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Periprocedural Outcomes of Direct Oral Anticoagulants vs. Warfarin in Non-Valvular Atrial Fibrillation: A Meta-analysis of Phase III Trials.
Circulation. 2018 May 24;:
Authors: Nazha B, Pandya B, Cohen J, Zhang M, Lopes RD, Garcia DA, Sherwood MW, Spyropoulos AC
Abstract
Background -Direct oral anticoagulants (DOACs) are surpassing warfarin as the anticoagulant of choice for stroke prevention in non-valvular atrial fibrillation (NVAF). DOACs outcomes in elective periprocedural settings have not been well elucidated and remain a source of concern for clinicians. The aim of this meta-analysis was to evaluate the periprocedural safety and efficacy of DOACs vs. warfarin in NVAF patients. Methods -We reviewed the literature for data from Phase III randomized controlled trials comparing DOACs with warfarin in the periprocedural period among NVAF patients. Sub-studies from 4 trials (RE-LY, ROCKET AF, ARISTOTLE, ENGAGE AF) were included in the meta-analysis. DOACs as a group and warfarin were compared in terms of the 30-day pooled risk for Stroke/Systemic Embolism (SSE), Major Bleed (MB) and death, according to whether the study drug was interrupted or not periprocedurally. The overall Relative Risk (RR) was estimated using a random effects model. The I² test was used to assess heterogeneity in RR among the studies. Results -In the uninterrupted anticoagulant strategy, there were no differences in the rates of SSE [pooled risk 0.6% (29 events/4519 procedures) vs. 1.1% (31/2971), RR=0.70, 95% CI= (0.41, 1.18)] and death [1.4% vs. 1.8%, RR=0.77, 95% CI= (0.53, 1.12)] between DOACs vs warfarin, and significantly fewer MB [2.0% vs. 3.3%, RR=0.62, 95% CI= (0.47, 0.82)] with DOACs compared to warfarin. Under an interrupted strategy, there was no significant difference between DOACs vs. warfarin for SSE [0.4% (41/9260) vs. 0.5% (31/7168), RR=0.95, 95% CI= (0.59, 1.55)], MB [2.1% vs. 2.0%, RR=1.05, 95% CI= (0.85, 1.30)], and death [0.7% vs. 0.6%, RR=1.24; 95% CI= (0.76, 2.04)]. The studies were homogeneous (I2= 0.0%) for all calculated pooled associations except for the RR of death in the interrupted strategy (I2= 26.3%). Conclusions -The short-term safety and efficacy of DOACs and warfarin are not different in NVAF patients periprocedurally. Under an uninterrupted anticoagulation strategy, DOACs are associated with a 38% lower risk of MB compared with warfarin.
PMID: 29794081 [PubMed - as supplied by publisher]