Elsevier

The Lancet

Volume 349, Issue 9054, 15 March 1997, Pages 759-762
The Lancet

Articles
Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis

https://doi.org/10.1016/S0140-6736(96)12215-7Get rights and content

Summary

Background

Post-thrombotic syndrome varies from mild oedema to incapacitating swelling with pain and ulceration. We investigated the rate of post-thrombotic syndrome after a first episode of deep-vein thrombosis and assessed the preventive effect of direct application of a sized-to-fit graded compression stocking.

Methods

Patients with a first episode of venogram-proven proximal deep-vein thrombosis were randomly assigned no stockings (the control group) or made-to-measure graded compression elastic stockings for at least 2 years. Post-thrombotic syndrome was assessed with a standard scoring system that combined clinical characteristics and objective leg measurements. Patients were assessed every 3 months during the first 2 years, and every 6 months thereafter for at least 5 years. The cumulative incidence of mild-to-moderate post-thrombotic syndrome was the primary outcome measure.

Findings

Of the 315 consecutive outpatients considered for inclusion, 44 were excluded and 77 did not consent to take part. 194 patients were randomly assigned compression stockings (n=96) or no stockings (n=98). The median follow-up was 76 months (range 60–96) in both groups. Mild-to-moderate post-thrombotic syndrome (score ⩾3 plus one clinical sign) occurred in 19 (20%) patients in the stocking group and in 46 (47%) control-group patients (p<0·001). 11 (11%) patients in the stocking group developed severe post-thrombotic syndrome (score ⩾4), compared with 23 (23%) patients in the control group (p<0·001). In both groups, most cases of post-thrombotic syndrome occurred within 24 months of the acute thrombotic event.

Interpretation

About 60% of patients with a first episode of proximal deep-vein thrombosis develop post-thrombotic syndrome within 2 years. A sized-to-fit compression stocking reduced this rate by about 50%.

Introduction

During the past 20 years much progress has been made in the diagnosis and treatment of venous thrombosis and its acute complications. However, the long-term consequence of venous thrombosis—post-thrombotic syndrome—is little understood. This syndrome varies from mild oedema with little discomfort to incapacitating limb swelling with pain and ulceration. It is generally believed that it takes 5–10 years before post-thrombotic syndrome becomes clinically manifest.1, 2 Previous studies have reported frequencies of the syndrome of between 5% and 100%.3, 4, 5, 6, 7, 8, 9 This wide range probably reflects the small size of these retrospective studies, with different periods of follow-up and selection criteria. Interpretation of the findings of these studies is hampered by the lack of an established definition of post-thrombotic syndrome. Thus, the precise incidence and the time of onset of post-thrombotic syndrome after deep-vein thrombosis is not known.

Post-thrombotic syndrome is probably caused by a combination of venous hypertension, which results from outflow obstruction and damage to venous valves, and abnormal microcirculation.1 Strategies to reduce the outflow obstruction, such as vascular surgery and thrombolytic therapy, have not been effective.7, 10, 11 Bandages are commonly used in the treatment of patients with established post-thrombotic symptoms.12 Brakkee and Kuiper13 suggested that early application of external compression in patients with acute deep-vein thrombosis may prevent post-thrombotic syndrome by stimulating the development of collaterals, reducing the transcapillary filtration, and increasing fibrinolytic activity.

We aimed to document prospectively the cumulative rate of post-thrombotic syndrome after a first episode of proximal deep-vein thrombosis and to assess the preventive effect of direct application of a sized-to-fit graded compression stocking.

Section snippets

Methods

Consecutive outpatients who were referred by their family doctors to the Academic Medical Centre or the Slotervaart Ziekenhuis, Amsterdam, Netherlands, with a first episode of venogram-proven proximal deep-vein thrombosis were considered for inclusion in our study. Proximal-vein thrombosis included thrombi involving the popliteal vein or above, irrespective of concomitant calf-vein thrombi.14

Our exclusion criteria were: a life expectancy of less than 6 months; paralysis of the leg; bilateral

Results

315 consecutive outpatients with a first episode of venogram-proven symptomatic acute proximal deep-vein thrombosis were considered for inclusion. We excluded 44 patients: 20 had a life expectancy of less than 6 months; 11 had leg paralysis; ten already wore elastic stockings; and three had leg ulcers, extensive varicosis, or bilateral thrombosis. 77 patients refused to give their consent to take part. Thus, 194 patients were randomly assigned made-to-measure graded compression elastic

Discussion

During the French-British war in the sixteenth century, the French surgeon Ambroise Paré was released from captivity after he used compression bandages to cure the leg of an English army commander.18 Nowadays, bandages are commonly used in patients with established post-thrombotic symptoms. Our data indicate that in patients with a first episode of proximal deep-vein thrombosis, the cumulative 6-year incidence of mild-to-moderate post-thrombotic syndrome is about 50%. In the group without

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