Abstract
Background Improved prediction of the risk of major bleeding in patients with acute pulmonary embolism (PE) receiving systemic thrombolysis is crucial to guide the choice of therapy.
Methods The study included consecutive patients with acute PE who received systemic thrombolysis in the RIETE registry. We used multivariable logistic regression analysis to create a risk score to predict 30-day major bleeding episodes. We externally validated the risk score in patients from the COMMAND VTE registry. In addition, we compared the newly created risk score against the Kuijer and RIETE scores.
Results Multivariable logistic regression identified four predictors for major bleeding: recent major bleeding (3 points), age >75 years (1 point), active cancer (1 point) and syncope (1 point) (BACS). Among 1172 patients receiving thrombolytic therapy in RIETE, 446 (38%) were classified as having low risk (none of the variables present, 0 points) of major bleeding according to the BACS score, and the overall 30-day major bleeding rate of this group was 2.9% (95% CI 1.6–4.9%), compared with 44% (95% CI 14–79%) in the high-risk group (>3 points). In the validation cohort, 51% (149 out of 290) of patients were classified as having low risk, and the overall 30-day major bleeding rate of this group was 1.3%. In RIETE, the 30-day major bleeding event rates in the Kuijer and RIETE low-risk strata were 5.3% and 4.4%, respectively.
Conclusions The BACS score is an easily applicable aid for prediction of the risk of major bleeding in the population of PE patients who receive systemic thrombolysis.
Abstract
The BACS score, based on easily available patient characteristics, could support physicians in their assessment of the risk of bleeding with systemic thrombolysis for acute pulmonary embolism https://bit.ly/3eVd0SH
Footnotes
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 (Republic of 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. Members of the RIETE Group: Spain: M.D. Adarraga, M. Agud, J. Aibar, M.A. Aibar, J. Alfonso, C. Amado, J.I. Arcelus, A. Ballaz, R. Barba, C. Barbagelata, M. Barrón, B. Barrón-Andrés, A. Blanco-Molina, A.M. Camon, I. Cañas, J. Castro, P. Cerdà, J. Criado, C. de Ancos, J. de Miguel, J. del Toro, P. Demelo-Rodríguez, J.A. Díaz-Peromingo, J. Díez-Sierra, I.M. Domínguez, J.C. Escribano, C. Falgá, A.I. Farfán, C. Fernández-Capitán, J.L. Fernández-Reyes, K. Fernández de Roitegui, M.A. Fidalgo, K. Flores, C. Font, L. Font, I. Francisco, C. Gabara, F. Galeano-Valle, M.A. García, F. García-Bragado, M.M. García-Mullor, O. Gavín-Blanco, O. Gavín-Sebastián, M.C. Gayol, A. Gil-Díaz, C. Gómez-Cuervo, J. González-Martínez, E. Grau, L. Guirado, J. Gutiérrez, L. Hernández-Blasco, M. Iglesias, L. Jara-Palomares, M.J. Jaras, D. Jiménez, M.D. Joya, I. Jou, B. Lacruz, A. Lalueza, R. Lecumberri, J. Lima, J.L. Lobo, H. López-Brull, L. López-Jiménez, P. López-Miguel, J.J. López-Núñez, R. López-Reyes, J.B. López-Sáez, M.A. Lorente, A. Lorenzo, M. Loring, O. Madridano, A. Maestre, P.J. Marchena, M. Martín del Pozo, J.M. Martín-Guerra, F. Martín-Martos, C. Mella, M. Mellado, M.I. Mercado, J. Moisés, M. Monreal, M.V. Morales, A. Muñoz-Blanco, D. Muñoz-Guglielmetti, J.A. Nieto, M.J. Núñez, M.C. Olivares, M.D. Ortega-Recio, J. Osorio, S. Otalora, R. Otero, D. Paredes, P. Parra, V. Parra, J.M. Pedrajas, G. Pellejero, D. Pesántez, J.A. Porras, J. Portillo, L. Reig, A. Riera-Mestre, A. Rivas, A. Rodríguez-Cobo, C. Rodríguez-Matute, V. Rosa, C.M. Rubio, P. Ruiz-Artacho, N. Ruiz-Giménez, J. Ruiz-Ruiz, P. Ruiz-Sada, J.C. Sahuquillo, G. Salgueiro, A. Sampériz, J.F. Sánchez-Muñoz-Torrero, T. Sancho, R. Sanmartín, S. Soler, S. Suárez, J.M. Suriñach, G. Tiberio, M.I. Torres, C. Tolosa, J. Trujillo-Santos, F. Uresandi, E. Usandizaga, R. Valle, J.R. Vela, G. Vidal, P. Villares, C. Zamora. Argentina: P. Gutiérrez, F.J. Vázquez. Belgium: T. Vanassche, C. Vandenbriele, P. Verhamme. Czech Republic: R. Malý. Ecuador: E. Salgado. France: I. Benzidia, L. Bertoletti, A. Bura-Riviere, B. Crichi, P. Debourdeau, O. Espitia, D. Farge-Bancel, H. Helfer, I. Mahé, F. Moustafa, G. Poenou. Germany: S. Schellong. Israel: A. Braester, B. Brenner, I. Tzoran. Italy: M. Amitrano, F. Bilora, C. Bortoluzzi, B. Brandolin, E. Bucherini, M. Ciammaichella, D. Colaizzo, F. Dentali, P. Di Micco, E. Giammarino, E. Grandone, R. Maida, S. Mangiacapra, D. Mastroiacovo, F. Pace, R. Pesavento, P. Prandoni, R. Quintavalla, A. Rocci, C. Siniscalchi, A. Tufano, A. Visonà, N. Vo Hong, B. Zalunardo. Latvia: V. Gibietis, D. Kigitovica, A. Skride. Portugal: M. Ferreira, S. Fonseca, F. Martins, J. Meireles. Republic of Macedonia: M. Bosevski, M. Zdraveska. Switzerland: H. Bounameaux, L. Mazzolai. USA: B. Bikdeli, J.A. Caprini, A.J. Tafur, I. Weinberg, H. Wilkins. Vietnam: H.M. Bui.
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Author contributions: Study concept and design: L. Jara-Palomares, D. Jiménez, B. Bikdeli, M. Monreal. Acquisition of data; analysis and interpretation of data; statistical analysis: L. Jara-Palomares, D. Jiménez, B. Bikdeli, A. Muriel, P. Rali, Y. Yamashita, T. Morimoto, T. Kimura, R. Le Mao, A. Riera-Mestre, A. Maestre, F. Moustafa, M. Monreal. Drafting of the manuscript: L. Jara-Palomares, D. Jiménez, B. Bikdeli, M. Monreal. Critical revision of the manuscript for important intellectual content: L. Jara-Palomares, D. Jiménez, B. Bikdeli, A. Muriel, P. Rali, Y. Yamashita, T. Morimoto, T. Kimura, R. Le Mao, A. Riera-Mestre, A. Maestre, F. Moustafa, M. Monreal. Study supervision: D. Jiménez, M. Monreal. All authors had full access to the data and take responsibility for the integrity of the data and accuracy of the analysis. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. D. Jiménez is guarantor.
Conflict of interest: L. Jara-Palomares has nothing to disclose.
Conflict of interest: D. Jiménez has nothing to disclose.
Conflict of interest: B. Bikdeli has nothing to disclose.
Conflict of interest: A. Muriel has nothing to disclose.
Conflict of interest: P. Rali has nothing to disclose.
Conflict of interest: Y. Yamashita has nothing to disclose.
Conflict of interest: T. Morimoto has nothing to disclose.
Conflict of interest: T. Kimura has nothing to disclose.
Conflict of interest: R. Le Mao has nothing to disclose.
Conflict of interest: A. Riera-Mestre has nothing to disclose.
Conflict of interest: A. Maestre has nothing to disclose.
Conflict of interest: F. Moustafa has nothing to disclose.
Conflict of interest: M. Monreal has nothing to disclose.
Support statement: This work was supported by Sanofi España. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received May 6, 2020.
- Accepted June 27, 2020.
- Copyright ©ERS 2020