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


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, 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;  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
Vyšlo v časopise: BMJ 2016, 353:i2691
Kategorie: Research
prolekare.web.journal.doi_sk: 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.

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.


Zdroje

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