Trial reportBMJ (Clinical research ed.)2022
Rivaroxaban treatment for six weeks versus three months in patients with symptomatic isolated distal deep vein thrombosis: randomised controlled trial.
Trial report in BMJ (Clinical research ed.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02722447 (Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- Anticoagulant treatment for isolated distal deep vein thrombosis: a systematic review and meta-analysis.Haematologica · 2025Pooled it
- Comparison of clinical outcomes among patients with isolated axial vs muscular calf vein thrombosis: A systematic review and meta-analysis.Journal of vascular surgery. Venous and lymphatic disorders · 2024Pooled it
- International Clinical Practice Guidelines for Acute Deep Vein Thrombosis: A Comparative Review of Recommendations, Evidence Gaps, and Emerging Trends.Journal of clinical medicine · 2026Review
- Post-discharge VTE prophylaxis after bariatric surgery: balancing bleeding risk and thrombosis prevention in 275,843 patients.Surgical endoscopy · 2026Article
- Prediction of bowel resection due to bowel necrosis in recent portal vein thrombosis based on CT presentations and clinical data.BMC gastroenterology · 2025Article
- Treatment of isolated distal deep vein thrombosis: an international survey of healthcare professionals.Journal of thrombosis and thrombolysis · 2025Article
- Impact of Dual Antithrombotic Therapy with Aspirin and Rivaroxaban on Secondary Cardiovascular Outcomes.Medical science monitor : international medical journal of experimental and clinical research · 2024Article
- Article
- Beyond Anticoagulation: A Comprehensive Review of Non-Vitamin K Oral Anticoagulants (NOACs) in Inflammation and Protease-Activated Receptor Signaling.International journal of molecular sciences · 2024Review
- Isolated Calf Muscle Venous Thrombosis: A Review of Anticoagulation Strategies.Medical science monitor : international medical journal of experimental and clinical research · 2024Review
- Recurrence in isolated distal DVT after anticoagulation: a systematic review and meta-analysis of axial and muscular venous thrombosis.Thrombosis journal · 2024Review
- The impact of COVID-19 on the prognosis of deep vein thrombosis following anticoagulation treatment: a two-year single-center retrospective cohort study.BMC pulmonary medicine · 2024Article
- The clinical outcomes of different doses of rivaroxaban in patients with isolated distal deep vein thrombosis.Journal of vascular surgery. Venous and lymphatic disorders · 2024Article
- A two-sample Mendelian randomization study of circulating lipids and deep venous thrombosis.Scientific reports · 2023Article
- High systemic inflammation response index level is associated with an increased risk of lower extremity deep venous thrombosis: a large retrospective study.Annals of medicine · 2023Article
- Investigating serum levels of IL-6 and TNF alpha, and the risk of thrombosis in newly diagnosed chemotherapy naïve obese cancer patients.Nigerian medical journal : journal of the Nigeria Medical AssociationArticle
- Isolated distal deep vein thrombosis: Diagnosis and management.Science progressReview
Corrections and comments
- Commented on by
Authors and funding
14 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare two different treatment durations of rivaroxaban in patients with symptomatic isolated distal deep vein thrombosis (DVT).
designRandomised, double blind, placebo controlled clinical trial.
setting28 outpatient clinics specialising in venous thromboembolism.
participants402 adults (≥18 years) with symptomatic isolated distal DVT.
interventionsAfter receiving standard dose rivaroxaban for six weeks, participants were randomly assigned to receive rivaroxaban 20 mg or placebo once daily for an additional six weeks. Follow-up was for 24 months from study inclusion. MAIN OUTCOMES MEASURES: The primary efficacy outcome was recurrent venous thromboembolism during follow-up after randomisation, defined as the composite of progression of isolated distal DVT, recurrent isolated distal DVT, proximal DVT, symptomatic pulmonary embolism, or fatal pulmonary embolism. The primary safety outcome was major bleeding after randomisation until two days from the last dose of rivaroxaban or placebo. An independent committee adjudicated the outcomes.
results200 adults were randomised to receive additional rivaroxaban treatment and 202 to receive placebo. Isolated distal DVT was unprovoked in 81 (40%) and 86 (43%) patients, respectively. The primary efficacy outcome occurred in 23 (11%) patients in the rivaroxaban arm and 39 (19%) in the placebo arm (relative risk 0.59, 95% confidence interval 0.36 to 0.95; P=0.03, number needed to treat 13, 95% confidence interval 7 to 126). Recurrent isolated distal DVT occurred in 16 (8%) patients in the rivaroxaban arm and 31 (15%) in the placebo arm (P=0.02). Proximal DVT or pulmonary embolism occurred in seven (3%) patients in the rivaroxaban arm and eight (4%) in the placebo arm (P=0.80). No major bleeding events occurred.
conclusionsRivaroxaban administered for six additional weeks in patients with isolated distal DVT who had an uneventful six week treatment course reduces the risk of recurrent venous thromboembolism, mainly recurrent isolated distal DVT, over a two year follow-up without increasing the risk of haemorrhage.
trial registrationEudraCT 2016-000958-36; ClinicalTrials.gov NCT02722447.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.