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Patient Evidence Summary
Doctor, I have atrial fibrillation and mitral stenosis, can I take Xarelto instead of warfarin to protect me from stroke?
People with mitral stenosis due to rheumatic heart disease who also have atrial fibrillation should not take Xarelto® for protection from stroke. Currently, the best anticoagulant for people with both of these problems at the same time is warfarin.
Study highlights
People with atrial fibrillation and mitral stenosis due to rheumatic heart disease who took Xarelto® had more of the combination of strokes, other blood clots, heart attack or death compared to people who took warfarin.
Understanding the problem
For some people, one of the heart valves (mitral valve) may become too narrow. One of the reasons this can happen is exposure to a bacterial infection called Rhematic Fever during childhood (rheumatic heart disease). The narrowed or stenotic valve slows blood through the heart. When a person with mitral stenosis also has atrial fibrillation, the risk of having a stroke is higher than the risk of stroke with atrial fibrillation without mitral stenosis.
Atrial fibrillation is a common abnormal heart rhythm where the upper chambers of the heart don't beat in a regular rhythm. This abnormal rhythm increases the risk of blood clots forming within the heart which can then break loose and travel to the blood vessels in the brain to cause a stroke or TIA. These clots can also travel to other arteries in the body (systemic embolization), for example, within the leg. Taking anticoagulants reduces the risk of forming blood clots.
Most commonly, people with both atrial fibrillation and mitral stenosis are given warfarin. People who take warfarin need to have regular blood testing (called INR), to ensure their medication dose is correct. Warfarin may interact with food and other medications.
Xarelto® does not require blood testing and interacts with few medications. From other studies, we know that Xarelto® is as safe and effective as warfarin for reducing the risk of stroke in people with atrial fibrillation without mitral stenosis. Researchers wanted to know if Xarelto® is as safe and effective as warfarin at reducing the risk of strokes and other blood clots in people with both atrial fibrillation and mitral stenosis due to rheumatic heart disease.
Who? The study included 4565 people (average age, 51 years; 72% women) who had mitral stenosis due to rheumatic heart disease, atrial fibrillation and at least one other risk factor for stroke such as high blood pressure, congestive heart failure, diabetes, or history of stroke or TIA. People who had a mechanical heart valve were excluded from this study.
What? The study compared Xarelto® with warfarin for an average of 3 years.
Xarelto® | vs | Warfarin |
|---|---|---|
Xarelto® 20 mg once daily OR 15 mg once daily for people with reduced kidney function | Warfarin at doses aimed to maintain an INR between 2.0 and 3.0. INRs were measured at least once every 4 weeks. |
Xarelto vs Warfarin in people who have mitral stenosis due to rheumatic heart disease and atrial fibrillation
Outcomes at average of 3 years | Rate of events with Xarelto® | Rate of events with Warfarin | Results |
|---|---|---|---|
Stroke, other blood clots, heart attack, or death | 8 out of 100 people per year | 6 out of 100 people per year | About 2 more people out of 100 per year who took Xarelto had either a stroke, blood clot, heart attack, or death compared to people who took warfarin |
| Major bleeding | 1 out of 100 people per year | 1 out of 100 people per year | No effect |
This Evidence Summary is based on the following article:
Connolly SJ, Karthikeyan G, Ntsekhe M, et al. Rivaroxaban in Rheumatic Heart Disease-Associated Atrial Fibrillation. N Engl J Med. 2022 Sep 15;387(11):978-988. doi: 10.1056/NEJMoa2209051. Epub 2022 Aug 28. PubMed
Lori-Ann Linkins, MD, MSc (Clin Epi), FRCPC
Dr. Linkins is an Associate Professor of Medicine (thrombosis) at McMaster University in Hamilton, Canada. She holds a Masters Degree in Health Research Methodology and is a Deputy Editor with the Health Information Research Unit, McMaster. She is Co-Editor of the ACP Journal Club and Co-lead on the CanVECTOR Knowledge Translation Platform.
Published: Tuesday, December 6, 2022
Please note that the information contained herein is not to be interpreted as an alternative to medical advice from a professional healthcare provider. If you have any questions about any medical matter, you should consult your professional healthcare providers, and should never delay seeking medical advice, disregard medical advice or discontinue medication based on information provided here.
, McMaster University