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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.
|Family Medicine (FM)/General Practice (GP)|
|General Internal Medicine-Primary Care(US)|
|Hemostasis and Thrombosis|
I would be reluctant to change practice based on this publication.
There has been an FDA warning that DOACS should not be used in artificial heart valves.
This network analysis of NOAC trials in AF examined data from subsets of patients with valvular heart disease (except moderate or severe MS or a mechanical heart valve), or a bioprosthetic heart valve. Overall compared with VKA 1). NOAC were associated with less systemic embolism, MI and ICH in valve disease, and 2) outcomes were similar in patients with a bioprosthetic valve - with wide confidence limits (only 280 patients). 3). The analysis finds more ICH and major bleeding with rivaroxaban than other NOAC, so the authors consider this 'might suggest caution in the selection of this agent for this subgroup of patients'. Recall, however, that entry criteria differed between ROCKET-AF, the pivotal rivaroxaban study in AF, and other NOAC trials (higher CHADs-2, more patients with previous TIA/Stroke) [CT Ruff t al, Lancet 2014; 383: 955], and this may well have also raised bleeding risk. It is perilous to make between drug comparisons when these are indirect, even by network analysis.