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Randomized Controlled Trial
. 2016 May 31:353:i2691.
doi: 10.1136/bmj.i2691.

One versus two years of elastic compression stockings for prevention of post-thrombotic syndrome (OCTAVIA study): randomised controlled trial

G C Mol  1 , M A van de Ree  2 , F A Klok  3 , M J A M Tegelberg  4 , F B M Sanders  5 , S Koppen  6 , O de Weerdt  7 , T Koster  8 , M M C Hovens  9 , H A H Kaasjager  10 , R E Brouwer  11 , E Kragten  11 , C G Schaar  12 , W Spiering  13 , W P Arnold  14 , D H Biesma  7 , M V Huisman  15
Affiliations
Randomized Controlled Trial

One versus two years of elastic compression stockings for prevention of post-thrombotic syndrome (OCTAVIA study): randomised controlled trial

G C Mol et al. BMJ. .

Abstract

Objective: To study whether stopping elastic compression stockings (ECS) after 12 months is non-inferior to continuing them for 24 months after proximal deep venous thrombosis.

Design: Multicentre single blind non-inferiority randomised controlled trial.

Setting: Outpatient clinics in eight teaching hospitals in the Netherlands, including one university medical centre.

Participants: Patients compliant with compression therapy for 12 months after symptomatic, ultrasound proven proximal deep venous thrombosis of the leg.

Interventions: Continuation or cessation of ECS 12 months after deep venous thrombosis.

Main outcome measures: The primary outcome was the incidence of post-thrombotic syndrome 24 months after diagnosis of deep venous thrombosis, as assessed by the standardised Villalta scale in an intention to treat analysis. The predefined non-inferiority margin was 10%. The main secondary outcome was quality of life (VEINES-QOL/Sym).

Results: 518 patients compliant with ECS and free of post-thrombotic syndrome were randomised one year after diagnosis of deep venous thrombosis to stop or continue ECS therapy for another year. In the stop-ECS group, 51 of 256 patients developed post-thrombotic syndrome, with an incidence of 19.9% (95% confidence interval 16% to 24%). In the continue-ECS group, 34 of 262 patients developed post-thrombotic syndrome (incidence 13.0%, 9.9% to 17%), of whom 85% used ECS six or seven days a week during the study period, for an absolute difference of 6.9% (95% confidence interval upper limit 12.3%). Because the upper limit of the 95% confidence interval exceeds the predefined margin of 10%, non-inferiority was not reached. The number needed to treat to prevent one case of post-thrombotic syndrome by continuing ECS was 14 (95% confidence interval lower limit 8). Quality of life did not differ between the two groups.

Conclusion: Stopping ECS after one year in compliant patients with proximal deep venous thrombosis seemed not to be non-inferior to continuing ECS therapy for two years in this non-inferiority trial.

Trial registration: Netherlands Trial Register NTR1442.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work other than that described above; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

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Fig 1 Study design (time in months). ECS=elastic compression stockings; VTE=venous thromboembolism
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Fig 2 Flow chart of study. DVT=deep venous thrombosis; ECS=elastic compression stockings; PTS=post-thrombotic syndrome
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Fig 3 Treatment difference outcome with non-inferiority margin. DVT=deep venous thrombosis; ECS=elastic compression stockings
See this image and copyright information in PMC

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