Thrombotic risk in patients with primary immune thrombocytopenia is only mildly increased and explained by personal and treatment‐related risk factors. (16th July 2014)

• Record Type: Journal Article
• Authors: Ruggeri, M.; Tosetto, A.; Palandri, F.; Polverelli, N.; Mazzucconi, M. G.; Santoro, C.; Gaidano, G.; Lunghi, M.; Zaja, F.; De Stefano, V.; Sartori, R.; Fazi, P.; Rodeghiero, F.; the Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Anemia and Thrombocytopenias Working Party. GIMEMA Study ITP0311
• Is Part Of: Journal of thrombosis and haemostasis. Volume 12:Number 8(2014:Aug.)
• Page Start: 1266
• Page End: 1273
• Publication Date: 2014-07-16
• Subjects: Thrombosis -- Periodicals; Hemostasis -- Periodicals; Blood coagulation disorders -- Periodicals; 616.1
• DOI: 10.1111/jth.12636
• Languages: English
• ISSNs: 1538-7933

Abstract

<abstract abstract-type="main" id="jth12636-abs-0001"> <title>Summary</title> <sec id="jth12636-sec-0001" sec-type="section"> <title>Background</title> <p>An increased risk of thrombosis has been reported in primary immune thrombocytopenia (ITP) and with the use of thrombopoietin (TPO) receptor agonists, on the basis of population studies using administrative databases.</p> </sec> <sec id="jth12636-sec-0002" sec-type="section"> <title>Objectives</title> <p>To evaluate if the incidence of venous and arterial thrombosis in patients with primary ITP is higher than a clinically significant cut‐off set at of 3% and 6.4%.</p> </sec> <sec id="jth12636-sec-0003" sec-type="section"> <title>Patients/Methods</title> <p>We undertook a retrospective multicenter investigation in a large cohort of patients requiring at least one treatment for ITP, enrolled from the major tertiary Italian centers treating ITP. A total of 986 patients were analyzed.</p> </sec> <sec id="jth12636-sec-0004" sec-type="section"> <title>Results</title> <p>During a 3888 patient‐year follow‐up, 43 first thrombotic events occurred: 28 arterial and 15 venous, resulting in a cumulative incidence of 3.2% for arterial (95% CI, 2.0–5.0) and 1.4% (95% CI, 0.8–2.5) for venous thrombosis at 5 years. The annualized rates for 100 patient‐years were 1.14 (95% CI, 0.84–1.54), 0.39 (95% CI, 0.23–0.65) and 0.71 (95% CI, 0.49–1.04) for total, venous and arterial thrombosis. Splenectomy, performed in 136 patients (13.7%), increased thrombotic risk (HR = 3.5, 95% CI) compared with non‐splenectomized patients. Age > 60 years, more than two risk factors for thrombosis at diagnosis and steroid use were independently associated with an increased risk of thrombosis.</p> </sec> <sec id="jth12636-sec-0005" sec-type="section"> <title>Conclusions</title> <p>In this study, we demonstrate that the 5‐year cumulative incidence of venous and arterial thrombosis in ITP is well below the predefined thresholds. Venous and arterial thromboembolism are not frequent complications in ITP, except in particular settings, such as in splenectomized and elderly patients.</p> </sec> </abstract>