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Elastic compression stockings failed to prevent post-thrombotic syndrome
Similar rates of post-thrombotic syndrome occurred in patients with deep vein thrombosis who wore elastic compression stockings as those who wore placebo stockings, according to study results.
The objective of the study was to determine whether elastic compression stockings were more effective than placebo stockings in preventing post-thrombotic syndrome in a cohort of patients with a first, symptomatic proximal DVT.
Investigators conducted the study at 24 centers in the United States and Canada.
Patients wore the stockings on the DVT-affected leg daily for up to 2 years. Patients did not wear their stockings at study follow-up visits, which occurred at 1, 6, 12, 18 and 24 months.
Post-thrombotic syndrome at or after the 6-month visit — determined by the Ginsberg measure — served as the primary outcome. Incidence and severity of the syndrome, venous ulcers, venous thromboembolism occurrence and death from VTE comprised the secondary endpoints.
There were 398 patients in the study stocking group and 408 patients in the placebo group.
At 750 days, the cumulative incidence of post-thrombotic syndrome was 14.8% in the study group and 12.3% in the placebo group (HR=1.17; 95% CI, 0.75-1.81).
The cumulative incidence of Villalta post-thrombotic syndrome was 52.1% in the study stocking group and 52.2% for placebo (HR=0.96; 95% CI, 0.78-1.19).
Researchers observed similar rates of ipsilateral leg ulcer, recurrent VTE and death in the two groups.
The rate of loss to follow-up was 5.5% in the study group and 5.4% for placebo. Withdrawal rates also were similar.
Approximately 70% of patients in both groups continued treatment through the follow-up duration. Of those patients, more than 80% in both groups used the stockings for at least 3 days per week.
For more information:
Kahn SR. Abstract #393. Presented at: the 2012 ASH Annual Meeting and Exposition; Dec. 8-11, 2012; Atlanta.
Disclosure: Kahn received research funding from NIH, the Canadian Institutes for Health Research and Sigvaris.
Perspective
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For many years, physicians have been encouraged to prescribe elastic compression stockings for patients with newly-diagnosed DVT in order to decrease the incidence of post-phlebitic syndrome (PTS). This randomized, placebo-controlled study is the largest to address this issue, and the first to use a true placebo arm in which patients were treated with stockings that did not offer significant compression.
The study enrolled 398 patients into the active treatment arm and 408 patients into the placebo arm. There were no significant differences in demographic characteristics or baseline clinical characteristic between the two study arms. PTS diagnosed using the Ginsberg criteria was the primary study outcome. It occurred in 14.8% of patients in the active treatment arm and 12.3% in the placebo arm (HR 1.17; 95% CI 0.75-1.81). Thus, this study suggests that elastic compression stockings do not reduce the subsequent development of PTS in patients with newly-diagnosed DVT, forcing reconsideration of the existing paradigm. The utility of elastic compression stockings in treating established PTS was not addressed, and will need further study.
Perspective
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Since elastic stockings may cause skin breakdown, particularly in post-DVT legs, these studies argue forcefully that they are not worth the effort and discomfort of using them.