Elsevier

Pathologie Biologie

Volume 52, Issue 5, June 2004, Pages 285-288
Pathologie Biologie

A prospective analysis of thrombotic events in the European collaboration study on low-dose aspirin in polycythemia (ECLAP)Analyse prospective des évènements vasculaires thrombotiques au cours de l'étude collaborative européene sur l'aspirine à faible dose dans la polyglobulie

https://doi.org/10.1016/j.patbio.2004.02.007Get rights and content

Abstract

Background. – The clinical course of polycythemia vera (PV) is often complicated by arterial and venous thrombosis. Current information on these vascular complications derives from very few prospective clinical trials and several retrospective studies. The purpose of this analysis is to report the incidence, clinical features and risk factors for thrombosis in a large number of patients prospectively followed in a multicountry European study.

Methods. – The European collaboration on low-dose aspirin in polycythemia vera (ECLAP) study is a multicenter project aimed at describing the natural history of PV. Overall, 1630 PV patients (57% males, median age at recruitment 65 years) were enrolled in the study. Five hundred and eighteen (32%) of these patients are entered into a parallel, double-blind, placebo-controlled, randomized clinical trial aimed at assessing the efficacy and safety of low-dose aspirin. The remaining 1112 (68%) are entered into an ongoing, observational, prospective, cohort study. The mean follow-up duration was 2.7 years (range 0–5.3).

Findings. – The cumulative incidence rate of cardiovascular events (i.e. cardiovascular death and non-fatal thrombotic events) was 5.5 events/100 persons per year. Thrombosis was the main cause of death. Age greater than 65 years and positive history of thrombosis were the two most important predictors of cardiovascular events. Smoking, hypertension and congestive heart failure were other significant risk factors for thrombosis. Platelet counts and myelosuppressive drugs were not associated with the risk of cardiovascular events. Antiplatelet therapy was the only variable associated with a lower risk of thrombosis.

Conclusion. – Cardiovascular events remain a major cause of mortality and morbidity in PV but the thrombotic risk seems to be more related to the patients’ characteristics (age, previous thrombosis, cardiovascular risk factors) than to the disease itself. Thus, control of red cell mass and antithrombotic therapy appear to be effective treatments in limiting the risk of thrombosis.

Résumé

L'évolution clinique de la maladie de Vaquez est souvent émaillée par des complications thrombotiques veineuses ou artérielles. Les informations dont nous disposons à propos de ces complications vasculaires sont tirées d'un nombre très limité d'études cliniques prospectives et surtout d'enquêtes rétrospectives beaucoup plus nombreuses.

L'objectif de ce travail est la détermination de l'incidence, de l'aspect clinique et les facteurs du risque de ces thromboses à partir d'une étude prospective européenne, multicentrique et portant sur un très grand nombre de patients.

Méthode. – L'étude ECLAP (European Collaboration on Low-dose Aspirin in Polycythaemia vera) est un projet multicentrique ayant pour objectif la description de l'histoire naturelle de la maladie de Vaquez. Un ensemble de 1630 patients atteints de cette maladie (57 % d'hommes, âge moyen au moment du recrutement 65 ans) ont été inclus dans l'étude. Cinq cent dix-huit (32 %) d'entre eux ont, en parallèle, été enrôlés dans une étude randomisée en double insu destinée à juger de l'efficacité et de la sécurité d'emploi de l'aspirine à faible dose comparée à un placebo. Les 1112 (68 %) patients restants font l'objet d'une surveillance prospective toujours en cours après un délai moyen de 2,7 ans (extrêmes 0–5,3).

Résultats. – L'incidence cumulée des évènements cardiovasculaires (mortalité liée à une complication cardiovasculaire et complications thrombotiques non fatales ) a été de 5,5 événements pour 100 patients année. La cause la plus fréquente de décès est la survenue de thrombose. L'âge, supérieur à 65 ans, et un antécédent de thrombose sont les deux facteurs les plus importants permettant de prédire la survenue de complications cardiovasculaires. Le fait de fumer, l'existence d'une hypertension artérielle ou d'une insuffisance cardiaque sont aussi des facteurs significativement liés au risque thrombotique. Le taux de plaquettes, l'utilisation ou non de traitements myélosuppresseurs n'ont pas en revanche d'incidence sur ce risque. L'utilisation d'un traitement antiagrégant s'est avérée la seule variable pouvant diminuer le risque de thrombose.

Conclusion. – La survenue de complications cardiovasculaires demeure la principale cause de mortalité ou de morbidité au cours de la polyglobulie de Vaquez. Le risque thrombotique paraît lié plus aux caractéristiques des patients eux-mêmes (âge, antécédents de thrombose, facteur de risques cardiovasculaires) qu'à celles de la maladie de Vaquez. Le contrôle de la masse globulaire totale et l'utilisation de médicaments antithrombotiques apparaissent comme les mesures thérapeutiques les plus efficaces pour limiter le risque de thrombose.

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