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578 results on '"Margolis, B."'

2. The High Energy Behavior of the Forward Scattering Parameters---An Amplitude Analysis Update

Author

Block, M. M., White, A. R., and Margolis, B.

Subjects
High Energy Physics - Phenomenology
Abstract

Utilizing the most recent experimental data, we reanalyze high energy \pbar p and pp data, using the asymptotic amplitude analysis, under the assumption that we have reached `asymptopia'. This analysis gives strong evidence for a $\log \,(s/s_0)$ dependence at {\em current} energies and {\em not} $\log^2 (s/s_0)$, and also demonstrates that odderons are {\em not} necessary to explain the experimental data., Comment: 7 pages in LaTeX, 4 figures and 5 files, uuencoded in file "sigall.uu"

Published
1995

3. CP-Violation and the Quark Mass Matrices

Author

Margolis, B., Punch, S., and Hamzaoui, ; C.

Subjects
High Energy Physics - Phenomenology
Abstract

We study a class of quark mass matrix models with the $\cal CP$-violating phase determined through making the $\cal CP$-violating parameter $J$ an extremum. These models assume that $m_u \ll m_c \ll m_t$ and that $m_d \ll m_s \ll m_b$. They have $\left|{V_{ub}\over{V_{cb}}}\right|\approx{\sqrt{m_u \over{m_c}}}$, $\left|{V_{td}\over{V_{ts}}}\right|\approx{\sqrt{m_d \over{m_s}}}$ and $|V_{us}|\approx|V_{cd}|\approx{\sqrt{{m_d \over{m_s}}+{m_u \over{m_c}}}}$. The Wolfenstein parameters $\rho$ and $\eta$ are found to be related by $\rho\approx\eta^2$. Finally, we examine a special class of such models where the masses are constrained to be roughly in geometric progression. Further application of the extremal condition to $J$ then leads to ${\sqrt{m_d \over{m_s}}}\approx 3{\sqrt{m_u \over{m_c}}}$ and hence $\eta\approx\frac{1}{3}$, for maximal $J$., Comment: 7 pages, PostScript; uuencoded, compressed

Published
1995

4. The High Energy Behavior of the Forward Scattering Parameters \sigma total $\rho$, and $B$

Author

Block, M. M., Halzen, F., Margolis, B., and White, A. R.

Subjects
High Energy Physics - Phenomenology
Abstract

Utilizing the most recent experimental data, we reanalyze high energy \pbar p and pp data, using two distinct (and {\em dissimilar}) analysis techniques: (1) asymptotic amplitude analysis, under the assumption that we have reached `asymptopia', and (2) an eikonal model whose amplitudes are designed to mimic real QCD amplitudes. The former gives strong evidence for a $\log \,(s/s_0)$ dependence at {\em current} energies and {\em not} $\log^2 (s/s_0)$, and demonstrates that odderons are {\em not} necessary to explain the experimental data. The latter gives a unitary model for extrapolation into true `asymptopia' from current energies, allowing us to predict the values of the total cross section at future supercolliders. Using our QCD-model, we obtain $\stot(16\,\, {\rm TeV})=109\pm4$\,mb and $\stot(40\,\, {\rm TeV})=124\pm4$\,mb., Comment: 14 pages in latex, 8 figures included as a uuencoded file (NUHEP preprint 389)

Published
1994

5. Quark model calculation of $\eta \to l^+ l^-$ to all orders in the bound state relative momentum

Author

Margolis, B., Ng, J., Phipps, M., and Trottier, H. D.

Subjects
High Energy Physics - Phenomenology
Abstract

The electromagnetic box diagram for the leptonic decays of pseudoscalar mesons in the quark model is evaluated to all orders in ${\bf p} / m_q$, where ${\bf p}$ is the relative three-momentum of the quark-antiquark pair and $m_q$ is the quark mass. We compute $B_P \equiv \Gamma(\eta \to l^+ l^-) / \Gamma(\eta \to \gamma\gamma)$ using a popular nonrelativistic (NR) harmonic oscillator wave function, and with a relativistic momentum space wave function that we derive from the MIT bag model. We also compare with a calculation in the limit of extreme NR binding due to Bergstr\"om. Numerical calculations of $B_P$ using these three parameterizations of the wave function agree to within a few percent over a wide kinematical range. We find that the quark model leads in a natural way to a negligible value for the ratio of dispersive to absorptive parts of the electromagnetic amplitude for $\eta \to \mu^+ \mu^-$ (unitary bound). However we find substantial deviations from the unitary bound in other kinematical regions, such as $\eta,\pi^0 \to e^+ e^-$. These quark models yield $B(\eta \to \mu^+\mu^-) \approx 4.3 \times 10^{-6}$, within errors of the recent SATURNE measurement of $5.1 \pm 0.8 \times 10^{-6}$, $B(\eta \to e^+ e^-) \approx 6.3 \times 10^{-9}$, and $B(\pi^0 \to e^+ e^-) \approx 1.0 \times 10^{-7}$., Comment: 17 pages REVTEX. Postscript figures appended

Published
1992
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6. Can perturbative QCD predict a substantial part of diffractive LHC/SSC physics?

Author

Cudell, J. R. and Margolis, B.

Subjects
High Energy Physics - Phenomenology
Abstract

We examine a model of hadronic diffractive scattering which interpolates between perturbative QCD and non-perturbative fits. We restrict the perturbative QCD resummation to the large transverse momentum region, and use a simple Regge-pole parametrization in the infrared region. This picture allows us to account for existing data, and to estimate the size of the perturbative contribution to future diffractive measurements. At LHC and SSC energies, we find that a cut-off BFKL equation can lead to a measurable perturbative component in traditionally soft processes. In particular, we show that the total pp cross section could become as large as 228 mb (160 mb) and the rho parameter as large as 0.23 (0.24) at the SSC (LHC)., Comment: 9 pages, McGill/92-37

Published
1992
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7. Perturbative QCD Corrections to the Soft Pomeron

Author

Cudell, J. R. and Margolis, B.

Subjects
High Energy Physics - Phenomenology
Abstract

We study the interface between soft and hard QCD at high energy and small momentum transfer. At LHC and SSC energies, we find that a cutoff BFKL equation leads one to expect a measurable perturbative component in traditionally soft processes. We show that the total cross section could become as large as 175 mb (122 mb) and the rho parameter 0.40 (0.25) at the SSC (LHC)., Comment: 10 pages, McGill/92--24

Published
1992

9. Function of PTB Domains

Author

Borg, J-P., Margolis, B., Compans, R. W., editor, Cooper, M., editor, Hogle, J. H., editor, Ito, Y., editor, Koprowski, H., editor, Melchers, F., editor, Oldstone, M., editor, Olsnes, S., editor, Potter, M., editor, Saedler, H., editor, Vogt, P. K., editor, Wagner, H., editor, and Pawson, Anthony J., editor

Published
1998
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22. Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients

Author

Legkonogov, O., Ramacciotti, E., Mikhailova, E., Koryk, V., Adzerikho, I., Schoenerr, H., Mathies, R., Konig, J., Huber, K., Rubinfeld, A., Finfer, S., Manenti, E., Bott, M., Blessing, E., Beyer-Westendorf, J., Coughlin, P., Baker, R., Poy, C., Dengler, T., Parody, M., Oliva, M., Macin, S., Jure, H., Ferrari, A. E., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Mitkovskaya, N., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Tiefenbacher, C., Weimar, C., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Berrouschot, J., Kirschner, R., Amann, B., Paposhvili, K., Pagava, Z., Kristof, P., Lakatos, F., Laszlo, Z., Freire, A., Lupkovics, G., Megreladze, I., Kobulia, B., Khintibidze, I., Khabeishvili, G., Datikashvili-David, I., Simoneau, G., Merkely, B., Andras, C. Nagy, Nemeth, L., Papp, A., Soltesz, P., Fiss, E., Schmidt, J., Roy, P-M., Quere, I., Proust, A., Pottier, P., Pernod, G., Payot, L., Bizzacchi, J. Annichino, Lienart, F., Paleiron, N., Montaclair, K., Mismetti, P., Messas, E., Lacroix, P., Grange, C., Falvo, N., El Kouri, D., Decoulx, E., Debourdeau, P., De Geeter, G., Brisot, D., Belhassane, A., Aquilanti, S., Agraou, B., Vikman, S., Tatlisumak, T., Saarinen, J., Kaaja, R., Honkaniemi, J., Airaksinen, J., Uuetoa, T., Lember, M., Urhammer, S., Tuxen, C., Storgaard, M., Lassen, M., Christensen, H., Vyhnanek, M., Vejvoda, J., Spacek, R., Reiterer, P., Podpera, I., Mikulova, J., Lang, P., Jajtner, P., Hubac, J., Horny, I., Holaj, R., Herold, M., Havelka, J., Francek, L., Dusek, J., Dunaj, M., Cizek, V., Chochola, J., Chlumsky, J., Cermak, O., Skerk, V., Vagic, J. Sikic, Marusic, S., Knezevic, A., Kalinic-Grgorinic, H., Jakopovic, M., Francetic, I., Ciglenecki, N., Car, S., Butkovic-Soldo, S., Cardenas, S. Potthoff, Lazcano, M. Opazo, Alarcon, M. Arias, Verreault, S., Provencher, S., Pearce, M., Le Gal, G., Douketis, J., Dhar, A., Tokmakova, M., Todorov, G., Syulemzova, S., Raymuno, S., Rocha, A., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Bello, F., Harrington, Robert A., Bandman, Olga, Kostadinova, M., Milanova, M., Dive, A., Pencheva, G., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Delforge, M., Vertes, A., Efrati, S., Elias, M., Gafter, A., Nazliel, BİJEN, Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Runev, N., Lembo, G., Lodigiani, C., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Stoeva, N., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Gold, Alex, Visona, A., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Stoyanov, M., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Pimanov, S., Polonetsy, L., Pereyra, R. Cotrina, Karlo, L. Farjardo, Horna, M., Soroka, N., Salas, M., Yanez, L. Toche, Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Walasek, L., Blockmans, D., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Popov, D., Privalova, E., Reshetko, O., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Bodikova, S., Cervenakova, A., Dvorak, M., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Mitha, I., Van Dyk, C., Alvarez Sala, L. A., Barbagelata Lopez, C., Bisbe, J., Castro Guardiola, A., Cepeda, J. M., Cereto, F., Diaz Santos, E., Ferrer, R., Gomez Cerezo, J., Hernandez, Adrian F., Gonzales-Porras, J. R., Grandes, J., Cohen, Alexander T., Gibson, C. Michael, Chi, Gerald, Halaby, Rim, Korjian, Serge, Daaboul, Yazan, Jain, Purva, Arbetter, Douglas, Goldhaber, Samuel Z., Hull, Russel, Jimenez, D., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Vargas Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Okumus, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., 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., Koshlia, V., Fraiz, J., Krakhmalova, O., 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., Kyrychenko, I., Svyshchenko, Y., Svyridova, I., Ryabichenko, T., Rudenko, L., Reshotko, D., Perepeliuk, M., Parkhomenko, O., Nikonov, V., Maslovaskyi, V., Malynovsky, Y., Sergeeva, E., and Kolman, P.

Subjects
Male, medicine.medical_specialty, Pyridines, Intracranial Hemorrhages, 030204 cardiovascular system & hematology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Medical illness, Physiology (medical), medicine, Humans, 030212 general & internal medicine, Enoxaparin, Intensive care medicine, Stroke, Aged, business.industry, Anticoagulants, Venous Thromboembolism, medicine.disease, Thrombosis, chemistry, Betrixaban, Benzamides, Emergency medicine, Female, Cardiology and Cardiovascular Medicine, business, Complication, Venous thromboembolism
Abstract

Background: Stroke is a morbid and potentially mortal complication among patients hospitalized with acute medical illness. The potential of extended-duration thromboprophylaxis with the factor Xa inhibitor betrixaban to reduce the risk of stroke compared with standard-dose enoxaparin in this population was assessed in this retrospective APEX trial substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban). Methods: Hospitalized acutely medically ill subjects (n=7513) were randomized in a double-dummy double-blind fashion to either extended-duration oral betrixaban (80 mg once daily for 35–42 days) or standard-dose subcutaneous enoxaparin (40 mg once daily for 10±4 days) for venous thromboprophylaxis. Stroke events were adjudicated by an independent, blinded event adjudication committee. Results: The mean age of study participants was 76 years; 45% were male; 13% had had a stroke; and 45% had congestive heart failure. There were fewer all-cause strokes (0.54% versus 0.97%; relative risk [RR]=0.56; 95% confidence interval, 0.32–0.96; P =0.032; adjusted RR=0.43%; number needed to treat=233) and ischemic strokes (0.48% versus 0.91%; RR=0.53; 95% confidence interval, 0.30–0.94; P =0.026; adjusted RR=0.43%; number needed to treat=233) among patients treated with betrixaban versus enoxaparin through 77 days of follow-up. Among high-risk subjects, those with congestive heart failure or ischemic stroke as their index event, betrixaban reduced the risk of all-cause stroke (0.72% versus 1.48%; RR=0.49; 95% confidence interval, 0.26–0.90; P =0.019; adjusted RR=0.76%; number needed to treat=132) and ischemic stroke (0.63% versus 1.38%; RR=0.45; 95% confidence interval, 0.24–0.87; P =0.014; adjusted RR=0.75%; number needed to treat=134) compared with enoxaparin. Conclusions: Among hospitalized medically ill patients, extended-duration betrixaban significantly reduced all-cause stroke and ischemic stroke through 77 days of follow-up Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01583218.

Published
2017
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23. Guanine-nucleotide-releasing factor hSos1 binds to Grb2 and links receptor tyrosine kinases to Ras signalling

Author

Li, N., Batzer, A., Daly, R., Yajnik, V., Skolnik, E., Chardin, P., Bar-Sagi, B., Margolis, B., and Schlessinger, J.

Subjects
G proteins -- Analysis, Cell interaction -- Analysis, Epidermal growth factor -- Research, Environmental issues, Science and technology, Zoology and wildlife conservation
Abstract

SH3 domains of Grb2 couple with hSos1's carboxy-terminal. This terminal is a human homologue of Drosophila guanine-nucleotide-releasing factor for Ras, which affects the command of Ras activity by epidermal growth factor (EGF) receptors. SH3 and hSos1 interaction illustrates a leap in conserved signalling pathway for regulation of cell growth and differentiation. Grb2/hSos1 complex couples induce EGF recepto to Ras signalling. But this interaction can be suppressed by a synthetic 10-amino-acid peptide having PPVPPR sequence.

Published
1993

26. Effect of phospholipase C-gamma overexpression on PDGF-induced second messengers and mitogenesis

Author

Margolis, B., Zilberstein, A., Franks, C., Felder, S., Kremer, S., Ullrich, A., Rhee, S.G., Skorecki, K., and Schlessinger, J.

Subjects
Physiological aspects, Genetic aspects, Research, Calcium channels -- Physiological aspects -- Research -- Genetic aspects, Phosphorylation -- Physiological aspects -- Research -- Genetic aspects, Cell physiology -- Genetic aspects -- Physiological aspects -- Research, Phospholipases -- Physiological aspects -- Genetic aspects -- Research, DNA -- Genetic aspects -- Research -- Physiological aspects, Messenger RNA -- Research -- Physiological aspects -- Genetic aspects, Platelet-derived growth factor -- Physiological aspects -- Genetic aspects -- Research
Abstract

Effect of Phospholipace C-γ Overexpression on PDGF-Induced Second Messengers and Mitogenesis THE BREAKDOWN OF [PIP.sub.2] BY PLC generates at least two intracellular messengers: inositol 1,4,5-trisphosphate [I(1,4,5)[P.sub.3.]], which releases [Ca.sup.2+] from [...]

Published
1990

28. Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely III Medical Patients: An APEX Trial Substudy

Author

Gibson, C. M., Korjian, S., Chi, G., Daaboul, Y., Jain, P., Arbetter, D., Goldhaber, S. Z., Hull, R., Hernandez, A. F., Lopes, R. D., Gold, A., Cohen, A. T., Harrington, R. A., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Oliva, M., Parody, M., Poy, C., Baker, R., Colquhoun, D., Coughlin, P., Finfer, S., Hammerschlag, G., Rubinfeld, A., Huber, K., Konig, J., Mathies, R., Pilger, E., Schoenerr, H., Adzerikho, I., Koryk, V., Mikhailova, E., Mitkovskaya, N., Pimanov, S., Polonetsy, L., Soroka, N., Blockmans, D., Delforge, M., Dive, A., Lienart, F., Motte, S., Annichino Bizzacchi, J., Fiss, E., Freire, A., Manenti, E., Ramacciotti, E., Raymuno, S., Rocha, A., Saraiva, J. F., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Kostadinova, M., Milanova, M., Mincheva, V., Pencheva, G., Raev, D., Runev, N., Stoeva, N., Stoyanov, M., Syulemzova, S., Todorov, G., Tokmakova, M., Dhar, A., Douketis, J., Kahn, S., Le Gal, G., Pearce, M., Provencher, S., Verreault, S., Arias Alarcon, M., Olivares Canon, C., Opazo Lazcano, M., Potthoff Cardenas, S., Butkovic-Soldo, S., Car, S., Ciglenecki, N., Francetic, I., Jakopovic, M., Kalinic-Grgorinic, H., Knezevic, A., Malojcic, B., Marusic, S., Sikic Vagic, J., Skerk, V., Cermak, O., Cervinka, P., Chlumsky, J., Chochola, J., Cizek, V., Dunaj, M., Dusek, J., Francek, L., Havelka, J., Herold, M., Holaj, R., Horny, I., Hubac, J., Jajtner, P., Kolman, P., Lang, P., Mayer, O., Mikulova, J., Podpera, I., Reiterer, P., Spacek, R., Vejvoda, J., Vyhnanek, M., Christensen, H., Lassen, M., Storgaard, M., Tuxen, C., Urhammer, S., Lember, M., Marandi, T., Uuetoa, T., Airaksinen, J., Honkaniemi, J., Kaaja, R., Lassila, R., Saarinen, J., Tatlisumak, T., Vikman, S., Agraou, B., Aquilanti, S., Belhassane, A., Brisot, D., De Geeter, G., Debourdeau, P., Decoulx, E., El Kouri, D., Falvo, N., Grange, C., Lacroix, P., Messas, E., Mismetti, P., Montaclair, K., Mottier, D., Paleiron, N., Payot, L., Pernod, G., Pottier, P., Proust, A., Quere, I., Roy, P. -M., Schmidt, J., Simoneau, G., Datikashvili-David, I., Khabeishvili, G., Khintibidze, I., Kobulia, B., Megreladze, I., Pagava, Z., Paposhvili, K., Shaburishvili, T., Amann, B., Berrouschot, J., Beyer-Westendorf, J., Blessing, E., Bott, M., Dengler, T., Diehm, C., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Schellong, S., Schmidt-Lucke, J., Singer, C., Tiefenbacher, C., Veltkamp, R., Weimar, C., Zeymer, U., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Kirschner, R., Kristof, P., Lakatos, F., Laszlo, Z., Lupkovics, G., Merkely, B., Nagy Andras, C., Nemeth, L., Papp, A., Soltesz, P., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Vertes, A., Efrati, S., Elias, M., Gafter, A., Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Zeltser, D., Ageno, W., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Lembo, G., Lodigiani, C., Luisetti, M., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Visona, A., Krievins, D., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Bagdonas, A., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Cotrina Pereyra, R., Farjardo Karlo, L., Horna, M., Lema Osores, J., Salas, M., Toche Yanez, L., Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Tomkowski, W., Walasek, L., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Mot, S., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Khurs, E., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Panchenko, E., Popov, D., Privalova, E., Reshetko, O., Sergeeva, E., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Tan, R. S., Bodikova, S., Cervenakova, A., Dvorak, M., Gaspar, L., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Jacobson, B., Mitha, I., Van Dyk, C., Alvarez Sala, L. A., Barbagelata Lopez, C., Bisbe, J., Castro Guardiola, A., Cepeda, J. M., Cereto, F., Diaz Santos, E., Ferrer, R., Gomez Cerezo, J., Gonzales-Porras, J. R., Grandes, J., Jimenez, D., Martin Loeches, I., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Vargas Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Nazliel, B., Okumus, G., Ongen, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Koshlia, V., Krakhmalova, O., Kyrychenko, I., Legkonogov, O., Malynovsky, Y., Maslovaskyi, V., Nikonov, V., Parkhomenko, O., Perepeliuk, M., Reshotko, D., Rudenko, L., Ryabichenko, T., Svyridova, I., Svyshchenko, Y., Tseluyko, V., Ursol, G., Vakaliuk, I., Vishnivestsky, I., Voronkov, L., Yagensky, A., Body, R., Chandra, D., Davis, M., Kesteven, P., Maccallum, P., Mccollum, C., Natarajan, I., Almasri, E., Amin, M., Anderson, C., Baker, S., Barney, J., Bastani, B. B. A., Bercz, P., Bidair, M., Carman, T., Chang, H., Clark, C., Concha, M., Cornell, J., Dhingra, R., Doshi, A., Ebrahimi, R., Farley, B., Fermann, G., Foster, G., Fraiz, J., Fulmer, J., Gaggin, H., Goytia-Leos, D., Hahn, B., Haidar, A., Hamad, A., Hazelrigg, M., Ioachimescu, O., Johnson, B., Kabler, H., Kao, C. -K., Kazimir, M., Kouras, F., Kung, M., Lerner, R., Lopez, J., Macchiavelli, A., Mahal, S., Margolis, B., Mclaren, G., Milling, T., Mittal, M., Nadar, V., Ohaju, V., Ortel, T., Overcash, J., Parthiban, K., Pearl, R., Pineda, L., Pratt, R., Pullman, J., Quintana, O., Rajan, R., Rastogi, P., Rees, C., Rodriguez, W., Saba, F., Shammas, N., Sharma, S., Sokol, S., Stoltz, S., Subich, D., Tuck, M., Updegrove, J., Warner, A., Welch, M., Welker, J., Whitman, B., Wichman, T., Yousef, K., Yusen, R., and Zakai, N.

Subjects
Male, pulmonary embolism, Time Factors, Pyridines, Intracranial hemorrhage, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Risk Factors, Clinical Studies, Medicine, 030212 general & internal medicine, Myocardial infarction, Original Research, Ischemic stroke, Hazard ratio, Absolute risk reduction, Venous Thromboembolism, Middle Aged, Interventional Cardiology, Pulmonary embolism, Death, myocardial infarction, Treatment Outcome, Cardiovascular Diseases, Anesthesia, Acute Disease, Benzamides, Number needed to treat, Female, Cardiology and Cardiovascular Medicine, Intracranial Hemorrhages, Adult, venous thromboembolism, Hemorrhage, 03 medical and health sciences, Double-Blind Method, death, ischemic stroke, Humans, Enoxaparin, Aged, Proportional Hazards Models, Inpatients, Venous thromboembolism, business.industry, Settore MED/09 - MEDICINA INTERNA, Anticoagulants, Thrombosis, medicine.disease, Clinical trial, chemistry, Betrixaban, business, Acute Coronary Syndromes, intracranial hemorrhage, Factor Xa Inhibitors
Abstract

Background Extended‐duration betrixaban showed a significant reduction in venous thromboembolism in the APEX trial (Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study). Given the variable clinical impact of different efficacy and safety events, one approach to assess net clinical outcomes is to include only those events that are either fatal or cause irreversible harm. Methods and Results This was a post hoc analysis of the APEX trial—a multicenter, double‐blind, randomized controlled trial comparing extended‐duration betrixaban versus standard‐of‐care enoxaparin. A composite of all fatal or irreversible safety (fatal bleeding or intracranial hemorrhage) and efficacy events (cardiopulmonary death, myocardial infarction, pulmonary embolism, and ischemic stroke) was evaluated in a time‐to‐first event analysis. In patients with positive D‐dimer results, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.80% versus 3.54%; hazard ratio, 0.73; absolute risk reduction, 1.26%; number needed to treat, 79 [ P =0.033]) and at study end at 77 days (6.27% versus 4.36%; hazard ratio, 0.70; absolute risk reduction, 1.91%; number needed to treat, 52 [ P =0.005]) versus enoxaparin. In all patients, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.08% versus 2.90%; hazard ratio, 0.71; absolute risk reduction, 1.18%; number needed to treat, 86 [ P =0.006]) and 77 days (5.17% versus 3.64%; hazard ratio, 0.70; absolute risk reduction, 1.53%; number needed to treat, 65 [ P =0.002]). Conclusions Among hospitalized medically ill patients, extended‐duration betrixaban demonstrated an ≈30% reduction in fatal or irreversible ischemic or bleeding events compared with standard‐duration enoxaparin. A total of 65 patients would require treatment with betrixaban to prevent 1 fatal or irreversible event versus enoxaparin. Clinical Trial Registration URL : http://www.ClinicalTrials.gov . Unique identifier: NCT 01583218.

Published
2017

30. The safety and efficacy of full- versus reduced-dose betrixaban in the Acute Medically Ill VTE (Venous Thromboembolism) Prevention With Extended-Duration Betrixaban (APEX) trial

Author

Raymuno, S., Ramacciotti, E., Manenti, E., Freire, A., Fiss, E., Bizzacchi, J. Annichino, Lienart, F., Dive, A., Delforge, M., Blockmans, D., Soroka, N., Kamenova, Z., Kostadinova, M., Milanova, M., Pencheva, G., Runev, N., Stoeva, N., Stoyanov, M., Syulemzova, S., Todorov, G., Polonetsy, L., Pimanov, S., Mitkovskaya, N., Tokmakova, M., Dhar, A., Mikhailova, E., Koryk, V., Adzerikho, I., Schoenerr, H., Mathies, R., Douketis, J., Konig, J., Le Gal, G., Pearce, M., Provencher, S., Verreault, S., Alarcon, M. Arias, Lazcano, M. Opazo, Cardenas, S. Potthoff, Butkovic-Soldo, S., Car, S., Ciglenecki, N., Francetic, I., Jakopovic, M., Kalinic-Grgorinic, H., Knezevic, A., Marusic, S., Vagic, J. Sikic, Skerk, V., Cermak, O., Gibson, C. Michael, Halaby, Rim, Korjian, Serge, Daaboul, Yazan, Arbetter, Douglas F., Yee, Megan K., Chlumsky, J., Chochola, J., Cizek, V., Goldhaber, Samuel Z., Hull, Russel, Hernandez, Adrian F., Huber, K., Lu, Shiao-ping, Dunaj, M., Dusek, J., Francek, L., Havelka, J., Herold, M., Holaj, R., Nazliel, BİJEN, Bandman, Olga, Leeds, Janet M., Gold, Alex, Harrington, Robert A., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Oliva, M., Parody, M., Horny, I., Hubac, J., Jajtner, P., Kolman, P., Poy, C., Baker, R., Lang, P., Mikulova, J., Podpera, I., Reiterer, P., Spacek, R., Vejvoda, J., Vyhnanek, M., Christensen, H., Lassen, M., Storgaard, M., Tuxen, C., Urhammer, S., Lember, M., Uuetoa, T., Airaksinen, J., Honkaniemi, J., Kaaja, R., Saarinen, J., Tatlisumak, T., Vikman, S., Agraou, B., Aquilanti, S., Belhassane, A., Brisot, D., De Geeter, G., Coughlin, P., Finfer, S., Debourdeau, P., Decoulx, E., El Kouri, D., Falvo, N., Grange, C., Rubinfeld, A., Lacroix, P., Messas, E., Mismetti, P., Montaclair, K., Paleiron, N., Payot, L., 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., Rastogi, P., Rajan, R., Quintana, O., Pullman, J., Pratt, R., Pineda, L., Pernod, G., Pearl, R., Parthiban, K., Ortel, T., Ohaju, V., Pottier, P., Proust, A., Quere, I., Roy, P-M., Schmidt, J., Simoneau, G., Datikashvili-David, I., Khabeishvili, G., Khintibidze, I., 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., 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., Grandes, J., Gonzales-Porras, J. R., Gomez Cerezo, J., Ferrer, R., Diaz Santos, E., Cereto, F., Cepeda, J. M., Castro Guardiola, A., Bisbe, J., Barbagelata Lopez, C., Alvarez Sala, L. A., Van Dyk, C., Mitha, I., Engelbrecht, J., Breedt, J., Basson, M., Adler, D., Spisakova, M., 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., 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., Kobulia, B., Megreladze, I., Pagava, Z., Paposhvili, K., Amann, B., Beyer-Westendorf, J., Blessing, E., Bott, M., Dengler, T., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Tiefenbacher, C., Weimar, C., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Kirschner, R., Kristof, P., Lakatos, F., Lupkovics, G., Merkely, B., Andras, C. Nagy, Nemeth, L., Papp, A., Soltesz, P., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Vertes, A., Efrati, S., Elias, M., Gafter, A., Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Lembo, G., Lodigiani, C., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Visona, A., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Pereyra, R. Cotrina, Karlo, L. Farjardo, Horna, M., Salas, M., Yanez, L. Toche, Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Walasek, L., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Musetescu, R., Podoleanu, C., Popescu, M., Kalpachki, R., Grigorov, M., Dimov, B., Rocha, A., Goloshchekin, B., Berrouschot, J., Laszlo, Z., Rees, C., Overcash, J., Prokop, D., and Cohen, Alexander T.

Subjects
Relative risk reduction, Male, Pyridines, Population, Hemorrhage, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Pharmacokinetics, Randomized controlled trial, Double-Blind Method, law, Medicine, Humans, 030212 general & internal medicine, Dosing, Enoxaparin, education, Aged, Aged, 80 and over, Venous Thrombosis, education.field_of_study, business.industry, Absolute risk reduction, Anticoagulants, Venous Thromboembolism, Hospitalization, chemistry, Concomitant, Betrixaban, Anesthesia, Benzamides, Female, Cardiology and Cardiovascular Medicine, business, Pulmonary Embolism, Factor Xa Inhibitors
Abstract

The APEX trial assessed the safety and efficacy of extended-duration thromboprophylaxis using betrixaban versus standard dosing of enoxaparin among hospitalized, acutely ill medical patients. The 80-mg betrixaban dose was halved to 40 mg among subjects with severe renal insufficiency and those receiving a concomitant strong P-glycoprotein inhibitor.This analysis assessed the pharmacokinetics, efficacy, and safety of full- (80 mg) and reduced-dose (40 mg) betrixaban relative to enoxaparin in the APEX trial.The median concentration of betrixaban among subjects administered the 80-mg dose was higher than that of the 40-mg dose (19 ng/mL vs 11 ng/mL, P.001). In the primary analysis cohort 1 (d-dimer ≥2× upper limit of normal), the primary efficacy outcome (asymptomatic proximal deep vein thrombosis, symptomatic proximal or distal deep vein thrombosis, symptomatic nonfatal pulmonary embolism, or venous thromboembolism-related death) was significantly reduced among subjects treated with 80 mg of extended-duration betrixaban versus enoxaparin (6.27% [95/1516] vs 8.39% [130/1549], relative risk reduction=0.26 [0.04-0.42], P=.023), and similarly in the entire primary efficacy outcome population (4.87% [122/2506] vs 7.06% [181/2562], relative risk reduction=0.30 [0.13-0.44], P=.001). There was no difference in the primary outcome for subjects treated with 40 mg betrixaban vs enoxaparin across cohorts. In addition, there was no excess of major bleeding associated with either betrixaban dose compared with enoxaparin.The 80-mg betrixaban dose achieves higher plasma concentrations than the 40-mg dose and, in contrast to the 40-mg dose, is associated with improved efficacy across all cohorts relative to standard-dose enoxaparin without an excess risk of major bleeding in the management of medically ill subjects.

Published
2016

32. 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
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33. The additional value of patient-reported health status in predicting 1-year mortality after invasive coronary procedures: a report from the Euro Heart Survey on Coronary Revascularisation

Author

Lenzen M. J., Scholte Op Reimer W. J. M., Pedersen S. S., Boersma E., Maier W., Widimsky P., Simoons M. L., Mercado N. F., Wijns W., Bertrand M., Meier B., Sechtem U., Sergeant P., Stahle E., Unger F., Manini M., Bramley C., Laforest V., Taylor C., Del Gaiso S., Huber K., De Backer G., Sirakova V., Cerbak R., Thayssen P., Lehto S., Blanc J. -J., Delahaye F., Kobulia B., Zeymer U., Cokkinos D., Karlocai K., Graham I., Shelley E., Behar S., Maggioni A., Grabauskiene V., Deckers J., Asmussen I., Stepinska J., Goncalves L., Mareev V., Riecansky I., Kenda M. F., Alonso A., Lopez-Sendon J. L., Rosengren A., Buser P., Okay T., Sychov O., Fox K., Wood D., Crijns H., McGregor K., Mulder B., Priori S., Ryden L., Tavazzi L., Vahanian A., Vardas P., Sarkisyan K., Glogar H. D., Frick M., Pachinger O., Zwick R., Vrints C., Van Hertbruggen E., Vercammen M., Sysmans T., Schroeder E., Domange J., De Pril H., De Vriese J., Van Hecke T., Legrand V., Gillon M. -F., Richardy M., Doneux P., Petrov I., Jorgova J., Starcevic B., Eeckhout E., Berger A., Prudent V., Camenzind E., Masson N., Zambartas C., Kleanthous H., Stellova B., Aschermann M., Simek S., Kautzner J., Karmazin V., Svab P., Indrak J., Branny M., Hladilova K., Kala P., Cappelen H., Jensen L. O., Gitt A., Gehrke K., am Rhein L., Erbel R., Gutersohn A., Eggebrecht H., Al Khani M., Rosenberger A., Vogelsberg H., Klepzig H., Schmidt A., Silber S., Mau B., Leuner C., Czyborra K., Reuschling C., Muno E., Nauheim B., Kleber F., Rux S., Saad A., Elabady M., Beiras A. C., Fernandez J. S., del Arno F. N., Romo A. I., Fernandez J. M. C., Mayoreal A. R., Rebanal F. J. R., de la Borbolla M. G., Chaparro M., Brotons C., Miralda C. P., Vila i Perez S. I., Moris C., Aviles F. F., de la Fuente Galan L., Vinuela P. T., de Torres F. M., Mora J., Rodriguez I. S., Bustamante I. P., Fernandez P. L. S., Torrent J. L. D., Diez Gil J. L., Perpinan J., Motilla V. P., Juango M. S. A., Berjon-Reyero J., Moreno R. M., Guerrero J. C. F., Savolainen K., Syvanne M., Cohen-Solal A., Oboa A. -S., Bassand J. P., Espinosa D. P., Jouet V., Cedex B., Montalescot G., Gallois V., Daubert J. C., Clerc J. M., Machecourt J., Cottin Y., Walker D., Holland F., Prosser J., Muir L., Barber K., Cleland J. G. F., Cook J., Chapichadze Z., Christos I. S. A., Tsiavou N., Chrysohoou C., Manginas A., Terrovitis J., Kanakakis J., Vavuranakis M., Drakos S., Farmakis T., Samara C., Papakosta C., Bourantas C., Michalis L. K., Christos M., Foussas S., Adamopoulou E., Vardas P. E., Marketou M., Alotti N., Basa A. M., Vigh A., Preda I., Csoti E., Keltai M., Kerkovits G., Hendler A., Blatt A., Yakov B., Beyar R., Shefer A., Halon D., Bentzvi M., Avramovitch N., Bakst A., Saba K., Cafri C., Grosbard A., Sheva B., Margolis B., Suleiman K., Banai S., Meerkin D., Mosseri M., Guita P., Jabara R., Jafari J., Shitrit D. B., Ghasan Salameh, Brezins M., van den Akker-Berman L., Guetta V., Hashomer T., Rozenman Y., Biagini A., Berti S., Ferrero M., Colombo A., Roccaforte R., Milici C., Scarpino L., Salvi A., Desideri A., Sabbadin D., Veneto C., Galassi A., Giuffrida G., Rognoni A., Vassanelli C., Paffoni P., Cioppa A., Rubino P., de Carlo M., Petronio A. S., Naccarella F., Saia F., Marzocchi A., Maranga S. S., Presbitero P., Valsecchi F., Piscione F., Esposito G., Santini N. M., Tubaro M., Erglis A., Narbute I., Kavoliuniene A., Zaliunas R., Navickas R., Luckute D., Subkovas E., Wagner D., Vermeer F., Lousberg A., Fransen H., Breeman A., Tebbe H., De Boer M. J., van der Wal M., Vos J., Leenders C. M., Veerhoek M. J., Jansen C., Bijl M., Koppelaar C., den Linden V., Brons R., Widdershofen J. W. M. G., Broers H., Kontny F., Jonzon M., Wodniecki J., Tomasik A., Trusz-Gluza M., Nowak S., Ruzyllo W., Deptuch T., Marques J., Matias F., Madeira H., Oliveira J., Sargento L., Ionac A., Dragulescu I. S., Mut-Vitcu B., Maximov D., Dorobantu M., Apetrei E., Niculescu R., Petrescu V., Bucsa A., Deleanu D., Bucharest, Benedek I. S., Hintea T., Aronov D., Tikhomirova E., Kranjec I., Prokselj K., Kanic V., Sepetoglu A., Aytekin S., Aytekin V., Catakoglu A. B., Parlar H., Tufekcioglu S., Ozyedek Z., Baltali M., Kiziltan D., Vukovic M., Neskovic A. N., Cardiology, Lenzen, M. J., Scholte Op Reimer, W. J. M., Pedersen, S. S., Boersma, E., Maier, W., Widimsky, P., Simoons, M. L., Mercado, N. F., Wijns, W., Bertrand, M., Meier, B., Sechtem, U., Sergeant, P., Stahle, E., Unger, F., Manini, M., Bramley, C., Laforest, V., Taylor, C., Del Gaiso, S., Huber, K., De Backer, G., Sirakova, V., Cerbak, R., Thayssen, P., Lehto, S., Blanc, J. -J., Delahaye, F., Kobulia, B., Zeymer, U., Cokkinos, D., Karlocai, K., Graham, I., Shelley, E., Behar, S., Maggioni, A., Grabauskiene, V., Deckers, J., Asmussen, I., Stepinska, J., Goncalves, L., Mareev, V., Riecansky, I., Kenda, M. F., Alonso, A., Lopez-Sendon, J. L., Rosengren, A., Buser, P., Okay, T., Sychov, O., Fox, K., Wood, D., Crijns, H., Mcgregor, K., Mulder, B., Priori, S., Ryden, L., Tavazzi, L., Vahanian, A., Vardas, P., Sarkisyan, K., Glogar, H. D., Frick, M., Pachinger, O., Zwick, R., Vrints, C., Van Hertbruggen, E., Vercammen, M., Sysmans, T., Schroeder, E., Domange, J., De Pril, H., De Vriese, J., Van Hecke, T., Legrand, V., Gillon, M. -F., Richardy, M., Doneux, P., Petrov, I., Jorgova, J., Starcevic, B., Eeckhout, E., Berger, A., Prudent, V., Camenzind, E., Masson, N., Zambartas, C., Kleanthous, H., Stellova, B., Aschermann, M., Simek, S., Kautzner, J., Karmazin, V., Svab, P., Indrak, J., Branny, M., Hladilova, K., Kala, P., Cappelen, H., Jensen, L. O., Gitt, A., Gehrke, K., am Rhein, L., Erbel, R., Gutersohn, A., Eggebrecht, H., Al Khani, M., Rosenberger, A., Vogelsberg, H., Klepzig, H., Schmidt, A., Silber, S., Mau, B., Leuner, C., Czyborra, K., Reuschling, C., Muno, E., Nauheim, B., Kleber, F., Rux, S., Saad, A., Elabady, M., Beiras, A. C., Fernandez, J. S., del Arno, F. N., Romo, A. I., Fernandez, J. M. C., Mayoreal, A. R., Rebanal, F. J. R., de la Borbolla, M. G., Chaparro, M., Brotons, C., Miralda, C. P., Vila i Perez, S. I., Moris, C., Aviles, F. F., de la Fuente Galan, L., Vinuela, P. T., de Torres, F. M., Mora, J., Rodriguez, I. S., Bustamante, I. P., Fernandez, P. L. S., Torrent, J. L. D., Diez Gil, J. L., Perpinan, J., Motilla, V. P., Juango, M. S. A., Berjon-Reyero, J., Moreno, R. M., Guerrero, J. C. F., Savolainen, K., Syvanne, M., Cohen-Solal, A., Oboa, A. -S., Bassand, J. P., Espinosa, D. P., Jouet, V., Cedex, B., Montalescot, G., Gallois, V., Daubert, J. C., Clerc, J. M., Machecourt, J., Cottin, Y., Walker, D., Holland, F., Prosser, J., Muir, L., Barber, K., Cleland, J. G. F., Cook, J., Chapichadze, Z., Christos, I. S. A., Tsiavou, N., Chrysohoou, C., Manginas, A., Terrovitis, J., Kanakakis, J., Vavuranakis, M., Drakos, S., Farmakis, T., Samara, C., Papakosta, C., Bourantas, C., Michalis, L. K., Christos, M., Foussas, S., Adamopoulou, E., Vardas, P. E., Marketou, M., Alotti, N., Basa, A. M., Vigh, A., Preda, I., Csoti, E., Keltai, M., Kerkovits, G., Hendler, A., Blatt, A., Yakov, B., Beyar, R., Shefer, A., Halon, D., Bentzvi, M., Avramovitch, N., Bakst, A., Saba, K., Cafri, C., Grosbard, A., Sheva, B., Margolis, B., Suleiman, K., Banai, S., Meerkin, D., Mosseri, M., Guita, P., Jabara, R., Jafari, J., Shitrit, D. B., Ghasan, Salameh, Brezins, M., van den Akker-Berman, L., Guetta, V., Hashomer, T., Rozenman, Y., Biagini, A., Berti, S., Ferrero, M., Colombo, A., Roccaforte, R., Milici, C., Scarpino, L., Salvi, A., Desideri, A., Sabbadin, D., Veneto, C., Galassi, A., Giuffrida, G., Rognoni, A., Vassanelli, C., Paffoni, P., Cioppa, A., Rubino, P., de Carlo, M., Petronio, A. S., Naccarella, F., Saia, F., Marzocchi, A., Maranga, S. S., Presbitero, P., Valsecchi, F., Piscione, F., Esposito, G., Santini, N. M., Tubaro, M., Erglis, A., Narbute, I., Kavoliuniene, A., Zaliunas, R., Navickas, R., Luckute, D., Subkovas, E., Wagner, D., Vermeer, F., Lousberg, A., Fransen, H., Breeman, A., Tebbe, H., De Boer, M. J., van der Wal, M., Vos, J., Leenders, C. M., Veerhoek, M. J., Jansen, C., Bijl, M., Koppelaar, C., den Linden, V., Brons, R., Widdershofen, J. W. M. G., Broers, H., Kontny, F., Jonzon, M., Wodniecki, J., Tomasik, A., Trusz-Gluza, M., Nowak, S., Ruzyllo, W., Deptuch, T., Marques, J., Matias, F., Madeira, H., Oliveira, J., Sargento, L., Ionac, A., Dragulescu, I. S., Mut-Vitcu, B., Maximov, D., Dorobantu, M., Apetrei, E., Niculescu, R., Petrescu, V., Bucsa, A., Deleanu, D., Bucharest, Benedek, I. S., Hintea, T., Aronov, D., Tikhomirova, E., Kranjec, I., Prokselj, K., Kanic, V., Sepetoglu, A., Aytekin, S., Aytekin, V., Catakoglu, A. B., Parlar, H., Tufekcioglu, S., Ozyedek, Z., Baltali, M., Kiziltan, D., Vukovic, M., and Neskovic, A. N.

Subjects
Male, medicine.medical_specialty, Epidemiology, medicine.medical_treatment, Health Status, Coronary Artery Disease, Revascularization, Coronary artery disease, Cohort Studies, Risk Factors, Surveys and Questionnaires, medicine, Myocardial Revascularization, Surveys and Questionnaire, Humans, Prospective Studies, Prospective cohort study, Aged, business.industry, Risk Factor, Mortality rate, Confounding, Middle Aged, medicine.disease, Surgery, Europe, Prospective Studie, Treatment Outcome, Emergency medicine, Population study, Female, Cohort Studie, Cardiology and Cardiovascular Medicine, business, Human, Cohort study
Abstract

Objective: Self-perceived health status may be helpful in identifying patients at high risk for adverse outcomes. The Euro Heart Survey on Coronary Revascularization (EHS-CR) provided an opportunity to explore whether impaired health status was a predictor of 1-year mortality in patients with coronary artery disease (CAD) undergoing angiographic procedures. Methods: Data from the EHS-CR that included 5619 patients from 31 member countries of the European Society of Cardiology were used. Inclusion criteria for the current study were completion of a self-report measure of health status, the EuroQol Questionnaire (EQ-5D) at discharge and information on 1-year follow-up, resulting in a study population of 3786 patients. Results: The 1-year mortality was 3.2% (n = 120). Survivors reported fewer problems on the five dimensions of the EQ-5D as compared with non-survivors. A broad range of potential confounders were adjusted for, which reached a p

Published
2006

34. Patients enrolled in coronary intervention trials are not representative of patients in clinical practice: results from the Euro Heart Survey on Coronary Revascularization

Author

Hordijk-Trion M., Lenzen M., Wijns W., De Jaegere P., Simoons M. L., Scholte Op Reimer W. J. M., Bertrand M. E., Mercado N., Boersma E., Maier W., Meier B., Moris C., Piscione F., Sechtem U., Sergeant P., Stahle E., Vos J., Widimsky P., Unger F., Manini M., Bramley C., Laforest V., Taylor C., Del Gaiso S., Huber K., De Backer G., Sirakova V., Cerbak R., Thayssen P., Lehto S., Blanc J. -J., Delahaye F., Kobulia B., Zeymer U., Cokkinos D., Karlocai K., Graham I., Shelley E., Behar S., Maggioni A., Grabauskiene V., Deckers J., Asmussen I., Stepinska J., Goncalves L., Mareev V., Riecansky I., Kenda M. F., Alonso A., Lopez-Sendon J. L., Rosengren A., Buser P., Okay T., Sychov O., Fox K., Wood D., Crijns H., McGregor K., Mulder B., Priori S., Ryden L., Tavazzi L., Vahanian A., Vardas P., Sarkisyan K., Glogar H. D., Frick M., Pachinger O., Zwick R., Vrints C., Van Hertbruggen E., Vercammen M., Sysmans T., Schroeder E., Domange J., De Pril H., De Vriese J., Van Hecke T., Legrand V., Gillon M. -F., Richardy M., Doneux P., Petrov I., Jorgova J., Starcevic B., Eeckhout E., Berger A., Prudent V., Camenzind E., Masson N., Zambartas C., Kleanthous H., Stellova B., Aschermann M., Simek S., Kautzner J., Karmazin V., Svab P., Indrak J., Branny M., Hladilova K., Kala P., Cappelen H., Jensen L. O., Gitt A., Gehrke K., am Rhein L., Erbel R., Gutersohn A., Eggebrecht H., Al Khani M., Rosenberger A., Vogelsberg H., Klepzig H., Schmidt A., Silber S., Mau B., Leuner C., Czyborra K., Reuschling C., Muno E., Nauheim B., Kleber F., Rux S., Saad A., Elabady M., Beiras A. C., Fernandez J. S., del Arno F. N., Romo A. I., Fernandez J. M. C., Mayoreal A. R., Rebanal F. J. R., de la Borbolla M. G., Chaparro M., Brotons C., Miralda C. P., Vila i Perez S. I., Aviles F. F., de la Fuente Galan L., Vinuela P. T., de Torres F. M., Mora J., Rodriguez I. S., Bustamante I. P., Fernandez P. L. S., Torrent J. L. D., Gil J. L. D., Perpinan J., Motilla V. P., Juango M. S. A., Berjon-Reyero J., Moreno R. M., Guerrero J. C. F., Savolainen K., Syvanne M., Cohen-Solal A., Oboa A. -S., Bassand J. P., Espinosa D. P., Jouet V., Cedex B., Montalescot G., Gallois V., Daubert J. C., Clerc J. M., Machecourt J., Cottin Y., Walker D., Holland F., Prosser J., Muir L., Barber K., Cleland J. G. F., Cook J., Chapichadze Z., Christos I. S. A., Tsiavou N., Chrysohoou C., Manginas A., Terrovitis J., Kanakakis J., Vavuranakis M., Drakos S., Farmakis T., Samara C., Papakosta C., Bourantas C., Michalis L. K., Christos M., Foussas S., Adamopoulou E., Marketou M., Alotti N., Basa A. M., Vigh A., Preda I., Csoti E., Keltai M., Kerkovits G., Hendler A., Blatt A., Yakov B., Beyar R., Shefer A., Halon D., Bentzvi M., Avramovitch N., Bakst A., Saba K., Cafri C., Grosbard A., Sheva B., Margolis B., Suleiman K., Banai S., Meerkin D., Mosseri M., Guita P., Jabara R., Jafari J., Shitrit D. B., Ghasan D., Salameh D., Brezins M., van den Akker-Berman L., Guetta V., Hashomer T., Rozenman Y., Biagini A., Berti S., Ferrero M., Colombo A., Roccaforte R., Milici C., Scarpino L., Salvi A., Desideri A., Sabbadin D., Veneto C., Galassi A., Giuffrida G., Rognoni A., Vassanelli C., Paffoni P., Cioppa A., Rubino P., de Carlo M., Petronio A. S., Naccarella F., Saia F., Marzocchi A., Maranga S. S., Presbitero P., Valsecchi F., Esposito G., Santini N. M., Tubaro M., Erglis A., Narbute I., Kavoliuniene A., Zaliunas R., Navickas R., Luckute D., Subkovas E., Wagner D., Vermeer F., Lousberg A., Fransen H., Breeman A., Tebbe H., De Boer M. J., van der Wal M., Leenders C. M., Veerhoek M. J., Jansen C., Bijl M., Koppelaar C., den Linden V., Brons R., Widdershofen J. W. M. G., Broers H., Kontny F., Jonzon M., Wodniecki J., Tomasik A., Trusz-Gluza M., Nowak S., Ruzyllo W., Deptuch T., Marques J., Matias F., Madeira H., Oliveira J., Sargento L., Ionac A., Dragulescu I. S., Mut-Vitcu B., Maximov D., Dorobantu M., Apetrei E., Niculescu R., Petrescu V., Bucsa A., Deleanu D., Bucharest, Benedek I. S., Hintea T., Aronov D., Tikhomirova E., Kranjec I., Prokselj K., Kanic V., Sepetoglu A., Aytekin S., Aytekin V., Catakoglu A. B., Parlar H., Tufekcioglu S., Ozyedek Z., Baltali M., Kiziltan, Vukovic M., Neskovic A. N., Cardiology, Hordijk-Trion, M., Lenzen, M., Wijns, W., De Jaegere, P., Simoons, M. L., Scholte Op Reimer, W. J. M., Bertrand, M. E., Mercado, N., Boersma, E., Maier, W., Meier, B., Moris, C., Piscione, F., Sechtem, U., Sergeant, P., Stahle, E., Vos, J., Widimsky, P., Unger, F., Manini, M., Bramley, C., Laforest, V., Taylor, C., Del Gaiso, S., Huber, K., De Backer, G., Sirakova, V., Cerbak, R., Thayssen, P., Lehto, S., Blanc, J. -J., Delahaye, F., Kobulia, B., Zeymer, U., Cokkinos, D., Karlocai, K., Graham, I., Shelley, E., Behar, S., Maggioni, A., Grabauskiene, V., Deckers, J., Asmussen, I., Stepinska, J., Goncalves, L., Mareev, V., Riecansky, I., Kenda, M. F., Alonso, A., Lopez-Sendon, J. L., Rosengren, A., Buser, P., Okay, T., Sychov, O., Fox, K., Wood, D., Crijns, H., Mcgregor, K., Mulder, B., Priori, S., Ryden, L., Tavazzi, L., Vahanian, A., Vardas, P., Sarkisyan, K., Glogar, H. D., Frick, M., Pachinger, O., Zwick, R., Vrints, C., Van Hertbruggen, E., Vercammen, M., Sysmans, T., Schroeder, E., Domange, J., De Pril, H., De Vriese, J., Van Hecke, T., Legrand, V., Gillon, M. -F., Richardy, M., Doneux, P., Petrov, I., Jorgova, J., Starcevic, B., Eeckhout, E., Berger, A., Prudent, V., Camenzind, E., Masson, N., Zambartas, C., Kleanthous, H., Stellova, B., Aschermann, M., Simek, S., Kautzner, J., Karmazin, V., Svab, P., Indrak, J., Branny, M., Hladilova, K., Kala, P., Cappelen, H., Jensen, L. O., Gitt, A., Gehrke, K., am Rhein, L., Erbel, R., Gutersohn, A., Eggebrecht, H., Al Khani, M., Rosenberger, A., Vogelsberg, H., Klepzig, H., Schmidt, A., Silber, S., Mau, B., Leuner, C., Czyborra, K., Reuschling, C., Muno, E., Nauheim, B., Kleber, F., Rux, S., Saad, A., Elabady, M., Beiras, A. C., Fernandez, J. S., del Arno, F. N., Romo, A. I., Fernandez, J. M. C., Mayoreal, A. R., Rebanal, F. J. R., de la Borbolla, M. G., Chaparro, M., Brotons, C., Miralda, C. P., Vila i Perez, S. I., Aviles, F. F., de la Fuente Galan, L., Vinuela, P. T., de Torres, F. M., Mora, J., Rodriguez, I. S., Bustamante, I. P., Fernandez, P. L. S., Torrent, J. L. D., Gil, J. L. D., Perpinan, J., Motilla, V. P., Juango, M. S. A., Berjon-Reyero, J., Moreno, R. M., Guerrero, J. C. F., Savolainen, K., Syvanne, M., Cohen-Solal, A., Oboa, A. -S., Bassand, J. P., Espinosa, D. P., Jouet, V., Cedex, B., Montalescot, G., Gallois, V., Daubert, J. C., Clerc, J. M., Machecourt, J., Cottin, Y., Walker, D., Holland, F., Prosser, J., Muir, L., Barber, K., Cleland, J. G. F., Cook, J., Chapichadze, Z., Christos, I. S. A., Tsiavou, N., Chrysohoou, C., Manginas, A., Terrovitis, J., Kanakakis, J., Vavuranakis, M., Drakos, S., Farmakis, T., Samara, C., Papakosta, C., Bourantas, C., Michalis, L. K., Christos, M., Foussas, S., Adamopoulou, E., Marketou, M., Alotti, N., Basa, A. M., Vigh, A., Preda, I., Csoti, E., Keltai, M., Kerkovits, G., Hendler, A., Blatt, A., Yakov, B., Beyar, R., Shefer, A., Halon, D., Bentzvi, M., Avramovitch, N., Bakst, A., Saba, K., Cafri, C., Grosbard, A., Sheva, B., Margolis, B., Suleiman, K., Banai, S., Meerkin, D., Mosseri, M., Guita, P., Jabara, R., Jafari, J., Shitrit, D. B., Ghasan, D., Salameh, D., Brezins, M., van den Akker-Berman, L., Guetta, V., Hashomer, T., Rozenman, Y., Biagini, A., Berti, S., Ferrero, M., Colombo, A., Roccaforte, R., Milici, C., Scarpino, L., Salvi, A., Desideri, A., Sabbadin, D., Veneto, C., Galassi, A., Giuffrida, G., Rognoni, A., Vassanelli, C., Paffoni, P., Cioppa, A., Rubino, P., de Carlo, M., Petronio, A. S., Naccarella, F., Saia, F., Marzocchi, A., Maranga, S. S., Presbitero, P., Valsecchi, F., Esposito, G., Santini, N. M., Tubaro, M., Erglis, A., Narbute, I., Kavoliuniene, A., Zaliunas, R., Navickas, R., Luckute, D., Subkovas, E., Wagner, D., Vermeer, F., Lousberg, A., Fransen, H., Breeman, A., Tebbe, H., De Boer, M. J., van der Wal, M., Leenders, C. M., Veerhoek, M. J., Jansen, C., Bijl, M., Koppelaar, C., den Linden, V., Brons, R., Widdershofen, J. W. M. G., Broers, H., Kontny, F., Jonzon, M., Wodniecki, J., Tomasik, A., Trusz-Gluza, M., Nowak, S., Ruzyllo, W., Deptuch, T., Marques, J., Matias, F., Madeira, H., Oliveira, J., Sargento, L., Ionac, A., Dragulescu, I. S., Mut-Vitcu, B., Maximov, D., Dorobantu, M., Apetrei, E., Niculescu, R., Petrescu, V., Bucsa, A., Deleanu, D., Bucharest, Benedek, I. S., Hintea, T., Aronov, D., Tikhomirova, E., Kranjec, I., Prokselj, K., Kanic, V., Sepetoglu, A., Aytekin, S., Aytekin, V., Catakoglu, A. B., Parlar, H., Tufekcioglu, S., Ozyedek, Z., Baltali, M., Kiziltan, Vukovic, M., and Neskovic, A. N.

Subjects
Male, medicine.medical_specialty, Randomization, medicine.medical_treatment, Euro Heart Survey, Coronary Artery Disease, Revascularization, law.invention, Coronary artery disease, Randomized controlled trial, law, Internal medicine, Angioplasty, medicine, Humans, cardiovascular diseases, Angioplasty, Balloon, Coronary, Coronary Artery Bypass, CABG, Aged, Randomized Controlled Trials as Topic, business.industry, Coronary Artery Bypa, Patient Selection, PCI, Health Survey, Middle Aged, medicine.disease, Health Surveys, Surgery, Clinical trial, Stenosis, surgical procedures, operative, Clinical Trials, Phase III as Topic, Conventional PCI, Female, Cardiology and Cardiovascular Medicine, business, Human
Abstract

Aims: Revascularization in patients with coronary artery disease changed over the last two decades, favouring the number of patients treated by means of percutaneous coronary interventions (PCI) when compared with coronary artery bypass grafting (CABG). Many randomized controlled trials (RCTs) have been performed to compare these two competing revascularization techniques. Because of the strict enrolment criteria of RCTs in which highly selected patients are recruited, the applicability of the results may be limited in clinical practice. The current study evaluates to what extent patients in clinical practice were similar to those who participated in RCTs comparing PCI with CABG. Methods and results: Clinical characteristics and 1-year outcome of 4713 patients enrolled in the Euro Heart Survey on Coronary Revascularization were compared with 8647 patients who participated in 14 major RCTs, comparing PCI with CABG. In addition, we analysed which proportion of survey patients would have disqualified for trial participation (n = 3033, 64%), aiming at identifying differences between trial-eligible and trial-ineligible survey patients. In general, important differences were observed between trial participants and survey patients. Patients in clinical practice were older, more often had comorbid conditions, single-vessel disease, and left main stem stenosis when compared with trial participants. Almost identical differences were observed between trial-eligible and trial-ineligible survey patients. In clinical practice, PCI was the treatment of choice, even in patients who were trial-ineligible (46% PCI, 26% CABG, 28% medical). PCI remained the preferred treatment option in patients with multi-vessel disease (57% in trial-eligible and 40% in trial-ineligible patients, respectively, P < 0.001); yet, the risk profile of patients treated by PCI was better than that for patients treated either by CABG or by medical therapy. In the RCTs, there was no mortality difference between PCI and CABG. In clinical practice, however, we observed 1-year unadjusted survival benefit for PCI vs. CABG (2.9 vs. 5.4%, P < 0.001). Survival benefit was only observed in trial-ineligible patients (3.3 vs. 6.2%, P < 0.001). Conclusion: Many patients in clinical practice were not represented in RCTs. Moreover, only 36% of these patients were considered eligible for participating in a trial comparing PCI with CABG. We demonstrated that RCTs included younger patients with a better cardiovascular risk profile when compared with patients in everyday clinical practice. This study highlights the disparity between patients in clinical practice and patients in whom the studies that provide the evidence for treatment guidelines are performed. © The European Society of Cardiology 2006. All rights reserved.

Published
2006

35. Extended thromboprophylaxis with betrixaban in acutely ill medical patients

Author

Cohen, A. T., Harrington, R. A., Goldhaber, S. Z., Hull, R. D., Wiens, B. L., Gold, A., Hernandez, A. F., Gibson, C. M., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Oliva, M., Parody, M., Poy, C., Baker, R., Colquhoun, D., Coughlin, P., Finfer, S., Rubinfeld, A., Huber, K., Konig, J., Mathies, R., Pilger, E., Schoenerr, H., Adzerikho, I., Koryk, V., Mikhailova, E., Mitkovskaya, N., Pimanov, S., Polonetsy, L., Soroka, N., Blockmans, D., Delforge, M., Dive, A., Lienart, F., Motte, S., Bizzacchi, J., Fiss, E., Freire, A., Manenti, E., Ramacciotti, E., Raymuno, S., Rocha, A., Saraiva, J. F., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Kostadinova, M., Milanova, M., Mincheva, V., Pencheva, G., Raev, D., Runev, N., Stoeva, N., Stoyanov, M., Syulemzova, S., Todorov, G., Tokmakova, M., Dhar, A., Douketis, J., Kahn, S., Le Gal, G., Pearce, M., Provencher, S., Verreault, S., Alarcon, M., Canon, C., Lazcano, M., Cardenas, S., Butkovic-Soldo, S., Car, S., Ciglenecki, N., Francetic, I., Jakopovic, M., Kalinic-Grgorinic, H., Knezevic, A., Malojcic, B., Marusic, S., Vagic, J., Skerk, V., Cermak, O., Chlumsky, J., Chochola, J., Cizek, V., Dunaj, M., Dusek, J., Francek, L., Havelka, J., Herold, M., Holaj, R., Horny, I., Hubac, J., Jajtner, P., Kolman, P., Lang, P., Mayer, O., Mikulova, J., Podpera, I., Reiterer, P., Spacek, R., Vejvoda, J., Vyhnanek, M., Christensen, H., Lassen, M., Storgaard, M., Tuxen, C., Urhammer, S., Lember, M., Marandi, T., Uuetoa, T., Airaksinen, J., Honkaniemi, J., Kaaja, R., Lassila, R., Saarinen, J., Tatlisumak, T., Vikman, S., Agraou, B., Aquilanti, S., Belhassane, A., Brisot, D., De Geeter, G., Debourdeau, P., Decoulx, E., El Kouri, D., Falvo, N., Grange, C., Lacroix, P., Messas, E., Mismetti, P., Montaclair, K., Mottier, D., Paleiron, N., Payot, L., Pernod, G., Pottier, P., Proust, A., Quere, I., Roy, P. M., Schmidt, J., Simoneau, G., Datikashvili-David, I., Khabeishvili, G., Khintibidze, I., Kobulia, B., Megreladze, I., Pagava, Z., Paposhvili, K., Shaburishvili, T., Amann, B., Berrouschot, J., Beyer-Westendorf, J., Blessing, E., Bott, M., Dengler, T., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Schellong, S., Tiefenbacher, C., Weimar, C., Zeymer, U., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Kirschner, R., Kristof, P., Lakatos, F., Laszlo, Z., Lupkovics, G., Merkely, B., Andras, C., Nemeth, L., Papp, A., Soltesz, P., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Vertes, A., Efrati, S., Elias, M., Gafter, A., Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Zeltser, D., Ageno, W., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, Raffaele, Lembo, G., Lodigiani, C., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Visona, A., Krievins, D., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Bagdonas, A., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Leon, R., Pereyra, R., Karlo, L., Horna, M., Osores, J., Salas, M., Yanez, L., Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Tomkowski, W., Walasek, L., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Mot, S., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Panchenko, E., Popov, D., Privalova, E., Reshetko, O., Sergeeva, E., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Tan, R. S., Bodikova, S., Cervenakova, A., Dvorak, M., Gaspar, L., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Jacobson, B., Mitha, I., Van Dyk, C., Sala, L. A., Lopez, C., Bisbe, J., Guardiola, A., Cepeda, J. M., Cereto, F., Santos, E., Ferrer, R., Cerezo, J., Gonzales-Porras, J. R., Grandes, J., Jimenez, D., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Nazliel, B., Okumus, G., Ongen, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Koshlia, V., Krakhmalova, O., Kyrychenko, I., Legkonogov, O., Malynovsky, Y., Maslovaskyi, V., Nikonov, V., Parkhomenko, O., Perepeliuk, M., Reshotko, D., Rudenko, L., Ryabichenko, T., Svyridova, I., Svyshchenko, Y., Tseluyko, V., Ursol, G., Vakaliuk, I., Vishnivestsky, I., Voronkov, L., Yagensky, A., Body, R., Davis, M., Maccallum, P., Mccollum, C., Natarajan, I., Almasri, E., Amin, M., Anderson, C., Baker, S., Barney, J., Bastani, A., Bercz, P., Bidair, M., Carman, T., Chang, H., Clark, C., Concha, M., Cornell, J., Dhingra, R., Doshi, A., Farley, B., Fermann, G., Fraiz, J., Fulmer, J., Gaggin, H., Goytia-Leos, D., Hahn, B., Haidar, A., Hamad, A., Hazelrigg, M., Ioachimescu, O., Kabler, H., Kao, C. K., Kazimir, M., Koura, F., Kung, M., Lerner, R., Lopez, J., Macchiavelli, A., Mahal, S., Margolis, B., Mclaren, G., Milling, T., Mittal, M., Nadar, V., Ohaju, V., Ortel, T., Overcash, J., Parthiban, K., Pearl, R., Pineda, L., Pratt, R., Pullman, J., Quintana, O., Rajan, R., Rastogi, P., Rees, C., Rodriguez, W., Saba, F., Shammas, N., Sharma, S., Sokol, S., Stoltz, S., Tuck, M., Updegrove, J., Warner, A., Welch, M., Welker, J., Whitman, B., Wichman, T., Yousef, K., Yusen, R., Zakai, N., Landolfi R. (ORCID:0000-0002-7913-8576), Cohen, A. T., Harrington, R. A., Goldhaber, S. Z., Hull, R. D., Wiens, B. L., Gold, A., Hernandez, A. F., Gibson, C. M., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Oliva, M., Parody, M., Poy, C., Baker, R., Colquhoun, D., Coughlin, P., Finfer, S., Rubinfeld, A., Huber, K., Konig, J., Mathies, R., Pilger, E., Schoenerr, H., Adzerikho, I., Koryk, V., Mikhailova, E., Mitkovskaya, N., Pimanov, S., Polonetsy, L., Soroka, N., Blockmans, D., Delforge, M., Dive, A., Lienart, F., Motte, S., Bizzacchi, J., Fiss, E., Freire, A., Manenti, E., Ramacciotti, E., Raymuno, S., Rocha, A., Saraiva, J. F., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Kostadinova, M., Milanova, M., Mincheva, V., Pencheva, G., Raev, D., Runev, N., Stoeva, N., Stoyanov, M., Syulemzova, S., Todorov, G., Tokmakova, M., Dhar, A., Douketis, J., Kahn, S., Le Gal, G., Pearce, M., Provencher, S., Verreault, S., Alarcon, M., Canon, C., Lazcano, M., Cardenas, S., Butkovic-Soldo, S., Car, S., Ciglenecki, N., Francetic, I., Jakopovic, M., Kalinic-Grgorinic, H., Knezevic, A., Malojcic, B., Marusic, S., Vagic, J., Skerk, V., Cermak, O., Chlumsky, J., Chochola, J., Cizek, V., Dunaj, M., Dusek, J., Francek, L., Havelka, J., Herold, M., Holaj, R., Horny, I., Hubac, J., Jajtner, P., Kolman, P., Lang, P., Mayer, O., Mikulova, J., Podpera, I., Reiterer, P., Spacek, R., Vejvoda, J., Vyhnanek, M., Christensen, H., Lassen, M., Storgaard, M., Tuxen, C., Urhammer, S., Lember, M., Marandi, T., Uuetoa, T., Airaksinen, J., Honkaniemi, J., Kaaja, R., Lassila, R., Saarinen, J., Tatlisumak, T., Vikman, S., Agraou, B., Aquilanti, S., Belhassane, A., Brisot, D., De Geeter, G., Debourdeau, P., Decoulx, E., El Kouri, D., Falvo, N., Grange, C., Lacroix, P., Messas, E., Mismetti, P., Montaclair, K., Mottier, D., Paleiron, N., Payot, L., Pernod, G., Pottier, P., Proust, A., Quere, I., Roy, P. M., Schmidt, J., Simoneau, G., Datikashvili-David, I., Khabeishvili, G., Khintibidze, I., Kobulia, B., Megreladze, I., Pagava, Z., Paposhvili, K., Shaburishvili, T., Amann, B., Berrouschot, J., Beyer-Westendorf, J., Blessing, E., Bott, M., Dengler, T., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Schellong, S., Tiefenbacher, C., Weimar, C., Zeymer, U., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Kirschner, R., Kristof, P., Lakatos, F., Laszlo, Z., Lupkovics, G., Merkely, B., Andras, C., Nemeth, L., Papp, A., Soltesz, P., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Vertes, A., Efrati, S., Elias, M., Gafter, A., Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Zeltser, D., Ageno, W., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, Raffaele, Lembo, G., Lodigiani, C., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Visona, A., Krievins, D., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Bagdonas, A., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Leon, R., Pereyra, R., Karlo, L., Horna, M., Osores, J., Salas, M., Yanez, L., Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Tomkowski, W., Walasek, L., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Mot, S., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Panchenko, E., Popov, D., Privalova, E., Reshetko, O., Sergeeva, E., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Tan, R. S., Bodikova, S., Cervenakova, A., Dvorak, M., Gaspar, L., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Jacobson, B., Mitha, I., Van Dyk, C., Sala, L. A., Lopez, C., Bisbe, J., Guardiola, A., Cepeda, J. M., Cereto, F., Santos, E., Ferrer, R., Cerezo, J., Gonzales-Porras, J. R., Grandes, J., Jimenez, D., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Nazliel, B., Okumus, G., Ongen, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Koshlia, V., Krakhmalova, O., Kyrychenko, I., Legkonogov, O., Malynovsky, Y., Maslovaskyi, V., Nikonov, V., Parkhomenko, O., Perepeliuk, M., Reshotko, D., Rudenko, L., Ryabichenko, T., Svyridova, I., Svyshchenko, Y., Tseluyko, V., Ursol, G., Vakaliuk, I., Vishnivestsky, I., Voronkov, L., Yagensky, A., Body, R., Davis, M., Maccallum, P., Mccollum, C., Natarajan, I., Almasri, E., Amin, M., Anderson, C., Baker, S., Barney, J., Bastani, A., Bercz, P., Bidair, M., Carman, T., Chang, H., Clark, C., Concha, M., Cornell, J., Dhingra, R., Doshi, A., Farley, B., Fermann, G., Fraiz, J., Fulmer, J., Gaggin, H., Goytia-Leos, D., Hahn, B., Haidar, A., Hamad, A., Hazelrigg, M., Ioachimescu, O., Kabler, H., Kao, C. K., Kazimir, M., Koura, F., Kung, M., Lerner, R., Lopez, J., Macchiavelli, A., Mahal, S., Margolis, B., Mclaren, G., Milling, T., Mittal, M., Nadar, V., Ohaju, V., Ortel, T., Overcash, J., Parthiban, K., Pearl, R., Pineda, L., Pratt, R., Pullman, J., Quintana, O., Rajan, R., Rastogi, P., Rees, C., Rodriguez, W., Saba, F., Shammas, N., Sharma, S., Sokol, S., Stoltz, S., Tuck, M., Updegrove, J., Warner, A., Welch, M., Welker, J., Whitman, B., Wichman, T., Yousef, K., Yusen, R., Zakai, N., and Landolfi R. (ORCID:0000-0002-7913-8576)

Abstract

BACKGROUND: Patients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown. METHODS: 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. RESULTS: 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). CONCLUSIONS: Among acutely ill medical patients with an elevated D-dimer level, there was no

Published
2016

37. Oral Apixaban for the Treatment of Acute Venous Thromboembolism

Author

Agnelli, G, Buller, H, Cohen, A, Gallus, A, Raskob, G, Weitz, J, Prins, M, Brandjes, D, Kolbach, D, Limburg, M, Mac Gillavry, M, Otten, Jm, Peters, R, Roos, Y, Segers, A, Slagboom, T, Bounameaux, H, Hirsh, J, Samama, Mm, Wedel, H, Curto, M, Johnson, M, Masiukiewicz, U, Pak, R, Porcari, A, Sanders, P, Sisson, M, Sullivan, B, Thompson, J, Auerbach, J, Cesario, L, Crawford, J, Gordon, M, Noble, M, Pennington, A, Reinhold, P, Simmons, M, Urwin, K, Ceresetto, J, Mcrae, S, Pabinger, I, Pereira, Ah, Spencer, F, Wang, C, Zhang, J, Gorican, K, Husted, Se, Mottier, D, Harenberg, J, Vértes, A, Pinjala, R, Zeltser, D, Prandoni, Paolo, Sandset, M, Torbicki, A, Fijalkowska, A, Alvares, Jp, Kirienko, A, Shvarts, Y, Sala, La, Jacobson, B, Gudz, I, Ortel, T, Spyropoulos, A, Beyer Westendorf, J, Sipos, G, Bredikhin, R, Della Siega, A, Klinke, W, Lawall, H, Zwettler, U, Prasol, V, Cannon, K, Vasylyuk, S, Jin, B, Prandoni, P, Desai, S, Zaichuk, A, Katelnitskiy, I, De Pellegrin, A, Santonastaso, M, Skupyy, O, Pesant, Y, Shvalb, P, Spacek, R, Visonà, A, Alvarez Sala, L, Borja, V, Noori, E, Sereg, M, Braester, A, Falvo, N, Vöhringer, H, Laperna, L, Oliven, A, Skalicka, L, Bolster, D, Haidar, A, Schellong, S, Smith, S, Sergeev, O, Pullman, J, Torp Pedersen, C, Zimlichman, R, Elias, M, Fourie, N, Pernod, G, Panchenko, E, Pendleton, R, van Nieuwenhuizen, E, Vinereanu, D, Becattini, C, Manina, G, Leduc, J, Dunaj, M, Frost, L, Gavish, D, Jakobsen, T, Lishner, M, Morales, L, Chochola, J, Gubka, O, Holaj, R, Hussein, O, Katona, A, Sergeeva, E, Bova, C, Cepeda, J, Cohen, K, Sobkowicz, B, Grzelakowski, P, Husted, S, Lupkovics, G, Dedek, V, Liu, C, Puskas, A, Ritchie, B, Ambrosio, G, Parisi, R, Heuer, H, Livneh, A, Podpera, I, Stanbro, M, Caraco, Y, Fulmer, J, Ghirarduzzi, A, Schmidt Lucke, J, Bergmann, J, Cizek, V, Leyden, M, Stein, R, Abramov, I, Chong, B, Colan, D, Jindal, R, Liu, S, Pereira, A, Porreca, E, Salem, H, Welker, J, Yusen, R, Dhar, A, Podczeck Schweighofer, A, Shtutin, O, Vital Durand, D, Balaji, V, Correa, J, Kline, J, Runyon, M, Laszlo, Z, Martelet, M, Parakh, R, Sandset, Pm, Schmidt, J, Yeo, E, Bhagavan, N, Bura Riviere, A, Ferrer, J, Lacroix, P, Lewczuk, J, Pilger, E, Sokurenko, G, Yu, H, Nikulnikov, P, Pabinger Fasching, I, Sanchez Diaz, C, Schuller, D, Suresh, K, Lobo, S, Lyons, R, Marschang, P, Palla, A, Schulman, S, Spyropoulous, A, Fraiz, J, Gerasymov, V, Lerner, R, Llamas Esperón, G, Manenti, E, Masson, J, Moreira, R, Poy, C, Rodoman, G, Bruckner, I, Gurghean, A, Carrier, M, Freire, A, Gan, E, Gibson, K, Herold, M, Hudcovic, M, Kamath, G, Koslow, A, Meneveau, N, Roos, J, Zahn, R, Balanda, J, Bratsch, H, Dolan, S, Gould, T, Hirschl, M, Hoffmann, U, Kaatz, S, Shah, V, Kadapatti, K, Kræmmer Nielsen, H, Lahav, M, Natarajan, S, Tuxen, C, Tveit, A, Alves, C, Formiga, A, Brudevold, R, Cardozo, M, Lorch, D, Marais, H, Mismetti, P, Panico, M, Pop, C, Quist Paulsen, P, Stevens, D, Tarleton, G, Yoshida, W, Cox, M, Crispin, P, Czekalski, P, Ebrahim, I, Game, M, Ghanima, W, Harrington, D, Jackson, D, Lee, A, Matoska, P, Meade, A, Camargo, Ac, Nishinari, K, Sanchez Llamas, F, Tosetto, A, Vejby Christensen, H, Basson, M, Blombery, P, Fu, G, Jha, V, Keltai, K, Le Jeunne, C, Lodigiani, C, Ma, Y, Nagy, A, Neumeister, A, Shotan, A, Wong, T, Ying, K, Anderson, S, Brenner, B, Carnovali, M, Cerana, S, Cunha, C, Diaz Castañon, J, Graham, M, Kirenko, A, Palareti, G, Rodriguez Cintron, W, Nathanson, A, Rosenthal, S, Sanders, D, Scheinberg, P, Schjesvold, F, Torp, R, van Zyl, L, Venher, I, Xia, G, Brockmyre, A, Chen, Z, Hakki, S, Hanefield, C, Mügge, A, Janczak, D, Karpovych, D, Lancaster, G, Lavigne, C, Lugassy, G, Melaniuk, M, Moran, J, Oliver, M, Schattner, A, Staroverov, I, Timi, J, Vöhringer, F, von Bilderling, P, Warr, T, White, R, Wronski, J, Wu, C, Almeida, C, Blum, A, Bono, J, Durán, M, Erzinger, F, Fu, W, Jagadesan, R, Jurecka, W, Korban, E, Nguyen, D, Raval, M, Willms, D, Zevin, S, Zhu, H, Abdullah, I, Achkar, A, Albuquerque, L, Ali, M, Bai, C, Bloomfield, D, Chen, J, Fajardo Campos, P, Garcia Bragado, F, Kobza, I, Lindhoff Last, E, Lourenço, A, Marchena Yglesias, P, Marshall, P, Siegel, M, Mikhailova, O, Oliva, M, Pottier, P, Pruszczyk, P, Sauer, M, Baloira, A, Cromer, M, D'Angelo, A, Faucher, J, Gutowski, P, Hong, S, Lissauer, M, Lopes, A, Lopes, R, Maholtz, M, Mesquita, E, Miekus, P, Mohan, B, Ng, H, Peterson, M, Piovella, F, Siragusa, S, Srinivas, R, Tiberio, G, Van Bellen, B, Arutyunov, G, Assi, N, Baker, R, Blanc, F, Curnow, J, Fu, C, Gonzalez Porras, J, Guijarro Merino, R, Gunasingam, S, Gupta, P, Laule, M, Liu, Z, Luber, J, Serifilippi, G, Paulson, R, Shevela, A, Simonneau, G, Siu, D, Sosa Liprandi, M, Takács, J, Tay, J, Vora, K, Witkiewicz, W, Zhao, L, Aquilanti, S, Dabbagh, O, Dellas, C, Denaro, C, Doshi, A, Flippo, G, Giumelli, C, Gomez Cerezo, J, Han, D, Harris, L, Hofmann L., Jr, Kamerkar, D, Kaminski, L, Kazimir, M, Kloczko, J, Ko, Y, Koura, F, Lavender, R, Maly, J, Margolis, B, Mos, L, Sanchez Escalante, L, Solvang, A, Soroka, V, Szopinski, P, Thawani, H, Vickars, L, Yip, G, Zangroniz, P., Internal and Cardiovascular Medicine - Stroke Unit (PERUGIA - ICM-SU), Università degli Studi di Perugia (UNIPG), Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), King's College Hospital (KCH), Department of Haematology (ADELAIDE - Dep Haemato), Flinders Medical Centre-Flinders University, Health Sciences Center (OKLAHOMA - HSC), University of Oklahoma (OU), Thrombosis and Atherosclerosis Research Institute (TARI), McMaster University [Hamilton, Ontario], Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, APH - Amsterdam Public Health, Cardiology, ANS - Amsterdam Neuroscience, Neurology, and Other departments

Subjects
Male, MESH: Factor Xa, [SDV]Life Sciences [q-bio], Administration, Oral, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, THERAPY, MESH: Venous Thromboembolism, chemistry.chemical_compound, 0302 clinical medicine, Edoxaban, MESH: Double-Blind Method, 030212 general & internal medicine, MESH: Warfarin, MESH: Treatment Outcome, MESH: Aged, RISK, MESH: Middle Aged, General Medicine, MESH: Follow-Up Studies, Venous Thromboembolism, Middle Aged, 3. Good health, Pulmonary embolism, Treatment Outcome, MESH: Administration, Oral, Acute Disease, MESH: Acute Disease, Apixaban, Female, MESH: Hemorrhage, medicine.drug, Andexanet alfa, Adult, medicine.medical_specialty, MESH: Enoxaparin, Pyridones, PULMONARY-EMBOLISM, Hemorrhage, MESH: Anticoagulants, 03 medical and health sciences, Double-Blind Method, BINOMIAL TRIALS, Internal medicine, MESH: Pyridones, medicine, Humans, Enoxaparin, MESH: Kaplan-Meier Estimate, RIVAROXABAN, Aged, Rivaroxaban, MESH: Humans, business.industry, Warfarin, Anticoagulants, MESH: Adult, medicine.disease, Confidence interval, MESH: Male, Surgery, chemistry, Relative risk, Pyrazoles, business, MESH: Female, MESH: Pyrazoles, Factor Xa Inhibitors, Follow-Up Studies
Abstract

International audience; BACKGROUND: Apixaban, an oral factor Xa inhibitor administered in fixed doses, may simplify the treatment of venous thromboembolism. METHODS: In this randomized, double-blind study, we compared apixaban (at a dose of 10 mg twice daily for 7 days, followed by 5 mg twice daily for 6 months) with conventional therapy (subcutaneous enoxaparin, followed by warfarin) in 5395 patients with acute venous thromboembolism. The primary efficacy outcome was recurrent symptomatic venous thromboembolism or death related to venous thromboembolism. The principal safety outcomes were major bleeding alone and major bleeding plus clinically relevant nonmajor bleeding. RESULTS: The primary efficacy outcome occurred in 59 of 2609 patients (2.3%) in the apixaban group, as compared with 71 of 2635 (2.7%) in the conventional-therapy group (relative risk, 0.84; 95% confidence interval [CI], 0.60 to 1.18; difference in risk [apixaban minus conventional therapy], -0.4 percentage points; 95% CI, -1.3 to 0.4). Apixaban was noninferior to conventional therapy (P

Published
2013
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45. Candida bloodstream infections in intensive care units: analysis of the extended prevalence of infection in intensive care unit study

Author

Keth, Th, Azoulay, E, Echeverria, Pm, Vincent, Jl, Collaboratorsmargarit, A, Valentini, R, Alan Javier, Z, Bevilacqua, C, Curone, M, Rabuffetti, R, Comignani, P, Torres Boden, M, Chertcoff, F, Cardonatti, G, Adén, F, Marcos, L, Dónofrio, M, Fernández, R, Lamberghini, R, Balasini, S, Teves, J, Las Heras, M, Sinner, J, Ceraso, D, Curcio, D, Aguilar, L, Weller, C, Cardonnet, L, Santa Cruz, R, Manrique, E, Bernardez, D, Iolster, T, Chiappero, G, Ramos, P, Vergara, J, Moine, I, Ilutovich, S, Jannello, G, Waschbusch, M, Rios Picaza, G, Raimondi, A, Miriam, M, Lovesio, C, Caridi, M, Leong, T, Orford, N, Reece, G, Ernest, D, Hawker, F, Tan, J, Giannellis, C, Ihle, B, Bersten, A, Mcinnes, J, Tallott, M, Mcfadyen, B, Vibert, J, Parr, M, Tran, K, Sutton, J, Webb, S, Groves, N, Cole, L, Long, D, Bass, F, Erickson, S, Lipman, J, Delzoppo, C, Thomas, J, Dobb, G, Daley, M, Roberts, B, Santamaria, J, Young, J, Festa, M, Holland, R, Mullany, D, Williams, P, Corkeron, M, Gales, M, Banerjee, A, Yung, M, Mutz, N, Hiesmayr, M, Faybik, P, Fitzgerald, R, Firlinger, F, Zasmeta, G, Zink, M, Sieber, W, Hildegard, J, Bakondy, R, Schlieber, J, Filzwieser, G, Beer, R, Joannidis, M, Schuster, R, Scherzer, W, Smolle, K, Fitzal, S, Manzoor, R, Brunain, J, D'Hondt, A, Huylenbroeck, G, Van der Schueren, M, 't Kindt, H, Slock, E, Rijckaert, D, Raemaekers, J, Bourgeois, M, Van Cotthem, I, Nackaerts, G, Gusu, D, Gadisseux, P, Vancollie, O, Lignian, H, Michel, P, Fraipont, V, Vander Stappen, M, Forêt, F, De Bels, D, Devriendt, J, Massaut, J, Biston, P, Roman, A, Lambermont, B, De Meulder, A, Frederic, V, Sottiaux, T, Ruyffelaere, P, Collin, V, Anane, S, Kleiren, P, Simon, M, Machayekhi, S, Frans, E, Leroy, G, Berghmans, T, Joseph, R, Eerens, J, Laterre, P, Lagrou, B, Rutsaert, R, Pisarek, W, Dive, A, De Waele, J, Spapen, H, Damas, P, Malbrain, M, Hidalgo, J, Baptista, M, Salgado, D, Braga, M, Avila, C, Westphal, G, Caser, E, Alves, A, Friedman, G, Luz, M, Assuncao, M, Reis, H, Gomes, A, Silva, U, Nogueira Fh, W, El Dash, S, Valiatti, J, Barbosa, A, Coelho, C, Knibel, M, Minelli, C, Caovilla, J, Teixeira, G, Hovnanian, A, Rea Neto, A, Lobo, S, Lugarinho, M, Souza, P, Ferreira, D, Duarte, P, Oliveira, M, Marques, J, Machado, R, Rehder, P, Mataloun, S, Grilo, M, Quesado, P, Moock, M, Ferreira, F, Teles, J, Silva, E, Morais, A, Bruzzi de Carvalho, F, Wanderley, M, Velasco, M, Brandão da Silva, N, Feijó, J, Souza Dantas, V, Costa Filho, R, Japiassú, A, Villela, D, Santos, C, Passos, R, Alheira Rocha, R, Silva, R, Houly, J, Aldrighi, J, Hatum, R, Suparregui Dias, F, Ferreira, L, Ferro, L, Gomez, J, Fleury, R, David, C, Resener, T, Mendes, C, Germano, A, De Marco, F, Lage, S, Salluh, J, Torelly, A, Sad, R, Oliveira, G, Lima, R, Paranhos, J, Rocha, M, Bitencourt, W, Grion, C, Forte, D, Guimarães, H, Piras, C, Stephanova, L, Lyubenov, L, Tsarianski, G, Dimov, G, Green, R, Levasseur, J, Ward, R, Lesur, O, Poirier, G, Wax, R, Wood, G, Cook, D, Marshall, J, Herridge, M, Ferguson, N, 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Nguyen Huu, C.

Published
2011

46. Apixaban versus Enoxaparin for Thromboprophylaxis in Medically Ill Patients

Author

Goldhaber, Sz, Leizorovicz, A, Kakkar, A, Haas, Sk, Merli, G, Weitz, Ji, Ceresetto, Jm, Kyrle, P, Gallus, A, Cools, F, Saraiva, J, Faucher, Jp, Chlumsky, J, Husted, S, Emmerich, J, Bauersachs, R, Zeltser, D, Prandoni, Paolo, Ghiraduzzi, A, Leiva, J, Sparby, Ja, Torbiki, A, Kobalava, Z, Jacobson, B, Suarez, C, Fu, M, Savas, I, Parkhomenko, A, Ansell, J, Landis, Jr, Elliott, Cg, Borris, Lc, Samama, Mm, Pinede, L, Becker, F, Coppere, B, Nony, P, Merah, A, Alves, M, Boulet, H, Loppinet, A, Nicol, C, Ohanessian, L, Roncato, C, Knabb, Rm, Liaw, D, Smith, K, Hess, T, Rossi, L, Chen, D, Doan, C, Doran, J, Matheis, E, Ballard, M, Tsarova, O, Levenstein, S, Tvedegaard, M, Akkal, Z, Jure, H, Mercado, Da, Zangroniz, P, Constantino, M, Bello, F, Giumelli, C, de Sagastizabal, D, Risso Patron, F, Ceresetto, J, Dran, R, Vita, N, Baratta, S, Ahuad Guerrero, R, Penchasky, D, Rubinfeld, A, Layden, M, Karrasch, J, Coughlin, P, Peters, M, Gibbs, H, Ward, Ch, Hahn, U, Pilger, E, Minar, E, El Allaf, D, Marechal, P, Motte, S, Verhamme, P, Wollaert, B, Duck, L, Freire, A, Piegas, L, Jorge, Jm, Guimaraes, H, Oliveira, M, Blacher, C, Leães, P, Toniolo, J, Okoshi, M, Rosa, Dd, Cunha, C, Lobo, S, Leader, R, Dhar, A, Tarabain, O, Miron, M, Brossoit, R, Kahn, S, Kassis, J, Douketis, J, Spencer, F, Faucher, J, Alarcon, Ma, Gutierrez Valenzuela, F, Bisbal Malig, C, Vejar, M, Jaramillo, N, Saaibi, D, Londono, D, Kolman, P, Reiterer, P, Ballek, L, Spacek, R, Soucek, M, Patek, F, Vitovec, M, Kovarova, K, Ceska, R, Podpera, I, Faber, J, Oestergaard, L, Vejby Christensen, H, Frost, L, Rasmussen, Sl, Tuxen, C, Ingerslev, J, Knudsen, T, Torp Pedersen, C, Pedersen, C, Nielsen, H, Mottier, D, Simoneau, G, Leduc, J, Lorcerie, B, Paleiron, N, Proust, A, Conri, C, Pernod, G, Mismetti, P, Achkar, A, Maignan, M, Harenberg, J, Beyer, J, Horacek, T, Lawall, H, Hecker, U, Hammerstingl, C, Weil, J, Fischer, D, Brachmann, J, Klepzig, H, Cheng, G, Soltesz, P, Schnabel, R, Futo, L, Jobbagy, L, Singh, P, Talwar, D, Bhadade, R, Bharani, A, Krishnamurthy, S, Goyal, A, Mehta, P, Samiuddin, M, D'Souza, G, Sinha, S, Sathe, P, Sethuraman, S, Jaganmani, S, Sundaram, P, Saxena, A, Mehta, M, Omar, A, Rajkumar, J, Jog, S, Kumar, S, Hayek, T, Hussein, O, Lahav, M, Efrati, S, Elias, M, Grossman, E, Lugassy, G, Porath, A, Porreca, E, Prandoni, P, Tosetto, A, Imberti, D, Pierfranceschi, G, Ghirarduzzi, A, Scannapieco, G, Testa, S, Ling, P, Yusoff, K, Yusof, Z, Lopez Rosas, E, Hernandez, I, Nanez Terreros, H, Flota, L, Campos, E, Alcocer, M, Viergever, P, Sparby, J, Cotrina, R, Salas, M, Pamo, O, Fajardo, L, Horna, M, Ulloa, V, Toce, L, Moncada, Z, Salazar, O, Habaluyas, R, Collado, F, Edmilao, M, Abola, T, Sevilla, R, Torbicki, A, Tracz, W, Kasprzak, J, Jastrzebski, D, Psuja, P, Hiczkiewicz, J, Piepiorka, M, Pulkowski, G, Tyszkiewicz, I, Kuc, K, Gordeev, I, Boyarkin, M, Privalov, D, Abrosimov, V, Reshetko, O, Goloshchekin, B, Vishnevsky, A, Boldueva, S, Kostenko, V, Mkrtchian, V, Chernichka, I, Belenkov, Y, Rodoman, G, Andreev, D, Shvarts, Y, Aleksandrov, O, Zadionchenko, V, Klochkov, O, Tay, J, Jagadesan, R, Basson, M, Siebert, R, Viljoen, J, Gray, T, Abdool Gaffar, M, Suh, G, In, K, Choi, D, Kim, S, Baek, S, Chung, H, Shin, J, Alvarez Sala, L, Cepeda, J, Ferrer, M, Mallibovsky, L, Garcia Morillo, J, Villalta, J, Gomez Cerezo, J, Capitán, F, Gonzalez Garrido, F, Guijarro, C, Jimenez, D, Richart, C, Elf, J, Ueng, K, Huang, T, Karan, A, Erten, N, Abrahamovych, O, Chopey, I, Gavrysiuk, V, Kraiz, I, Karpenko, A, Volkov, V, Denesyuk, V, Kharchenko, N, Tseluyko, V, Batushkin, V, Sushko, V, Yagensky, A, Ignatenko, G, Dziublyk, O, Cohen, A, Bareford, D, Kesteven, P, Mccollum, P, Das, S, Conrad, S, Botnick, W, Nathanson, A, Hamad, A, Fraiz, J, Goytia Leos, D, Fulmer, J, Mclaren, G, Streiff, M, Hahn, B, Ardolic, B, Klausner, H, Welch, M, Pullman, J, Phillips, D, Felt, J, Mitchell, G, Margolis, B, Pendleton, R, Mahesh, A, Barney, J, Shadan, F, Schuller, D, Joslin, S, Feldman, J, Pearl, R, Welker, J, Hazelrigg, M, Stevens, S, Siegel, M, Meade, A, Bates, J, Tahirkheli, N, Rosenberg, D, Dishman, K, Ikerd, T, Feldman, G, O'Connell, C, Vaince, U, Dabbagh, O, Eyster, E, Weinstein, G, Ginsberg, R, Fine, J, Tillinghast, A, Alabi, F, Nathan, R, Haught, H, Oliver, M., Cardiovascular Division (SZG), Brigham and Women's Hospital [Boston], Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Thrombosis Research Institute (AKK), University College of London [London] (UCL), Institute for Experimental Oncology and Therapy Research (IEOTR), Technische Universität Munchen - Université Technique de Munich [Munich, Allemagne] (TUM), Jefferson Medical College (JMC), Thomas Jefferson University Hospitals, Thrombosis and Atherosclerosis Research Institute (TARI), McMaster University [Hamilton, Ontario], Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), and Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, MESH: Pulmonary Embolism, Placebo-controlled study, MESH: Hospitalization, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, MESH: Venous Thromboembolism, chemistry.chemical_compound, 0302 clinical medicine, MESH: Aged, 80 and over, Randomized controlled trial, law, Risk Factors, MESH: Risk Factors, Medicine, MESH: Double-Blind Method, 030212 general & internal medicine, MESH: Treatment Outcome, Aged, 80 and over, MESH: Aged, MESH: Middle Aged, General Medicine, Orvostudományok, Venous Thromboembolism, Middle Aged, 3. Good health, Pulmonary embolism, Hospitalization, Treatment Outcome, Acute Disease, MESH: Acute Disease, Apixaban, Female, Respiratory Insufficiency, MESH: Hemorrhage, medicine.drug, Adult, medicine.medical_specialty, Randomization, MESH: Enoxaparin, Pyridones, Medicina, Hemorrhage, MESH: Anticoagulants, MESH: Drug Administration Schedule, Klinikai orvostudományok, Drug Administration Schedule, 03 medical and health sciences, Double-Blind Method, Internal medicine, MESH: Pyridones, Humans, Risk factor, Enoxaparin, MESH: Kaplan-Meier Estimate, Aged, Heart Failure, MESH: Humans, business.industry, Anticoagulants, MESH: Adult, medicine.disease, MESH: Male, Surgery, chemistry, Relative risk, Betrixaban, MESH: Heart Failure, Pyrazoles, business, Pulmonary Embolism, MESH: Female, MESH: Pyrazoles, MESH: Respiratory Insufficiency, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

The efficacy and safety of prolonging prophylaxis for venous thromboembolism in medically ill patients beyond hospital discharge remain uncertain. We hypothesized that extended prophylaxis with apixaban would be safe and more effective than short-term prophylaxis with enoxaparin. METHODS: In this double-blind, double-dummy, placebo-controlled trial, we randomly assigned acutely ill patients who had congestive heart failure or respiratory failure or other medical disorders and at least one additional risk factor for venous thromboembolism and who were hospitalized with an expected stay of at least 3 days to receive apixaban, administered orally at a dose of 2.5 mg twice daily for 30 days, or enoxaparin, administered subcutaneously at a dose of 40 mg once daily for 6 to 14 days. The primary efficacy outcome was the 30-day composite of death related to venous thromboembolism, pulmonary embolism, symptomatic deep-vein thrombosis, or asymptomatic proximal-leg deep-vein thrombosis, as detected with the use of systematic bilateral compression ultrasonography on day 30. The primary safety outcome was bleeding. All efficacy and safety outcomes were independently adjudicated. RESULTS: A total of 6528 subjects underwent randomization, 4495 of whom could be evaluated for the primary efficacy outcome - 2211 in the apixaban group and 2284 in the enoxaparin group. Among the patients who could be evaluated, 2.71% in the apixaban group (60 patients) and 3.06% in the enoxaparin group (70 patients) met the criteria for the primary efficacy outcome (relative risk with apixaban, 0.87; 95% confidence interval [CI], 0.62 to 1.23; P = 0.44). By day 30, major bleeding had occurred in 0.47% of the patients in the apixaban group (15 of 3184 patients) and in 0.19% of the patients in the enoxaparin group (6 of 3217 patients) (relative risk, 2.58; 95% CI, 1.02 to 7.24; P = 0.04). CONCLUSIONS: In medically ill patients, an extended course of thromboprophylaxis with apixaban was not superior to a shorter course with enoxaparin. Apixaban was associated with significantly more major bleeding events than was enoxaparin, Supported by Bristol-Myers Squibb and Pfizer

Published
2011
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50. The High Energy Behavior of the Forward Scattering Parameters ��total $��$, and $B$

Author

Block, M. M., Halzen, F., Margolis, B., and White, A. R.

Subjects
High Energy Physics - Phenomenology (hep-ph), FOS: Physical sciences
Abstract

Utilizing the most recent experimental data, we reanalyze high energy \pbar p and pp data, using two distinct (and {\em dissimilar}) analysis techniques: (1) asymptotic amplitude analysis, under the assumption that we have reached `asymptopia', and (2) an eikonal model whose amplitudes are designed to mimic real QCD amplitudes. The former gives strong evidence for a $\log \,(s/s_0)$ dependence at {\em current} energies and {\em not} $\log^2 (s/s_0)$, and demonstrates that odderons are {\em not} necessary to explain the experimental data. The latter gives a unitary model for extrapolation into true `asymptopia' from current energies, allowing us to predict the values of the total cross section at future supercolliders. Using our QCD-model, we obtain $\stot(16\,\, {\rm TeV})=109\pm4$\,mb and $\stot(40\,\, {\rm TeV})=124\pm4$\,mb., 14 pages in latex, 8 figures included as a uuencoded file (NUHEP preprint 389)

Published
1994
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