Rivaroxaban does not prevent cardiovascular events in patients with rheumatic heart disease and atrial fibrillation

1. Rivaroxaban was not associated with a lower rate of cardiovascular events and death compared with vitamin K antagonist therapy in patients with atrial fibrillation associated with rheumatic heart disease.

2. There were no significant differences between groups in the incidence of major bleeding safety outcomes.

Level of evidence assessment: 1 (Excellent)

Summary of the study: Previous randomized trials have demonstrated the efficacy of non-vitamin K antagonist oral coagulants, such as rivaroxaban, a factor Xa inhibitor, for the prevention of stroke in patients with atrial fibrillation. Compared to vitamin K antagonist therapy, rivaroxaban therapy does not require regular blood sampling to monitor anticoagulation status. However, these trials largely excluded patients with rheumatic heart disease. This randomized controlled trial evaluated the efficacy and safety of rivaroxaban in preventing cardiovascular events in patients with atrial fibrillation associated with rheumatic heart disease. Patients were followed for an average of 3.1 years. The incidence of a primary outcome event, defined as a composite of stroke, systemic embolism, myocardial infarction, or death, was higher in the rivaroxaban group than in the vitamin antagonist group. K. Mortality was higher in the rivaroxaban group, due to higher rates of sudden cardiac death or mechanical or pump failure. Rates of hospitalization for heart failure and valve replacement surgery were not significantly different between the groups. There were no significant differences in major bleeding rates, the primary safety outcome, between the groups. As a limitation, there was a higher incidence of discontinuation of rivaroxaban than vitamin K antagonists, which may result in more cardiovascular events in the rivaroxaban group. In addition, outcome measures had to be redefined during the trial due to lower than expected cardiovascular event rates.

Click to read the study in the NEJM

In depth [randomized controlled trial]: In the present randomized controlled trial, adults aged 18 years and older with documented atrial fibrillation and echocardiographically confirmed rheumatic heart disease (n=4531) were recruited from 138 trial sites in Africa, Asia and America Latin. Patients were randomized 1:1 to receive either rivaroxaban (n=2275) or a locally available vitamin K antagonist (n=2256). Depending on renal function, rivaroxaban was administered at a daily dose of 15 or 20 mg. The most administered vitamin K antagonist was warfarin (79 to 85% of patients in the group). Patients were followed up to one month after randomization and every six months thereafter for a mean follow-up of 3.1 (standard deviation, 1.2) years. The incidence of trial discontinuation was higher in the rivaroxaban group than in the vitamin K antagonist group (79.0% and 96.4% compliance at year four, respectively). A primary outcome event, defined as stroke, systemic embolism, myocardial infarction, or death, occurred in 560 and 446 patients in the rivaroxaban and vitamin K antagonist groups, respectively (proportional hazard ratio, 1 .25, 95% confidence interval [CI], 1.10 to 1.41). For the secondary endpoints, the incidence of cerebrovascular accidents (90 and 65 patients in the rivaroxaban and vitamin K antagonist groups, respectively) and mortality (difference in restricted mean survival time, -72 days; CI to 95%, -117 to -28) were higher in the rivaroxaban group. Rates of hospitalization for heart failure or valve replacement surgery were not significantly different between the groups. There were no significant differences in major bleeding rates. The results of this trial support current guidelines that recommend vitamin K antagonists, not rivaroxaban, for the prevention of stroke in patients with atrial fibrillation associated with rheumatic heart disease.

Picture: PD

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