Fondaparinux in the initial and long-term treatment of venous thromboembolism

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 longterm fondaparinux. Our small sample does not allowto derive relevant conclusions on the use of fondaparinux in cancer patients

Long-term anticoagulant therapy of patients with venous thromboembolism. What are the practices?

Current guidelines of antithrombotic therapy suggest early initiation of vitamin K antagonists (VKA) in non-cancer patients with venous thromboembolism (VTE), and long-term therapy with low-molecular weight heparin (LMWH) for those with cancer. We used data from RIETE (international registry of patients with VTE) to report the use of long-term anticoagulant therapy over time and to identify predictors of anticoagulant choice (regarding international guidelines) in patients with- and without cancer. Among 35,280 patients without cancer, 82% received long-term VKA (but 17% started after the first week). Among 4,378 patients with cancer, 66% received long term LMWH as monotherapy. In patients without cancer, recent bleeding (odds ratio [OR] 2.70, 95% CI 2.26-3.23), age >70 years (OR 1.15, 95% CI 1.06-1.24), immobility (OR 2.06, 95% CI 1.93-2.19), renal insufficiency (OR 2.42, 95% CI 2.15-2.71) and anemia (OR 1.75, 95% CI 1.65-1.87) predicted poor adherence to guidelines. In those with cancer, anemia (OR 1.83, 95% CI 1.64-2.06), immobility (OR 1.51, 95% CI 1.30-1.76) and metastases (OR 3.22, 95% CI 2.87-3.61) predicted long-term LMWH therapy. In conclusion, we report practices of VTE therapy in real life and found that a significant proportion of patients did not receive the recommended treatment. The perceived increased risk for bleeding has an impact on anticoagulant treatment decision

Fatal events in cancer patients receiving anticoagulant therapy for venous thromboembolism

none144siIn cancer patients treated for venous thromboembolism (VTE), including deep-vein thrombosis (DVT) and pulmonary embolism (PE), analyzing mortality associated with recurrent VTE or major bleeding is needed to determine the optimal duration of anticoagulation. This was a cohort study using the Registro Informatizado de Enfermedad TromboEmbólica (RIETE) Registry database to compare rates of fatal recurrent PE and fatal bleeding in cancer patients receiving anticoagulation for VTE. As of January 2013, 44,794 patients were enrolled in RIETE, of whom 7911(18%) had active cancer. During the course of anticoagulant therapy (mean, 181 ±210 days), 178 cancer patients (4.3%) developed recurrent PE (5.5 per 100 patient-years; 95% CI: 4.8-6.4), 194 (4.7%) had recurrent DVT (6.2 per 100 patient-years; 95% confidence interval [CI]: 5.3-7.1), and 367 (8.9%) bled (11.3 per 100 patient-years; 95% CI: 10.2-12.5). Of 4125 patients initially presenting with PE, 43 (1.0%) died of recurrent PE and 45 (1.1%) of bleeding; of 3786 patients with DVT, 19 (0.5%) died of PE, and 55 (1.3%) of bleeding. During the first 3 months of anticoagulation, there were 59 (1.4%) fatal PE recurrences and 77 (1.9%) fatal bleeds. Beyond the third month, there were 3 fatal PE recurrences and 23 fatal bleeds. In RIETE cancer patients, the rate of fatal recurrent PE or fatal bleeding was much higher within the first 3 months of anticoagulation therapy.openFarge D.; Trujillo-Santos J.; Debourdeau P.; Bura-Riviere A.; Rodriguez-Beltran E.M.; Nieto J.A.; Peris M.L.; Zeltser D.; Mazzolai L.; Hij A.; Monreal M.; Durante A.; Alcalde M.; Arcelus J.I.; Ballaz A.; Barba R.; Barron M.; Barron-Andres B.; Bascunana J.; Bedate P.; Blanco-Molina A.; Bueso T.; Casado I.; Conget F.; Del Molino F.; Del Toro J.; Falga C.; Fernandez-Capitan C.; Fuentes M.I.; Gallego P.; Garcia J.; Garcia-Bragado F.; Gavin O.; Gomez V.; Gonzalez J.; Gonzalez-Bachs E.; Grau E.; Guil M.; Guijarro R.; Gutierrez J.; Hernandez L.; Jara-Palomares L.; Jaras M.J.; Jimenez D.; Jimenez S.; Lobo J.L.; Lopez-Jimenez L.; Lopez-Saez J.B.; Lorente M.A.; Lorenzo A.; Luque J.M.; Madridano O.; Macia M.; Maestre A.; Marchena P.J.; Martin M.; Monreal M.; Mora J.M.; Munoz F.J.; Nauffal M.D.; Nieto J.A.; Nunez M.J.; Ogea J.L.; Otero R.; Pedrajas J.M.; Peris M.L.; Riera-Mestre A.; Rivas A.; Rodriguez-Davila M.A.; Roman P.; Rosa V.; Ruiz J.; Ruiz-Ribo M.D.; Ruiz-Gamietea A.; Ruiz-Gimenez N.; Sahuquillo J.C.; Samperiz A.; Sanchez Munoz-Torrero J.F.; Soler S.; Tiberio G.; Tilvan R.M.; Tolosa C.; Trujillo J.; Uresandi F.; Valdes M.; Valero B.; Valle R.; Vela J.; Vidal G.; Villalobos A.; Villalta J.; Gadelha T.; Maly R.; Hirmerova J.; Tomko T.; Bertoletti L.; Bura-Riviere A.; Farge-Bancel D.; Grange C.; Hij A.; Mahe I.; Merah A.; Quere I.; Schellong S.; Babalis D.; Papadakis M.; Tzinieris I.; Faul J.; Braester A.; Brenner B.; Tzoran I.; Zeltser D.; Barillari G.; Ciammaichella M.; Dalla Valle F.; Di Micco P.; Duce R.; Maida R.; Pasca S.; Piovella C.; Poggio R.; Prandoni P.; Quintavalla R.; Rocci A.; Rota L.; Schenone A.; Tiraferri E.; Tonello D.; Tufano A.; Visona A.; Zalunardo B.; Brinquinho M.; Gomes D.; Goncalves F.; Santos M.; Saraiva M.; Bosevski M.; Kovacevic D.; Alatri A.; Aujeski D.; Bounameaux H.; Calanca L.; Mazzolai L.; Caprini J.Farge, D.; Trujillo-Santos, J.; Debourdeau, P.; Bura-Riviere, A.; Rodriguez-Beltran, E. M.; Nieto, J. A.; Peris, M. L.; Zeltser, D.; Mazzolai, L.; Hij, A.; Monreal, M.; Durante, A.; Alcalde, M.; Arcelus, J. I.; Ballaz, A.; Barba, R.; Barron, M.; Barron-Andres, B.; Bascunana, J.; Bedate, P.; Blanco-Molina, A.; Bueso, T.; Casado, I.; Conget, F.; Del Molino, F.; Del Toro, J.; Falga, C.; Fernandez-Capitan, C.; Fuentes, M. I.; Gallego, P.; Garcia, J.; Garcia-Bragado, F.; Gavin, O.; Gomez, V.; Gonzalez, J.; Gonzalez-Bachs, E.; Grau, E.; Guil, M.; Guijarro, R.; Gutierrez, J.; Hernandez, L.; Jara-Palomares, L.; Jaras, M. J.; Jimenez, D.; Jimenez, S.; Lobo, J. L.; Lopez-Jimenez, L.; Lopez-Saez, J. B.; Lorente, M. A.; Lorenzo, A.; Luque, J. M.; Madridano, O.; Macia, M.; Maestre, A.; Marchena, P. J.; Martin, M.; Monreal, M.; Mora, J. M.; Munoz, F. J.; Nauffal, M. D.; Nieto, J. A.; Nunez, M. J.; Ogea, J. L.; Otero, R.; Pedrajas, J. M.; Peris, M. L.; Riera-Mestre, A.; Rivas, A.; Rodriguez-Davila, M. A.; Roman, P.; Rosa, V.; Ruiz, J.; Ruiz-Ribo, M. D.; Ruiz-Gamietea, A.; Ruiz-Gimenez, N.; Sahuquillo, J. C.; Samperiz, A.; Sanchez Munoz-Torrero, J. F.; Soler, S.; Tiberio, G.; Tilvan, R. M.; Tolosa, C.; Trujillo, J.; Uresandi, F.; Valdes, M.; Valero, B.; Valle, R.; Vela, J.; Vidal, G.; Villalobos, A.; Villalta, J.; Gadelha, T.; Maly, R.; Hirmerova, J.; Tomko, T.; Bertoletti, L.; Bura-Riviere, A.; Farge-Bancel, D.; Grange, C.; Hij, A.; Mahe, I.; Merah, A.; Quere, I.; Schellong, S.; Babalis, D.; Papadakis, M.; Tzinieris, I.; Faul, J.; Braester, A.; Brenner, B.; Tzoran, I.; Zeltser, D.; Barillari, G.; Ciammaichella, M.; Dalla Valle, F.; Di Micco, P.; Duce, R.; Maida, R.; Pasca, S.; Piovella, C.; Poggio, R.; Prandoni, P.; Quintavalla, R.; Rocci, A.; Rota, L.; Schenone, A.; Tiraferri, E.; Tonello, D.; Tufano, A.; Visona, A.; Zalunardo, B.; Brinquinho, M.; Gomes, D.; Goncalves, F.; Santos, M.; Saraiva, M.; Bosevski, M.; Kovacevic, D.; Alatri, A.; Aujeski, D.; Bounameaux, H.; Calanca, L.; Mazzolai, L.; Caprini, J

Outcomes in Neurosurgical Patients Who Develop Venous Thromboembolism

International audienceOBJECTIVES: Registro Informatizado de Enfermedad TromboEmbólica (RIETE) database was used to investigate whether neurosurgical patients with venous thromboembolism (VTE) were more likely to die of bleeding or VTE and the influence of anticoagulation on these outcomes.METHODS:Clinical characteristics, treatment details, and 3-month outcomes were assessed in those who developed VTE after neurosurgery.RESULTS: Of 40 663 patients enrolled, 392 (0.96%) had VTE in less than 60 days after neurosurgery. Most patients in the cohort (89%) received initial therapy with low-molecular-weight heparin, (33% received subtherapeutic doses). In the first week, 10 (2.6%) patients died (8 with pulmonary embolism [PE], no bleeding deaths; P = .005). After the first week, 20 (5.1%) patients died (2 with fatal bleeding, none from PE). Overall, this cohort was more likely to develop a fatal PE than a fatal bleed (8 vs 2 deaths, P = .058).CONCLUSIONS: Neurosurgical patients developing VTE were more likely to die from PE than from bleeding in the first week, despite anticoagulation

Fondaparinux in the initial and long-term treatment of venous thromboembolism

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 Tromboemb\uf3lica (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

Outcomes in Neurosurgical Patients Who Develop Venous Thromboembolism: A Review of the RIETE Registry

OBJECTIVES: Registro Informatizado de Enfermedad TromboEmb\uf3lica (RIETE) database was used to investigate whether neurosurgical patients with venous thromboembolism (VTE) were more likely to die of bleeding or VTE and the influence of anticoagulation on these outcomes. METHODS: Clinical characteristics, treatment details, and 3-month outcomes were assessed in those who developed VTE after neurosurgery. RESULTS: Of 40 663 patients enrolled, 392 (0.96%) had VTE in less than 60 days after neurosurgery. Most patients in the cohort (89%) received initial therapy with low-molecular-weight heparin, (33% received subtherapeutic doses). In the first week, 10 (2.6%) patients died (8 with pulmonary embolism [PE], no bleeding deaths; P = .005). After the first week, 20 (5.1%) patients died (2 with fatal bleeding, none from PE). Overall, this cohort was more likely to develop a fatal PE than a fatal bleed (8 vs 2 deaths, P = .058). CONCLUSIONS: Neurosurgical patients developing VTE were more likely to die from PE than from bleeding in the first week, despite anticoagulation

D-dimer levels and 90-day outcome in patients with acute pulmonary embolism with or without cancer

BACKGROUND: The prognostic value of D-dimer testing in patients with acute pulmonary embolism (PE) has not been thoroughly studied. METHODS: We used the RIETE Registry data to assess the 90-day prognostic value of increased IL Test D-dimer levels at baseline in patients with PE, according to the presence or absence of cancer. RESULTS: As of May 2013, 3,283 patients with acute PE underwent D-dimer testing using IL Test D-dimer. Among 2,588 patients without cancer, those with D-dimer levels in the highest quartile had a higher rate of fatal PE (2.6% vs. 0.9%; p=0.002), fatal bleeding (1.1% vs. 0.3%; p=0.017) and all-cause death (9.1% vs. 4.4%; p<0.001) at 90 days compared with those with levels in the lowest quartiles. Among 695 patients with cancer, those with levels in the highest quartile had a similar rate of fatal PE or fatal bleeding but higher mortality (35% vs. 24%; p<0.01). On multivariate analysis, non-cancer patients with D-dimer levels in the highest quartile had an increased risk for fatal PE (odds ratio [OR]: 3.3; 95% CI: 1.6-6.6), fatal bleeding (OR: 4.3; 95% CI: 1.4-13.7) and all-cause death (OR: 2.1; 95% CI: 1.4-3.1) compared with patients with levels in the lowest quartiles. CONCLUSIONS: Non-cancer patients with acute PE and IL Test D-dimer levels in the highest quartile had an independently higher risk for fatal PE, fatal bleeding and all-cause death at 90 days than those with levels in the lowest quartiles. In patients with cancer, D-dimer levels failed to predict fatal PE or fatal bleeding