In this episode, I’ll discuss the use of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve.
Atrial fibrillation is a common rhythm in patients that have bioprosthetic mitral valves. Life-long anticoagulation is often prescribed in such patients to manage the risk of valve thrombosis and thromboembolism in general.
Limited data on the use of DOACs in patients with atrial fibrillation and a bioprosthetic mitral valve are available, coming from small sub group analysis.
The main trial that secured rivaroxaban’s approval for use in patients with afib excluded patients with valve replacements.
To improve the data available in this patient population, investigators in Brazil completed a multicenter, randomized, open-label, noninferiority trial with 1000 patients comparing rivaroxaban with warfarin for patients with atrial fibrillation and a bioprosthetic mitral valve.
The primary outcome was a composite of death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months.
The mean time until a primary event was ~347 days in the rivaroxaban group and ~340 days in the warfarin group for a P<0.001 for noninferiority and P=0.10 for superiority. Death from cardiovascular causes or thromboembolic events occurred in 3.4% of patients in the rivaroxaban group and in 5.1% of patients in the warfarin group. While this trend favored rivaroxaban, the 95% confidence interval for the hazard ratio included, and surpassed 1, so this was not statistically significant. There was a 4-fold lower risk of stroke in the rivaroxaban group which was statistically significant however the 95% confidence interval for the hazard ratio was extremely wide at 0.07 to 0.88. Bleeding and other adverse events were not statistically significantly different between groups. The authors concluded:
In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months.
This trial is very likely to bring acceptance to the use of rivaroxaban in patients with atrial fibrillation and bioprosthetic mitral valves.
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