8 research outputs found
Cause of Death and Predictors of All-Cause Mortality in Anticoagulated Patients With Nonvalvular Atrial Fibrillation : Data From ROCKET AF
- Author
- Abadier R.
- Abelson M.
- Abhyankar A.
- Abram N.
- Achimastos A.
- Agacdiken Agir A.
- Agah R.
- Agamasu J.
- Aganauskiene J.
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- Agnelli G.
- Aguirre A.
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- Aidietiene S.
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- Akyea Djamson A.
- Al Saghir Y.
- Al Zoebi A.
- Albina G.
- Albirini A.
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- Alekseeva N.
- Alessi S.
- Alexeeva O.
- Alfieri A.
- Almaguer E.
- Almquist A.
- Altunkeser B.
- Alvarado O.
- Alvarez Garcia P.
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- Alvariqueta A.
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- Field of study
Get PDFM. Kaste on työryhmän ROCKET AF Steering Comm jäsen.Background-Atrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all-cause mortality may guide interventions. Methods and Results-In the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose-adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all-cause mortality in the 14 171 participants in the intention-to-treat population. The median age was 73 years, and the mean CHADS(2) score was 3.5. Over 1.9 years of median follow-up, 1214 (8.6%) patients died. Kaplan-Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all-cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33-1.70, P= 75 years (hazard ratio 1.69, 95% CI 1.51-1.90, P Conclusions-In a large population of patients anticoagulated for nonvalvular atrial fibrillation, approximate to 7 in 10 deaths were cardiovascular, whereasPeer reviewe
Development of a Preclinical PK/PD Model to Assess Antitumor Response of a Sequential Aflibercept and Doxorubicin-Dosing Strategy in Acute Myeloid Leukemia
- Author
- A Aguayo
- A Andersen
- AA Tarhini
- AA Veldt Van der
- AJ Primeau
- B Davies
- B Lowenberg
- C Ortholan
- C Schaefer
- CV Pastuskovas
- D Lal
- Deepika Lal
- ED Lobo
- EJ Feldman
- EM Lee
- Eunice S. Wang
- F Ayala
- FB Pruijn
- FJ Giles
- Gerald J. Fetterly
- GJ Roboz
- H Akaike
- H Gourdeau
- H Sim
- HF Fernandez
- HP Gerber
- HT Thai
- J Holash
- J Ma
- J Ma
- J Wellbrock
- J Yang
- JE Karp
- JF Groot de
- K Goteti
- K Nooter
- K Nooter
- LB Saltz
- LK Webster
- LT Baxter
- M Simeoni
- Michael Murphy
- NB Leighl
- P Twardowski
- Patricia D. Meholick
- PO Iversen
- RK Jain
- RL Coleman
- RP Brown
- RT Tong
- SB Gjedde
- SR Urva
- T Efferth
- T Troiani
- Urvi Aras
- W Fiedler
- W Fiedler
- W Fiedler
- Publication venue
- 'American Association of Pharmaceutical Scientists (AAPS)'
- Publication date
- Field of study
No full textCause of death and predictors of all-cause mortality in anticoagulated patients with nonvalvular atrial fibrillation: Data from ROCKET AF
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- 'Ovid Technologies (Wolters Kluwer Health)'
- Publication date
- 01/01/2015
- Field of study
No full textBackground-Atrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all-cause mortality may guide interventions. Methods and Results-In the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose-adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all-cause mortality in the 14 171 participants in the intentionto- treat population. The median age was 73 years, and the mean CHADS2 score was 3.5. Over 1.9 years of median follow-up, 1214 (8.6%) patients died. Kaplan-Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all-cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33-1.70, P<0.0001) and age 6575 years (hazard ratio 1.69, 95% CI 1.51-1.90, P<0.0001) were associated with higher all-cause mortality. Multiple additional characteristics were independently associated with higher mortality, with decreasing creatinine clearance, chronic obstructive pulmonary disease, male sex, peripheral vascular disease, and diabetes being among the most strongly associated (model C-index 0.677). Conclusions-In a large population of patients anticoagulated for nonvalvular atrial fibrillation, 487 in 10 deaths were cardiovascular, whereas <1 in 10 deaths were caused by nonhemorrhagic stroke or systemic embolism. Optimal prevention and treatment of heart failure, renal impairment, chronic obstructive pulmonary disease, and diabetes may improve survival
Apixaban versus warfarin in patients with atrial fibrillation
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- A Ahsan
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- A Al-Mudamgha
- A Alexander
- A Alfieri
- A Alings
- A Alwail
- A Bakhai
- A Barsotti
- A Bartkowiak
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- A Bethencourt González
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- Sherri Hinton
- Shinya Goto
- Steen Husted
- Stefan H Hohnloser
- Stuart Pocock
- Sumeet Subherwal
- Sunil Nepal
- Susan Mullin
- T Akihiko
- T Andersson
- T Ayres
- T Czerski
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- V Terekhov
- V Tseluyko
- V Vizir
- V Volkov
- V Yakusevich
- V Zadionchenko
- Veli Pekka Harjola
- Verheugt F. W. A.
- W Bowden
- W Cabrera
- W Haught
- W Haverkamp
- W Heddle
- W Henry 3rd
- W Herzog
- W Jaffrani
- W Kufs
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- Wallentin L. Collaborators ARISTOTLE Committees and Investigators: Christopher B Granger
- Witold Ruzyllo
- X Albert
- X Chen
- X Jiang
- X Wang
- X Yang
- Y Atsushi
- Y Burmak
- Y Chandrashekhar
- Y Chen
- Y Cohen
- Y Higashi
- Y K Chan
- Y K Wong
- Y Karpov
- Y Kawase
- Y Kobayashi
- Y Koretsune
- Y Mostovoy
- Y N Kim
- Y Nakamura
- Y Pozdnyakov
- Y Sato
- Y Shubik
- Y Tsubokou
- Y Turgeman
- Y Yin
- Y Zhang
- Z Kiedrowicz
- Z László
- Z Meneghelo
- Z Q Li
- Z Sizova
- Z Telyatnikova
- Z Yousef
- Z Yousef
- Z Yusof
- Zhu J.
- Zubin Eapen
- Á Illés
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2011
- Field of study
No full textBACKGROUND: Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. METHODS: In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. RESULTS: The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P<0.001 for noninferiority; P = 0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P = 0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P = 0.42). CONCLUSIONS: In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. Copyright © 2011 Massachusetts Medical Society. All rights reserved
Apixaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: A subgroup analysis of the ARISTOTLE trial
- Author
- A Agarwal
- A Ahsan
- A Ajala
- A Al-Mudamgha
- A Alexander
- A Alfieri
- A Alings
- A Alwail
- A Bakhai
- A Barsotti
- A Bartkowiak
- A Bauer
- A Bazylevych
- A Bazzi
- A Bethencourt González
- A Bharani
- A Bittersohl
- A Boruczkowska-Kaszkowiak
- A Boyle
- A Bragina
- A Bredero
- A Brockmyre
- A Budaj
- A Buxton
- A Caccavo
- A Cassettari
- A Chhabra
- A Chmielinski
- A Cohen
- A Cooke
- A Cziraki
- A D'Angelo
- A De Paola
- A Dharmadhikari
- A Dowell
- A Francis
- A Gabito
- A Galicia
- A Ghirarduzzi
- A Golovach
- A Gordienko
- A Govorin
- A Hamad
- A Hershson
- A Hetzel
- A Hrabar
- A Ivleva
- A Jacob
- A Jones
- A Kabour
- A Kastanayan
- A Katona
- A Kelly
- A Koniakhin
- A Kovács
- A Lebowitz
- A Levin
- A Liu
- A Lorga Filho
- A Lowy
- A MacKinnon
- A Magnano
- A Marmor
- A Matsushima
- A Meholick
- A Mirode
- A Mohácsi
- A Moriarty
- A Muniz
- A Mügge
- A Mügge
- A Naik
- A Nambiar
- A Obrezan
- A Ocicka-Kozakiewicz
- A Pandey
- A Papp
- A Parkhomenko
- A Patel
- A Peeters
- A Pálinkás
- A Quick
- A Rabelo Alves Jr
- A Reyes
- A Rodriguez
- A Roman
- A Rubin
- A Salacata
- A Salajan
- A Samal
- A Sanchez
- A Schaap
- A Sinopalnikov
- A Skolnick
- A Solomon
- A Svistov
- A Ugarriza
- A Utech
- A Vértes
- A Wade
- A Warner
- A Weiss
- A Wellford
- A Yagensky
- Aldo Maggione
- Alexander J. H.
- Alexander Parkhomenko
- Ali Zomorodi
- Alings M.
- Alvaro Albrecht
- Alvaro Avezum
- Andreas Terent
- Anna Stenborg
- Antonio Carlos Lopes
- Antonio G Hermosillo
- Antonio M W Alings
- Axel Akerblom
- B Bachhuber
- B Beanblossom
- B Blue
- B Bruneel
- B Bryhni
- B Coutu
- B Garbelini Jr
- B Gervais
- B Gorenek
- B Griewing
- B H Oh
- B Hattler
- B Iteld
- B Jackson
- B Kowalski
- B Lachterman
- B Lasko
- B Lewis
- B Malipeddi
- B McClements
- B Peart
- B Pieske
- B Platt
- B Podogrodzka
- B Ramagiri
- B Ramjattan
- B Schifferdecker
- B Sidorenko
- B Srinivasasastry
- B Stockins
- B Winkelmann
- B Wollaert
- B Yu
- B Øie
- Bahit M. C.
- Basil S Lewis
- Bernard J Gersh
- Bradley Kolls
- Byung-Hee Oh
- C Arean Martinez
- C Arsenescu Georgescu
- C Beneitez
- C Bredlau
- C Calvo Vargas
- C Chavez
- C Christersson
- C Corder
- C Cuneo
- C D Tseng
- C Dézsi
- C East
- C Erol
- C Fortin
- C G Fierbinteanu-Braticevici
- C Gonzalez Juanatey
- C Hassel
- C Höglund
- C J Lindholm
- C JerJes-Sanchez
- C Kaoru Indio do Brasil
- C Levin
- C Lovell
- C Massey
- C McPherson
- C Mihaela Tanaseanu
- C Muratore
- C Olivieri
- C Pincetti
- C Pop
- C Powers
- C Poy
- C Raffo
- C Riojas
- C Rios Vasquez
- C Rodriguez-Fierro
- C Russo
- C Sofley
- C Sotolongo
- C Toftager Larsen
- C Torp-Pedersen
- C Tuxen
- C Van der Zwaan
- C W Lee
- C Weimar
- C Y Rhim
- C Yu
- C Zaidman
- Carlo Lombardi
- Cetin Erol
- Cheryl Bushnell
- Christoph Varenhorst
- Claes Held
- D Agarwal
- D Albuquerque
- D Ashby
- D Belenky
- D Borts
- D Brieger
- D Chiu
- D Clark
- D Colan
- D Cross
- D De Jong
- D Dohan
- D Donovan
- D Duplyakov
- D Dutka
- D El Allaf
- D Fell
- D Fischer
- D G Shin
- D Gaita
- D Garcia
- D Goldscher
- D Gottlieb
- D Gupta
- D Hassman
- D Humiston
- D Isaza
- D J Choi
- D Jiang
- D Kelbe
- D Kereiakes
- D Lighezan
- D Linden
- D Lok
- D Mercado
- D Mishkel
- D Morales
- D Moreira
- D Murdoch
- D O'Keefe
- D Perloff
- D Piskorz
- D Precoma
- D Rhodes
- D Riff
- D Rupka
- D Santos
- D Spence
- D Stapleton
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- D Tudor Zdrenghea
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- D Vinereanu
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- Dan Atar
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- David Garcia
- Denis Xavier
- Diener H. -C. ARISTOTLE Committees and Investigators: Christopher B Granger
- Dipen Parikh
- Dragos Vinereanu
- E Ball
- E Blumberg
- E Carasca
- E Engeron
- E Flores
- E Galve
- E Gomez
- E Hasbani
- E Haskel
- E Julian Chuquiure-Valenzuela
- E Klainman
- E Kosinski
- E Lopez Rosas
- E Manenti
- E Mazur
- E Morales-Palomares
- E Mouhayar
- E Panchenko
- E Pelloso
- E Privalova
- E Ramos
- E Retyk
- E Richiardi
- E Rivera
- E Sabbah
- E Schwarz
- E Sivkova
- E Suprun.
- E van Nieuwenhuizen
- E von Hodenberg
- E Zemtsovsky
- E Zidkova
- Easton J. D.
- Elaine M Hylek
- Elaine M Hylek
- Emil Hagstrom
- Erik Lundstrom
- F Agnone
- F Al-Khalili
- F Al-Khalili
- F Albrecht
- F Bai
- F Collado
- F Collado
- F De Leon
- F de Looze
- F de Looze
- F de Looze
- F de Looze
- F Dunn
- F Grondin
- F Kouichi
- F Lakatos
- F Maislos
- F Medina
- F Olías de la Cruz
- F Provenier
- F Rolandi
- F Schlachetzki
- F St Maurice
- F Stockenhuber
- F Stögbauer
- F Verheugt
- F Villaça Guimaraes Filho
- F Zhang
- Fernando Lanas
- Freek W A Verheugt
- G Andrei Dan
- G Arutyunov
- G Aycock
- G Boxho
- G Brooks
- G Bustamante
- G Casolo
- G Dzyak
- G Feldman
- G Filonenko
- G Ford
- G Gojanur
- G Hanovich
- G Ignatenko
- G Jensen
- G Kahrmann
- G Kamalov
- G Kania
- G Lavabre
- G Lip
- G Lu
- G Lupkovics
- G Lysenko
- G Mairesse
- G McInnes
- G Noble
- G Oliveira
- G Popik
- G Rasmanis
- G Reis
- G Rogelio
- G Sabe-Affaki
- G Sosa-Suarez
- G Stenzel
- G Syan
- George Wyse
- Goto S.
- Granger C. B.
- Greg Flaker
- Greg Stashenko
- H B Gowdappa
- H Colombo
- H F Vöhringer
- H Hamer
- H Ikeda
- H Jure
- H Kadr
- H Karunaratne
- H Kihara
- H Kultursay
- H Lastiri
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- H Li
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- H Parikka
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- H Punatar
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- H Salem
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- H Takagi
- H Tan
- H Weich
- H Yoshii
- Hanna M.
- Hans-Christoph Diener
- Helio Guimaraes
- I Aisiku
- I Benedek
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- I Chernichka
- I Chopey
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- Stefan H Hohnloser
- Stuart Pocock
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- W Piotrowski
- W Ridsdill Smith
- W Rieker
- W Ruzyllo
- W Smith
- W Tracz
- W Wilson
- W Zonggui
- Wallentin L.
- Witold Ruzyllo
- Wojdyla D. M.
- X Albert
- X Chen
- X Jiang
- X Wang
- X Yang
- Y Atsushi
- Y Burmak
- Y Chandrashekhar
- Y Chen
- Y Cohen
- Y Higashi
- Y K Chan
- Y K Wong
- Y Karpov
- Y Kawase
- Y Kobayashi
- Y Koretsune
- Y Mostovoy
- Y N Kim
- Y Nakamura
- Y Pozdnyakov
- Y Sato
- Y Shubik
- Y Tsubokou
- Y Turgeman
- Y Yin
- Y Zhang
- Z Kiedrowicz
- Z László
- Z Meneghelo
- Z Q Li
- Z Sizova
- Z Telyatnikova
- Z Yousef
- Z Yousef
- Z Yusof
- Zubin Eapen
- Á Illés
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2012
- Field of study
No full textBackground: In the ARISTOTLE trial, the rate of stroke or systemic embolism was reduced by apixaban compared with warfarin in patients with atrial fibrillation (AF). Patients with AF and previous stroke or transient ischaemic attack (TIA) have a high risk of stroke. We therefore aimed to assess the efficacy and safety of apixaban compared with warfarin in prespecified subgroups of patients with and without previous stroke or TIA. Methods: Between Dec 19, 2006, and April 2, 2010, patients were enrolled in the ARISTOTLE trial at 1034 clinical sites in 39 countries. 18 201 patients with AF or atrial flutter were randomly assigned to receive apixaban 5 mg twice daily or warfarin (target international normalised ratio 2·0-3·0). The median duration of follow-up was 1·8 years (IQR 1·4-2·3). The primary efficacy outcome was stroke or systemic embolism, analysed by intention to treat. The primary safety outcome was major bleeding in the on-treatment population. All participants, investigators, and sponsors were masked to treatment assignments. In this subgroup analysis, we estimated event rates and used Cox models to compare outcomes in patients with and without previous stroke or TIA. The ARISTOTLE trial is registered with ClinicalTrials.gov, number NTC00412984. Findings: Of the trial population, 3436 (19%) had a previous stroke or TIA. In the subgroup of patients with previous stroke or TIA, the rate of stroke or systemic embolism was 2·46 per 100 patient-years of follow-up in the apixaban group and 3·24 in the warfarin group (hazard ratio [HR] 0·76, 95% CI 0·56 to 1·03); in the subgroup of patients without previous stroke or TIA, the rate of stroke or systemic embolism was 1·01 per 100 patient-years of follow-up with apixaban and 1·23 with warfarin (HR 0·82, 95% CI 0·65 to 1·03; p for interaction=0·71). The absolute reduction in the rate of stroke and systemic embolism with apixaban versus warfarin was 0·77 per 100 patient-years of follow-up (95% CI -0·08 to 1·63) in patients with and 0·22 (-0·03 to 0·47) in those without previous stroke or TIA. The difference in major bleeding with apixaban compared with warfarin was 1·07 per 100 patient-years (95% CI 0·09-2·04) in patients with and 0·93 (0·54-1·32) in those without previous stroke or TIA. Interpretation: The effects of apixaban versus warfarin were consistent in patients with AF with and without previous stroke or TIA. Owing to the higher risk of these outcomes in patients with previous stroke or TIA, the absolute benefits of apixaban might be greater in this population. Funding: Bristol-Myers Squibb and Pfizer. © 2012 Elsevier Ltd
Edoxaban versus warfarin in patients with atrial fibrillation
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- Zamlynskyy M
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- Zarpentin C
- Zateyshchikov D
- Zateyshchikova A
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- Zharinov O
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- Zimmermann EB
- Zimmermann S
- Zoghi M
- Zoghi M
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- Zubeeva G
- Zyatenkova E
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- Östberg S
- Ŝpinar J
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2013
- Field of study
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125374.pdf (publisher's version ) (Open Access)BACKGROUND: Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known. METHODS: We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2.8 years). The primary efficacy end point was stroke or systemic embolism. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. The principal safety end point was major bleeding. RESULTS: The annualized rate of the primary end point during treatment was 1.50% with warfarin (median time in the therapeutic range, 68.4%), as compared with 1.18% with high-dose edoxaban (hazard ratio, 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; P<0.001 for noninferiority) and 1.61% with low-dose edoxaban (hazard ratio, 1.07; 97.5% CI, 0.87 to 1.31; P=0.005 for noninferiority). In the intention-to-treat analysis, there was a trend favoring high-dose edoxaban versus warfarin (hazard ratio, 0.87; 97.5% CI, 0.73 to 1.04; P=0.08) and an unfavorable trend with low-dose edoxaban versus warfarin (hazard ratio, 1.13; 97.5% CI, 0.96 to 1.34; P=0.10). The annualized rate of major bleeding was 3.43% with warfarin versus 2.75% with high-dose edoxaban (hazard ratio, 0.80; 95% CI, 0.71 to 0.91; P<0.001) and 1.61% with low-dose edoxaban (hazard ratio, 0.47; 95% CI, 0.41 to 0.55; P<0.001). The corresponding annualized rates of death from cardiovascular causes were 3.17% versus 2.74% (hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), and 2.71% (hazard ratio, 0.85; 95% CI, 0.76 to 0.96; P=0.008), and the corresponding rates of the key secondary end point (a composite of stroke, systemic embolism, or death from cardiovascular causes) were 4.43% versus 3.85% (hazard ratio, 0.87; 95% CI, 0.78 to 0.96; P=0.005), and 4.23% (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.32). CONCLUSIONS: Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes. (Funded by Daiichi Sankyo Pharma Development; ENGAGE AF-TIMI 48 ClinicalTrials.gov number, NCT00781391.)
Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI) : a phase 3, placebo-controlled, randomised trial
- Author
- Abbott J
- Abe Mitsuru
- Abouglila Kamal
- Abrahamovych Orest
- Abu-Fadel Mazen
- Accini Jose
- Acikel Sadik
- Adhyapak Srilakshmi
- Agaiby John
- Aggarwala Guarav
- Aguilera Roberto M
- Ahn Taehoon
- Aksentiev Sergei
- Akyea-Djamson Ayim
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- Asenjo Roberto M
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- Dawood Saleem
- de Cosmo Salvatore
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- de Labriolle Axel
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- HASH(0x55aa09b7f480)
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- Mediavilla García Juan D
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- Rasputina Lesya
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- Wu Chih-Cheng
- Wu Yen-Wen
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- Yakushin Sergey
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- Yaneva Zdravka
- Yeh Hung-I
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- Young Douglas
- Younis Liwa
- Yuan Zuyi
- Zadra Remo
- Zakharov Konstantin
- Zakhary Bosh
- Zaman Azfar
- Zamorano Gómez José L
- Zangroniz Pedro
- Zaniewski Michelle
- Zanini Alejandra
- Zarich Stuart
- Zateyschikova Anna
- Zateyshchikov Dmitry A
- Zebrack James
- Zelazowska Katarzyna
- Zhang Aidong
- Zhang Jian
- Zhang Ningru
- Zhang Wenwu
- Zhao Qiang
- Zhao Qiang
- Zhao Xue-Qiao
- Zharinova Viktoria
- Zidkova Eva
- Zilahi Zsolt
- Zinka Elzbieta
- Zonova Elena
- Zubeeva Galina
- Zucconi-Mazzini Roberto
- Zurakowski Aleksander
- Zólyomi Szilárd
- Édes István
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2019
- Field of study
No full textBackground:
Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor.
Methods:
The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) was a phase 3 randomised, double-blinded, placebo-controlled trial, done in 1315 sites in 42 countries. Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria: a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery. Eligible patients were randomly assigned (1:1) to either ticagrelor or placebo, by use of an interactive voice-response or web-response system. The THEMIS-PCI trial comprised a prespecified subgroup of patients with previous PCI. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population).
Findings:
Between Feb 17, 2014, and May 24, 2016, 11 154 patients (58% of the overall THEMIS trial) with a history of previous PCI were enrolled in the THEMIS-PCI trial. Median follow-up was 3·3 years (IQR 2·8–3·8). In the previous PCI group, fewer patients receiving ticagrelor had a primary efficacy outcome event than in the placebo group (404 [7·3%] of 5558 vs 480 [8·6%] of 5596; HR 0·85 [95% CI 0·74–0·97], p=0·013). The same effect was not observed in patients without PCI (p=0·76, p interaction=0·16). The proportion of patients with cardiovascular death was similar in both treatment groups (174 [3·1%] with ticagrelor vs 183 (3·3%) with placebo; HR 0·96 [95% CI 0·78–1·18], p=0·68), as well as all-cause death (282 [5·1%] vs 323 [5·8%]; 0·88 [0·75–1·03], p=0·11). TIMI major bleeding occurred in 111 (2·0%) of 5536 patients receiving ticagrelor and 62 (1·1%) of 5564 patients receiving placebo (HR 2·03 [95% CI 1·48–2·76], p<0·0001), and fatal bleeding in 6 (0·1%) of 5536 patients with ticagrelor and 6 (0·1%) of 5564 with placebo (1·13 [0·36–3·50], p=0·83). Intracranial haemorrhage occurred in 33 (0·6%) and 31 (0·6%) patients (1·21 [0·74–1·97], p=0·45). Ticagrelor improved net clinical benefit: 519/5558 (9·3%) versus 617/5596 (11·0%), HR=0·85, 95% CI 0·75–0·95, p=0·005, in contrast to patients without PCI where it did not, p interaction=0·012. Benefit was present irrespective of time from most recent PCI.
Interpretation:
In patients with diabetes, stable coronary artery disease, and previous PCI, ticagrelor added to aspirin reduced cardiovascular death, myocardial infarction, and stroke, although with increased major bleeding. In that large, easily identified population, ticagrelor provided a favourable net clinical benefit (more than in patients without history of PCI). This effect shows that long-term therapy with ticagrelor in addition to aspirin should be considered in patients with diabetes and a history of PCI who have tolerated antiplatelet therapy, have high ischaemic risk, and low bleeding risk
Cardiac myosin activation with omecamtiv mecarbil in systolic heart failure
- Author
- A Alan Chu
- A Shekhar Pandey
- Aaron Sverdlov
- Abbasi S. A.
- Abdallah Al Mohammad
- Abdul Al-Hesayen
- Adams K. F.
- Adnan Malik
- Adriaan Voors
- Adrian Shandling
- Agata Marina Floresta
- Ahmet Celik
- Ailiman Mahemuti
- Aize van der Sluis
- Akihiro Koike
- Akihiro Nakamura
- Akihiro Terasawa
- Alan Gass
- Alan Kono
- Alan Meholick
- Alberto Caccavo
- Alberto Cadena Bonfanti
- Alberto Esteban Bazzoni Ruiz
- Alberto Fernandez
- Alberto Margonato
- Aldo Prado
- Alejandro Recio Mayoral
- Aleksander Wlodarczyk
- Aleksandra Manolova
- Alessandro Fucili
- Alex Mauricio Villablanca Sepulveda
- Alexander Adler
- Alexander Bykov
- Alexander Parkhomenko
- Alexander Sherenkov
- Alexander Timofeev
- Alexander Vishnevsky
- Alexandr Schee
- Alexandra Arias Mendoza
- Alexandre Tognon
- Alexey Repin
- Alicia Contreras Rodriguez
- Alina Giuca
- Alisdair Ryding
- Alistair Begg
- Almir Ferraz
- Alonzo Jones
- Amal Muthumala
- Aman Amanullah
- Amarinder Bindra
- Amin Karim
- Amin Yehya
- Amit Shah
- Amrut Ambardekar
- Ana Maria De Leon Flores
- Anand I.
- Anays Santana Izquierdo
- Andras Papp
- Andre Artis
- Andrea Mortara
- Andrej Dzupina
- Andres Iñiguez Romo
- Andrew Boyle
- Andrew Civitello
- Andrew Clark
- Andrew Coletti
- Andrew Hamilton
- Andrew Ludman
- Andrew Sauer
- Andrew Sindone
- Andriy Yagensky
- Andrzej Rynkiewicz
- Aniko Papp
- Anil Shah
- Anna Paszczuk
- Anna Stankiewicz
- Anselmo Paulino Bordonava
- Anthony Gemignani
- Anthony King
- Antonella Vincenzi
- Antonio Juan Castro Fernandez
- Antonio Lara Padron
- Apostolos Karavidas
- Arias-Mendoza A.
- Arif Elvan
- Arman Postadzhiyan
- Armando Garcia Castillo
- Arnold Seto
- Arthur Eberly 3rd
- Arun Krishnamoorthy
- Arunima Misra
- Assad Mouhaffel
- Assen Goudev
- Athanasios Manolis
- Atilio Costa-Vitali
- Atsushi Hirayama
- Atsutoshi Takagi
- Atsuyuki Wada
- Attila Mohacsi
- Aurelio Ortiz
- Aysha Badat
- Badrinathan Chandrasekaran
- Balgit Chhokar
- Barbara Pisani
- Barna Szabo
- Barry Bertolet
- Barry H Greenberg
- Barry Uretsky
- Batlagundu Lakshminarayanan
- Beat Knusel
- Beata Wozakowska-Kaplon
- Beatriz Diaz Molina
- Bela Herczeg
- Bela Merkely
- Benjamin Trichon
- Bhola Rama
- Biering-Sorensen T.
- Binoy Skaria
- Binu Jacob
- Bohm M.
- Bojidar Dimov
- Bonderman D.
- Boris Goloshchekin
- Bozena Sobkowicz
- Brack Hattler
- Bradley Weinberg
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- Brenda Peart
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- Brian Houston
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- Carsten Schmalfuss
- Celeste Williams
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- Claire Varin
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- Cleland J. G. F.
- Coenraad van der Zwaan
- Constantin Militaru
- Corbalan R.
- Craig Barr
- Craig Hametz
- Crespo-Leiro M. G.
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- Vyacheslav Mareev
- Vyacheslav Ryabov
- W Schuyler Jones
- Wael AboAuda
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- Weiheng Wu
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- Weimin Li
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- William Randall
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- Xin Fu
- Xuelian Zhang
- Xuming Yang
- Yafei Mi
- Yajun Han
- Yang Zheng
- Yanling Qu
- Yann Rosamel
- Yasuchika Takeishi
- Yasuhiro Maejima
- Yasuki Kihara
- Yasunori Ueda
- Yasuo Okumura
- Yasushi Sakata
- Yevgeniya Svishchenko
- Yi Wang
- Yilmaz M. B.
- Yinjun Li
- Yorihiko Higashino
- Yoshihiko Saito
- Yoshiki Hata
- Yoshinori Yasaka
- Yoshitoshi Urabe
- Yu Wei
- Yuemin Sun
- Yugang Dong
- Yuhui Zhang
- Yuji Nakazato
- Yukihiko Momiyama
- Yukihito Sato
- Yukiko Morita
- Yuksel Cavusoglu
- Yuqing Zhang
- Yurii Lymar
- Yuriy Mostovoy
- Yury Lukyanov
- Yury Shvarts
- Yutaka Akatsuka
- Yves Pesant
- Zannad F.
- Zbigniew Bednarkiewicz
- Zbigniew Chmielak
- Zbigniew Gola
- Zbigniew Kalarus
- Zbigniew Pijanowski
- Zbynek Pozdisek
- Zdenek Coufal
- Zdenek Klimsa
- Zdenek Monhart
- Zehra Lale Koldas
- Zerrin Yigit
- Zhanna Kobalava
- Zhanquan Li
- Zhaoping Li
- Zhe Zheng
- Zhenyu Yang
- Zhifang Wang
- Zoltan Laszlo
- Zsolt Zilahi
- Zuyi Yuan
- Zuzana Motovska
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2021
- Field of study
No full textBACKGROUND The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. METHODS We randomly assigned 8256 patients (inpatients and outpatients) with symptomatic chronic heart failure and an ejection fraction of 35% or less to receive omecamtiv mecarbil (using pharmacokinetic-guided doses of 25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart-failure therapy. The primary outcome was a composite of a first heart-failure event (hospitalization or urgent visit for heart failure) or death from cardiovascular causes. RESULTS During a median of 21.8 months, a primary-outcome event occurred in 1523 of 4120 patients (37.0%) in the omecamtiv mecarbil group and in 1607 of 4112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.86 to 0.99; P = 0.03). A total of 808 patients (19.6%) and 798 patients (19.4%), respectively, died from cardiovascular causes (hazard ratio, 1.01; 95% CI, 0.92 to 1.11). There was no significant difference between groups in the change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptom score. At week 24, the change from baseline for the median N-terminal pro-B-type natriuretic peptide level was 10% lower in the omecamtiv mecarbil group than in the placebo group; the median cardiac troponin I level was 4 ng per liter higher. The frequency of cardiac ischemic and ventricular arrhythmia events was similar in the two groups. CONCLUSIONS Among patients with heart failure and a reduced ejection, those who received omecamtiv mecarbil had a lower incidence of a composite of a heart-failure event or death from cardiovascular causes than those who received placebo. (Funded by Amgen and others; GALACTIC-HF ClinicalTrials.gov number, NCT02929329; EudraCT number, 2016 -002299-28.)
