Risk assessment of thromboembolic events in hospitalized cancer patients

Abstract Hospitalized cancer patients are at increased risk for Thromboembolic Events (TEs). As untailored thromboprophylaxis is associated with hemorrhagic complications, the definition of a risk-assessment model (RAM) in this population is needed. INDICATE was a prospective observational study enr...

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Autores principales:	Federico Nichetti, Francesca Ligorio, Giulia Montelatici, Luca Porcu, Emma Zattarin, Leonardo Provenzano, Andrea Franza, Luca Lalli, Filippo de Braud, Marco Platania
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/9995703f54ba4beaa82758302c0bb1ca
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spelling	oai:doaj.org-article:9995703f54ba4beaa82758302c0bb1ca2021-12-02T17:24:02ZRisk assessment of thromboembolic events in hospitalized cancer patients10.1038/s41598-021-97659-92045-2322https://doaj.org/article/9995703f54ba4beaa82758302c0bb1ca2021-09-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-97659-9https://doaj.org/toc/2045-2322Abstract Hospitalized cancer patients are at increased risk for Thromboembolic Events (TEs). As untailored thromboprophylaxis is associated with hemorrhagic complications, the definition of a risk-assessment model (RAM) in this population is needed. INDICATE was a prospective observational study enrolling hospitalized cancer patients, with the primary objective of assessing the Negative Predictive Value (NPV) for TEs during hospitalization and within 45 days from discharge of low-grade Khorana Score (KS = 0). Secondary objectives were to assess KS Positive Predictive Value (PPV), the impact of TEs on survival and the development of a new RAM. Assuming 7% of TEs in KS = 0 patients as unsatisfactory percentage and 3% of as satisfactory, 149 patients were needed to detect the favorable NPV with one-sided α = 0.10 and power = 0.80. Stepwise logistic regression was adopted to identify variables included in a new RAM. Among 535 enrolled patients, 153 (28.6%) had a KS = 0. The primary study objective was met: 29 (5.4%) TEs were diagnosed, with 7 (4.6%) cases in the KS = 0 group (NPV = 95.4%, 95% CI 90.8–98.1%; one-sided p = 0.084). However, the PPV was low (5.7%, 95% CI 1.9–12.8%); a new RAM based on albumin (OR 0.34, p = 0.003), log(LDH) (OR 1.89, p = 0.023) and presence of vascular compression (OR 5.32, p < 0.001) was developed and internally validated. Also, TEs were associated with poorer OS (median, 5.7 vs 24.8 months, p < 0.001). INDICATE showed that the KS has a good NPV but poor PPV for TEs in hospitalized cancer patients. A new RAM was developed, and deserves further assessment in external cohorts.Federico NichettiFrancesca LigorioGiulia MontelaticiLuca PorcuEmma ZattarinLeonardo ProvenzanoAndrea FranzaLuca LalliFilippo de BraudMarco PlataniaNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Federico Nichetti Francesca Ligorio Giulia Montelatici Luca Porcu Emma Zattarin Leonardo Provenzano Andrea Franza Luca Lalli Filippo de Braud Marco Platania Risk assessment of thromboembolic events in hospitalized cancer patients
description	Abstract Hospitalized cancer patients are at increased risk for Thromboembolic Events (TEs). As untailored thromboprophylaxis is associated with hemorrhagic complications, the definition of a risk-assessment model (RAM) in this population is needed. INDICATE was a prospective observational study enrolling hospitalized cancer patients, with the primary objective of assessing the Negative Predictive Value (NPV) for TEs during hospitalization and within 45 days from discharge of low-grade Khorana Score (KS = 0). Secondary objectives were to assess KS Positive Predictive Value (PPV), the impact of TEs on survival and the development of a new RAM. Assuming 7% of TEs in KS = 0 patients as unsatisfactory percentage and 3% of as satisfactory, 149 patients were needed to detect the favorable NPV with one-sided α = 0.10 and power = 0.80. Stepwise logistic regression was adopted to identify variables included in a new RAM. Among 535 enrolled patients, 153 (28.6%) had a KS = 0. The primary study objective was met: 29 (5.4%) TEs were diagnosed, with 7 (4.6%) cases in the KS = 0 group (NPV = 95.4%, 95% CI 90.8–98.1%; one-sided p = 0.084). However, the PPV was low (5.7%, 95% CI 1.9–12.8%); a new RAM based on albumin (OR 0.34, p = 0.003), log(LDH) (OR 1.89, p = 0.023) and presence of vascular compression (OR 5.32, p < 0.001) was developed and internally validated. Also, TEs were associated with poorer OS (median, 5.7 vs 24.8 months, p < 0.001). INDICATE showed that the KS has a good NPV but poor PPV for TEs in hospitalized cancer patients. A new RAM was developed, and deserves further assessment in external cohorts.
format	article
author	Federico Nichetti Francesca Ligorio Giulia Montelatici Luca Porcu Emma Zattarin Leonardo Provenzano Andrea Franza Luca Lalli Filippo de Braud Marco Platania
author_facet	Federico Nichetti Francesca Ligorio Giulia Montelatici Luca Porcu Emma Zattarin Leonardo Provenzano Andrea Franza Luca Lalli Filippo de Braud Marco Platania
author_sort	Federico Nichetti
title	Risk assessment of thromboembolic events in hospitalized cancer patients
title_short	Risk assessment of thromboembolic events in hospitalized cancer patients
title_full	Risk assessment of thromboembolic events in hospitalized cancer patients
title_fullStr	Risk assessment of thromboembolic events in hospitalized cancer patients
title_full_unstemmed	Risk assessment of thromboembolic events in hospitalized cancer patients
title_sort	risk assessment of thromboembolic events in hospitalized cancer patients
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/9995703f54ba4beaa82758302c0bb1ca
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Risk assessment of thromboembolic events in hospitalized cancer patients

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