IRIS

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, extendedduration betrixaban significantly reduced all-cause stroke and ischemic stroke through 77 days of follow-up

Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients An APEX Trial Substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban) / Gibson, Cm; Chi, G; Halaby, R; Korjian, S; Daaboul, Y; Jain, P; Arbetter, D; Goldhaber, Sz; Hull, R; Hernandez, Af; Gold, A; Bandman, O; Harrington, Ra; Cohen, At; Bello, F; Ferrari, Ae; Jure, H; Macin, S; Oliva, M; Parody, M; Poy, C; Baker, R; Coughlin, P; Finfer, S; Rubinfeld, A; Huber, K; Konig, J; Mathies, R; Schoenerr, H; Adzerikho, I; Koryk, V; Mikhailova, E; Mitkovskaya, N; Pimanov, S; Polonetsy, L; Soroka, N; Blockmans, D; Delforge, M; Dive, A; Lienart, F; Bizzacchi, Ja; Fiss, E; Freire, A; Manenti, E; Ramacciotti, E; Raymuno, S; Rocha, A; Dimov, B; Grigorov, M; Kalpachki, R; Kamenova, Z; Kostadinova, M; Milanova, M; Pencheva, G; Runev, N; Stoeva, N; Stoyanov, M; Syulemzova, S; Todorov, G; Tokmakova, M; Dhar, A; Douketis, J; Le Gal, G; Pearce, M; Provencher, S; Verreault, S; Alarcon, Ma; Lazcano, Mo; Cardenas, Sp; Butkovic-Soldo, S; Car, S; Ciglenecki, N; Francetic, I; Jakopovic, M; Kalinic-Grgorinic, H; Knezevic, A; Marusic, S; Vagic, Js; 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; 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; Debourdeau, P; Decoulx, E; El Kouri, D; Falvo, N; Grange, C; Lacroix, P; Messas, E; Mismetti, P; Montaclair, K; Paleiron, N; Payot, L; Pernod, G; Pottier, P; Proust, A; Quere, I; Roy, Pm; Schmidt, J; Simoneau, G; Datikashvili-David, I; Khabeishvili, G; Khintibidze, I; Kobulia, B; Megreladze, I; Pagava, Z; Paposhvili, K; 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; Tiefenbacher, C; Weimar, C; Alkonyi, B; Falukozy, J; Futo, L; Katona, A; Kirschner, R; Kristof, P; Lakatos, F; Laszlo, Z; Lupkovics, G; Merkely, B; Andras, Cn; 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; Leon, Rc; Pereyra, Rc; Karlo, Lf; Horna, M; Salas, M; Yanez, Lt; 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, Ze; 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; 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; 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; Sala, Laa; Lopez, Cb; Bisbe, J; Guardiola, Ac; Cepeda, Jm; Cereto, F; Santos, Ed; Ferrer, R; Cerezo, Jg; Gonzales-Porras, Jr; Grandes, J; Jimenez, D; Mellibovsky, L; Richart, C; Riera, A; Trujillo, J; Nunez, Jav; Villalta, J; Akgul, O; Guneri, S; Kilichesmez, K; Kirma, C; Kutluk, H; Nazliel, B; 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; 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, Ck; 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; Tuck, M; Updegrove, J; Warner, A; Welch, M; Welker, J; Whitman, B; Wichman, T; Yousef, K; Zakai, N. - In: CIRCULATION. - ISSN 0009-7322. - 135:7(2017), pp. 648-655. [10.1161/CIRCULATIONAHA.116.025427]

Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients An APEX Trial Substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban)

Imberti D;
2017-01-01

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, extendedduration betrixaban significantly reduced all-cause stroke and ischemic stroke through 77 days of follow-up
2017
Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients An APEX Trial Substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban) / Gibson, Cm; Chi, G; Halaby, R; Korjian, S; Daaboul, Y; Jain, P; Arbetter, D; Goldhaber, Sz; Hull, R; Hernandez, Af; Gold, A; Bandman, O; Harrington, Ra; Cohen, At; Bello, F; Ferrari, Ae; Jure, H; Macin, S; Oliva, M; Parody, M; Poy, C; Baker, R; Coughlin, P; Finfer, S; Rubinfeld, A; Huber, K; Konig, J; Mathies, R; Schoenerr, H; Adzerikho, I; Koryk, V; Mikhailova, E; Mitkovskaya, N; Pimanov, S; Polonetsy, L; Soroka, N; Blockmans, D; Delforge, M; Dive, A; Lienart, F; Bizzacchi, Ja; Fiss, E; Freire, A; Manenti, E; Ramacciotti, E; Raymuno, S; Rocha, A; Dimov, B; Grigorov, M; Kalpachki, R; Kamenova, Z; Kostadinova, M; Milanova, M; Pencheva, G; Runev, N; Stoeva, N; Stoyanov, M; Syulemzova, S; Todorov, G; Tokmakova, M; Dhar, A; Douketis, J; Le Gal, G; Pearce, M; Provencher, S; Verreault, S; Alarcon, Ma; Lazcano, Mo; Cardenas, Sp; Butkovic-Soldo, S; Car, S; Ciglenecki, N; Francetic, I; Jakopovic, M; Kalinic-Grgorinic, H; Knezevic, A; Marusic, S; Vagic, Js; 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; 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; Debourdeau, P; Decoulx, E; El Kouri, D; Falvo, N; Grange, C; Lacroix, P; Messas, E; Mismetti, P; Montaclair, K; Paleiron, N; Payot, L; Pernod, G; Pottier, P; Proust, A; Quere, I; Roy, Pm; Schmidt, J; Simoneau, G; Datikashvili-David, I; Khabeishvili, G; Khintibidze, I; Kobulia, B; Megreladze, I; Pagava, Z; Paposhvili, K; 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; Tiefenbacher, C; Weimar, C; Alkonyi, B; Falukozy, J; Futo, L; Katona, A; Kirschner, R; Kristof, P; Lakatos, F; Laszlo, Z; Lupkovics, G; Merkely, B; Andras, Cn; 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; Leon, Rc; Pereyra, Rc; Karlo, Lf; Horna, M; Salas, M; Yanez, Lt; 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, Ze; 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; 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; 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; Sala, Laa; Lopez, Cb; Bisbe, J; Guardiola, Ac; Cepeda, Jm; Cereto, F; Santos, Ed; Ferrer, R; Cerezo, Jg; Gonzales-Porras, Jr; Grandes, J; Jimenez, D; Mellibovsky, L; Richart, C; Riera, A; Trujillo, J; Nunez, Jav; Villalta, J; Akgul, O; Guneri, S; Kilichesmez, K; Kirma, C; Kutluk, H; Nazliel, B; 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; 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, Ck; 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; Tuck, M; Updegrove, J; Warner, A; Welch, M; Welker, J; Whitman, B; Wichman, T; Yousef, K; Zakai, N. - In: CIRCULATION. - ISSN 0009-7322. - 135:7(2017), pp. 648-655. [10.1161/CIRCULATIONAHA.116.025427]
1.1 Articolo su rivista
File in questo prodotto:
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/3036625
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus ND
  • ???jsp.display-item.citation.isi??? 56
social impact