Trial reportBMJ (Clinical research ed.)2016
One versus two years of elastic compression stockings for prevention of post-thrombotic syndrome (OCTAVIA study): randomised controlled trial.
Trial report in BMJ (Clinical research ed.), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 4 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 83 citations in OpenAlex.
- Medical compression therapy of the extremities with medical compression stockings (MCS), phlebological compression bandages (PCB), and medical adaptive compression systems (MAC) : S2k guideline of the German Phlebology Society (DGP) in cooperation with the following professional associations: DDG, DGA, DGG, GDL, DGL, BVP.Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2021Guideline
- [Medical compression therapy of the extremities with medical compression stockings (MCS), phlebological compression bandages (PCB), and medical adaptive compression systems (MAC) : S2k guideline of the German Phlebology Society (DGP) in cooperation with the following professional associations: DDG, DGA, DGG, GDL, DGL, BVP. German version].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2021Guideline
- Compression therapy for treating post-thrombotic syndrome.The Cochrane database of systematic reviews · 2019Pooled it
- Compression therapy for prevention of post-thrombotic syndrome.The Cochrane database of systematic reviews · 2017Pooled it
- Physical activity in children at risk of postthrombotic sequelae: a pilot randomized controlled trial.Blood advances · 2020Trial
- Relationships between the use of pharmacomechanical catheter-directed thrombolysis, sonographic findings, and clinical outcomes in patients with acute proximal DVT: Results from the ATTRACT Multicenter Randomized Trial.Vascular medicine (London, England) · 2019Trial
- Post-Thrombotic Syndrome: Pathophysiology, Clinical Implications, and Advances in Management.Health science reports · 2025Article
- Compression Therapy in Acute Deep Venous Thrombosis of the Lower Limb and for the Prevention of Post-Thrombotic Syndrome—a Review Based on a Structured Literature Search.Deutsches Arzteblatt international · 2024Review
- Current challenges in the prevention and management of post-thrombotic syndrome-towards improved prevention.International journal of hematology · 2023Review
- Controversies in the management of proximal deep vein thrombosis.The Medical journal of Australia · 2023Article
- Article
- Elastic compression stockings for prevention of the post-thrombotic syndrome in patients with and without residual vein thrombosis and/or popliteal valve reflux.Haematologica · 2022Article
- Article
- Caging the dragon: Research approach to COVID-19-related thrombosis.Research and practice in thrombosis and haemostasis · 2021Review
- Compression therapy in venous diseases: current forms of compression materials and techniques.Postepy dermatologii i alergologii · 2020Review
- Compression stockings to prevent postthrombotic syndrome: Literature overview and presentation of the CELEST trial.Research and practice in thrombosis and haemostasis · 2020Review
- Catheter-Based Therapies and Other Management Strategies for Deep Vein Thrombosis and Post-Thrombotic Syndrome.Journal of clinical medicine · 2020Review
- Prevention and Management of the Post-Thrombotic Syndrome.Journal of clinical medicine · 2020Review
- Prevention and treatment of the post-thrombotic syndrome.Research and practice in thrombosis and haemostasis · 2018Article
- Empirical Consequences of Current Recommendations for the Design and Interpretation of Noninferiority Trials.Journal of general internal medicine · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 9 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo study whether stopping elastic compression stockings (ECS) after 12 months is non-inferior to continuing them for 24 months after proximal deep venous thrombosis.
designMulticentre single blind non-inferiority randomised controlled trial.
settingOutpatient clinics in eight teaching hospitals in the Netherlands, including one university medical centre.
participantsPatients compliant with compression therapy for 12 months after symptomatic, ultrasound proven proximal deep venous thrombosis of the leg.
interventionsContinuation or cessation of ECS 12 months after deep venous thrombosis.
main outcome measuresThe primary outcome was the incidence of post-thrombotic syndrome 24 months after diagnosis of deep venous thrombosis, as assessed by the standardised Villalta scale in an intention to treat analysis. The predefined non-inferiority margin was 10%. The main secondary outcome was quality of life (VEINES-QOL/Sym).
results518 patients compliant with ECS and free of post-thrombotic syndrome were randomised one year after diagnosis of deep venous thrombosis to stop or continue ECS therapy for another year. In the stop-ECS group, 51 of 256 patients developed post-thrombotic syndrome, with an incidence of 19.9% (95% confidence interval 16% to 24%). In the continue-ECS group, 34 of 262 patients developed post-thrombotic syndrome (incidence 13.0%, 9.9% to 17%), of whom 85% used ECS six or seven days a week during the study period, for an absolute difference of 6.9% (95% confidence interval upper limit 12.3%). Because the upper limit of the 95% confidence interval exceeds the predefined margin of 10%, non-inferiority was not reached. The number needed to treat to prevent one case of post-thrombotic syndrome by continuing ECS was 14 (95% confidence interval lower limit 8). Quality of life did not differ between the two groups.
conclusionStopping ECS after one year in compliant patients with proximal deep venous thrombosis seemed not to be non-inferior to continuing ECS therapy for two years in this non-inferiority trial.
trial registrationNetherlands Trial Register NTR1442.
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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.