Open AccessDifferences in outcomes between oral anticoagulation “new starters” and “switchers” in patients with nonvalvular atrial fibrillation: A pooled analysis of the AMADEUS and BOREALIS trials
Author(s) -
Bai Ying,
Shantsila Alena,
Lip Gregory Y. H.
Publication year - 2019
Publication title -
journal of arrhythmia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.463
H-Index - 21
eISSN - 1883-2148
pISSN - 1880-4276
DOI - 10.1002/joa3.12255
Subject(s) - medicine , post hoc analysis , atrial fibrillation , stroke (engine) , hazard ratio , proportional hazards model , pooled analysis , major bleeding , post hoc , clinical trial , cardiology , meta analysis , confidence interval , mechanical engineering , engineering
Background To explore differences in outcomes between dose‐adjusted vitamin K antagonists (VKAs) “new starters” and “switchers” in patients with nonvalvular atrial fibrillation (AF). Methods A post hoc analysis was performed to assess the outcome differences between VKA “new starters” and “switchers” in AF patients using pooled individual patient data of AMADEUS and BOREALIS trials. Results A total of 4169 AF patients were included in the present analysis, which included 1383 “VKA new starters” and 2786 “VKA switchers”. VKA new starters had higher crude rates of all‐cause mortality ( P = .035) and cardiovascular death ( P = .047) compared to switchers. On multivariable Cox regression analysis, both “new starters” and “switchers” showed nonsignificant trends for different risks of stroke/systemic thromboembolism (SE) (hazard ratio (HR): 1.66, 95%CI: 0.95‐2.90, P = .08), major bleeding (HR: 1.25, 95% CI: 0.73‐2.16, P = .42), and all‐cause death (HR: 1.09, 95% CI: 0.75‐1.57, P = .65). On Kaplan‐Meier analysis, both groups had similar risks of stroke/systemic embolism ( P = .09), major bleeding ( P = .28), and all‐cause death ( P = .06). Conclusions In this post hoc analysis of clinical trial patients with AF, “new starters” and “switchers” for VKA initiation had nonstatistically significant rates of trial‐adjudicated thromboembolism, major bleeding, and all‐cause mortality.