Key result
In patients with atrial fibrillation and valvular heart disease, NOACs significantly reduced stroke or systemic embolisation compared to warfarin (0.70; 95% CI 0.57-0.85; P<0.001).
Why the study?
Little is known regarding the safety and efficacy of NOACs in patients with AF and valvular heart disease, with a similar paucity of data in patients with a bioprosthetic heart valve.
Do NOACs reduce stroke, systemic embolization, and bleeding compared to warfarin in patients with atrial fibrillation and valvular heart disease or bioprosthetic heart valves?
Meta-Analysis
Do NOACs reduce stroke, systemic embolization, and bleeding compared to warfarin in patients with atrial fibrillation and valvular heart disease or bioprosthetic heart valves?
Effect estimate: 0.70 (95% CI 0.57-0.85)
p-value: p=<0.001
NOACs are more effective and safer than warfarin in patients with atrial fibrillation and valvular heart disease, with similar outcomes observed in a small subgroup with bioprosthetic valves.
Supports NOAC preference over warfarin in AF with valvular heart disease; confirms efficacy and extends evidence to bioprosthetic valves.
OBJECTIVE: Current guidelines endorse the use of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF). However, little is known about their safety and efficacy in valvular heart disease (VHD). Similarly, there is a paucity of data regarding NOACs use in patients with a bioprosthetic heart valve (BPHV). We, therefore, performed a network meta-analysis in the subgroups of VHD and meta-analysis in patients with a BPHV. METHODS: PubMed, Cochrane and Embase were searched for randomised controlled trials. Summary effects were estimated by the random-effects model. The outcomes of interest were a stroke or systemic embolisation (SSE), myocardial infarction (MI), all-cause mortality, major adverse cardiac events, major bleeding and intracranial haemorrhage (ICH). RESULTS: In patients with VHD, rivaroxaban was associated with more ICH and major bleeding than other NOACs, while edoxaban 30 mg was associated with least major bleeding. Data combining all NOACs showed a significant reduction in SSE, MI and ICH (0.70, [0.57 to 0.85; p<0.001]; 0.70 [0.50 to 0.99; p<0.002]; and 0.46 [0.24 to 0.86; p<0.01], respectively). Analysis of 280 patients with AF and a BPHV showed similar outcomes with NOACs and warfarin. CONCLUSIONS: NOACs performed better than warfarin for a reduction in SSE, MI and ICH in patients with VHD. Individually NOACs performed similarly to each other except for an increased risk of ICH and major bleeding with rivaroxaban and a reduced risk of major bleeding with edoxaban 30 mg. In patients with a BPHV, results with NOACs seem similar to those with warfarin and this needs to be further explored in larger studies.
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Malik et al. (2019) conducted a meta-analysis in Atrial fibrillation with valvular heart disease and bioprosthetic heart valves. Non-vitamin K antagonist oral anticoagulants (NOACs) vs. Warfarin was evaluated on Stroke or systemic embolisation (SSE) (0.70, 95% CI 0.57-0.85, p=<0.001). In patients with atrial fibrillation and valvular heart disease, NOACs significantly reduced stroke or systemic embolisation compared to warfarin (0.70; 95% CI 0.57-0.85; P<0.001).
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