marakomichelakis, G, Matuska, J, Moraglia, L, Pillon, S, Poredos, P, Prior, M, Salvador, D, Schlager, O, Schernthaner, G, Sieron, A, Spaak, J, Spyropoulos, A, Sprynger, M, Suput, D, Stanek, A, Stvrtinova, V, Szuba, A, Tafur, A, Vandreden, P, Vardas, P, Vasic, D, Vikkula, M, Wennberg, P, Zhai, Z, Bikdeli, B, Guo, Y, Harenberg, J, Hu, Y, Lip, G, Roldan, V, Gerotziafas G. T., Catalano M., Colgan M. -P., Pecsvarady Z., Wautrecht J. C., Fazeli B., Olinic D. -M., Farkas K., Elalamy I., Falanga A., Fareed J., Papageorgiou C., Arellano R. S., Agathagelou P., Antic D., Auad L., Banfic L., Bartolomew J. R., Benczur B., Bernardo M. B., Boccardo F., Cifkova R., Cosmi B., De Marchi S., Dimakakos E., Dimopoulos M. A., Dimitrov G., Durand-Zaleski I., Edmonds M., El Nazar E. A., Erer D., Esponda O. L., Gresele P., Gschwandtner M., Gu Y., Heinzmann M., Hamburg N. M., Hamade A., Jatoi N. -A., Karahan O., Karetova D., Karplus T., Klein-Weigel P., Kolossvary E., Kozak M., Lefkou E., Lessiani G., Liew A., Marcoccia A., Marshang P., Marakomichelakis G., Matuska J., Moraglia L., Pillon S., Poredos P., Prior M., Salvador D. R. K., Schlager O., Schernthaner G., Sieron A., Spaak J., Spyropoulos A., Sprynger M., Suput D., Stanek A., Stvrtinova V., Szuba A., Tafur A., Vandreden P., Vardas P. E., Vasic D., Vikkula M., Wennberg P., Zhai Z., Bikdeli B., Guo Y., Harenberg J., Hu Y., Lip G. Y. H., Roldan V., Gerotziafas, G, Catalano, M, Colgan, M, Pecsvarady, Z, Wautrecht, J, Fazeli, B, Olinic, D, Farkas, K, Elalamy, I, Falanga, A, Fareed, J, Papageorgiou, C, Arellano, R, Agathagelou, P, Antic, D, Auad, L, Banfic, L, Bartolomew, J, Benczur, B, Bernardo, M, Boccardo, F, Cifkova, R, Cosmi, B, De Marchi, S, Dimakakos, E, Dimopoulos, M, Dimitrov, G, Durand-Zaleski, I, Edmonds, M, El Nazar, E, Erer, D, Esponda, O, Gresele, P, Gschwandtner, M, Gu, Y, Heinzmann, M, Hamburg, N, Hamade, A, Jatoi, N, Karahan, O, Karetova, D, Karplus, T, Klein-Weigel, P, Kolossvary, E, Kozak, M, Lefkou, E, Lessiani, G, Liew, A, Marcoccia, A, Marshang, P, Marakomichelakis, G, Matuska, J, Moraglia, L, Pillon, S, Poredos, P, Prior, M, Salvador, D, Schlager, O, Schernthaner, G, Sieron, A, Spaak, J, Spyropoulos, A, Sprynger, M, Suput, D, Stanek, A, Stvrtinova, V, Szuba, A, Tafur, A, Vandreden, P, Vardas, P, Vasic, D, Vikkula, M, Wennberg, P, Zhai, Z, Bikdeli, B, Guo, Y, Harenberg, J, Hu, Y, Lip, G, Roldan, V, Gerotziafas G. T., Catalano M., Colgan M. -P., Pecsvarady Z., Wautrecht J. C., Fazeli B., Olinic D. -M., Farkas K., Elalamy I., Falanga A., Fareed J., Papageorgiou C., Arellano R. S., Agathagelou P., Antic D., Auad L., Banfic L., Bartolomew J. R., Benczur B., Bernardo M. B., Boccardo F., Cifkova R., Cosmi B., De Marchi S., Dimakakos E., Dimopoulos M. A., Dimitrov G., Durand-Zaleski I., Edmonds M., El Nazar E. A., Erer D., Esponda O. L., Gresele P., Gschwandtner M., Gu Y., Heinzmann M., Hamburg N. M., Hamade A., Jatoi N. -A., Karahan O., Karetova D., Karplus T., Klein-Weigel P., Kolossvary E., Kozak M., Lefkou E., Lessiani G., Liew A., Marcoccia A., Marshang P., Marakomichelakis G., Matuska J., Moraglia L., Pillon S., Poredos P., Prior M., Salvador D. R. K., Schlager O., Schernthaner G., Sieron A., Spaak J., Spyropoulos A., Sprynger M., Suput D., Stanek A., Stvrtinova V., Szuba A., Tafur A., Vandreden P., Vardas P. E., Vasic D., Vikkula M., Wennberg P., Zhai Z., Bikdeli B., Guo Y., Harenberg J., Hu Y., Lip G. Y. H., and Roldan V.

Abstract

COVID-19 is also manifested with hypercoagulability, pulmonary intravascular coagulation, microangiopathy, and venous thromboembolism (VTE) or arterial thrombosis. Predisposing risk factors to severe COVID-19 are male sex, underlying cardiovascular disease, or cardiovascular risk factors including noncontrolled diabetes mellitus or arterial hypertension, obesity, and advanced age. The VAS-European Independent Foundation in Angiology/Vascular Medicine draws attention to patients with vascular disease (VD) and presents an integral strategy for the management of patients with VD or cardiovascular risk factors (VD-CVR) and COVID-19. VAS recommends (1) a COVID-19-oriented primary health care network for patients with VD-CVR for identification of patients with VD-CVR in the community and patients' education for disease symptoms, use of eHealth technology, adherence to the antithrombotic and vascular regulating treatments, and (2) close medical follow-up for efficacious control of VD progression and prompt application of physical and social distancing measures in case of new epidemic waves. For patients with VD-CVR who receive home treatment for COVID-19, VAS recommends assessment for (1) disease worsening risk and prioritized hospitalization of those at high risk and (2) VTE risk assessment and thromboprophylaxis with rivaroxaban, betrixaban, or low-molecular-weight heparin (LMWH) for those at high risk. For hospitalized patients with VD-CVR and COVID-19, VAS recommends (1) routine thromboprophylaxis with weight-adjusted intermediate doses of LMWH (unless contraindication); (2) LMWH as the drug of choice over unfractionated heparin or direct oral anticoagulants for the treatment of VTE or hypercoagulability; (3) careful evaluation of the risk for disease worsening and prompt application of targeted antiviral or convalescence treatments; (4) monitoring of D-dimer for optimization of the antithrombotic treatment; and (5) evaluation of the risk of VTE before hospital dischar

Published
2020

26. Pharmacological Agents Targeting Thromboinflammation in COVID-19: Review and Implications for Future Research

Author

Bikdeli, B, Madhavan, M, Gupta, A, Jimenez, D, Burton, J, Der Nigoghossian, C, Chuich, T, Nouri, S, Dreyfus, I, Driggin, E, Sethi, S, Sehgal, K, Chatterjee, S, Ageno, W, Madjid, M, Guo, Y, Tang, L, Hu, Y, Bertoletti, L, Giri, J, Cushman, M, Quéré, I, Dimakakos, E, Gibson, C, Lippi, G, Favaloro, E, Fareed, J, Tafur, A, Francese, D, Batra, J, Falanga, A, Clerkin, K, Uriel, N, Kirtane, A, Mclintock, C, Hunt, B, Spyropoulos, A, Barnes, G, Eikelboom, J, Weinberg, I, Schulman, S, Carrier, M, Piazza, G, Beckman, J, Leon, M, Stone, G, Rosenkranz, S, Goldhaber, S, Parikh, S, Monreal, M, Krumholz, H, Konstantinides, S, Weitz, J, Lip, G, Global COVID-19 Thrombosis Collaborative, G, Bikdeli B, Madhavan MV, Gupta A, Jimenez D, Burton JR, Der Nigoghossian C, Chuich T, Nouri SN, Dreyfus I, Driggin E, Sethi S, Sehgal K, Chatterjee S, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Bertoletti L, Giri J, Cushman M, Quéré I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Tafur AJ, Francese DP, Batra J, Falanga A, Clerkin KJ, Uriel N, Kirtane A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Leon MB, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH, Global COVID-19 Thrombosis Collaborative Group., Bikdeli, B, Madhavan, M, Gupta, A, Jimenez, D, Burton, J, Der Nigoghossian, C, Chuich, T, Nouri, S, Dreyfus, I, Driggin, E, Sethi, S, Sehgal, K, Chatterjee, S, Ageno, W, Madjid, M, Guo, Y, Tang, L, Hu, Y, Bertoletti, L, Giri, J, Cushman, M, Quéré, I, Dimakakos, E, Gibson, C, Lippi, G, Favaloro, E, Fareed, J, Tafur, A, Francese, D, Batra, J, Falanga, A, Clerkin, K, Uriel, N, Kirtane, A, Mclintock, C, Hunt, B, Spyropoulos, A, Barnes, G, Eikelboom, J, Weinberg, I, Schulman, S, Carrier, M, Piazza, G, Beckman, J, Leon, M, Stone, G, Rosenkranz, S, Goldhaber, S, Parikh, S, Monreal, M, Krumholz, H, Konstantinides, S, Weitz, J, Lip, G, Global COVID-19 Thrombosis Collaborative, G, Bikdeli B, Madhavan MV, Gupta A, Jimenez D, Burton JR, Der Nigoghossian C, Chuich T, Nouri SN, Dreyfus I, Driggin E, Sethi S, Sehgal K, Chatterjee S, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Bertoletti L, Giri J, Cushman M, Quéré I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Tafur AJ, Francese DP, Batra J, Falanga A, Clerkin KJ, Uriel N, Kirtane A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Leon MB, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH, and Global COVID-19 Thrombosis Collaborative Group.

Abstract

Coronavirus disease 2019 (COVID-19), currently a worldwide pandemic, is a viral illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The suspected contribution of thrombotic events to morbidity and mortality in COVID-19 patients has prompted a search for novel potential options for preventing COVID-19-associated thrombotic disease. In this article by the Global COVID-19 Thrombosis Collaborative Group, we describe novel dosing approaches for commonly used antithrombotic agents (especially heparin-based regimens) and the potential use of less widely used antithrombotic drugs in the absence of confirmed thrombosis. Although these therapies may have direct antithrombotic effects, other mechanisms of action, including anti-inflammatory or antiviral effects, have been postulated. Based on survey results from this group of authors, we suggest research priorities for specific agents and subgroups of patients with COVID-19. Further, we review other agents, including immunomodulators, that may have antithrombotic properties. It is our hope that the present document will encourage and stimulate future prospective studies and randomized trials to study the safety, efficacy, and optimal use of these agents for prevention or management of thrombosis in COVID-19.

Published
2020

27. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review

Author

Bikdeli, B, Madhavan, M, Jimenez, D, Chuich, T, Dreyfus, I, Driggin, E, Nigoghossian, C, Ageno, W, Madjid, M, Guo, Y, Tang, L, Hu, Y, Giri, J, Cushman, M, Quéré, I, Dimakakos, E, Gibson, C, Lippi, G, Favaloro, E, Fareed, J, Caprini, J, Tafur, A, Burton, J, Francese, D, Wang, E, Falanga, A, Mclintock, C, Hunt, B, Spyropoulos, A, Barnes, G, Eikelboom, J, Weinberg, I, Schulman, S, Carrier, M, Piazza, G, Beckman, J, Steg, P, Stone, G, Rosenkranz, S, Goldhaber, S, Parikh, S, Monreal, M, Krumholz, H, Konstantinides, S, Weitz, J, Lip, G, Global COVID-19 Thrombosis Collaborative, G, Endorsed by the, I, Natf, Esvm, and the, I, Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular, F, Bikdeli B, Madhavan MV, Jimenez D, Chuich T, Dreyfus I, Driggin E, Nigoghossian C, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Giri J, Cushman M, Quéré I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Caprini JA, Tafur AJ, Burton JR, Francese DP, Wang EY, Falanga A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Steg PG, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH, Global COVID-19 Thrombosis Collaborative Group, Endorsed by the ISTH, NATF, ESVM, and the IUA, Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function., Bikdeli, B, Madhavan, M, Jimenez, D, Chuich, T, Dreyfus, I, Driggin, E, Nigoghossian, C, Ageno, W, Madjid, M, Guo, Y, Tang, L, Hu, Y, Giri, J, Cushman, M, Quéré, I, Dimakakos, E, Gibson, C, Lippi, G, Favaloro, E, Fareed, J, Caprini, J, Tafur, A, Burton, J, Francese, D, Wang, E, Falanga, A, Mclintock, C, Hunt, B, Spyropoulos, A, Barnes, G, Eikelboom, J, Weinberg, I, Schulman, S, Carrier, M, Piazza, G, Beckman, J, Steg, P, Stone, G, Rosenkranz, S, Goldhaber, S, Parikh, S, Monreal, M, Krumholz, H, Konstantinides, S, Weitz, J, Lip, G, Global COVID-19 Thrombosis Collaborative, G, Endorsed by the, I, Natf, Esvm, and the, I, Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular, F, Bikdeli B, Madhavan MV, Jimenez D, Chuich T, Dreyfus I, Driggin E, Nigoghossian C, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Giri J, Cushman M, Quéré I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Caprini JA, Tafur AJ, Burton JR, Francese DP, Wang EY, Falanga A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Steg PG, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH, Global COVID-19 Thrombosis Collaborative Group, Endorsed by the ISTH, NATF, ESVM, and the IUA, and Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function.

Abstract

Coronavirus disease-2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), may predispose patients to thrombotic disease, both in the venous and arterial circulations, because of excessive inflammation, platelet activation, endothelial dysfunction, and stasis. In addition, many patients receiving antithrombotic therapy for thrombotic disease may develop COVID-19, which can have implications for choice, dosing, and laboratory monitoring of antithrombotic therapy. Moreover, during a time with much focus on COVID-19, it is critical to consider how to optimize the available technology to care for patients without COVID-19 who have thrombotic disease. Herein, the authors review the current understanding of the pathogenesis, epidemiology, management, and outcomes of patients with COVID-19 who develop venous or arterial thrombosis, of those with pre-existing thrombotic disease who develop COVID-19, or those who need prevention or care for their thrombotic disease during the COVID-19 pandemic.

Published
2020

30. Guidance for the Management of Patients with Vascular Disease or Cardiovascular Risk Factors and COVID-19: Position Paper from VAS-European Independent Foundation in Angiology/Vascular Medicine

Author

Gerotziafas G. T., Catalano M., Colgan M. -P., Pecsvarady Z., Wautrecht J. C., Fazeli B., Olinic D. -M., Farkas K., Elalamy I., Falanga A., Fareed J., Papageorgiou C., Arellano R. S., Agathagelou P., Antic D., Auad L., Banfic L., Bartolomew J. R., Benczur B., Bernardo M. B., Boccardo F., Cifkova R., Cosmi B., De Marchi S., Dimakakos E., Dimopoulos M. A., Dimitrov G., Durand-Zaleski I., Edmonds M., El Nazar E. A., Erer D., Esponda O. L., Gresele P., Gschwandtner M., Gu Y., Heinzmann M., Hamburg N. M., Hamade A., Jatoi N. -A., Karahan O., Karetova D., Karplus T., Klein-Weigel P., Kolossvary E., Kozak M., Lefkou E., Lessiani G., Liew A., Marcoccia A., Marshang P., Marakomichelakis G., Matuska J., Moraglia L., Pillon S., Poredos P., Prior M., Salvador D. R. K., Schlager O., Schernthaner G., Sieron A., Spaak J., Spyropoulos A., Sprynger M., Suput D., Stanek A., Stvrtinova V., Szuba A., Tafur A., Vandreden P., Vardas P. E., Vasic D., Vikkula M., Wennberg P., Zhai Z., Bikdeli B., Guo Y., Harenberg J., Hu Y., Lip G. Y. H., Roldan V., Gerotziafas, G, Catalano, M, Colgan, M, Pecsvarady, Z, Wautrecht, J, Fazeli, B, Olinic, D, Farkas, K, Elalamy, I, Falanga, A, Fareed, J, Papageorgiou, C, Arellano, R, Agathagelou, P, Antic, D, Auad, L, Banfic, L, Bartolomew, J, Benczur, B, Bernardo, M, Boccardo, F, Cifkova, R, Cosmi, B, De Marchi, S, Dimakakos, E, Dimopoulos, M, Dimitrov, G, Durand-Zaleski, I, Edmonds, M, El Nazar, E, Erer, D, Esponda, O, Gresele, P, Gschwandtner, M, Gu, Y, Heinzmann, M, Hamburg, N, Hamade, A, Jatoi, N, Karahan, O, Karetova, D, Karplus, T, Klein-Weigel, P, Kolossvary, E, Kozak, M, Lefkou, E, Lessiani, G, Liew, A, Marcoccia, A, Marshang, P, Marakomichelakis, G, Matuska, J, Moraglia, L, Pillon, S, Poredos, P, Prior, M, Salvador, D, Schlager, O, Schernthaner, G, Sieron, A, Spaak, J, Spyropoulos, A, Sprynger, M, Suput, D, Stanek, A, Stvrtinova, V, Szuba, A, Tafur, A, Vandreden, P, Vardas, P, Vasic, D, Vikkula, M, Wennberg, P, Zhai, Z, Bikdeli, B, Guo, Y, Harenberg, J, Hu, Y, Lip, G, Roldan, V, Centre de Recherche Saint-Antoine (CR Saint-Antoine), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Trinity College Dublin, Hôpital Erasme [Bruxelles] (ULB), Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Mashhad University of Medical Sciences, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Gerotziafas G.T., Catalano M., Colgan M.-P., Pecsvarady Z., Wautrecht J.C., Fazeli B., Olinic D.-M., Farkas K., Elalamy I., Falanga A., Fareed J., Papageorgiou C., Arellano R.S., Agathagelou P., Antic D., Auad L., Banfic L., Bartolomew J.R., Benczur B., Bernardo M.B., Boccardo F., Cifkova R., Cosmi B., De Marchi S., Dimakakos E., Dimopoulos M.A., Dimitrov G., Durand-Zaleski I., Edmonds M., El Nazar E.A., Erer D., Esponda O.L., Gresele P., Gschwandtner M., Gu Y., Heinzmann M., Hamburg N.M., Hamade A., Jatoi N.-A., Karahan O., Karetova D., Karplus T., Klein-Weigel P., Kolossvary E., Kozak M., Lefkou E., Lessiani G., Liew A., Marcoccia A., Marshang P., Marakomichelakis G., Matuska J., Moraglia L., Pillon S., Poredos P., Prior M., Salvador D.R.K., Schlager O., Schernthaner G., Sieron A., Spaak J., Spyropoulos A., Sprynger M., Suput D., Stanek A., Stvrtinova V., Szuba A., Tafur A., Vandreden P., Vardas P.E., Vasic D., Vikkula M., Wennberg P., Zhai Z., Bikdeli B., Guo Y., Harenberg J., Hu Y., Lip G.Y.H., Roldan V., and UCL - SSS/DDUV/GEHU - Génétique

Subjects
030204 cardiovascular system & hematology, antithrombotic, antiplatelet, chemistry.chemical_compound, 0302 clinical medicine, Rivaroxaban, Risk Factors, cardiovascular disease, Thrombophilia, 030212 general & internal medicine, antiplatelets, low-molecular-weight heparin, Societies, Medical, Low-Molecular-Weight, Hematology, 3. Good health, Europe, Cardiovascular Diseases, Thrombosi, Practice Guidelines as Topic, Position Paper, Risk assessment, medicine.drug, Human, medicine.medical_specialty, anticoagulants, medicine.drug_class, DOAC, Cardiology, Low molecular weight heparin, peripheral artery disease, deep vein thrombosis, 03 medical and health sciences, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Medical, medicine, Humans, COVID-19 - cardiovascular disease - peripheral artery disease - deep vein thrombosis - antithrombotic - antiplatelets - anticoagulants - low-molecular-weight heparin - DOAC, Intensive care medicine, Contraindication, Angiology, Inflammation, Vascular disease, business.industry, Heparin, SARS-CoV-2, Risk Factor, anticoagulant, deep vein thrombosi, COVID-19, Thrombosis, Heparin, Low-Molecular-Weight, medicine.disease, COVID-19 Drug Treatment, chemistry, Betrixaban, business, Societies
Abstract

COVID-19 is also manifested with hypercoagulability, pulmonary intravascular coagulation, microangiopathy, and venous thromboembolism (VTE) or arterial thrombosis. Predisposing risk factors to severe COVID-19 are male sex, underlying cardiovascular disease, or cardiovascular risk factors including noncontrolled diabetes mellitus or arterial hypertension, obesity, and advanced age. The VAS-European Independent Foundation in Angiology/Vascular Medicine draws attention to patients with vascular disease (VD) and presents an integral strategy for the management of patients with VD or cardiovascular risk factors (VD-CVR) and COVID-19. VAS recommends (1) a COVID-19-oriented primary health care network for patients with VD-CVR for identification of patients with VD-CVR in the community and patients' education for disease symptoms, use of eHealth technology, adherence to the antithrombotic and vascular regulating treatments, and (2) close medical follow-up for efficacious control of VD progression and prompt application of physical and social distancing measures in case of new epidemic waves. For patients with VD-CVR who receive home treatment for COVID-19, VAS recommends assessment for (1) disease worsening risk and prioritized hospitalization of those at high risk and (2) VTE risk assessment and thromboprophylaxis with rivaroxaban, betrixaban, or low-molecular-weight heparin (LMWH) for those at high risk. For hospitalized patients with VD-CVR and COVID-19, VAS recommends (1) routine thromboprophylaxis with weight-adjusted intermediate doses of LMWH (unless contraindication); (2) LMWH as the drug of choice over unfractionated heparin or direct oral anticoagulants for the treatment of VTE or hypercoagulability; (3) careful evaluation of the risk for disease worsening and prompt application of targeted antiviral or convalescence treatments; (4) monitoring of D-dimer for optimization of the antithrombotic treatment; and (5) evaluation of the risk of VTE before hospital discharge using the IMPROVE-D-dimer score and prolonged post-discharge thromboprophylaxis with rivaroxaban, betrixaban, or LMWH.

Published
2020

32. Cellular Indices and Outcome in Patients with Acute Venous Thromboembolism

Author

Siddiqui, F, Garcia-Ortega, A, Kantarcioglu, B, Sinacore, J, Tafur, A, Demelo-Rodriguez, P, Nieto, JA, Usandizaga, E, Fareed, J, and Monreal, M

Subjects
major bleeding, venous thromboembolism (VTE), systemic immune inflammation index (SII), platelet to lymphocyte ratio (PLR), neutrophil to lymphocyte ratio (NLR), mortality
Abstract

Background Cellular indices provide integrative information about systemic inflammation status which is readily available from routine laboratory parameters. This study aimed to evaluate the prognostic role of three cellular indices in patients with venous thromboembolism (VTE). Methods The RIETE registry database was used to determine the association between the baseline neutrophil-to-lymphocyte-ratio (NLR), platelet-to-lymphocyte-ratio (PLR) and systemic-immune-inflammation-index (SII) for 90-day adverse outcomes in patients with acute VTE. Results From January 2020 to April 2021, 4487 patients with acute VTE were recruited in the RIETE registry. Of these, 2683 presented with symptomatic pulmonary embolism (PE); 283 with incidental PE; 1129 with lower-limb deep vein thrombosis (DVT); 175 with upper-limb DVT; 69 with splanchnic vein thrombosis; 142 with superficial vein thrombosis and 20 with retinal vein thrombosis. Mean values were: NLR 5.9 +/- 7.1, PLR 190 +/- 158 and SII 1459 +/- 2028. During the first 90-days, 38 patients (0.8%) developed recurrent DVT, 45 (1.0%) had recurrent PE, 152 (3.4%) suffered major bleeding, and 484 (11%) died. On multivariable analysis, patients with NLR >4.41 were at an increased risk for major bleeding and patients with NLR >4.96 were at the risk of death, while those with SII >1134.5 were at increased risk for death. Conclusions This study reports the results of a large cohort to date which evaluate the prognostic value of three cellular indices simultaneously in patients with acute VTE. Results support that none of the three baseline cellular indices were sufficient for prediction of VTE recurrences in acute VTE patients. The patients with higher baseline NLR values were at an increased risk of major bleeding or death, those with high SII values were only at an increased risk for mortality.

Published
2022

34. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review

Author

Bikdeli B, Madhavan MV, Jimenez D, Chuich T, Dreyfus I, Driggin E, Nigoghossian C, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Giri J, Cushman M, Quéré I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Caprini JA, Tafur AJ, Burton JR, Francese DP, Wang EY, Falanga A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Steg PG, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH, Global COVID-19 Thrombosis Collaborative Group, Endorsed by the ISTH, NATF, ESVM, and the IUA, Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function., Bikdeli, B, Madhavan, M, Jimenez, D, Chuich, T, Dreyfus, I, Driggin, E, Nigoghossian, C, Ageno, W, Madjid, M, Guo, Y, Tang, L, Hu, Y, Giri, J, Cushman, M, Quéré, I, Dimakakos, E, Gibson, C, Lippi, G, Favaloro, E, Fareed, J, Caprini, J, Tafur, A, Burton, J, Francese, D, Wang, E, Falanga, A, Mclintock, C, Hunt, B, Spyropoulos, A, Barnes, G, Eikelboom, J, Weinberg, I, Schulman, S, Carrier, M, Piazza, G, Beckman, J, Steg, P, Stone, G, Rosenkranz, S, Goldhaber, S, Parikh, S, Monreal, M, Krumholz, H, Konstantinides, S, Weitz, J, Lip, G, Global COVID-19 Thrombosis Collaborative, G, Endorsed by the, I, Natf, Esvm, and the, I, and Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular, F

Subjects
SARS-CoV-2, anticoagulant, antithrombotic therapy, COVID-19, thrombosi, antiplatelet, thrombosis
Abstract

Coronavirus disease-2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), may predispose patients to thrombotic disease, both in the venous and arterial circulations, because of excessive inflammation, platelet activation, endothelial dysfunction, and stasis. In addition, many patients receiving antithrombotic therapy for thrombotic disease may develop COVID-19, which can have implications for choice, dosing, and laboratory monitoring of antithrombotic therapy. Moreover, during a time with much focus on COVID-19, it is critical to consider how to optimize the available technology to care for patients without COVID-19 who have thrombotic disease. Herein, the authors review the current understanding of the pathogenesis, epidemiology, management, and outcomes of patients with COVID-19 who develop venous or arterial thrombosis, of those with pre-existing thrombotic disease who develop COVID-19, or those who need prevention or care for their thrombotic disease during the COVID-19 pandemic.

Published
2020

47. Defibrotide: potential for treating endothelial dysfunction related to viral and post-infectious syndromes

Author

Richardson, E, Garcia-Bernal, D, Calabretta, E, Jara, R, Palomo, M, Baron, RM, Yanik, G, Fareed, J, Vlodavsky, I, Iacobelli, M, Diaz-Ricart, M, Richardson, PG, Carlo-Stella, C, and Moraleda, JM

Subjects
Defibrotide, Ebola, coronavirus, COVID-19, viral hemorrhagic fever, influenza A, complement cascade, endothelial dysfunction
Abstract

Introduction Defibrotide (DF) is a polyribonucleotide with antithrombotic, pro-fibrinolytic, and anti-inflammatory effects on endothelium. These effects and the established safety of DF present DF as a strong candidate to treat viral and post-infectious syndromes involving endothelial dysfunction. Areas Covered We discuss DF and other therapeutic agents that have the potential to target endothelial components of pathogenesis in viral and post-infectious syndromes. We introduce defibrotide (DF), describe its mechanisms of action, and explore its established pleiotropic effects on the endothelium. We describe the established pathophysiology of Coronavirus Disease 2019 (COVID-19) and highlight the processes specific to COVID-19 potentially modulated by DF. We also present influenza A and viral hemorrhagic fevers, especially those caused by hantavirus, Ebola virus, and dengue virus, as viral syndromes in which DF might serve therapeutic benefit. Finally, we offer our opinion on novel treatment strategies targeting endothelial dysfunction in viral infections and their severe manifestations. Expert Opinion Given the critical role of endothelial dysfunction in numerous infectious syndromes, in particular COVID-19, therapeutic pharmacology for these conditions should increasingly prioritize endothelial stabilization. Several agents with endothelial protective properties should be further studied as treatments for severe viral infections and vasculitides, especially where other therapeutic modalities have failed.

Published
2021

48. The COVID-19 Pandemic and the Need for an Integrated and Equitable Approach: An International Expert Consensus Paper.

Author

Gerotziafas G.T., Catalano M., Theodorou Y., Dreden P.V., Marechal V., Spyropoulos A.C., Carter C., Jabeen N., Harenberg J., Elalamy I., Falanga A., Fareed J., Agathaggelou P., Antic D., Antignani P.L., Bosch M.M., Brenner B., Chekhonin V., Colgan M.-P., Dimopoulos M.-A., Douketis J., Elnazar E.A., Farkas K., Fazeli B., Fowkes G., Gu Y., Gligorov J., Ligocki M.A., Indran T., Kannan M., Kantarcioglu B., Kasse A.A., Konstantinidis K., Leivano F., Lewis J., Makatsariya A., Mbaye P.M., Mahe I., Panovska-Stavridis I., Olinic D.-M., Papageorgiou C., Pecsvarady Z., Pillon S., Ramacciotti E., Abdel-Razeq H., Sabbah M., Sassi M., Schernthaner G., Siddiqui F., Shiomura J., Slama-Schwok A., Wautrecht J.C., Tafur A., Taher A., Klein-Wegel P., Zhai Z., Zoubida T.M., Lip G.Y.H., Makris M., Schulman S., Siess W., Weber C., Gerotziafas G.T., Catalano M., Theodorou Y., Dreden P.V., Marechal V., Spyropoulos A.C., Carter C., Jabeen N., Harenberg J., Elalamy I., Falanga A., Fareed J., Agathaggelou P., Antic D., Antignani P.L., Bosch M.M., Brenner B., Chekhonin V., Colgan M.-P., Dimopoulos M.-A., Douketis J., Elnazar E.A., Farkas K., Fazeli B., Fowkes G., Gu Y., Gligorov J., Ligocki M.A., Indran T., Kannan M., Kantarcioglu B., Kasse A.A., Konstantinidis K., Leivano F., Lewis J., Makatsariya A., Mbaye P.M., Mahe I., Panovska-Stavridis I., Olinic D.-M., Papageorgiou C., Pecsvarady Z., Pillon S., Ramacciotti E., Abdel-Razeq H., Sabbah M., Sassi M., Schernthaner G., Siddiqui F., Shiomura J., Slama-Schwok A., Wautrecht J.C., Tafur A., Taher A., Klein-Wegel P., Zhai Z., Zoubida T.M., Lip G.Y.H., Makris M., Schulman S., Siess W., and Weber C.

Abstract

Background One year after the declaration of the coronavirus disease 2019 (COVID-19) pandemic by the World Health Organization (WHO) and despite the implementation of mandatory physical barriers and social distancing, humanity remains challenged by a long-lasting and devastating public health crisis. Management Non-pharmacological interventions (NPIs) are efficient mitigation strategies. The success of these NPIs is dependent on the approval and commitment of the population. The launch of a mass vaccination program in many countries in late December 2020 with mRNA vaccines, adenovirus-based vaccines, and inactivated virus vaccines has generated hope for the end of the pandemic. Current Issues The continuous appearance of new pathogenic viral strains and the ability of vaccines to prevent infection and transmission raise important concerns as we try to achieve community immunity against severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) and its variants. The need of a second and even third generation of vaccines has already been acknowledged by the WHO and governments. Perspectives There is a critical and urgent need for a balanced and integrated strategy for the management of the COVID-19 outbreaks organized on three axes: (1) P revention of the SARS-CoV-2 infection, (2) Detection and early diagnosis of patients at risk of disease worsening, and (3) Anticipation of medical care (PDA). Conclusion The PDA strategy integrated into state policy for the support and expansion of health systems and introduction of digital organizations (i.e., telemedicine, e-Health, artificial intelligence, and machine-learning technology) is of major importance for the preservation of citizens' health and life world-wide.Copyright © 2021 Georg Thieme Verlag. All rights reserved.

Published
2021

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