1. Direct Oral Anticoagulants for Thromboprophylaxis
in Orthopedic Surgery in the real world:
A Systematic Review of Population Based Studies
Fatimah Al-Ani MD MRCP 1; Alejandro Garcia-Horton MD 1; Alejandro Lazo-Langner MD MSc1,2
1Department of Medicine, Division of Hematology; 2Department of Epidemiology and Biostatistics
University of Western Ontario, London, Canada
OBJECTIVES
METHODS
To assess the efficacy and safety of DOACS in the prevention of thromboembolism in patients undergoing orthopedic surgery (OS) in population-based studies, outside the framework of clinical trials
We conducted a systematic review of observational studies assessing the safety and efficacy of DOACs in patients undergoing OS. Efficacy outcomes included VTE, and safety outcomes included major bleeding (MB), gastrointestinal (GI), central nervous system (CNS) bleeding, and bleeding-related deaths. When feasible, we conducted a meta-analysis of proportions using both fixed and random effects models.
Table1. Proportions of VTE, bleedings, bleeding related deaths with rivaroxaban
RESULTS
Outcome
Study
design
No. of studies
n/N
Prop.
(%)
Fixed
Model
95% CI
Prop. (%)
Random
VTE
All 8
227/27,158
0.8
1.6
Retrosp 4
144/15,150
0.9
2.2
Prosp
83/12,008
0.7 MB 7
192/27,130 5
125/15,590
2.8 2
64/11,540
0.55
GI bleed
48/13,458
0.3
0.2
Bleeding related mortality 3
1/1,250
0.08
0.05
A total of 10 full text articles, published between 2012 and 2016, were included. Of those 10 studies, 9 assessed rivaroxaban, 1 assessed dabigatran, and no studies found assessing apixaban. The analysis included rivaroxaban studies only. The total number of evaluable participants was 27,158 for VTE, and 27,130 for MB. Studies assessing rivaroxaban in patients undergoing orthopedic surgery showed a VTE rate of 0.8% [95%CI: ] (fixed) and 1.6% [95%CI: ] (random). The MB rate with rivaroxaban was 0.7% [95%CI: ] (fixed) and 2.2% [95%CI: ] (random). The bleeding related mortality was reported in only 3 studies (n=1,250), and found to be extremely low: 0.05% [95%CI: ] (fixed) and 0.08% [95%CI: ] (random). Table 1 shows the proportions of VTE, MB and GI bleeding according to study design.
Prop: proportion; n/N: number of patients with positive outcome/total number of patients; retrosp: retrospective; prosp: prospective
CONCLUSIONS
REFERENCES
In “real life”, the main DOAC used for VTE prophylaxis in orthopedic surgery is rivaroxaban. Rivaroxaban is effective and safe in orthopedic surgery in real-world studies as in RCTs. However, in this context, data of bleeding related mortality is still scarce. Data for apixaban is currently limited.
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