Post-thrombotic Syndrome Clinical Trial
Official title:
Prospective Evaluation of the Quality of Life of Patients With Post-thrombotic Syndrome Who Receive Compression Therapy and Sulodexide — SQUARES Study
This study aims to evaluate whether, in a standardised cohort of patients with mild to
moderate PTS, monitored for a sufficiently long follow-up period, quality of life measured by
generic instruments and disease-specific instruments evolves favourably in this patient
profile.
Study objective: to evaluate the evolution of quality of life in general and in the specific
context of the disease of patients who have experienced an episode of deep-vein thrombosis
(DVT), are affected by post-thrombotic syndrome, are subject to compression therapy and
receive an additional standard venoactive agent (sulodexide 15 mg twice daily during 6
months).
Chronic venous insufficiency, or chronic venous disease (CVD), after prior deep-vein
thrombosis (DVT), is diagnosed as post-thrombotic syndrome (PTS). It has been calculated that
PTS occurs in between 20% and 50% of patients after an episode of DVT, even after having
received optimal anticoagulant treatment, and this disorder usually consolidates in the first
2 years after the acute thrombotic episode. The presentation of PTS varies from mild symptoms
or clinical signs to severe presentations in approximately 10% of cases, including chronic
pain in the limbs that limits activity and ability to work, untreatable oedema and ulcers in
the legs.
The cornerstone of the treatment of consolidated PTS is compression treatment, especially in
the form of elastic compression stockings, and frequent elevation of the leg, despite the low
level of evidence, but these measures require the strictest possible therapeutic compliance
on the part of the patient. There is still little evidence that "venoactive" agents are
effective in PTS symptoms; nevertheless, the use of medications in PTS is very widespread. In
a study by González- Fajardo et al., the use of compression stockings is described in 75% of
patients and, in a study by Lozano -Sánchez et al., their use is described in 62% of
patients. In the latter study, venoactive drugs were used in approximately 90% of patients.
The diagnosis, staging, prognosis and evolution of the severity of the various entities
grouped together under the heading of CVD, including PTS, are based mainly on scales and
scoring systems. Objective evaluation of CVD severity tends to be based on the "clinical,
etiologic, anatomic and pathophysiologic" (CEAP) clinical classification, the Venous Clinical
Severity Score (VCSS) and the Villalta score. Nevertheless, at the present time it is
recognised that the assessment of severity does not necessarily coincide with the perception
that patients themselves have of their quality of life, which is estimated with generic
questionnaires (such as the abbreviated 36-item Short-Form Health Survey questionnaire Short
Form (SF-36) and disease-specific questionnaires (such as the Venous Insufficiency
Epidemiological and Economic Study questionnaire (VEINES-QOL).
Various studies used some of these scales, usually more than one. All the studies agree that
patients with PTS have a lower QoL than those without PTS, and this is shown by both generic
and specific instruments. Nonetheless, the population examined in the studies was extremely
heterogeneous with respect to use of compression treatment, use of drugs and duration of
observations.
The problem that remains to be solved is whether the therapeutic measures applied lead to a
change in the QoL measured by generic and disease-specific instruments over a relatively long
treatment period. Achieving favourable changes in patients' perception of quality of life
remains fundamental for therapeutic compliance and for a suitable physician-patient
relationship in the treatment of any chronic disease, and therefore in PTS. This matter can
be properly examined, first, in a cohort of patients that is as standardised as possible with
respect to the stage and seriousness of the disease and the use of compression treatment and
pharmacological treatment.
The standardisation of the stage and seriousness of the disease, as well as the means of
standardising the compression treatment, can be achieved with appropriate inclusion and
exclusion criteria. As pharmacological treatment is generally administered, sulodexide was
chosen for purposes of standardisation. This is a venoactive treatment with antithrombotic,
profibrinolytic and endothelium-protective activity, already being used in PTS patients with
favourable results. The guidelines of the Society for Vascular Surgery, the American Venous
Forum and the American College of Chest Physicians (ACCP) include it among the recommended
pharmacological treatments, along with compression, for patients with manifest chronic venous
disease. Standardisation of the determination of QoL is envisaged using the generic
questionnaire SF-36 and the disease-specific questionnaire VEINES-QOL.
In this way, this study aims to evaluate whether, in a standardised cohort of patients with
mild to moderate PTS, monitored for a sufficiently long follow-up period, quality of life
measured by generic instruments and disease-specific instruments evolves favourably in this
patient profile. If this is the case, a different approach to the treatment of the disease
will be necessary.
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