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

English version České info

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.

Autoři: G. C Mol ^1,2,3; M; Van De Ree ¹; F; Klok ⁴; M. J; M. Tegelberg ⁵; F. B M Sanders ⁶; S. Koppen ⁷; O. De Weerdt ⁸; T. Koster ⁹; M. M C Hovens ¹⁰; H; H. Kaasjager ²; R. E Brouwer ¹¹; E. Kragten ¹¹; C. G Schaar ¹²; W. Spiering ³; W. P Arnold ¹³; D. H Biesma ⁸; M. V Huisman ⁴
Působiště autorů: Department of Internal Medicine, Diakonessenhuis Hospital, Utrecht, Netherlands ¹; Department of Internal Medicine, University Medical Center, Utrecht, Netherlands ²; Department of Vascular Medicine, University Medical Center, 3 0 GA Utrecht, Netherlands ³; Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, Netherlands ⁴; Department of Dermatology, Diakonessenhuis Hospital, Utrecht, Netherlands ⁵; Department of Radiology, Diakonessenhuis Hospital, Utrecht, Netherlands ⁶; Department of Dermatology, St Antonius Hospital, Nieuwegein, Netherlands ⁷; Department of Hematology, St Antonius Hospital, Nieuwegein, Netherlands ⁸; Department of Internal Medicine, Groene Hart Hospital, Gouda, Netherlands ⁹; Department of Internal Medicine, Rijnstate Hospital, Arnhem, Netherlands ¹⁰; Department of Hematology, Reinier de Graaf Group, Delft, Netherlands ¹¹; Department of Internal Medicine, Gelre Hospitals, Apeldoorn, Netherlands ¹²; Department of Dermatology, Gelderse Vallei Hospital, Ede, Netherlands ¹³
Vyšlo v časopise: BMJ 2016, 353:i2691
Kategorie: Research
prolekare.web.journal.doi_sk: https://doi.org/10.1136/bmj.i2691

© 2016 BMJ Publishing Group Ltd
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial.

Souhrn

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.

Trial registration:
Netherlands Trial Register NTR1442.

Zdroje

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