Abstract Number: OC 64.2
Meeting: ISTH 2021 Congress
Background: After a deep vein thrombosis (DVT), elastic compression stockings (ECS) are commonly prescribed to prevent post-thrombotic syndrome (PTS). Suboptimal compliance to ECS constitutes an important limitation of this strategy. Use of lower-strength ECS (<30mmHg) than that used in previous RCT should favor compliance, but their efficacy is unknown.
Aims: To assess whether 25mmHg ECS are non-inferior to 35mmHg ECS to prevent PTS after proximal DVT.
Multicentre, double-blind RCT of 25mmHg versus 35mmHg ECS used for 2 years to prevent PTS after a first proximal DVT. Study design, inclusion/exclusion criteria are presented in Figure 1. The primary outcome was PTS diagnosed at 1 or 2 years using the Villalta scale assessed by intention to treat. The predefined non-inferiority margin for the difference in success rates was set at 12.5%. Optimal compliance was defined as use of ECS>=80% of time. Study obtained ethics approval, is registered on ClinicalTrials.gov (NCT01578122) and is completed. All patients provided written informed consent.
|– Age, years, mean (SD)||57.6 (15.5)||57.6 (16.9)|
|– Men, n (%)||117 (68.4)||116 (68.2)|
|– Obese, n (%)||36 (21.1)||34 (20.1)|
|– Previous venous thromboembolism, n (%)||40 (23.4)||30 (18.1)|
|– Cancer , n (%)||20 (11.7)||19 (11.2)|
|– Baseline contralateral Villalta Score>4, n (%)||14 (8.2)||14 (8.4)|
|– Time from DVT diagnosis to randomization < 3 days, n (%)||124 (72.5)||134 (78.8)|
|– Right leg DVT, n (%)||70 (40.9)||71 (41.8)|
|– Most Proximal DVT extent, n (%)
From 2012 to 2017, 350 patients were randomly assigned to receive either 25mmHg or 35mmHg ECS (Table 1). Cumulative incidence of PTS was 31.0% in 25mmHg ECS versus 33.3% in 35mmHg ECS (absolute difference -2.3%, (90%CI -12.1;7.4), p=0.006 for non-inferiority). Cumulative incidence of moderate-severe PTS was 4.0% in 25mmHg ECS versus 9.4% in 35mmHg ECS, p=0.09. Compliance of patients allocated to 25mmHg and 35mmHg ECS was optimal in 51.4% and 41.8% of cases respectively (p=0.1). In the subgroup of optimally compliant patients, cumulative incidence of PTS in 25mmHg and 35mmHg ECS groups was 29.4% and 21.6% respectively, p=0.3.
Conclusions: 25mmHg ECS are non-inferior to 35mmHg ECS to prevent PTS and compliance is better. There seems to be a dose-response relationship among optimally compliant patients, the impact of which on PTS was offset by the impact of the overall better compliance in the 25mmHg ECS group.
To cite this abstract in AMA style:Galanaud JP, Genty-Vermorel C, Barrellier MT, Becker F, Bertaina I, Blaise S, Bura Riviere A, Comte A, Grange C, Guenneguez H, Maufus M, Ouvry P, Richaud C, Rolland C, Schmidt J, Sevestre MA, Verrière F, Bosson J-, CELEST Trial Investigators . 25mmHg vs. 35mmHg Elastic Compression Stockings to Prevent Post Thrombotic Syndrome after Deep Vein Thrombosis: The CELEST Double-blind Trial [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/25mmhg-vs-35mmhg-elastic-compression-stockings-to-prevent-post-thrombotic-syndrome-after-deep-vein-thrombosis-the-celest-double-blind-trial/. Accessed July 1, 2022.
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