OBJECTIVE: Meta-analysis of small, randomized, placebo-controlled trials demonstrated efficacy and safety of aprotinin. After highly publicized retrospective studies and the early stopping of the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART), aprotinin was withdrawn. We conducted a new meta-analysis (including BART) on safety and efficacy of aprotinin in cardiac surgery. METHODS: We conducted a mixed treatment comparisons network meta-analysis estimating the effects of aprotinin and alternative agents in reducing blood loss during surgery. We implemented a combination of direct and indirect evidence in mixed treatment comparisons and estimated relative effects for different agents on all-cause mortality and return to the operating room for bleeding and conducted a supportive analysis of the effects of different agents with only directly randomized trials. RESULTS: Mixed treatment analysis of 88 trials randomizing 15,528 patients to 1 of 3 antifibrinolytic agents demonstrated no difference in mortality between placebo and antifibrinolytic agents. Analysis of aprotinin versus tranexamic acid and ε-aminocaproic acid in 17 and 6 trials, respectively and tranexamic acid versus ε-aminocaproic acid in 5 trials demonstrated no difference in mortality between treatment allocations. All agents were superior to placebo in reducing reexploration for bleeding, with aprotinin numerically superior: aprotinin odds ratio, 2.6 (95% confidence interval, 1.9-3.7); tranexamic acid odds ratio, 1.79 (1.2-2.9), and ε-aminocaproic acid odds ratio, 2.4 (1.3-6.6). CONCLUSIONS: This mixed treatment comparisons meta-analysis demonstrates no increased mortality risk with aprotinin versus other antifibrinolytic agents. All agents were superior to placebo in reducing reexploration for bleeding after adult cardiac surgery.
OBJECTIVE: Meta-analysis of small, randomized, placebo-controlled trials demonstrated efficacy and safety of aprotinin. After highly publicized retrospective studies and the early stopping of the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART), aprotinin was withdrawn. We conducted a new meta-analysis (including BART) on safety and efficacy of aprotinin in cardiac surgery. METHODS: We conducted a mixed treatment comparisons network meta-analysis estimating the effects of aprotinin and alternative agents in reducing blood loss during surgery. We implemented a combination of direct and indirect evidence in mixed treatment comparisons and estimated relative effects for different agents on all-cause mortality and return to the operating room for bleeding and conducted a supportive analysis of the effects of different agents with only directly randomized trials. RESULTS: Mixed treatment analysis of 88 trials randomizing 15,528 patients to 1 of 3 antifibrinolytic agents demonstrated no difference in mortality between placebo and antifibrinolytic agents. Analysis of aprotinin versus tranexamic acid and ε-aminocaproic acid in 17 and 6 trials, respectively and tranexamic acid versus ε-aminocaproic acid in 5 trials demonstrated no difference in mortality between treatment allocations. All agents were superior to placebo in reducing reexploration for bleeding, with aprotinin numerically superior: aprotinin odds ratio, 2.6 (95% confidence interval, 1.9-3.7); tranexamic acid odds ratio, 1.79 (1.2-2.9), and ε-aminocaproic acid odds ratio, 2.4 (1.3-6.6). CONCLUSIONS: This mixed treatment comparisons meta-analysis demonstrates no increased mortality risk with aprotinin versus other antifibrinolytic agents. All agents were superior to placebo in reducing reexploration for bleeding after adult cardiac surgery.
Authors: Pierre Tibi; R Scott McClure; Jiapeng Huang; Robert A Baker; David Fitzgerald; C David Mazer; Marc Stone; Danny Chu; Alfred H Stammers; Tim Dickinson; Linda Shore-Lesserson; Victor Ferraris; Scott Firestone; Kalie Kissoon; Susan Moffatt-Bruce Journal: J Extra Corpor Technol Date: 2021-06
Authors: Umberto Benedetto; Douglas G Altman; Stephen Gerry; Alastair Gray; Belinda Lees; Gianni D Angelini; Marcus Flather; David P Taggart Journal: J Am Heart Assoc Date: 2018-03-03 Impact factor: 5.501
Authors: Aneta Radziwon-Balicka; Cesar Moncada de la Rosa; Barbara Zielnik; Adrian Doroszko; Paul Jurasz Journal: PLoS One Date: 2013-03-15 Impact factor: 3.240