Vena cava filters in patients presenting with major bleeding during anticoagulation for venous thromboembolism

The RIETE Investigators

doi:10.1007/s11739-019-02077-5

Vena cava filters in patients presenting with major bleeding during anticoagulation for venous thromboembolism

The RIETE Investigators

Bar-Ilan University - Azrieli Faculty of Medicine

Research output: Contribution to journal › Article › peer-review

12 Scopus citations

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.

Original language	English
Pages (from-to)	1101-1112
Number of pages	12
Journal	Internal and Emergency Medicine
DOIs	https://doi.org/10.1007/s11739-019-02077-5
State	Published - 1 Oct 2019

Bibliographical note

Publisher Copyright:
© 2019, Società Italiana di Medicina Interna (SIMI).

Funding

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.

Funders
Bilora F
H Medical Science Service
Henri Bounameaux
Inna Tzoran (Israel), Abilio Reis
Marijan Bosevski
Pierpaolo Di Micco
S&H Medical Science Service
Bayer

Keywords

Anticoagulants
Bleeding
Mortality
Vena cava filter
Venous thromboembolism

Access to Document

10.1007/s11739-019-02077-5

Cite this

@article{91e03a86806a4f6094996e74dd441a22,

title = "Vena cava filters in patients presenting with major bleeding during anticoagulation for venous thromboembolism",

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.",

keywords = "Anticoagulants, Bleeding, Mortality, Vena cava filter, Venous thromboembolism",

author = "\{The RIETE Investigators\} and Meritxell Mellado and Javier Trujillo-Santos and Behnood Bikdeli and David Jim{\'e}nez and N{\'u}{\~n}ez, \{Manuel Jes{\'u}s\} and Martin Ellis and Marchena, \{Pablo Javier\} and Vela, \{Jer{\'o}nimo Ram{\'o}n\} and Albert Clara and Far{\`e}s Moustafa and Manuel Monreal and Adarraga, \{M. D.\} and Aibar, \{M. A.\} and M. Alfonso and Arcelus, \{J. I.\} and A. Ballaz and P. Ba{\~n}os and R. Barba and M. Barr{\'o}n and J. Bascu{\~n}ana and A. Blanco-Molina and Camon, \{A. M.\} and C. Carrasco and L. Chasco and Cruzs, \{A. J.\} and \{del Pozo\}, R. and \{del Toro\}, J. and D{\'i}az-Pedroche, \{M. C.\} and D{\'i}az-Peromingo, \{J. A.\} and M. Encabo and C. Falg{\'a} and C. Fern{\'a}ndez-Aracil and C. Fern{\'a}ndez-Capit{\'a}n and Fidalgo, \{M. A.\} and C. Font and L. Font and I. Furest and Garc{\'i}a, \{M. A.\} and F. Garc{\'i}a-Bragado and M. Garc{\'i}a-Morillo and A. Garc{\'i}a-Raso and I. Garc{\'i}a-S{\'a}nchez and O. Gav{\'i}n and C. G{\'o}mez and V. G{\'o}mez and J. Gonz{\'a}lez and E. Grau and R. Guijarro and L. Guirado and A. Braester",

note = "Publisher Copyright: {\textcopyright} 2019, Societ{\`a} Italiana di Medicina Interna (SIMI).",

year = "2019",

month = oct,

day = "1",

doi = "10.1007/s11739-019-02077-5",

language = "אנגלית",

pages = "1101--1112",

journal = "Internal and Emergency Medicine",

issn = "1828-0447",

publisher = "Springer-Verlag Italia s.r.l.",

}

TY - JOUR

T1 - Vena cava filters in patients presenting with major bleeding during anticoagulation for venous thromboembolism

AU - The RIETE Investigators

AU - Mellado, Meritxell

AU - Trujillo-Santos, Javier

AU - Bikdeli, Behnood

AU - Jiménez, David

AU - Núñez, Manuel Jesús

AU - Ellis, Martin

AU - Marchena, Pablo Javier

AU - Vela, Jerónimo Ramón

AU - Clara, Albert

AU - Moustafa, Farès

AU - Monreal, Manuel

AU - Adarraga, M. D.

AU - Aibar, M. A.

AU - Alfonso, M.

AU - Arcelus, J. I.

AU - Ballaz, A.

AU - Baños, P.

AU - Barba, R.

AU - Barrón, M.

AU - Bascuñana, J.

AU - Blanco-Molina, A.

AU - Camon, A. M.

AU - Carrasco, C.

AU - Chasco, L.

AU - Cruzs, A. J.

AU - del Pozo, R.

AU - del Toro, J.

AU - Díaz-Pedroche, M. C.

AU - Díaz-Peromingo, J. A.

AU - Encabo, M.

AU - Falgá, C.

AU - Fernández-Aracil, C.

AU - Fernández-Capitán, C.

AU - Fidalgo, M. A.

AU - Font, C.

AU - Font, L.

AU - Furest, I.

AU - García, M. A.

AU - García-Bragado, F.

AU - García-Morillo, M.

AU - García-Raso, A.

AU - García-Sánchez, I.

AU - Gavín, O.

AU - Gómez, C.

AU - Gómez, V.

AU - González, J.

AU - Grau, E.

AU - Guijarro, R.

AU - Guirado, L.

AU - Braester, A.

PY - 2019/10/1

Y1 - 2019/10/1

N2 - 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.

AB - 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.

KW - Anticoagulants

KW - Bleeding

KW - Mortality

KW - Vena cava filter

KW - Venous thromboembolism

UR - https://www.scopus.com/pages/publications/85065297770

U2 - 10.1007/s11739-019-02077-5

DO - 10.1007/s11739-019-02077-5

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C2 - 31054013

AN - SCOPUS:85065297770

SN - 1828-0447

SP - 1101

EP - 1112

JO - Internal and Emergency Medicine

JF - Internal and Emergency Medicine

ER -

Vena cava filters in patients presenting with major bleeding during anticoagulation for venous thromboembolism

Abstract

Bibliographical note

Funding

Keywords

Access to Document

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