{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,8]],"date-time":"2025-12-08T11:45:19Z","timestamp":1765194319049,"version":"3.46.0"},"reference-count":21,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T00:00:00Z","timestamp":1764547200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["17\/147\/47"],"award-info":[{"award-number":["17\/147\/47"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Approximately half of adults diagnosed with deep vein thrombosis will develop the post-thrombotic syndrome leading to chronic symptoms \u2013 including leg pain, oedema, venous ectasia and, in 5% of cases, venous ulceration. Risk factors include older age, obesity, a history of blood clots, cancer and heart failure. Despite adequate anticoagulation, post-thrombotic syndrome remains a chronic health condition with significant financial burden for patients and health services.<\/jats:p>\n                    <jats:p>The effectiveness of compression stockings in preventing post-thrombotic syndrome is unclear and whether the risks and costs associated with compression stockings are justified.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-2\">\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>The Compression Hosiery to Avoid Post-Thrombotic Syndrome study was a multicentre, pragmatic, assessor-blind, randomised controlled trial of adults with a first proximal deep vein thrombosis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-3\">\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Secondary care National Health Service hospitals in the United Kingdom.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-4\">\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Patients \u2265\u200518 years, with imaging-confirmed, symptomatic presentation of first deep vein thrombosis in the lower limb (popliteal, femoral, iliac or combination), \u2264\u20053 weeks from diagnosis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-5\">\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>Participants were randomised 1\u2005:\u20051 to standard care (anticoagulation as per local guidelines) or intervention (anticoagulation as per local guidelines and regular use of a graduated compression stocking).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-6\">\n                    <jats:title>Primary outcome<\/jats:title>\n                    <jats:p>The primary outcome was any incidence of post-thrombotic syndrome using the Villalta criteria over a median of 18-month follow-up (range 6\u201330 months). This was planned to be assessed on up to three occasions (6 and 12 months post randomisation and at study end), depending on when an individual was randomised.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-7\">\n                    <jats:title>Secondary outcomes<\/jats:title>\n                    <jats:p>Planned secondary outcomes:<\/jats:p>\n                    <jats:list list-type=\"bullet\">\n                      <jats:list-item>\n                        <jats:p>incidence of venous ulceration (measured by the validated Villalta criteria)<\/jats:p>\n                      <\/jats:list-item>\n                      <jats:list-item>\n                        <jats:p>employment status (change in the number of days working from baseline)<\/jats:p>\n                      <\/jats:list-item>\n                      <jats:list-item>\n                        <jats:p>change in disease-specific and generic quality of life \u2013 Venous Insufficiency Epidemiological and Economic Study (VEINES-QOL\/Sym) and EuroQol-5 Dimensions scales from baseline over 6\u2005months, 12\u2005months and end of study visit<\/jats:p>\n                      <\/jats:list-item>\n                      <jats:list-item>\n                        <jats:p>adherence to stockings and anticoagulants (patient self-report)<\/jats:p>\n                      <\/jats:list-item>\n                      <jats:list-item>\n                        <jats:p>cost-effectiveness of stocking prescription \u2013 incremental cost-effectiveness ratio from the EuroQol-5 Dimensions questionnaire, with appropriate sensitivity analysis.<\/jats:p>\n                      <\/jats:list-item>\n                    <\/jats:list>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-8\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The trial closed early due to poor recruitment during the COVID-19 pandemic; and, of the planned sample size of 864, 152 participants were randomised. Post-thrombotic syndrome occurred in 51% of the control arm and in 30% of the intervention arm at last follow-up. No serious adverse events relating to stockings were recorded. Stocking adherence was a mean of 6 days (standard deviation 2) per week.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-9\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The sample size was not reached, which precluded any formal statistical analysis. Although a difference in the incidence of post-thrombotic syndrome was demonstrated, the effect size could not be determined. There is interest in understanding optimal strategies for the prevention of post-thrombotic syndrome in these patients and a re-run of this trial should occur.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-10\">\n                    <jats:title>Limitations<\/jats:title>\n                    <jats:p>The main limitation was its early termination. As a result, it did not reach the required sample size to draw any adequately powered conclusions. The analyses are descriptive and therefore we cannot determine whether there were any differences between trial arms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-11\">\n                    <jats:title>Future work<\/jats:title>\n                    <jats:p>Answering the question of whether graduated compression stockings help prevent the post-thrombotic syndrome is important to both patients and clinicians.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-12\">\n                    <jats:title>Funding<\/jats:title>\n                    <jats:p>This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 17\/147\/47.<\/jats:p>\n                  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