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Patient Evidence Summary
Doctor, I have been on Xarelto® for treatment of a blood clot in my calf veins. Can I stop taking it after 6 weeks?
Completing 3 months of treatment with Xarelto® will reduce your risk of developing another blood clot when compared to just 6 weeks of treatment.
Study highlights
For people with a distal (calf) DVT, treatment with 3 months of Xarelto® reduced the risk of new PE or DVT and did not increase the risk of bleeding when compared to treatment with 6 weeks of Xarelto®.
Understanding the problem
When people have a blood clot in one or more leg veins (DVT), there is a risk that the blood clot may grow larger or travel from the leg veins up to the lungs and cause a pulmonary embolism (PE).
When a blood clot in the leg is located in the veins above the level of the knee, called a proximal DVT, there is a high risk of the blood clot travelling up to the lungs so doctors recommend a minimum of 3 months of anticoagulant therapy to reduce this risk. Some people develop a blood clot in the veins below the level of the knee (in the calf veins), called a distal DVT. A distal DVT on its own is generally considered to be less dangerous than a proximal DVT as there is a lower risk of the blood clot travelling to the lungs. For this reason, not all distal DVT are treated. However, some studies have shown that up to 2 out of 10 people who are not treated with anticoagulants for their distal DVT end up with their blood clot progressing into a proximal DVT or causing a PE. Because of this, some doctors will treat people who have a distal DVT with anticoagulants.
When treating a distal DVT with anticoagulants, doctors disagree for how long anticoagulants should be given. The goal of treatment with anticoagulants is to (1) prevent the clot from progressing into a proximal DVT or causing a PE and (2) reduce the risk of forming a new DVT. Researchers wanted to know whether there is a difference in the risk of recurrence of blood clots for people with distal DVT who are treated with Xarelto® for 3 months compared to patients treated with Xarelto® for only 6 weeks.
Who? The study included 402 adults who had a distal DVT in their leg veins. People who also had a proximal DVT or PE were excluded from the study. People who were younger than 18, pregnant or breastfeeding, had active cancer, severe kidney disease or severe liver disease were also excluded from the study.
What? The study compared 3 months of treatment with Xarelto® versus 6 weeks of treatment with Xarelto®.
Three Months of Xarelto® | vs | Six Weeks of Xarelto® |
|---|---|---|
Xarelto® (rivaroxaban) 15 mg twice a day for three weeks then 20 mg once a day for a total of 3 months. | Xarelto® (rivaroxaban) 15 mg twice a day for 3 weeks then 20 mg once a day for a total of 6 weeks. Placebo ("sugar pill") for 6 additional weeks. |
Three months of Xarelto® vs six weeks of Xarelto® in people who have a distal DVT
Outcomes after two years | Rate of events with 3 months of Xarelto® | Rate of events with 6 weeks of Xarelto® | Results |
|---|---|---|---|
Blood clot recurrence (distal DVT progressing into a proximal DVT, new distal DVT in opposite leg, new proximal DVT in opposite leg, PE or death from PE) | 11 out of 100 people | 19 out of 100 people | About 8 more people out of 100 had recurrence of their blood clot when treated with Xarelto® for only 6 weeks compared to those treated for 3 months |
Major bleeding | 0 out of 100 people | 0 out of 100 people | No difference |
This Evidence Summary is based on the following article:
Ageno W, Bertu L, Bucherini E, et al. Rivaroxaban treatment for six weeks versus three months in patients with symptomatic isolated distal deep vein thrombosis: randomised controlled trial. BMJ. 2022 Nov 23;379:e072623. doi: 10.1136/bmj-2022-072623. PubMed
Shaima Kaka
Shaima Kaka is an Internal Medicine resident at the University of Ottawa and research trainee at the Ottawa Hospital Research Institute. Her current clinical research interests include the diagnosis of venous thromboembolism and validity of clinical decision rules for venous thromboembolism diagnosis. Her non-clinical research interests include medical education and mentorship program quality improvement.
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: Wednesday, April 5, 2023
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