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.
Click to read the study in BMJ
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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