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Published on: February 26, 2013
Oral anticoagulation in patients with atrial fibrillation and heart valve prosthesis: A substudy from the Left Atrial
Domenico Paparella1, Emilie P Belley-Cote2, Michele Di Mauro3
1Division of Cardiac Surgery, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy; Division of Cardiac Surgery, Santa Maria Hospital, GVM Care & Research, Bari, Italy.
Insights
Direct oral anticoagulants (DOACs) demonstrated similar safety and efficacy compared to vitamin K antagonists (VKAs) in patients after bioprosthetic heart valve implantation or repair. This suggests DOACs are a viable alternative to VKAs in this patient population.
Area of Science:
- Cardiology
- Cardiovascular Surgery
- Pharmacology
Background:
- Current guidelines recommend vitamin K antagonists (VKAs) for patients with atrial fibrillation undergoing biological valve implantation.
- The safety and efficacy of direct oral anticoagulants (DOACs) in this specific patient group, particularly in the early postoperative phase, remain less understood.
Purpose of the Study:
- To compare thromboembolic and bleeding outcomes between patients discharged on VKAs versus DOACs after bioprosthesis implantation or mitral valve repair.
- To evaluate the safety and efficacy of DOACs as an alternative to VKAs in the early postoperative period following cardiac valve procedures.
Main Methods:
- A substudy of the Left Atrial Appendage Occlusion Study (LAAOS) III trial included 2645 patients (461 on DOACs, 2184 on VKAs).
- Exclusion criteria included mechanical valves or isolated coronary surgery.
- Cox proportional hazard models were used to analyze stroke, systemic thromboembolism, and major bleeding events, adjusted for relevant clinical factors.
Main Results:
- Patients on DOACs were older, predominantly male, and had lower rates of rheumatic heart disease compared to VKA users.
- No significant differences were found in thromboembolic events (HR 0.754; P=.185) or major bleeding (HR 0.760; P=.197) between the DOAC and VKA groups.
- A trend towards worse outcomes was observed in patients who switched or discontinued anticoagulation therapy.
Conclusions:
- Direct oral anticoagulants (DOACs) exhibit comparable thromboembolic and bleeding risks to vitamin K antagonists (VKAs) in patients following mitral and/or aortic bioprosthesis implantation or mitral valve repair.
- DOACs represent a potentially safe and effective alternative to VKAs in this clinical setting.
Objective:
Societal guidelines recommend vitamin K antagonists (VKAs) for patients with atrial fibrillation with recent biological valve implantation, but the safety and efficacy of direct oral anticoagulants (DOACs) in this setting remain uncertain, especially in the early postoperative period. This substudy of the Left Atrial Appendage Occlusion Study (LAAOS) III trial aimed to compare thromboembolic and bleeding outcomes in patients discharged on VKAs versus DOACs after bioprosthesis implantation or mitral valve repair.
Methods:
A total of 2645 patients were included, with 461 discharged on DOACs and 2184 on VKAs. Patients with mechanical valves or isolated coronary surgery were excluded. The primary end point was stroke or systemic thromboembolism. Major bleeding was a secondary end point. Cox proportional hazard models adjusted for time-dependent covariates and clinical factors (eg, age, previous stroke, left atrial appendage occlusion) were applied to assess outcomes.
Results:
Patients discharged on DOACs were older, mostly male, and had lower rates of rheumatic heart disease than those on VKAs. During follow-up, no significant differences were observed in thromboembolic (hazard ratio, 0.754; 95% confidence interval, 0.496-1.145; P = .185) or major bleeding events (hazard ratio, 0.760; 95% confidence interval, 0.601-1.153; P = .197) between groups. A nonsignificant trend toward worse outcomes was noted for patients who discontinued or switched anticoagulation.
Conclusions:
In this large cohort of patients after mitral and/or aortic bioprosthesis implantation or mitral valve repair within the LAAOS III, DOACs showed similar thromboembolic and bleeding risks as VKAs, suggesting they may be a safe alternative.
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