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著者: Susan R Kahn, Stan Shapiro, Philip S Wells, Marc A Rodger, Michael J Kovacs, David R Anderson, Vicky Tagalakis, Adrielle H Houweling, Thierry Ducruet, Christina Holcroft, Mira Johri, Susan Solymoss, Marie-José Miron, Erik Yeo, Reginald Smith, Sam Schulman, Jeannine Kassis, Clive Kearon, Isabelle Chagnon, Turnly Wong, Christine Demers, Rajendar Hanmiah, Scott Kaatz, Rita Selby, Suman Rathbun, Sylvie Desmarais, Lucie Opatrny, Thomas L Ortel, Jeffrey S Ginsberg, SOX trial investigators
雑誌名: Lancet. 2014 Mar 8;383(9920):880-8. doi: 10.1016/S0140-6736(13)61902-9. Epub 2013 Dec 6.
Abstract/Text
BACKGROUND: Post-thrombotic syndrome (PTS) is a common and burdensome complication of deep venous thrombosis (DVT). Previous trials suggesting benefit of elastic compression stockings (ECS) to prevent PTS were small, single-centre studies without placebo control. We aimed to assess the efficacy of ECS, compared with placebo stockings, for the prevention of PTS.
METHODS: We did a multicentre randomised placebo-controlled trial of active versus placebo ECS used for 2 years to prevent PTS after a first proximal DVT in centres in Canada and the USA. Patients were randomly assigned to study groups with a web-based randomisation system. Patients presenting with a first symptomatic, proximal DVT were potentially eligible to participate. They were excluded if the use of compression stockings was contraindicated, they had an expected lifespan of less than 6 months, geographical inaccessibility precluded return for follow-up visits, they were unable to apply stockings, or they received thrombolytic therapy for the initial treatment of acute DVT. The primary outcome was PTS diagnosed at 6 months or later using Ginsberg's criteria (leg pain and swelling of ≥1 month duration). We used a modified intention to treat Cox regression analysis, supplemented by a prespecified per-protocol analysis of patients who reported frequent use of their allocated treatment. This study is registered with ClinicalTrials.gov, number NCT00143598, and Current Controlled Trials, number ISRCTN71334751.
FINDINGS: From 2004 to 2010, 410 patients were randomly assigned to receive active ECS and 396 placebo ECS. The cumulative incidence of PTS was 14·2% in active ECS versus 12·7% in placebo ECS (hazard ratio adjusted for centre 1·13, 95% CI 0·73-1·76; p=0·58). Results were similar in a prespecified per-protocol analysis of patients who reported frequent use of stockings.
INTERPRETATION: ECS did not prevent PTS after a first proximal DVT, hence our findings do not support routine wearing of ECS after DVT.
FUNDING: Canadian Institutes of Health Research.
Copyright © 2014 Elsevier Ltd. All rights reserved.
PMID 24315521 Lancet. 2014 Mar 8;383(9920):880-8. doi: 10.1016/S0140-6736(13)61902-9. Epub 2013 Dec 6.
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