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4. Factors at Admission Associated With Bleeding Risk in Medical Patients: Findings From the IMPROVE Investigators

Author

Decousus, Hervé, Tapson, Victor F., Bergmann, Jean-François, Chong, Beng H., Froehlich, James B., Kakkar, Ajay K., Merli, Geno J., Monreal, Manuel, Nakamura, Mashio, Pavanello, Ricardo, Pini, Mario, Piovella, Franco, Spencer, Frederick A., Spyropoulos, Alex C., Turpie, Alexander G.G., Zotz, Rainer B., FitzGerald, Gordon, and Anderson, Frederick A.

Published
2011
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10. Extended prophylaxis of venous thromboembolism with idraparinux

Author

Buller, Harry R., Cohen, Ander T., Davidson, Bruce, Decousus, Herve, Gallus, Alex S., Gent, Michael, Pillion, Gerard, Piovella, Franco, Prins, Martin H., and Raskob, Gary E.

Subjects
Thrombophlebitis -- Risk factors, Hemorrhage -- Risk factors, Vitamin K -- Health aspects
Abstract

The efficiency and the safety of a continuous use of vitamin K for prophylaxis against the venous thromboembolism with idraparinux in various patients were examined. The results showed that though idraparinux helps in preventing recurrent thromboembolism, it also increases the risks of a major hemorrhage.

Published
2007

11. Idraparinux versus standard therapy for venous thromboembolic disease

Author

Buller, Harry R., Cohen, Ander T., Davidson, Bruce, Decousus, Herve, Gal, Alex S., Gent, Michael, Pillion, Gerard, Piovella, Franco, Prins, Martin H., and Raskob, Gary E.

Subjects
Thrombophlebitis -- Drug therapy, Anticoagulants (Medicine) -- Health aspects
Abstract

The use of idraparinux, a long-acting inhibitor of activated factor X, instead of the standard therapy of treating the venous thromboembolic disease is investigated. The analysis reveals that idraparinux is less effective than the standard therapy for patients with pulmonary embolism.

Published
2007

13. Venous Thromboembolism Prophylaxis in Acutely Ill Hospitalized Medical Patients*: Findings From the International Medical Prevention Registry on Venous Thromboembolism

Author

Tapson, Victor F., Decousus, Hervé, Pini, Mario, Chong, Beng H., Froehlich, James B., Monreal, Manuel, Spyropoulos, Alex C., Merli, Geno J., Zotz, Rainer B., Bergmann, Jean-François, Pavanello, Ricardo, Turpie, Alexander G.G., Nakamura, Mashio, Piovella, Franco, Kakkar, Ajay K., Spencer, Frederick A., FitzGerald, Gordon, and Anderson, Frederick A., Jr

Published
2007
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14. Enoxaparin plus compression stockings compared with compression stockings alone in the prevention of venous thromboembolism after elective neurosurgery

Author

Agnelli, Giancarlo, Piovella, Franco, Buoncristiani, Pio, Severi, Paolo, Pini, Mario, D'Angelo, Armando, Beltrametti, Chiara, Damiani, Marcello, Andrioli, Gian Carlo, Pugliese, Raffaelino, Iorio, Alfonso, and Brambilla, Gianluigi

Subjects
Thromboembolism -- Prevention, Enoxaparin -- Evaluation
Abstract

The drug enoxaparin plus compression stockings is more effective in preventing venous thromboembolism than compression stockings alone. Venous thromboembolism occurs when a blood clot forms in large veins and travels to another part of the body. Researchers randomly assigned 307 surgical patients to receive either compression stockings alone or stockings plus enoxaparin, which is a form of low-molecular-weight heparin. The drug cut the risk of thromboembolism in half and did not increase the risk of bleeding.

Published
1998

18. Treatment of venous thrombosis with intravenous unfractionated heparin administered in the hospital as compared with subcutaneous low-molecular-weight heparin administered at home

Author

Koopman, Maria M.W., Prandoni, Paolo, Piovella, Franco, Ockelford, Paul A., Brandjes, Desiderius P.M., Meer, Jan van der, Gallus, Alexander S., Simonneau, Gerald, Chesterman, Colin H., Prins, Martin H., Bossuyt, Patrick M.M., Haes, Hanneke de, Belt, Angelique G.M. van den, Sagnard, Luc, d'Azemar, Pascal, and Buller, Harry R.

Subjects
Venous thrombosis -- Drug therapy, Heparin -- Health aspects
Abstract

Low-molecular-weight heparin appears to offer safe and effective home treatment for deep leg vein clots. Researchers randomly assigned 400 patients with proximal deep-vein clots and no other complications to either the traditional in-hospital intravenous treatment with standard heparin or twice-daily injections of low-molecular-weight heparin administered by the patient or a family member at home. Questionnaires assessed quality of life. During the 24-week follow-up period, 9% of the hospital group versus 7% of the home treatment group experienced a recurrent, symptom-causing clot. Two percent of patients in the hospital group had a hemorrhage versus 0.5% of the home treatment group. Fifteen patients in the hospital group versus 27 patients in the home treatment group had minor bleeding. The hospital group averaged 8 days in the hospital versus 3 days for the home treatment group. The home treatment group scored higher in physical activity and social functioning.

Published
1996

22. Travel and risk of venous thrombosis

Author

Kraaijenhagen, Roderik A, Haverkamp, Daniël, Koopman, Maria M W, Prandoni, Paolo, Piovella, Franco, and Büller, Harry R

Published
2000

24. Low-molecular-weight heparins and unfractionated heparin in the treatment of patients with acute venous thromboembolism: results of a meta-analysis

Author

Siragusa, Sergio, Cosmi, Benilde, Piovella, Franco, Hirsh, Jack, and Ginsberg, Jeffrey S.

Subjects
Heparin -- Evaluation, Thrombophlebitis -- Drug therapy, Health, Health care industry
Abstract

PURPOSE: To obtain reliable estimates of the relative efficacy and safety of low-molecular-weight heparins (LMWHs) and unfractionated heparin (UFH) in the treatment of patients with venous thromboembolism. METHODS: A literature search of randomized trials evaluating LMWH and UFH for the period from 1980 to 1994 was conducted to obtain data for a meta-analysis. Studies were classified as level I if they were double-blind or if there was blinded assessment of outcome measures, and level 2 if they did not provide assurance of blinded outcome assessment. RESULTS: In level 1 studies, the relative risk (RR) of recurrent venous thromboembolism during the first 15-days and over the entire period of anticoagulant therapy was 0.24 (95% confidence intervals [Cl] 0.06 to 0.80, P= 0.02) and 0.39 (95% Cl 0.30 to 0.80, P = 0.006), respectively, in favor of LMWH treatment. The RR for major bleeding was 0.42 (95% Cl 0.2 to 0.9, P = 0.01), in favor of LMWH. In level 2 studies, no significant differences in the rates of recurrent venous thromboembolism or major bleeding were observed. Pooling level I and level 2 studies, the RR for overall mortality and mortality in cancer patients was 0.51 (95% Cl 0.2 to 0.9, P = 0.01) and 0.33 (95% Cl 0.1 to 0.8, P = 0.01), respectively, in favor of LMWH. CONCLUSIONS: LMWH are likely to be more effective than UFH in preventing recurrent venous thromboembolism, to produce less major bleeding, and to be associated with a lower mortality rate, particularly in the subgroup of patients with cancer.

Published
1996

26. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients

Author

Engelbrecht, J., Finfer, S., Van Dyk, C., Cohen, Alexander, Grandes, J., Cepeda, J. M., NAZLIEL, BİJEN, Cohen, Alexander T., Efrati, S., Zakai, N., Yousef, K., Wichman, T., Whitman, B., Welker, J., Welch, M., Warner, A., Updegrove, J., Tuck, M., Stoltz, S., Sokol, S., Sharma, S., Shammas, N., Saba, F., Rodriguez, W., Rees, C., Rastogi, P., Rajan, R., Quintana, O., Pullman, J., Pratt, R., Pineda, L., Pearl, R., Parthiban, K., Overcash, J., Ortel, T., Ohaju, V., Nadar, V., Mittal, M., Milling, T., McLaren, G., Margolis, B., Mahal, S., Macchiavelli, A., Lopez, J., Lerner, R., Kung, M., Kouras, F., Kazimir, M., Kao, C-K., Kabler, H., Ioachimescu, O., Hazelrigg, M., Hamad, A., Haidar, A., Hahn, B., Goytia-Leos, D., Gaggin, H., Fulmer, J., Fraiz, J., Fermann, G., Farley, B., Doshi, A., Dhingra, R., Cornell, J., Concha, M., Clark, C., Chang, H., Carman, T., Bidair, M., Bercz, P., Bastani, A., Barney, J., Baker, S., Anderson, C., Amin, M., Almasri, E., Natarajan, I., McCollum, C., MacCallum, P., Davis, M., Body, R., Yagensky, A., Voronkov, L., Vishnivestsky, I., Vakaliuk, I., Ursol, G., Tseluyko, V., Svyshchenko, Y., Svyridova, I., Ryabichenko, T., Rudenko, L., Alekniene, B., Reshotko, D., Perepeliuk, M., Parkhomenko, O., Nikonov, V., Maslovaskyi, V., Malynovsky, Y., Legkonogov, O., Kyrychenko, I., Krakhmalova, O., Koshlia, V., Kopytsya, M., Karpenko, O., Gryb, V., Goncharova, Y., Goloborodko, B., Goloborodko, A., Godlevska, O., Burmak, I., Brozhyk, J., Batushkin, V., Abrahamovych, O., Tuncay, E., Topcuoglu, M., Tigen, K., Okumus, G., Kutluk, H., Kirma, C., Kilichesmez, K., Guneri, S., Akgul, O., Villalta, J., Vargas Nunez, J. A., Trujillo, J., Riera, A., Richart, C., Mellibovsky, L., Jimenez, D., Gonzales-Porras, J. R., Gomez Cerezo, J., Ferrer, R., Diaz Santos, E., Cereto, F., Castro Guardiola, A., Bisbe, J., Barbagelata Lopez, C., Alvarez Sala, L. A., Mitha, I., Breedt, J., Basson, M., Adler, D., Spisakova, M., Prokop, D., Payer, J., Krastev, G., Kokles, M., Hrubon, A., Herman, O., Dvorak, M., Cervenakova, A., Bodikova, S., Miloradovic, V., Kovacevic-Kuzmanovic, A., Ilic, S., Celic, V., Apostolovic, S., Vishnevskiy, A., Vishneva, E., Solovyov, O., Simanenkov, V., Shvarts, Y., Shpagina, L., Shapovalova, Y., Sergeeva, E., Reshetko, O., Privalova, E., Popov, D., Nilk, R., Nikolaev, K., Mordovin, V., Maslova, N., Martynenko, V., Martynenko, T., Malygin, A., Kostenko, V., Kosmacheva, E., Kobalava, Z., Klein, G., Khachatryan, N., Goloshchekin, B., Ershova, O., Dovgalevskiy, Y., Chefranova, Z., Boldueva, S., Bogdanov, E., Belskaya, G., Barbarash, O., Averkov, O., Arkhipov, M., Apartsin, K., Andreev, D., Abashev, A., Vida-Simiti, L., Stanciulescu, G., Stamate, S., Harrington, Robert A., Goldhaber, Samuel Z., Hull, Russell D., Popescu, M., Wiens, Brian L., Gold, Alex, Hernandez, Adrian F., Gibson, C. Michael, Harrington, Robert, Hull, Russell, Goldhaber, Samuel, Hernandez, Adrian, Ceresetto, Jose Manuel, Colquhoun, David, Pilger, Ernst, Polonetsky, Leonid, Podoleanu, C., Musetescu, R., Marin, I., Bojinca, M., Motte, Serge, Saraiva, Jose Francisco, Balogh, Z. E., Wrzesinski, K., Waldemar, K., Walasek, L., Raev, Dimitar, Mincheva, Valentina, Kahn, Susan, Sulik, P., Canon, Claudia Olivares, Malojcic, Branko, Mayer, Otto, Husted, Steen, Marandi, Toomas, Lassila, Riitta, Mottier, Dominique, Shaburishvili, Tamaz, Bauersachs, Rupert, Zeymer, Uwe, Hajko, Erik, Sobkowicz, B., Zeltser, David, Ageno, Walter, Krievins, Dainis, Bagdonas, Alfredas, Osores, Juan Lema, Tomkowski, Witold, Mot, Stefan, Panchenko, Elizaveta, Tan, Ru San, Gaspar, Ludovit, Jacobson, Barry, Monreal, Manuel, Ongen, Gul, Parkhomenko, Alexander, Uprichard, James, Pulkowski, G., Mirek-Bryniarska, E., Kucharski, L., Jastrzebski, D., Yusen, Roger, Grzelakowski, P., Merli, Geno, Gruenpeter, P., Gorecka, D., Gniot, J., Gaciong, Z., Fryze, W., Peacock, Frank, Schellong, Sebastian, Januzzi, James, Piovella, Franco, Cochet, Madeleine, Michalak, Nathan, Stepanchak, Maria, Spielman, Kathryn, Neal, Brandon, Florea, Ana, Chi, Gerald, Szlosek, Donald, Jain, Purva, Popma, Christopher, Korjian, Serge, Daaboul, Yazan, Halaby, Rim, Yanez, L. Toche, Lemor, Alejandro, Zacarkim, Marcelo, Romero, Gonzalo, Hernandez Elenes, Jesus Rosario, Alvarado, Alonso, Susheela, Ammu, Leitao, Meghan, Salas, M., Bandman, Olga, Horna, M., Strumph, Peter, Vinh, Nancy, Visona, A., Kostadinova, M., Vance, Annemarie, Moia, M., Wiens, Brian, Orlandini, F., Parisi, R., Pontaga, N., Smoak, Carey, Storgaard, M., Molteni, M., Castelino, Rennie, Goodman, Shelly, Stukena, I., Leeds, Janet, al-Khalidi, Hussein, Milanova, M., Karlo, L. Farjardo, Leimberger, Jeffrey, Phillips, Thomas, Rizos, T., Pencheva, G., Pomero, F., Francis, Charles, Novo, S., Pereyra, R. Cotrina, Tiefenbacher, C., Buller, Harry, Roberts, Robin, Prins, Martin, Weimar, C., Tuxen, C., Urhammer, S., Lember, M., Runev, N., Uuetoa, T., Spyropoulos, Alex, Carrier, Marc, Alkonyi, B., Lopes, Renato D., Horacek, T., Airaksinen, J., Honkaniemi, J., Pottier, P., Falukozy, J., Kaaja, R., Stoeva, N., Saarinen, J., Stoyanov, M., Pizzini, A., Devor, Adam, Tatlisumak, T., Kolls, Bradley, Dedrick, Joseph, Todd, Jamie, Jones, William Schuyler, Vikman, S., Agraou, B., Futo, L., Castillo Leon, R., Eapen, Zubin, Katona, A., Proust, A., Quere, I., Kirschner, R., Syulemzova, S., Valavicius, A., Todorov, G., Tokmakova, M., Dhar, A., Klimpe, S., Ahmad, Tariq, Brenna, J. Matthew, Douketis, J., Le Gal, G., Pearce, M., Susinskiene, D., Brito, Flavio, Provencher, S., Rozitis, V., Roy, P-M., Kroning, R., Gulack, Brian, Schmidt, J., Meza, James, Parikh, Kishan, Cooper, Lauren, Poskiene, R., Aquilanti, S., Lapp, H., Kristof, P., Lakatos, F., Laszlo, Z., Belhassane, A., Petrauskiene, R., Pagidipati, Neha, Simoneau, G., Verreault, S., Guimaraes, Patricia, Brisot, D., Perkins, Lynn M., De Geeter, G., Debourdeau, P., Alarcon, M. Arias, Lupkovics, G., Norviliene, R., Wilson, Matthew, Merkely, B., Lazcano, M. Opazo, Collier, Jeannie, Andras, C. Nagy, Cardenas, S. Potthoff, Butkovic-Soldo, S., Norvaisiene, R., Decoulx, E., Hayden, Nikieia, El Kouri, D., Car, S., Nemeth, L., Leizorovicz, Alain, Ciglenecki, N., Naudziunas, A., Datikashvili-David, I., Francetic, I., Jakopovic, M., Becker, Francois, Jennings, Lisa, Khabeishvili, G., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Griskeviciene, V., Kalinic-Grgorinic, H., Falvo, N., Khintibidze, I., Grange, C., Kobulia, B., Knezevic, A., Megreladze, I., Marusic, S., Papp, A., Pagava, Z., Lawall, H., Oliva, M., Paposhvili, K., Parody, M., Amann, B., Soltesz, P., Sudar, Z., Butkiene, Z., Szabo, G., Vagic, J. Sikic, Szegedi, N., Poy, C., Timar, G., Skerk, V., Cermak, O., Valco, J., Baker, R., Coughlin, P., Vertes, A., Rubinfeld, A., Elias, M., Berrouschot, J., Gafter, A., Hayek, T., Chlumsky, J., Lacroix, P., Messas, E., Chochola, J., Cizek, V., Basijokiene, V., Hussein, O., Dunaj, M., Dusek, J., Huber, K., Lishner, M., Lugassy, G., Cerveri, I., D'Angelo, A., De Pellegrin, A., Francek, L., Havelka, J., Konig, J., Beyer-Westendorf, J., Herold, M., Holaj, R., Imberti, D., Landolfi, R., Blessing, E., Mathies, R., Schoenerr, H., Adzerikho, I., Koryk, V., Licka, M., Martinova, V., Horny, I., Mikhailova, E., Mitkovskaya, N., Pimanov, S., Polonetsy, L., Soroka, N., Blockmans, D., Delforge, M., Dive, A., Lienart, F., Bizzacchi, J. Annichino, Fiss, E., Mismetti, P., Freire, A., Hubac, J., Jajtner, P., Manenti, E., Ramacciotti, E., Lembo, G., Raymuno, S., Rocha, A., Kolman, P., Lang, P., Bott, M., Dengler, T., Mikulova, J., Dimov, B., Podpera, I., Reiterer, P., Dziewas, R., Montaclair, K., Genth-Zotz, S., Hamann, F., Paleiron, N., Spacek, R., Payot, L., Vejvoda, J., Vyhnanek, M., Christensen, H., Salvi, A., Lodigiani, C., Pernod, G., Grigorov, M., Lassen, M., Mumoli, N., Kalpachki, R., Kamenova, Z., Schenone, A., Guy's and St Thomas' Hospital [London], Stanford Medicine, Stanford University, Brigham and Women's Hospital [Boston], Thrombosis Research Unit, University of Calgary, Portola Pharmaceuticals (Portola), PORTOLA PHARMACEUTICALS, Division of Cardiology, Duke University Medical Center, Duke Clinical Research Institute (DCRI - DURHAM), Duke University [Durham], Beth Israel Deaconess Medical Center [Boston, USA], Harvard Medical School [Boston] (HMS), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), and Université de Brest (UBO)-Université de Brest (UBO)

Subjects
Male, Pyridines, Medizin, 030204 cardiovascular system & hematology, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Risk Factors, law, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, Ultrasonography, Venous Thrombosis, Factors de risc en les malalties, Medicine (all), Acute Disease, Adult, Aged, Benzamides, Double-Blind Method, Drug Administration Schedule, Factor Xa Inhibitors, Female, Fibrin Fibrinogen Degradation Products, Hemorrhage, Hospitalization, Humans, Middle Aged, Pulmonary Embolism, Venous Thromboembolism, General Medicine, 3. Good health, Pulmonary embolism, Venous thrombosis, Cohort, medicine.medical_specialty, Patients, Risk factors in diseases, Placebo, 03 medical and health sciences, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Internal medicine, Thromboembolism, medicine, Pacients, Betrixaban, Thromboprophylaxis, Acutely Ill Medical Patients, Tromboembolisme, business.industry, Settore MED/09 - MEDICINA INTERNA, ta3121, Population cohort, medicine.disease, Surgery, chemistry, Once daily, business
Abstract

Background\ud Patients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown.\ud \ud Methods\ud Patients who were hospitalized for acute medical illnesses were randomly assigned to receive subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days plus oral betrixaban placebo for 35 to 42 days or subcutaneous enoxaparin placebo for 10±4 days plus oral betrixaban (at a dose of 80 mg once daily) for 35 to 42 days. We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients with an elevated d-dimer level (cohort 1), patients with an elevated d-dimer level or an age of at least 75 years (cohort 2), and all the enrolled patients (overall population cohort). The statistical analysis plan specified that if the between-group difference in any analysis in this sequence was not significant, the other analyses would be considered exploratory. The primary efficacy outcome was a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism. The principal safety outcome was major bleeding.\ud \ud Results\ud A total of 7513 patients underwent randomization. In cohort 1, the primary efficacy outcome occurred in 6.9% of patients receiving betrixaban and 8.5% receiving enoxaparin (relative risk in the betrixaban group, 0.81; 95% confidence interval [CI], 0.65 to 1.00; P=0.054). The rates were 5.6% and 7.1%, respectively (relative risk, 0.80; 95% CI, 0.66 to 0.98; P=0.03) in cohort 2 and 5.3% and 7.0% (relative risk, 0.76; 95% CI, 0.63 to 0.92; P=0.006) in the overall population. (The last two analyses were considered to be exploratory owing to the result in cohort 1.) In the overall population, major bleeding occurred in 0.7% of the betrixaban group and 0.6% of the enoxaparin group (relative risk, 1.19; 95% CI, 0.67 to 2.12; P=0.55).\ud \ud Conclusions\ud Among acutely ill medical patients with an elevated d-dimer level, there was no significant difference between extended-duration betrixaban and a standard regimen of enoxaparin in the prespecified primary efficacy outcome. However, prespecified exploratory analyses provided evidence suggesting a benefit for betrixaban in the two larger cohorts. (Funded by Portola Pharmaceuticals; APEX ClinicalTrials.gov number, NCT01583218. opens in new tab.)

Published
2016

28. Idraparinux versus standard therapy for venous thromboembolic disease

Author

Renseigné, Non, Buller, Harry R, Cohen, Ander T, Davidson, Bruce, Decousus, Hervé, Gallus, Alex S, Gent, Michael, Pillion, Gerard, Piovella, Franco, Prins, Martin H, Raskob, Gary E, Architectures, Languages and Compilers to Harness the End of Moore Years (ALCHEMY), Laboratoire de Recherche en Informatique (LRI), Université Paris-Sud - Paris 11 (UP11)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Université Paris-Sud - Paris 11 (UP11)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Inria Saclay - Ile de France, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), Groupe de recherche sur la thrombose (GRT (EA 3065)), Université Jean Monnet [Saint-Étienne] (UJM), Cluster Infectious Diseases, Amsterdam BioMed Cluster, ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, Groupe de recherche sur la thrombose, pharmacologie des antithrombotiques et situations à risque (GRT), and Université Jean Monnet - Saint-Étienne (UJM)

Subjects
Male, MESH: Pulmonary Embolism, Vitamin K, MESH: Heparin, Idraparinux, Oligosaccharides, 030204 cardiovascular system & hematology, 0302 clinical medicine, Recurrence, MESH: Incidence, 030212 general & internal medicine, MESH: Treatment Outcome, Venous Thrombosis, MESH: Middle Aged, Incidence, Hazard ratio, MESH: Follow-Up Studies, General Medicine, Heparin, Middle Aged, Vitamin K antagonist, Thrombosis, 3. Good health, Pulmonary embolism, Venous thrombosis, Treatment Outcome, Anesthesia, Female, MESH: Hemorrhage, medicine.drug, medicine.drug_class, Hemorrhage, MESH: Anticoagulants, 03 medical and health sciences, medicine, Humans, MESH: Humans, business.industry, Anticoagulants, MESH: Vitamin K, Odds ratio, medicine.disease, MESH: Male, MESH: Recurrence, MESH: Venous Thrombosis, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Pulmonary Embolism, business, MESH: Female, MESH: Oligosaccharides, Follow-Up Studies
Abstract

International audience; BACKGROUND: Venous thromboembolism is treated with unfractionated heparin or low-molecular-weight heparin, followed by a vitamin K antagonist. We investigated the potential use of idraparinux, a long-acting inhibitor of activated factor X, as a substitute for standard therapy. METHODS: We conducted two randomized, open-label noninferiority trials involving 2904 patients with deep-vein thrombosis and 2215 patients with pulmonary embolism to compare the efficacy and safety of idraparinux versus standard therapy. Patients received either subcutaneous idraparinux (2.5 mg once weekly) or a heparin followed by an adjusted-dose vitamin K antagonist for either 3 or 6 months. The primary efficacy outcome was the 3-month incidence of symptomatic recurrent venous thromboembolism (nonfatal or fatal). RESULTS: In the study of patients with deep venous thrombosis, the incidence of recurrence at day 92 was 2.9% in the idraparinux group as compared with 3.0% in the standard-therapy group (odds ratio, 0.98; 95% confidence interval [CI], 0.63 to 1.50), a result that satisfied the prespecified noninferiority requirement. At 6 months, the hazard ratio for idraparinux was 1.01. The rates of clinically relevant bleeding at day 92 were 4.5% in the idraparinux group and 7.0% in the standard-therapy group (P=0.004). At 6 months, bleeding rates were similar. In the study of patients with pulmonary embolism, the incidence of recurrence at day 92 was 3.4% in the idraparinux group and 1.6% in the standard-therapy group (odds ratio, 2.14; 95% CI, 1.21 to 3.78), a finding that did not meet the noninferiority requirement. CONCLUSIONS: In patients with deep venous thrombosis, once-weekly subcutaneous idraparinux for 3 or 6 months had an efficacy similar to that of heparin plus a vitamin K antagonist. However, in patients with pulmonary embolism, idraparinux was less efficacious than standard therapy. (ClinicalTrials.gov numbers, NCT00067093 [ClinicalTrials.gov] and NCT00062803 [ClinicalTrials.gov].).

Published
2007

32. Safety and efficacy of low-dose fondaparinux (1.5 mg) for the prevention of venous thromboembolism in acutely ill medical patients with renal impairment: the FONDAIR study

Author

Ageno, W, Riva, N., Noris, P., Di Nisio, M., La Regina, M., Arioli, D., Ria, L., Monzani, V., Cuppini, S., Lupia, E., Pierfranceschi, M. G., Dentali, Francesco, Ageno, Walter, Squizzato, Alessandro, Imberti, Davide, Pini, Mario, Di Nisio, Marcello, Silingardi, Mauro, Agnelli, Giancarlo, Riva, Nicoletta, Cavi, Raffaella, Moia, Marco, Piovella, Franco, and Palareti, Gualtiero

Subjects
Male, Renal failure, medicine.medical_specialty, Acute medical patients, Population, Venous thromboembolism, Prevention, Renal impairment, Fondaparinux, Renal function, Hemorrhage, Prophylaxis, Aged, Aged, 80 and over, Anticoagulants, Creatinine, Female, Humans, Incidence, Middle Aged, Polysaccharides, Prospective Studies, Pulmonary Embolism, Renal Insufficiency, Risk Factors, Treatment Outcome, Venous Thromboembolism, Venous Thrombosis, Hematology, Internal medicine, 80 and over, medicine, education, Prospective cohort study, Univariate analysis, education.field_of_study, business.industry, Incidence (epidemiology), Confidence interval, Surgery, business, medicine.drug
Abstract

Summary. Background: Renal impairment is common, affecting around 40% of acutely ill medical patients, and is associated with an increased risk of both venous thromboembolism (VTE) and bleeding. The clinical benefit of effective thromboprophylactic strategies may be outweighed in these patients by an excessive rate of hemorrhage. Objective: To assess the safety and efficacy of lower prophylactic doses of fondaparinux in acutely ill medical patients with renal impairment. Patients/Methods: We carried out a multicenter, investigator-initiated, prospective cohort study. Patients at risk of VTE with a creatinine clearance between 20 and 50 mL min−1 were treated with fondaparinux 1.5 mg qd for a minimum of 6 to a maximum of 15 days. The primary outcome was the incidence of major bleeding; secondary outcomes were clinically relevant non-major bleeding (CRNMB) and symptomatic VTE. Results: We enrolled 206 patients with a mean age of 82 years, mean creatinine clearance of 33 mL min−1, and a mean Charlson co-morbidity index of 8.2. One patient had major bleeding (0.49%, 95% confidence interval [CI] 0.03–3.10), eight had CRNMB (3.88%, 95% CI 1.81–7.78) and three developed symptomatic VTE (1.46%, 0.38–4.55). Twenty-three patients (11.17%, 7.36–16.48) died. No independent predictors of bleeding were found at univariate analysis. Conclusions: The addition of moderate to severe renal impairment to patients with traditional risk factors for VTE identified a population of very elderly acutely ill medical patients potentially at high risk of both VTE and bleeding complications. The recently approved lower prophylactic dose of fondaparinux appears to be a safe and relatively effective strategy in these patients.

Published
2012

36. Extended prophylaxis of venous thromboembolism with idraparinux

Author

Renseigné, Non, Buller, Harry R, Cohen, Ander T, Davidson, Bruce, Decousus, Hervé, Gallus, Alex S, Gent, Michael, Pillion, Gerard, Piovella, Franco, Prins, Martin H, Raskob, Gary E, Architectures, Languages and Compilers to Harness the End of Moore Years (ALCHEMY), Laboratoire de Recherche en Informatique (LRI), Université Paris-Sud - Paris 11 (UP11)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Université Paris-Sud - Paris 11 (UP11)-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Inria Saclay - Ile de France, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), Groupe de recherche sur la thrombose, pharmacologie des antithrombotiques et situations à risque (GRT), Université Jean Monnet - Saint-Étienne (UJM), Cluster Infectious Diseases, Amsterdam BioMed Cluster, Groupe de recherche sur la thrombose (GRT (EA 3065)), Université Jean Monnet [Saint-Étienne] (UJM), ACS - Amsterdam Cardiovascular Sciences, and Vascular Medicine

Subjects
Male, MESH: Pulmonary Embolism, Vitamin K, MESH: Factor Xa, Idraparinux, Oligosaccharides, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, 0302 clinical medicine, Secondary Prevention, Medicine, MESH: Double-Blind Method, 030212 general & internal medicine, MESH: Kaplan-Meiers Estimate, MESH: Treatment Outcome, Venous Thrombosis, MESH: Aged, MESH: Middle Aged, Incidence (epidemiology), Anticoagulant, General Medicine, MESH: Follow-Up Studies, Vitamin K antagonist, Middle Aged, 3. Good health, Pulmonary embolism, Venous thrombosis, Treatment Outcome, Anesthesia, Female, MESH: Hemorrhage, medicine.drug_class, Injections, Subcutaneous, Hemorrhage, MESH: Anticoagulants, MESH: Drug Administration Schedule, Placebo, Drug Administration Schedule, 03 medical and health sciences, Double-Blind Method, Recurrent thromboembolism, Humans, Aged, MESH: Humans, business.industry, MESH: Injections, Subcutaneous, Anticoagulants, MESH: Vitamin K, medicine.disease, MESH: Male, MESH: Recurrence, MESH: Venous Thrombosis, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, business, Pulmonary Embolism, MESH: Oligosaccharides, MESH: Female, Factor Xa Inhibitors, Follow-Up Studies
Abstract

International audience; BACKGROUND: The extended use of vitamin K antagonists for prophylaxis against venous thromboembolism is often constrained by risk-benefit limitations and inconvenience. We evaluated the efficacy and safety of a 6-month extension of prophylaxis against recurrent venous thromboembolism with idraparinux in patients who had initially received 6 months of prophylaxis with an anticoagulant. METHODS: We randomly assigned patients who had completed 6 months of prophylaxis with idraparinux or a vitamin K antagonist and in whom extended anticoagulation was warranted to receive once-weekly injections of 2.5 mg of idraparinux or placebo for 6 months without monitoring. The primary efficacy and safety outcomes were recurrent venous thromboembolism and major bleeding. RESULTS: Of 1215 patients, 6 of 594 (1.0%) in the idraparinux group and 23 of 621 (3.7%) in the placebo group had recurrent venous thromboembolism (P=0.002). Major bleeding occurred in 11 patients (1.9%) in the idraparinux group and in none in the placebo group (P

Published
2007

38. Acute pulmonary embolism: risk assessment, risk stratification and treatment options.

Author

Piovella, Franco and Iosub, Diana Irina

Subjects
*ADULT respiratory distress syndrome, *EMBOLISMS, *ANTITHROMBINS, *RISK assessment, *CARDIOVASCULAR agents, *ANTICOAGULANTS
Abstract

Introduction Pulmonary embolism ( PE) is a potentially life-threatening cardiovascular emergency with a high mortality rate. Rapid diagnosis and treatment are important in optimising clinical outcomes in patients with PE, and anticoagulants are the mainstay of treatment. Traditionally, anticoagulant therapy involves parenteral anticoagulants, overlapping with and followed by oral vitamin K antagonists. Direct oral anticoagulants ( DOACs), including the factor Xa inhibitors rivaroxaban, apixaban and edoxaban, and the direct thrombin inhibitor dabigatran etexilate, have been developed to address limitations associated with traditional anticoagulant therapy. Apixaban, dabigatran and rivaroxaban have recently been approved for the treatment of acute deep vein thrombosis ( DVT) and PE and prevention of recurrent DVT or PE. Edoxaban is approved in the United States but not currently in the European Union for the treatment of DVT and PE; approval of edoxaban in Europe is anticipated in the near future. Objective To summarise the management of patients with suspected PE in accordance with recent guidelines, and to discuss the evidence behind the recent approvals of the DOACs for the treatment of PE. Discussion Diagnosis and treatment of PE is guided by clinical probability scoring systems and tools for prognostic stratification and early mortality risk evaluation. Anticoagulants remain the mainstay of treatment. Successful phase III trials have demonstrated the efficacy of the DOACs for the treatment of DVT and PE, with a potentially improved safety profile, leading to their recent approval in this indication, and giving the clinician greater choice of anticoagulant therapies in this setting. Conclusions DOACs offer an alternative and potentially simplified option for anticoagulation therapy in patients with PE compared with traditional anticoagulants and are likely to assist physicians in optimising management of patients with PE and improve clinical outcomes. [ABSTRACT FROM AUTHOR]

Published
2016
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41. The Effect of Prothrombotic Blood Abnormalities on Risk of Deep Vein Thrombosis in Users of Hormone Replacement Therapy

Author

Douketis, Jim D., primary, Julian, Jim A., additional, Crowther, Mark A., additional, Kearon, Clive, additional, Bates, Shannon M., additional, Barone, Marisa, additional, Piovella, Franco, additional, Middeldorp, Saskia, additional, Prandoni, Paolo, additional, Johnston, Marilyn, additional, Costantini, Lorrie, additional, and Ginsberg, Jeffrey S., additional

Published
2010
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48. Efficacy of Fondaparinux in the Treatment of Heparin-Induced Thrombocytopenia with Venous Thromboembolism: Reduction of Thromboembolic Burden, Normalization of Platelet Count and Disappearance of Anti-Platelet Factor 4/Heparin Antibodies.

Author

Piovella, Franco, primary, Barone, Marisa, additional, Beltrametti, Chiara, additional, Piovella, Chiara, additional, D’Armini, Andrea M., additional, Marzani, Federico Capra, additional, Arici, Vittorio, additional, De Amici, Mara, additional, Barco, Stefano L., additional, Castellani, Gianluca, additional, and Langer, Martin, additional

Published
2006
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