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Ciprian, Manuela (2010) Fattori di rischio per il primo evento trombotico in soggetti positivi per anticorpi antifosfolipidi. Studio multicentrico, prospettico, di follow-up. [Tesi di dottorato]

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Abstract (inglese)

RISK FACTORS FOR A FIRST THROMBOTIC EVENT IN ANTIPHOSPHOLIPID ANTIBODY CARRIERS. A MULTICENTRE, PROSPECTIVE, FOLLOW-UP STUDY

Background. Antiphospholipid syndrome (APS) is defined by the persistent presence of antiphospholipid antibodies (aPL) in the blood in association with thrombotic events and/or pregnancy morbidity. Several studies have recently endeavoured to identify the predictors of thrombotic events in aPL carriers, but substantial differences in study designs, patient selection criteria, aPL profiles and risk factors make it is difficult to draw any conclusions.
Objectives. To asses risk factors for first thrombotic events in aPL positive carriers and to evaluate the efficacy of prophylactic treatments.
Methods. The study included patients/subjects attending 11 Rheumatologic Centres belonging to the network of the APS Study Group of the Italian Society of Rheumatology. The inclusion criteria were the following: age between 18 and 65 years and no history of thrombosis. The laboratory criteria were: two consecutive, positive aPL tests carried out, in accordance with the Sydney criteria, at least 12 weeks apart. Women with APS-related pregnancy morbidity were also included. Demographic, laboratory and clinical parameters were collected at enrolment and once a year during the follow-up period. Testing was also carried out at the time of the thrombotic event. Anticardiolipin and anti-beta2 Glycoprotein I antibodies were measured in 5 Centres by “in-house” ELISAs and in the remaining 6 Centres by commercial kits. Lupus Anticoagulant (LA) was tested using platelet-poor plasma following internationally accepted guidelines.
Results. Two hundred fifty-eight patients/subjects (223 women and 35 men; mean age: 40.9 years ± 11.1 SD) were recruited between October 2004 and October 2008. The mean follow-up was 35.0 months ± 11.9 SD. Fourteen patients (5.4%, with an annual incidence rate of 1.86%) developed a first thrombotic event (9 venous and 5 arterial) during the follow-up period. Seven of these were receiving prophylactic treatment at the time of the event (6 continuous and 1 during pregnancy prophylaxis). Five of the first-time events occurred during high risk periods (pregnancy/puerperium, immobilization or surgery). Hypertension and LA activity were identified by multivariate logistic regression analysis as independent risk factors for thrombosis (OR=3.6 with 95% CI= 1.2-11, p<0.05 and OR=3.7 with 95% CI= 1-13.8, p<0.05, respectively). It was found, moreover, that thromboprophylaxis with low dose aspirin (100 mg) and/or heparin during high risk periods was significantly protective (OR=0.1 with 95% CI= 0.01-0.9, p<0.05), whereas .prophylaxis continuously administered was not protective
Conclusions. The findings of this prospective, follow-up study is in line with those of our previous retrospective one as hypertension was found to be a risk factor for first thrombotic events in asymptomatic aPL carriers. LA was found to be a risk factor for thrombosis, and thromboprophylaxis, administered during high risk periods, was, indeed, protective.



Abstract (italiano)

FATTORI DI RISCHIO PER IL PRIMO EVENTO TROMBOTICO IN SOGGETTI POSITIVI PER ANTICORPI ANTIFOSFOLIPIDI. STUDIO MULTICENTRICO, PROSPETTICO, DI FOLLOW-UP

Introduzione. La sindrome da anticorpi antifosfolipidi (APS) è definita dalla persistente presenza di anticorpi antifosfolpidi (aPL) nel sangue in associazione a manifestazioni trombotiche e/o impegno ostetrico. Alcuni studi hanno recentemente tentato di identificare gli elementi predittivi dell’evento trombotico negli aPL carriers, ma differenze sostanziali nel disegno degli studi, nei criteri di selezione dei pazienti, nei profili anticorpali e nei fattori di rischio considerati rendono difficile trarre delle conclusioni definitive.
Obiettivi. Identificare i fattori di rischio per il primo evento trombotico nei pazienti positivi per aPL e valutare l’efficacia della profilassi.
Metodi. Lo studio ha incluso pazienti/soggetti provenienti da 11 Centri Reumatologici facenti parte del Gruppo di Studio sulla APS della Società Italiana di Reumatologia.
I criteri di inclusione erano i seguenti: età compresa tra 18 e 65 anni, anamnesi negativa per trombosi. I criteri di laboratorio erano: due positività consecutive per aPL, in accordo con i criteri di Sidney, ad almeno 12 settimane di distanza l’una dall’altra. Le donne con l’impegno ostetrico della APS erano incluse. I dati demografici, di laboratorio e clinici erano raccolti all’arruolamento e una volta all’anno durante il follow-up. Il profilo anticorpale era determinato anche al momento dell’evento trombotico. Gli anticorpi anti-cardiolipina e anti-beta2glicoproteina I sono stati determinati da 5 Centri con metodo Elisa “in-house” e dai rimanenti 6 Centri con kits commerciali. Il Lupus Anticoagulant (LA) è stato testato secondo i criteri dell’ International Society of Thrombosis and Haemostasis.
Risultati. Duecentocinquantotto pazienti/soggetti (223 donne e 35 uomini di età media 40.9 anni ± 11.1 SD) sono stati reclutati tra l’Ottobre 2004 e l’Ottobre 2008. Il follow-up medio è stato di 35 mesi ± 11.9 SD (range 1-48). Quattordici pazienti (5.4%, annual incidence rate 1.86%) hanno sviluppato il primo evento trombotico (in 9 casi venoso, in 5 arterioso) durante il follow-up. Sette di questi stavano assumendo un trattamento profilattico al momento dell’evento (6 in modo continuativo ed 1 in corso di gravidanza). In 5 casi il primo evento trombotico si è verificato durante un periodo ad alto rischio (gravidanza/puerperio, immobilizzazione o chirurgia). L’ipertensione ed il LA sono stati identificati dall’analisi multivariata come fattori di rischio indipendenti per la trombosi (OR=3.6 con 95% CI= 1.2-11, p<0.05 e OR=3.7 con 95% CI= 1-13.8, p<0.05, rispettivamente). E’ risultato inoltre che la profilassi con aspirina a basso dosaggio (100 mg) e/o eparina durante i periodi ad alto rischio è significativamente protettiva (OR=0.1 con 95% CI= 0.01-0.9, p<0.05), mentre la profilassi data in modo continuativo non è protettiva.
Conclusioni. Da questo studio prospettico di follow-up è risultato, in linea con quanto emerso nel nostro precedente studio retrospettivo, che l’ipertensione è un fattore di rischio per il primo evento trombotico in aPL carriers asintomatici. Inoltre anche il LA è risultato un fattore di rischio per trombosi e la profilassi, somministrata nei periodi ad alto rischio, è risultata, infine, protettiva.





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Tipo di EPrint:Tesi di dottorato
Relatore:Ruffatti, Amelia
Dottorato (corsi e scuole):Ciclo 22 > Scuole per il 22simo ciclo > SCIENZE MEDICHE, CLINICHE E SPERIMENTALI > SCIENZE REUMATOLOGICHE
Data di deposito della tesi:NON SPECIFICATO
Anno di Pubblicazione:11 Marzo 2010
Parole chiave (italiano / inglese):anticorpi antifosfolipidi, carriers, trombosi
Settori scientifico-disciplinari MIUR:Area 06 - Scienze mediche > MED/16 Reumatologia
Struttura di riferimento:Dipartimenti > Dipartimento di Medicina Clinica e Sperimentale
Codice ID:3053
Depositato il:03 Nov 2010 09:14
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