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Risk factors for a first thrombotic event in antiphospholipid antibody carriers: a prospective multicentre follow-up study
  1. Amelia Ruffatti1,
  2. Teresa Del Ross1,
  3. Manuela Ciprian1,
  4. Maria T Bertero2,
  5. Sciascia Salvatore2,
  6. Salvatore Scarpato3,
  7. Carlomaurizio Montecucco4,
  8. Silvia Rossi4,
  9. Paola Caramaschi5,
  10. Domenico Biasi5,
  11. Andrea Doria1,
  12. Mariaelisa Rampudda1,
  13. Nuzzo Monica6,
  14. Fabio Fischetti7,
  15. Ugo Picillo8,
  16. Antonio Brucato9,
  17. Elisa Salvan1,
  18. Pengo Vittorio10,
  19. Pierluigi Meroni11,
  20. Angela Tincani6,
  21. ; Antiphospholipid Syndrome Study Group of the Italian Society of Rheumatology
  1. 1Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Padua, Padua, Italy
  2. 2Clinical Immunology and Allergology Units, Mauriziano Hospital, Turin, Italy
  3. 3Rheumatology Unit, M Scarlato Hospital, Salerno, Italy
  4. 4Rheumatology Unit, IRCCS Policlinico S Matteo Foundation, University of Pavia, Pavia, Italy
  5. 5Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Verona, Verona, Italy
  6. 6Rheumatology and Clinical Immunology Unit, University of Brescia, Brescia, Italy
  7. 7Department of Medical, Technological and Translational Sciences, University of Trieste, Trieste, Italy
  8. 8Rheumatology Unit, Department of Internal Medicine, 2nd University of Naples, Naples, Italy
  9. 9Department of Internal Medicine, Hospital of Bergamo, Bergamo, Italy
  10. 10Clinical Cardiology, Thrombosis Centre, University of Padua, Padua, Italy
  11. 11Department of Internal Medicine, Auxologico Institute, University of Milan, Milan, Italy
  1. Correspondence to Amelia Ruffatti, Reumatologia, Policlinico Universitario, Via Giustiniani 2, 35128 Padova, Italy; amelia.ruffatti{at}


Objectives To assess risk factors for a first thrombotic event in confirmed antiphospholipid (aPL) antibody carriers and to evaluate the efficacy of prophylactic treatments.

Methods Inclusion criteria were age 18–65 years, no history of thrombosis and two consecutive positive aPL results. Demographic, laboratory and clinical parameters were collected at enrolment, once a year during the follow-up and at the time of the thrombotic event, whenever that occurred.

Results 258 subjects were prospectively observed between October 2004 and October 2008. The mean±SD follow-up was 35.0±11.9 months (range 1–48). A first thrombotic event (9 venous, 4 arterial and 1 transient ischaemic attack) occurred in 14 subjects (5.4%, annual incidence rate 1.86%). Hypertension and lupus anticoagulant (LA) were significantly predictive of thrombosis (both at p<0.05) and thromboprophylaxis was significantly protective during high-risk periods (p<0.05) according to univariate analysis. Hypertension and LA were identified by multivariate logistic regression analysis as independent risk factors for thrombosis (HR 3.8, 95% CI 1.3 to 11.1, p<0.05, and HR 3.9, 95% CI 1.1 to 14, p<0.05, respectively).

Conclusions Hypertension and LA are independent risk factors for thrombosis in aPL carriers. Thromboprophylaxis in these subjects should probably be limited to high-risk situations.

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  • Antiphospholipid Syndrome Study Group of the Italian Society of Rheumatology AR, TDR, MC, MTB, SSci, SSca, CM, SR, PC, DB, AD, MR, MN, FF, UP, AB, ES, VP, PM and AT.

  • Competing interests None.

  • Patient consent Obtained.

  • Ethics approval The study protocol was approved by the local ethics committee of participating rheumatology centres.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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