Статья

Dabigatran versus Warfarin in Patients with Atrial Fibrillation

Stuart J. ConnollyPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. [email protected]Michael D. EzekowitzLankenau Institute for Medical Research and the Heart Center, Wynnewood, PASalim YusufPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, CanadaJohn W. EikelboomPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, CanadaJonas OldgrenAmit ParekhLankenau Institute for Medical Research and the Heart Center, Wynnewood, PAJanice PoguePopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, CanadaPaul ReillyBoehringer Ingelheim Pharmaceuticals, Ridgefield, CTEllison ThemelesPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, CanadaJeanne VarroneBoehringer Ingelheim Pharmaceuticals, Ridgefield, CTSusan WangBoehringer Ingelheim Pharmaceuticals, Ridgefield, CTMarco AlingsWorking Group on Cardiovascular Research the Netherlands, Utrecht, the NetherlandsDenis XavierSt. John's National Academy of Health Sciences, Bangalore, IndiaJun ZhuFuWai Hospital, BeijingRafael DíazEstudios Clínicos Latinoamérica, Rosario, ArgentinaBasil S. LewisLady Davis Carmel Medical Center, Haifa, IsraelHarald DariusVivantes Klinikum Neukölln, BerlinHans‐Christoph DienerUniversity Duisburg-Essen, Essen, GermanyCampbell JoynerSunnybrook Health Sciences Centre, TorontoLars Wallentin

2009en

ABI

Аннотация

BACKGROUND: Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor. METHODS: In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran--110 mg or 150 mg twice daily--or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism. RESULTS: Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P=0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P=0.13) and 3.64% per year with 150 mg of dabigatran (P=0.051). CONCLUSIONS: In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600.)

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Идентификаторы

DOI: 10.1056/nejmoa0905561

Цитирования и источники

Цитирований: 2Использованных источников: 0

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