Abstract
The association between inferior vena cava filter (IVC) use and outcome in patients presenting with major bleeding during anticoagulation for venous thromboembolism (VTE) has not been thoroughly investigated. We used the RIETE registry to compare the 30-day outcomes (death, major re-bleeding or VTE recurrences) in VTE patients who bled during the first 3 months of therapy, regarding the insertion of an IVC filter. A propensity score matched (PSM) analysis was performed to adjust for potential confounders. From January 2001 to September 2016, 1065 VTE patients had major bleeding during the first 3 months of anticoagulation (gastrointestinal 370; intracranial 124). Of these, 122 patients (11%) received an IVC filter. Patients receiving a filter restarted anticoagulation later (median, 4 vs. 2 days) and at lower doses (95 ± 52 IU/kg/day vs. 104 ± 55 of low-molecular-weight heparin) than those not receiving a filter. During the first 30 days after bleeding (after excluding 246 patients who died within the first 24 h), 283 patients (27%) died, 63 (5.9%) had non-fatal re-bleeding and 19 (1.8%) had recurrent pulmonary embolism (PE). In PSM analysis, patients receiving an IVC filter (n = 122) had a lower risk for all-cause death (HR 0.49; 95% CI 0.31–0.77) or fatal bleeding (HR 0.16; 95% CI 0.07–0.49) and a similar risk for re-bleeding (HR 0.55; 95% CI 0.23–1.40) or PE recurrences (HR 1.57; 95% CI 0.38–6.36) than those not receiving a filter (n = 429). In VTE patients experiencing major bleeding during the first 3 months, use of an IVC filter was associated with reduced mortality rates.
Clinical Trial Registration NCT02832245.
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Change history
20 June 2019
In the original publication, part of conflict of statement was incorrectly published
27 November 2019
In the original publication, part of the conflict of statement was incorrectly published as ���Dr. Bikdeli reports that he was approached by lawyers on behalf of plaintiffs in litigation related to IVC filters���. The correct statement should read as ���Dr. Bikdeli reports that he is a consulting expert (on behalf of the plaintiff) for litigation related to a specific type of IVC filters���.
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Acknowledgements
We express our gratitude to Sanofi Spain for supporting this Registry with an unrestricted educational grant. We also express our gratitude to Bayer Pharma AG for supporting this Registry. Bayer Pharma AG’s support was limited to the part of RIETE outside Spain, which accounts for a 24.35% of the total patients included in the RIETE Registry. We also thank the RIETE Registry Coordinating Center, S&H Medical Science Service, for their quality control data, logistic and administrative support.
Coordinator of the RIETE Registry: Manuel Monreal.
RIETE Steering Committee Members: Hervé Decousus, Paolo Prandoni and Benjamin Brenner.
RIETE National Coordinators: Raquel Barba (Spain), Pierpaolo Di Micco (Italy), Laurent Bertoletti (France), Inna Tzoran (Israel), Abilio Reis (Portugal), Marijan Bosevski (R. Macedonia), Henri Bounameaux (Switzerland), Radovan Malý (Czech Republic), Philip Wells (Canada) and Peter Verhamme (Belgium).
RIETE Registry Coordinating Center: S & H Medical Science Service.
The members of the RIETE Group: Spain: Adarraga MD, Aibar MA, Alfonso M, Arcelus JI, Ballaz A, Baños P, Barba R, Barrón M, Bascuñana J, Blanco-Molina A, Camon AM, Carrasco C, Chasco L, Cruz AJ, del Pozo R, del Toro J, Díaz-Pedroche MC, Díaz-Peromingo JA, Encabo M, Falgá C, Fernández-Aracil C, Fernández-Capitán C, Fidalgo MA, Font C, Font L, Furest I, García MA, García-Bragado F, García-Morillo M, García-Raso A, García-Sánchez I, Gavín O, Gómez C, Gómez V, González J, Grau E, Guijarro R, Guirado L, Gutiérrez J, Hernández-Blasco L, Hernando E, Isern V, Jara-Palomares L, Jaras MJ, Jiménez D, Joya MD, Lima J, Llamas P, Lobo JL, López-Jiménez L, López-Reyes R, López-Sáez JB, Lorente MA, Lorenzo A, Loring M, Lumbierres M, Madridano O, Maestre A, Marchena PJ, Martín M, Martín-Martos F, Mellado M, Monreal M, Morales MV, Nieto JA, Núñez MJ, Olivares MC, Otalora S, Otero R, Pedrajas JM, Pellejero G, Pérez-Ductor C, Peris ML, Pons I, Porras JA, Riera-Mestre A, Rivas A, Rodríguez-Dávila MA, Rodríguez-Galán I, Rosa V, Rubio CM, Ruiz-Artacho P, Sahuquillo JC, Sala-Sainz MC, Sampériz A, Sánchez-Artola B, Sánchez-Martínez R, Sancho T, Soler S, Soto MJ, Suriñach JM, Tolosa C, Torres MI, Trujillo-Santos J, Uresandi F, Usandizaga E, Valero B, Valle R, Vela J, Vidal G, Villalobos A, Xifre B, Argentina: Vázquez FJ, Vilaseca A, Belgium: Vanassche T, Vandenbriele C, Verhamme P, Brazil: Yoo HHB, Canada: Wells P, Czech Republic: Hirmerova J, Malý R, Ecuador: Salgado E, France: Benzidia I, Bertoletti L, Bura-Riviere A, Falvo N, Farge-Bancel D, Hij A, Merah A, Mahé I, Moustafa F, Quere I, Israel: Braester A, Brenner B, Ellis M, Tzoran I, Italy: Antonucci G, Bilora F, Bucherini E, Cattabiani C, Ciammaichella M, Dentali F, Di Micco P, Doddi M, Duce R, Giorgi-Pierfranceschi M, Grandone E, Imbalzano E, Lessiani G, Maggi F, Maida R, Mastroiacovo D, Pace F, Pesavento R, Poggio R, Prandoni P, Quintavalla R, Rocci A, Siniscalchi C, Tiraferri E, Tonello D, Visonà A, Zalunardo B, Latvia: Gibietis V, Skride A, Vitola B, Republic of Macedonia: Zdraveska M, Switzerland: Bounameaux H, Calanca L, Fresa M, Mazzolai L, USA: Bikdeli B.
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The sponsors of the study (Sanofi and Bayer) had no role in study design, data collection, data analysis, data interpretation or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
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Dr. Bikdeli is supported by the National Heart, Lung, and Blood Institute, National Institutes of Health, through grant number T32 HL007854. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. Dr. Bikdeli reports that he was approached by lawyers on behalf of plaintiffs in litigation related to IVC filters. He was contacted as a result of a Viewpoint published elsewhere in the past. The lawyers were unaware of the current submission and this manuscript has not been shared with them. The current study was designed before the communication related to the litigation case. Dr. Moustafa has served as an advisor or consultant for Bayer HealthCare Pharmaceuticals and Sanofi; has served as a speaker for Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, Daiichi-Sankyo and Sanofi; and has received grants from Sanofi, Bayer HealthCare and LFB. Dr. Monreal has served as an advisor or consultant for Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, Leo Pharma, Pfizer, and Sanofi; has served as a speaker or a member of a speaker’s bureau for Bayer HealthCare Pharmaceuticals, Daiichi-Sankyo, Leo Pharma, and Sanofi; and has received grants for clinical research from Sanofi and Bayer. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the author.
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A full list of RIETE investigators is given in the acknowledgements.
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Mellado, M., Trujillo-Santos, J., Bikdeli, B. et al. Vena cava filters in patients presenting with major bleeding during anticoagulation for venous thromboembolism. Intern Emerg Med 14, 1101–1112 (2019). https://doi.org/10.1007/s11739-019-02077-5
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DOI: https://doi.org/10.1007/s11739-019-02077-5