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International Venous Digest
For the attention of
Vol XI N°35
Editor : Prof John Bergan
Editorial Board : C. Allegra, M. Cairols, G. Jantet, H. Partsch, M. Perrin, M. Vandendriessche.
EFFECT OF PROLONGED TREATMENT WITH COMPRESSION STOCKINGS
TO PREVENT POST-THROMBOTIC SEQUELAE: A RANDOMIZED CONTROLLED TRIAL
Aschwanden M, Jeanneret C, Koller MT, Thalhammer C, Bucher HC, Jaeger KA. J Vasc Surg. 2008;47:1015-1021.
ABSTRACT AND COMMENTARY BY
Michel Perrin, Chassieu, France
ABSTRACT
Of 900 patients screened and presenting with a first or recurrent
proximal deep vein thrombosis, 169 were randomly allocated to
this study. All were treated for 6 months by standard
anticoagulation and stockings, and then randomized to 2
groups—continuation of compression stockings or not (control
group)—to differentiate the symptoms or signs related to acute
deep vein thrombosis (DVT) from those due to postthrombotic
syndrome (PTS). Initial DVT diagnosis was based on ultrasound
investigation, which was repeated during the follow-up as well as
on clinical examination. Patients were investigated every 3
months the first year and then every 6 months, which allowed
assessment not only clinical status but also compliance with
compression.
Primary efficacy analysis was performed on the
nd point of emerging skin changes (C4-C6 in the CEAP
classification). Secondary analysis was done on
symptoms associated with PTS. All analyses were intention-totreat.
The follow-up duration for the treatment group was 3.2 years
(range, 2 months-6.8 years) and 2.9 years (range, 1.5 months-7.0
years) in the control group.
The primary end point occurred in 11 patients (13.1%) in the
treatment group and in 17 (20.0%) in the control group (HR 0.6;
CI 0.28-1.28; P=.19). No venous ulceration was observed in
either group, knowing that 5 additional patients in the control
group required compression treatment owing to postthrombotic
signs and symptoms not included in the primary end point.
Benefit was not seen in men, but was significant in women.
Symptom relief was significant in favor of compression during
the first year but not after. Noncompliance with compression was
4 times more frequent in men (11%) than in women (3.6%)
COMMENTARY
Estimated prevalence of PTS after DVT ranges from 5% to 50%
according to the definition of PTS, thrombosis location and
extension, initial treatment, and duration of follow-up. Three
randomized, controlled trials on the effectiveness of compression
in alleviating PTS onset have yielded more or less contradictory
conclusions.1-3 The present study is well conducted in terms of
the statistical analysis and provides valuable but not conclusive
information, as the follow-up duration is short, but is
underpowered considering the small number of patients included.
The authors’ conclusions are in accordance with these remarks as
they state that compression after proximal DVT reduces
symptoms the first year and may prevent postthrombotic skin
changes and particularly venous ulcer. In my opinion, the major
bias of this study is that no information is given on the extension
or location of the initial thrombosis. Separate evaluation of
iliocaval thrombosis would have been valuable. Also, the venous
severity scoring of Rutherford and colleagues, which is a
valuable tool for patient assessment in PTS, was not used. 4
REFERENCES
1. Brandjes DP, Büller HR, Heijboer H, et al. Randomised trial
of effect of compression stockings in patients with symptomatic
proximal-vein thrombosis. Lancet. 1997;349:759-762.
2. Ginsberg JS, Hirsh J, Julian J, et al. Prevention and treatment
of postphlebitic syndrome—result of a 3-part study. Arch Intern
Med.2001;161:2105-2109. 3. Eichlisberger R, Widmer MT,
Frauchiger B, Widmer L, Jaeger K. The incidence of postthrombotic
syndrome. Wien Med Wochenschr. 1994;144:192-
195. 4. Rutherford RB, Padberg Jr. FT, Comerota J, Kistner RL,
Meissner, MH, Moneta GL. Venous severity scoring: An adjunct
to venous outcome assessment. J Vasc Surg 2000;31:1307-1312.
_________________
Viktor Knyazhev
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