25 mm Hg versus 35 mm Hg elastic compression stockings to prevent post-thrombotic syndrome after deep vein thrombosis (CELEST): a randomised, double-blind, non-inferiority trial - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue The Lancet Haematology Année : 2022

25 mm Hg versus 35 mm Hg elastic compression stockings to prevent post-thrombotic syndrome after deep vein thrombosis (CELEST): a randomised, double-blind, non-inferiority trial

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Céline Genty-Vermorel
  • Fonction : Auteur
François Becker
  • Fonction : Auteur
Violaine Jabbour
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Alexa Comte
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Pierre Ouvry
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Cécile Richaud
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François Verrière
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Mario Maufus
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Hervé Guenneguez
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Pierre Ouvry
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Anna Di Maio
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Jeannot Schmidt
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Jean-Philippe Galanaud
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Alessandra Bura-Rivière
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Francis Couturaud
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Marc Danguy Des Déserts
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Claire Grange
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Patrick Mismetti
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Marie-Thérèse Barrellier
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Damien Laneelle
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Béatrice Terriat
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Audrey Stansal
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Myriam Martin
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Constant Quashie
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Mickaël Bonaldi
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Patrick Lanoye
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Francine Ponchaux-Crépin
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Toufek Berremili
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Santhi Samy-Modeliar
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Azeddine Addala
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Luc Toffin
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Bruno Rouquet
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Maïlys Michot-Casbas
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Guillaume Lacaze
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Pierre-Marie Roy
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Cécile Durant
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Anne-Laure Baldassini-Esquis
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Alain Cazanave
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Damien Rouvière
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Hélène Skolka
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Tewfik Salem
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Jean-Michel Monsallier
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Benoit Roger
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Thien-Quang Tra
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Mutendi Kalolwa
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Antoine Diard
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Marc Lambert
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Mebarka Taiar
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Céline Gaudout
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Sylvain Ancey
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Christine Jurus
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Résumé

Background: The optimal strength of compression needed to prevent post-thrombotic syndrome (PTS) after a proximal deep vein thrombosis (DVT) is debated. We aimed to assess whether 25 mm Hg elastic compression stockings (ECS) are non-inferior to 35 mm Hg ECS in preventing PTS after a DVT. Methods: In this multicentre, double-blind, non-inferiority, randomised controlled trial, we enrolled adults (≥18 years) with a first ipsilateral proximal DVT attending 46 French vascular medicine hospital departments or private practices. Participants were randomly allocated (1:1, stratified by centre, age, and sex; with varying block sizes of two and four) to wear 25 mm Hg or 35 mm Hg ECS for 2 years. The primary outcome was the cumulative rate of PTS 2 years after inclusion, defined by a Villalta scale (≥5). Efficacy was assessed by intention-to-treat and in eligible participants who had complete primary outcome data. A per-protocol analysis was also conducted among compliant patients as a secondary outcome measure. Safety was assessed in all participants who used ECS at least once, and for which we have at least some tolerance information during follow-up. The margin for non-inferiority was 12·5%. This study is registered with ClinicalTrials.gov, NCT01578122, and has been completed. Findings: Between June 28, 2012, and July 21, 2017, we enrolled 341 eligible participants who consented to randomisation. 233 (68%) were men and median age was 59 years (IQR 45-70). Collection of ethnicity and race as a routine research variable is not authorised in France. Median follow-up was 735 days (IQR 721-760). 249 (73%) had complete data at 2 years. For the primary analysis, 40 (31%) of 129 participants with complete data in the 25 mm Hg ECS group and 40 (33%) of 120 in the 35 mm Hg group had PTS (absolute difference -2·3% [90% CI -12·1 to 7·4], pnon-inferiority=0·0062; relative risk 0·93, 95% CI 0·65 to 1·33). Results remained similar after imputation of missing data in patients we were authorised to do so: the cumulative proportion of PTS was 45 (29%) of 154 in the 25 mm Hg ECS group versus 52 (35%) of 148 in the 35 mm Hg ECS group (relative risk 0·83, 95% CI 0·60 to 1·16). Absolute difference was -5·9%, (90% CI -14·7 to 2·9), p=0·0003 for non-inferiority. Adherence was optimal (>80% and modified GIRERD score of 0-2) for 75 (51%) of 146 patients assigned to 25 mm Hg ECS and for 56 (42%) of 134 patients assigned to 35 mm Hg ECS (p=0·11). Regarding major adverse events related to ECS, there were no between-group differences in rates of deep vein thrombosis (0 vs 1 [0·6%]), ipsilateral leg ulcer (0 vs 1 [0·6%]), infection (0 vs 0), or death (0 vs 0) between the 169 patients evaluated in the 25 mm Hg ECS group and the 159 patients in the 35 mm Hg ECS group. Two (1%) of 328 patients who ever wore ESC developed ECS-related serious adverse events, one distal DVT and one leg ulcer (both in the 35 mm Hg ECS group). In the 25 mm Hg group, 6 patients died, 14 had a venous thromboembolic recurrence (proximal DVT or pulmonary embolism), and 7 had a major bleed. In the 35 mm Hg group, 5 patients died, 10 had a venous thromboembolic recurrence (proximal DVT or pulmonary embolism), and 6 had a major bleed. Interpretation: Although we did not reach the prespecified sample size, our results suggest that 25 mm Hg ECS are non-inferior to 35 mm Hg ECS in preventing PTS. Larger more powerful studies are needed.
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Dates et versions

hal-03890237 , version 1 (08-12-2022)

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Citer

Jean-Philippe Galanaud, Céline Genty-Vermorel, Marie-Thérèse Barrellier, François Becker, Violaine Jabbour, et al.. 25 mm Hg versus 35 mm Hg elastic compression stockings to prevent post-thrombotic syndrome after deep vein thrombosis (CELEST): a randomised, double-blind, non-inferiority trial. The Lancet Haematology, 2022, 9 (12), pp.e886-e896. ⟨10.1016/S2352-3026(22)00247-2⟩. ⟨hal-03890237⟩
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