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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 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.

SUBMITTER: Kilo R

PROVIDER: S-EPMC8290002 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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

Kilo Roubi R Laporte Silvy S Arab Rama R Mainbourg Sabine S Provencher Steeve S Grenet Guillaume G Bertoletti Laurent L Villeneuve Laurent L Cucherat Michel M Lega Jean-Christophe JC

Scientific reports 20210719 1

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 calc ...[more]

PMID: 34282198

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Dataset Information

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

Publications

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

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