アブストラクト | OBJECTIVE: To compare real-world effectiveness and safety of direct oral anticoagulants (DOACs) in patients with nonvalvular atrial fibrillation (AFib) for prevention of stroke. STUDY DESIGN AND SETTING: A comparative cohort study in UK general practice data from The Health Improvement Network database. PARTICIPANTS AND INTERVENTIONS: Before matching, 5655 patients >/=18 years with nonvalvular AFib who initiated at least one DOAC between 1 July 2014 and 31 December 2020 were included. DOACs of interest included apixaban, rivaroxaban, edoxaban and dabigatran, with the primary comparison between apixaban and rivaroxaban. Initiators of DOACs were defined as new users with no record of prescription for any DOAC during 12 months before index date. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was stroke (ischaemic or haemorrhagic). Secondary outcomes included the occurrence of all-cause mortality, myocardial infarction (MI), transient ischaemic attacks (TIA), major bleeding events and a composite angina/MI/stroke (AMS) endpoint. RESULTS: Compared with rivaroxaban, patients initiating apixaban showed similar rates of stroke (HR: 0.93; 95% CI 0.64 to 1.34), all-cause mortality (HR: 1.03; 95% CI 0.87 to 1.22), MI (HR: 0.95; 95% CI 0.54 to 1.68), TIA (HR: 1.03; 95% CI 0.61 to 1.72) and AMS (HR: 0.96; 95% CI 0.72 to 1.27). Apixaban initiators showed lower rates of major bleeding events (HR: 0.60; 95% CI 0.47 to 0.75). CONCLUSIONS: Among patients with nonvalvular AFib, apixaban was as effective as rivaroxaban in reducing rate of stroke and safer in terms of major bleeding episodes. This head-to-head comparison supports conclusions drawn from indirect comparisons of DOAC trials against warfarin and demonstrates the potential for real-world evidence to fill evidence gaps and reduce uncertainty in both health technology assessment decision-making and clinical guideline development. |
ジャーナル名 | BMJ open |
Pubmed追加日 | 2022/10/18 |
投稿者 | Jaksa, Ashley; Gibbs, Liza; Kent, Seamus; Rowark, Shaun; Duffield, Stephen; Sharma, Manuj; Kincaid, Lynne; Ali, Ayad K; Patrick, Amanda R; Govil, Priya; Jonsson, Pall; Gatto, Nicolle |
組織名 | Scientific Research and Strategy, Aetion, Inc, Boston, Massachusetts, USA;ashley.jaksa@aetion.com.;Scientific Research and Strategy, Aetion, Inc, Boston, Massachusetts, USA.;Data and Analytics, National Institute for Health and Care Excellence,;Manchester, UK.;Scientific Research and Strategy, Aetion, Inc, New York City, New York, USA.;Department of Epidemiology, Columbia University, New York City, New York, USA. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36253039/ |