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VTE and thromboprophylaxis in patients with IPD - the SPATA-DVT Study
large patient series in an area difficult to explore with clin- ical trials, like subjects at high bleeding risk.41 Indeed, interventional clinical trials generally exclude patients at bleeding risk, limiting the generalizability of the evidence. Registries have been helpful for improving our under- standing of the epidemiology, pattern of care and out- comes in such patient subgroups.41
Third, our study has a relatively small sample size and it involves a rather heterogeneous population undergoing a wide range of interventions performed over a fairly broad time period, thus limiting the strength of our results com- pared with studies carried out in the general population, especially when subgroup analyses are concerned. Although this is true, a case series of over 200 procedures carried out in rare-disease patients is not negligible in this clinical context, if one considers that phase 3 studies on LMWH prophylaxis in high-risk surgery and trauma have included between 100 and 440 patients.42-45
Despite the above limitations, to the best of our knowl- edge this is the first study which explored VTE-risk of sur- gical procedures in a large series of patients with IPD, and our results may represent the starting point for an evi- dence-based approach to the antithrombotic management of these subjects.
Conclusions
Our findings suggest that VTE incidence is low in patients with IPD undergoing at risk surgery. Moreover, among IPD subjects as well as in the general population,
patients at high VTE-risk may be identified by the Caprini score. Our data also suggest that mechanical thrombopro- phylaxis may be of benefit in patients with IPD undergo- ing invasive procedures at VTE-risk and that LMWH should be considered for major surgery. Prospective stud- ies are required to further clarify the impact of pharmaco- logic thromboprophylaxis on VTE and bleeding complica- tions in patients with IPD undergoing surgery.
Funding
This study was promoted by the Scientific Working Group on Thrombocytopenias and Platelet Function Disorders of the European Hematology Association (EHA). LB and EF were sup- ported by a scholarship grant from Fondazione Umberto Veronesi. This study was supported in part by a Telethon grant (GGP15063) to PG. NB holds grants from FIS-FONDOS FEDER (CP14/00024 and PI15/01457).
Acknwoledgments
The authors thank Dr. Giuseppe Guglielmini for help with statistical analysis, Prof. Marco Cattaneo (Università degli Studi di Milano, Italy), Prof. Christian Gachet (University of Strasbourg, France), Dr Alessandro Pecci, Drs Davide Rancitelli, Silvia Ferrari and Irene Bertozzi (University of Padua, Italy) and Dr. Giovanni Favuzzi (IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy) for their contribution to the study.
We thank Dr. Rino Migliacci (Division of Internal Medicine, Ospedale della Valdichiana "S. Margherita", Cortona, Italy) and Prof. Carlo Balduini (Department of Internal Medicine, IRCCS Policlinico S. Matteo Foundation, University of Pavia, Italy) for the critical reading of the manuscript.ì
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