Meta-regression of randomized control trials with antithrombotics: weak correlation between net clinical benefit and all cause-mortality

Abstract This study aimed to explore the validity of the use of the net clinical benefit (NCB), i.e. the sum of major bleeding and thrombotic events, as a potential surrogate for all-cause mortality in clinical trials assessing antithrombotics. Published randomized controlled trials testing anticoag...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Roubi Kilo, Silvy Laporte, Rama Arab, Sabine Mainbourg, Steeve Provencher, Guillaume Grenet, Laurent Bertoletti, Laurent Villeneuve, Michel Cucherat, Jean-Christophe Lega, META-EMBOL Group
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/6ede1d7ffd7e45c089cbac448dc01abd
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:6ede1d7ffd7e45c089cbac448dc01abd
record_format	dspace
spelling	oai:doaj.org-article:6ede1d7ffd7e45c089cbac448dc01abd2021-12-02T16:17:21ZMeta-regression of randomized control trials with antithrombotics: weak correlation between net clinical benefit and all cause-mortality10.1038/s41598-021-94160-12045-2322https://doaj.org/article/6ede1d7ffd7e45c089cbac448dc01abd2021-07-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-94160-1https://doaj.org/toc/2045-2322Abstract This study aimed to explore the validity of the use of the net clinical benefit (NCB), i.e. the sum of major bleeding and thrombotic events, as a potential surrogate for all-cause mortality in clinical trials assessing antithrombotics. Published randomized controlled trials testing anticoagulants in the prevention or treatment of venous thromboembolism (VTE) and non-valvular atrial fibrillation (NVAF) were systematically reviewed. The validity of NCB as a surrogate endpoint was estimated by calculating the strength of correlation of determination (R2) and its 95% confidence interval (CI) between the relative risks of NCB and all-cause mortality. Amongst the 125 trials retrieved, the highest R2 trial values were estimated for NVAF (R2 trial = 0.41, 95% CI [0.03; 0.48]), and acute VTE (R2 trial = 0.30, 95% CI [0.04; 0.84]). Conversely, the NCB did not correlate with all-cause mortality in prevention studies with medical (R2 trial = 0.12, 95% CI [0.00; 0.36]), surgical (R2 trial = 0.05, 95% CI [0.00; 0.23]), and cancer patients (R2 trial = 0.006, 95% CI [0.00; 1.00]). A weak correlation between NCB and all cause-mortality was found in NVAF and acute VTE, whereas no correlation was observed in clinical situations where the mortality rate was low. Consequently, NCB should not be considered a surrogate outcome for all cause-mortality in anticoagulation trials.Roubi KiloSilvy LaporteRama ArabSabine MainbourgSteeve ProvencherGuillaume GrenetLaurent BertolettiLaurent VilleneuveMichel CucheratJean-Christophe LegaMETA-EMBOL GroupNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-15 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Roubi Kilo Silvy Laporte Rama Arab Sabine Mainbourg Steeve Provencher Guillaume Grenet Laurent Bertoletti Laurent Villeneuve Michel Cucherat Jean-Christophe Lega META-EMBOL Group Meta-regression of randomized control trials with antithrombotics: weak correlation between net clinical benefit and all cause-mortality
description	Abstract This study aimed to explore the validity of the use of the net clinical benefit (NCB), i.e. the sum of major bleeding and thrombotic events, as a potential surrogate for all-cause mortality in clinical trials assessing antithrombotics. Published randomized controlled trials testing anticoagulants in the prevention or treatment of venous thromboembolism (VTE) and non-valvular atrial fibrillation (NVAF) were systematically reviewed. The validity of NCB as a surrogate endpoint was estimated by calculating the strength of correlation of determination (R2) and its 95% confidence interval (CI) between the relative risks of NCB and all-cause mortality. Amongst the 125 trials retrieved, the highest R2 trial values were estimated for NVAF (R2 trial = 0.41, 95% CI [0.03; 0.48]), and acute VTE (R2 trial = 0.30, 95% CI [0.04; 0.84]). Conversely, the NCB did not correlate with all-cause mortality in prevention studies with medical (R2 trial = 0.12, 95% CI [0.00; 0.36]), surgical (R2 trial = 0.05, 95% CI [0.00; 0.23]), and cancer patients (R2 trial = 0.006, 95% CI [0.00; 1.00]). A weak correlation between NCB and all cause-mortality was found in NVAF and acute VTE, whereas no correlation was observed in clinical situations where the mortality rate was low. Consequently, NCB should not be considered a surrogate outcome for all cause-mortality in anticoagulation trials.
format	article
author	Roubi Kilo Silvy Laporte Rama Arab Sabine Mainbourg Steeve Provencher Guillaume Grenet Laurent Bertoletti Laurent Villeneuve Michel Cucherat Jean-Christophe Lega META-EMBOL Group
author_facet	Roubi Kilo Silvy Laporte Rama Arab Sabine Mainbourg Steeve Provencher Guillaume Grenet Laurent Bertoletti Laurent Villeneuve Michel Cucherat Jean-Christophe Lega META-EMBOL Group
author_sort	Roubi Kilo
title	Meta-regression of randomized control trials with antithrombotics: weak correlation between net clinical benefit and all cause-mortality
title_short	Meta-regression of randomized control trials with antithrombotics: weak correlation between net clinical benefit and all cause-mortality
title_full	Meta-regression of randomized control trials with antithrombotics: weak correlation between net clinical benefit and all cause-mortality
title_fullStr	Meta-regression of randomized control trials with antithrombotics: weak correlation between net clinical benefit and all cause-mortality
title_full_unstemmed	Meta-regression of randomized control trials with antithrombotics: weak correlation between net clinical benefit and all cause-mortality
title_sort	meta-regression of randomized control trials with antithrombotics: weak correlation between net clinical benefit and all cause-mortality
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/6ede1d7ffd7e45c089cbac448dc01abd
work_keys_str_mv	AT roubikilo metaregressionofrandomizedcontroltrialswithantithromboticsweakcorrelationbetweennetclinicalbenefitandallcausemortality AT silvylaporte metaregressionofrandomizedcontroltrialswithantithromboticsweakcorrelationbetweennetclinicalbenefitandallcausemortality AT ramaarab metaregressionofrandomizedcontroltrialswithantithromboticsweakcorrelationbetweennetclinicalbenefitandallcausemortality AT sabinemainbourg metaregressionofrandomizedcontroltrialswithantithromboticsweakcorrelationbetweennetclinicalbenefitandallcausemortality AT steeveprovencher metaregressionofrandomizedcontroltrialswithantithromboticsweakcorrelationbetweennetclinicalbenefitandallcausemortality AT guillaumegrenet metaregressionofrandomizedcontroltrialswithantithromboticsweakcorrelationbetweennetclinicalbenefitandallcausemortality AT laurentbertoletti metaregressionofrandomizedcontroltrialswithantithromboticsweakcorrelationbetweennetclinicalbenefitandallcausemortality AT laurentvilleneuve metaregressionofrandomizedcontroltrialswithantithromboticsweakcorrelationbetweennetclinicalbenefitandallcausemortality AT michelcucherat metaregressionofrandomizedcontroltrialswithantithromboticsweakcorrelationbetweennetclinicalbenefitandallcausemortality AT jeanchristophelega metaregressionofrandomizedcontroltrialswithantithromboticsweakcorrelationbetweennetclinicalbenefitandallcausemortality AT metaembolgroup metaregressionofrandomizedcontroltrialswithantithromboticsweakcorrelationbetweennetclinicalbenefitandallcausemortality
_version_	1718384236341231616

Meta-regression of randomized control trials with antithrombotics: weak correlation between net clinical benefit and all cause-mortality

Ejemplares similares