1. In a randomized controlled trial of over 500 patients with a diagnosis of deep vein thrombosis (DVT), the use of elastic compression therapy (ECT) for 1 year was inferior to use of ECT for 2 years.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Post-thrombotic syndrome is a complication of DVT, characterized by leg swelling, pain, and skin ulcerations, which can cause significant impairment in quality of life. Previous studies have demonstrated that the use of ECT for 2 years after DCT significantly reduces the occurrence of post-thrombotic syndrome after DVT. However, compliance to ECT has been a challenge due to local irritation and cosmetic reasons. The purpose of this study was to determine whether a shorter duration of ECT is inferior to the standard two-year therapy.
The trial randomized over 500 patients with a diagnosis of DVT to either 1- or 2-year duration of ECT treatment. The main outcome was the incidence of post-thrombotic syndrome at 24 months. At the conclusion of the trial, a 1-year duration of ECT was not non-inferior to completing a 2-year duration of ECT. The patients in the 1-year ECT group was associated with a significantly increased number of post-thrombotic syndrome within the second year. The results of this study demonstrate that strong adherence to ECT may affect the natural history of post-thrombotic syndrome. The study is strengthened by the large sample size and multi-center design. However, only patients with high compliance to ECT were included in the study, which may limit the external generalizability of the results.
Relevant Reading: 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
In-Depth [randomized controlled trial]: This was a single-blind, multi-center randomized controlled trial of 1- versus 2-year ECT therapy in the prevention of post-thrombotic syndrome. Overall, 518 patients from eight centers in the Netherlands were recruited between 2009 to 2013. The primary outcome measured was the occurrence of post-thrombotic syndrome two years after DVT diagnosis. At the conclusion of the trial, the incidence of post-thrombotic syndrome for the one-year ECT duration group was 19.9% (95%CI: 16%-24%). In the 2-year ECT group, the incidence of post-thrombotic syndrome at 24 months was 13% (95%CI: 9.9% to 17%). As such, non-inferiority could not be reached between the two groups. Overall, the number needed to treat one case of post-thrombotic syndrome by the continued use of ECT was 14.
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