Major bleeding in patients with pulmonary embolism presenting with syncope

The RIETE Investigators

doi:10.1111/eci.13774

Major bleeding in patients with pulmonary embolism presenting with syncope

The RIETE Investigators

Bar-Ilan University - Azrieli Faculty of Medicine

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

3 Scopus citations

Abstract

Introduction: Syncope has been shown to be a risk factor of bleeding in patients receiving thrombolytic therapy for acute pulmonary embolism (PE). Whether syncope predicts bleeding in a broader population of patients with PE remains unknown. Methods: We used the RIETE registry data to assess whether initial presentation with syncope could predict bleeding in PE patients receiving anticoagulant therapy, and to explore the association between presence of syncope and timing and site of major bleeding events. Results: Among 45,765 patients with acute PE from March 2001 to January 2021, 6760 (14.8%) had syncope. Patients with syncope were older and more likely to have hypotension, tachycardia, hypoxaemia or elevated troponin levels than those without syncope. They also were more likely to receive thrombolytics. During the first 90 days, 1097 patients (2.4%) suffered major bleeding (gastrointestinal 335, hematoma 271 and intracranial 163) and 3611 died (158 had fatal bleeding). Patients with syncope had a higher rate of major bleeding (odds ratio [OR]: 1.63; 95% CI: 1.41–1.89) and a nonsignificantly higher rate of fatal bleeding (OR: 1.47; 95% CI: 0.99–2.17) than those without syncope. Multivariable analysis confirmed that patients with syncope were at increased risk for major bleeding (adjusted hazard ratio [aHR]: 1.34; 95% CI: 1.15–1.55). On sensitivity analysis, the increased risk for major bleeding was confirmed in patients initially receiving anticoagulant therapy without thrombolytics at 7 days (aHR: 1.47; 95% CI: 1.13–1.91) and 90 days (aHR: 1.33; 95%CI: 1.13–1.56). Discussion: Syncope is a predictor of major bleeding events in patients with PE, even among those receiving anticoagulation monotherapy.

Original language	English
Article number	e13774
Journal	European Journal of Clinical Investigation
Volume	52
Issue number	7
DOIs	https://doi.org/10.1111/eci.13774
State	Published - Jul 2022

Bibliographical note

Publisher Copyright:
© 2022 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.

Funding

We express our gratitude to Sanofi Spain, LEO PHARMA and ROVI for supporting this Registry with an unrestricted educational grant. We also thank the RIETE Registry Coordinating Center, S&H Medical Science Service, for their quality control data, logistic and administrative support and Prof. Salvador Ortiz, Universidad Autónoma Madrid and Silvia Galindo, both Statistical Advisors in S&H Medical Science Service for the statistical analysis of the data presented in this paper. Coordinator of the RIETE Registry: Manuel Monreal. RIETE Steering Committee Members: Paolo Prandoni, Benjamin Brenner and Dominique Farge-Bancel. RIETE National Coordinators: Raquel Barba (Spain), Pierpaolo Di Micco (Italy), Laurent Bertoletti (France), Sebastian Schellong (Germany), Inna Tzoran (Israel), Abilio Reis (Portugal), Marijan Bosevski (R. Macedonia), Henri Bounameaux (Switzerland), Radovan Malý (Czech Republic), Peter Verhamme (Belgium), Joseph A. Caprini (USA), Hanh My Bui (Vietnam). RIETE Registry Coordinating Center: S & H Medical Science Service.

Funders	Funder number
H Medical Science Service
Hanh My Bui
Henri Bounameaux
Inna Tzoran (Israel), Abilio Reis
Joseph A. Caprini
Marijan Bosevski
Pierpaolo Di Micco
S&H Medical Science Service
Universidad Autónoma Madrid and Silvia Galindo

Keywords

bleeding
outcome
pulmonary embolism
syncope

Access to Document

10.1111/eci.13774

Cite this

@article{329273755c544171bed3e3f5e3df399b,

title = "Major bleeding in patients with pulmonary embolism presenting with syncope",

abstract = "Introduction: Syncope has been shown to be a risk factor of bleeding in patients receiving thrombolytic therapy for acute pulmonary embolism (PE). Whether syncope predicts bleeding in a broader population of patients with PE remains unknown. Methods: We used the RIETE registry data to assess whether initial presentation with syncope could predict bleeding in PE patients receiving anticoagulant therapy, and to explore the association between presence of syncope and timing and site of major bleeding events. Results: Among 45,765 patients with acute PE from March 2001 to January 2021, 6760 (14.8\%) had syncope. Patients with syncope were older and more likely to have hypotension, tachycardia, hypoxaemia or elevated troponin levels than those without syncope. They also were more likely to receive thrombolytics. During the first 90 days, 1097 patients (2.4\%) suffered major bleeding (gastrointestinal 335, hematoma 271 and intracranial 163) and 3611 died (158 had fatal bleeding). Patients with syncope had a higher rate of major bleeding (odds ratio [OR]: 1.63; 95\% CI: 1.41–1.89) and a nonsignificantly higher rate of fatal bleeding (OR: 1.47; 95\% CI: 0.99–2.17) than those without syncope. Multivariable analysis confirmed that patients with syncope were at increased risk for major bleeding (adjusted hazard ratio [aHR]: 1.34; 95\% CI: 1.15–1.55). On sensitivity analysis, the increased risk for major bleeding was confirmed in patients initially receiving anticoagulant therapy without thrombolytics at 7 days (aHR: 1.47; 95\% CI: 1.13–1.91) and 90 days (aHR: 1.33; 95\%CI: 1.13–1.56). Discussion: Syncope is a predictor of major bleeding events in patients with PE, even among those receiving anticoagulation monotherapy.",

keywords = "bleeding, outcome, pulmonary embolism, syncope",

author = "\{The RIETE Investigators\} and Ana Maestre and Escribano, \{Jos{\'e} Carlos\} and Lobo, \{Jos{\'e} Luis\} and Luis Jara-Palomares and David Jim{\'e}nez and Behnood Bikdeli and Fernando Armestar and Alessandra Bura-Riviere and Alicia Lorenzo and Manuel Monreal and Adarraga, \{M. D.\} and P. Agudo and J. Aibar and C. Amado and Arcelus, \{J. I.\} and A. Ballaz and R. Barba and C. Barbagelata and M. Barr{\'o}n and B. Barr{\'o}n-Andr{\'e}s and J. Bascu{\~n}ana and A. Blanco-Molina and \{Beddar Chaib\}, F. and E. Botella and J. Castro and L. Chasco and J. Criado and \{De Ancos\}, C. and \{De Miguel\}, J. and \{Del Toro\}, J. and P. Demelo-Rodr{\'i}guez and D{\'i}az-Brasero, \{A. M.\} and D{\'i}az-Pedroche, \{M. C.\} and D{\'i}az-Peromingo, \{J. A.\} and Dom{\'i}nguez, \{I. M.\} and A. Dubois-Silva and Escribano, \{J. C.\} and Farf{\'a}n-Sedano, \{A. I.\} and C. Fern{\'a}ndez-Capit{\'a}n and Fern{\'a}ndez-Reyes, \{J. L.\} and Fidalgo, \{M. A.\} and C. Font and I. Francisco and C. Gabara and F. Galeano-Valle and Garc{\'i}a, \{M. A.\} and F. Garc{\'i}a-Bragado and \{Garc{\'i}a de Herreros\}, M. and \{Garc{\'i}a de la Garza\}, R. and A. Braester",

note = "Publisher Copyright: {\textcopyright} 2022 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley \& Sons Ltd.",

year = "2022",

month = jul,

doi = "10.1111/eci.13774",

language = "אנגלית",

volume = "52",

journal = "European Journal of Clinical Investigation",

issn = "0014-2972",

publisher = "John Wiley and Sons Inc.",

number = "7",

}

TY - JOUR

T1 - Major bleeding in patients with pulmonary embolism presenting with syncope

AU - The RIETE Investigators

AU - Maestre, Ana

AU - Escribano, José Carlos

AU - Lobo, José Luis

AU - Jara-Palomares, Luis

AU - Jiménez, David

AU - Bikdeli, Behnood

AU - Armestar, Fernando

AU - Bura-Riviere, Alessandra

AU - Lorenzo, Alicia

AU - Monreal, Manuel

AU - Adarraga, M. D.

AU - Agudo, P.

AU - Aibar, J.

AU - Amado, C.

AU - Arcelus, J. I.

AU - Ballaz, A.

AU - Barba, R.

AU - Barbagelata, C.

AU - Barrón, M.

AU - Barrón-Andrés, B.

AU - Bascuñana, J.

AU - Blanco-Molina, A.

AU - Beddar Chaib, F.

AU - Botella, E.

AU - Castro, J.

AU - Chasco, L.

AU - Criado, J.

AU - De Ancos, C.

AU - De Miguel, J.

AU - Del Toro, J.

AU - Demelo-Rodríguez, P.

AU - Díaz-Brasero, A. M.

AU - Díaz-Pedroche, M. C.

AU - Díaz-Peromingo, J. A.

AU - Domínguez, I. M.

AU - Dubois-Silva, A.

AU - Escribano, J. C.

AU - Farfán-Sedano, A. I.

AU - Fernández-Capitán, C.

AU - Fernández-Reyes, J. L.

AU - Fidalgo, M. A.

AU - Font, C.

AU - Francisco, I.

AU - Gabara, C.

AU - Galeano-Valle, F.

AU - García, M. A.

AU - García-Bragado, F.

AU - García de Herreros, M.

AU - García de la Garza, R.

AU - Braester, A.

PY - 2022/7

Y1 - 2022/7

N2 - Introduction: Syncope has been shown to be a risk factor of bleeding in patients receiving thrombolytic therapy for acute pulmonary embolism (PE). Whether syncope predicts bleeding in a broader population of patients with PE remains unknown. Methods: We used the RIETE registry data to assess whether initial presentation with syncope could predict bleeding in PE patients receiving anticoagulant therapy, and to explore the association between presence of syncope and timing and site of major bleeding events. Results: Among 45,765 patients with acute PE from March 2001 to January 2021, 6760 (14.8%) had syncope. Patients with syncope were older and more likely to have hypotension, tachycardia, hypoxaemia or elevated troponin levels than those without syncope. They also were more likely to receive thrombolytics. During the first 90 days, 1097 patients (2.4%) suffered major bleeding (gastrointestinal 335, hematoma 271 and intracranial 163) and 3611 died (158 had fatal bleeding). Patients with syncope had a higher rate of major bleeding (odds ratio [OR]: 1.63; 95% CI: 1.41–1.89) and a nonsignificantly higher rate of fatal bleeding (OR: 1.47; 95% CI: 0.99–2.17) than those without syncope. Multivariable analysis confirmed that patients with syncope were at increased risk for major bleeding (adjusted hazard ratio [aHR]: 1.34; 95% CI: 1.15–1.55). On sensitivity analysis, the increased risk for major bleeding was confirmed in patients initially receiving anticoagulant therapy without thrombolytics at 7 days (aHR: 1.47; 95% CI: 1.13–1.91) and 90 days (aHR: 1.33; 95%CI: 1.13–1.56). Discussion: Syncope is a predictor of major bleeding events in patients with PE, even among those receiving anticoagulation monotherapy.

AB - Introduction: Syncope has been shown to be a risk factor of bleeding in patients receiving thrombolytic therapy for acute pulmonary embolism (PE). Whether syncope predicts bleeding in a broader population of patients with PE remains unknown. Methods: We used the RIETE registry data to assess whether initial presentation with syncope could predict bleeding in PE patients receiving anticoagulant therapy, and to explore the association between presence of syncope and timing and site of major bleeding events. Results: Among 45,765 patients with acute PE from March 2001 to January 2021, 6760 (14.8%) had syncope. Patients with syncope were older and more likely to have hypotension, tachycardia, hypoxaemia or elevated troponin levels than those without syncope. They also were more likely to receive thrombolytics. During the first 90 days, 1097 patients (2.4%) suffered major bleeding (gastrointestinal 335, hematoma 271 and intracranial 163) and 3611 died (158 had fatal bleeding). Patients with syncope had a higher rate of major bleeding (odds ratio [OR]: 1.63; 95% CI: 1.41–1.89) and a nonsignificantly higher rate of fatal bleeding (OR: 1.47; 95% CI: 0.99–2.17) than those without syncope. Multivariable analysis confirmed that patients with syncope were at increased risk for major bleeding (adjusted hazard ratio [aHR]: 1.34; 95% CI: 1.15–1.55). On sensitivity analysis, the increased risk for major bleeding was confirmed in patients initially receiving anticoagulant therapy without thrombolytics at 7 days (aHR: 1.47; 95% CI: 1.13–1.91) and 90 days (aHR: 1.33; 95%CI: 1.13–1.56). Discussion: Syncope is a predictor of major bleeding events in patients with PE, even among those receiving anticoagulation monotherapy.

KW - bleeding

KW - outcome

KW - pulmonary embolism

KW - syncope

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JO - European Journal of Clinical Investigation

JF - European Journal of Clinical Investigation

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ER -

Major bleeding in patients with pulmonary embolism presenting with syncope

Abstract

Bibliographical note

Funding

Keywords

Access to Document

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