Individualised versus standard duration of elastic compression therapy for prevention of post-thrombotic syndrome (IDEAL DVT): a multicentre, randomised, single-blind, allocation-concealed, non-inferiority trial.

Autor: Ten Cate-Hoek AJ; Department of Vascular Medicine, Heart and Vascular Center, Maastricht University Medical Center, Maastricht, Netherlands. Electronic address: arina.tencate@maastrichtuniversity.nl., Amin EE; Department of Vascular Medicine, Heart and Vascular Center, Maastricht University Medical Center, Maastricht, Netherlands., Bouman AC; Department of Vascular Medicine, Heart and Vascular Center, Maastricht University Medical Center, Maastricht, Netherlands., Meijer K; Department of Hematology, Groningen University Medical Center, Groningen, Netherlands., Tick LW; Department of Internal Medicine, Maxima Medical Center, Veldhoven, Netherlands., Middeldorp S; Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands., Mostard GJM; Department of Vascular Medicine, Zuyderland Medical Center, Sittard, Netherlands., Ten Wolde M; Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands; Department of Medicine, Flevo Hospital, Almere, Netherlands., van den Heiligenberg SM; Department of Medicine, Westfriesgasthuis, Hoorn, Netherlands., van Wissen S; Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands; Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands., van de Poel MH; Department of Hematology, Laurentius Hospital, Roermond, Netherlands., Villalta S; Department of Internal Medicine, Cà Foncello University Hospital, Treviso, Italy., Serné EH; Department of Internal Medicine, VU University Medical Center, Amsterdam, Netherlands., Otten HM; Department of Internal Medicine, Slotervaart Hospital, Amsterdam, Netherlands., Klappe EH; Department of Internal Medicine, Radboud University Medical Center, Nijmegen, Netherlands., Bistervels IM; Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands; Department of Medicine, Flevo Hospital, Almere, Netherlands., Lauw MN; Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands., Piersma-Wichers M; Department of Hematology, Groningen University Medical Center, Groningen, Netherlands., Prandoni P; Department of Cardiovascular Sciences, Vascular Medicine Unit, University of Padua, Padua, Italy., Joore MA; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, Netherlands., Prins MH; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, Netherlands., Ten Cate H; Department of Vascular Medicine, Heart and Vascular Center, Maastricht University Medical Center, Maastricht, Netherlands; Laboratory of Clinical Thrombosis and Hemostasis, Cardio Vascular Research Institute, Maastricht University, Maastricht, Netherlands.
Jazyk: angličtina
Zdroj: The Lancet. Haematology [Lancet Haematol] 2018 Jan; Vol. 5 (1), pp. e25-e33. Date of Electronic Publication: 2017 Dec 05.
DOI: 10.1016/S2352-3026(17)30227-2
Abstrakt: Background: Therapy with elastic compression stockings has been the cornerstone for prevention of post-thrombotic syndrome for decades in patients after acute deep venous thrombosis. It is uncertain who benefits most from therapy, and what the optimum duration of therapy should be. We therefore aimed to assess the safety and efficacy of individualised duration of compression therapy versus the standard duration of 24 months following an initial treatment period of 6 months.
Methods: We did a multicentre, randomised, single-blind, allocation-concealed, non-inferiority trial at 12 hospitals in the Netherlands and two in Italy. We randomly assigned patients (1:1) with acute proximal deep vein thrombosis of the leg and without pre-existent venous insufficiency (Clinical Etiological Anatomical and Pathophysiological score Findings: Between March 22, 2011, and July 1, 2015, we enrolled 865 patients and randomly assigned 437 to individualised duration compression stockings and 428 to standard duration. 283 (66%) of 432 patients in the intervention group were advised before 24 months to stop wearing elastic compression stockings (236 [55%] of 432 patients after 6 months, and 47 [11%] of 432 at 12 months). Post-thrombotic syndrome occurred in 125 (29%) of 432 patients receiving individualised duration of therapy and in 118 (28%) of 424 receiving standard duration of therapy (odds ratio for difference 1·06, 95% CI 0·78 to 1·44). The absolute difference was 1·1% (95% CI -5·2 to 7·3), thus meeting the non-inferiority margin. 24 patients died, 17 (4%) in the individualised treatment group and seven (2%) in the standard duration group, but no deaths were related to treatment. No serious adverse events related to the intervention occurred.
Interpretation: Individualised therapy with elastic compression stockings for the prevention of post-thrombotic syndrome was non-inferior to standard duration of therapy of 24 months. Individualising the duration is effective and could shorten the length of therapy needed, potentially enhancing patients' wellbeing.
Funding: ZonMw (Netherlands).
(Copyright © 2018 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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