2 research outputs found
Edoxaban versus warfarin in patients with atrial fibrillation
- Author
- Abdullakutty J
- Abi-Mansour P
- Abril SB
- Accini J
- Accini M
- Acikel M
- Acikel M
- Adachi C
- Adams K
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- Adamus J
- Adler J
- Adler P
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- Ahuad Guerrero R
- Ajioka M
- Akhter F
- Akihisa U
- Akilli H
- Al-Maliky T
- Al-Zoebi A
- Albert L. Waldo
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- Zhang Z
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- Zharinov O
- Zheng X
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- Åkerberg A
- Östberg S
- Ŝpinar J
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2013
- Field of study
Contains fulltext :
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
- Al-Amin Jessie
- Al-Faleh Hussam
- Al-Saif Shukri
- Al-Shehri Abdullah
- Al-Zoebi Ayham
- Aladellie Layth
- Albisu Juan
- Alfata Sarab
- Alshehri Halia
- Alvarado Odilon
- Alvarez Jose
- Alvarisqueta Andres
- Amerena John
- Amerena John
- Amin Amit
- Amoroso Giovanni
- Andersson Marielle
- Andersson Marielle
- Andersson Marielle
- Andrawis Nabil
- Andries Alin
- Andrássy Péter
- Angerås Oskar
- Angiolillo Dominick
- Angoulvant Denis
- Ansari Saadat
- Antalik Lubomir
- Aoyama Takahiko
- Appel Karl-Friedrich
- Arana Camilo
- Arat Alev
- Arbanil Hugo
- Arora Satish
- Arriagada German
- Arshad Tamjeed
- Arslan Sakir
- Arvind Moogali
- Arya Ktut
- Asenjo Roberto M
- Asfour Wail
- Askar Alfredo N
- Assanelli Emilio
- Atieh Mahmoud
- Auer Johann
- Avino David
- Babapulle Mohan
- Babilonia Noe
- Babilonia Noe A
- Bae Jang-Whan
- Baglikov Andrey
- Bailey Allan
- Bailey Gordon
- Bain Stephen
- Bakai Judit
- Bakhtari Ladan
- Ballyuzek Marina
- Bander Jeffrey
- Bandh Stellan
- Banerjee Subhash
- Banerjee Supratim
- Banerjee Suvro
- Barabashkina Anna
- Baracioli Luciano
- Barbarash Olga
- Barbas Benny
- Barettella Mark
- Bashkin Amir
- Basiak Marcin
- Baszak Jacek
- Bata Iqbal
- Bauer Michael
- Bayat Junaid
- Bazari Rasha
- Bednarova Jana
- Behnke Thomas
- Bell Alan
- Belle-Isle Jasmin
- Bellotti Sandro
- Belohlavek Jan
- Benczur Bela
- Bennett James
- Berg-Johansen Jan
- Berger Rudolf
- Berrospi Percy
- Bertolet Barry
- Bertrand Olivier
- Bertsch John
- Besada Diego
- Bessoudo Ricardo
- Beth Mary
- Bhargava Anuj
- Bhatt Deepak L
- Bhatt Deepak L
- Bhavsar Janak
- Bijata-Bronisz Renata
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- Boldueva Svetlana
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- Bongo Angelo S
- Bordonava Anselmo
- Borges Joao
- Borisov Borislav
- Bortnick Anna
- Bos Robert
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- Botero Rodrigo
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- Bott Jochen
- Bouza Manuel
- Boyrazian Hagop
- Brabham David
- Braganza Denise
- Brath Helmut
- Brockmyre Andrew
- Broker Robert
- Brown Christopher
- Buchbinder Maurice
- Bueno Héctor
- Bugan Viliam
- Bula Larysa
- Burgess Lesley
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- Butman Samuel
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- Chacon Carolina
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- Chai Yingru
- Chamnarnphol Noppadol
- Chan Michael
- Chan Shih-Hung
- Chang Kiyuk
- Chang Kuan-Cheng
- Chatrathi Sridhar
- Chavez Carlos
- Chehayeb Raja
- Cheirif Jorge
- Chen Jersey
- Chen Jersey
- Chen Zhih-Cherng
- Chernyavsky Alexander
- Cheung Deanna
- Cheung Stephen
- Chhabra Anil
- Chiang Chern
- Chiang Chern-En
- Choi Si-Wan
- Choi Young J
- Chompalova Boryana
- Chorin Ehud
- Chouinard Guy
- Cinteza Mircea
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- Clifford Piers
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- Czigány Anna
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- Dalby Anthony
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- Das Asit
- Dawood Saleem
- de Cosmo Salvatore
- de la Torre Hernández José M
- de Labriolle Axel
- de los Ríos Ibarra Manuel
- de Luca Leonardo
- de Maeseneire Stefan
- de Melker Edwin
- de Nooijer Cornelis
- de Souza Weimar
- Debs-Perez Giselle
- Decoulx Eric
- Dedek Vratislav
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- Ebenbichler Christoph
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- Egstrup Kenneth
- Eki Yutaka
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- Elamin Omer
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- Gomez-Cortes Jose
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- Goodfellow Ross
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- Goto Shinya
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- Goube Pascal
- Gowdaiah Prakash
- Graham Bruce
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- Gravdal Stein A
- Green Sandy
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- Grena Paul
- Greschik István
- Gring Christian
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- Guillen Mario
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- Hearne Steven
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- Jesionowski Pawel
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- Kerr Saraiva José F
- Khaira Ajit
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- Khirmanov Vladimir
- Khlevchuk Tatiana
- Khomazyuk Tetyana
- Khovaeva Yaroslava
- Khrustalev Oleg
- Khurana Charanjit
- Khusrawi Alamdar
- Kichura George
- Kim Byung J
- Kim Doo-Il
- Kim Weon
- Kinasz Leszek
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- Kiss Robert G
- Kiss Róbert G
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- Markov Dimitar
- Markov Valentin
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- Nakamura Toshihiro
- Nakhle Samer
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- Nanji Alykhan
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- Navarro Manuel J
- Nechaeva Galina
- Negron Sandra
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- Oral Ivo
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- Randeva Harpal S.
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- Urbano Rafael H
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- Vallejo Gregorio S
- van de Wal Ruud
- van den Heuvel Christian
- van der Zwaan Coen
- van Eck Martijn
- van Kesteren Henricus
- van Zyl Louis
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- Varleta Paola
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- Willems Frank
- Willis John
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- Wilson William
- Wiseman Alan
- Witek Robert
- Wojcik Ronald
- Wojnowski Lukasz
- Wolzt Michael
- Wong Brian
- Wong Michelle
- Wongvipaporn Chaiyasith
- Woolf Kevin
- Worthley Matthew
- Wozakowska-Kaplon Beata
- Wu Chih-Cheng
- Wu Yen-Wen
- Wujkowski Marek
- Yagensky Andriy
- Yakushin Sergey
- Yalcin Ahmet
- Yamamoto Fumi
- Yaneva Zdravka
- Yeh Hung-I
- Ying Man
- Yokoya Koichi
- Yoon Junghan
- 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
Background:
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