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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, 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.

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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2 Kahn SR, Comerota AJ, Cushman M, et al. American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The postthrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association. Circulation 2014;130:1636-61. doi:10.1161/CIR.0000000000000130.

3 Saarinen J, Kallio T, Lehto M, Hiltunen S, Sisto T. The occurrence of the post-thrombotic changes after an acute deep venous thrombosis. A prospective two-year follow-up study. J Cardiovasc Surg (Torino) 2000;41:441-6.

4 Brandjes DP, Büller HR, Heijboer H, et al. Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis. Lancet 1997;349:759-62. doi:10.1016/S0140-6736(96)12215-7.

5 Kahn SR, Ginsberg JS. Relationship between deep venous thrombosis and the postthrombotic syndrome. Arch Intern Med 2004;164:17-26. doi:10.1001/archinte.164.1.17.

6 Prandoni P, Lensing AW, Prins MH, et al. Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med 2004;141:249-56. doi:10.7326/0003-4819-141-4-200408170-00004.

7 Baldwin MJ, Moore HM, Rudarakanchana N, Gohel M, Davies AH. Post-thrombotic syndrome: a clinical review. J Thromb Haemost 2013;11:795-805. doi:10.1111/jth.12180.

8 Kahn SR, Shbaklo H, Lamping DL, et al. Determinants of health-related quality of life during the 2 years following deep vein thrombosis. J Thromb Haemost 2008;6:1105-12. doi:10.1111/j.1538-7836.2008.03002.x.

9 Guanella R, Ducruet T, Johri M, et al. Economic burden and cost determinants of deep vein thrombosis during 2 years following diagnosis: a prospective evaluation. J Thromb Haemost 2011;9:2397-405. doi:10.1111/j.1538-7836.2011.04516.x.

10 Kahn SR, Shapiro S, Wells PS, et al. SOX trial investigators. Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial. Lancet 2014;383:880-8. doi:10.1016/S0140-6736(13)61902-9.

11 Prandoni P, Villalta S, Bagatella P, et al. The clinical course of deep-vein thrombosis. Prospective long-term follow-up of 528 symptomatic patients. Haematologica 1997;82:423-8.

12 ten Cate-Hoek AJ, ten Cate H, Tordoir J, Hamulyák K, Prins MH. Individually tailored duration of elastic compression therapy in relation to incidence of the postthrombotic syndrome. J Vasc Surg 2010;52:132-8. doi:10.1016/j.jvs.2010.01.089.

13 ten Cate-Hoek AJ, Bouman AC, Joore MA, Prins M, Ten Cate H. IDEAL DVT trial investigators. The IDEAL DVT study, individualised duration elastic compression therapy against long-term duration of therapy for the prevention of post-thrombotic syndrome: protocol of a randomised controlled trial. BMJ Open 2014;4:e005265. doi:10.1136/bmjopen-2014-005265.

14 Villalta S, Bagatella P, Piccioli A, et al. Assessment of validity and reproducibility of a clinical scale for the post-thrombotic syndrome. Haemostasis 1994;24:158a.

15 Kahn SR, Partsch H, Vedantham S, Prandoni P, Kearon C. Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of post-thrombotic syndrome of the leg for use in clinical investigations: a recommendation for standardization. J Thromb Haemost 2009;7:879-83. doi:10.1111/j.1538-7836.2009.03294.x.

16 Kahn SR. Measurement properties of the Villalta scale to define and classify the severity of the post-thrombotic syndrome. J Thromb Haemost 2009;7:884-8. doi:10.1111/j.1538-7836.2009.03339.x.

17 Kahn SR, Lamping DL, Ducruet T, et al. VETO Study investigators. VEINES-QOL/Sym questionnaire was a reliable and valid diseasespecific quality of life measure for deep venous thrombosis. J Clin Epidemiol 2006;59:1049-56. doi:10.1016/j.jclinepi.2005.10.016.

18 Lamping DL, Schroter S, Kurz X, Kahn SR, Abenhaim L. Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life. J Vasc Surg 2003;37:410-9. doi:10.1067/mva.2003.152.

19 Catarinella F, Nieman F, de Wolf M, Wittens C. Short-term follow-up of Quality-of-Life in interventionally treated patients with postthrombotic syndrome after deep venous occlusion. Phlebology 2014;29(suppl):104-11. doi:10.1177/0268355514529505.

20 Catarinella FS, Nieman FH, de Wolf MA, Toonder IM, de Graaf R, Wittens CH. Quality-of-life in interventionally treated patients with post-thrombotic syndrome. Phlebology 2015;30(Suppl):89-94. doi:10.1177/0268355515569431.

21 Kearon C, Ginsberg JS, Hirsh J. The role of venous ultrasonography in the diagnosis of suspected deep venous thrombosis and pulmonary embolism. Ann Intern Med 1998;129:1044-9. doi:10.7326/0003-4819-129-12-199812150-00009.

22 Prandoni P, Cogo A, Bernardi E, et al. A simple ultrasound approach for detection of recurrent proximal-vein thrombosis. Circulation 1993;88:1730-5. doi:10.1161/01.CIR.88.4.1730.

23 Tan M, Mol G, Kees van Rooden J, Huisman MV. The diagnostic management of recurrent deep vein thrombosis and pulmonary embolism. Semin Respir Crit Care Med 2012;33:151-5. doi:10.1055/s-0032-1311798.

24 Aschwanden M, Jeanneret C, Koller MT, Thalhammer C, Bucher HC, Jaeger KA. Effect of prolonged treatment with compression stockings to prevent post-thrombotic sequelae: a randomized controlled trial. J Vasc Surg 2008;47:1015-21. doi:10.1016/j.jvs.2008.01.008.

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