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Published on: February 26, 2013
Thromboembolic and bleeding events after valvular intervention in patients with atrial fibrillation
Ebba-Louise Skogseid1, Gorav Batra2,3, Johan Westerbergh2
1Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden ebba-louise.skogseid@medsci.uu.se.
Insights
Non-vitamin K antagonist oral anticoagulants (NOACs) showed similar efficacy and safety to warfarin in atrial fibrillation patients undergoing valvular interventions. However, patients not on oral anticoagulants faced higher cardiovascular risks, and NOACs increased CV death in specific surgical subgroups.
Area of Science:
- Cardiology
- Pharmacology
- Public Health
Background:
- Atrial fibrillation (AF) is common in patients undergoing valvular heart interventions.
- Optimal oral anticoagulant (OAC) management post-intervention is crucial for preventing cardiovascular (CV) events and bleeding.
- Understanding the comparative effectiveness and safety of different OACs, including non-vitamin K antagonist oral anticoagulants (NOACs) versus warfarin, is essential.
Purpose of the Study:
- To evaluate outcomes in patients with AF undergoing surgical biological valve replacement, valve repair, or transcatheter aortic valve implantation (TAVI).
- To compare the efficacy and safety of NOACs and warfarin in this patient population.
- To assess the impact of OAC exposure on cardiovascular events and major bleeding.
Main Methods:
- A Swedish registry-based cohort study included patients with AF undergoing valvular intervention.
- Cox regression analysis was used to investigate associations between OAC exposure and composite CV events (CV death, ischemic stroke, systemic embolism) and major bleeding.
- Analyses were stratified into early (0-3 months) and later (3-12 months) postoperative periods.
Main Results:
- Among 4730 patients, NOAC use was associated with similar risks of CV outcomes and major bleeding compared to warfarin in the 0-3 month period.
- Patients not receiving OACs had a significantly increased risk of CV events (HR 1.71) but similar bleeding risk.
- In the surgical bioprosthetic valve replacement subgroup, NOACs and no OAC were associated with increased CV death compared to warfarin in the early postoperative phase.
Conclusions:
- NOACs appear comparable to warfarin for efficacy and safety in AF patients undergoing various valvular interventions.
- Patients not on OACs have a higher risk of CV events, highlighting the importance of anticoagulation.
- Caution is advised when extrapolating NOAC data to all patient groups, particularly in the early post-surgical bioprosthetic valve replacement phase, warranting further investigation.
Aim:
To assess outcomes after cardiac surgery with biological valve replacement, valve repair or transcatheter aortic valve implantation (TAVI) in patients with atrial fibrillation (AF) in accordance with oral anticoagulant (OAC) treatment.
Methods:
All patients in Sweden undergoing valvular intervention with AF were included. Associations between OAC exposure and cardiovascular (CV) events (composite of CV death, ischaemic stroke or systemic embolism) and major bleeding were investigated using Cox regression analysis. The analysis was separated in time periods of 0-3 and 3-12 months after discharge.
Results:
4730 patients were included in the first time period, 54.0% had received a surgical biological valve prosthesis, 23.8% valve repair and 22.2% TAVI. Exposure to warfarin (comparator) was 62.3%, to non-vitamin K antagonist oral anticoagulants (NOACs) 10.0% and to no OAC 27.7%. NOAC exposure was associated with similar risk of the composite CV outcome and major bleeding from 0 to 3 months. No OAC was associated with increased risk of the composite CV outcome (HR 1.71; 95% CI 1.26 to 2.32) and similar risk of major bleeding. Further analysis of the bioprosthetic valve replacement subgroup indicated increased risk of CV death when exposed to NOAC (HR 2.58; 95% CI 1.15 to 5.78) and no OAC (HR 2.82; 95% CI 1.65 to 4.82) compared with warfarin from 0 to 3 months. No differences were seen between 3 and 12 months.
Conclusion:
In this registry-based cohort study of patients with AF with severe valvular heart disease undergoing various valvular interventions, NOAC appears to be comparable with warfarin regarding efficacy and safety. Patients not receiving OAC had higher risk of CV events. NOAC was associated with increased CV death compared with warfarin in the surgical bioprosthetic valve replacement subgroup, illustrating the importance of being cautious when extrapolating data from one patient group to another. Further studies comparing NOAC and warfarin in the early postoperative phase are warranted, especially following surgical bioprosthetic valve replacement.
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