Abstract
Background: Real-world data on non-vitamin K oral anticoagulants (NOACs) are essential in determining whether evidence from randomised controlled clinical trials translate into meaningful clinical benefits for patients in everyday practice. RIVER (RIVaroxaban Evaluation in Real life setting) is an ongoing international, prospective registry of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) and at least one investigator-determined risk factor for stroke who received rivaroxaban as an initial treatment for the prevention of thromboembolic stroke. The aim of this paper is to describe the design of the RIVER registry and baseline characteristics of patients with newly diagnosed NVAF who received rivaroxaban as an initial treatment. Methods and results: Between January 2014 and June 2017, RIVER investigators recruited 5072 patients at 309 centres in 17 countries. The aim was to enroll consecutive patients at sites where rivaroxaban was already routinely prescribed for stroke prevention. Each patient is being followed up prospectively for a minimum of 2-years. The registry will capture data on the rate and nature of all thromboembolic events (stroke / systemic embolism), bleeding complications, all-cause mortality and other major cardiovascular events as they occur. Data quality is assured through a combination of remote electronic monitoring and onsite monitoring (including source data verification in 10% of cases). Patients were mostly enrolled by cardiologists (n = 3776, 74.6%), by internal medicine specialists 14.2% (n = 718) and by primary care/general practice physicians 8.2% (n = 417). The mean (SD) age of the population was 69.5 (11.0) years, 44.3% were women. Mean (SD) CHADS2 score was 1.9 (1.2) and CHA2DS2-VASc scores was 3.2 (1.6). Almost all patients (98.5%) were prescribed with once daily dose of rivaroxaban, most commonly 20 mg (76.5%) and 15 mg (20.0%) as their initial treatment; 17.9% of patients received concomitant antiplatelet therapy. Most patients enrolled in RIVER met the recommended threshold for AC therapy (86.6% for 2012 ESC Guidelines, and 79.8% of patients according to 2016 ESC Guidelines). Conclusions: The RIVER prospective registry will expand our knowledge of how rivaroxaban is prescribed in everyday practice and whether evidence from clinical trials can be translated to the broader cross-section of patients in the real world.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 7 |
| Tidsskrift | Thrombosis Journal |
| Vol/bind | 17 |
| Antal sider | 11 |
| ISSN | 1477-9560 |
| DOI | |
| Status | Udgivet - apr. 2019 |
| Udgivet eksternt | Ja |
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International longitudinal registry of patients with atrial fibrillation and treated with rivaroxaban : RIVaroxaban Evaluation in Real life setting (RIVER). / Beyer-Westendorf, Jan; Camm, A. John; Fox, Keith A.A.; Le Heuzey, Jean Yves; Haas, Sylvia; Turpie, Alexander G.G.; Virdone, Saverio; Kakkar, Ajay K.; Pieper, Karen S.; Kayani, Gloria; Gersh, Bernard J.; Hildebrandt, P.; Dominguez, H.; Comuth, W.; Frost, L.; Moller, D. S.; Christensen, H.; Bruun, L. M.; Milhem, A.; Gauthier, J.; Mielot, C.; Chanseaume, S.; Chopra, S.; Amlaiky, A.; Tricot, O.; Sierra, V.; Dompnier, A.; Zannad, N.; Pinzani, A.; Quatre, A.; Mansourati, J.; Fauchier, L.; Badenco, N.; Gandjbakhch, E.; Chachoua, K. F.; Malquarti, V.; Pierron, F.; Sacher, F.; Taieb, J.; Davy, J. M.; Marijon, E.; Lellouche, N.; Leenhardt, A.; Salem, A.; Lesto, I.; Muller, J. J.; Garcia, R.; Neau, J. P.; Berneau, J. B.; Schön, N.; Gulba, D.; Appel, K. F.; Merke, J.; Dshabrailov, J.; Bauknecht, C.; Scheuermann, O.; Schröder, T.; Jung, W.; Kopf, A.; Brachmann, J.; Leschke, M.; Taggeselle, J.; Seige, M.; Läßig, T.; Appel, S.; Schmiedl, M.; Müller, K.; Heinz, G. U.; Axthelm, C.; Eberhard, K.; Hügl, B.; Schwarz, T.; Sechtem, U.; Falanga, A.; Rubino, V.; Calo, L.; Ageno, W.; Massari, F.; Imberti, D.; Di Gennaro, L.; Gaita, F.; Margonato, A.; Cannava, G.; Capasso, F.; Diemberger, I.; Pelliccia, F.; Cafolla, A.; Bardari, S.; Mattei, L.; Ruocco, L.; Boriani, G.; Poli, D.; Testa, S.; Indolfi, C.; Quintavalla, R.; Mos, L.; Ladyjanskaia, G.; Aksoy, I.; Van De Wetering, M.; Theunissen, L.; Den Hartog, F.; Nijmeijer, R.; Van De Wal, R.; Reinders, S.; Patterson, M.; Melker, E. D.; Troquay, R.; Korecki, J.; Szyszka, A.; Diks, F.; Sumis, J.; Cygler, J.; Miklaszewicz, B.; Litwiejko-Pietrynczak, E.; Napora, P.; Drelich, G.; Kawka-Urbanek, T.; Wranicz, J. K.; Mierzejewski, M.; Drzewiecka, A.; Wronska, D.; Fares, I.; Baska, J.; Stania, K.; Krzyzanowski, W.; Miekus, P.; Tyminski, M.; Dronov, D.; Zenin, S.; Isaeva, E.; Lopukhov, A.; Yakusevich, V.; Kuznetsov, D.; Kameneva, T.; Pokushalov, E.; Karetnikova, V.; Dik, I.; Karpushina, I.; Nikolin, D.; Doletsky, A.; Ardashev, A.; Timofeeva, A.; Miller, O.; Lyamina, N.; Shubik, Y.; Boldueva, S.; Blanco Coronado, J. L.; Gonzalez Juanatey, C.; Otero, E.; Alonso, D.; Torres Llergo, J.; Gonzalez Lama, J.; De Prada Tiffe, J. A.V.; Garcia Seara, F. J.; Gomez Doblas, J. J.; Riancho, J. A.; Clua-Espuny, J. L.; Motero, J.; Arrarte, V. I.; Martin Raymondi, D.; Isasti Aizpurua, G.; Marin, F.; Nieto, J. A.; Fernandez Portales, J.; Alvarez Garcia, P.; Torstensson, I.; Cederin, B.; Kalm, T.; Rosenqvist, U.; Thulin, J.; Hajimirsadeghi, A.; Crisby, M.; Manoj, A.; Bakhai, A.; Mistri, A.; Krishnan, M.; Kumar, S.; Kirubakaran, S.; Thomas, H.; Camm, J.; Ahmed, F.; Ross, A. M.; Barry, K.; Stockwell, R.; Broadley, A.; Mamun, M.; Chatterjee, K.; Cooke, J.; McCready, J.; Dutta, D.; John, K.; Pandya, P.; Howlett, R.; Vinson, P.; Lim; Foley, P.; Bruce, D.; Dixit, A.; Broughton, D.; Taylor, J.; Schilling, R.; Leon, K.; Saeed, K.; Shaheen, S.; Tawfik, M.; Mortadda, A.; Seleem, M.; Aly, M. S.I.; Kazamel, G.; Elbadry, M.; Kamal, S.; Hassan, M.; Mostafa, M.; Medhat, M. E.S.; Ekhlas; Ghaleb, R.; Taha, M. O.; Daoud, I.; Al Din, H.; Imam, A. M.; El Hameed, M. A.; Helmy; Al-Murayeh, M.; Akhtar, N.; Matto, B. M.; Ghani, M. A.; Amoudi, O. A.; Morsy, M. M.; Bashir, A. A.F.; Al Hossni, Y. M.; Al Ghamdi, B.; Zia-Ul-Sabah; Mir, S.; Dardir, D.; Masswary, A.; Al Shehri, A. R.; Masswary, A.; Iqbal, J.; Almansori, M. A.J.; Venkitachalam, C. G.; Kurian, J.; Rao, J.; Aisheh, A.; Albawab, A. A.; Subbaraman, B.; Amanat, A.; Esfehani, K. J.; Lochan, R.; Bin Brek, A.; Mittal, B.; Ghazi, Y.; Krishna, M.; Tabatabaei, S. B.; Thoppil, P. S.; Nasim, S.; El Khider Nour, S.; Barros, P.; Almeida, A. P.; Andrade, M.; Garbelini, B.; Silvestrini, T. L.; Alves, A. R.; De Lima, C. E.B.; Kormann, A.; De Lima, G. G.; Halperin, C.; Salvadori Junior, D.; Freitas, A. F.; Gemelli, J. R.; Ornelas, C. E.; Dantas, J. M.M.; Aziz, J. L.; Backes, L. M.; Barroso, W. S.; Paiva, M. S.; De Figueiredo Neto, J. A.; Dos Santos, F. R.; De Lima Neto, J. A.; Bergo, R.; Salvador Junior, P. R.; López, A. G.; Alva, J. C.P.; Gamba, M. A.A.; Padilla-Padilla, F. G.; Ruiz, A. E.B.; Berlingieri, J.; Bakbak, A.; Gupta, M.; Saunders, K.; Costa-Vitali, A.; Beaudry, P. R.; Bhargava, R.; Khaykin, Y.; Healey, J. S.; Crystal, E.; Nadeau; Dhillon; Begg, Alistair; Anderson, C.; Baveja, S.; Cross, D.; Catanchin, A.; Brieger, D.; Lim, K. T.; Davidson, P.; Tan, R.; Bhindi, R.; Hickey, J.; Layland, J.; Bloch, M.; Itty, C.; Singh, B.; Carroll, P.; Lee, A.; Starmer, G.; Lehman, R.
I: Thrombosis Journal, Bind 17, 7, 04.2019.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review
}
TY - JOUR
T1 - International longitudinal registry of patients with atrial fibrillation and treated with rivaroxaban
T2 - RIVaroxaban Evaluation in Real life setting (RIVER)
AU - Beyer-Westendorf, Jan
AU - Camm, A. John
AU - Fox, Keith A.A.
AU - Le Heuzey, Jean Yves
AU - Haas, Sylvia
AU - Turpie, Alexander G.G.
AU - Virdone, Saverio
AU - Kakkar, Ajay K.
AU - Pieper, Karen S.
AU - Kayani, Gloria
AU - Gersh, Bernard J.
AU - Hildebrandt, P.
AU - Dominguez, H.
AU - Comuth, W.
AU - Frost, L.
AU - Moller, D. S.
AU - Christensen, H.
AU - Bruun, L. M.
AU - Milhem, A.
AU - Gauthier, J.
AU - Mielot, C.
AU - Chanseaume, S.
AU - Chopra, S.
AU - Amlaiky, A.
AU - Tricot, O.
AU - Sierra, V.
AU - Dompnier, A.
AU - Zannad, N.
AU - Pinzani, A.
AU - Quatre, A.
AU - Mansourati, J.
AU - Fauchier, L.
AU - Badenco, N.
AU - Gandjbakhch, E.
AU - Chachoua, K. F.
AU - Malquarti, V.
AU - Pierron, F.
AU - Sacher, F.
AU - Taieb, J.
AU - Davy, J. M.
AU - Marijon, E.
AU - Lellouche, N.
AU - Leenhardt, A.
AU - Salem, A.
AU - Lesto, I.
AU - Muller, J. J.
AU - Garcia, R.
AU - Neau, J. P.
AU - Berneau, J. B.
AU - Schön, N.
AU - Gulba, D.
AU - Appel, K. F.
AU - Merke, J.
AU - Dshabrailov, J.
AU - Bauknecht, C.
AU - Scheuermann, O.
AU - Schröder, T.
AU - Jung, W.
AU - Kopf, A.
AU - Brachmann, J.
AU - Leschke, M.
AU - Taggeselle, J.
AU - Seige, M.
AU - Läßig, T.
AU - Appel, S.
AU - Schmiedl, M.
AU - Müller, K.
AU - Heinz, G. U.
AU - Axthelm, C.
AU - Eberhard, K.
AU - Hügl, B.
AU - Schwarz, T.
AU - Sechtem, U.
AU - Falanga, A.
AU - Rubino, V.
AU - Calo, L.
AU - Ageno, W.
AU - Massari, F.
AU - Imberti, D.
AU - Di Gennaro, L.
AU - Gaita, F.
AU - Margonato, A.
AU - Cannava, G.
AU - Capasso, F.
AU - Diemberger, I.
AU - Pelliccia, F.
AU - Cafolla, A.
AU - Bardari, S.
AU - Mattei, L.
AU - Ruocco, L.
AU - Boriani, G.
AU - Poli, D.
AU - Testa, S.
AU - Indolfi, C.
AU - Quintavalla, R.
AU - Mos, L.
AU - Ladyjanskaia, G.
AU - Aksoy, I.
AU - Van De Wetering, M.
AU - Theunissen, L.
AU - Den Hartog, F.
AU - Nijmeijer, R.
AU - Van De Wal, R.
AU - Reinders, S.
AU - Patterson, M.
AU - Melker, E. D.
AU - Troquay, R.
AU - Korecki, J.
AU - Szyszka, A.
AU - Diks, F.
AU - Sumis, J.
AU - Cygler, J.
AU - Miklaszewicz, B.
AU - Litwiejko-Pietrynczak, E.
AU - Napora, P.
AU - Drelich, G.
AU - Kawka-Urbanek, T.
AU - Wranicz, J. K.
AU - Mierzejewski, M.
AU - Drzewiecka, A.
AU - Wronska, D.
AU - Fares, I.
AU - Baska, J.
AU - Stania, K.
AU - Krzyzanowski, W.
AU - Miekus, P.
AU - Tyminski, M.
AU - Dronov, D.
AU - Zenin, S.
AU - Isaeva, E.
AU - Lopukhov, A.
AU - Yakusevich, V.
AU - Kuznetsov, D.
AU - Kameneva, T.
AU - Pokushalov, E.
AU - Karetnikova, V.
AU - Dik, I.
AU - Karpushina, I.
AU - Nikolin, D.
AU - Doletsky, A.
AU - Ardashev, A.
AU - Timofeeva, A.
AU - Miller, O.
AU - Lyamina, N.
AU - Shubik, Y.
AU - Boldueva, S.
AU - Blanco Coronado, J. L.
AU - Gonzalez Juanatey, C.
AU - Otero, E.
AU - Alonso, D.
AU - Torres Llergo, J.
AU - Gonzalez Lama, J.
AU - De Prada Tiffe, J. A.V.
AU - Garcia Seara, F. J.
AU - Gomez Doblas, J. J.
AU - Riancho, J. A.
AU - Clua-Espuny, J. L.
AU - Motero, J.
AU - Arrarte, V. I.
AU - Martin Raymondi, D.
AU - Isasti Aizpurua, G.
AU - Marin, F.
AU - Nieto, J. A.
AU - Fernandez Portales, J.
AU - Alvarez Garcia, P.
AU - Torstensson, I.
AU - Cederin, B.
AU - Kalm, T.
AU - Rosenqvist, U.
AU - Thulin, J.
AU - Hajimirsadeghi, A.
AU - Crisby, M.
AU - Manoj, A.
AU - Bakhai, A.
AU - Mistri, A.
AU - Krishnan, M.
AU - Kumar, S.
AU - Kirubakaran, S.
AU - Thomas, H.
AU - Camm, J.
AU - Ahmed, F.
AU - Ross, A. M.
AU - Barry, K.
AU - Stockwell, R.
AU - Broadley, A.
AU - Mamun, M.
AU - Chatterjee, K.
AU - Cooke, J.
AU - McCready, J.
AU - Dutta, D.
AU - John, K.
AU - Pandya, P.
AU - Howlett, R.
AU - Vinson, P.
AU - Lim, null
AU - Foley, P.
AU - Bruce, D.
AU - Dixit, A.
AU - Broughton, D.
AU - Taylor, J.
AU - Schilling, R.
AU - Leon, K.
AU - Saeed, K.
AU - Shaheen, S.
AU - Tawfik, M.
AU - Mortadda, A.
AU - Seleem, M.
AU - Aly, M. S.I.
AU - Kazamel, G.
AU - Elbadry, M.
AU - Kamal, S.
AU - Hassan, M.
AU - Mostafa, M.
AU - Medhat, M. E.S.
AU - Ekhlas, null
AU - Ghaleb, R.
AU - Taha, M. O.
AU - Daoud, I.
AU - Al Din, H.
AU - Imam, A. M.
AU - El Hameed, M. A.
AU - Helmy, null
AU - Al-Murayeh, M.
AU - Akhtar, N.
AU - Matto, B. M.
AU - Ghani, M. A.
AU - Amoudi, O. A.
AU - Morsy, M. M.
AU - Bashir, A. A.F.
AU - Al Hossni, Y. M.
AU - Al Ghamdi, B.
AU - Zia-Ul-Sabah, null
AU - Mir, S.
AU - Dardir, D.
AU - Masswary, A.
AU - Al Shehri, A. R.
AU - Masswary, A.
AU - Iqbal, J.
AU - Almansori, M. A.J.
AU - Venkitachalam, C. G.
AU - Kurian, J.
AU - Rao, J.
AU - Aisheh, A.
AU - Albawab, A. A.
AU - Subbaraman, B.
AU - Amanat, A.
AU - Esfehani, K. J.
AU - Lochan, R.
AU - Bin Brek, A.
AU - Mittal, B.
AU - Ghazi, Y.
AU - Krishna, M.
AU - Tabatabaei, S. B.
AU - Thoppil, P. S.
AU - Nasim, S.
AU - El Khider Nour, S.
AU - Barros, P.
AU - Almeida, A. P.
AU - Andrade, M.
AU - Garbelini, B.
AU - Silvestrini, T. L.
AU - Alves, A. R.
AU - De Lima, C. E.B.
AU - Kormann, A.
AU - De Lima, G. G.
AU - Halperin, C.
AU - Salvadori Junior, D.
AU - Freitas, A. F.
AU - Gemelli, J. R.
AU - Ornelas, C. E.
AU - Dantas, J. M.M.
AU - Aziz, J. L.
AU - Backes, L. M.
AU - Barroso, W. S.
AU - Paiva, M. S.
AU - De Figueiredo Neto, J. A.
AU - Dos Santos, F. R.
AU - De Lima Neto, J. A.
AU - Bergo, R.
AU - Salvador Junior, P. R.
AU - López, A. G.
AU - Alva, J. C.P.
AU - Gamba, M. A.A.
AU - Padilla-Padilla, F. G.
AU - Ruiz, A. E.B.
AU - Berlingieri, J.
AU - Bakbak, A.
AU - Gupta, M.
AU - Saunders, K.
AU - Costa-Vitali, A.
AU - Beaudry, P. R.
AU - Bhargava, R.
AU - Khaykin, Y.
AU - Healey, J. S.
AU - Crystal, E.
AU - Nadeau, null
AU - Dhillon, null
AU - Begg, Alistair
AU - Anderson, C.
AU - Baveja, S.
AU - Cross, D.
AU - Catanchin, A.
AU - Brieger, D.
AU - Lim, K. T.
AU - Davidson, P.
AU - Tan, R.
AU - Bhindi, R.
AU - Hickey, J.
AU - Layland, J.
AU - Bloch, M.
AU - Itty, C.
AU - Singh, B.
AU - Carroll, P.
AU - Lee, A.
AU - Starmer, G.
AU - Lehman, R.
PY - 2019/4
Y1 - 2019/4
N2 - Background: Real-world data on non-vitamin K oral anticoagulants (NOACs) are essential in determining whether evidence from randomised controlled clinical trials translate into meaningful clinical benefits for patients in everyday practice. RIVER (RIVaroxaban Evaluation in Real life setting) is an ongoing international, prospective registry of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) and at least one investigator-determined risk factor for stroke who received rivaroxaban as an initial treatment for the prevention of thromboembolic stroke. The aim of this paper is to describe the design of the RIVER registry and baseline characteristics of patients with newly diagnosed NVAF who received rivaroxaban as an initial treatment. Methods and results: Between January 2014 and June 2017, RIVER investigators recruited 5072 patients at 309 centres in 17 countries. The aim was to enroll consecutive patients at sites where rivaroxaban was already routinely prescribed for stroke prevention. Each patient is being followed up prospectively for a minimum of 2-years. The registry will capture data on the rate and nature of all thromboembolic events (stroke / systemic embolism), bleeding complications, all-cause mortality and other major cardiovascular events as they occur. Data quality is assured through a combination of remote electronic monitoring and onsite monitoring (including source data verification in 10% of cases). Patients were mostly enrolled by cardiologists (n = 3776, 74.6%), by internal medicine specialists 14.2% (n = 718) and by primary care/general practice physicians 8.2% (n = 417). The mean (SD) age of the population was 69.5 (11.0) years, 44.3% were women. Mean (SD) CHADS2 score was 1.9 (1.2) and CHA2DS2-VASc scores was 3.2 (1.6). Almost all patients (98.5%) were prescribed with once daily dose of rivaroxaban, most commonly 20 mg (76.5%) and 15 mg (20.0%) as their initial treatment; 17.9% of patients received concomitant antiplatelet therapy. Most patients enrolled in RIVER met the recommended threshold for AC therapy (86.6% for 2012 ESC Guidelines, and 79.8% of patients according to 2016 ESC Guidelines). Conclusions: The RIVER prospective registry will expand our knowledge of how rivaroxaban is prescribed in everyday practice and whether evidence from clinical trials can be translated to the broader cross-section of patients in the real world.
AB - Background: Real-world data on non-vitamin K oral anticoagulants (NOACs) are essential in determining whether evidence from randomised controlled clinical trials translate into meaningful clinical benefits for patients in everyday practice. RIVER (RIVaroxaban Evaluation in Real life setting) is an ongoing international, prospective registry of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) and at least one investigator-determined risk factor for stroke who received rivaroxaban as an initial treatment for the prevention of thromboembolic stroke. The aim of this paper is to describe the design of the RIVER registry and baseline characteristics of patients with newly diagnosed NVAF who received rivaroxaban as an initial treatment. Methods and results: Between January 2014 and June 2017, RIVER investigators recruited 5072 patients at 309 centres in 17 countries. The aim was to enroll consecutive patients at sites where rivaroxaban was already routinely prescribed for stroke prevention. Each patient is being followed up prospectively for a minimum of 2-years. The registry will capture data on the rate and nature of all thromboembolic events (stroke / systemic embolism), bleeding complications, all-cause mortality and other major cardiovascular events as they occur. Data quality is assured through a combination of remote electronic monitoring and onsite monitoring (including source data verification in 10% of cases). Patients were mostly enrolled by cardiologists (n = 3776, 74.6%), by internal medicine specialists 14.2% (n = 718) and by primary care/general practice physicians 8.2% (n = 417). The mean (SD) age of the population was 69.5 (11.0) years, 44.3% were women. Mean (SD) CHADS2 score was 1.9 (1.2) and CHA2DS2-VASc scores was 3.2 (1.6). Almost all patients (98.5%) were prescribed with once daily dose of rivaroxaban, most commonly 20 mg (76.5%) and 15 mg (20.0%) as their initial treatment; 17.9% of patients received concomitant antiplatelet therapy. Most patients enrolled in RIVER met the recommended threshold for AC therapy (86.6% for 2012 ESC Guidelines, and 79.8% of patients according to 2016 ESC Guidelines). Conclusions: The RIVER prospective registry will expand our knowledge of how rivaroxaban is prescribed in everyday practice and whether evidence from clinical trials can be translated to the broader cross-section of patients in the real world.
KW - Anticoagulant
KW - Antithrombotic
KW - Atrial fibrillation
KW - Outcomes
KW - Registry
KW - Rivaroxaban
U2 - 10.1186/s12959-019-0195-7
DO - 10.1186/s12959-019-0195-7
M3 - Journal article
C2 - 31169831
AN - SCOPUS:85066403168
VL - 17
JO - Thrombosis Journal
JF - Thrombosis Journal
SN - 1477-9560
M1 - 7
ER -