Trial reportCirculation2025
Aspirin Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis Among Patients With Post-Thrombotic Syndrome: The Multicenter, Multinational, Randomized, Open-Label ARIVA Trial.
Trial report in Circulation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04128956 (Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With Post-thrombotic Syndrome a Multi-center, International, Randomized, Open Label, Controlled Trial), which is not on this map. Cited by 7 papers.
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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.
Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With Post-thrombotic Syndrome a Multi-center, International, Randomized, Open Label, Controlled Trial
Who cites it
7 citing papers in PubMed.
- Quality of life and functional recovery after venous stent placement for postthrombotic syndrome: insights from the ARIVA multinational randomized trial.Research and practice in thrombosis and haemostasis · 2026Trial
- Factors associated with patency loss after iliocaval and iliofemoral venous stenting.Journal of vascular surgery. Venous and lymphatic disorders · 2026Review
- Synergistic fusion of CD47, VE-cadherin and mussel adhesion protein promotes endothelialization and suppresses inflammation in vascular stents.Bioactive materials · 2026Article
- Patient-reported outcomes after upper-extremity deep vein thrombosis due to compression syndromes: a multinational longitudinal retrospective study.Research and practice in thrombosis and haemostasis · 2026Article
- Construction and validation of a predictive model for postoperative stent occlusion in patients undergoing iliac vein stenting based on an explainable machine learning model.Frontiers in surgery · 2025Article
- Dual Therapy vs. Single Anticoagulation After Acute Deep Vein Thrombosis Iliac Stenting: A Doubly Robust Multicenter Study.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisArticle
- Dual-Channel Inhibition With Rivaroxaban and Aspirin for Thromboprophylaxis in Patients With Long-Term Inferior Vena Cava Filter Implantation: A Two-Center Cohort Study.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisArticle
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn patients with post-thrombotic syndrome, stent recanalization of iliofemoral veins or the inferior vena cava can restore venous patency and improve functional outcomes. The risk of stent thrombosis is particularly increased during the first 6 months after intervention. The ARIVA trial (Aspirin Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With PTS) tested whether 100 mg of daily aspirin plus 20 mg of rivaroxaban is superior to 20 mg of rivaroxaban alone to prevent stent thrombosis within 6 months after stent placement for post-thrombotic syndrome.
methodsIn this multinational, academic, open-label, independently adjudicated trial, patients with a Villalta score >4 points and a stenosis or occlusion of the inferior vena cava, iliac veins, or common femoral vein successfully treated with venous stent placement were randomized in a 1:1 fashion to the study groups. Key exclusion criteria included <18 or >75 years of age, contraindications to anticoagulant use, or acute venous thrombosis <3 months. The primary efficacy outcome was the composite of no occlusion in the treated segment assessed at serial duplex ultrasound examinations or no reintervention needed to maintain patency within 6 months. Secondary outcomes, including Villalta score, quality of life, and safety outcomes, were also assessed. The study was registered at ClinicalTrials.gov (NCT04128956).
resultsFrom 2020 through 2022, 172 patients were screened, 169 were randomized, and 162 were included in the full analysis set, receiving either aspirin plus rivaroxaban (n=80) or rivaroxaban alone (n=82) for 6 months. Mean±SD age was 42.8±14.7 years; 103 patients (60.9%) were women; 154 patients (97.5%) were White; and leg ulcers were present in 7% of patients. The primary patency rate at 6 months was 94.8% versus 92.4% (absolute risk difference, 2.4% [95% CI, -13.6 to 18.0]), respectively. The mean±SD decrease in the Villalta score for the affected leg (without ulcer) from baseline to 6 months was -6.7±4.4 and -7.0±5.2 points (
conclusionsThe overall primary patency rate during the first 6 months after endovascular intervention for post-thrombotic syndrome was higher than expected and comparable between patients receiving aspirin combined with rivaroxaban and those receiving rivaroxaban alone. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04128956.
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