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Safety and Efficacy of Non-Vitamin K Oral Anticoagulant Use Early After Cardiac Surgery: A Systematic Review
Erica H Z Wang1, Jian Ye1, Ricky Turgeon1
1University of British Columbia, Vancouver, BC, Canada.
Objective:
To determine the safety and efficacy of non-vitamin K oral anticoagulants (NOACs) initiated early after cardiac surgery.
Data Sources:
Cochrane Central Register of Controlled Trials, EMBASE, and MEDLINE (database inception to January 20, 2021), www.clinicaltrials.gov, www.who.int/ictrp/search/en/, NOAC trial registries, and bibliographies of relevant guidelines and other reviews were used.
Study Selection And Data Extraction:
Observational studies and randomized controlled trials (RCTs) that initiated NOACs within the index hospitalization and that reported bleeding for the primary outcome were included.
Data Synthesis:
A total of 6 cohort studies, 1 RCT, and 3 ongoing RCTs were included. Most studies were single-centered, limited to postoperative atrial fibrillation after coronary artery bypass grafting, and with 30-day follow-up; few studies included patients with isolated bioprosthetic valve replacement or valve repair. Bleeding risk varied (0%-28.6%), and all but one study showed no significantly higher risk with NOAC compared with warfarin.
Relevance To Patient Care And Clinical Practice:
Overall, NOACs were used in 26% to 37.5% of patients early after cardiac surgery. Starting a NOAC on postoperative day 4 appeared to have similar bleeding rates compared with warfarin, but clinical application is limited by heterogeneity of outcome definitions, confounding, and bias. Compared with warfarin, NOACs may have similar thromboembolism risk, reduced length of stay, and cost.
Conclusions:
There is limited evidence to guide NOAC use early after cardiac surgery. Three ongoing randomized trials will add to the literature and provide guidance for clinicians on whether, in whom, when, and how to use NOACs safely early after cardiac surgery.
Insights
Non-vitamin K oral anticoagulants (NOACs) show similar bleeding risk to warfarin when started early after cardiac surgery. More research is needed to guide safe NOAC use in these patients.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Non-vitamin K oral anticoagulants (NOACs) are increasingly used for stroke prevention.
- Their early initiation after cardiac surgery requires careful safety and efficacy evaluation.
- Limited data exists on NOACs in the immediate postoperative period following cardiac procedures.
Purpose of the Study:
- To assess the safety and efficacy of initiating non-vitamin K oral anticoagulants (NOACs) early after cardiac surgery.
- To synthesize current evidence on bleeding risk and other outcomes associated with early NOAC use.
- To identify gaps in knowledge and guide future clinical practice.
Main Methods:
- Systematic review and meta-analysis of observational studies and randomized controlled trials (RCTs).
- Searched multiple databases (Cochrane, EMBASE, MEDLINE) and trial registries up to January 20, 2021.
- Included studies initiating NOACs during index hospitalization, reporting bleeding as a primary outcome.
Main Results:
- Included 6 cohort studies and 1 RCT; 3 RCTs are ongoing.
- Bleeding risk varied widely (0%-28.6%); most studies found no significant difference compared to warfarin.
- Early NOAC initiation (postoperative day 4) showed similar bleeding rates to warfarin, but with heterogeneity in definitions and potential bias.
Conclusions:
- Evidence for early NOAC use post-cardiac surgery is limited.
- Ongoing RCTs are crucial for establishing guidance on safe and effective NOAC application.
- NOACs may offer benefits like reduced length of stay and cost compared to warfarin, pending further evidence.
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