Highlights
- •We evaluated the outcome of long-term therapy with fondaparinux in VTE patients.
- •The 10-day outcome was similar to that of patients treated with heparins.
- •The 90-day outcome was similar to that of cancer patients treated with LMWHs.
- •A 90-day high major bleeding rate was observed in non-cancer fondaparinux patients.
- •No relevant conclusions can be derived on the few enrolled cancer patients.
Abstract
Background
Even in the absence of evidence on its long-term efficacy and safety, a number of
patients with venous thromboembolism (VTE) receive long-term therapy with fondaparinux
alone in everyday practice.
Methods
We used the Registro Informatizado de Enfermedad Tromboembólica (RIETE) registry to
compare the rate of VTE recurrences and major bleeding at 10 and 90 days in patients with and without cancer. For long-term therapy, fondaparinux was
compared with vitamin K antagonists (VKA) in patients without cancer and with low-molecular-weight
heparin (LMWH) in those with cancer Results
Of 47,378 patients recruited, 46,513 were initially treated with heparin, 865 with
fondaparinux. Then, 263 patients (78 with cancer) were treated for at least 3 months with fondaparinux. After propensity-score matching, there were no differences
between patients receiving initial therapy with heparin or fondaparinux. Among patients
with cancer, there were no differences between fondaparinux and LMWH. Among patients
without cancer, the long-term use of fondaparinux was associated with an increased
risk of major bleeding (3.24 % vs. 0.95 %, p < 0.05).
Conclusions
An unexpected high rate of major bleeding was observed in non-cancer patients treated
with long-term fondaparinux. Our small sample does not allow to derive relevant conclusions
on the use of fondaparinux in cancer patients.
Abbreviations:
VTE (venous thromboembolism), LMWH (low molecular weight heparin), UFH (unfractioned heparin), VKA (vitamin k antagonists), RIETE (Registro Informatizado de Enfermedad TromboEmbólica), DVT (deep vein thrombosis), PE (pulmonary embolism), CUS (compressive ultrasonography), IU (international units), SD (standard deviation), CrCl (creatinine clearance), CI (confidence intervals)Keywords
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Article info
Publication history
Published online: December 12, 2014
Accepted:
November 30,
2014
Received in revised form:
October 24,
2014
Received:
August 28,
2014
Identification
Copyright
© 2014 Elsevier Ltd. Published by Elsevier Inc. All rights reserved.
