Servier – Phlebolymphology

RATIONALE OF TRIANGLE SURVEY

TRIANGLE is an international observational research program developed to provide information on the prevalence of chronic venous disease (CVD) and to help achieve better understanding of the triangular relationship between symptoms, signs, and the quality of life in patients suffering from CVD. Chronic venous disease of the lower limb is characterized by symptoms or signs produced by venous hypertension as a result of structural or functional abnormalities of major veins and capillaries. As a result, CVD must be considered to be at stages C0 to C6 of the CEAP classification.¹ From former studies, ^2,3 we know that quality of life of patients suffering from CVD is mainly impaired by the presence of symptoms, and that it is poorly influenced by the sex of the patients, the age, the presence of reflux or not, the severity of signs, or the duration of CVD disease.
The primary objective of TRIANGLE was to extend our knowledge regarding prevalence of CVD-related symptoms, and its relationship with the presence of signs, together with the impact both symptoms and signs may have on the quality of life.
Symptoms are not specific to CVD. To be attributed to chronic venous disease, the variability of such symptoms should be seen in at least two of the following situations: exacerbated after prolonged standing, but diminished after rest, or improve or disappear on walking, exacerbated at the end of the day, but disappear in the morning, after night rest, exacerbated by warmth (during the summertime season, hot baths, floor-based heating systems, hot waxing to remove body hair), but are less intense in winter and with cold temperatures, and for women, exacerbated before the menstrual period or occur with hormonal therapy, but disappear with discontinuation of such treatment, or after the menstrual period. The secondary objective was to evaluate the outcome of lifestyle advice or treatment after a 3-month follow-up period.
The Bulgarian TRIANGLE program which is reported on in this paper is focused mostly on the symptoms and signs of CVD, without reporting data on the quality of life. It is part of these recent surveys that used the basic CEAP classification,⁴ in which the single highest descriptor is used for clinical class.
It must be stressed however, that data regarding clinical classification coded as C0-C6 do not provide a full epidemiological background, as recorded information referred only to a single venous pathology, eg, varicose veins, skin changes, or active ulcers, corresponding to the highest clinical category. However, there is a hypothesis for internal consistency in which, in the extremities with a reported higher C category of venous pathologies, were also observed at lower stages of C category in a certain percentage.⁵
Little epidemiologic research has been conducted in non- Western countries; the prevalence of CVD is considered to be low in these areas. It is not known whether the prevalence, clinical expression, and complaints are the same in Eastern European countries as in the Western population. The Bulgarian TRIANGLE survey provided updated figures on the prevalence of symptoms and signs of CVD, using clear and globally accepted clinical definitions for venous disease, based on the CEAP classification.

REFERENCES

The TRIANGLE screening program: bulgarian results

ABSTRACT

CVD is a very common condition, which is often overlooked. The epidemiological data for Bulgaria are limited. The TRIANGLE program is an observational study designed to give an initial picture of the demographics and the prevalence of stages, symptoms, and signs of CVD among patients seeing their GPs. Over a period of 5 months, 3047 patients with chronic venous disease were entered in the study and were statistically processed. The majority of Bulgarian patients with CVD were in classes C0, C1, and C2 (63.8% cumulative incidence of patients with CVD). Female gender prevailed (70.5%). The mean age was 55.4 years. The distribution by age corresponded to the progressive nature of CVD. The most common complaints were fatigue, heaviness in the legs, pain, swelling, and cramps. Nearly half of the patients had not been given prior treatment. In order to improve subjective symptoms, MPFF at a dose of 500 mg was the treatment of choice in any stage.

INTRODUCTION

Chronic venous disease (CVD) is one of the most common diseases around the world.^1-3 Nevertheless, the problems associated with CVD are overlooked, and often underestimated by medical authorities, physicians, and patients. CVD is characterized by a broad spectrum of clinical symptoms, including heaviness in the legs, pain, muscle cramps, and a feeling of swelling accompanied or not by clinical signs such as leg edema and trophic skin changes, including venous ulcers. The disease progression is also accompanied by an increased risk of thrombophlebitis, deep vein thrombosis, and pulmonary thromboembolism – conditions that not only worsen patients’ quality of life, but may also threaten their lives.⁴
The epidemiological data concerning CVD in Bulgaria are limited, while worldwide the problem of insufficient information has begun to change, especially after the publication of RELIEF,⁵ the largest clinical epidemiological study carried out in 23 countries all over the world, which provided data on the prevalence of venous reflux, the impact of CVD on quality of life, and the protective effects of MPFF at a dose of 500 mg (micronized purified flavonoid fraction). Thus, the need for deeper knowledge on CVD in our country led us to carry out this study.*

*The TRIANGLE program was carried out with the sponsorship of Les Laboratoires Servier.

AIMS

The primary aims of the TRIANGLE study were:
– To obtain reliable information on the prevalence of the different CEAP stages of CVD among individuals seeing their general practitioners in Bulgaria.
– To obtain reliable information about the most common complaints urging CVD patients to visit a doctor.

STUDY POPULATION AND METHODS

TRIANGLE is an epidemiological observation carried out in 16 of the largest Bulgarian cities (Blagoevgrad, Burgas, Varna, Veliko Tarnovo, Vratza, Dobritch, Kyustendil, Lovetch, Montana, Pazardjik, Pleven, Plovdiv, Russe, Sliven, Sofia, and Stara Zagora) designed to obtain nationally representative data.
Twenty-one surgeons from the BSSAVS (Bulgarian Scientific Society for Angiology and Vascular Surgery) educated 500 general practitioners on the symptoms and signs of CVD; how to diagnose the illness in a patient: through an interview, physical examination, and medical tests, and how to collect the information in the case report form.
Between 1 April and 31 August 2004, the 500 GPs actively looked for patients with CVD, among all their over 16-years old patients, regardless of the visit purpose, excluding patients needing emergency care.
For this period, 3900 CVD patients were enrolled in the observational study. Of these, 3047 met the inclusion criteria and had correctly completed CRFs, and their data were entered and statistically processed.
The first section of the case report forms included anthropometrical data of the patient and data concerning their clinical history and the presence of vascular risk factors (family history, patient’s history of vein disease, prior treatment for CVD, prior history of thrombophlebitis, and other risk factors predisposing to CVD). The second section reflected the interviewing physician’s evaluation of the severity of disease, classified as C0 to C6 in accordance with the clinical criteria of the CEAP⁶ classification (proposed at the Hawaiian meeting of the American Venous Forum in 1995 and nowadays considered to be the most elaborate of all existing classifications), and a description of the symptoms characterizing the disease, such as pain, heaviness in the legs, swelling, cramps, burning sensation, itching, fatigue, and pulsation quantified by a 4-degree verbal scale depending on the severity of the patient’s complaints.

STATISTICS

The statistical methods used for data processing and analysis included:

Descriptive methods
• For nonmetrical and group data: tables with absolute and relative distribution rate.
• For metrical parameters: mean values, standard deviation, minimum and maximum values, and median value.
Methods of graphic presentation
• For nonmetrical and group data: column diagrams.
• Methods of statistical processing: in accordance with the nature of data, a chi-square test was applied to test the hypotheses. The real probability for type I errors was calculated using the precise Fisher’s criterion. The level of significance when testing an invalid hypothesis was predetermined to be 0.05.

All the calculations were made using the SPSS statistical pack.⁷

RESULTS

Distribution of the CVD patients according to the CEAP classification

The results from this study show that the majority of the observed Bulgarian CVD patients (63.8% cumulative incidence) belonged to classes C0, C1, and C2, according to the CEAP classification (symptoms without signs, telangiectasias, varicose veins), and class C2 signs (varicose veins) prevail – 28.6% relative incidence. Class C3 (edema) and C4 is common among the study population: 15.9% and 13.2%, respectively. The prevalence of class C5, skin changes with healed ulcerations, and class C6, skin changes with active ulcerations, are lower among the observed CVD patients, respectively 4.5% and 2.4% (Table I).

Demographic distribution of CVD patients seeking medical consultation

Female gender prevails: 70.5% female vs 29.5% male patients. The mean age of the patients included in the study population was 55.41 years. The distribution by age: 43.2% (41 to 60 years) vs 17.4% (19 to 40 years) confirm the progressive nature of chronic venous insufficiency (Table II).

Table I. Distribution of patients according to the CEAP classification.

Table II. Demographic distribution.

Prevalence of symptoms

Among Bulgarian CVD patients, the most common complaints that urged them to see their doctors were: fatigue, heaviness in the legs, pain, swelling, and cramps (Figure 1).

Figure 1. Prevalence of symptoms among chronic venous
insufficiency patients.

Distribution according to prior management of CVD patients belonging to different CEAP classes

The distribution of CVD patients belonging to different CEAP classes according to prior management indicates that chronic venous insufficiency is overlooked as nearly half of the patients regardless of the presence of symptoms, varicose veins, and edema did not receive prior treatment (Figure 2).

CONCLUSIONS

Thanks to countrywide enrolment of 3900 patients, the TRIANGLE program constitutes a large database on the prevailing CVD stages in Bulgaria.
The large number of patients seeking medical help during the study period justifies the conclusion that CVD is a widely prevalent disease among the Bulgarian population.
The study results show that the majority of Bulgarian CVD patients seeking medical help (63.8%) belong to the CEAP classes C0 and C2 (symptoms without signs, telangiectasias, varicose veins), with the latter class (C2, varicose veins) being a majority.
Another important conclusion drawn from the first CVD screening program carried out in Bulgaria is that there was a general lack of prior management within the study population, especially among those at the early stages of disease. This means that, despite its progressive nature, during the initial stages, when complaints are present but signs are trivial or lacking, the disease is often overlooked. However, the early diagnosis and management of CVD is crucial for avoiding severe late complications.
Management should combine changes of lifestyle, phlebotropic agents and, at the advanced stages of the illness, more specific treatments, such as elastic bandages, sclerotherapy, and surgical procedures.
MPFF at a dose of 500 mg was the phlebotropic agent of choice for participants at any stage of the disease, because it is highly effective in relieving symptoms that sometimes make the life of the patient unbearable, and in preventing the progression of CVD to its complications.
The TRIANGLE program is only the beginning of a wider study of CVD morbidity and its consequences in Bulgaria.

REFERENCES

AUTHORS

Vassil ANASTASSOV1, Prof Andrea ANDREEV2, Liubomir BESHEV3, Mihail CHESHMEDJIEV4, Georgi GEORGIEV5, Elena GORANOVA7, Prof Lachezar GROZDINSKI7, Svilen HRELEV4, Prof Tanyo KAVRAKOV2, Prof Victor KNIAJEV4, Prof Girov KUZMAN6, Angel MARINOV3, Dimitar MARKOV8, Ognian MATKOV3, Sasho RUSSANOV5, Prof Mario STANKEV7, Stefan STEFANOV7, Drago ZHELEV1

1. Medical University Plovdiv, Bulgaria
2. Medical University Stara Zagora, Bulgaria
3. Medical University Pleven, Bulgaria
4. Medical University Varna, Bulgaria
5. MHAT Russe, Bulgaria
6. Military Hospital, Sofia, Bulgaria
7. National Cardiological Hospital, Sofia, Bulgaria
8. University Hospital St. Ekaterina, Sofia, Bulgaria