Raffaele Pesavento1, Maria Amitrano2, Javier Trujillo-Santos3, Pierpaolo Di Micco4, Sara Mangiacapra2, Luciano López-Jiménez5, Conxita Falgá6, Fernando García-Bragado7, Chiara Piovella8, Paolo Prandoni8, Manuel Monreal9. 1. Department of Medicine- DIMED, 2nd Chair of Internal Medicine, University of Padua Padua, Italy. Electronic address: raffaele.pesavento@unipd.it. 2. Department of Internal Medicine, AORN San Giuseppe Moscati Avellino Campania, Italy. 3. Department of Internal Medicine, Hospital General Universitario Santa Lucía Cartagena, Murcia, Spain. 4. Emergency Room, Department of Medicine, Ospedale Buonconsiglio Fatebenefratelli Naples, Italy. 5. Department of Internal Medicine, Hospital Universitario Reina Sofía Córdoba, Spain. 6. Department of Internal Medicine, Consorci Hospitalari de Mataró Barcelona, Spain. 7. Department of Internal Medicine, Hospital Universitari de Girona Dr. Josep Trueta. Gerona, Spain. 8. Department of Medicine- DIMED, 2nd Chair of Internal Medicine, University of Padua Padua, Italy. 9. Department of Internal Medicine, Hospital Universitari Germans Trias i Pujol. Badalona, Barcelona, Spain.
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.
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-cancerpatients treated with long-term fondaparinux. Our small sample does not allow to derive relevant conclusions on the use of fondaparinux in cancerpatients.
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