Effectiveness and Safety of Dabigatran Compared to Vitamin K Antagonists in Non-Asian Patients with Atrial Fibrillation: A Systematic Review and Meta-Analysis
Por:
Escobar, C, Barrios, V, Lip, GYH, Amin, AN, Auladell-Rispau, A, Santero, M, Salazar, J, Requeijo, C
Publicada:
1 nov 2021
Ahead of Print:
1 oct 2021
Resumen:
Background and Objective Real-life data about the use of dabigatran in patients with non-valvular atrial fibrillation are warranted. The objective of this systematic review and meta-analysis was to assess the effectiveness and safety of dabigatran, globally and stratified by dose (110/150 mg twice daily), vs vitamin K antagonists in non-Asian patients with non-valvular atrial fibrillation from "real-world" studies. Methods A systematic review was performed according to Cochrane methodological standards. The results were reported according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses Statement) statement. The ROBINS-I tool was used to assess bias risk. MEDLINE and EMBASE, from inception up to May 2021, using appropriate controlled vocabulary and free search terms, were searched. Results A total of 34 studies, corresponding to 37 articles involving 1,600,722 participants (1,154,283 exposed to vitamin K antagonists and 446,439 to dabigatran) were eligible for this review. Dabigatran 150 mg reduced the risk of ischemic stroke compared with vitamin K antagonists, with a 14% risk reduction (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.74-0.98). Globally, dabigatran reduced the risk of all-cause mortality compared with vitamin K antagonists (HR 0.76, 95% CI 0.69-0.84), with a greater effect observed with dabigatran 150 mg (HR 0.65, 95% CI 0.58-0.73). There was a trend towards a lower risk of myocardial infarction with dabigatran 150 mg (HR 0.86, 95% CI 0.71-1.04). Regarding the primary safety outcomes, dabigatran (either at a dose of 150 mg or 110 mg) reduced the risk of major bleeding compared with vitamin K antagonists (HR 0.77, 95% CI 0.70-0.83), as well as the risk of intracranial bleeding (HR 0.44, 95% CI 0.39-0.50) and fatal bleeding (HR 0.76, 95% CI 0.60-0.95), but with a slight increase in gastrointestinal bleeding risk (HR 1.16, 95% CI 1.08-1.26). Conclusions Dabigatran has a favorable impact on effectiveness and safety outcomes compared with vitamin K antagonists in real-world populations.
Filiaciones:
Escobar, C:
Hosp Univ La Paz, Serv Cardiol, Paseo Castellana 261, Madrid 28046, Spain
Barrios, V:
Hosp Univ Ramon Cajal, Serv Cardiol, Madrid, Spain
Lip, GYH:
Univ Liverpool & Liverpool Heart & Chest, Liverpool, Merseyside, England
Amin, AN:
Univ Calif Irvine, Sch Med, Dept Med, Irvine, CA USA
Auladell-Rispau, A:
Inst Invest Biomed St Pau IIB St Pau, Grp Rec Epidemiol Clin & Serv Sanit, Barcelona, Spain
Santero, M:
Inst Invest Biomed St Pau IIB St Pau, Grp Rec Epidemiol Clin & Serv Sanit, Barcelona, Spain
Salazar, J:
Inst Invest Biomed St Pau IIB St Pau, Grp Rec Epidemiol Clin & Serv Sanit, Barcelona, Spain
Requeijo, C:
Inst Invest Biomed St Pau IIB St Pau, Grp Rec Epidemiol Clin & Serv Sanit, Barcelona, Spain
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