Efficacy and safety of rivaroxaban in real-life patients with atrial fibrillation

Abstract

Rivaroxaban is a once-daily oral anticoagulant currently marketed for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. This indication is largely based on the results of the ROCKET-AF trial. Although these results are robust, studies performed in clinical practice are necessary to confirm these data in real-life patients. These studies have shown rates of stroke and bleeding similar to that found in ROCKET-AF. As an anticoagulant, attention should be paid to making a correct prescription of rivaroxaban, particularly in fragile patients, to reduce the risk of bleeding. In addition, a number of studies have shown that rivaroxaban is cost-effective in clinical practice. Moreover, rivaroxaban is a good alternative to warfarin in patients undergoing elective cardioversion or atrial fibrillation ablation.

Keywords:

• atrial fibrillation
• bleeding
• clinical practice
• real-life
• rivaroxaban
• ROCKET-AF
• stroke

Financial & competing interests disclosure

Gonzalo Barón-Esquivias has received honoraria as advisor from Bayer, Daiichi-Sankyo, BMS-Pfizer and Rovi; and honoraria as speaker from Boehringer-Ingelheim, Bayer, Daiichi-Sankyo, BMS and Pfizer. Felipe Atienza has received honoraria as advisor from Medtronic, Sorin and Bayer. Marcelo Sanmartín Fernández has received grant support from Bayer; has received honoraria as advisor from Bayer, Boehringer and BMS; and honoraria as speaker from Bayer, Boehringer, and Pfizer. Francisco Fernández-Avilés, Pablo Pastor Pueyo and Rocío Toro have no conflict of interest to declare. The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Editorial assistance was provided by Content Ed Net, Madrid, Spain.

Key issues

• Chronic oral anticoagulation is required in the vast majority of patients with atrial fibrillation (AF) to prevent thromboembolic complications.

• Vitamin K antagonists have many disadvantages that limit their use in clinical practice. Moreover, the available evidence about vitamin K antagonists is mainly limited to warfarin.

• Rivaroxaban is a once-daily, direct factor Xa inhibitor currently approved for the prevention of stroke and systemic embolism in patients with non-valvular AF and at least one risk factor for stroke.

• This indication is largely based on the results of ROCKET-AF.

• The information provided by clinical trials is very relevant. However, patients included in randomized clinical trials may be quite different from those of clinical practice.

• Studies that included real-life patients showed similar rates of stroke and bleeding to that found in ROCKET-AF.

• Particular attention should be paid to making a correct prescription of rivaroxaban, particularly in fragile patients (i.e., elderly, renal insufficiency) to reduce the risk of bleeding.

• A number of studies have shown that rivaroxaban reduces hospital length of stay and that it is cost-effective option compared with warfarin in clinical practice.

• Rivaroxaban is also a good alternative to warfarin in patients undergoing elective cardioversion or AF ablation.

Notes