The Ideal Deep Venous Thrombosis (DVT) Study (IDEAL)

Individually Tailored Elastic Compression Therapy After Deep Venous Thrombosis in Relation to the Incidence of Post Thrombotic Syndrome, a Randomized Multicenter Trial

In the Netherlands, 25.000 patients each year are diagnosed with Deep Venous Thrombosis (DVT). Elastic compression stocking (ECS) therapy reduces the incidence of post thrombotic syndrome (PTS) following DVT from 50% without ECS to 20-30% after ECS therapy for two years. It is however unclear whether all patients benefit to the same extent from this therapy or what the optimal duration of ECS therapy for individual patients should be. ECS therapy is not only costly, inconvenient and demanding but sometimes also even debilitating. Substantial costs could be saved by tailoring therapy to individual needs and as a result the quality of life for individual patients can be expected to improve. This study aims to assess the costs and effects of tailoring the duration of ECS therapy after DVT to individual patients needs. ECS therapy with a standard duration of 24 months will be compared with tailored ECS therapy, following an initial therapeutic period of 6 months, in patients with acute proximal DVT. The primary outcome is the percentage of patients with PTS at two year follow-up. This is a multi-center, randomized, allocation concealed, single-blinded clinical trial.

Individually tailored duration of elastic compression therapy, based on signs and symptoms according to the Villalta scale, following an initial therapeutic period of 6 months.

Individually tailored duration of elastic compression therapy,based on signs and symptoms according to the Villalta scale, following an initial therapeutic period of 6 months

Costs will include direct costs (e.g. medical therapy) and indirect costs (e.g. travel) and will be measured by case record forms, hospital data and 5 retrospective cost-questionnaires

Inclusion Criteria: Legal age (18 yrs) Informed consent Acute objectively documented DVT of the leg Adequate anticoagulation Exclusion Criteria: Previous DVT in the affected leg Recurrent DVT in the first 6 months following inclusion Preexistent venous insufficiency (skin signs C4-C6 on CEAP score or requiring ECS therapy) Contraindication for elastic compression therapy (arterial insufficiency) Active thrombolysis Life expectancy < 6 months

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 Sep 4;4(9):e005265. doi: 10.1136/bmjopen-2014-005265.

Ten Cate-Hoek AJ, Amin EE, Bouman AC, Meijer K, Tick LW, Middeldorp S, Mostard GJM, Ten Wolde M, van den Heiligenberg SM, van Wissen S, van de Poel MH, Villalta S, Serne EH, Otten HM, Klappe EH, Bistervels IM, Lauw MN, Piersma-Wichers M, Prandoni P, Joore MA, Prins MH, Ten Cate H; IDEAL DVT investigators. Individualised versus standard duration of elastic compression therapy for prevention of post-thrombotic syndrome (IDEAL DVT): a multicentre, randomised, single-blind, allocation-concealed, non-inferiority trial. Lancet Haematol. 2018 Jan;5(1):e25-e33. doi: 10.1016/S2352-3026(17)30227-2. Epub 2017 Dec 5.

Amin EE, Ten Cate-Hoek AJ, Bouman AC, Meijer K, Tick L, Middeldorp S, Mostard G, Ten Wolde M, van den Heiligenberg S, van Wissen S, van de Poel M, Villalta S, Serne E, Otten HM, Klappe E, Prandoni P, Prins MH, Ten Cate H, Joore MA. Individually shortened duration versus standard duration of elastic compression therapy for prevention of post-thrombotic syndrome: a cost-effectiveness analysis. Lancet Haematol. 2018 Nov;5(11):e512-e519. doi: 10.1016/S2352-3026(18)30151-0. Epub 2018 Oct 9.

Amin EE, Bistervels IM, Meijer K, Tick LW, Middeldorp S, Mostard G, van de Poel M, Serne EH, Otten HM, Klappe EM, Joore MA, Ten Cate H, Ten Wolde M, Ten Cate-Hoek AJ. Reduced incidence of vein occlusion and postthrombotic syndrome after immediate compression for deep vein thrombosis. Blood. 2018 Nov 22;132(21):2298-2304. doi: 10.1182/blood-2018-03-836783. Epub 2018 Sep 20.

Amin EE, Joore MA, Ten Cate H, Meijer K, Tick LW, Middeldorp S, Mostard GJM, Ten Wolde M, van den Heiligenberg SM, van Wissen S, van de Poel MHW, Villalta S, Serne EH, Otten HM, Klappe EH, Prandoni P, Ten Cate-Hoek AJ. Clinical and economic impact of compression in the acute phase of deep vein thrombosis. J Thromb Haemost. 2018 Jun 1. doi: 10.1111/jth.14163. Online ahead of print.