Periprocedural Outcomes of Direct Oral Anticoagulants vs. Warfarin in Non-Valvular Atrial Fibrillation: A Meta-analysis of Phase III Trials
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.
- heparin bridging
- direct oral anticoagulants
- vitamin K antagonists
- atrial fibrillation
- Received September 2, 2017.
- Revision received April 30, 2018.
- Accepted May 3, 2018.